Director of Drug Substance CMC

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.
• 8+ 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.