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 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 leadershi…