Cogent Biosciences - Senior Manager, Quality Control GMP
Requirements
• Ph.D. in Chemistry, Pharmaceutical Sciences, or a related discipline, with significant experience in QC or analytical sciences in a GMP environment; or M.S./B.S. with substantial relevant industry experience. • 5-8 years of experience with QC testing and GMP compliance supporting clinical and/or commercial stage programs. • Strong expertise in analytical techniques relevant to small‑molecule pharmaceuticals (e.g., HPLC/UPLC, GC, dissolution, spectroscopic methods, and wet chemistry). • Deep understanding of method validation, transfer, and lifecycle management in a regulated environment. • Demonstrated experience supporting or leading deviation investigations (OOS/OOT) and CAPA processes. • Working knowledge of global regulatory requirements, including FDA, EMA, ICH guidelines, and compendial standards (USP, EP). • Experience working with and overseeing external laboratories, CMOs, or CROs. • Proven ability to operate independently, manage multiple priorities, and influence cross‑functional stakeholders. • Strong written and verbal communication skills, with the ability to clearly present technical concepts and data.
Responsibilities
• Provide scientific leadership for QC GMP activities, including method transfer, qualification, validation, and lifecycle management for drug substance (DS) and drug product (DP). • Serve as a QC subject‑matter expert supporting release and stability testing, including data review, trending, and interpretation. • Lead or support investigations of deviations, OOS, and OOT results, including root cause analysis and development of corrective and preventive actions (CAPAs). • Collaborate closely with Analytical Development and CMC teams to ensure successful method transfers to QC laboratories and external CMOs. • Provide oversight of QC activities conducted at contract testing laboratories and manufacturing partners, including review of data packages and ensuring compliance with quality and regulatory requirements. • Contribute to the development and execution of control strategies for small‑molecule drug substance and drug product. • Author, review, and approve QC‑related documents, including methods, specifications, protocols, validation reports, and regulatory submission content. • Support regulatory inspections and audits, including preparation, response, and follow‑up activities. • Identify opportunities for continuous improvement in QC processes, technologies, and compliance practices. • Mentor junior staff and serve as a technical resource across functional teams.
Benefits
• $155,000 - 185,000 USD • Target Bonus: 15% • Exact compensation will vary based on skills, experience, and location. • Our Locations • Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building. • Boulder, CO: Our Boulder location is home to Cogent’s discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline. • At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart. We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles. Our benefits also include a 401(k) match with immediate vesting, generous paid time off, 12 weeks of fully paid parental leave, paid family and medical leave for all employees regardless of location, and company-paid short-term disability coverage for up to 20 weeks. Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.
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