Executive Director, Small Molecule CMC Lead

Role: Strategic CMC leader responsible for guiding development, regulatory submission, and commercialization of drug programs from clinical to post-approval. Responsibilities: develop and execute comprehensive CMC strategies, oversee drug substance and product development, manage risk mitigation, coordinate with external vendors, and ensure readiness for regulatory inspections and commercial supply. Serve as primary cross-functional CMC representative, leading teams across R&D, quality, manufacturing, and regulatory functions to align technical development with business objectives. Requirements: Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or related; 8+ years in CMC development within pharma/biotech; experience supporting IND/NDA submissions; strong GMP, regulatory knowledge, and leadership of cross-functional teams. Preferred: experience with pipeline management, global regulatory agencies (FDA, EMA, NMPA), commercialization, tech transfer, and lifecycle management. HighValue: biologics or small molecules, early to late-stage development, GMP manufacturing, regulatory submissions, external vendor management, and lifecycle strategies. WorkSetup: not specified.