Associate Director, Synthetic Organic Chemist, MSAT

Role: Associate Director of Process Development overseeing synthetic organic chemistry for API manufacture of a novel dye in biopharma. Responsibilities: lead process development, design and review external protocols, analyze experimental data with CROs/CDMOs, support scale-up, tech transfer, and regulatory submissions (IND/NDA), establish impurity control strategies, and evaluate synthetic routes for robustness and scalability. Collaborate cross-functionally across Tech Ops, Quality, Regulatory, and external partners. Requirements: PhD/MS in Chemistry/Process Sciences, 10+ years in synthetic organic chemistry, experience with cGMP, API process development, and working with third-party manufacturing partners. Experience in regulatory documentation, impurity profiling, and process scale-up highly valued. HighValue: API synthesis, process scale-up, cGMP compliance, regulatory submissions, external CRO/CDMO collaboration, development of impurity control strategies. Work setup: not specified, travel as required.