Prime Medicine is a biotechnology company focused on developing innovative RNA-based therapeutics to treat genetic diseases. The company's cutting-edge research and technology aim to revolutionize the field of medicine by providing personalized treatments for patients with rare and common genetic disorders. With a dedicated team of scientists and experts, Prime Medicine is committed to advancing the future of healthcare through its groundbreaking approach to gene therapy.

prime-medicine

<div class="content-intro"><p><strong>Company Overview:</strong></p>
<p>Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. &nbsp;</p>
<p>Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology &amp; oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit <a href="http://www.primemedicine.com/">www.primemedicine.com</a>.</p></div><p><strong>POSITION SUMMARY</strong></p>
<p>The Vice President, Regulatory Affairs will report to the Chief Medical Officer and will partner closely with leaders across Research, CMC, Clinical Development, and Program Management. This is a critical role that will shape regulatory global strategy from early development through BLA/ MAA submission, while building and mentoring a high-performing regulatory affairs function.</p>
<p><strong>KEY RESPONSIBILITIES</strong></p>
<p><strong>Regulatory Strategy &amp; Leadership</strong></p>
<ul>
<li>Develop and own global regulatory strategies for all Prime Medicine programs, including gene editing (Prime Editing), cell therapy, pulmonary and combination product modalities</li>
<li>Serve as the primary regulatory interface with the FDA (CBER/CDER), EMA, and other global health authorities; lead and manage high-stakes regulatory meetings, negotiations, and correspondences</li>
<li>Provide strategic and technical guidance on INDs, CTAs, BLAs, MAAs, and related regulatory submissions, ensuring timely and high-quality filings</li>
<li>Lead the development of regulatory risk assessments and mitigation strategies across all pipeline programs</li>
<li>Represent regulatory affairs in executive leadership forums, Board communications, and due diligence activities for in-licensing, collaborations, and M&amp;A</li>
</ul>
<p><strong>&nbsp;</strong></p>
<p><strong>Submissions &amp; Interactions with Health Authorities</strong></p>
<ul>
<li>Oversee preparation, review, and submission of all IND and CTA filings, ensuring scientific rigor and regulatory compliance across US, EU, and other global regions</li>
<li>Lead strategy and execution for Breakthrough Therapy, RMAT, Orphan Drug, and other expedited designation requests as applicable</li>
<li>Direct interactions with FDA, EMA, and other regulatory agencies on all matters including clinical holds, major objections, product labeling, and post-approval commitments</li>
<li>Maintain a thorough understanding of evolving regulatory guidance for advanced medicinal therapy products (ATMPs), gene therapies, and gene-edited cell therapies</li>
</ul>
<p>&nbsp;</p>
<p><strong>Team Building &amp; Cross-Functional Collaboration</strong></p>
<ul>
<li>Able to function in lean teams and being a hands-on operator</li>
<li>Partners with CMC, Clinical, Nonclinical, Program Management and Manufacturing teams to integrate regulatory strategy into all stages of program development</li>
<li>Champion and drive cross-functional regulatory readiness, including preparation for pre-BLA meetings, advisory committee meetings, and inspection readiness activities</li>
<li>Provide regulatory oversight and guidance for CMO/CRO activities, ensuring regulatory compliance throughout the supply and clinical development chain</li>
<li>Manage regulatory consultants and CROs</li>
</ul>
<p>&nbsp;</p>
<p><strong>Regulatory Intelligence &amp; Compliance</strong></p>
<ul>
<li>Monitor and interpret evolving global regulatory requirements, guidance, and precedents relevant to gene editing, cell therapy, and rare/genetic disease programs</li>
<li>Champion continuous process improvements in regulatory operations, submission quality, and knowledge management</li>
<li>Maintain compliance with ICH guidelines and all applicable regional regulatory requirements</li>
</ul>
<p>&nbsp;</p>
<p><strong>KEY REQUIREMENTS</strong></p>
<p><strong>Education</strong></p>
<ul>
<li>Bachelor's degree in a scientific discipline required; and advanced degree (PhD, PharmD, or MD) strongly preferred</li>
</ul>
<p>&nbsp;</p>
<p><strong>Experience</strong></p>
<ul>
<li>Minimum 15+ years of progressively responsible regulatory affairs or comparable experience in the pharmaceutical or biotechnology industry, gene/ cell/ novel platform therapy will be preferred</li>
<li>Minimum 5+ years of leadership experience in a global regulatory affairs role, with demonstrated success managing teams</li>
<li>Significant experience in gene therapy, gene editing, cell therapy, or other advanced medicinal therapy products (ATMPs) is strongly preferred</li>
<li>Experience working in rare and orphan disease, and familiar with unique regulatory frameworks guiding development in this therapeutic area.</li>
<li>Demonstrated track record of successful IND and CTA submissions for novel modalities, including experience with CBER-regulated programs</li>
<li>Demonstrated track record of successful BLA, NDA, and/or MAA submissions, including driving regulatory strategy and critical submission activities within expedited timelines across US and international regions.</li>
<li>Prior experience engaging with FDA (CBER preferred), EMA, and other global health authorities on complex regulatory questions</li>
<li>Familiarity with RMAT, Breakthrough Therapy, and Orphan Drug designation pathways is highly desirable</li>
<li>Is enthusiastic about keeping up with regulatory guidance and the changing environment and putting into practice those updates</li>
</ul>
<p>&nbsp;</p>
<p><strong>Skills &amp; Competencies</strong></p>
<ul>
<li>Exceptional strategic thinking with the ability to translate complex scientific and regulatory challenges into clear, actionable regulatory plans</li>
<li>Hands-on mentality, with ability to work in a very lean environment and willingness to generate regulatory content when necessary.</li>
<li>Comfort and experience managing contract research organizations.</li>
<li>Strong leadership presence with proven ability to build, develop, and inspire high-performing teams in a dynamic, fast-paced environment</li>
<li>Excellent negotiation, communication, and interpersonal skills; ability to represent Prime Medicine credibly before regulatory agencies and external partners</li>
<li>Proven ability to work cross-functionally and influence without authority across Research, CMC, Clinical, and Commercial functions</li>
<li>Demonstrated ability to manage multiple programs simultaneously, prioritize effectively, and deliver results on schedule</li>
<li>Entrepreneurial mindset and comfort operating in an innovative, science-driven, start-up/growth-stage environment</li>
<li>Ability and willingness to travel domestically and internationally as needed</li>
</ul>
<p><strong>WHAT WE OFFER</strong></p>
<ul>
<li>Competitive base salary commensurate with experience</li>
<li>Performance-based annual bonus eligibility</li>
<li>Equity participation (stock options) reflects our commitment to shared success</li>
<li>Comprehensive benefits package including medical, dental, vision, 401(k), and more</li>
<li>A collaborative, mission-driven culture at the forefront of genetic medicine innovation</li>
<li>The opportunity to shape the regulatory function of a leading gene editing company at a pivotal stage of growth</li>
</ul>
<p>&nbsp;</p>
<p>US citizenship or valid work authorization required</p>
<p>Prime Medicine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.</p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).</p>
<p>Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.</p>
<p>Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.</p></div><div class="title">U.S. Pay Range</div><div class="pay-range"><span>$313,000</span><span class="divider">&mdash;</span><span>$348,000 USD</span></div></div></div><div class="content-conclusion"><p>Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.</p></div>

VP, Regulatory Affairs

<div class="content-intro"><p><strong>Company Overview:</strong></p>
<p>Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. &nbsp;</p>
<p>Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology &amp; oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit <a href="http://www.primemedicine.com/">www.primemedicine.com</a>.</p></div><p><strong>Department: </strong>Quality Assurance, GMP Systems Readiness and Validation</p>
<p><strong>Reports to: </strong>Laboratory Operations Lead</p>
<h2>Position Summary</h2>
<p>The Laboratory Operations Specialist keeps Prime Medicine's laboratory instruments in working order and ready for inspection. The role manages the vendors who calibrate and maintain that equipment and owns the system that tracks it. The specialist works half time within Laboratory Operations and reports to the Laboratory Operations Lead.</p>
<h2>Essential Duties and Responsibilities</h2>
<ul>
<li>Own the master service calendar for all laboratory instruments and equipment. Schedule every qualification, preventive maintenance, calibration, and repair visit with outside vendors. Arrange repair service with vendors to return instruments to working order.</li>
<li>Carry out equipment maintenance and calibration, whether directly or through a vendor technician. Confirm that records satisfy SOP requirements and specifications, escalating to QA any deviations or excursions.</li>
<li>Serve as the business owner of Qualer as the system of record for equipment and calibration. Maintain equipment records, keeping calibration certificates, maintenance logs, and service records ready for inspection at all times.</li>
<li>Track the calibration and maintenance status of every instrument. Tag equipment that falls out of service or calibration due date. Periodically reconcile the physical equipment inventory against Qualer and review upcoming or overdue activities, recurring failures, and other equipment-performance trends.</li>
<li>Serve as the business owner of Elemental Machines as the monitoring system of controlled temperature storage units. Monitor the system for alerts and alarms, acknowledging, communicating and investigating as required by procedure.</li>
<li>Maintain vendor service contacts, scopes of work, access requirements, and performance records, and provide input into the qualification or periodic evaluation of critical calibration and maintenance vendors.</li>
</ul>
<h2>Qualifications</h2>
<ul>
<li>Associate's or bachelor's degree in a life science or technical field, or equivalent hands-on laboratory experience.</li>
<li>Experience maintaining equipment in a GMP-regulated laboratory.</li>
<li>Working knowledge of calibration and asset management systems such as Qualer.</li>
<li>Strong organizational skills and comfort managing multiple vendors and schedules at once.</li>
</ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).</p>
<p>Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.</p>
<p>Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.</p></div><div class="title">U.S. Pay Range</div><div class="pay-range"><span>$92,000</span><span class="divider">&mdash;</span><span>$103,000 USD</span></div></div></div><div class="content-conclusion"><p>Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.</p></div>

Laboratory Operations Specialist

<div class="content-intro"><p><strong>Company Overview:</strong></p>
<p>Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. &nbsp;</p>
<p>Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology &amp; oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit <a href="http://www.primemedicine.com/">www.primemedicine.com</a>.</p></div><p><strong>Position Overview:</strong></p>
<p>We are seeking a physician-scientist with an interest and/or background in gene therapy to lead Prime Medicine’s programs from pre-clinical development into the clinic.&nbsp; The medical director will serve an integral role in the clinical development organization.&nbsp; They will interact broadly across the organization with research and with regulatory affairs in order to implement Prime’s strategies across one or more therapeutic areas.&nbsp; In concert with the clinical operations and clinical sciences teams, they will be responsible for the development, implementation and execution of clinical trials across multiple therapeutic areas.&nbsp; They will act as a representative of Prime Medicine in interactions with key opinion leaders, site investigators and regulators.&nbsp; The medical director will report to clinical development leadership.&nbsp;</p>
<p><strong>&nbsp;Key Responsibilities:</strong></p>
<ul>
<li>In collaboration with research, clinical sciences, regulatory affairs and clinical operations, develop a clinical trials strategy for the efficient and safe introduction of Prime gene editing therapeutics into human study participants, through in-human proof-of-concept.</li>
<li>With support from clinical sciences and medical writing, conceptualize and author clinical trials protocols, including observational and all interventional trials from phase I - IV</li>
<li>Serve as medical monitor, responsible for interfacing with site investigators, overseeing patient safety and analyzing data from clinical trials</li>
<li>Represent clinical development on cross functional program teams</li>
<li>Organize Scientific Advisory Boards and solicit feedback from Key Opinion Leaders</li>
<li>Support Prime Medicine regulatory interactions both in the formulation of regulatory documents and in face-to-face discussions with regulators</li>
<li>Collaborate with pre-clinical research to implement a translational biomarkers program for all clinical trials, and analyze translational data from Prime Medicine’s trials.</li>
<li>Attend scientific and medical conferences as needed, to support presentation of Prime Medicine data and/or acquire state-of-the-art information in a relevant therapeutic field.</li>
<li>Travel to investigator sites, regulatory meetings and conferences will be required.&nbsp; Must be able to travel up to 25%.</li>
</ul>
<p><strong>Qualifications:</strong></p>
<ul>
<li>M.D. or equivalent degree, preferably M.D.-PhD</li>
<li>Minimum 3+ years industry or equivalent academic experience, either overseeing clinical trials or performing relevant research</li>
<li>Track record of scientific and medical excellence</li>
<li>Rigorous understanding of core scientific concepts in gene therapy, genetics and immunology</li>
<li>Specialization in Pulmonology or Hepatology preferred, but not required.&nbsp; Broad medical knowledge and facility with novel medical concepts is required.</li>
<li>Basic understanding of Good Clinical Practice</li>
<li>Facility and comfort with standard statistical methodologies and analytical tools</li>
<li>Strong communication skills, with demonstrated experience composing scientific publications and delivering oral presentations.</li>
<li>Ability to work in a heavily matrixed, cross-functional environment</li>
</ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).</p>
<p>Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.</p>
<p>Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.</p></div><div class="title">U.S. Pay Range</div><div class="pay-range"><span>$272,000</span><span class="divider">&mdash;</span><span>$302,000 USD</span></div></div></div><div class="content-conclusion"><p>Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.</p></div>

Medical Director, Clinical Development

<div class="content-intro"><p><strong>Company Overview:</strong></p>
<p>Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. &nbsp;</p>
<p>Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology &amp; oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit <a href="http://www.primemedicine.com/">www.primemedicine.com</a>.</p></div><p>&nbsp;</p>
<div class="content-intro">
<p><strong>Company Overview:</strong></p>
<p>Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. &nbsp;</p>
<p>Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology &amp; oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit&nbsp;<a href="http://www.primemedicine.com/">www.primemedicine.com</a>.</p>
</div>
<p><strong>About the role</strong></p>
<p>&nbsp;</p>
<p>Department: Quality Assurance</p>
<p>Reports to: VP, Quality Assurance</p>
<p>Location: Cambridge, MA</p>
<h2>Position Summary</h2>
<p>The Senior Quality Engineering Specialist provides hands-on operational support for Prime Medicine’s GxP software, equipment, calibration, preventive maintenance, and vendor oversight activities. Working with Quality, Laboratory Operations, IT/Informatics, system and equipment owners, and external vendors, the Specialist executes qualification activities, maintains accurate records, coordinates scheduled work, and helps keep systems and equipment compliant and inspection-ready.</p>
<p>The role also conducts risk-based assessments of software vendors in accordance with current FDA guidance, as well as assessments of equipment and material suppliers and service providers, to ensure the quality and reliability of externally supplied inputs.</p>
<h2>Key Responsibilities</h2>
<p>Software Assurance and Vendor Assessments</p>
<ul>
<li>Draft, execute, and review software assurance test scripts using approved requirements, specifications, risk assessments, and intended-use documentation.</li>
<li>Support quality oversight of GxP computerized systems, including AI-enabled software tools, in accordance with company procedures and applicable regulatory expectations.</li>
<li>Conduct and document risk-based assessments of software, equipment, material, and service providers.</li>
<li>Collect and review vendor questionnaires, certifications, audit materials, quality agreements, and other supporting evidence.</li>
<li>Work with IT/Informatics, system owners, Quality colleagues, and vendors to resolve documentation or performance gaps and complete assigned actions.</li>
</ul>
<p>Equipment Qualification and Maintenance</p>
<ul>
<li>Draft, execute, and review equipment qualification protocols, including IQ/OQ/PQ activities.</li>
<li>Review executed protocols, reports, raw data, test results, certificates, and supporting records for completeness, accuracy, and consistency.</li>
<li>Support the documentation and investigation of equipment qualification discrepancies.</li>
<li>Maintain equipment, calibration, and preventive maintenance records in the computerized maintenance management system.</li>
<li>Review and electronically maintain calibration certificates, maintenance records, and service reports, ensuring that documentation is complete and properly linked to the applicable equipment.</li>
<li>Oversee scheduled calibration, maintenance, and service activities with equipment owners and external providers, escalating delays and compliance risks promptly.</li>
</ul>
<p>Supplier Quality and Quality Systems Support</p>
<ul>
<li>Conduct supplier audits and remote assessments under the direction of Supplier Quality leadership.</li>
<li>Prepare assessment plans, document requests, questionnaires, reports, and follow-up actions.</li>
<li>Track vendor corrective actions and other assigned quality actions through closure.</li>
<li>Support change controls, deviations, CAPAs, and other quality records involving software, equipment, calibration, maintenance, or vendors.</li>
<li>Maintain trackers, dashboards, and status reports for qualification activities, calibration and maintenance schedules, vendor assessments, and open actions.</li>
<li>Identify recurring issues, documentation gaps, overdue activities, and opportunities for practical process improvement.</li>
<li>Participate in audits, regulatory inspections, and inspection-readiness activities as needed.</li>
</ul>
<p>Qualifications</p>
<ul>
<li>Bachelor’s degree in a scientific, engineering, technical, or quality-related field, or equivalent relevant experience.</li>
<li>At least four years of experience in a regulated life-sciences environment, including experience in equipment qualification, software assurance/CSV, calibration or maintenance oversight, supplier quality, or a related quality function.</li>
<li>Working knowledge of GxP documentation, data integrity, computerized systems, equipment qualification, calibration, and preventive maintenance requirements.</li>
<li>Experience drafting, executing, or reviewing qualification protocols, test scripts, assessments, or other controlled quality records.</li>
<li>Experience using a computerized maintenance management, calibration management, or equipment tracking system.</li>
<li>Strong technical writing, organization, and cross-functional coordination skills.</li>
<li>Ability to manage multiple operational priorities, maintain accurate records, and escalate risks or delays promptly.</li>
</ul>
<p>Preferred Experience</p>
<ul>
<li>Experience in biotechnology, gene therapy, cell therapy, or another regulated life sciences environment.</li>
<li>Familiarity with equipment lifecycle activities (URS, IQ/OQ/PQ, periodic review, calibration, maintenance) or software assurance/CSV practices.</li>
<li>Experience supporting supplier qualification, vendor assessments, or laboratory instruments and CMMS records.</li>
</ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).</p>
<p>Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.</p>
<p>Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.</p></div><div class="title">U.S. Pay Range</div><div class="pay-range"><span>$111,000</span><span class="divider">&mdash;</span><span>$123,000 USD</span></div></div></div><div class="content-conclusion"><p>Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.</p></div>

Senior Quality Engineering Specialist

<div class="content-intro"><p><strong>Company Overview:</strong></p>
<p>Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. &nbsp;</p>
<p>Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology &amp; oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit <a href="http://www.primemedicine.com/">www.primemedicine.com</a>.</p></div><p><strong>About the role</strong></p>
<p>We're hiring an Informatics Engineer to build the scientific data and computing platform that powers Prime Medicine's gene editing programs.</p>
<p>You will work in close partnership with our computational biology team and our cloud infrastructure team. The role suits someone who's comfortable owning a platform end-to-end, building the engineering foundations that scientists across the organization rely on, including data pipelines and APIs through to AI-enabled internal tooling. Your engineering judgment about what to build and how to build it will shape how Prime Medicine works with scientific data day-to-day.</p>
<p><strong>What you'll do</strong></p>
<ul>
<li>Design and build the data platform connecting NGS instruments, laboratory informatics systems (Benchling), and AWS cloud compute; covering automated ingestion, provenance tracking, scalable storage, and observability.</li>
<li>Build production-grade APIs, SDKs, and internal tools that bring genomic data and analytical capabilities to scientists across the organization.</li>
<li>Build the orchestration layer for the automated, event-triggered execution of our scientific pipelines. The pipelines themselves (amplicon-seq, off-target analysis, and others) are co-developed with our computational biology team; you'll own how they run, scale, and integrate.</li>
<li>Ship AI-powered and agentic capabilities such as RAG over internal scientific data, agentic workflows with human-in-the-loop review, and internal copilots that streamline routine workflows across the organization connecting both science and business needs.</li>
<li>Build integrations across the scientific tool chain so data moves reliably between ELNs, LIMS, instrument software, and cloud compute.</li>
<li>Translate scientific requirements into reliable, maintainable software, helping bring research prototypes into production-grade systems.</li>
<li>Partner with computational biologists, lab scientists, and our cloud-support team to continuously improve platform performance, cost, and reliability.</li>
</ul>
<p><strong>What we're looking for</strong></p>
<p>This is an Infrastructure engineering focused role, well suited to candidates whose primary background is software engineering, data engineering, or scientific platform engineering, with a strong interest in applying those skills to scientific problems.</p>
<p><strong>Requirements</strong>:</p>
<ul>
<li><strong>5+ years of full-time engineering experience</strong> (3+ for those with an MS or PhD) in production environments.</li>
<li>Strong Python programming skills.</li>
<li><strong>Production AWS experience with depth in event-driven, cloud-native architectures</strong>, including AWS Lambda, EventBridge (or comparable event-routing infrastructure), and Infrastructure as Code with Terraform or CDK.</li>
<li><strong>Docker / containerization</strong>, Git-based workflows, CI/CD, code review, and testing code in DEV/TEST environments before deploying to production.</li>
<li><strong>A track record of building integrations and automations.</strong> <strong>Experience in a life-science related industry involving scientific or regulated data, such as biotech, pharma, healthtech, clinical informatics, scientific instrumentation, or agricultural genomics. </strong></li>
</ul>
<p><strong>Nice to have</strong></p>
<ul>
<li><strong>NGS expertise.</strong> Knowledge of NGS technology, workflows and pipeline architecture is strongly preferred.</li>
<li><strong>Hands-on workflow orchestration experience.</strong> Familiarity with Nextflow/NextFlow Tower/Seqera Platform preferred.</li>
<li><strong>Laboratory informatics experience</strong> with Benchling or comparable ELN/LIMS, as an operator, builder, or administrator.</li>
<li><strong>AI / LLM tooling and agentic systems</strong> (LangChain, LangGraph, MCPs, RAG architectures).</li>
<li><strong>Gene editing familiarity:</strong> CRISPR, base editing, prime editing.</li>
<li><strong>GxP / 21 CFR Part 11 / regulated-software experience.</strong></li>
<li><strong>Plotly Dash, Streamlit, Spotfire, Retool, </strong>or similar tools for internal apps and data visualizations.</li>
<li>Experience managing or querying relational databases (PostgreSQL, MSSQL).</li>
</ul>
<p><strong>Interview process</strong></p>
<p>The process includes a recruiter conversation, a hiring manager interview, and a small panel that includes computational biology, engineering, and wet lab partners. A Python coding exercise is part of the process</p>
<p><strong>Logistics and policy</strong></p>
<ul>
<li><strong>Hybrid with office in Cambridge, MA.</strong> <strong>We are not currently able to sponsor visas.</strong> US work authorization at the time of application is required.</li>
<li>Competitive base salary, equity, and standard benefits.</li>
</ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).</p>
<p>Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.</p>
<p>Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.</p></div><div class="title">U.S. Pay Range</div><div class="pay-range"><span>$134,000</span><span class="divider">&mdash;</span><span>$163,000 USD</span></div></div></div><div class="content-conclusion"><p>Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.</p></div>

Informatics Engineer

<div class="content-intro"><p><strong>Company Overview:</strong></p>
<p>Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. &nbsp;</p>
<p>Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology &amp; oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit <a href="http://www.primemedicine.com/">www.primemedicine.com</a>.</p></div><p>Prime Medicine was founded to bring the promise of gene editing to patients. We use Prime Editing, a next-generation technology that can "search and replace" to restore normal genetic function almost anywhere in the genome. Prime Editing searches to find the precise place in the genome to edit and replace the segment of faulty DNA with a correct copy of DNA. A single Prime Editor can correct the individual mutations found across patients, meaning Prime Editing can potentially address more than 90 percent of known disease-causing genetic mutations.</p>
<p>We envision a world where this technology can cure, halt, and ultimately prevent genetic diseases, providing lifelong benefits to patients. Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease.</p>
<p><strong>Position Summary</strong></p>
<p>The Senior Scientist / Senior Engineer, LNP Process Development will provide technical leadership for the development, characterization, and scale-up of robust, scalable lipid nanoparticle (LNP) formulation and drug product manufacturing processes. This individual will be responsible for driving LNP process development — spanning formulation, process optimization and characterization, scale-up, and technology transfer support for key pipeline assets.</p>
<p><strong>Key Responsibilities</strong></p>
<p><strong>Technical Leadership &amp; Process Development</strong></p>
<ul>
<li>Lead the design, execution, and optimization of LNP processes to accommodate novel formulations and drug product manufacturing processes (LNP mixing and tangential flow filtration [TFF]) from bench through GLP/GMP scale, with emphasis on developing robust and scalable processes</li>
<li>Serve as a subject matter expert for LNP process development across programs and therapeutic areas, partnering with Research, Platform, Hematology, and other teams to translate novel modalities into developable drug products</li>
<li>Evaluate and implement emerging technologies, novel materials, delivery and process innovations that continuously improve delivery efficiency, drug product quality, manufacturability, and cost of goods</li>
<li>Support technology transfer activities to external contract development and manufacturing organizations (CDMOs), including preparation of tech transfer packages, on-site execution support (Person-in-Plant), and process troubleshooting</li>
<li>Author and contribute to Chemistry, Manufacturing, and Controls (CMC) sections of regulatory filings, briefing books, and regulatory responses related to LNP drug product</li>
<li>Maintain impeccable documentation using electronic lab notebooks (ELNs); generate experimental protocols, development reports, technology transfer packages, SOPs, and technical reports to support clinical development</li>
<li>Communicate complex technical information clearly through presentations, written reports, and everyday collaboration to diverse audiences including cross-functional stakeholders and external partners</li>
</ul>
<p><strong>Qualifications &amp; Experience</strong></p>
<ul>
<li>Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, Materials Science, or a related discipline with 8+ years of relevant industrial experience in LNP process development and formulation development; M.S. with 12+ years</li>
<li>Demonstrated expertise in LNP formulation processes, TFF operations, and related characterization methods</li>
<li>Hands-on experience with LNP delivery and formulation development, process scale-up from bench to GLP/GMP scale, and technology transfer to GMP facilities and/or CDMOs</li>
<li>Strong proficiency in analytical characterization techniques (HPLC/UPLC, DLS/SLS, TEM, DSC, SAXS, UV-Vis, fluorescence spectrophotometry) to support process development</li>
<li>Experience with statistical design of experiments (DoE) and knowledge of Quality by Design (QbD) methodologies</li>
<li>Hands-on experience with defining and setting up equipment systems for LNP and TFF processes</li>
<li>Knowledge of CMC regulatory requirements and experience contributing to IND/CTA submissions</li>
<li>Excellent communication skills, with the ability to effectively collaborate cross-functionally, prioritize activities to meet program goals, and present complex technical information to diverse audiences</li>
<li>Highly self-motivated with strong organizational skills, the ability to manage competing priorities, and a hands-on approach to problem-solving</li>
</ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).</p>
<p>Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.</p>
<p>Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.</p></div><div class="title">U.S. Pay Range</div><div class="pay-range"><span>$145,000</span><span class="divider">&mdash;</span><span>$177,000 USD</span></div></div></div><div class="content-conclusion"><p>Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.</p></div>

Senior Scientist / Senior Engineer, LNP Process Development

<div class="content-intro"><p><strong>Company Overview:</strong></p>
<p>Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. &nbsp;</p>
<p>Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology &amp; oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit <a href="http://www.primemedicine.com/">www.primemedicine.com</a>.</p></div><p>Reports To: VP of Clinical Development</p>
<p><strong>Position Summary</strong></p>
<p>Prime Medicine is seeking an experienced Senior Director, Biometrics to serve as the senior biostatistics leader for the organization while providing strategic and operational leadership for the broader Biometrics function, including Clinical Data Management, in support of our gene editing clinical programs.</p>
<p>This individual will provide statistical expertise across Prime’s clinical portfolio, including input on study design, protocol development, dose-escalation strategy, interim analyses, regulatory interactions, and submission planning. In parallel, the individual will build and lead an integrated Biometrics function by providing strategic oversight and line management of Clinical Data Management while partnering closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, Translational Medicine and other functions.</p>
<p>This role requires both strategic vision and hands-on oversight, particularly in a lean, fast-moving biotech environment.&nbsp; Although responsible for the broader Biometrics function, this position is first and foremost a senior biostatistics leadership role requiring deep expertise in clinical trial design, statistical methodology, regulatory interactions, and quantitative decision-making across clinical development.&nbsp; This is a high visibility role with significant influence on clinical development decisions.</p>
<p><strong>Key Responsibilities</strong></p>
<p><strong>Biometrics Strategy &amp; Leadership</strong></p>
<ul>
<li>Provide overall biometrics leadership across Prime Medicine’s clinical programs, spanning:</li>
<ul>
<li>Biostatistics</li>
<li>Data Management</li>
<li>Statistical programming (via vendors)</li>
</ul>
<li>Define and implement biometrics strategies appropriate for early- and mid-stage gene therapy development, including:</li>
<ul>
<li>Study design and statistical approaches</li>
<li>Endpoint selection and estimands</li>
<li>Data standards and quality frameworks</li>
</ul>
<li>Serve as the primary biometrics representative on cross-functional program and study teams.</li>
</ul>
<p><strong>Lead Biostatistician Responsibilities </strong></p>
<p>Function as the lead statistician across Prime's clinical development portfolio, providing scientific and strategic statistical leadership from protocol concept through regulatory submission.</p>
<ul>
<li>Provide strategic input into:</li>
<ul>
<li>Clinical trial design</li>
<li>Sample size and power considerations</li>
<li>Randomization and statistical analysis plans (SAPs)</li>
<li>As needed, data extraction and compilation for publications and external presentation activities</li>
</ul>
<li>Review, approve, and oversee key statistical deliverables, including:</li>
<ul>
<li>SAPs</li>
<li>Interim and final analyses, including supporting SRC and DMC outputs</li>
<li>Clinical Study Reports (statistical sections)</li>
</ul>
<li>Support regulatory interactions by contributing to:</li>
<ul>
<li>IND/CTA submissions</li>
<li>Health authority briefing packages</li>
<li>Responses to regulatory questions related to study design and analyses</li>
</ul>
</ul>
<p><strong>Data Management Oversight</strong></p>
<p>Provide strategic leadership and line management for the Clinical Data Management function, ensuring close integration between data management and statistical activities.</p>
<ul>
<li>Oversee data management strategy and execution, including:</li>
<ul>
<li>CRF design and database build</li>
<li>Data cleaning, validation, and lock</li>
<li>Data standards (e.g., CDISC/SDTM/ADaM expectations)</li>
</ul>
<li>Ensure data quality, integrity, and inspection readiness across all clinical programs.</li>
<li>Provide input into protocol development and study start-up activities to ensure efficient data collection</li>
<li>Partner with Clinical Operations and vendors to proactively identify and resolve data-related risks.</li>
</ul>
<p><strong>Vendor Management &amp; Operational Execution</strong></p>
<ul>
<li>Lead vendor selection, onboarding, and governance for biometrics-related CROs and service providers.</li>
<li>Provide active oversight of vendor performance, timelines, quality, and budgets.</li>
<li>Ensure clear scopes of work, deliverable expectations, and communication pathways.</li>
<li>Act as the escalation point for biometrics-related issues and drive timely resolution.</li>
</ul>
<ul>
<li>Ensure biometrics deliverables are aligned with clinical, regulatory, and program objectives.</li>
<li>Contribute to inspection readiness activities and support audits as needed.</li>
</ul>
<p><strong>Function Building &amp; Future Growth</strong></p>
<ul>
<li>Establish scalable biometrics SOPs/processes, standards, and best practices appropriate for a growing organization.</li>
<li>Contribute to longer-term planning for internal capability development, including future team growth as the pipeline expands.</li>
<li>Mentor and guide internal team members or matrixed contributors as applicable.</li>
</ul>
<p><strong>Qualifications</strong></p>
<p><strong>Required</strong></p>
<ul>
<li>Advanced degree in Statistics, Biostatistics, Mathematics, or a related quantitative field.</li>
<li>10+ years of experience in biometrics (biostatistics and/or data management) within biotech or pharmaceutical development.</li>
<li>Demonstrated experience supporting clinical development programs, including regulatory submissions, ideally with experience supporting early-phase (FIH) through later stage programs.</li>
<li>Experience serving as the lead statistician for clinical studies and regulatory submissions.</li>
<li>Strong understanding of clinical trial design, statistical principles, and data management practices especially in rare disease and/or gene and cell therapies.</li>
<li>Proven experience leading biometrics through CRO/vendor models.</li>
<li>Deep familiarity with regulatory expectations (FDA, EMA, ICH) related to biometrics.</li>
<li>Experience leading or managing Clinical Data Management is strongly preferred but is not required.</li>
<li>Excellent leadership, communication, and cross-functional collaboration skills.</li>
</ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).</p>
<p>Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.</p>
<p>Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.</p></div><div class="title">U.S. Pay Range</div><div class="pay-range"><span>$263,000</span><span class="divider">&mdash;</span><span>$321,000 USD</span></div></div></div><div class="content-conclusion"><p>Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.</p></div>

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