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Lead development, qualification, and validation of analytical and QC-ready methods for LNP-formulated drug products (HPLC/UPLC/LC-MS, DLS, biophysical assays). Drive analytical control strategy, author regulatory CMC documentation, support release/stability testing and tech transfer, oversee external testing, and collaborate cross-functionally to ensure data integrity and stage-appropriate assay readiness.
Company Overview:
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.
Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & 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 www.primemedicine.com.
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 replaces 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.
We envision a world where this technology can cure, halt, and ultimately prevent genetic diseases, providing lifelong benefit to patients. Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease. Realizing the promise of Prime Editing requires a talented team with diversity of viewpoints and expertise. We’re building a group of dedicated, scientifically curious individuals who are passionate about helping patients live longer, healthier lives.
Position Overview
We are seeking a motivated, experienced, and collaborative scientific/technical leader to drive the development of analytical and QC-ready methods for lipid nanoparticle (LNP) formulated Prime Editor drug products (DP). Working as a member of a highly collaborative Technical Development / CMC organization, this individual will contribute to strategy and hands-on execution of method development to enable stage-appropriate development from early formulation/process development through clinical development stages, leveraging platform approaches when possible.
This is a scientific leadership and hands-on role. The successful candidate will be responsible for developing, qualifying, and validating analytical methods for DP release and stability testing, as well as in-process control and characterization. The ideal candidate has a strong chemistry background (particularly lipids and lipid excipients), deep expertise in chromatography and LC-MS, and experience with LNP biophysical characterization (e.g., DLS), and stays abreast of innovations in the field for these and other techniques. Excellent communication skills—especially technical writing, including authoring analytical sections of regulatory submissions and responding to regulatory questions—are strongly preferred. Bioanalysis experience supporting preclinical studies using LC-MS is a plus.
Key Responsibilities:
- Develop strategic plans and drive execution of analytical development activities for LNP DP programs, in alignment with program strategies
- Contribute to the development and refinement of the analytical control strategy, aligned with QTPP/CQAs and stage-appropriate development needs (early to late phase).
- Identify assay gaps, establish fit-for-purpose methods, and drive assay readiness for technology transfer and/or validation.
- Apply a strong understanding of LNP drug product–specific CQAs—including particle size/PDI, encapsulation efficiency, lipid and RNA composition, impurities and degradants, and stability-indicating attributes—to inform analytical strategy, method development, and control approaches.
- Develop and implement separation-based methods for LNP analytical characterization and lipid analytics
- Develop/optimize HPLC/UPLC/LC-MS methods for lipid components, impurities, degradants, and formulation-related analytes.
- Support assays for lipid identity/composition, residuals, and stability-indicating methods, as appropriate.
- Design and interpret forced degradation studies; support impurity/degradant identification; and evaluate stability trends to support control strategy and product understanding.
- Advance, optimize, and maintain chromatographic and/or electrophoretic methods for RNA analysis.
- Support biophysical characterization and orthogonal analytics for LNPs
- Develop/optimize DLS methods (particle size, PDI) and support complementary biophysical characterization techniques (e.g., zeta potential, particle concentration, morphology, and other orthogonal methods as needed).
- Interpret characterization data in the context of formulation/process changes, stability, and comparability.
- Regulatory documentation and inspection readiness
- Author, review, and approve protocols, SOPs, method reports, validation/verification documents, and CMC sections for regulatory submissions.
- Prepare written responses to regulatory information requests and support Health Authority interactions.
- Support DP release and stability testing, comparability evaluations, and technology transfer activities, as appropriate for development stage
- Support in-house and external DP release and stability testing activities.
- Provide technical oversight for external testing at CDMOs/CROs, ensure method performance, and review external data packages.
- Cross-functional collaboration and scientific communication
- Partner cross-functionally and contribute to timely decisions; communicate data, risks, and recommendations clearly.
- Data integrity and documentation excellence
- Maintain detailed and complete records in electronic lab notebooks and associated systems; ensure data integrity, traceability, and alignment with GxP expectations as programs progress.
- Contribute to continuous improvement of analytical workflows, LIMS/ELN utilization, and laboratory best practices.
Qualifications:
- Education/Experience
- PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related discipline with a minimum of 3 years of relevant industry experience; or BS/MS with 10+ years of relevant industry experience.
- Core technical expertise (highly preferred)
- Strong chemistry background, ideally with experience in lipids, lipid excipients, or related small-molecule chemistry.
- Deep hands-on experience with HPLC/UPLC method development (including troubleshooting, robustness, and stability-indicating methods).
- Strong experience with LC-MS (qualitative and/or quantitative), including method development and data interpretation for complex matrices.
- LNP characterization experience (preferred)
- Experience with DLS and interpretation of size/PDI trends; familiarity with other LNP-relevant techniques (e.g., zeta potential, particle concentration, cryo/TEM collaborations, DSC, spectroscopy, or other orthogonal tools depending on platform needs).
- Drug development and CMC mindset
- Experience developing analytical assays in a fast-paced, flexible CMC environment, using phase-appropriate qualification and validation strategies; ability to stay current with evolving regulatory guidance and pathways for innovative technologies.
- Regulatory document writing (preferred)
- Demonstrated ability to author technical documentation and contribute to regulatory submissions, and to respond to Health Authority questions with clear scientific justification.
- Bioanalysis experience (plus)
- LC-MS experience supporting preclinical bioanalysis (e.g., exposure/PK, tissue distribution, or related studies), including sample prep and quantitative workflows.
- Ways of working
- Demonstrated productivity and strong track record of delivery in a matrixed, fast-paced environment.
- Excellent written and verbal communication skills; ability to influence cross-functional stakeholders and mentor others.
- Passion for learning, strong problem-solving ability, attention to detail, and a commitment to scientific rigor and data integrity.
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).
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.
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.
U.S. Pay Range
$145,000—$177,000 USD
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.
Top Skills
Cryo-Tem
Dls
Dsc
Eln
Gxp
Hplc
Lc-Ms
Lims
Particle Concentration
Spectroscopy
Uplc
Zeta Potential
Prime Medicine Cambridge, Massachusetts, USA Office
21 Erie St, Cambridge, MA, United States, 02139
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