Director, Peptide API Process Development & Scale-Up

Scorpion Therapeutics; Newark (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Protagonist Therapeutics in Newark, CA is seeking a Senior API process R&D chemist to lead synthesis route development and scale-up for peptide drugs. The role focuses on delivering scalable routes and robust processes for complex molecules in a fast-paced discovery-to-clinic setting.

You will oversee process research, manage CDMOs, collaborate with analytical and toxicology teams, contribute to regulatory filings, and ensure cGMP-compliant documentation across programs.

Qualifications

• PhD in synthetic organic chemistry with 15+ years in peptide and small molecule process R&D.
• Strong knowledge of FDA/ICH/cGMP guidelines.
• Proven project leadership and regulatory filing experience.

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

Skills

DoE

Process risk management

Team leadership

Regulatory filings

cGMP knowledge

Education

PhD in synthetic organic chemistry

Job description

Protagonist Therapeutics in Newark, CA is seeking a Senior API process R&D chemist to lead synthesis route development and scale-up for peptide drugs. The role focuses on delivering scalable routes and robust processes for complex molecules in a fast-paced discovery-to-clinic setting.

You will oversee process research, manage CDMOs, collaborate with analytical and toxicology teams, contribute to regulatory filings, and ensure cGMP-compliant documentation across programs.