---
title: 'Director, Drug Substance Manufacturing & Development at Cogent Biosciences'
canonical: 'https://feeny.ai/job/director-drug-substance-manufacturing-development-cogent-biosciences-united-3xsj3y1318p1'
type: 'job'
last_seen: '2026-09-16'
---

# Director, Drug Substance Manufacturing & Development 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/4321545009

## Job description

Who We Are:

Cogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically defined diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease and offer meaningful hope to patient's.

The company’s lead therapeutic candidate, bezuclastinib, is a highly selective tyrosine kinase inhibitor designed to potently target KIT D816V and other mutations in KIT exon 17. These mutations are known drivers of systemic mastocytosis (SM) and advanced gastrointestinal stromal tumors (GIST) - both serious conditions driven by oncogenic KIT signaling. Bezuclastinib is currently being evaluated in multiple registration-directed trials across Non-Advanced SM (NonAdvSM), Advanced SM (AdvSM), and GIST.  In July 2025, Cogent announced that its registration-direct SUMMIT trial in patients with NonAdvSM achieved statistical significance across all primary and key secondary endpoints, and the company is on track to file its first New Drug Application for this patient population by the end of 2025.  The company also remains on track to announce top-line results for its APEX trial in patients with AdvSM in the second half of 2025 and for its PEAK trial in patients with GIST by the end of 2025.  The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor, and the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting other serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.

Through its commitment to precision medicine and targeted innovation, Cogent Biosciences is working to transform the treatment landscape for patients with serious and underserved diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease. Our culture of inquisitiveness fuels continuous learning and innovation; we challenge assumptions, ask bold questions, and embrace a mindset of discovery to uncover transformative insights.

The Role:

We are seeking a Director responsible for phase-appropriate small molecule drug substance development. This critical hire will bring a strong process development background and experience managing external vendors and will define and execute on a strategy for synthetic route, process optimization, site transfer, scale-up and validation.

Responsibilities:

- Subject matter expert for all aspects of drug substance process and controls.
- Manage development and manufacturing activities at drug substance CDMOs.
- Lead small molecule drug substance route selection/evaluation, scale up, and process control development including identification of critical process parameters, critical quality attributes, and acceptance criteria.
- Review and approve external vendor documentation including protocols, reports, raw data, master and executed batch records.
- Perform impurities fate analysis and manufacturing process parameters assessment and develop an overall end-to-end control strategy.
- Lead solid state evaluation and development activities to support process control, formulation development, and intellectual property protection.
- Provide drug substance support for quality events including deviation investigation, corrective and preventative action implementation and change control for both internal and external operations.
- Author, review, and approve documents in support of regulatory filings including module 3 sections of Investigational New Drug (IND) applications and New Drug Application (NDA) as well as CMC section in a global regulatory submission.
- Provide guidance as a subject matter expert in drug substance manufacturing and development for internal CMC and discovery organization.
- Provide on-site support at external suppliers including project initiation, routine visits and technical leadership as needed.

Qualifications:

- Degree in Organic chemistry - Bachelor’s/Master’s degree with 12+ years of experience or PhD degree with 8+ years of experience.
- Subject matter expert in small molecule drug substance production techniques, processing, and characterization and have a demonstrated track record of successful CDMO management.
- Extensive experience in small molecule cGMP manufacturing and proficient knowledge of ICH Q7 guidelines.
- Experience in evaluating and setting phase appropriate controls including raw material, in-process, intermediate, and final drug substance specifications. Familiar with ICH guidelines as they relate to these controls.
- History writing, reviewing and approving quality documents (batch records, SOPs, change controls) and participating in quality events (deviation investigation, CAPA, audits).
- Experience writing, reviewing and approving technical documents including development reports, risk assessments, and regulatory drug substance sections (IND, IMPD,NDA).
- Working knowledge of solid-state development and characterization. The ability to lead polymorph, salt/co-crystal evaluation, and selection. Familiar with the use of XRPD, DSC, TGA, DVS, PSD, and microscopy to support characterization.
- Ability to collaborate with diverse stakeholders, both internally and external contract manufacturers.
- Detail oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment.
- Ability to troubleshoot problems, work within a team.
- Ability to manage multiple projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.
- Ability to travel internationally and within the USA up to 10 – 30%, as required, to meet project objectives.

Salary Range:

$210,000 - 240,000 USD

Target Bonus: 20%

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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