Sr. Manager, QC

Prime Medicine • Cambridge, MA

1d

About The Position

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.

Requirements

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

Nice To Haves

• Experience in advanced cell and gene-editing therapeutics development is not mandatory, but highly desirable
• 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

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees