ProKidney is a healthcare technology company specializing in developing innovative solutions for kidney disease management. With a commitment to revolutionizing renal care, ProKidney leverages cutting-edge technology and medical expertise to provide advanced tools and services that enhance patient outcomes and streamline healthcare processes in the field of nephrology.

ASAT Scientist

Senior Analyst, QC

Manager, MS&T

Manager, Training Manufacturing

Sr. Manager, Microbiology

Position Summary:The Scientist, Analytical Science and Technology (ASAT) role is responsible for executing analytical strategies/testing to support late-stage product development, method lifecycle management, and technology transfer for biologics and cell/gene therapy products. The primary location for this role is Morrisville location; however, this role will require travel to the Winston Salem location for the meetings, troubleshooting methods, and method validation activities. Responsibilities: Perform laboratory bench work with focus on executing scientific experimentation for analytical method development, regent development, improvement and troubleshooting analytical methods. Perform experiments as needed to generate data for validations and other projects Perform data processing, evaluation and interpretation of experimental data, drawing conclusions based on the results.&nbsp; Perform analytical testing of finished products and development samples.&nbsp; Participate in analytical activities including method development, validation, and various analytical studies.&nbsp; Assist in maintaining and updating all required SOP’s, test methods, protocols and reports. Present data at team and cross functional level on the current projects. Maintain current knowledge in the field of expertise and develop subject matter expertise with analytical technology. Perform overall lab support functions including routine maintenance of analytical instruments, ordering and maintaining inventory of sample, reagents and lab supplies.&nbsp; The primary location for this role is Morrisville location; however this role will require travel to the Winston Salem location for the meetings, troubleshooting methods, and method validation activities. &nbsp;Qualifications: &nbsp; BS in Biochemistry or Biology science or relevant scientific field with a minimum of 5 years of relevant industry/academic experience in a laboratory environment. Prior working experience with multi-color flow cytometry, ELISA assays, and cell culture-based assays Experience in authoring test methods supporting Quality Control operations. Prior experience with conducting method development, and /or method validation is required. Experience in Gene and/or Cell therapy is desirable. Experience of using JMP or similar statistical tools is a plus Working knowledge and experience with good documentation practices in cGMP settings is a plus. Knowledge of ICH Quality Guidelines related to analytical method development and validation is desirable. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Scientist, Analytical Science and Technology

Position Summary: Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates. Is knowledgeable and complies with all pertinent safety policies, rules and regulations. Ensure that all team members comply with safety rules and regulations. The Technical Investigator is responsible for the initiation, investigation and completion of process deviations, Change Controls, and CAPA’s for the assigned department. The incumbent is responsible for completion of process deviations with the aim at identification of root cause, determining any product quality impact and implementation of corrective actions to prevent recurrence. They will also be responsible for drafting and managing Departmental Change Controls. *This is a contract position and will not include ProKidney benefits* Responsibilities: Technical writing for the educated reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product. Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report. Gathering Data from various sources across the site, performance of Root Cause Analysis to determine the most likely cause of the deviation investigation, assessment of event for impact to Safety, Identity, Strength, Quality, Purity, perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing. Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner. Work with the appropriate department(s) for data gathering, observing processes for investigations, and performance of associate interviews. Meeting Facilitation and participation, aligning internal team and area subject matter experts on an agreed investigational path forward. Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objective. Understand Regulatory requirements around Cell Therapy processing. Able to lead and track Change controls through the process ensuring timely completion. Perform other duties as assigned. Qualifications: Undergraduate degree in science discipline 5+ years’ experience in a Cell Therapy environment in the department hired. Strong organizational skills and record keeping with the ability to work overtime when needed. Ability to engage and interview co-workers to obtain relevant information pertaining to investigations. Strong attention to detail and organizational skills. Strong communication skills (written and oral). Independent and self-motivated. Familiarity with cGMP quality systems. Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records). Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint). ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Investigator, Mfg Compliance (Contract)

Position Summary:Join us in developing pioneering therapies that aim to transform the treatment of Chronic Kidney Disease (CKD) and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells, potentially preventing or delaying the need for dialysis or transplant. The Environmental Monitoring (EM) Analyst supports ProKidney’s Environmental Monitoring Program by performing routine and critical monitoring activities to maintain a cGMP-compliant facility. This role involves working closely with manufacturing operations, collecting environmental and utility samples, and ensuring timely documentation and reporting. Essential Duties &amp; Responsibilities: Perform routine Environmental Monitoring (EM) of GMP-controlled areas Conduct Personnel Monitoring during Manufacturing Operations Set up and operate EM equipment per established procedures Follow Standard Operating Procedures (SOPs), Work Instructions (WIs), and Protocols Participate in reading, revising, and training on SOPs, WIs, Forms, and Protocols Support QC Micro Analysts with sample receipt from Manufacturing Track and trend EM, Bioburden, Sterility, and Endotoxin data Maintain inventory levels in QC labs and coordinate material requests with the warehouse Perform streaking and isolation of recovered organisms Complete documentation accurately and in a timely manner Other duties as assigned Minimum Qualifications: Education/Training: High School Diploma or greater Experience: 1–3 years of relevant experience; prior work in a GMP facility is highly desirable Knowledge: Basic understanding of GMP regulations and cleanroom behavior Familiarity with microbiology lab practices is a plus Skills: Ability to read and follow schedules and instructions Strong organizational skills and attention to detail Ability to work independently and in a team environment Comfortable with compliance-driven work and documentation Proficient in Microsoft Office (Excel, Word, Visio, etc.) Good hand-eye coordination Ability to lift up to 30 pounds Effective verbal and written communication skills Dependable with a strong work ethic ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

EM Analyst (Contract)

The Cell Therapy Process Development Scientist will play a critical role in the development and optimization of robust and reproducible processes for the manufacturing of ProKidney’s cell therapy product, Rilparencel, which is in phase three clinical trial. The process development scientist will design and execute studies and implementation of cutting-edge technologies for commercial production. You will work in a fast-paced, highly collaborative environment, engaging with various internal teams, external partners, and key stakeholders to ensure the seamless transition of processes from the laboratory to clinical and, eventually, commercial production. This role offers an exciting opportunity to make a direct impact on the development of life-saving therapies while applying your scientific expertise to solve complex challenges in cell therapy. Key Responsibilities Design and execute studies to develop and optimize cell therapy manufacturing processes, including cell expansion, selection, purification, formulation, and cryopreservation. Analyze and interpret experiment results. Write and review study reports. Design and implement process improvements that reduce cost, improve efficiency, and enhance product quality, while maintaining compliance with regulatory requirements. Work closely with Manufacturing teams to ensure smooth technology transfer and the successful execution of GMP manufacturing runs, ensuring process robustness and troubleshooting any issues that arise. Perform process risk assessment using tools including FMEA. Design and execute experimental plans to characterize and validate critical process parameters (CPPs) of cell therapy products. Participate in project teams and contribute technical expertise to support the transition from pre-clinical to clinical and commercial manufacturing. Stay current with the latest trends, technologies, and regulatory developments in the cell therapy field. Contribute to scientific publications, presentations, and internal knowledge sharing. Qualifications Degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Cell Biology, Bioengineering, or a related discipline. PhD with 2+ years experience, MS with 8+ years experience, or BS with 12+ years experience in bioprocess or cell therapy process development. Extensive hands-on experience with cell expansion, cell selection and cell purification. Proven track record of contributing to successful technology transfer of manufacturing processes. Experience in QbD and process characterization including the use of DoE (Design of Experiments) and statistical analysis. Knowledge of analytical methods such as flow cytometry, PCR, ELISA, cell counting, and other assays for cell therapy characterization. Excellent problem-solving skills and the ability to troubleshoot complex process-related challenges. Strong communication skills, with the ability to articulate complex technical information to both technical and non-technical stakeholders. Self-motivated, detail-oriented, and able to manage multiple priorities effectively in a fast-paced, dynamic environment. Strong interpersonal skills and the ability to work collaboratively in a cross-functional, multidisciplinary team. Preferred Qualifications Experience in preparing regulatory filings. Familiarity with data analysis software (e.g., JMP). Experience in GMP regulations. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

PD Research Scientist

Position Summary:The role of MSAT Senior Engineer will provide technical leadership for cell therapy manufacturing operations, ensuring processes are robust, scalable, and compliant with GMP standards. The Senior MSAT Engineer will play a critical role in technology transfer, process improvement, facility start-up, and regulatory readiness, supporting both clinical and commercial production. Essential Duties &amp; Responsibilities: Project &amp; Facility Support Lead or support projects to improve process robustness, scalability, and GMP compliance. Contributes to the construction, qualification, and start-up of new commercial manufacturing facilities. Author, review, and approve technical documentation including project plans, test protocols, reports, and SOPs. Technical Process Support Serve as the MSAT point-of-contact for development, manufacturing, supply chain, QC, QA, and vendor projects. Provide hands-on technical support for cell processing operations, including troubleshooting and optimization. Lead investigations for process deviations, perform root cause analyses, and implement corrective/preventive actions (CAPAs). Data &amp; Compliance Analyze process and project data, presenting clear findings and recommendations to stakeholders. Ensure compliance with cGMP, safety standards, and company SOPs. Support regulatory submissions by preparing technical documentation and data summaries. Act as a subject matter expert (SME) during inspections and audits. Risk &amp; Material Management Identify risks in manufacturing processes and implement mitigation strategies. Assess and qualify raw materials, ensuring suitability, reliability, and supply chain continuity. Qualifications: Bachelor’s or master’s degree in chemical engineering, Biochemical engineering, Biotechnology, or related discipline 8+ years with a Bachelor’s or 6+ years with a Master’s in MSAT, cell therapy, or biopharmaceutical manufacturing. Proven leadership in GMP project implementation, technology transfer, and process troubleshooting. Experience with process validation and lifecycle management preferred Strong understanding of cell therapy or biopharmaceutical processes, including aseptic processing, cell expansion, and purification. Familiarity with GMP, GLP, and regulatory requirements for cell-based therapies. Experience supporting regulatory submissions and audits. Experience handling human-derived materials in cleanroom environments. Familiarity with MES or ERP systems. Knowledge of ICH guidelines (Q8, Q9, Q10) and Quality by Design (QbD) principles. Excellent problem-solving, analytical, and critical-thinking abilities. Strong communication and technical writing skills (SOPs, batch records, reports). Ability to work effectively in cross-functional, fast-paced environments. Flexibility to occasionally support weekend manufacturing operations. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

MSAT Sr. Engineer

Position Summary: We are seeking a dynamic and highly motivated Scientist/Senior Scientist, Clinical Development to be an essential contributor to the scientiﬁc, clinical, and operational scope of the clinical development program with an emphasis on program-speciﬁc activities. This position in Clinical Development is responsible for providing scientiﬁc input during protocol development/amendments, oversight of clinical aspects of study conduct, and interpretation of study results through the ﬁnal study report. This role will work on cross-functional program development and study management teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication to both internal and external stakeholders. The successful candidate will be highly collaborative and motivated, with excellent knowledge of late-phase clinical trials, preferably with experience in kidney disease or cardio-renal-metabolic syndrome, and/or cell therapy. The candidate must also possess excellent communication, and organizational skills, be solution-oriented, exhibit high attention to detail and quality, and have strong initiative and execution to timelines. *This is a contract position and will not be eligible for ProKidney benefits* This position is expected to work 20-30 hours/week. Responsibilities: Co-leads the cross-functional study team to execute on the clinical development strategy Protocol and ICF development processes with minimal guidance; including writing, reviewing, resolution of cross functional comments and ensuring high clinical quality. Woks in partnership with Clinical Operations and collaborates with cross-functional study team members (e.g., Regulatory Aﬀairs, Safety, Data Management). Maintain a thorough understanding of assigned protocols and protocol requirements Supports the coordination of relevant and timely data analyses and presentations in collaboration with safety, data management, biometrics, and other relevant teams to meet timelines Act as recognized scientific expert for assigned programs. Draft/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, regulatory responses) Support safety evaluations and processes related to the program. Support labelling, distribution, and operational activities for clinical study, as needed. Qualifications: MD and/or PhD from an accredited institution with proven clinical/academic Board eligibility or certification in medical subspecialty preferred. At least 5 years of clinical development experience at a pharmaceutical, CRO or biotechnology company with experience in nephrology, cardio-metabolism or cell therapy Late-stage drug development experience preferred. BLA experience is a plus. Excellent knowledge of current Good Clinical Practices (GCP), research ethics and guidance in the pharmaceutical Proﬁcient knowledge of drug development process, study design, statistics, clinical operations. Reasonable experience with clinical evaluation projects including development of protocols, case report forms, informed consent and study initiation and monitoring preferred. Excellent written communication, oral communication, and presentation skills are required. Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy. Proﬁcient knowledge and skills to support program speciﬁc data review, trend identiﬁcation, data interpretation. Ability to share scientiﬁc data eﬀectively across functions and through presentations. Demonstrated ability to think analytically and strategically, work independently and solve&nbsp;problems. Skilled at prioritizing tasks to deliver on deadlines in a highly collaborative and collegial work style. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Sr. Scientist, Clinical Development Contractor (Part-Time)

Responsibilities: Supervision:&nbsp; Provides direct guidance, supervision, and task assignments to manufacturing personnel, maintaining a physical presence on the floor during all critical process steps.&nbsp; Coach, develop, and train direct reports to enhance their abilities and expertise.&nbsp;&nbsp; Responsible for conducting one on one meetings, performance reviews and assisting with career development.&nbsp;&nbsp; Support recruiting, staffing, hiring, onboarding, and performance management of team.&nbsp;&nbsp; Maintain individual training plans and ensure team remains up to date with training readiness.&nbsp;&nbsp; Production Management:&nbsp; Ensure completeness and accuracy of all documentation at the end of every shift.&nbsp;&nbsp; Assist with the managing of the day-to-day operations and scheduling of Manufacturing Personnel.&nbsp; Facilitate the transition of new processes from Product Development to manufacturing.&nbsp; Monitor production processes and adjust schedules as needed.&nbsp; Coordinates the production schedule and coordinates raw material inventory with support of Supply Chain personnel.&nbsp; Performs cGMP manufacturing tasks in an aseptic manner in an aseptic environment.&nbsp; Executes routine transactions with the ERP system, including material requisitions, production tracking, updating work orders and production BOMs, etc.&nbsp;&nbsp; Clearly communicates problems and observations with management from other departments.&nbsp; Quality Assurance, Safety, and Compliance:&nbsp; Reviews and approves Batch Records, Change Controls, Deviations and other manufacturing documentation required for cGMP production operations.&nbsp; Ensures overall cGMP compliance with the department and represents manufacturing during project team meetings or during external audits.&nbsp;&nbsp;&nbsp; Enforce safety protocols and procedures to ensure a safe working environment.&nbsp; Ensure compliance with all relevant regulations and standards. Deliver to Plan: Lead and direct the safety, quality, and daily production operations for suite. Oversee all tasks on the floor as they are carried out and aid with troubleshooting where required. Coordinate with other departments to ensure on time delivery of the production schedule.&nbsp; Monitor and coach staff to ensure full compliance with GMP and Quality system requirements, maintaining inspection readiness and minimal errors. Lead and oversee the on-time completion of document review (batch record, logbook, SOPs) for completeness, clarity, accuracy to support on-time release of batches with minimal errors.&nbsp; Adapts departmental plans and priorities to address resource and operational challenges.&nbsp; Collaborate effectively with Senior Management in a dynamic environment, demonstrating outstanding communication skills.&nbsp;&nbsp; Maintain continuous readiness of the manufacturing facility for production and GMP audits.&nbsp; Administrative tasks – leading shift exchange, assigning duties, attending meetings, sending/receiving emails, and participating in continuous improvement projects. Demonstrate strong technical writing abilities (deviation initiations, SOP creation, etc.).&nbsp; Perform other duties as assigned Qualifications: 4+ years’ experience in manufacturing (6+ years’ experience without AS/BS); GMP setting preferred, previous supervisory experience required.&nbsp; Computer software skills, organization, record keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills&nbsp; Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management regarding serious compliance or quality issues. Must have experience in writing technical documents and protocols.&nbsp; Proven logic and decision-making abilities, critical thinking skills.&nbsp; Aseptic practices and clean room operations&nbsp;&nbsp; Statistical and auditing techniques&nbsp; Environmental control procedures/equipment&nbsp; Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Gene/Viral therapy products focusing on Downstream Operations&nbsp; Strong knowledge of current industry trends and can use the latest technologies.ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Mfg Cell Processing Supervisor

Position Summary:The IT Project Manager will lead and deliver critical technology projects supporting GxP-compliant manufacturing, R&amp;D, and clinical operations. This role will oversee new system implementations, system enhancements, and validation activities for existing systems, ensuring alignment with regulatory requirements and business priorities. The ideal candidate will be adept at managing cross-functional teams, driving timelines, and ensuring successful project outcomes in highly regulated life sciences environments. Responsibilities: Project Leadership – Manage the full lifecycle of IT projects from planning through deployment, including requirements gathering, design, testing, go-live, and post-implementation support. Cross-Functional Collaboration – Lead and motivate cross-functional teams, fostering clear communication and accountability to ensure deliverables are met on time and within scope. Vendor &amp; Stakeholder Management – Coordinate with internal stakeholders and external vendors; hold all parties accountable for timely completion of project tasks and milestones. Requirements Translation – Facilitate business requirements sessions, translate needs into actionable project plans, and manage change requests effectively. Risk &amp; Issue Management – Proactively identify, assess, and mitigate project risks; escalate critical issues promptly with recommended solutions. Progress Tracking &amp; Reporting – Maintain detailed project documentation, track progress against milestones, and provide weekly status reports to leadership. Validation Expertise – Support GxP validation and 21 CFR Part 11 compliance activities, ensuring documentation and testing meet regulatory and quality standards. Meeting &amp; Event Coordination – Organize and facilitate key project events including system demos, document reviews, and testing sessions. Process Expertise – Develop and maintain deep knowledge of IT project management and GxP validation processes to guide teams effectively. Travel &amp; Onsite Support – Be available during core business hours (9:00 am – 5:00 pm EST) and travel to company sites for critical project phases. Qualifications: Bachelor’s degree in Information Technology, Computer Science, Engineering, or related discipline. 2–5 years of IT project management experience, including system implementation in regulated environments. 1–2 years in life sciences (cell therapy experience preferred). Experience in FDA-regulated industries strongly preferred. Proven track record leading GxP system implementations and validation projects (21 CFR Part 11). Strong command of Microsoft Office Suite; Smartsheet experience preferred. Exceptional organizational skills with the ability to manage multiple priorities in fast-paced environments. Strong facilitation and communication skills, capable of working effectively with technical and non-technical audiences. PMP certification a plus, but not required ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

IT Project Manager (Contractor)

Responsibilities: Prepares, edits, reviews, and finalizes regulatory documents and related clinical documents of all complexity levels Provides conceptual contributions to projects; participates and contributes to regulatory and clinical development strategy, as needed Leads cross-functional teams in document preparation, including but not limited to, development of content strategy, coordination of content contributions, development and maintenance of applicable timelines Collaborates with cross-functional team to interpret study results and ensure messaging is consistently reflected across relevant regulatory documents Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations Ensures that medical writing deliverables are compliant with International Conference on Harmonization (ICH) and other relevant regulatory guidelines Create, maintains, and ensure corporate compliance with standard operating procedures and work instructions for applicable clinical regulatory deliverables Proactively identifies and subsequently leads initiatives that improve quality, efficiency, and productivity of medical writing processes and templates Contribute to vendor oversight as needed May serve as functional area representative Participate in interdepartmental activities as deemed necessary Qualifications: Bachelor’s degree +8 years, Master’s Degree +5 years, Doctoral Degree +2 years of relevant medical writing experience in the pharmaceutical industry, especially writing in BLA areas; graduate degree (master’s or doctoral) preferred An understanding of the drug development process Broad experience managing the medical writing responsibilities associated at various stages Experience interacting with cross-functional study team members Must have a thorough knowledge and experience in the application of regulatory and clinical research concepts, practices, medical writing standards , and Health Authority Guidelines across drug development phases Ability to work independently with minimal supervision; possess excellent project management skills; attentive to details Ability to communicate with teams; monitor and communicate progress against milestones; escalate complex issues appropriately. Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate Read, write and speak fluent English; excellent verbal and written communication skills ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Medical Writer (Contractor)

Prokidney is seeking a highly experienced scientific team leader- Director of Cell Therapy Process Development. This is an exciting and highly visible role for a well qualified and motivated professional. &nbsp;The successful candidate will play a critical role in providing scientific and operational leadership to support the development and optimization of a robust commercial manufacturing process for a cell therapy product which is in phase III trial. Utilizing sound scientific principles, the Director will support the development of program strategy and lead activities for manufacturing processes development, identification of critical process parameters, technical transfers, validation, and preparation of regulatory filing documents.&nbsp; A key aspect of the role is building strong collaborations with customers and stakeholders to gather inputs on new processes and provide support to technology transfer and manufacturing. It is important for this leader to develop a diverse and inclusive culture and prioritize career development of team members. Key Responsibilities Direct the development of processes for manufacturing of Prokidney’s cell therapy product. Ensure processes are robust and reproducible. Lead technology transfer activities between development and manufacturing. Spearhead process optimization initiatives to increase productivity, improve yield, and maintain product quality. Implement state-of-the-art techniques in manufacturing. Lead the execution of process validation and qualification studies, ensuring that the final process meets regulatory requirements and quality standards. Develop and implement control strategies for critical process parameters (CPPs), ensuring optimal process performance and product quality. Build and lead a high-performing team of scientists, engineers, and technical experts responsible for process development activities. Foster collaboration across PD, manufacturing, quality, regulatory, and clinical teams to ensure seamless execution. Provide mentorship and career development opportunities for team members. Encourage a culture of continuous learning and innovation while managing team performance. Lead the preparation of technical documentation for regulatory submissions (INDs, BLAs, etc.), ensuring compliance with regulatory requirements and that process development data supports regulatory filings. Identify and assess technical, operational, and regulatory risks associated with process development. Develop and implement risk mitigation strategies to proactively address potential issues. Collaborate with senior leadership to define strategic goals for process development, setting clear milestones, timelines. Align departmental objectives with broader organizational goals and prioritize resources accordingly. Establish and monitor key performance indicators (KPIs) to assess process performance and team productivity. Regularly report progress to senior management, providing data-driven insights and recommending corrective actions when necessary. Qualifications PhD in Biochemistry, Chemical Engineering, Biotechnology, or a related field. MS or equivalent with extensive relevant experience may also be considered. A minimum of 12 years of industry experience in bioprocess development, with at least 8 years in a leadership role within a biopharmaceutical company. Cell therapy experience preferred. Extensive experience in cell culture or cell therapy manufacturing. Knowledge of bioprocess modeling, data analysis, and automation. Familiar with process FMEA, QbD, DoE, and statistical analysis tools (JMP). Deep understanding of FDA, EMA, and ICH guidelines for biologics and/or cell therapy development. Experience with IND and BLA submissions. Knowledge of analytical methods (e.g., flow cytometry, ELISA, biological activity or potency of cellular products) to support process development and release testing. Strong project management skills, with experience in managing multiple concurrent projects, resource planning, and budget oversight. Excellent leadership, people management, and team-building skills with the ability to inspire, coach, and lead cross-functional teams in a fast-paced environment. Exceptional verbal and written communication skills, with the ability to present complex technical information to both technical and non-technical stakeholders. Demonstrated ability to apply critical thinking and technical expertise to solve complex process development challenges. Strong ability to work collaboratively across teams, departments, and external partners to achieve common goals. Preferred Qualifications Experience working with cell-based therapeutics or personalized medicine. Familiarity with process control systems, data analytics, and automation tools for process monitoring and optimization. Experience with global regulatory filings, including the preparation of CMC sections of regulatory submissions. Experience in a dynamic, high-growth, or start-up environment, with the ability to drive innovation and process development in the face of evolving challenges. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Director, Process Development

Position Summary: The Facilities Mechanic will be responsible for maintaining and repairing facility systems and equipment, ensuring operational efficiency and compliance with safety and regulatory standards. Responsibilities: Perform advanced maintenance and repairs on HVAC, electrical, plumbing, and environmental systems. Oversee preventive maintenance scheduling and execution. Ensure compliance with cGMP, safety protocols, and industry standards (LOTO, OSHA, NEC). Document maintenance activities in the Work Order system and equipment logbooks. Provide on-call support for facility issues outside of regular hours. Contribute to continuous improvement initiatives to reduce downtime and improve operations. Qualifications: Associate’s or technical degree/certification in Facilities Maintenance or a related field. 3+ years of experience in facilities maintenance with a focus on utility equipment and mechanical systems. Strong knowledge of cGMP, HVAC, electrical, and plumbing systems. Experience with maintenance software systems (e.g., Work Order management). Strong communication skills and problem-solving abilities. Ability to lift up to 50 lbs and use PPE safely. Certifications in HVAC, Electrical, or Mechanical Systems. Experience in regulated industries such as pharmaceuticals or manufacturing. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Facilities Mechanic

Position Summary: The Manager, QC Laboratory Systems Engineer is responsible for supporting laboratory instrumentation and computerized systems within a GMP-regulated environment, with a strong focus on data integrity. This role acts as a subject matter expert (SME) and system administrator for instruments and systems used in QC testing, Analytical and Microbiological Analysis (GMA) instruments. The engineer provides technical oversight, manages qualification activities, and ensures regulatory compliance and data reliability throughout system lifecycles. Responsibilities: Serve as SME and system administrator for QC laboratory instruments and computerized systems, including GMA equipment. Ensure all computerized systems are implemented and maintained in compliance with data integrity principles, GMP regulations, and internal policies. Manage qualification, validation, and periodic review activities for laboratory instruments and computerized systems. Troubleshoot instrumentation/system issues and coordinate resolution with internal teams (IT, Engineering) or external vendors. Author and review documentation including SOPs, user requirements, system specifications, and validation protocols. Collaborate with IT, Validation, and QC personnel on change controls, deviations, investigations, and CAPAs. Serve as key laboratory resource for audit/inspection readiness activities; presenting data integrity and system management processes during regulatory inspections. Lead and participate in risk assessments and continuous improvement initiatives to enhance system reliability and compliance. Provide training to QC staff on the operation and administration of laboratory computerized systems. Maintain current knowledge of regulatory expectations and best practices related to data integrity and computerized system validation. Foster effective working relationships with internal and external stakeholders. Ensure all laboratory activities are conducted in full compliance with cGMP and applicable quality system requirements. Implement and maintain robust data backup and disaster recovery strategies for critical laboratory systems. Contribute to regulatory inspection readiness through proactive compliance and documentation practices. Ensure continued GxP compliance of QC laboratory computer systems and software. Perform additional duties and projects as assigned by management. Qualifications: Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field is required. Master’s degree preferred. Strong understanding of data integrity principles and ALCOA+. Strong understanding of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Minimum 5 years of experience in a GMP-regulated QC laboratory, preferably within the biopharmaceutical industry. Experience managing laboratory systems in a GxP environment. Hands-on experience with instrument qualification, computerized system validation, and administration. Prior experience supporting QC instrumentation. Experience with platforms such as LIMs, MODA, LabX, or equivalent. Experience with regulatory submissions (IND/BLA) and GMP inspections is a plus. Strong verbal and written communication skills. Excellent organizational, planning, and time management abilities. Proficiency in software systems, data analysis, and project coordination. Demonstrated problem-solving and critical thinking skills. Ability to manage multiple priorities and meet deadlines in a dynamic environment. Ability to work effectively across functional teams and manage stakeholder relationships. Demonstrated ability to apply logical reasoning and sound decision-making. Expected to stay informed on evolving regulatory guidance for data integrity and computerized systems compliance ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manager, QC Laboratory Systems Engineer

Position Summary: The Manufacturing Cell Processing Specialist 3 at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and driving continuous improvement. The Manufacturing Specialist 3 is responsible for mentoring team members, leading investigations, and ensuring high levels of quality and compliance. Please note: This is a contract position which will not include ProKidney benefits. Responsibilities: Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards. Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members. Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and preventive maintenance. Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to procedures and maintaining quality standards. Revise, update, and ensure adherence to SOPs, batch records, and MS forms, maintaining GMP compliance. Lead routine cycle counts and ensure accurate inventory tracking and control. Execute transactions within the ERP system, including material requisitions and production tracking. Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP). Lead investigations into deviations and Corrective and Preventative Actions (CAPA) efforts, compiling data and information as required. Provide mentorship and training to junior team members in cell processing techniques, procedures, and cGMP compliance. Drive continuous improvement, incident investigations, and deviation resolutions. Perform and support investigations into deviations, incidents, and process improvements. Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment. Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards. Perform material qualification tests to qualify lots of incoming manufacturing material. Support process development and validation activities as needed. Assist in data collection, analysis, and reporting for process optimization and regulatory submissions. Perform other duties assigned to support and improve manufacturing operations. Qualifications: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may be a substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience. Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 2-3 years of proven expertise in a cGMP-regulated environment. Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills. Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manufacturing Cell Processing Specialist III (Contract)

Position Summary: ProKidney is seeking an experienced Research Associate for our Cell Therapy Process Development team. The ideal candidate will have a strong background in cell therapy or biopharmaceutical development, process optimization, and technology transfer. In this role, you will lead or support the development and improvement of cell therapy manufacturing processes, contributing to the advancement of cutting-edge therapies. This is a great opportunity for individuals who are passionate about making an impact in the evolving field of cell therapy. Responsibilities: Design and execution of experiments to optimize and improve processes for cell therapy manufacturing, including but not limited to media preparation, cell expansion and harvest, and product formulation. Analyze experimental data and present results in a clear and actionable manner to stakeholders. Provide technical expertise in the development and implementation of new techniques and technologies. Support troubleshooting and process improvement initiatives. Work closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure the successful transfer of process into GMP clinical and commercial manufacturing. Support the characterization and validation of cell therapy processes, ensuring compliance with regulatory guidelines and internal standards. Conduct process performance qualification (PPQ) studies and support clinical trial material production. Ensure that all process development activities adhere to GMP and applicable regulatory standards. Support regulatory filings and audits as needed. Preparation and review of technical documentation, including process development reports, batch records, SOPs (Standard Operating Procedures), and change controls. Assist to identify potential risks in process development and manufacturing and implement strategies for mitigation, ensuring the successful advancement of cell therapy programs. Qualifications: Bachelor's or Master's degree in Cell Biology, Biotechnology, Biochemical Engineering, or a related field. 2 plus years of experience in cell therapy and /or biopharmaceutical process development. Ability in execution and troubleshooting experiments, analyzing/ reporting/presenting data. Experience in aseptic techniques is essential. Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects. Strong problem-solving abilities, critical thinking, and the ability to collaborate with cross-functional teams. Strong verbal and written communication skills, including technical writing. Understanding of GMP, GLP, and regulatory requirements for the development of cell-based therapies. Experience with regulatory submissions and support for inspections is a plus. Demonstrated troubleshooting and problem-solving skills. Understanding of basic statistics and working knowledge of statistical software (e.g. JMP). Must be comfortable handling human tissues. There will be occasional weekend work. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

PD Research Associate

Position Summary:The QA Specialist 2 will provide essential Quality Assurance (QA) support to Quality Operations, with a primary focus on material and batch release activities. In a fast-paced pharmaceutical environment, the successful candidate will leverage strong documentation, organizational, and communication skills to ensure compliance with Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGxP) regulations. This role requires a detail-oriented individual with the ability to assess and maintain the quality of materials, products, and processes. Essential Duties &amp; Responsibilities: Maintain GMP Databases: Ensure accurate and consistent tracking, data entry, and follow-up within departmental GMP databases. Review Manufacturing and Analytical Records: Evaluate completed manufacturing, filling, labeling records, and analytical data to ensure conformance with applicable regulations, Standard Operating Procedures (SOPs), specifications, and acceptance criteria. GMP System Procedure Review: Regularly review and update GMP system procedures to ensure alignment with current regulatory standards and company policies. Monitor Production Activities: Perform hands-on monitoring of production and non-production activities, identifying and reporting any observed non-compliance to Quality Management. Product Compliance: Ensure that finished products conform to both government and company standards while meeting cGxP regulations. Batch and Material Release Documentation: Prepare and conduct initial reviews of documentation for the release of acceptable product lots and vendor materials. Deviation Investigation Support: Assist in investigating deviations, identifying root causes, and proposing corrective actions. SOP, Change Control, and Protocol Review: Review and provide input on SOPs, change control documents, and protocols related to cGxP programs as assigned by management. Quality Metrics Reporting: Report key quality metrics and performance indicators as required. Audit Participation: Participate in internal and external audits, including customer and regulatory audits, as directed by Quality Management. Compliance Risk Management: Identify compliance risks, effectively communicate them to senior management, and oversee the implementation of action plans to mitigate risks. Cross-Department Collaboration: Collaborate with internal departments to develop strategies and implement quality principles and regulatory requirements. Escalate Critical Issues: Promptly escalate critical quality issues to senior management for resolution. Stay Current with Industry Trends: Maintain up-to-date knowledge of industry trends, standards, and methodologies related to cGxP and GMP. Support Quality System Implementation: Assist in the implementation and maintenance of regulated Quality Systems. Minimum Qualifications: Associate's Degree + 4 years of relevant experience Bachelor's + 2 years of relevant experience Working knowledge of deviation management and CAPA resolution Familiarity with FDA, EU, and ISO regulatory frameworks (preferred). Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers Must be able to organize and prioritize work effectively to meet timelines with quality deliverables Demonstrates proficiency in managing projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines Proficient with Microsoft Word, Excel, Adobe ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

QA Specialist 2 (Contract)

Position Summary:This on-site Quality Assurance On the Floor (OTF) Specialist 2 reports directly to the Manager, QA Floor Support. This position will be based at our cGMP Manufacturing site and will directly support the CMC clinical manufacturing program.&nbsp; The main responsibility for this position is to provide real-time on the floor quality oversight of all Manufacturing activities, with a focus on adherence to aseptic technique, GMP principles during processing, batch record review, and deviations. Strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with Manufacturing, Quality Control, Validation, Supply Chain and Facility teams. Responsibilities: Provide quality on-the-floor support of manufacturing processes, reviewing batch record documentation, and providing real-time support of manufacturing, issues, changeovers etc. Participate in quality oversight of manufacturing through real-time observations of activities. Provide guidance on GMP principles and aseptic technique during routine operations. Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data. Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise. Perform review of Environmental Monitoring results associated with GMP operations. Support quality decisions that may impact operations, ensuring appropriate escalation. Identify risks and communicate gaps for quality and GMP process/systems. Review and approve facility alarms, facility work order requests, inventory requests, batch record requests, and return-to-service documentation. Supports, reviews and approves Deviations and Change Controls Identify risks and communicate gaps for quality and GMP process/systems. Make quality decisions that may impact operations, ensuring appropriate escalation to management when needed. Partners with manufacturing and support teams to initiate and triage new deviation events, reviews minor and major manufacturing deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Ability to manage multiple assignments and/or projects in a fast-paced environment. Collaborate and lead effectively in a dynamic, cross-functional matrix environment Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations. Participate in quality focused teams across ProKidney’s broad ecosystem of functions. Support internal audits. Collaborate with Manufacturing and Quality Operations to ensure appropriate and rapid disposition of clinical products. Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review. Utilize knowledge to improve operational efficiency. Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems. All other duties as assigned. Qualifications: Bachelor’s degree in applied science. 2+ years’ relevant experience with working in Quality Assurance, ideally within cGMP aseptic manufacturing operations. Preferred experience in cell or gene therapy. Weekend work may be required based on business needs Strong organizational, analytical, and time management skills. Ability to work well in a team environment with a positive attitude that is willing to assist other areas of the organization. Excellent verbal and written communication skills as well as strong focus and attention to detail. Demonstrate ability to handle multiple tasks at one time and maintain a strong attention to detail. Ability to perform frequent physical tasks with strength and mobility. Flexible scheduling required. Any equivalency combination of education, experience, and training may substitute. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

QA Specialist II

Position Summary The Staff Accountant plays a key role in ensuring the financial health and accuracy of the organization. This role provides exposure to multiple areas of accounting, including general ledger, accounts payable, payroll, and financial reporting. The Staff Accountant is responsible for managing the monthly close process for multiple entities, supporting audits, and serving as the primary back-up for Accounts Payable and Payroll functions. This is an excellent opportunity for an accounting professional who thrives in a dynamic environment and enjoys broad exposure across the finance function. ResponsibilitiesGeneral Accounting Perform general ledger activities, including journal entries, intercompany transactions, and account reconciliations for multiple entities. Support the preparation of monthly, quarterly, and annual financial statements. Assist with external and internal audit requests. Participate in process improvement initiatives to drive efficiency and strengthen internal controls. Accounts Payable Process vendor invoices during peak times, ensuring accuracy, compliance, and timely payments. Maintain vendor records and resolve vendor inquiries. Reconcile invoices, purchase orders, and payments to ensure accuracy. In the absence of the AP Lead, process electronic payments and transfers. Review and process employee expense reports via Certify and manual submissions. Manage clinical study site payments and prepare remittance submissions. Prepare monthly credit card accruals and reconcile actual charges. Generate AP-related reports and support audits as needed. Payroll (Back-Up Support) Ensure accurate and timely bi-weekly payroll processing in the absence of the Payroll Manager. Maintain employee payroll records and ensure compliance with federal, state, and local payroll regulations. Support payroll functions including deductions, benefits, and garnishments. Respond to payroll-related employee inquiries and resolve issues promptly. Assist in preparing payroll reports and maintaining accurate documentation. Qualifications ·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Education/Training: Bachelor’s degree in Accounting, Finance, or related field. ·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Experience: 3+ years of general accounting experience. Experience in payroll processing. Experience with Paylocity payroll software preferred. Experience with SAGE X3 ERP system preferred. Prior experience in a multi-faceted role with exposure to multiple accounting functions preferred. Strong knowledge of accounting principles and practices Proficiency in Microsoft Excel and accounting software. Excellent attention to detail, accuracy, and organizational skills. Ability to handle confidential information with integrity. Strong communication and interpersonal skills. · &nbsp; &nbsp; &nbsp; &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Staff Accountant

Responsibilities: Uses SAS to develop programming code to generate summary tables, data listings, graphs, and derived datasets, SDTM and ADaM, as specified in the statistical analysis plan and programming specifications. Creates SDTM and ADaM mapping specifications and, if required, annotation of case report forms (CRFs) to CDISC standards. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follows applicable SOPs, WIs, and relevant regulatory guidelines. Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Adapts to timeline or priority changes. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Performs other tasks as assigned. Qualifications: 10+ years' experience in Pharma, Biotech, or CRO. Preference for Phase 3 and BLA/NDA submission experience. Master’s degree preferred (in Statistics, Computer Science, or a related science discipline). Strong team player. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Programming Contractor

Position Summary:The role of MSAT Engineer will support technical transfer and ongoing process performance within a GMP-regulated manufacturing environment. This role will serve as a key technical owner of critical process deliverables—including the Bill of Materials (BoM), process flow diagrams, process descriptions, and equipment lists—and will play an essential part in ensuring robust, compliant, and efficient operations. The Process Engineer will partner closely with Manufacturing, QA, Validation, and Regulatory functions to enable successful production, investigations, and continuous improvement. Essential Duties &amp; Responsibilities: Lead and support material qualification activities, including technical assessments, documentation, and implementation to ensure materials meet process and quality standards. Contribute to technology transfer activities, including authoring and reviewing technical reports, protocols, and SOPs. Own and maintain core process deliverables such as the BoM, process descriptions, process flow diagrams, and equipment lists throughout the product lifecycle. Generate, analyze, and maintain the Process Performance Report, ensuring processes remain in control and identifying opportunities for improvement. Execute technical studies and investigations to resolve deviations, support CAPA development, or enable process improvements. Partner cross-functionally with QA, Manufacturing, Validation, and Regulatory to ensure effective execution of investigations, audits, and regulatory commitments. Support and document change control activities related to processes, equipment, and materials. Qualifications: Bachelor’s or master’s degree in chemical engineering, Biotechnology, Life Sciences, or related discipline 5+ years of experience in pharmaceutical, biotechnology, or cell therapy manufacturing within a GMP environment. Experience with digital manufacturing systems (e.g., MES, EBR) preferred. Proven experience with technical documentation and ownership of process deliverables. Familiarity with technology transfer and material qualification. Strong understanding of pharmaceutical unit operations and GMP manufacturing processes. Working knowledge of GMP and regulatory requirements (FDA, EMA, ICH). Excellent technical writing, documentation, and communication skills. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

MSAT Engineer

Position Summary This is a new onsite opportunity to join our high performing team as we strive to develop pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. The Talent Acquisition and Operations Associate will support the entire recruitment lifecycle by owning our temp to perm openings, managing job postings, scheduling interviews, maintaining candidate databases, assisting with onboarding, and providing administrative support to the talent acquisition team and hiring managers. Key responsibilities include recruiting for temporary to perm roles, utilizing the Greenhouse Applicant Tracking Systems (ATS) to coordinate scheduling with candidates and hiring managers, and ensuring the recruiting process runs smoothly, ultimately helping to attract and secure high quality talent for ProKidney. This role is best suited for an individual who will enjoy collaborating with various functions within our HR team and who desires to develop as an HR professional. Responsibilities Partner with hiring managers to identify best in class talent for ProKidney’s temp to perm openings. Manage Contingent/Consultant workforce tracker to ensure the successful onboarding/offboarding of all temporary staff. Ensure a smooth and professional candidate journey by managing communications, resolving issues, and providing timely updates throughout the hiring process. Schedule interviews using Greenhouse Applicant Tracking system, manage candidate on site visits and ensure all necessary details are communicated to candidates and interviews in a timely manner. Work with Corporate Traveler to coordinate candidate travel and logistics. Maintain candidate records in Greenhouse, ensuring accuracy, confidentiality and compliance. Collaborate with TA Partners to develop offer letters, launch background investigations and conduct timely candidate references. Track HireRight background investigations through completion. Collaborate with TA Partners to resolve any discrepancies/issues. Act as an SME for Greenhouse Applicant Tracking System, troubleshooting issues, managing templates, and escalating system concerns as needed. Participate in projects related to TA processes, systems/tools, procedures, and compliance. Participate and assist with ProKidney’s employment branding initiatives and university recruiting efforts. Provide general administrative support to the TA team and hiring managers, which may include data analysis, reporting and assisting with HR related projects. Qualifications Bachelor’s degree or equivalent Three years’ experience in recruiting. Ability to work independently in an administrative/operations capacity Exceptional technical skills specific to Microsoft Outlook, experience with utilizing an applicant tracking system a plus Ability to thrive in a dynamic, fast-paced and changing environment Strong interpersonal and problem-solving skills with a passion for outstanding customer service ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

TA & Operations Associate (Contractor)

Position Summary The Chemistry Manufacturing and Control (CMC) Technical Trainer Liaison is a subject matter expert in cGMP cellular therapy operations, aseptic technique, and closed/open processing in a biological safety cabinet (BSC). This role is responsible for designing, delivering, and maintaining training programs that ensure manufacturing personnel are fully competent in executing clinical and commercial cell therapy production. The successful candidate brings deep hands-on experience in aseptic manipulation, cell processing workflows, and batch record execution within a regulated environment. The successful candidate must possess a strong technical understanding of the inter-disciplinary nature of cell therapy production (including the cross functional roles of manufacturing, MSAT, PD, QC and quality assurance), demonstrated with previous experience. The position is required to develop and provide documented evidence supporting the manual portions of the Rilparencel Manufacturing Control Strategy.&nbsp; The position may require participation, review and/or authorship of CMC-related GMP documents, protocols, SOPs, etc., such as tech transfer protocols, validation protocols, risk assessments, FMEA, etc.&nbsp; This is an onsite position (Winston-Salem) with minimal travel to Morrisville NC site. This role partners closely with Manufacturing, MSAT, and Quality Assurance to ensure consistent operational readiness, training compliance, and continuous improvement of technical training systems. Responsibilities CMC Training Program Development Develop, implement, and sustain competency-based technical training for cell therapy manufacturing and other CMC departments as required, including: In collaboration with QA Learning department, the development of curricula and training matrices for technical competency-based training on the manual aseptic manufacturing process in compliance with the manufacturing control strategy. Cell isolation, expansion, harvest, and cryopreservation workflows. Assess process requirements for batch execution and review to ensure completeness and accuracy from operators. Open and Closed system processing (e.g., LOVO, Sepax C-Pro, Xuri, G-Rex, bioreactors, etc.). Manual process manipulation in compliance with approved contamination control principles and environmental monitoring requirements. Deliver hands-on training for manufacturing personnel on execution of the manufacturing process. Perform Train-the-Trainer qualification for manufacturing department trainers. Qualifications &amp; Compliance Ensure compliance with training requirements and provide documented evidence to ensure training records are complete and up to date, including: Conduct operator assessments, OJT approvals, and procedural compliance. Perform training, observation, and qualification of operators in the execution of the manufacturing process, in accordance with oversight/training program documentation requirements to ensure compliance with manufacturing and aseptic process control requirements. Ensure training content complies with FDA/EMA expectations, and internal quality standards. In compliance with Quality System requirements, provide documented evidence of training, qualification and competency of operators in the execution of the manufacturing process. Continuous Improvement &amp; Technical Expertise Ensure ongoing process improvements are identified and implemented, for example: Serve as an on-floor coach and subject matter expert to support manufacturing process execution. Identify skill gaps, training risks, and improvement opportunities in manufacturing operations. Collaborate with QA, PD, MS&amp;T and MFG to ensure alignment between training, SOPs, batch records, and process changes. Develop and provide necessary training for Technical Transfers or Action Items identified within the Quality System. Support deviation investigations related to human performance or techniques linked to batch records, SOPs, Work Instructions and/or Manufacturing Process Control, and identify improvement opportunities to ensure right first-time execution; implement corrective process training as needed. Cross Functional Support Provide cross-functional support to Manufacturing, MSAT, and PD by: Authoring or reviewing training-related documentation (SOPs, job aids, qualification checklists, training curricula). Assisting with process transfers, and manufacturing scale-up from a training readiness perspective. Communicating effectively to team members and executives through written, verbal and project summary updates, providing line of site to key issues and accomplishments. Qualifications Bachelor's degree in sciences or related field 15+ years of relevant biopharmaceutical industry experience with 10+ years of cell therapy, biologics manufacturing or aseptic processing. Must have a proven track record of effective collaboration with cross-functional CMC teams. Previous experience in QC, analytical development, process development and/or manufacturing of biologics/cell &amp; gene therapy Prior background in CMC development at a biotech/pharma company focused on cell therapy. Must have previous direct technical training experience with cell-based medicinal products. Experience with new facilities, cleanroom startup, comparability, FDA submissions, tech transfer, batch analysis Must be a “hands-on” and active contributor in all aspects ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

CMC Technical Training Liaison

Position Summary:The Senior Contracts Attorney will play a key role in managing and negotiating a broad range of agreements supporting all aspects of business operations. This position requires strong expertise in contract law, preferably with experience at a public life sciences company. The successful candidate will demonstrate exceptional organizational skills, the ability to manage multiple priorities, and have a proactive approach to problem-solving and stakeholder engagement. Responsibilities: Draft, review, negotiate, and manage a wide variety of contracts, including but not limited to CDAs, consulting agreements, master service agreements, vendor agreements, real estate contracts, clinical trial related contracts and research collaborations. Serve as a subject matter expert on contract matters and processes and provide guidance to internal stakeholders. Collaborate with cross-functional teams (Clinical Operations, Finance, Procurement, HR, Manufacturing, Research) to ensure compliance and efficiency in contract execution. Develop and maintain standardized templates and processes for contract management. Provide training and support to business units on contract requirements and approval workflows. Advise stakeholders on contractual rights, obligations, and risk mitigation strategies. Identify and resolve issues impacting timely completion of contracts. Utilize e-signature platforms and ensure proper document finalization and execution. &nbsp;Qualifications: Juris Doctor (J.D.) from an accredited law school. Minimum of 5 years of experience drafting, negotiating, and managing contracts, preferably in a public life sciences company. Experience in a law firm and/or in-house legal department required. Comprehensive understanding of contract law and working knowledge of drug development or commercialization a plus. Exceptional negotiation, drafting, and analytical skills. Strong organizational and time-management abilities; capable of handling multiple projects under tight deadlines. Excellent interpersonal and communication skills with a customer-service mindset. Ability to work independently and collaboratively in a fast-paced environment. Admission to the bar in at least one U.S. state. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Sr. Contracts Attorney

Position Summary: As an Sr. Manager, Process Excellence, you will play a strategic role in driving efficiency, compliance, and transformation within Operational Excellence. You will guide cross-functional teams across manufacturing operations, fostering a culture of innovation, continuous improvement, and operational excellence. Leveraging your expertise in GMP compliance, process improvement methodologies, and digital manufacturing technologies, you will elevate manufacturing performance and drive strategic initiatives. Responsibilities: Develop and implement innovative process improvement strategies, leveraging digital technologies and GMP best practices to enhance efficiency and compliance. Collaborate with cross-functional teams to assess and execute strategies that enhance process efficiency, reduce costs, and improve overall performance, align to organizational objectives. Develop and maintain comprehensive process documentation (SOPs, process maps, work instructions, RACI). Lead change management initiatives to support adoption of new processes and technologies. Stay current on industry advancements, best practices, and emerging trends in manufacturing operations management. Proactively identify opportunities for optimization, cost reduction, and value creation. Identify opportunities for digital transformation within manufacturing operations (automation, data analytics, and tool integration). Utilize data analytics and KPIs to monitor performance and identify trends, compliance issues, and improvement opportunities. Produce clear reports and insights for senior leadership to inform strategic decisions and provide visibility into manufacturing performance. Communicate effectively at all levels, translating complex concepts and strategies into actionable objectives. Foster a culture of openness, transparency, and collaboration across manufacturing operations. Qualifications: Bachelor’s degree in Operations Management, Engineering, Life Sciences, or related field. Master’s degree or relevant certifications (e.g., Lean Six Sigma, PMP, CQE) preferred. Minimum of 5 years of experience in manufacturing operations management, GMP compliance, process improvement, or related roles in a regulated environment. Strong knowledge of GMP regulations and regulatory compliance requirements. Expertise in Operational Excellence and continuous improvement methodologies (Lean, Six Sigma, VSM, DMAIC). Proficient in process documentation, mapping, and RACI frameworks (SOPs, WI). Familiarity with autologous aseptic manufacturing and cleanroom operations. Proficiency with manufacturing digital technologies (ERP, MES, LIMS) and process analytics tools (Excel, Visio, data visualization software). Knowledge of Chain of Identity/Chain of Custody is a plus. Track record of inspection readiness and remediation is a plus. Strong analytical, strategic thinking, and change management skills. Executive presence with excellent communication skills across all organizational levels. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Sr. Manager, Process Excellence

Position Summary:The IT Assurance and Compliance Manager is responsible for ensuring all GxP computerized systems are implemented, validated, and maintained in compliance with applicable regulatory and industry standards, including FDA, ICH, GAMP 5, and global Health Authority requirements. This role leads validation efforts for new software implementations, manages the lifecycle of validated systems, and ensures sustained compliance through continuous monitoring and governance. This role will combine deep technical expertise in computer system validation, a strong understanding of quality systems, and excellent cross-functional collaboration skills to ensure IT systems operate reliably, securely, and compliantly across the enterprise. Responsibilities: Lead or support validation projects, including the planning, execution, and documentation of computer system validation deliverables. Collaborate with QA teams to ensure alignment of priorities and delivery of outcomes (policies, procedures and documents). Provide guidance and oversight to ensure computerized systems are deployed and maintained following the full system lifecycle (SDLC), IT change control, and applicable SOPs. Review and approve validation deliverables authored by internal teams and external vendors. Manage multiple validation and compliance projects simultaneously, balancing priorities across manufacturing, clinical, and corporate systems. Ensure audit and inspection readiness by maintaining documentation quality, traceability, and regulatory alignment. Lead or support the creation, revision, and implementation of IT governance SOPs and quality documentation, ensuring alignment with FDA Computer Software Assurance (CSA) principles and risk-based validation strategies. Conduct and/or support audits of IT systems, vendors, and validation documentation. Partner with QA and business stakeholders to maintain validated system compliance through release management, change control, incident management, CAPA, periodic reviews, and audit trail reviews. Conduct impact and risk assessments for changes affecting validated systems and ensure appropriate mitigation actions. Maintain the inventory of all GxP computerized systems, ensuring re-qualification/revalidation schedules are current and properly documented. Perform system risk assessments to determine GxP classification and validation requirements. Participate in vendor qualification activities, including the distribution and evaluation of IT vendor questionnaires and supporting audits or assessments. Qualifications: Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related technical or scientific discipline required. 5–8 years of experience in computer system validation (CSV), IT quality, or IT compliance roles within a regulated environment. Strong background in validation of systems such as eTMF, LIMS, ERP, EDC, MES, and other Clinical/Manufacturing systems. Experience supporting both Manufacturing and Clinical Study Systems required. In-depth understanding of global CSV guidelines and regulatory expectations, including 21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices (GCP), and Data Integrity principles. Familiarity with FDA Computer Software Assurance (CSA) guidance and risk-based validation methodologies. Strong working knowledge of cloud-based and SaaS system validation approaches. Excellent organizational, analytical, and problem-solving skills with the ability to manage multiple priorities. Strong written and verbal communication skills, with proven ability to work effectively across departments. High attention to detail and commitment to quality and compliance. Ability to foster collaboration between IT, Quality, and business functions. Preferred: ITIL, PMP, or equivalent certification in quality or regulatory compliance. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manager, IT Assurance and Compliance

Position Summary: This role is responsible for maximizing site performance and site engagement in clinical studies. Leveraging strong clinical operational and therapeutic expertise (scientific, clinical, disease states, and treatment alternatives knowledge within the therapeutic area(s)) to support execution of clinical studies. Engages with clinical sites to develop, build, and maintain strong relationships with investigators/staff that will ensure high-quality investigative sites to support clinical development programs. Collaborate with internal and external stakeholders as well as third-party vendors. Provide operational support to the CPM/Sr CPM to deliver the study within planned timelines and according to required standards of quality and compliance. Evaluate, screen and develop high-quality investigative sites to support clinical development programs. This is a field-based position, fully remote with domestic travel required 50%-75% of the time to sites within assigned territory. The preferred location for this position is Midwest. Responsibilities: Site Engagement Deliverables: Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Clinical Team and key internal stakeholders throughout the life cycle of clinical trials Support the clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial roadblocks, and using motivational tactics to ensure the timely delivery of trials Engage, evaluate, and develop a network of high-performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of its activities thereby increasing their desire to partner with ProKidney Develop &amp; maintain relationships with site engagement organizations; assist identification of high-performing sites and key opinion leaders that can contribute to forums, boards and/or discussions. Interact/train new investigators to work on clinical trials ensuring the clinical and scientific understanding of the trial Support site with enrollment, including the development of patient material, advertisement materials, new requests for concierge services for participants (including travel/accommodation/appreciation items) Serve as primary contact for biopsy and/or procedure injections scheduling, logistics and Support site with screen failures during the enrollment phase, including pre-screening activities to improve patient selection and trial readiness Monitoring Deliverables: Responsible for attending Site Initiation Visits and managing the sites’ performance regarding protocol and procedure knowledge and support Acts as the primary contact for the site regarding the general organization of the study, timelines, status, educational needs, and process flows. Responsible for the early engagement with Key Opinion Leaders (KOLs)/sites/patients organizations and key contact points for these throughout the study. Interact/train new investigators to work on clinical Attend key therapeutic training/meetings and/or industry Close collaboration and partnership with CRO to inform of all aspects of the clinical trial status at the site. Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities. Support the development of presentations at Investigator Meetings or other trial-related Contributes to updates of clinical program information, g., annual safety updates, Investigator’s Brochure, and on query resolution, as needed, etc. In collaboration with CPM/study team, ensure that the study is audit/inspection ready and any resulting findings from audits/inspections are addressed appropriately and in a timely manner. Qualifications: Bachelor's Degree Preferably in life/physical sciences, RN or clinical degree highly preferred. Experience working in renal therapeutic area required Strong scientific background with at least 5 years of experience in Clinical Operations, Clinical Development, or as a Clinical Trial Liaison or Medical Science Liaison. Strong understanding of start-up activities, clinical trial planning, (site) management, and metrics. Strong communication and leadership Travel required to Boston and Raleigh HQs for team meetings as needed ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Clinical Trial Liaison

Position Summary:The Quality Control Analyst position involves performing various testing activities to support the Quality Control department, including bio-analytical testing, raw material testing, and protocol testing. The role requires maintaining quality systems and data generated by team members, contributing to investigations, and ensuring compliance with industry standards Responsibilities: Performs routine Bioanalytical testing and release of in-process, stability and REACT Final Product samples as scheduled Executes routine and non-routine analysis, including but not limited to raw materials, in-process items and finished product according to established operating procedures; may include: Flow Cytometry ELISA Kinetic Assays Cell Counting/Viability Visual Appearance Initiates and Supports Deviation/OOS investigations in MasterControl Initiates and Supports Action Item completion as assigned in MasterControl Initiates and Supports AQEM activities as assigned in Master Control Follows Test Methods (TSMs) Standard Operating Procedures (SOPs), Work Instructions (WRKs), and Protocols Authors originals, revisions, and training on TSMs, SOPs, WRKs, Test Forms, and Protocols Support QC Analytics with sample receipt from Manufacturing Trains and mentors incoming QC Analysts (all levels) Track and trend all QC Analytical testing performance of patient lot data along with critical reagent trending Maintain inventory levels in QC labs and coordinate material requests with Warehouse/Supply Chain Initiates, and participates in Change Control (MOC) management Authors/Initiates Aborted/Invalidated Assays in the QC Analytical Lab. Complete documentation accurately and in a timely manner Partakes in special projects on analytical methods and instrumentation problems related to execution of assays. Other duties as assigned Minimum Qualifications: Minimum of Bachelor’s Degree (or better) in chemistry, biochemistry, microbiology or related science 3-5 years’ experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry Knowledge of cGMP and understanding of GxP, good clinical practices, and FDA guidelines Familiarity with bioassays, and raw material test methods Knowledge of LIMS systems Deviation Handling Change Control Management OOS Investigation experience Subject Matter Expertise in assays relevant to the QC Labs Strong communication skills with the ability to interact with various individuals Detail-oriented with problem-solving and decision-making abilities ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

QC Analyst 3

QC Analyst 3 (Contractor)

POSITION SUMMARY The Validation Engineer will support equipment, process, and cleaning validation activities. This role will help develop, author, review and execute all validation protocols and reports with guidance from senior level staff. The Validation Engineer will help coordinate all validation activities and projects with departmental manager. RESPONSIBILITIES Lead validation projects to include planning, scheduling execution and reports. Develop and Author Validation/Qualification protocols at the manufacturing facility for cleaning processes, equipment, utility, and facilities. Execute validation/qualification protocols for cleaning processes, equipment, utility, and facilities. Prepare validation/qualification summary reports for the executed protocols with support and guidance from senior level staff. Contribute to the generation and review required documentation (Standard Operating Procedures, protocols, change controls and change requests) to support validation activities and program. Applies standard techniques and procedures to carry out a series of scientific and/or engineering tasks. Provide adequate reporting and communication of projects to project manager, stakeholders and department manager. QUALIFICATIONS Bachelor’s degree in science/engineering or related field with 3-5 years’ work experience. 3-5 years of related validation experience in a cGMP environment. Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques. Minimum of 3 years of prior experience developing, authoring and execution of validation protocols in a manufacturing environment. Skills/Abilities Detail orientated and ability to work in a fast-paced environment with the ability to handle multitude of projects with overlapping schedules. Knowledge and understanding of validation lifecycle. Strong Mechanical aptitude and strong technical writing skills. Experience with equipment qualification methodologies. Experience interacting with various groups at facility to develop plan/validation strategy for projects. Experience interacting with project engineers to obtain the necessary information to fulfill validation documents. Ability to read/interpret P&amp;ID drawings ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Validation Engineer

Position SummaryThe QC Analyst 3 will support various duties within the Quality Control (QC) department. This position plays a key role in ensuring the technical operations of QC, focusing on the technical suitability of bioanalytical test methods rather than day-to-day product testing. The role includes responsibility for the analytical method lifecycle, including method transfer, validation, compendial verification, performance monitoring, and continuous improvement, as well as ensuring analytical equipment is installed and qualified. The QC Analyst will support ProKidney’s pipeline, from Phase III clinical development through commercial operations. Responsibilities • Writes and executes procedures for analytical method protocols, generating reports related to QC method transfer, validation, and verification.• May write standard operating procedures (SOPs), protocols, and/or participate in instrument qualifications and analytical system validation.• Support monitoring of analytical method performance, including assessment of analytical method system suitability requirements.• Assist with data trending and aid in compilation of trend reports utilizing statistical tools.• Work with internal departments to ensure system lifecycle document readiness and support analytical instrument qualification and system validation.• Present to cross-functional teams and effectively communicate critical analytical issues and solutions.• Familiarity with FDA and EMA guidance documents relevant to cell therapy, and compendial methods from USP and EP.• Working knowledge of quality systems requirements.• Ability to work in a fast-paced, collaborative environment, managing workload based on changing priorities.• Demonstrated leadership skills and the ability to collaborate with and effectively influence others.• Establish, revise, review, perform gap-assessment, and maintain procedures (including protocols and technical reports).• Assure laboratory procedures are compliant with current requirements and facilitate updates as needed.• Complete documentation in accordance with current Good Manufacturing Practices (cGMP).• Maintain QC lab and related systems to ensure compliance with industry standards and inspection readiness.• Support CAPA’s, deviations, investigations, and OOS’s, ensuring effective resolution and continuous improvement.• Other tasks as assigned. Qualifications • Bachelor’s degree or equivalent in Chemistry/Biochemistry, or a related discipline.• Minimum of 5 years of relevant professional experience, including a combination of Quality Control, Analytical Development, or Microbiology. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed.• Troubleshoot equipment and analytical testing methods.• Prior experience with analytical method validations.• Excellent technical writing skills.• Familiar with ICH quality guidelines and their application in QC laboratory environments.• Thorough understanding of industry testing requirements/standards.• Excellent time management skills; organized and able to meet company deadlines.• Ability to work and prioritize under pressure in an international environment.• Familiar with FDA and EMA guidance documents relevant to gene therapy.• Experience with Analytical Instrument Qualification and System Validation in laboratory environments.• Familiarity with compendial methods including USP and EP.ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Position Summary:The Quality Assurance On-The-Floor (OTF) Manager will lead and develop the QA On-The-Floor program for ProKidney. Reporting to the Director, Quality Assurance, this role will be based at our cGMP Manufacturing sites and will directly support the expanding CMC development programs. The Manager will efficiently manage, plan, organize, and direct QA floor support scheduling during manufacturing activities. Strong decision-making skills and independent thinking are crucial for success in this role, which involves close collaboration with Manufacturing, Quality Control, Supply Chain, and Facility teams. Essential Duties &amp; Responsibilities: • Lead the team responsible for on-the-floor support of manufacturing, including reviewing documentation and providing real-time support during changeovers and other manufacturing issues.• Develop direct reports and ensure completion of required training.• Review and approve activities performed by direct reports.• Delegate activities to support team responsibilities.• Ensure all on-the-floor support personnel are gowning qualified at all times.• Oversee and generate quality on-the-floor support schedules aligned with the manufacturing schedule.• Execute floor support activities, including routine walkthroughs of manufacturing suites, partnering with manufacturing on suite maintenance, implementing Quality best practices, and troubleshooting issues as they arise.• Perform real-time quality batch record review and identify potential deviations requiring reporting.• Document observations identified during manufacturing runs and escalate or resolve issues as appropriate.• Review documentation related to GMP activities such as forms, logbooks, testing documentation, Building Management System alarms, equipment alarms/cleaning, and kitting processes.• Ensure all quarantined materials are stored appropriately post-manufacturing activities. Additional Responsibilities: Communicate significant Quality issues to key stakeholders promptly. Interact frequently with direct manager, subordinates, and cross-functional peers to align on quality decisions. Make or support quality decisions impacting operations, ensuring appropriate escalation and resolution of complex issues. Identify risks and communicate quality and GMP process/system gaps. Review and approve facility alarms, work order requests, and return-to-service documentation. Support, review, and approve Deviations and Change Controls associated with operational activities, batch records, or manufacturing improvements. Train new employees on Batch Record Review, Floor Support activities, and Room Release processes. Collaborate effectively in a dynamic, cross-functional matrix environment, managing multiple projects in a fast-paced setting. Author and review SOPs and policies to ensure compliance with regulations and cGMP operations. Participate in quality-focused teams across ProKidney’s functions. Support internal audits to ensure adherence to cGMP, SOPs, and manufacturing documentation. Establish and follow procedures for clear and accurate documentation of equipment operation, process instructions, and data. Perform other duties as assigned by manager. Education And Experience: • Bachelor’s degree in applied science or a related field.• 5+ years of relevant experience in Quality Assurance or Quality Control, ideally within cGMP aseptic manufacturing operations.• Strong organizational, analytical, and time management skills.• Ability to work well in a team environment with a positive attitude and willingness to assist other areas of the organization.• Excellent verbal and written communication skills with a strong focus on attention to detail.• Ability to handle multiple tasks simultaneously while maintaining a strong attention to detail.• Demonstrated working knowledge of FDA, EU, and ICH Regulatory requirements and guidelines.• Physical ability to perform frequent tasks requiring strength and mobility; flexible scheduling may be required.• Any equivalent combination of education, experience, and training may substitute. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manager, QA Floor Support

Position Summary: The Senior Director, Quality Operations – is responsible for leadership of all aspects of GMP Quality Assurance overseeing the production of all ProKidney drug products at all manufacturing sites, as well as individual contributions, to establish and support long-term quality operations for ProKidney. In addition to product release and disposition, this position is responsible for overseeing all aspects of Material release and disposition as well as all GMP equipment and GMP facility-related validations (e.g. EMPQ). This role will manage and execute Quality Assurance as it is directly related to batch and material release for clinical trial material supply and that directly related to the establishment of a phase III/commercial GMP quality system. The leader in this role must assure that quality systems and controls are effectively in-place for phase III investigational new drug GMP manufacturing (investigational medicinal products) to meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations leading to commercialization. Essential Duties &amp; Responsibilities: Responsible for the QA Product Release team, the QA Material Release team, and the QA Validation team. Responsible for clinical batch Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition. Responsible for raw material release and disposition for all class of materials received at ProKidney for GMP purposes. Responsible for the QA review of all GMP equipment and Facilities upgrades that the QA Validation team performs for all GMP equipment and Facilities. Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions. Non-conformance/CAPA Management support. Review and approve non- conformance reports specifically associated with GMP manufacturing Mentor investigators and approvers on the investigation process and technical writing. Ensure compliance with current S. and EU cGMP regulations and industry standards. Provide leadership to both Quality and Manufacturing staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction. Provide input for continuous improvement company quality systems related to GMP manufacturing. Identify product quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner. Perform risk assessments of new programs for entry into the GMP Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends. Lead and manage complex projects/teams within corporate objectives and project timelines and participates in cross-functional projects in Quality expert and leader role. Provide strategies to address GMP manufacturing compliance gaps or determine enhancements to cross-functional quality systems. Ensures quality staff assesses and approves change controls associated with GMP manufacturing. Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels. Establish, educate, and enforce standard operating procedures required under Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions related to GMP manufacturing Identify performance or compliance gaps and implement or propose solutions; solve complex problems of a technical nature. Manage complexities within a product development environment to plan, organize, execute, monitor staff assignments and all activities necessary to achieve continuous clinical supply Knowledge, Skills, And Abilities Quality GMP operational experience implementing and overseeing investigational drug manufacture and aseptic processing operations in a manufacturing facility. Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required. Demonstrated experience building and leading exceptional GMP Quality Assurance teams. Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products. Strong knowledge of current industry trends and the ability to use the latest Working knowledge of aseptic practices and clean room design/operations, auditing techniques. Strong leadership skills with the ability to thrive in a high throughput Ability to lead and manage projects/teams within corporate objectives and project Successful in mentoring people Collaboration / Teamwork / Conflict Management Preferred Experience and Skills: Biologic or cell therapy manufacturing and/or analytical A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include quality assurance of GMP operations, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment, or facilities management. Diverse experiences in a GMP environment including but not limited to batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems. Ability to identify, focus, and solve problems in a timely and efficient Experience with quality audits and EU regulatory Experience or working knowledge of R&amp;D or clinical supply areas and Education And Experience Bachelor’s degree in a scientific or allied health field with 10+ years of relevant work experience, or relevant comparable background in Biologics or Cell and Gene Therapy Manufacturing &nbsp; The position reports directly to the VP, GMP Quality AssuranceProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Sr. Director, Quality Operations

Position Summary: We are seeking a detail-oriented and resourceful Lab and Office Operations Specialist to support the smooth functioning of our research site. This role is responsible for executing day-to-day purchasing activities to support research and development activities in support of autologous cell therapy environment. In addition, this role will focus on the operational aspects of purchasing, such as placing orders, tracking shipments, and ensuring timely delivery of necessary materials. The lab and operations specialist will also help in coordinating equipment maintenance, and scheduling facilities services while also providing administrative support to scientific and operational staff. The ideal candidate thrives in a fast-paced environment, can manage multiple responsibilities, and works effectively across teams. This role will be required to be onsite five (5) days a week. Essential Duties &amp; Responsibilities:1. Purchase Order Management• &nbsp; &nbsp; Create, process, and track purchase orders (POs) for materials and services required to support the research and development activities and purchase requisitions placed by others in the organization.• &nbsp; &nbsp; &nbsp;Maintain accurate procurement records within enterprise resource planning (ERP) or supply chain management systems.• &nbsp; &nbsp; &nbsp;Reconcile orders as received in procurement system.• &nbsp; &nbsp;Track spending towards budget and report to monthly to Morrisville budget managers.2. Vendor Coordination• &nbsp; &nbsp; Serve as a primary point of contact for vendors on routine order placements, delivery schedules, and basic inquiries.• &nbsp; &nbsp; Escalate issues or concerns—such as pricing discrepancies, supply shortages, or quality problems—to the Senior Manager as needed.3. Inventory Monitoring• &nbsp; &nbsp;Collaborate with internal teams to understand inventory levels and anticipated demand for essential materials (e.g., reagents, disposables).• &nbsp; &nbsp;Report potential shortages or order delays to senior team members, helping to ensure uninterrupted supply for manufacturing.4. Lab Management• &nbsp; &nbsp;Maintain lab inventory of consumables and office supplies; track and restock as needed.• &nbsp; &nbsp;Coordinate lab equipment maintenance, including cleaning schedules, calibration, and service/vendor interactions.• &nbsp; &nbsp;Assist with facilities management: gas supply, janitorial coordination, PPE restocking, and waste disposal.• &nbsp; &nbsp;Participate in lab safety initiatives and represent site needs as part of the safety committee. Author and update safety related SOPs as necessary.• &nbsp; &nbsp;Manage visitor control processes, including answering phones and overseeing badge/sign-in protocols.5. Office Administration• &nbsp; &nbsp;Schedule and support internal and external meetings, including agenda coordination and documentation.• &nbsp; &nbsp;Track and assist in processing invoices and expense reports.• &nbsp; &nbsp;Help organize internal events and activities for the site.6. Continuous Improvement Participation• &nbsp; &nbsp; Identify areas for process improvement in purchasing execution, such as streamlining order entry or enhancing data accuracy.• &nbsp; &nbsp; Share feedback and suggestions with the Senior Manager and other stakeholders to help refine overall procurement strategies and processes. Qualifications: • &nbsp; &nbsp;Education/Training:&nbsp;o &nbsp; &nbsp;Bachelor’s degree in supply chain management, Business Administration, Life Sciences, or a related field.&nbsp;o &nbsp; &nbsp;Relevant work experience in lieu of degree will be considered.• &nbsp; &nbsp;Experience:&nbsp;o &nbsp; &nbsp;2 - 4 years of experience in lab operations, facilities, or administrative support role (biotech or pharma preferred).o &nbsp; &nbsp;Familiarity with laboratory safety standards and facilities support operations.• &nbsp; &nbsp;Knowledge:&nbsp;o &nbsp; &nbsp;Experience working with procurement system, inventory tools, and vendor management, and using an electronic notebook (ELN)o &nbsp; &nbsp;Basic familiarity with Microsoft Office suite (Excel, Word, PowerPoint).&nbsp;o &nbsp; &nbsp;Familiarity with lab safety protocols and general scientific environment operations is a plus.• &nbsp; &nbsp;Skills:&nbsp;o &nbsp; &nbsp;Detail Orientation: Capable of accurately handling documentation and data entry for purchasing activities.&nbsp;o &nbsp; &nbsp;Communication: Strong written and verbal communication skills; comfortable interacting with vendors and internal teams.&nbsp;o &nbsp; &nbsp;Time Management: Ability to manage multiple purchase orders and priorities in a fast-paced environment.&nbsp;o &nbsp; &nbsp;Problem-Solving: Eagerness to troubleshoot routine procurement issues and escalate more complex problems to the Senior Manager.&nbsp;• &nbsp; &nbsp;Certifications/Licenses:&nbsp;o &nbsp; &nbsp;n/aProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Lab & Office Operations Specialist

Position Summary: Responsible for supervising daily operations within the manufacturing cell processing area, ensuring compliance with GMP standards, efficient production workflows, and team performance. Essential Duties &amp; Responsibilities: • Direct supervision of manufacturing personnel including coaching, training, and performance evaluations.• Oversee production schedules, batch documentation, and ERP transactions to ensure timely and accurate processing.• Ensure compliance with GMP, FDA, EMA, and other regulatory standards.• Review and approve batch records and support deviation investigations and CAPA implementation.• Monitor production processes and adjust schedules as needed.• Perform cGMP manufacturing tasks in an aseptic manner in an aseptic environment.• Enforce safety protocols and procedures to ensure a safe working environment.• Ensure compliance with all relevant regulations and standards.• Coordinate with cross-functional teams including Supply Chain, Process Development, and Quality Assurance.• Maintain audit readiness and support internal and external audits.• Monitor and report key performance indicators such as batch release timelines and error rates.• Collaborate with Senior Management in a dynamic environment, demonstrating outstanding communication skills. Qualifications:• Education/Training: Associate's or Bachelor's degree in a scientific discipline preferred; High school diploma acceptable with relevant experience.ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manufacturing Cell Processing Supervisor

Position Summary: The Manufacturing Cell Processing Specialist 2 at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and driving continuous improvement. The Manufacturing Specialist 3 is responsible for mentoring team members, leading investigations, and ensuring high levels of quality and compliance. Please note: This is a contract position which will not include ProKidney benefits. Responsibilities: Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards. Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members. Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and preventive maintenance. Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to procedures and maintaining quality standards. Revise, update, and ensure adherence to SOPs, batch records, and MS forms, maintaining GMP compliance. Lead routine cycle counts and ensure accurate inventory tracking and control. Execute transactions within the ERP system, including material requisitions and production tracking. Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP). Lead investigations into deviations and Corrective and Preventative Actions (CAPA) efforts, compiling data and information as required. Provide mentorship and training to junior team members in cell processing techniques, procedures, and cGMP compliance. Drive continuous improvement, incident investigations, and deviation resolutions. Perform and support investigations into deviations, incidents, and process improvements. Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment. Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards. Perform material qualification tests to qualify lots of incoming manufacturing material. Support process development and validation activities as needed. Assist in data collection, analysis, and reporting for process optimization and regulatory submissions. Perform other duties assigned to support and improve manufacturing operations. Qualifications: Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.• Experience: Preferred minimum 2-4 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 1-2 years of proven expertise in a cGMP-regulated environment.• Skills/Abilities: Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills.• Other: Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Mfg Cell Processing Specialist 3 (Contract)

POST DESCRIPTION HEREProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Clinical Monitoring Oversight Strategist

Position Summary Provide high-level administrative and operational support to the CEO, CHRO and executive leadership team. Manage calendars, meetings, board-related logistics, travel, and key communications. Help keep executive priorities on track and improve day-to-day processes. Support a small Boston office location, as the Boston office manager. Responsibilities&nbsp; - Manage complex calendars for the CEO, CHRO and, as needed, other executives; prioritize conflicting requests and communicate changes clearly.&nbsp; - Plan and support executive meetings (including weekly leadership team meetings): prepare agendas/materials, take notes, track action items, and follow up.&nbsp; - Coordinate board meetings and related events: scheduling, logistics, materials, and communication with internal and external attendees.&nbsp; - Arrange travel and speaking/event logistics; submit and track expense reports.&nbsp; - Draft, edit, and format executive communications, presentations, and other documents.&nbsp; - Support basic administration and coordination related to smooth operations for the Boston office staff, as needed.&nbsp; - Improve administrative processes and document standard procedures, as needed.&nbsp; - Serve as the main coordinator/contact for the Boston satellite office (minimum 3 days onsite per week).&nbsp; - Support cross-functional projects as assigned; help coordinate executive offsites and leadership events.&nbsp; - Partner with People/HR leadership on culture and inclusion work including hosting our monthly all company town halls (as assigned).&nbsp; Skills and experience&nbsp; - Strong judgment, discretion, and ability to handle confidential information.&nbsp; - Comfortable managing multiple priorities with tight deadlines.&nbsp; - Clear, professional written and verbal communication.&nbsp; - Able to work effectively with senior leaders and external stakeholders (e.g., board members, investors).&nbsp; - Proactive and organized; able to work independently and follow through.&nbsp; - Advanced Microsoft Office (PowerPoint, Word, Excel) and collaboration tools (SharePoint/OneDrive) or equivalent; able to learn new systems quickly.&nbsp; &nbsp;Requirements&nbsp; - Bachelor’s degree and 8–10 years of related experience (or equivalent combination of education and experience).&nbsp; - Experience supporting executives in a publicly traded, scaling biotech environment.&nbsp; - Hybrid schedule: at least 3 non-consecutive days/week onsite in Boston.&nbsp; - Occasional travel to North Carolina headquarters.ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Associate Director, Executive Administration - Office of the CEO

&nbsp;Position Summary: We are seeking a highly motivated and experienced Clinical Scientist to join our clinical development team, focusing on the design, execution, and oversight of late stage clinical trials. The Clinical Scientist will play a critical role in advancing our clinical programs, ensuring the generation of high-quality data, and contributing to the successful submission of regulatory dossiers. Responsibilities: Clinical Trial Design and Planning: Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, Biostatistics, and Regulatory Affairs, to design scientifically rigorous late stage clinical trials. Contribute to the development of study protocols, investigator brochures, informed consent forms, and other essential study documents. Provide scientific input for trial endpoints, patient populations, and statistical analyses. Study Execution and Oversight: Act as the scientific lead for assigned late stage studies, ensuring adherence to clinical trial protocols and regulatory requirements. Provide ongoing scientific and clinical input during trial execution, including participation in investigator meetings, site initiation visits, study monitoring activities, and medical data review. Review and interpret clinical trial data, ensuring consistency and alignment with study objectives. Address protocol-related questions from investigators and site staff. Regulatory and Compliance: Contribute to the preparation of regulatory submissions, including clinical study reports (CSRs) and documentation for Investigational New Drug (IND) and New Drug Application (NDA) filings. Ensure clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory standards. Data Analysis and Reporting: Collaborate with the Biostatistics and Data Management teams to review and interpret study data, ensuring accuracy and completeness. Participate in the preparation of abstracts, presentations, clinical study reports, and manuscripts for scientific meetings and publications. Cross-Functional Collaboration: Partner with cross functional team members to develop and execute clinical development strategies. Serve as a subject matter expert within the clinical team, providing scientific insights to support decision-making. &nbsp;Qualifications: &nbsp;BA/BS required with 10+ years of relevant experience Advanced degree in a scientific discipline (PhD, PharmD, MD, or equivalent) preferred. Late-stage development/registrational study experience, and specifically filing experience i.e. BLA or NDA Comprehensive understanding of drug development processes and GCP guidelines. Proven ability to interpret and synthesize clinical and scientific data. Strong written and verbal communication skills, with experience preparing regulatory documents and scientific publications. Ability to work collaboratively in a fast-paced, team-oriented environment. Detail-oriented with strong organizational and project management skills. Preferred Qualifications: Experience in a specific therapeutic area (e.g., oncology, cardiology, endocrinology, or rare diseases) relevant to the company’s pipeline. Familiarity with regulatory requirements for global clinical trials, including FDA and EMA guidelines. Proficiency in using clinical trial management systems and other relevant software. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Clinical Scientist

The Manager, Regulatory CMC is responsible for supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to the development and commercialization of the company’s product. This role works closely with cross-functional teams, including Manufacturing, Quality Assurance, Quality Control, and Research, to compile and maintain high-quality regulatory submissions. The Manager will assist in the preparation of CMC content for INDs/CTAs and amendments, assess change controls for regulatory impact, and help ensure compliance with applicable US and global regulatory requirements.This position offers an excellent opportunity to grow in regulatory affairs within an innovative, fast-paced biotechnology environment focused on advanced therapies. Responsibilities:Regulatory Documentation &amp; Submissions:• &nbsp; &nbsp;Contribute to the preparation, review, and coordination of CMC sections for global regulatory submissions, including INDs, CTAs, and amendments.• &nbsp; &nbsp;Assist with compiling technical data from Manufacturing, QA, and QC teams to support submissions.• &nbsp; &nbsp;Maintain and track regulatory submission timelines and deliverables.• &nbsp; &nbsp;Support responses to health authority information requests related to CMC topics.Change Control &amp; Compliance Support:• &nbsp; &nbsp;Review and assess change controls to determine potential regulatory impact and filing requirements.• &nbsp; &nbsp;Maintain awareness of relevant regulatory guidance, ICH guidelines, and agency expectations for cell/gene therapies.• &nbsp; &nbsp;Help ensure documentation and submissions meet current regulatory standards and internal quality requirements.Cross-functional Collaboration:• &nbsp; &nbsp;Collaborate effectively with cross-functional partners in Process Development, Manufacturing, QA, QC, and Regulatory Affairs.• &nbsp; &nbsp;Participate in project team meetings and provide CMC regulatory support under the guidance of senior regulatory staff.Process and Documentation Support:• &nbsp; &nbsp;Assist with developing or revising SOPs, working instructions, and templates used in Regulatory CMC activities.• &nbsp; &nbsp;Participate in the organization of regulatory archives and tracking systems for submission history and regulatory documentation. Qualifications:• &nbsp; &nbsp;Bachelor’s or master’s degree in a scientific or engineering discipline (e.g., biology, chemistry, biochemistry, pharmaceutical sciences).•&nbsp; &nbsp; 5+ years of experience in Regulatory Affairs or related experience in Manufacturing, QA, or QC in a biotech/pharmaceutical environment.• &nbsp; &nbsp;Exposure to CMC regulatory filings (INDs, CTAs, or amendments) preferred.• &nbsp; &nbsp;Experience in cell or gene therapy is a plus, but not required.• &nbsp; &nbsp;Understanding of the drug development process and the role of CMC in regulatory submissions.• &nbsp; &nbsp;Familiarity with ICH guidelines and US/global regulatory requirements.• &nbsp; &nbsp;Strong organizational and communication skills.• &nbsp; &nbsp;Detail-oriented with a focus on quality and accuracy.• &nbsp; &nbsp;Ability to manage multiple tasks and timelines in a dynamic environment.• &nbsp; &nbsp;Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) and document management systems.ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Regulatory Manager Contractor - CMC

Position Summary:&nbsp; &nbsp;We are seeking a highly skilled and motivated Contract Scientist – Translational Biology to support mechanistic hypothesis testing and sample generation for rilparencel, our autologous kidney cell therapy currently being evaluated in a Phase 3 clinical study, as well as next-generation cell therapy programs. This role will focus on primary human tissue/cell culture models (BSL-2) and the execution of multi-condition studies that generate high-quality samples for downstream molecular and NGS-based readouts. In partnership with the Translational Biology team, this scientist will contribute to experimental design and method development for workflows involving small human biopsy-derived samples, with an emphasis on reproducible execution, rigorous sample tracking, and clear communication of results. &nbsp; Essential Duties &amp; Responsibilities:&nbsp; Primary Human Tissue Culture (BSL-2) &amp; Model Execution&nbsp; Establish,&nbsp;maintain, and troubleshoot primary human&nbsp;kidney&nbsp;tissue/cell cultures using strict aseptic&nbsp;technique&nbsp;and contamination prevention.&nbsp; Experimental Design &amp; Method Development&nbsp;&nbsp; Develop&nbsp;and execute&nbsp;experimental plans with&nbsp;the translational team&nbsp;to test mechanistic hypotheses in vitro (e.g., media perturbations, multi-factor time courses), including&nbsp;appropriate controls&nbsp;and&nbsp;replicates.&nbsp; Contribute&nbsp;to method development/optimization for primary tissue workflows (e.g., tissue handling, digestion/single-cell prep where applicable, culture conditions, sampling strategy, preservation), documenting protocol iterations and outcomes.&nbsp; Execute complex study layouts&nbsp;with many&nbsp;conditions,&nbsp;timepoints,&nbsp;replicates,&nbsp;etc&nbsp;when&nbsp;required.&nbsp; Sample Processing &amp; Molecular Assays&nbsp; Harvest tissue/cells and perform RNA/DNA/protein/metabolite&nbsp;extraction, quantification, and basic QC (e.g., yield, purity; integrity checks where applicable).&nbsp; Run and troubleshoot core&nbsp;molecular&nbsp;assays, such as RT-qPCR, ELISA, Western blot, and/or reporter assays (e.g., luciferase), including control&nbsp;selection.&nbsp; Prepare assay- and omics-ready sample sets with complete metadata for internal use and/or external partners,&nbsp;as needed.&nbsp; NGS Library Preparation &amp; Omics Support&nbsp; Perform NGS library preparation for approaches such as RNA-seq, ATAC-seq, and CITE-seq (bulk and/or&nbsp;10x&nbsp;single-cell), including essential QC steps (quantification, sizing where applicable, yield assessment).&nbsp; Support handoff of libraries/samples to sequencing vendor pipelines,&nbsp;maintaining&nbsp;traceability of sample IDs, library indices, and processing conditions.&nbsp; Documentation &amp; Communication&nbsp; Maintain high-quality experiment documentation&nbsp;(ELN)&nbsp;and&nbsp;accurate&nbsp;sample inventories&nbsp;(LIMS).&nbsp; Participate in&nbsp;interpretation&nbsp;translational data&nbsp;to uncover key insights for cell therapy&nbsp;mechanism of action elucidation.&nbsp; Communicate findings effectively across cross-functional teams, including research, process&nbsp;&amp; analytical&nbsp;development, and clinical translation groups.&nbsp; Contribute to regulatory filings, scientific publications, and presentations at key&nbsp;industry&nbsp;and academic conferences.&nbsp; &nbsp;Qualifications:&nbsp; Education/Training&nbsp; M.S. or Ph.D. in Cell Biology, Molecular Biology, Immunology, Bioengineering, or related&nbsp;field.&nbsp;&nbsp; Required Experience &amp; Skills&nbsp; Demonstrated hands-on experience with primary human tissue/cell culture and comfort working with human-derived materials in a BSL-2 environment.&nbsp; Experience executing multi-condition in vitro experiments with strong attention to detail and sample tracking.&nbsp; Experience with RNA/DNA/protein extraction and basic QC/quantification.&nbsp; Experience with at least two of: qPCR/RT-qPCR, ELISA, Western blot, reporter assays.&nbsp; Hands-on experience with NGS library preparation for one or more of: RNA-seq, ATAC-seq, CITE-seq (bulk and/or single-cell).&nbsp; Able to work effectively in a fast-moving R&amp;D environment with multiple parallel experiments and time-sensitive sample processing needs.&nbsp; Preferred&nbsp; Flow cytometry and/or FACS experience (sample prep, staining,&nbsp;acquisition&nbsp;and/or sorting workflows).&nbsp; Familiarity with common bioinformatics/QC concepts and tools used in sequencing workflows;&nbsp;familiarity&nbsp;with at least one scripting language (Python and/or R).&nbsp; Skills:&nbsp;&nbsp; Ability to work in a fast-paced environment and collaborate across disciplines&nbsp; Strong team&nbsp;player&nbsp; Goal-oriented mindset&nbsp; Ability to focus efforts &amp; complete deliverables&nbsp;on-time&nbsp; Certifications/Licenses:&nbsp;Licenses / Certification welcome&nbsp; &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Scientist Contractor- Translational Biology

Position Summary:The Senior Director, Supply Chain Operations is a strategic, hands-on leader responsible for designing and executing an integrated, end-to-end supply chain operating model across planning, manufacturing scheduling, warehousing, logistics, and the external partner network. This role leads S&amp;OP, inventory strategy, and supply network optimization to deliver service excellence, cost discipline, speed, and operational resilience. As a critical enabler of patient access, this leader ensures a reliable, compliant, and patient-centered supply network — making certain therapies are available when and where patients need them. Responsibilities Strategy &amp; Leadership Develop and operationalize a multi‑year supply chain operations strategy aligned to enterprise objectives and commercial growth plans. Build and lead a high‑performing team spanning planning, scheduling, warehousing, logistics, and network operations. Establish and cascade KPIs (service, cost, agility, inventory, plan accuracy). Own the supply chain operations budget. Planning, S&amp;OP, and Scheduling Lead the enterprise S&amp;OP process integrating demand, supply, capacity, and financial plans. Oversee master production scheduling (MPS), materials planning (MRP). Standardize planning and scheduling processes. Inventory, Warehousing, Logistics &amp; Distribution Set enterprise inventory policies. Lead internal warehousing and 3PL operations. Govern international logistics, customs &amp; trade compliance. Ensure product availability and on-time distribution to support uninterrupted patient treatment. Partner cross-functionally (Commercial, Patient Services, Clinical, Quality) to proactively mitigate supply disruptions impacting patients. External Network &amp; Partner Management Manage strategic relationships with CMOs, suppliers, and logistics partners. Align systems and processes with external partners. Risk, Quality &amp; Compliance Assess supply, capacity, quality, and logistics risks and implement mitigation strategies to prevent disruptions to patient access and care continuity. Ensure adherence to regulatory and quality standards. Technology, Data &amp; Analytics Own the supply chain technology roadmap. Drive data governance and real-time reporting. People &amp; Culture Recruit, develop, and retain diverse talent. Champion safety, quality, and a patient-first mindset across the supply chain organization. This embeds patient experience into leadership expectations. Qualifications: Bachelor’s degree required; Master’s degree or MBA preferred. 12–15+ years in end‑to‑end supply chain operations. Proven track record leading global or outsourced networks. Deep expertise in S&amp;OP, inventory, MPS/MRP, logistics, and compliance. Strong understanding of ERP (SAP) and planning systems. Strategic thinking, analytics, communication, negotiation. Committed to Operational Excellence by exemplifying our Leadership Principles – Transparency, Respect, Accountability, and Collaboration. Certifications/Licenses: APICS/ASCM (CPIM/CSCP) or Lean Six Sigma preferred. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Senior Director, Supply Chain

&nbsp; Position summary The Quality Assurance Specialist III supports Quality oversight of the Analytical and Microbiology Laboratories within a fast-paced, regulated cell therapy manufacturing environment. This role ensures compliance with cGMP, regulatory expectations, internal quality standards, and industry best practices. The Specialist serves as a key QA liaison to both labs, providing elevated level review, technical assessment, issue resolution, and continuous improvement support for testing activities that ensure product quality, patient safety, and data integrity. Primary Responsibilities:&nbsp; &nbsp; &nbsp; Provide Quality Assurance oversight of daily operations within the Analytical and Microbiology laboratories to&nbsp;ensure full compliance with cGMP, regulatory expectations, and internal quality standards. Review and approve laboratory data packages, including analytical raw data, microbiological test results, environmental&nbsp;monitoring results, and associated documentation for completeness, accuracy, and data integrity&nbsp;(including audit trail review). Serve as QA reviewer for analytical and microbiology-related deviations, OOS/OOT investigations, EM excursions,&nbsp;and other laboratory events. Assess and approve change controls relating to laboratory methods, instrumentation, workflows, and controlled&nbsp;documents. Perform routine GxP walkthroughs of laboratory areas, identify compliance gaps, document observations, and&nbsp;ensure timely resolution. Review and approve method validation protocols/reports, equipment qualification documents, and relevant SOPs. Provide QA representation during internal audits, regulatory inspections, and laboratory readiness activities. Act as QA subject matter expert (SME) for analytical testing, microbiological methods, and quality expectations&nbsp;related to cell therapy products.&nbsp; Pulling QC samples from the LN2 and storing IPC samples within the LN2. Support training and mentoring of QC staff on quality principles, documentation standards, and deviation/OOLS/OOT/CAPA management. Collaborate cross-functionally with QC labs, Manufacturing, Quality Systems, ASAT and Regulatory Affairs to support efficient sample testing and product release. Participate in continuous improvement initiatives to enhance data integrity, streamline workflow, and strengthen laboratory compliance. Contribute to risk assessments related to laboratory operations, equipment, and method lifecycle activities. Review of lab system entries, electronic data workflows, and lab system upgrades. Provide QA input during method transfers, new assay implementation, and introduction of new laboratory equipment or technologies. Requirements: Bachelor’s degree in Life Sciences, Microbiology, Chemistry, Biotechnology, or a related scientific field required. · Advanced degree (MS) preferred but not required Minimum of 5 years of QA or QC experience in a regulated biopharmaceutical, cell therapy, biologics, or sterile manufacturing environment. · Demonstrated familiarity with analytical methods (e.g., flow cytometry, qPCR, ELISA) and microbiological techniques (e.g., sterility, endotoxin, bioburden, mycoplasma, EM).&nbsp; &nbsp;Prior experience reviewing laboratory data under cGMP required. Experience supporting or leading laboratory investigations (deviations, OOS, OOT, EM excursions) Strong working knowledge of cGMP, 21 CFR Parts 210/211, Part 1271, ICH guidelines, and data integrity (ALCOA+) principles.&nbsp; Understanding of laboratory instrumentation, method validation, equipment qualification, and change control processes. Experience with electronic systems such as LIMS, Empower, or other data acquisition platforms is preferred. Excellent attention to detail and strong decision-making skills. Ability to independently manage multiple priorities in a fast-paced, dynamic environment. Strong communication skills to partner effectively with laboratory, manufacturing, and quality teams. Ability to analyze technical data, identify compliance risks, and propose sound corrective actions. &nbsp; &nbsp; &nbsp; &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

QA Specialist 3, QC Oversight

Position Summary: Provide support to develop and implement data repository and analytics tools in support of pharmaceutical regulated GMP (Good Manufacturing Practices) data and with the focus on manufacturing and quality domains. Essential Duties &amp; Responsibilities: Analyze business needs and requirements for data and analytics to support regulatory filings. Identify, classify, and map data sources. Build data lineage diagram from data source to analytics ready datasets Determine data curation requirements to help organize, clean, manage, and maintain data so it can be used reliably for analytical use cases. Provide support for technical activities such as building data integration, design data architecture, and data transformation and processing. Develop data governance standards to comply with company and industry best practices. Lead development of key project documents such as user requirements, design specifications, and configuration specifications. Lead development of test scenarios and scripts in partnership with business, technical, and validation team members. Lead test execution according to test protocols. Provide support for development of standard operating procedures and other documentation required to go-Live. Monitor execution of testing and relay results to technical team to address issues. Provide support for training business teams for Go-Live Development of training materials as needed Provide regular updates to project team &nbsp;Qualifications: Education/Training: Bachelor’s Degree. Experience: Minimum of 5-10 years of experience in IT experience working in the role of business and technical analyst with the focus on data, business intelligence, and analytics projects Experience working in Biotech/Pharma (Regulated Industry) Experience with developing requirements, design, and testing documents. Hands-on experience with data analysis and reporting in support of Pharmaceutical GMP environment. Understanding of GMP data sources across pharmaceutical manufacturing process and quality control testing environment sources such as Laboratory Management Information Systems, Quality Systems, Manufacturing Execution Systems, Data Historian, and other tools. Experience with design and development and usage of data repository and analytics platforms Demonstrated experience managing lifecycle documentation and validation in FDA-regulated environments. Versed in FDA/Industry regulations and policies (Part 11, Computer System Validation) Experience with system administration responsibilities Experience with helping lead data analysis and engineering projects Ability to work under tight timelines Ability to communicate and work across teams in collaborative manner Ability to work independently with minimal supervision Knowledge: GxP, Pharmaceutical Manufacturing and Quality Data (GMP data), Data analysis and reporting Understanding of data modeling tools Experience working with analytics (Python, R, Excel, Tableau, Spotfire, other reporting and analytics for manufacturing process industries) Experience with database (SQL) and ETL development Experience with cloud environments (AWS, Azure) Experience with usage of process analytic software is a plus (Aveva, Seeq). Skills: System Support/System Administration, Communications, Project Management, Training, Computer System Validation, Business Requirements Documentation. Certifications/Licenses: None ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Senior GMP Data Analytics Analyst Contractor

Position Summary The Sr. Manager of Validation will lead the Qualification and Validation, Cleaning, Sterility assurance and Computer System Validation (CSV) teams at the site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and validation initiatives as needed. Will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle as well as 21CFR Part11 and FDA’s guide to Computer Software Assurance. Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment. The Sr. Validation Manger will be responsible for supporting the Validation/Qualification program by: Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks Ensure adequate resourcing (capacity and capability) to accomplish site and OST objectives. Recommend solutions to alleviate constraints Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change. Continuously improving the culture of the Validation team and the site Represents Validation and Emergent during GMP and other regulatory agency inspections (CDC, OSHA, etc.) Identify areas to drive down operations costs and improve project delivery efficiency. Develop specific investment strategies to realize these savings Hands on troubleshooting and problem solving at the Gemba in support of engineering team members and operations Develop and lead small and medium sized continuous improvement projects, remain involved in projects led by staff members Direct support to OST head or lead annual OPEX budget for Validation department Staff and System Development Effective delegation and building confidence and competence within direct reports Drive engagement in the technical and personal development of the Validation team and members Develops strong relationships with partners (QA, Mfg., etc.) and cultivates these with all team members Provide effective and collaborative cross functional leadership to facilitate development of the site strategy and delivery of site objectives Improve the culture of the Validation team and the site Qualifications Education/Training Bachelor’s degree. Preferred Fields of Study: Life Sciences or Engineering with 10+ years work experience. A minimum of 8 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 3 years in a leadership role Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc) Strong understanding of Validation Lifecycle (GAMP 5) principles Experience with calibration and maintenance management software Knowledge of electronic document management systems Experience with data integrity practices and compliance Strong technical writing skills for qualification documents, SOPs, and work instructions Ability to manage multiple projects simultaneously with minimal supervision Detail-oriented with excellent verbal and written communication abilities Ability to adapt to changing priorities in a deadline-oriented environment Significant hands on experience and regulatory expectations knowledge with controls, automation and computer system validation. Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage. Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques. Experience in writing computer system test scripts, validation protocols and summary reports ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Sr Manager Validation

Position Summary: The Manufacturing Specialist II, Cell Processing at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves setting up, operating, and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and providing guidance to junior staff while leading improvements in cell processing operations. This position is located onsite in Winston Salem, NC.&nbsp; &nbsp; Essential Duties &amp; Responsibilities: Lead and participate in cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards.• Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to other team members as needed.• Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and maintaining preventive maintenance schedules.• Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to specified procedures and quality standards.• Revise, update, and ensure adherence to approved documents, including SOPs, batch records, and MS forms, maintaining GMP compliance.• Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).• Train and mentor junior team members in cell processing techniques, procedures, and cGMP compliance.• Perform and support investigations into deviations, incidents, and process improvements.• Lead efforts in process development, qualification, and validation activities as needed.• Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment. Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards. Secondary Responsibilities: Lead and assist in material qualification tests to ensure the suitability of manufacturing materials.• Provide guidance and support for continuous process improvement initiatives.• Assist in data collection, analysis, and reporting for process optimization and regulatory submissions.• Perform other duties as assigned to support and improve manufacturing operations. &nbsp; Minimum Qualifications: Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.• Experience: Preferred minimum 2-4 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 1-2 years of proven expertise in a cGMP-regulated environment.• Skills/Abilities: Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills.• Other: Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manufacturing Cell Processing Specialist 2

Position Summary: The Team Lead, Cell Processing serves as a technical resource within the manufacturing team, supporting daily cell processing operations in a cGMP-regulated environment. This role provides on-the-floor guidance to manufacturing staff, supports execution of cell processing activities, and assists the Shift Manufacturing Supervisor with coordination of production activities. The Team Lead functions as a leader in manufacturing processes, promotes adherence to cGMP and aseptic techniques, and contributes to operational consistency, training, and continuous improvement. This position is located onsite in Winston Salem, NC. Essential Duties &amp; Responsibilities: Provide on-the-floor leadership and technical guidance during cell processing operations, supporting the manufacturing team in executing production activities safely and Serve as a technical guide for cell processing operations, including cell culture, expansion, harvesting, formulation, and cryopreservation. Support coordination of daily manufacturing activities to ensure alignment with the production schedule and operational priorities. Assist in task coordination and workflow organization during manufacturing operations to support efficient execution of batch activities. Perform complex or critical manufacturing steps in a cleanroom environment in accordance with cGMP and aseptic processing requirements. Support troubleshooting of process or equipment issues and escalate concerns to the Manufacturing Supervisor when appropriate. Assist with review of batch documentation, logbooks, and manufacturing records to ensure accuracy and adherence to Good Documentation Practices (GDP). Support the development and training of manufacturing personnel on cell processing techniques, SOPs, and cleanroom practices. Contribute to deviation investigations, CAPA activities, and process improvements by providing technical input and operational knowledge. Assist with implementation or revision of manufacturing procedures, batch records, and documentation as processes evolve. Participate in daily tier meetings and communicate operational updates, risks, or resource needs to the Supervisor. Maintain compliance with safety procedures, cGMP regulations, and internal quality Support audit readiness and participate in inspections as Perform other duties as assigned to support manufacturing Minimum Qualifications: &nbsp; Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or equivalent; preferred area of study in a Science-related discipline. High School Diploma or Equivalent with relevant experience may be considered. Experience: Preferred minimum 4 years of relevant experience in biotechnology manufacturing or a related field. Skills/Abilities: Proficiency in biological processing techniques such as cell culture, ultra-filtration, and column Advanced knowledge of cGMP facilities and requirements. Strong organizational skills with the ability to manage multiple projects and meet deadlines. Critical thinking ability and judgment to make appropriate decisions within defined procedures. Other: Excellent eye/hand coordination, effective written and oral communication skills, team-oriented with a strong work ethic. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manufacturing Cell Processing Team Lead

Position Summary The Senior Talent Acquisition Coordinator manages the logistics and administrative operations of the hiring process, ensuring a smooth and positive candidate experience. &nbsp;This role supports recruiters and hiring managers through interview scheduling, ATS management, and onboarding coordination. The position requires strong organization, communication, and proficiency with HR software systems. This role supports a fast‑paced Talent Acquisition function and requires comfort working with confidential information, managing shifting timelines, and coordinating across cross‑functional teams. This is a hybrid position based in Winston‑Salem, NC, requiring three days per week onsite, with additional onsite days as needed. Responsibilities Partner with TA colleagues to schedule candidates using Greenhouse applicant tracking system. Contribute to a successful candidate and hiring manager experience by ensuring all necessary details are communicated to candidates and interviewers in a timely manner. Work with Corporate Traveler to coordinate candidate travel and logistics. Maintain candidate records in Greenhouse, ensuring accuracy, confidentiality and compliance. Collaborate with TA Partners to develop offer letters, launch background investigations and conduct timely candidate references. Track HireRight background investigations through completion. Collaborate with TA Partners to resolve any discrepancies/issues. Build strong relationships with candidates, ensuring clear communication and a positive experience throughout the hiring process. Manage job postings and maintain accurate applicant records in the Applicant Tracking System (ATS). Work with TA Partners to coordinate expense reporting and reimbursement. Supports Talent Acquisition by assisting with TA project tasks, running reports as needed, and managing related activities within the ATS. Provides logistical support for Talent Acquisition events and assists with event coordination and execution as needed. Qualifications 5+ years of experience in recruiting coordination, HR operations, or a fast-paced administrative role. Strong organizational skills with the ability to manage multiple calendars and shifting priorities. Excellent verbal and written communication skills for interactions with candidates and hiring managers. Proficiency with ATS platforms and Microsoft Office Suite High attention to detail, reliability, and a service‑oriented mindset. High School diploma required; Bachelor’s degree preferred or an equivalent combination of education and experience. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Sr TA Coordinator Contractor

Position Summary The Quality Assurance (QA) Specialist III provides independent, real-time QA support within classified manufacturing areas, including cleanrooms. The Specialist III applies solid cGMP expertise to perform documentation review, issue identification, escalation, and accurate records to ensure cGMP compliance. The role requires shift work, full gowning, on-floor presence, and collaboration with Manufacturing, Quality Control, Facilities, and other stakeholders to ensure compliant and efficient manufacturing operations. This role is an onsite position in Winston Salem, NC requiring full‑time presence in classified manufacturing environments. Due to the hands‑on, real‑time nature of quality activities, this role is not eligible for remote or hybrid work. &nbsp; Essential Duties &amp; Responsibilities Provide QA review of moderate‑complexity manufacturing operations in classified environments. Maintain continuous on‑floor presence to support compliance, production activities, and issue resolution. Conduct complex in‑process batch record reviews and evaluate documentation for compliance and accuracy. Review manufacturing records, environmental monitoring data, and related documentation. Perform and verify line clearance activities for assigned processes. Identify, document, and resolve standard quality issues; escalate higher-risk or non-routine issues as required. Support and contribute to deviation investigations, CAPAS, and remediation activities. Review and approve facility alarms, work orders, and return‑to‑service documentation. Participate in internal audits, inspections, and cross‑functional quality initiatives. Follow all gowning, safety, and cleanroom behavior requirements. &nbsp; Education &amp; Experience Requirements Bachelor’s degree in an applied science field or equivalent experience. 5 years of QA experience in a GMP‑regulated manufacturing or quality environment Aseptic manufacturing experience preferred. Knowledge &amp; Skills Solid professional knowledge of cGMP regulations and quality systems. Ability to apply judgement to moderately complex quality issues. Strong documentation, analytical and problem-solving skills. Effective cross-functional communication and collaboration. Ability to manage multiple priorities with limited supervision. &nbsp; Working Conditions This position requires full‑time onsite work in a GMP manufacturing environment. Not eligible for remote or hybrid work. Requires full gowning and extended time in cleanroom and classified areas. Ability to stand for extended periods and perform physical tasks as required. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Quality Assurance Specialist 3, Floor Support

The Associate Director of EHS – is responsible for leading and executing environmental, health, and safety programs across all ProKidney sites and operations to ensure regulatory compliance and a safe working environment. This role provides oversight for EHS strategy and partners cross-functionally with Manufacturing, Quality, Facilities, Supply Chain, and Laboratory teams to implement standardized safety programs, conduct risk assessments, manage hazardous materials and waste programs, and promote a proactive culture of safety consistent with regulatory and industry standards across the organization. Essential Duties &amp; Responsibilities Lead the development, implementation, and continuous improvement of EHS programs across all ProKidney sites, supporting laboratory, manufacturing, and operational environments. Establish standardized EHS policies, procedures, and safety management systems to ensure consistent safety practices across multiple locations. Conduct Job Hazard Analyses (JHAs), safety inspections, and risk assessments to identify hazards and implement mitigation strategies across facilities. Ensure organizational compliance with federal, state, and local environmental and safety regulations, including OSHA, EPA, CDC, and applicable biosafety and laboratory safety standards. Provide oversight of site EHS leads or local safety representatives, ensuring alignment with company-wide safety expectations and regulatory requirements. Oversee laboratory safety programs including chemical hygiene, biosafety practices, hazardous materials handling, and safe laboratory operations. Lead investigations of safety incidents, near misses, and environmental events across sites and drive corrective and preventive actions to prevent recurrence. Develop and deliver EHS training programs related to laboratory safety, chemical handling, hazardous waste management, emergency response, and workplace safety. Support hazardous waste management programs, chemical inventory systems, and environmental compliance programs across facilities. Partner with Quality and operational leadership to support internal audits, regulatory inspections, and continuous improvement initiatives across all ProKidney locations. Monitor EHS performance metrics and drive initiatives that improve safety culture, reduce risk, and support operational excellence. &nbsp; Education / Training Bachelor’s degree in Environmental Health &amp; Safety, Environmental Science, Industrial Hygiene, or related field preferred. Experience 7–10+ years of Environmental Health &amp; Safety experience, preferably within biotechnology, pharmaceutical, or life sciences manufacturing environments. Experience supporting multi-site operations or enterprise EHS programs in regulated environments. Experience supporting GMP manufacturing operations and regulatory compliance programs. Experience implementing safety management systems, risk assessments, and environmental compliance programs within regulated industries. Knowledge Working knowledge of OSHA, EPA, and applicable environmental health and safety regulations. Understanding of laboratory safety standards, biosafety practices, and hazardous materials management. Knowledge of EHS governance models supporting multi-site organizations. Skills Strong analytical and problem-solving skills with the ability to conduct hazard assessments and risk evaluations. Effective communication and training capabilities across scientific and operational teams. Ability to partner cross-functionally with Quality, Manufacturing, Facilities, Supply Chain, and laboratory personnel across multiple sites. Strong documentation and regulatory compliance mindset. Ability to influence safety culture and drive organizational alignment across geographically dispersed teams. Certifications / Licenses Associate Safety Professional (ASP), Certified Safety Professional (CSP), or equivalent certification preferred. Biosafety or laboratory safety certification preferred. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Associate Director, Environmental Health & Safety (EHS)

Position Summary: The Manufacturing Cell Processing Specialist 3 at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and driving continuous improvement. The Manufacturing Specialist 3 is responsible for mentoring team members, leading investigations, and ensuring high levels of quality and compliance. This position is located in Winston Salem, NC. &nbsp; Responsibilities: Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards. Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members. Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and preventive maintenance. Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to procedures and maintaining quality standards. Revise, update, and ensure adherence to SOPs, batch records, and MS forms, maintaining GMP compliance. Lead routine cycle counts and ensure accurate inventory tracking and control. Execute transactions within the ERP system, including material requisitions and production tracking. Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP). Lead investigations into deviations and Corrective and Preventative Actions (CAPA) efforts, compiling data and information as required. Provide mentorship and training to junior team members in cell processing techniques, procedures, and cGMP compliance. Drive continuous improvement, incident investigations, and deviation resolutions. Perform and support investigations into deviations, incidents, and process improvements. Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment. Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards. Perform material qualification tests to qualify lots of incoming manufacturing material. Support process development and validation activities as needed. Assist in data collection, analysis, and reporting for process optimization and regulatory submissions. Perform other duties assigned to support and improve manufacturing operations. Qualifications: Education: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may be a substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience. Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 2-3 years of proven expertise in a cGMP-regulated environment. Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills. Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manufacturing Cell Processing Specialist 3

&nbsp; The Manufacturing Cell Processing Specialist 3 at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and driving continuous improvement. The Manufacturing Specialist 3 is responsible for mentoring team members, leading investigations, and ensuring high levels of quality and compliance. This position is a contract role located in Winston Salem, NC. &nbsp; Responsibilities: Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards. Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members. Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and preventive maintenance. Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to procedures and maintaining quality standards. Revise, update, and ensure adherence to SOPs, batch records, and MS forms, maintaining GMP compliance. Lead routine cycle counts and ensure accurate inventory tracking and control. Execute transactions within the ERP system, including material requisitions and production tracking. Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP). Lead investigations into deviations and Corrective and Preventative Actions (CAPA) efforts, compiling data and information as required. Provide mentorship and training to junior team members in cell processing techniques, procedures, and cGMP compliance. Drive continuous improvement, incident investigations, and deviation resolutions. Perform and support investigations into deviations, incidents, and process improvements. Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment. Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards. Perform material qualification tests to qualify lots of incoming manufacturing material. Support process development and validation activities as needed. Assist in data collection, analysis, and reporting for process optimization and regulatory submissions. Perform other duties assigned to support and improve manufacturing operations. Qualifications: Education: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may be a substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience. Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 2-3 years of proven expertise in a cGMP-regulated environment. Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills. Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role. &nbsp; ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manufacturing Cell Processing Specialist 3 Contractor

The Associate Director, Manufacturing Operations is responsible for leading GMPmanufacturing operations while developing and sustaining a highly capable, compliant, andproduction-ready workforce. This role integrates strategic operational leadership with end-to-endownership of manufacturing programs, ensuring alignment with GMP, aseptic processing, andregulatory expectations. This leader oversees daily manufacturing execution, material readiness, and production supportactivities while designing and driving robust training strategies that ensure continuousoperational readiness. The role serves as a key business partner to Manufacturing, Quality, andcross-functional teams to enable safe, compliant, and efficient production while fostering aculture of quality, accountability, and continuous improvement. Essential Duties &amp; Responsibilities:· Provide leadership for GMP manufacturing operations, ensuring safety, quality, and productiontargets are consistently achieved while driving right-first-time execution.· Oversee material readiness, batch preparation, labeling verification, and productioncoordination to support uninterrupted manufacturing operations.· Own audit readiness of cleanrooms and minimize equipment downtime for schedule adherenceof manufacturing activities· Own and lead the manufacturing training strategy, including onboarding, OJT programs,aseptic qualifications, and continuous workforce development.· Partner with Quality to lead deviation investigations, CAPAs, and change controls, ensuringstrong documentation practices and sustained audit readiness.· Oversee aseptic and controlled environment operations, ensuring all personnel are properlytrained, qualified, and compliant with GMP standards.· Drive continuous improvement initiatives across operations and training by identifying gaps,optimizing processes, and enhancing efficiency and compliance. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed,color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status,militarystatus, application for military service or any other class protected by state or federal law.Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship. Education/Training:· Bachelor’s degree in Life Sciences, Engineering, Operations Management, or related fieldrequired; Master’s degree preferredExperience:· 7+ years of direct manufacturing experience in GMP-regulated pharmaceutical, biotech, or celltherapy manufacturing· 5+ years of managerial experience directly managing people and leadership experience leadingteams.· 5+ years of GMP training program development, instructional design, and LMS management· Demonstrated leadership experience in manufacturing operations, training, or both· Experience with batch records, deviation management, CAPA, and working incontrolled/aseptic environments Experience:· Minimum 5 years of direct, hands-on manufacturing experience in a GMP-regulatedenvironment, including managerial responsibilities and proven leadership in operational settings.· 5+ years of experience developing GMP training programs, instructional design, and managinglearning management systems, preferably with a background in manufacturing operations. Knowledge:· Strong knowledge of cGMP, GDP, and global regulatory requirements (FDA, EMA)· Expertise in aseptic processing and manufacturing compliance standards· Familiarity with ERP/MES/eQMS systems (e.g., SAP) Skills:· Strong leadership, coaching, and team development capabilities· Expertise in training program development, instructional design, and management· Excellent technical writing skills (SOPs, deviations, training materials)· Strong problem-solving, communication, and cross-functional collaboration skillsCertifications/Licenses:· None required; relevant GMP or instructional design certifications preferredProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Associate Director, Manufacturing Operations

Position Summary: The Manufacturing Specialist, Cell Processing at ProKidney is responsible for supporting cell processing operations, ensuring compliance with cGMP guidelines in the development and production of regenerative medicine therapies. This role involves setting up and operating production equipment, including control rate freezers, orbital shakers, and other equipment, while contributing to efficient processing, freezing, and storage of cell therapy products. This is a contractor position which is located onsite in Winston Salem, NC. &nbsp; Essential Duties &amp; Responsibilities: Coordinate with team members and perform tasks with minimal supervision. Set up and operate production equipment such as control rate freezers, orbital shakers, and other systems to support cell processing activities. Assist in processing, freezing, and storage of biologic and cell therapy products, ensuring adherence to cGMP standards. Accurately complete GMP documentation, including batch records, logbooks, and forms, ensuring compliance with Good Documentation Practices (GDP). Maintain inventory and monitor conditions related to biologic and cell therapy products, including temperature control, expiration dates, and equipment calibration. Ensure the accuracy and integrity of cell processing workflows, identifying deviations from established procedures and taking corrective actions as necessary. Collaborate with cross-functional teams to support process improvements, troubleshooting, and equipment maintenance. Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards. Secondary Responsibilities and Functions: Assist in data collection, analysis, and reporting for process improvement initiatives.• Support material qualification, process development, and validation efforts as required.• Maintain compliance with all relevant safety policies, rules, and regulations.• Perform other duties as assigned. &nbsp; Minimum Qualifications: Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.• Experience: Preferred minimum 0-2 years of experience in cell processing, biotechnology manufacturing, or a related field. Experience with biologic or cell therapy production is highly desirable.• Skills/Abilities: Strong understanding of cGMP requirements, with proficiency in operating cell processing equipment. Ability to work independently or collaboratively, demonstrate attention to detail, and follow complex protocols. Strong organizational, record-keeping, and time management skills.• Other: Good eye/hand coordination, effective written and oral communication skills, a team-oriented approach, and a strong work ethic are essential for success. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manufacturing Cell Processing Specialist 1 Contractor

The Manufacturing Support Specialist I is essential in supporting manufacturing operations and maintaining the sterility and cleanliness of GMP facilities. This role involves aseptic processing of in-house solutions, media and kit preparation, GMP cleaning, and supporting manufacturing cell processing teams. The specialist is responsible for ensuring compliance with current Good Manufacturing Practices (cGMP), performing routine aseptic processing, preparing cleaning solutions for cleanroom sanitization, and ensuring proper documentation for biopsy and product shipments. This role also contributes to maintaining controlled environments, executing cleaning procedures, managing inventories, and collaborating with teams to improve manufacturing processes and cleanliness protocols. This is a contractor position. Key Responsibilities: Aseptic Cleaning &amp; Maintenance:&nbsp; Perform routine aseptic processing of in-house solutions according to cGMPs, ensuring compliance with all aseptic processing standards. Prepare cleaning solutions for sanitizing cleanrooms, following approved procedures and ensuring that cleanroom areas, production zones, and laboratories remain sterile. Maintain cleanliness in GMP suites, gowning rooms, biosafety cabinets, and other critical areas to minimize contamination risks.&nbsp; Execute GMP equipment cleaning procedures, ensuring that all actions align with current Good Manufacturing Practices. Documentation &amp; Compliance:&nbsp; Complete cleaning logs, batch records, and other required GMP documentation with accuracy, ensuring compliance with FDA and other regulatory bodies. Document all activities in alignment with Good Documentation Practices (GDP), ensuring that all relevant records are kept up-to-date. Support internal and external audits by providing documentation and verifying compliance with GMP and regulatory standards. Material &amp; Equipment Management:&nbsp; Track and manage inventory of cleaning materials and supplies, ensuring proper storage and reporting of stock needs.&nbsp; Maintain and store cleaning tools and equipment appropriately to prevent contamination and ensure readiness for use. Prepare product shippers and assist in media and kit preparation, ensuring correct documentation in compliance with Electronic Batch Records (EBR). Safety &amp; Training: Follow safety protocols to maintain a safe working environment and minimize accidents. Engage in ongoing training to stay current with GMP regulations and aseptic techniques. Report any safety hazards, deviations, or non-conformances to supervisors in a timely manner. Collaboration &amp; Process Improvement: Collaborate with manufacturing, quality assurance, and other teams to ensure effective coordination of cleanliness and regulatory compliance.&nbsp; &nbsp;Contribute to the development and improvement of cleaning procedures and manufacturing protocols. Assist in data gathering, troubleshooting, and provide support for other tasks within the manufacturing process as needed. Minimum Qualifications:Education/Training: High school diploma or equivalent required; AS/BS in Biotechnology, Biology, Chemistry, or related field preferred. Additional certification in aseptic techniques or GMP training is beneficial. Relevant experience may substitute for formal education.Experience: &nbsp;0-2 years of experience in biotechnology manufacturing, GMP facilities, or related fields. Familiarity with aseptic cleaning procedures and GMP standards is preferred.Skills &amp; Abilities: Strong attention to detail, organizational skills, and the ability to multitask in a fast-paced environment. Proficiency in aseptic gowning, with the ability to work independently and within a team. Experience with strong documentation practices, including familiarity with batch records, logbooks, and compliance forms. Effective communication skills, both written and oral, with an ability to follow instructions accurately. Ability to stand for extended periods and perform repetitive tasks.Other: Strong eye/hand coordination and work ethic. Ability to wear protective clothing and equipment, and lift objects up to [specific weight, e.g., 25 pounds].&nbsp; &nbsp;Team-oriented mindset with the ability to collaborate effectively across diverse teams.Physical Requirements: Ability to stand for extended periods and perform repetitive tasks. Capability to lift and move objects up to [specific weight, e.g., 25 pounds]. Willingness to wear protective clothing and equipment in compliance with GMP standards. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manufacturing Support Specialist 1 Contractor

Position Summary This is a new opportunity to join our high performing team as we strive to develop pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. The Associate Director, Talent Acquisition will support the entire recruitment lifecycle by owning temp-to-perm openings, managing job postings, scheduling interviews, maintaining candidate databases and ensuring a seamless onboarding experience. Key responsibilities include recruiting for temporary to perm roles, utilizing the Greenhouse Applicant Tracking Systems (ATS) to coordinate scheduling with candidates and hiring managers, and ensuring the recruiting process runs smoothly, ultimately helping to attract and secure high quality talent for ProKidney.&nbsp; This role is best suited for an individual who will enjoy collaborating with various functions within our HR team and who desires to develop as an HR professional. Responsibilities Develop and execute innovative sourcing strategies, utilizing market intelligence to meet complex, high-priority hiring demands. Serve as a strategic partner to business unit leaders, translating complex business needs into actionable hiring plans and workforce strategies. Partner extensively with hiring managers, HR Business Partners, and functional leaders as a strategic talent advisor providing market and talent insights Ensure a smooth and professional candidate journey by managing communications, resolving issues, and providing timely updates throughout the hiring process. Collaborate with the business and HR Business Partners to continue to embed structured, candidate-centered selection practices that ensure consistent, high-quality hiring decisions and positive experience Schedule interviews using Greenhouse Applicant Tracking system, manage candidate on site visits and ensure all necessary details are communicated to candidates and interviews in a timely manner. Work with Corporate Traveler to coordinate candidate travel and logistics. Maintain candidate records in Greenhouse, ensuring accuracy, confidentiality and compliance. Collaborate with Total Rewards Partners to develop offer letters, launch background investigations and conduct timely candidate references. Track HireRight background investigations through completion. Act as an SME for Greenhouse Applicant Tracking System, troubleshooting issues, managing templates, and escalating system concerns as needed. Participate in projects related to TA processes, systems/tools, procedures, and compliance. Participate and assist with ProKidney’s employment branding initiatives and university recruiting efforts. Qualifications&nbsp; Bachelor’s degree or equivalent 10+ years progressive experience in talent acquisition, biotech/pharma experience required Exceptional technical skills specific to Microsoft Outlook, experience with utilizing an applicant tracking system a plus Ability to thrive in a dynamic, fast-paced and changing environment Strong interpersonal and problem-solving skills with a passion for outstanding customer service ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Associate Director, Talent Acquisition

Position Summary The Principal Training Liaison – Manufacturing is the functional authority for GMP training strategy within Manufacturing, shaping the curricula frameworks, qualification standards, and workforce capability models that underpin ProKidney's clinical and commercial readiness. This role establishes the methodologies, best practices, and performance standards that define how Manufacturing develops, qualifies, and sustains a compliant, high-performing workforce. Operating at the intersection of regulatory science, adult learning, and manufacturing operations, this individual drives functional training strategy across Manufacturing and serves as a subject-matter authority and strategic consultant to QA, CMC, QC, Supply Chain, Facilities, and Engineering. This role anticipates compliance risk, proactively architects mitigation strategies, and influences cross-functional decisions that shape site-wide quality culture and inspection readiness. The Principal Training Liaison leads through expertise and influence, mentoring senior professionals and elevating the functional capability of the Manufacturing organization. &nbsp; Key Responsibilities GMP Training Strategy &amp; Program Architecture Architect and own the end-to-end GMP training strategy for Manufacturing, establishing frameworks, methodologies, and evaluation standards that define the function's approach to workforce readiness. Define the instructional model for GMP onboarding, including competency benchmarks, qualification criteria, and bootcamp curriculum design; set the standard others across the site adopt and follow. Anticipate regulatory trends and evolving GMP expectations; proactively integrate emerging requirements into training strategy before gaps materialize. Serve as Manufacturing's senior representative during regulatory inspections, agency interactions, and internal audits; shape the training-related narrative and lead responses to inspector inquiries. Establish and maintain curriculum governance processes, ensuring training content is current, SOP-aligned, and reflective of operational and regulatory requirements. &nbsp; Training Content Development &amp; Functional Standards Define the standards and methodology for GMP training content development across Manufacturing, including SOP-based courses, e-learning modules, job aids, and instructor-led programs; serve as the functional benchmark for quality and effectiveness. Apply advanced instructional design principles and deep cGMP expertise to design high-impact training that drives measurable improvements in compliance, operational performance, and workforce capability. Establish a systematic training effectiveness framework — including assessment design, observational audits, and feedback mechanisms — to evaluate and continuously improve program outcomes. Deliver high-stakes, specialized instructor-led training for complex regulated operations (e.g., aseptic technique, cleanroom behaviors, advanced GMP topics) where subject-matter authority is essential. &nbsp; Compliance Oversight &amp; Risk Management Define and own training compliance standards for Manufacturing; establish the metrics, governance model, and accountability structures that sustain a ≥90% training adherence rate across the site. Set and continuously optimize the qualification pathway for new hires, ensuring all personnel are trained and operationally qualified within defined timelines (target: 14 weeks from hire). Serve as the site's functional authority on aseptic technique and cleanroom behavior training, establishing the standards and qualification criteria applied across all manufacturing roles. Lead the training-related root cause analysis and CAPA development process for deviations and audit findings; anticipate systemic compliance risks and develop proactive mitigation strategies. Own the annual curriculum and job code review process, aligning training requirements with evolving role responsibilities and regulatory expectations. &nbsp; Cross-Functional Influence &amp; Continuous Improvement Act as a strategic consultant to QA, CMC, QC, Supply Chain, Facilities, and Engineering, influencing cross-functional decisions related to training, operational readiness, and cleanroom impact. Lead the training and readiness strategy for new equipment qualifications, material changes, and process introductions; shape how change is absorbed and sustained across the manufacturing workforce. Develop and own the training and operational KPI framework for Manufacturing; translate performance data into strategic insights that inform leadership decisions and drive continuous improvement. Conduct targeted floor observations and internal compliance audits; synthesize findings into recommendations that influence site-wide quality systems and operational practices. Champion and model a culture of quality, safety, accountability, and continuous improvement; shape the behavioral norms and expectations that define ProKidney's manufacturing quality culture. &nbsp; Trainer Development &amp; Organizational Capability Building Define the qualification model, competency standards, and ongoing evaluation framework for GMP trainers; serve as the functional authority on trainer certification and effectiveness measurement. Architect and lead cross-functional mentorship and capability-building initiatives that elevate technical depth and instructional quality across Manufacturing and GMP functions. Drive long-term workforce capability strategies aligned with ProKidney's clinical and commercial growth trajectory; translate organizational milestones into proactive training roadmaps. Qualifications Education / Training Bachelor's degree in Life Sciences, Engineering, Education, or related field required Advanced degree (M.S., MBA, or equivalent) preferred Instructional Design certification (e.g., ATD, CPTD) or equivalent advanced experience preferred &nbsp; Experience 8–12+ years of progressive experience in a GMP-regulated, FDA-compliant environment (biotech, pharma, or cell therapy strongly preferred) Demonstrated track record of owning and shaping GMP training strategy and program architecture — not just program execution Deep expertise in cGMP regulations, aseptic processing, cleanroom behaviors, and regulatory inspection expectations Experience influencing cross-functional decisions and serving as a strategic consultant to manufacturing and quality functions Proven ability to anticipate compliance risk and develop proactive mitigation strategies Experience with Learning Management Systems (e.g., MasterControl) and advanced instructional design methodologies &nbsp; Skills &amp; Competencies Functional authority in instructional design and advanced cGMP principles; recognized as a go-to expert within and beyond the function Strong strategic thinking and business acumen; ability to connect training outcomes to organizational and regulatory imperatives Exceptional communication, facilitation, and influencing skills across all levels of the organization, including senior leadership Ability to synthesize complex data and translate insights into strategic recommendations that drive decision-making Proven cross-functional collaboration and consultant-style engagement with partner functions Continuous improvement mindset with demonstrated ability to drive systemic, lasting change &nbsp; &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Principal Training Liaison, Manufacturing

The Manufacturing Support Specialist III plays a key leadership role in supporting manufacturing operations, with a primary focus on aseptic processing, GMP cleaning, and adherence to cGMP guidelines. This position requires a high level of expertise in performing complex aseptic processing of in-house solutions, preparing materials and kits, managing GMP areas, and ensuring stringent compliance with Standard Operating Procedures (SOPs). The role also involves actively participating in document revision, providing training and mentoring to junior staff, and assisting in deviation and CAPA (Corrective and Preventive Action) investigations. As a senior position, the Specialist III will be a key contributor to maintaining high standards of GMP documentation and will work with a high degree of accountability and independence to ensure the continuous improvement of manufacturing operations. Key Responsibilities: Aseptic Processing &amp; GMP Maintenance: Perform aseptic processing of in-house solutions according to current cGMP guidelines, ensuring all processes maintain the highest standards of sterility and quality. Participate in material kit preparation, ensuring alignment with Good Documentation Practices (GDP) and cGMP standards. Perform and oversee cleaning and sanitization of GMP areas and manufacturing equipment following approved cleaning procedures and industry best practices. Ensure proper documentation of cleaning and maintenance activities, including batch records and logbooks, in strict adherence to GMP and GDP standards. Support the maintenance of the clean room environment, ensuring it remains below alert level limits and is consistently compliant with cleanliness standards. Documentation &amp; Compliance: Review, revise, and update SOPs, batch records, and other manufacturing documents to maintain compliance with current regulatory requirements and best practices. Complete and ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, in compliance with GDP. Participate in internal and external audits, supporting the team in ensuring compliance with regulatory bodies, including the FDA. Monitor and support compliance with GMP standards and assist with deviation investigations, ensuring corrective actions are implemented where necessary. Training, Mentoring &amp; Leadership: Mentor and train new and less experienced staff on manufacturing processes, GMP procedures, and safety protocols. Lead by example to foster a culture of compliance and quality, ensuring all team members follow established guidelines and safety regulations. Assist in training initiatives for the broader team, focusing on aseptic techniques, GMP best practices, and proper documentation practices. Support the continuous improvement of manufacturing processes and SOPs through participation in cross-functional meetings and projects. Material &amp; Equipment Management: Conduct routine cycle counts in cleanrooms to ensure accurate inventory levels and prevent shortages. Manage and execute routine transactions in the ERP system, including material requisitions, production tracking, and inventory management. Ensure proper handling, storage, and documentation of materials and equipment to prevent contamination and maintain compliance with GMP standards. Safety &amp; Process Improvement: Promote and enforce adherence to safety policies and procedures to prevent workplace accidents and injuries. Proactively identify deviations from SOPs and GMP standards and take immediate corrective action. Assist in the implementation of Corrective and Preventive Actions (CAPAs), identifying root causes of issues and ensuring solutions are effectively put in place. Support process optimization initiatives and work with teams to improve operational efficiencies while maintaining regulatory compliance. Collaboration &amp; Data Collection: Collaborate with cross-functional teams, including production, quality assurance, and engineering, to ensure seamless operations and continuous adherence to manufacturing standards. Assist in data collection efforts for troubleshooting, CAPA investigations, and other manufacturing-related tasks. Provide insights and contribute to the development of new procedures, technologies, and improvements within manufacturing operations. Secondary Responsibilities: Perform additional tasks as needed to support the manufacturing team and ensure the smooth operation of the manufacturing process. Contribute to data analysis and reporting efforts as directed. Minimum Qualifications: Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or a related field; a Science-related discipline is preferred. High School Diploma or equivalent may be considered with relevant experience. Certification in aseptic techniques or GMP training is preferred. Experience: 2-4 years of relevant experience in biotechnology manufacturing, GMP environments, or a related field. Demonstrated experience with aseptic techniques, GMP cleaning, and working in a regulated environment. Experience with SOP revision, documentation control, and deviation/CAPA investigations is preferred. Skills &amp; Abilities: Strong knowledge of cGMP and GDP standards, with the ability to follow production schedules and SOPs. Proficiency in aseptic gowning, aseptic processing, and performing in a team-oriented environment. High level of attention to detail and the ability to manage multiple tasks and priorities effectively. Strong computer skills, including proficiency in Microsoft Office, ERP systems, and other relevant software tools. Excellent organizational, record-keeping, and time management abilities. Ability to communicate effectively, both written and verbally, with a diverse team and in cross-functional environments. Ability to exercise independent judgment, solve problems, and identify improvements. Other: Strong eye/hand coordination and commitment to maintaining a high quality of work. A leadership mindset with the ability to mentor and train others. Willingness to wear protective clothing and equipment as required in a GMP environment. Ability to lift and move objects up to [specific weight, e.g., 25 pounds]. Physical Requirements: Ability to stand for extended periods and perform repetitive tasks. Capability to lift and move objects up to [specific weight, e.g., 25 pounds]. Willingness to wear protective clothing and equipment as required. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Mfg Support Specialist 3

The Mfg Cell Processing Specialist 3 at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and driving continuous improvement. The Mfg Specialist 3 is responsible for mentoring team members, leading investigations, and ensuring high levels of quality and compliance. &nbsp; Responsibilities: Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards. Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members. Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and preventive maintenance. Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to procedures and maintaining quality standards. Revise, update, and ensure adherence to SOPs, batch records, and MS forms, maintaining GMP compliance. Lead routine cycle counts and ensure accurate inventory tracking and control. Execute transactions within the ERP system, including material requisitions and production tracking. Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP). Lead investigations into deviations and Corrective and Preventative Actions (CAPA) efforts, compiling data and information as required. Provide mentorship and training to junior team members in cell processing techniques, procedures, and cGMP compliance. Drive continuous improvement, incident investigations, and deviation resolutions. Perform and support investigations into deviations, incidents, and process improvements. Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment. Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards. Perform material qualification tests to qualify lots of incoming manufacturing material. Support process development and validation activities as needed. Assist in data collection, analysis, and reporting for process optimization and regulatory submissions. Perform other duties assigned to support and improve manufacturing operations. Qualifications: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may be a substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience. Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 2-3 years of proven expertise in a cGMP-regulated environment. Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills. Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role. &nbsp; ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Mfg Cell Processing Specialist 3

The QA Specialist 2 provides essential Quality Assurance support to Quality Operations, with a primary focus on material and batch release activities. Working within established GMP processes and under moderate supervision, this role contributes to maintaining compliance with Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGxP) regulations. The successful candidate applies developing professional knowledge, strong attention to detail, and effective communication skills to support documentation, compliance monitoring, and quality system activities in a fast-paced pharmaceutical environment. &nbsp; Key Responsibilities GMP Database &amp; Documentation Support Maintain accurate and consistent tracking, data entry, and follow-up within departmental GMP databases under established procedures Prepare and conduct initial reviews of batch and material release documentation, ensuring conformance with applicable SOPs, specifications, and acceptance criteria Evaluate completed manufacturing, filling, labeling records, and analytical data for compliance with regulatory standards and company requirements; escalate discrepancies to senior QA staff Report key quality metrics and performance indicators as required, using established templates and reporting tools &nbsp; Production Monitoring &amp; Product Compliance Perform hands-on monitoring of production and non-production activities; identify and report observed non-compliance to Quality Management in a timely manner Support confirmation that finished products conform to government and company standards and meet cGxP regulations Participate in internal and external audits, including customer and regulatory audits, as directed by Quality Management &nbsp; Deviation &amp; CAPA Support Assist in investigating deviations under the guidance of senior QA staff; contribute to root cause identification and propose corrective actions for review and approval Identify compliance risks and effectively communicate observations to senior management; support the implementation of assigned action plans to mitigate risks Promptly escalate critical quality issues to senior management with relevant documentation and context &nbsp; Quality System &amp; Procedure Support Regularly review and update GMP system procedures to ensure alignment with current regulatory standards and company policies, as assigned Review and provide input on SOPs, change control documents, and protocols related to cGxP programs as assigned by management Assist in the implementation and maintenance of regulated Quality Systems under the direction of senior QA personnel &nbsp; Collaboration &amp; Professional Development Collaborate with internal departments to support the implementation of quality principles and regulatory requirements Maintain up-to-date knowledge of industry trends, standards, and methodologies related to cGxP and GMP through continuous learning Apply developing technical and analytical skills while building professional judgment and deepening subject matter knowledge &nbsp; Qualifications Education/Experience Associate’s Degree + years of relevant experience in a GMP-regulated environment, OR Bachelor’s Degree in Life Sciences, Chemistry, Pharmacy, or a related field + 2 years of relevant experience in a GMP-regulated environment &nbsp; Knowledge Working knowledge of GMP and cGxP regulations as they apply to pharmaceutical manufacturing and quality operations Familiarity with deviation management and CAPA processes; experience participating in or supporting investigations preferred Basic familiarity with FDA, EU, and/or ISO regulatory frameworks preferred &nbsp; Skills Communicates professionally, clearly, and concisely — both verbally and in writing — with internal and external stakeholders Strong attention to detail with the ability to maintain accuracy in documentation and data entry under defined processes Able to organize and prioritize assigned work effectively to meet timelines with quality deliverables Works collaboratively within a team environment; receptive to feedback and committed to continuous improvement Proficient with Microsoft Word, Excel, and Adobe; experience with electronic batch record or LMS systems a plus &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

QA Specialist 2, Batch Release Contractor

The Manufacturing Specialist II, Cell Processing at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves setting up, operating, and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and providing guidance to junior staff while leading improvements in cell processing operations. &nbsp; Essential Duties &amp; Responsibilities: Lead and participate in cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards.• Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to other team members as needed.• Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and maintaining preventive maintenance schedules.• Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to specified procedures and quality standards.• Revise, update, and ensure adherence to approved documents, including SOPs, batch records, and MS forms, maintaining GMP compliance.• Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).• Train and mentor junior team members in cell processing techniques, procedures, and cGMP compliance.• Perform and support investigations into deviations, incidents, and process improvements.• Lead efforts in process development, qualification, and validation activities as needed.• Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment. Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards. &nbsp; &nbsp; Secondary Responsibilities: Lead and assist in material qualification tests to ensure the suitability of manufacturing materials.• Provide guidance and support for continuous process improvement initiatives.• Assist in data collection, analysis, and reporting for process optimization and regulatory submissions.• Perform other duties as assigned to support and improve manufacturing operations. &nbsp; Minimum Qualifications: Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.• Experience: Preferred minimum 2-4 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 1-2 years of proven expertise in a cGMP-regulated environment.• Skills/Abilities: Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills.• Other: Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role. &nbsp; &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Position Summary: The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-quality, compliant datasets, tables, listings, and figures while ensuring adherence to project timelines, SOPs, regulatory requirements, and CDISC standards. Responsibilities: Program and validate tables, listings, figures, and derived datasets using SAS. Develop SDTM and ADaM datasets and supporting documentation. Prepare and review mapping specifications and annotated case report forms (CRFs). Perform quality control and validation activities for programming deliverables. Collaborate with study team members to identify, investigate, and resolve data and output issues. Review study documents and provide input to improve programming quality, efficiency, and consistency. Maintain complete, accurate, and audit-/inspection-ready programming documentation. Communicate project status, risks, issues, and timeline impacts clearly to stakeholders. &nbsp;Qualifications: Bachelor’s degree required; Master’s degree preferred in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. Minimum of 10 years of relevant statistical programming experience within the pharmaceutical, biotechnology, or CRO industry. Phase 3 and regulatory submission experience preferred. Strong SAS programming skills, with experience developing SDTM, ADaM, tables, listings, and figures. Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation. High attention to detail, with strong analytical, problem-solving, and communication skills. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Statistical Programmer Contractor

Statistical Programmer Contractor Position Summary: The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-quality, compliant datasets, tables, listings, and figures while ensuring adherence to project timelines, SOPs, regulatory requirements, and CDISC standards. Responsibilities: Program and validate tables, listings, figures, and derived datasets using SAS. Develop SDTM and ADaM datasets and supporting documentation. Prepare and review mapping specifications and annotated case report forms (CRFs). Perform quality control and validation activities for programming deliverables. Collaborate with study team members to identify, investigate, and resolve data and output issues. Review study documents and provide input to improve programming quality, efficiency, and consistency. Maintain complete, accurate, and audit-/inspection-ready programming documentation. Communicate project status, risks, issues, and timeline impacts clearly to stakeholders. &nbsp;Qualifications: Bachelor’s degree required; Master’s degree preferred in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. Minimum of 10 years of relevant statistical programming experience within the pharmaceutical, biotechnology, or CRO industry. Phase 3 and regulatory submission experience preferred. Strong SAS programming skills, with experience developing SDTM, ADaM, tables, listings, and figures. Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation. High attention to detail, with strong analytical, problem-solving, and communication skills. &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

The Manufacturing Operations Supervisor provides front-line supervision for the manufacturing support function, ensuring safe, compliant, and reliable execution of daily operations in accordance with cGMP requirements. This role coordinates core support activities including media preparation, material kitting, and GMP cleaning to enable on-time manufacturing execution by following the approved schedule and standard work. The supervisor assigns daily work, supports training and qualification compliance, addresses routine operational issues, and escalates constraints, deviations, and staffing concerns to management as appropriate. This position partners with Manufacturing, Quality, Supply Chain, Training, and Facilities to maintain operational continuity and serves as a floating supervisor, providing supervisory coverage for the Cell Processing team as needed.Supervision &amp; Leadership• &nbsp; &nbsp;Provide day-to-day supervision and guidance for the manufacturing support team, reinforcing safe, efficient, and compliant execution of assigned operations• &nbsp; &nbsp;Assign and coordinate daily workload and priorities across media preparation, material kitting, GMP cleaning, and related support activities to meet production demand• &nbsp; &nbsp;Maintain routine floor presence and conduct shift huddles to communicate priorities, monitor progress, and reinforce standard work and cGMP behaviors• &nbsp; &nbsp;Provide coaching and on-the-job guidance; document observations and communicate recurring performance concerns to management/HR for follow-up as needed• &nbsp; &nbsp;Promote a culture of safety, quality, and accountability through clear expectations, timely feedback, and consistent follow-throughProduction &amp; Scheduling• &nbsp; &nbsp;Coordinate end-of-day cleaning activities to support next-day readiness; ensure tasks are executed and documented and communicate any missed activities and recovery needs• &nbsp; &nbsp;Coordinate daily/weekly support execution (materials, media, and cleaning) to align with the production plan; communicate readiness and issues to the appropriate stakeholders• &nbsp; &nbsp;Partner with the Manufacturing Scheduler to align priorities and communicate schedule impacts and constraints; support mitigation actions as directed• &nbsp; &nbsp;Coordinate shift coverage (including time-off coverage) and communicate coverage risks to management; support coverage plans to minimize impact to operations• &nbsp; &nbsp;Support timely task execution by removing routine barriers, adjusting priorities within the shift, and escalating issues that may impact schedule adherence• &nbsp; &nbsp;Track and communicate shift performance items (e.g., completion status, documentation issues, and safety/quality observations) and escalate recurring issues for corrective actionManufacturing Compliance• &nbsp; &nbsp;Provide daily floor-level quality oversight for the support team by reinforcing procedures, safety expectations, and Quality System requirements• &nbsp; &nbsp;Verify manufacturing documentation is completed correctly and on time, including Batch Records and Electronic Batch Records (EBRs); coordinate timely correction of errors and coaching to prevent recurrence• &nbsp; &nbsp;Review batch records, SOPs, and logbooks for accuracy and completeness; route documentation per procedure and promptly escalating discrepancies to Quality and Manufacturing management• &nbsp; &nbsp;Support internal and external audits and inspections by ensuring documentation readiness for the shift and by completing assigned follow-up actions within required timelinesSystem &amp; Documentation Management:• &nbsp; &nbsp;Perform and verify accurate ERP transactions supporting manufacturing execution (e.g., material requisitions/allocation, production tracking, and work order updates)• &nbsp; &nbsp;Oversee documentation-related workstreams (labels, EBR updates, media and materials requests), ensuring prioritization, accuracy, and on-time completion• &nbsp; &nbsp;Author and updated controlled documents (e.g., SOPs, deviations, protocols) in alignment with GMP requirements; route completed documents for review and approval through the appropriate Quality Systems workflow• &nbsp; &nbsp;Ensure training records are current and audit-ready; verify team compliance with required curricula, certifications, and role-based qualification plansContinuous Improvement &amp; Operational Efficiency• &nbsp; &nbsp;Collaborate with cross-functional stakeholders to identify operational risks, capacity constraints, and resource needs; escalate findings and support mitigation plans as directed• &nbsp; &nbsp;Coordinate evaluation and implementation of new materials and equipment by defining user requirements, supporting trials, and confirming readiness for GMP use• &nbsp; &nbsp;Maintain visibility to improvement ideas, deviations/operational issues, and employee concerns; track progress and escalate unresolved items to leadership• &nbsp; &nbsp;Participate in and support continuous improvement activities (standardization, 5S, waste reduction, error-proofing) to improve safety, quality, and cycle time• &nbsp; &nbsp;Participate in cross-functional projects as a team representative to support manufacturing support capability and business continuity Team Development &amp; Training• &nbsp; &nbsp;Provide training support for material kitting and cleaning (as a trainer and/or by coordinating with qualified trainers) to support consistent execution to approved procedures• &nbsp; &nbsp;Coach employees on standard work and GMP expectations; reinforce good practices through routine observations and feedback• &nbsp; &nbsp;Coordinate with Training to schedule and complete required curricula; identify training gaps and communicate needs and impacts to management• &nbsp; &nbsp;Monitor training completion and communicate non-compliance or qualification risks; support recovery actions as directed• &nbsp; &nbsp;Support onboarding and orientation for new team members by coordinating training plans and documenting progress toward role qualification milestonesAdministrative &amp; Communication Responsibilities• &nbsp; &nbsp;Manage shift handoffs and coverage changes, assign daily responsibilities, and represent the team in daily/departmental communications as needed• &nbsp; &nbsp;Communicate status, risks, and needs to the manager and partner departments to support timely issue resolution in a fast-paced manufacturing environment• &nbsp; &nbsp;Provide clear, timely written communication (emails, shift updates, and documentation) to ensure alignment and traceabilityAdditional Responsibilities• &nbsp; &nbsp;Provide supervisory coverage across manufacturing operations as needed to maintain safe, compliant, and uninterrupted execution• &nbsp; &nbsp;Ensure manufacturing areas remain clean and inspection-ready, including equipment staging, waste management, and housekeeping to established standards• &nbsp; &nbsp;Support initiatives that improve team performance against safety, quality, delivery, and compliance expectations; reinforce gains through standard work• &nbsp; &nbsp;Perform other duties as assigned to support departmental objectives and changing business needs QualificationsEducation / Training• &nbsp; &nbsp;Bachelor’s degree or equivalent experience in a related field (e.g., Life Sciences, Manufacturing, or Engineering)Experience/Education• &nbsp; &nbsp;AS/BS in Biotechnology, Biology, Chemistry or equivalent• &nbsp; &nbsp;Minimum 4+ years of experience in a manufacturing or GMP environment&nbsp;• &nbsp; &nbsp;2+ years of experience in lead, training, or coordination role&nbsp;Knowledge/Skills• &nbsp; &nbsp;Strong knowledge of GMP guidelines, safety protocols, and regulatory requirements• &nbsp; &nbsp;Familiarity with ERP systems (Sage X3 or similar) and document management systems• &nbsp; &nbsp;Good communication, leadership, and problem-solving skills• &nbsp; &nbsp;Ability to work in a fast-paced environment while maintaining high standards of quality and compliance• &nbsp; &nbsp;Technical writing experience is a plus (e.g., SOPs, deviation reports, protocols) &nbsp; &nbsp; &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Manufacturing Operations Supervisor

Position Summary:Join us in developing pioneering therapies that aim to transform the treatment of Chronic Kidney Disease (CKD) and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells, potentially preventing or delaying the need for dialysis or transplant. Quality Control (QC) Microbiology Analyst III provides support and execution on ProKidney’s Environmental Monitoring and Microbiological testing, maintaining GMP compliance, and mentoring junior analysts. This role involves monitoring during manufacturing operations, routine EM and utilities, root cause analysis of excursions, and documentation and continuous improvement within the QC Microbiology team. The Analyst III will work a 5/8 schedule (Sunday–Thursday or Monday-Friday), with weekend and holiday support. Shifts from either 0700–1600, 0800–1700 or 1030-1930.&nbsp; Essential Duties and Responsibilities Perform Change Control and CAPA investigations, ensuring timely closure, impact assessments, and regulatory compliance. Support and internal and external audits. Generate and present metrics and trends for Management Review. Support training on Good Documentation Practices, Data Integrity, and Change Management. Review and maintain SOPs, Work Instructions, Validation studies, Risk Assessments and protocols. Participate in continuous improvement initiatives, harmonization efforts, and risk assessments related to quality control. Perform Routine Environmental Monitoring (EM) of classified GMP areas Conduct Personnel Monitoring during Aseptic Manufacturing Operations and EMPQ activities Operate, maintain and troubleshoot EM and laboratory equipment Adhere to Standard Operating Procedures (SOPs), Work Instructions (WIs), Protocols and safety requirements and document laboratory work consistent with cGMP requirements Participate in revising, and training on SOPs, WIs, Forms, and Protocols Supports lean initiatives in the area of lab operations, standard work, test method execution, documentation updates and equipment qualification &nbsp; Minimum Qualifications: Education/Training: Bachelor’s degree in a science or technical discipline preferred, or equivalent experience. Experience: 3-5 years of progressive experience in quality systems within regulated pharma, biotech, or medical device industries. Experience with commercial manufacturing and cleanroom monitoring strongly preferred. Knowledge: Strong working knowledge of quality systems operations (Deviations, CAPA, Change Control, Training, Complaints, Document Control). Excellent technical writing, training, and communication skills. Analytical mindset with ability to trend data and identify improvement opportunities. Skills: Strong attention to detail and organizational skills Ability to work independently Competence with Microsoft Office (Excel, Word, Visio); LIMS or data tracking systems a plus Comfortable performing tasks in a cleanroom setting and wearing PPE for extended periods Strong written and verbal communication skills Hands-on experience with electronic QMS, particularly MasterControl (system administration and process ownership). Hand-on experience with LIMS or sample management programs Ability to lift up to 30 pounds and maintain good hand-eye coordination. Bending, lifting and squatting required. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

QC Microbiology Analyst 3

The Technical Investigator is responsible for the initiation, investigation and completion of process deviations, Change Controls, and CAPA’s for the assigned department. The incumbent is responsible for completion of process deviations with the aim at identification of root cause, determining any product quality impact and implementation of corrective actions to prevent recurrence. They will also be responsible for drafting and managing Departmental Change Controls• Technical writing for the educated reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product. Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report.• Gathering Data from various sources across the site, performance of Root Cause Analysis to determine the most likely cause of the deviation investigation, assessment of event for impact to Safety, Identity, Strength, Quality, Purity, perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing.• Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.• Work with the appropriate department(s) for data gathering, observing processes for investigations, and performance of associate interviews.• Meeting Facilitation and participation, aligning internal team and area subject matter experts on an agreed investigational path forward. Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objective.• Understand Regulatory requirements around Cell Therapy processing.• Able to lead and track Change controls through the process ensuring timely completion.• Perform other duties as assigned. &nbsp; Requirements: Undergraduate degree in science discipline 5+ years’ experience in a Cell Therapy environment in the department hired. Strong organizational skills and record keeping with the ability to work overtime when needed.• Ability to engage and interview co-workers to obtain relevant information pertaining to investigations.• Strong attention to detail and organizational skills.• Strong communication skills (written and oral).• Independent and self-motivated.• Familiarity with cGMP quality systems.• Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records).• Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint). &nbsp; &nbsp; &nbsp; &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Investigator, MFG Compliance

Position Summary:The Senior Manager, IT Assurance and Compliance is responsible for ensuring all GxP Laboratory and Manufacturing instrument and equipment software and computerized systems are implemented, validated, and maintained in compliance with applicable regulatory and industry standards, including FDA, including FDA, ICH, GAMP 5, and global Health Authority requirements. This role leads validation efforts for new and existing software implementations, manages the lifecycle of validated systems, and ensures sustained compliance through continuous monitoring and governance. This role combines deep technical expertise in computer system validation, a strong understanding of quality systems, and excellent cross-functional collaboration skills to ensure IT systems operate reliably, securely, and compliantly across the enterprise. &nbsp; Essential Duties &amp; Responsibilities: Lead validation projects, including the planning, execution, and documentation of computer system validation deliverables. Lead qualification, validation, and periodic review activities for laboratory and manufacturing instrument software and systems Ensure continued GxP compliance of QC laboratory computer systems and software. Coordinate with IT Operations team to ensure data backup and disaster recovery strategies for critical laboratory systems are setup. Collaborate with QA teams to ensure alignment of priorities and delivery of outcomes (policies, procedures and documents). Provide guidance and oversight to ensure computerized systems are deployed and maintained following the full system lifecycle (SDLC), IT change control, and applicable SOPs. Review and approve validation deliverables authored by internal teams and external vendors. Manage multiple validation and compliance projects simultaneously, balancing priorities across manufacturing, clinical, and corporate systems. Ensure audit and inspection readiness by maintaining documentation quality, traceability, and regulatory alignment. Lead the creation, revision, and implementation of IT governance SOPs and quality documentation, ensuring alignment with FDA Computer Software Assurance (CSA) principles and risk-based validation strategies. Conduct audits of IT systems, vendors, and validation documentation. Partner with QA and business stakeholders to maintain validated system compliance through release management, change control, incident management, CAPA, periodic reviews, and audit trail reviews. Conduct impact and risk assessments for changes affecting validated systems and ensure appropriate mitigation actions. Maintain the inventory of all GxP computerized systems, ensuring re-qualification/revalidation schedules are current and properly documented. Perform system risk assessments to determine GxP classification and validation requirements. Manage vendor qualification activities, including the distribution and evaluation of IT vendor questionnaires and supporting audits or assessments. Be onsite to provide vendor oversight, when needed. &nbsp; Qualifications: &nbsp; Education/Training: Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related technical or scientific discipline required. Experience: 8+ years of experience in computer system validation (CSV), IT quality, or IT compliance roles within a regulated environment. Strong background in validation of systems such as, LIMS, MES, and other Laboratory/Manufacturing systems. Experience supporting both Manufacturing and Clinical Study Systems required. Knowledge: In-depth understanding of global CSV guidelines and regulatory expectations, including 21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices (GCP), and Data Integrity principles. Familiarity with FDA Computer Software Assurance (CSA) guidance and risk-based validation methodologies. Strong working knowledge of cloud-based and SaaS system validation approaches. Skills: Excellent organizational, analytical, and problem-solving skills with the ability to manage multiple priorities. Strong written and verbal communication skills, with proven ability to work effectively across departments. High attention to detail and commitment to quality and compliance. Ability to foster collaboration between IT, Quality, and business functions. Certifications/Licenses: Preferred: Certification in quality or regulatory compliance. ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Sr Manager IT Assurance and Compliance

Position Summary: The Manufacturing Specialist, Cell Processing at ProKidney is responsible for supporting cell processing operations, ensuring compliance with cGMP guidelines in the development and production of regenerative medicine therapies. This role involves setting up and operating production equipment, including control rate freezers, orbital shakers, and other equipment, while contributing to efficient processing, freezing, and storage of cell therapy products. &nbsp; Essential Duties &amp; Responsibilities: Coordinate with team members and perform tasks with minimal supervision. Participate in cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards.• Set up and operate production equipment such as control rate freezers, orbital shakers, and other systems to support cell processing activities.• Assist in processing, freezing, and storage of biologic and cell therapy products, ensuring adherence to cGMP standards.• Accurately complete GMP documentation, including batch records, logbooks, and forms, ensuring compliance with Good Documentation Practices (GDP).• Maintain inventory and monitor conditions related to biologic and cell therapy products, including temperature control, expiration dates, and equipment calibration.• Ensure the accuracy and integrity of cell processing workflows, identifying deviations from established procedures and taking corrective actions as necessary.• Collaborate with cross-functional teams to support process improvements, troubleshooting, and equipment maintenance. Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards. &nbsp; Secondary Responsibilities and Functions: Assist in data collection, analysis, and reporting for process improvement initiatives.• Support material qualification, process development, and validation efforts as required.• Maintain compliance with all relevant safety policies, rules, and regulations.• Perform other duties as assigned. &nbsp; Minimum Qualifications: Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.• Experience: Preferred minimum 0-2 years of experience in cell processing, biotechnology manufacturing, or a related field. Experience with biologic or cell therapy production is highly desirable.• Skills/Abilities: Strong understanding of cGMP requirements, with proficiency in operating cell processing equipment. Ability to work independently or collaboratively, demonstrate attention to detail, and follow complex protocols. Strong organizational, record-keeping, and time management skills.• Other: Good eye/hand coordination, effective written and oral communication skills, a team-oriented approach, and a strong work ethic are essential for success. &nbsp; &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Mfg Cell Processing Specialist 1

Position Summary:The MSAT Research Associate II performs standard laboratory and manufacturing-support activities with increasing independence. The role supports routine process monitoring, technical data collection, experimental execution, and documentation for cell therapy manufacturing processes while developing broader understanding of process performance, product quality, and control requirements. This role supports a GMP cell therapy manufacturing environment and requires work in laboratories, manufacturing areas, cleanrooms, or office settings. The role may involve occasional weekend, evening, or on-call support depending on manufacturing campaign needs, patient scheduling, and product lifecycle priorities. &nbsp; Essential Duties &amp; Responsibilities: Standard Technical Execution Execute standard MSAT experiments and process-support studies using approved procedures. Support cell therapy process steps including cell culture, expansion, harvest, wash/concentration, formulation, cryopreservation, and thaw assessment. Collect and summarize process data including cell count, viability, growth kinetics, yield, recovery, and in-process control results. Process Monitoring and Quality-System Support Support routine process monitoring and continued process verification activities. Assist with deviation investigations, CAPAs, change controls, and batch record reviews. Maintain accurate GMP and technical documentation. Support chain of identity, chain of custody, contamination control, aseptic processing, and data integrity requirements. Escalation and Cross-Functional Support Escalate abnormal trends, procedural issues, or unexpected results to senior technical staff. Contribute data and documentation that support technical assessments, product-impact evaluations, and lifecycle-management activities. Qualifications: Education/Training: BS degree in biology, cell biology, biochemistry, bioengineering, chemical engineering, biotechnology, or related field. BS degree with 2–4 years of relevant experience, or MS degree with limited experience. Experience: Experience in laboratory operations, cell culture, biologics manufacturing, process development, or technical operations. Knowledge: Working knowledge of standard laboratory and cell-processing techniques. Basic understanding of GMP, GDP, aseptic technique, and data integrity expectations. Skills: Ability to perform routine calculations, data summaries, and documentation review. Collaborates effectively within MSAT, Manufacturing, and Quality teams. Builds technical ownership of assigned tasks. Contributes to a team culture focused on accuracy, compliance, and patient impact. Certifications/Licenses: n/a ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Associate 2, MS&T

&nbsp; Position Summary We are seeking a highly skilled and motivated Scientist / Senior Scientist to support mechanism of action (MoA) elucidation for rilparencel, our autologous kidney cell therapy currently being evaluated in a Phase 3 clinical study, as well as the development of next-generation cell therapies. Working closely with cross-functional teams, you will translate translational biology hypotheses into rigorous experimental designs that generate the definitive data needed to support publications and potential regulatory filings. The ideal candidate is a strategic scientific problem-solver who navigates the non-linear dynamics of complex biological systems. You possess the scientific maturity to design robust experimental frameworks that deconstruct biological noise and contextualize donor variability. Leveraging hands-on expertise in multi-parameter flow cytometry, cell sorting, and genetic engineering, you will design advanced models to deconvolute cellular heterogeneity and interrogate pathways of interest. You possess the ability to synthesize high-dimensional, multi-modal datasets into actionable insights that shape our overarching translational strategy and cross-functional decision-making. Essential Duties &amp; Responsibilities Mechanism of Action Elucidation Autologous Modeling: Design in vitro systems that deliberately account for and characterize donor heterogeneity and functional variability within an in vitro disease model system. Phenotypic Profiling: Utilize multi-parameter flow cytometry (FACS) for high-resolution cell sorting, phenotyping, and functional characterization within heterogeneous populations. Target validation: Apply gene editing technologies to interrogate specific molecular mechanisms. R&amp;D Analytical Development Mechanism-Informed Assay Design: Develop and evaluate novel functional testing methodologies to identify and inform prospective therapeutic potency metrics. Optimization &amp; Diagnostics: Establish rigorous experimental controls to maximize signal-to-noise ratios and autonomously investigate complex biological datasets to inform experimental strategies. Quality &amp; Reproducibility: Design highly reproducible workflows that ensure data integrity and adherence to standard operating procedures. Data Interpretation &amp; Communication Data Synthesis: Integrate and visualize multi-modal datasets to generate a cohesive understanding of biological mechanisms. Scientific Communication: Communicate experimental findings effectively across cross-functional groups. Qualifications &amp; Experience Education &amp; Experience Scientist / Sr. Scientist: Ph.D. in Cell Biology, Systems Biology, Immunology, Molecular Biology, Bioengineering, or a related field with 0+ / 2+ years of industry or relevant post-doctoral experience; OR a Master’s degree with 2+ / 4+ years of industry experience; OR a Bachelor’s degree with 4+ / 8+ years of industry experience Knowledge &amp; Skills Flow Cytometry / FACS: Multi-parameter flow cytometry panel design, execution, and data analysis for cellular phenotyping and functional profiling. Gene Editing: Hands-on experience with molecular gene editing tools to engineer cells or model specific pathway manipulations. Assay Development: A proven track record of independently designing, optimizing, and functionally validating non-standard cell-based assays. Complex Systems: Hands-on experience working with primary human cells, complex co-culture systems, or tissue models where cell behavior is highly context dependent. Autonomy &amp; Agility: Capability to operate with autonomy in a fast-paced environment, shifting technical directions fluidly as new data emerges. &nbsp; Skills List: Assay development and validation Flow cytometry / FACS Molecular biology and gene editing Mammalian cell culture / co-culture Analytical instrument troubleshooting Data synthesis and statistical analysis SOP compliance Analytical problem solving Cross-functional collaboration Project management and autonomy ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Sr Scientist In Vitro R&D Contractor

The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP guidelines. This role involves overseeing day-to-day operations of the manufacturing team, troubleshooting issues, leading deviation and CAPA investigations, and mentoring staff. The Team Lead is a Subject Matter Expert (SME) in manufacturing processes, driving continuous improvement, ensuring high-quality GMP documentation, and promoting operational efficiency. &nbsp; Lead the day-to-day operations of the manufacturing team, ensuring all manufacturing processes are completed efficiently and effectively.• Initiate manufacturing deviations, Corrective and Preventive Actions (CAPAs), and Critical Change Requests (CCRs) as required, leading investigations and compiling relevant data and information.• Serve as a Subject Matter Expert (SME) on all manufacturing processes, providing guidance and training to team members.• Quickly and efficiently troubleshoot manufacturing issues, directing team members on corrective actions.• Complete manufacturing batch record reviews for all manufacturing processes, ensuring compliance with cGMP guidelines.• Participate in the aseptic processing of in-house solutions and patient processes in accordance with cGMPs.• Read, understand, and follow Standard Operating Procedures (SOPs) and assist in the development and revision of SOPs, batch records, and MS forms as needed.• Assist in the selection, hiring, training, and mentoring of new staff, ensuring personnel are adequately trained and scheduled to support manufacturing operations.• Perform routine transactions in the ERP system, including material requisitions, production tracking, work order updates, and managing production BOMs.• Complete GMP documentation, including batch records, logbooks, and forms, according to Good Documentation Practices (GDP).• Support the maintenance of the cleanroom environment, ensuring cleanliness and compliance with alert-level limits.• Comply with all relevant safety policies, rules, and regulations, ensuring team members adhere to safety protocols.• Perform procedures according to written guidelines, recognizing deviations from accepted practices, and taking corrective action as necessary.• Lead and direct the work of others, with a wide degree of creativity and latitude expected. May provide consultation on projects and serve as a high-level contributor/specialist. Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards. &nbsp; Secondary Responsibilities: Participate in internal and external audits as required.• Compile and analyze data, prepare reports, and make recommendations for process improvements.• Perform routine logbook reviews and data tracking.• Provide support for process development activities as needed.• Perform other duties as assigned to support manufacturing operations effectively. &nbsp; Minimum Qualifications: Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline preferred. High School Diploma or equivalent may be considered with significant relevant experience.• Experience: Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with 3-4 years of proven expertise in a cGMP-regulated environment.• Skills/Abilities:• Thorough knowledge of various biological processing techniques, including cell culture, relevant to ProKidney’s cell therapy process. • Advanced knowledge of cGMP facilities and requirements.• Proficiency in Microsoft applications, especially Word, Excel, etc.• Strong organizational skills and the ability to manage and prioritize multiple projects or assignments, meeting deadlines effectively.• Critical thinking and troubleshooting skills to handle unexpected events.• Ability to exercise judgment within defined procedures and practices to determine appropriate actions.• Other: Good eye/hand coordination, effective written and oral communication, a team-oriented approach, and a strong work ethic. &nbsp; &nbsp;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Senior Analyst, QC

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