Director of Drug Substance CMC

Director of Chemical Development
Boston/Hybrid/Remote

Overview
We are partnered with a well funded, clinical stage biopharmaceutical organization focused on advancing innovative small molecule therapeutics targeting serious diseases with high unmet need. The company is building an integrated CMC organization to support multiple clinical programs and is seeking a Director of Chemical Development to lead drug substance development from late pre-clinical through clinical stages and beyond.

This role will play a critical leadership position across technical strategy, external partnerships, and cross functional execution as programs advance through key clinical and regulatory milestones.

Key Responsibilities

• Own and drive drug substance development strategy, including route scouting, process optimization, scale up, and control strategy development.
• Lead external CDMO relationships, overseeing process development, tech transfer, campaign execution, and ongoing optimization.
• Ensure chemical processes are robust, scalable, cost effective, and compliant with global regulatory expectations.
• Partner cross functionally with Formulation, Analytical, Quality, Regulatory, and Clinical teams to align CMC strategy with program timelines.
• Author and review CMC sections of regulatory filings, including INDs, amendments, and supporting documentation.
• Identify and mitigate technical, supply chain, and execution risks related to drug substance manufacturing.
• Build and mentor internal team members and contribute to the broader development and governance of the CMC function.
• Support long term planning for late stage development and commercialization readiness as the pipeline matures.

Qualifications & Experience

• PhD (or MS with significant industry experience) in Organic Chemistry, Chemical Engineering, or related discipline.
• 10 years of experience in small molecule chemical development within biotech or pharmaceutical environments.
• Proven experience advancing programs from pre-clinical into clinical development (Phase 1-2 required; Phase 3/commercial a plus).
• Strong background in external manufacturing, including hands on management of CDMOs.
• Solid understanding of regulatory CMC expectations across early and mid stage development.
• Track record of operating effectively in lean, fast moving organizations with limited infrastructure.
• Strong leadership, communication, and cross functional collaboration skills.