Sr. Manager, QC

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

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.

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.