Cogent Biosciences

Director, Drug Substance Manufacturing & Development

Remote, United States · Director

Sponsorship not specified$210k-$240kDetected 6 days ago

Process ImprovementIntellectual PropertyGMPMicroscopyResearchLeadershipCommunication

About 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

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.
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.
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

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.
Working knowledge of solid-state development and characterization.
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 travel internationally and within the USA up to 10 - 30%, as required, to meet project objectives.
Degree in Organic chemistry - Bachelor's/Master's degree with 12+ years of experience or PhD degree with 8+ years of experience.
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.
Ability to manage multiple projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.

Compensation

$210,000 - 240,000 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 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.
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.

Equal opportunity

We are proud to be an Equal Opportunity Employer.
Our goal is to have a diverse workforce.
Equal Opportunity Employer.

Apply directly at Cogent Biosciences →Create a free account for alerts like this View Cogent Biosciences immigration profile

This listing is sourced directly from Cogent Biosciences's careers page and normalized into a canonical job model.