Senior Director, API Development

Role

Senior API process R&D chemist leading synthesis route development and scale-up for peptide drugs at Protagonist Therapeutics.

• 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

• 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

• experience with regulatory submissions for all phases, global markets, and managing large-scale peptide synthesis and API sourcing

• peptide therapeutics
• process scale-up
• regulatory filings
• external vendor management
• cGMP compliance
• laboratory to production transfer
• Newark CA onsite
• no explicit travel