Director, Process Chemistry

Role: Director, Process Chemistry in API Development, responsible for managing API/Intermediate/RSM manufacturing at CMOs, including synthesis route development, process optimization, tech transfer, and process validation. Objectives: support early-stage process identification, scale-up, and manufacturing strategy to enable clinical and commercial supply for serious diseases. Responsibilities: oversee CMO operations, collaborate with R&D on lead optimization, manage tech transfer and process improvements, provide technical review of quality documentation, and lead process characterization efforts. Qualifications: PhD in Organic Chemistry or Chemical Engineering with 5+ years of experience in API process development, including managing development teams and CMO operations in regulated environments. Skills: expertise in NCE synthesis, physical organic chemistry, validation, quality systems, and regulatory filings; strong communication and leadership skills. Preferred: 10+ years of experience across full API development lifecycle, including marketed products. High-Value: biopharma, API synthesis, process development, early to late-stage development, regulated environment, global regulatory compliance, remote work with occasional travel (~10%). Collaboration with research, regulatory, and manufacturing teams; no specific therapeutic focus indicated.