Senior Director, API Process Development & Scale-Up

Protagonist Therapeutics; Newark (CA); On-site; USD 245,000 - 280,000; Full time

Benefits offered by this job

Health Care benefits

401(k) Plan

Flexible Vacation Policy

Life Insurance (Basic, Voluntary & AD&

Disability coverage

Job summary

Protagonist Therapeutics is seeking an experienced API process research and development chemist to support route scouting, organic synthesis process development and scale up of peptide drugs. The successful candidate will manage the API group and coordinate scale up with CDMOs.

The role requires a PhD in synthetic organic chemistry and at least 15 years of process R&D experience in peptides and small molecules, with strong knowledge of FDA/ICH/cGMP guidelines and regulatory filings.

Qualifications

• Experience with DoE applied to process development.
• Familiar with FDA/ICH/cGMP guidance and regulatory expectations.
• Proven ability to lead cross-functional teams and manage projects.

Responsibilities

• Foster collaboration with Drug Discovery and Pre-clinical teams to develop scalable manufacturing routes for peptides and small molecules.
• Analyze data to evaluate synthesis routes for peptides using SPPS and LPPS.
• Communicate results clearly to internal and external teams to drive API development.
• Develop manufacturing and supply strategies with CDMOs to meet global regulatory expectations.
• Lead evaluation of third-party contractors and suppliers for process development and manufacturing.

Skills

DoE methods

Regulatory CMC filings

Project leadership

Analytical thinking

Education

PhD in synthetic organic chemistry

Job description

Protagonist Therapeutics is seeking an experienced API process research and development chemist to support route scouting, organic synthesis process development and scale up of peptide drugs. The successful candidate will manage the API group and coordinate scale up with CDMOs.

The role requires a PhD in synthetic organic chemistry and at least 15 years of process R&D experience in peptides and small molecules, with strong knowledge of FDA/ICH/cGMP guidelines and regulatory filings.