Sr. Manager, QC
Prime Medicine is seeking a Senior Manager to join the Analytical Development & Quality Control team within the Technology, Development & Operations division. This role focuses on overseeing Quality Control activities across all programs, including the management and technical oversight of technology transfer, qualification, validation, and release and stability testing for both ex vivo cell therapy and in vivo LNP-based drug products. The position requires collaboration with internal teams and external partners to ensure the successful implementation of Prime Editing therapies.
Key responsibilities include designing and reviewing analytical procedures and protocols supporting method lifecycle activities such as optimization, qualification, validation, transfer, verification, performance monitoring, bridging, and comparability studies. The role also involves managing and conducting release, stability, and in-process testing for drug substances, drug products, and gene-editing components, as well as analyzing and trending data. Additionally, the Senior Manager will support or manage analytical method transfers to contract testing laboratories and contract development and manufacturing organizations, providing oversight and troubleshooting to meet technical and timeline objectives.
The ideal candidate will possess a BS/MS/PhD in Biochemistry, Molecular Biology, Chemistry, Bioengineering, or a related discipline, with industry experience commensurate with their degree level. They should have expertise in 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, and flow cytometry assays is essential. Familiarity with ICH and FDA guidelines for CMC development during the clinical stage is required, and experience in advanced cell and gene-editing therapeutics development is highly desirable.
Prime Medicine offers a comprehensive Total Rewards package, including robust health, financial, and wellness benefits such as medical, dental, vision, life insurance, a 401(k) match, and equity programs. Employees also enjoy generous paid time off, wellness days, and company-wide recharge breaks. The company is committed to employee well-being, reflecting the belief that caring for their people strengthens their ability to put patients first and make meaningful impacts together.
Prime Medicine fosters a collaborative and innovative company culture, bringing together dedicated, scientifically curious individuals passionate about helping patients live longer, healthier lives. The company provides opportunities to shape the future of gene editing and transform how medicines are used to treat disease, offering growth opportunities for employees to contribute to groundbreaking advancements in the field.