Position Overview

We are seeking a motivated and skilled Senior Scientist to join the Nonclinical Development group, contributing to the DMPK function in support of exploratory and IND-enabling programs across Prime Medicine’s pipeline. Reporting to the Associate Director, DMPK/Bioanalytical Sciences, this individual will independently analyze and interpret datasets from in vivo studies, contribute to nonclinical regulatory documents, and work cross-functionally with pharmacology, translational biology and external CROs, to ensure high-quality DMPK data packages are delivered to support program timelines. The ideal candidate has a strong foundation in in vivo pharmacokinetics for RNA therapeutics and/or LNP-based delivery systems, thrives in a fast-paced and matrixed organization, and possesses the flexibility and positive attitude needed to make meaningful contributions to the Nonclinical Development team.

Primary Responsibilities

• Analyze and interpret PK study data from exploratory and IND-enabling in vivo
• Perform non-compartmental analysis (NCA) using Phoenix WinNonlin to derive key PK parameters (Cmax, AUC, T½, Vd, CL).
• Leverage expertise in DMPK to provide recommendations for in vivo study designs in collaboration with pharmacology and key stakeholders.
• Perform bioanalytical assay development (30%) and collaborate with bioanalytical scientists to trouble-shoot challenges during method development to ensure quantitative methods for key analytes (LNP lipid components, mRNA, pegRNA, PD biomarkers) meet regulatory expectations and data quality standards..
• Contribute to nonclinical regulatory documents including pharmacokinetics summaries and nonclinical study reports under the guidance of senior stakeholders in Nonclinical Development.
• Maintain thorough records in the electronic laboratory notebook (ELN); prepare clear data summaries, presentations, and technical memos for program team and governance meetings.

Qualifications

Minimum Qualifications

• D. in pharmacokinetics, pharmaceutical sciences, pharmacology, biochemistry, or a related discipline.
• 6+ years of cumulative experience. Industry experience (biotech or pharmaceutical) with direct responsibility for in vivo DMPK study design, execution, and interpretation is required; postdoctoral training in a DMPK or translational pharmacology setting is strongly preferred
• Demonstrated experience with in vivo PK studies in preclinical models and proficiency in NCA using Phoenix WinNonlin or equivalent software.
• Familiarity with regulatory expectations for nonclinical DMPK assessments and bioanalytical assay development.
• Demonstrated ability to coordinate with external CROs, including scientific guidance, protocol development, and data review..
• Strong written and verbal communication skills; ability to present complex DMPK data clearly to multidisciplinary audiences.
• Highly self-motivated, collaborative, and organized, with the ability to manage multiple priorities independently in a fast-paced matrix environment.

Preferred Qualifications

• Familiarity with PK/PD modeling concepts; experience with Phoenix WinNonlin modeling modules a plus.
• Experience with LNP-based delivery systems and/or RNA therapeutics (mRNA, siRNA, ASO, sgRNA or related modalities).
• Experience with exploratory DMPK studies, evaluating new delivery vehicles and evaluation of biodistribution using in vivo
• Familiarity with bioanalytical platforms supporting DMPK studies, including LC-MS/MS, RT-qPCR/ddPCR, ELISA/MSD.
• Ability and excitement to contribute to the development and success of the Nonclinical Development team.

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

Prime Medicine is seeking a talented and motivated Sr. Manager to join the Analytical Development & QC team within Technology, Development & Operations. This role will focus on Quality Control (QC) related activities for all programs, including management and technical oversight of tech transfer, qualification/validation and release and stability testing carried out at both CDMOs, CTLs and internally at Prime for our prime editing ex vivo cell therapy and in vivo LNP-based drug products.

The successful candidate will have deep understanding of method lifecycle management, including method optimization, qualification, validation/verification, transfer, and implementation in a cGMP environment, as well as previous hands-on experience in at least some aspects of the above. This is a role requiring strong cross-functional collaboration with Analytical Development, Quality, Process Development, Formulation, Informatics, and external partners (CTLs/CDMOs). 

The ideal candidate thrives in a matrixed, fast-paced environment, works effectively with limited supervision, and demonstrates strong technical ownership and execution.

Key Responsibilities

• Design or review analytical procedures and protocols supporting method lifecycle activities, including optimization, qualification, validation, transfer, verification, performance monitoring, bridging, and comparability studies
• Manage and conduct select release, stability, and in-process testing for drug substances, drug products, and gene-editing components, and carry out data analysis and trending
• Support and/or manage analytical method transfer to CTLs/CDMOs, providing oversight, troubleshooting, and ensuring technical and timeline objectives are met
• Manage GMP sample inventory and chain-of-custody documentation
• Lead, manage and maintain well-designed stability programs and reference standard programs
• Author and review protocols, reports, SOPs, and analytical sections of regulatory submissions
• Familiarity with and ability to learn and use new tools for productivity, project management, documentation, tracking scheduling, and data management.
• Support IQ/OQ/PQ of QC equipment and ensure compliance with 21 CFR Part 11
• Maintain GxP-compliant electronic documentation and thorough laboratory records
• Collaborate with Quality to ensure data integrity, regulatory compliance, and audit readiness
• Lead or support investigations, deviations, and root-cause analyses
• Present data and findings to cross-functional teams
• Prepare technical reports and documents for global regulatory submissions

Qualifications

Education & Experience

• BS/MS/PhD in Biochemistry, Molecular biology, Chemistry, Bioengineering, or a related discipline
• Industry experience:
• BS: 10+ years
• MS: 8+ years
• PhD: 3+ years

Technical Expertise

• Experience with analytical method optimization, tech-transfer, qualification, validation, and verification used for critical components, drug substance and drug product release and stability testing
• Hands-on experience with analytical methodologies such as:
• Chromatography-based assays
• Absorbance-based assays
• Cell-based assays
• Compendial assays
• Molecular-based assays
• Flow cytometry assays
• Familiarity with ICH and FDA guidelines for CMC development during clinical stage is required
• Experience in advanced cell and gene-editing therapeutics development is not mandatory, but highly desirable
• Experience working with CMOs/CDMOs is required
• Experience with stability and/or reference standard programs is a plus
• Knowledge of assays, instrumentation, and facility qualification/validation requirements is desirable
• Familiarity with regulatory writing

Personal Attributes

• Highly self-motivated with strong project ownership
• Strong collaborator with internal cross-functional and external partners
• Adaptable in a dynamic, fast-paced environment
• Detail-oriented with strong troubleshooting and problem-solving skills
• Excellent written and verbal communication skills
• Strong abilities to lead and facilitate technical meetings with CDMO and CTL SMEs
• Work with purpose and drive meaningful results
• Ability to innovate and challenge industry status quo
• Ability to travel for up to 5 - 10% of the time

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, sexual orientation, gender identity, disability, protected veteran status, or any other characteristic protected by law.

Position Overview

We are seeking an enthusiastic, self-motivated Senior Scientist to join the Nonclinical Development group, supporting the nonclinical safety assessment function for IND-enabling programs across Prime Medicine’s pipeline. Reporting to the Associate Director, Safety Assessment, the successful candidate will support the design, execution, and interpretation of nonclinical safety studies conducted both in-house and at CROs, with an initial focus on liver-targeted therapeutics. This role requires hands-on involvement in assay execution and troubleshooting, as well as active participation in study oversight of work being done at CRO and data analysis.

This role requires collaboration within cross-functional teams. The ideal candidate will hold a Ph.D. in toxicology or a related field with 6+ years of pharma/biotech experience in nonclinical safety assessment, or an M.S. in toxicology or a related field with 10+ years of experience in nonclinical safety assessment, the ability to work independently, provide domain expertise and leadership, as well as cross-functionally in a fast-paced, matrixed environment with a positive, flexible attitude.   

Primary Responsibilities

• Contribute to nonclinical safety activities as part of cross-functional Discovery and Development project teams, supporting program progression through IND-enabling stages.
• Design, execute, and troubleshoot nonclinical safety studies, including hands-on laboratory work (~30%) to support assay development, data generation, and issue resolution.
• Support the execution and oversight of nonclinical safety studies (GLP and non-GLP) at CROs, including active involvement in troubleshooting assay and study-related challenges.
• Analyze and interpret study data with guidance and contribute to the preparation of study reports and supporting documents for regulatory submissions.
• Collaborate with Pharmacology, DMPK, and other functions to support exploratory studies (e.g., exploratory toxicology, DMPK, biodistribution, and delivery platform evaluation).
• Contribute to evaluation of new delivery approaches, Lipid and RNA components, and emerging targets to support pipeline expansion.
• Assist in identifying potential safety findings and contribute to discussions on data interpretation and next steps.
• Ensure studies and internal activities are conducted in compliance with regulatory guidelines and internal standards.

Preferred Qualifications

• Ph.D. in toxicology or a related discipline with 6+ years of biopharmaceutical industry experience, or M.S. in toxicology or a related field with 10+ years of relevant biopharmaceutical industry experience supporting drug development in nonclinical safety/toxicology.
• Experience in large molecule therapeutic development, along with a background in immunology, is desirable.
• Understanding of toxicology principles, nonclinical safety evaluation, and the drug development process, with some experience interpreting toxicology data and contributing to technical and scientific reports.
• Demonstrates strong scientific judgment and leadership with the ability to evaluate information, identify potential issues, and propose practical solutions with guidance as needed.
• Highly organized and detail-oriented with strong attention to accuracy and quality.
• Strong communication and collaboration skills, with the ability to work effectively across multidisciplinary teams and with external partners.
• Experience supporting nonclinical studies at CROs is preferred but not required.