Senior Manager, Quality Assurance GMP
Who We Are:
Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.
The Role:
We are seeking a Senior Manager, Quality Control GMP to provide scientific and technical leadership for Quality Control activities supporting clinical and commercial manufacturing. This role is a senior individual contributor within the Quality organization and is responsible for driving method lifecycle management, ensuring GMP compliance, and supporting release and stability testing strategies for drug substance and drug product.
The successful candidate will serve as a key QC subject‑matter expert, working closely with CMC, Analytical Development, Manufacturing, Quality Assurance, and external partners to ensure robust, compliant, and efficient QC operations. This role requires strong leadership in complex problem solving, as well as the ability to influence cross‑functional teams and external vendors.
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.
Qualifications:
- 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.
Salary Range:
$155,000 - 185,000 USD
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.
Our Offer To You
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.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
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