Senior Director, API Development

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

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

High Value

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