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<