Associate Director, Drug Substance

Role: Associate Director of CMC Drug Substance supporting GMP manufacturing, process tech transfer, validation, and regulatory documentation for biologics pipeline candidates. Responsibilities: oversee process characterization, validation, external manufacturing, batch review, troubleshooting, and process risk analysis; serve as person-in-plant for CDMO management; lead technology transfer; support authoring Module 3 of CTD for regulatory submissions; contribute to CPV programs; collaborate with analytical, formulation, quality, and regulatory teams for batch release and investigations. Requirements: Master's in Chemical/Biochemical Engineering, Biological Sciences or related; 8+ years in biotech/pharma manufacturing; 3+ years managing or working with biologics CDMOs; 2+ years in late-phase biologics and CMC technical writing; strong interpersonal skills. High-Value: biologics (clinical and commercial), GMP, process validation, CDMO management, late-phase biologics, regulatory documentation, cross-functional collaboration. Work setup: on-site with 10-15% travel.