Senior Director, API Development

Role: Senior API process R&D chemist leading synthesis route development and scale-up for peptide drugs at Protagonist Therapeutics. Responsibilities: oversee process research, develop scalable manufacturing routes for peptides, amino acids, and small molecules supporting preclinical and clinical trials; manage external CDMOs; collaborate closely with analytical and toxicology teams on process optimization and impurity profiling; contribute to regulatory documentation (IND, NDA, IMPD, PAS); maintain current knowledge of peptide process R&D and global regulatory standards; document activities thoroughly; lead evaluation of third-party contractors. Requirements: PhD in synthetic organic chemistry with at least 15 years’ experience in peptide and small molecule process R&D; strong knowledge of FDA/ICH/cGMP guidelines; proven project leadership and regulatory filing experience; skilled in DoE, process risk management, and team collaboration. Preferred: experience with regulatory submissions for all phases, global markets, and managing large-scale peptide synthesis and API sourcing. HighValue: peptide therapeutics, process scale-up, regulatory filings, external vendor management, cGMP compliance, laboratory to production transfer, Newark CA onsite, no explicit travel.