Cogent Biosciences

Cogent Biosciences

Senior Manager, Quality Control GMP

Remote, United States · Senior

Sponsorship not specified$155k-$185kDetected 1 day ago
GMPFDA RegulatoryResearchMass SpectrometryLeadershipCommunicationProblem Solving

About 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.

Responsibilities

  • 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.
  • 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.
  • 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.

Requirements

  • Ph.D. in Chemistry, Pharmaceutical Sciences, or a related discipline, with significant experience in QC or analytical sciences in a GMP environment
  • 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).
  • 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.
  • Strong written and verbal communication skills, with the ability to clearly present technical concepts and data.
  • This role requires strong leadership in complex problem solving, as well as the ability to influence cross‑functional teams and external vendors.
  • or M.S./B.S. with substantial relevant industry experience.
  • 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.
  • Proven ability to operate independently, manage multiple priorities, and influence cross‑functional stakeholders.

Compensation

  • $155,000 - 185,000 USD
  • Exact compensation will vary based on skills, experience, and location.
  • At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that se t s us apart.

Benefits

  • At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that se t s 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.
  • A dditional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.

Company info

  • 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.
  • 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 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.
  • Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection.
  • We are proud to be an

Equal opportunity

  • We are proud to be an Equal Opportunity Employer.
  • Our goal is to have a diverse workforce.
  • Equal Opportunity Employer.
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This listing is sourced directly from Cogent Biosciences's careers page and normalized into a canonical job model.