Executive Director, API Development, Small Molecule

Role: Executive Director, API Development, Small Molecule, leading strategic API synthesis and process development for preclinical and clinical small molecule candidates within biopharma R&D. Responsibilities: establish and execute long-term API development strategy, oversee process design, scale-up, technology transfer, validation, manufacturing readiness, and lifecycle management; collaborate with Discovery, Clinical, Quality, Regulatory, and Commercial teams; influence portfolio and resource allocation decisions; represent the company externally through scientific publications and industry forums; develop organizational talent and performance metrics. Requirements: PhD with 10+ years (or MS with 12+ years, BS with 15+ years) of CMC experience in pharma, specific expertise in route design, process development, validation, manufacturing sciences, and regulatory strategy for small molecule APIs; experience managing CROs/CMOs; strong problem-solving and communication skills; thorough understanding of cGxP, ICH, and regulatory submission processes. Nice-to-have: experience with inhalation compounds or combination products. WorkSetup: fully remote with occasional travel (~25%). HighValue: small molecules, API development, cGxP, process validation, global regulatory standards, leadership in technical operations.