Associate Director, Manufacturing Operations

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 & 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.

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.