Director, Drug Substance Manufacturing & Development

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 an Associate 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.