Senior Manager, Quality Assurance GMP
Benefits
12w maternity
12w paternity
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The Role:
- Provide scientific leadership for QC GMP activities supporting clinical and commercial manufacturing.
- Serve as a QC subject-matter expert for release and stability testing.
- Drive method lifecycle management and ensure GMP compliance.
Key Responsibilities:
- Lead method transfers, validations, and investigations of OOS/OOT results.
- Oversee QC activities at contract testing labs and CMOs.
- Author and review QC-related documents and support regulatory inspections.
Qualifications:
- Ph.D. in Chemistry or related field with significant GMP experience; or M.S./B.S. with substantial industry experience.
- 5-8 years of QC testing and GMP compliance experience.
- Strong expertise in analytical techniques (HPLC, GC, dissolution) and method validation.
Benefits:
- 100% paid medical, dental, and vision premiums for you and your family.
- 12 weeks fully paid parental leave and 401(k) match with immediate vesting.
- Wellness programs, tuition reimbursement, and family-forming support.
Cogent Biosciences
Cogent Biosciences is a publicly traded biotechnology company developing novel precision therapies for rare diseases and cancer. With a collaborative culture and offices in Waltham, MA and Boulder, CO, they focus on advancing their pipeline through clinical trials.