---
title: 'Senior Manager, Quality Control GMP at Cogent Biosciences'
canonical: 'https://feeny.ai/job/senior-manager-quality-control-gmp-cogent-biosciences-united-states-wdgyhgjzbkmw'
type: 'job'
last_seen: '2026-09-16'
---

# Senior Manager, Quality Control GMP at Cogent Biosciences

- **Company:** Cogent Biosciences
- **Location:** United States
- **Work type:** remote
- **Posted:** 2026-07-16
- **Last confirmed live:** 2026-09-16
- **Apply:** https://job-boards.greenhouse.io/cogentbiosciences/jobs/4321874009

## Job description

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

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.

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.

## About Cogent Biosciences

## Company Overview
- **One-liner**: Cogent Biosciences is a publicly traded biotechnology company developing precision therapies for genetically defined diseases, with its lead program bezuclastinib targeting KIT D816V mutations in systemic mastocytosis and gastrointestinal stromal tumors.
- **Entity Type**: Public (NASDAQ: COGT)
- **Headquarters**: Waltham, Massachusetts, United States (with additional office in Boulder, Colorado)
- **Founded**: 2014
- **Founders**: Not publicly available

## Core Business
- **Primary industry**: Biotechnology research and therapeutics development
- **Target customers**: Patients with genetically defined diseases, healthcare providers, and pharmaceutical partners (B2B/B2C hybrid)
- **Mission**: “To discover, develop, and commercialize best-in-class therapies that have a dramatic impact for patients with genetically defined diseases” [cogentbio.com](https://www.cogentbio.com/)

## Products & Services
- **Bezuclastinib**: A selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation and other KIT exon 17 mutations. In late-stage clinical development for advanced systemic mastocytosis (AdvSM), non‑advanced SM, and advanced gastrointestinal stromal tumors (GIST). Positive registration‑directed trial results reported in 2025. [greenhouse.io](https://job-boards.greenhouse.io/cogentbiosciences)
- **Novel JAK2 V617F inhibitor**: A potential best‑in‑class mutant‑selective JAK2 inhibitor currently in preclinical development, with data presented at the 2026 EHA Congress. [cogentbio.com](https://www.cogentbio.com/)
- **Additional pipeline programs**: Research‑stage targeted therapies addressing mutations in ErbB2, PI3Kα, KRAS, and JAK2. [greenhouse.io](https://job-boards.greenhouse.io/cogentbiosciences)

## Market Standing
- **Valuation/Market Cap**: USD $762.7 million (as of mid‑2026, based on LinkedIn data) [linkedin.com](https://www.linkedin.com/company/cogentbiosciences)
- **Key Metric**: Annual revenue of USD $7.9 million (likely from partnerships or grants); total funding to date ~USD $1.82 billion (including post‑IPO equity, debt, and Series A). [linkedin.com](https://www.linkedin.com/company/cogentbiosciences)
- **Notable Investors/Partners**: Series A led by Atlas Venture and F‑Prime; post‑IPO equity rounds led by Commodore Capital (2024, $225M), Fairmount Funds Management (2020, $104.4M) [linkedin.com](https://www.linkedin.com/company/cogentbiosciences)
- **Growth Signals**: Headcount grew 27.6% year‑over‑year to 223 employees; monthly LinkedIn follower growth of 3.0% (+61.7% annually); positive late‑stage trial results in 2025; expanded pipeline with new preclinical assets. [linkedin.com](https://www.linkedin.com/company/cogentbiosciences)

## Competitive Advantages
- **Selective targeting of KIT D816V**: Bezuclastinib is designed to selectively and potently inhibit the key driver mutation in systemic mastocytosis, potentially offering a better safety/tolerability profile than earlier multi‑kinase inhibitors.
- **Late‑stage momentum**: Registration‑directed trials (APEX pivotal trial) have reported clinically meaningful results, positioning the company for potential regulatory submissions and commercialization.
- **Broad pipeline beyond KIT**: Research into JAK2, KRAS, PI3Kα, and ErbB2 mutations diversifies the platform and reduces single‑asset risk.
- **Strong capital position**: Over $760M market cap and access to public equity markets provide financial runway for multiple programs.

## Strategic Focus
- **Advance bezuclastinib to market**: Continue regulatory interactions and preparation for potential FDA approval in AdvSM and GIST, while expanding into non‑advanced SM.
- **Build a portfolio of precision therapies**: Invest in early‑stage discovery (Boulder, CO) to generate novel molecules targeting validated oncogenic drivers.
- **Commercial readiness**: Hiring commercial leadership (Chief Commercial Officer, Market Access, Field Medical Affairs) indicates preparation for a future product launch. [greenhouse.io](https://job-boards.greenhouse.io/cogentbiosciences)

## Why Work Here
- **Culture**: Emphasizes collaboration, urgency, inquisitiveness, and ingenuity. Corporate values include “Patients are waiting” (urgency), “Learning excites us” (inquisitiveness), “Succeed Together” (trust), and “Navigate uncertainty” (ingenuity). [cogentbio.com](https://www.cogentbio.com/careers/)
- **Work model**: Hybrid/remote flexibility – many roles are listed as remote (e.g., Area Directors for Field Medical Affairs, Patient Educators), while research roles are onsite in Boulder, CO. [greenhouse.io](https://job-boards.greenhouse.io/cogentbiosciences)
- **Growth and impact**: As a late‑stage clinical company with an expanding pipeline, employees have direct influence on programs that could change patient lives. Fast‑paced environment with high autonomy.

## Sources
1. [Cogent Biosciences Corporate Website](https://www.cogentbio.com/)
2. [Cogent Biosciences About Page](https://www.cogentbio.com/about/)
3. [Cogent Biosciences Careers Page](https://www.cogentbio.com/careers/)
4. [Cogent Biosciences Job Board (Greenhouse)](https://job-boards.greenhouse.io/cogentbiosciences)
5. [Cogent Biosciences LinkedIn Profile](https://www.linkedin.com/company/cogentbiosciences)

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