Senior / Executive Director of Chemistry, Manufacturing, and Controls (CMC)

Role: Senior/Executive Director leading CMC for small molecule development from candidate selection through clinical phases. Responsibilities: define and execute global CMC strategy, oversee drug substance (API) process development and scale-up, lead formulation and drug product design for oral dosages, manage analytical and QC testing, oversee CDMO selection and performance, ensure regulatory compliance and authoring of CMC sections for filings, and collaborate with cross-functional discovery and clinical teams. Requirements: PhD in a relevant scientific discipline with 12+ years or MS with 16+ years of industrial CMC experience; extensive expertise in synthetic organic chemistry, process chemistry, formulation, and modern drug delivery approaches; proven leadership in analytical development, QC oversight, and CDMO management; deep understanding of cGMP, ICH guidelines, and global regulatory standards. Preferred: experience with early to late-stage small molecule APIs, advanced formulation technologies (e.g., amorphous dispersions, lipid-based delivery), and regulatory interactions with FDA/EMA. HighValue: small molecule therapeutics, oral solid dosage form, preclinical to clinical stage development, global regulatory engagement, external CDMO oversight, strategic portfolio leadership.