Senior Director, API Development

Position:

Senior Director, API Development

Location:

Newark, CAJob :

430

# of Openings:

0

Senior Director, API Development About UsProtagonist Therapeutics is a biopharmaceutical company built on a proprietary peptide technology platform that has now produced two FDA-approved, first-in-class medicines, generating royalties and milestones from global commercial partnerships with Johnson and Johnson and Takeda Pharmaceutical Company Limited. ICOTYDE (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor.

ICOTYDE was launched in the U.S. in March 2026 for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further clinical and regulatory development and commercialization.

Protagonist also discovered and led research and development through Phase 3 for MIMRYLO (rusfertide), a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceutical Company Limited for worldwide commercialization. MIMRYLO is approved in the U.S. for the treatment of erythrocytosis in adults with PV. The Company also has a number of clinical and preclinical programs based on clinically and commercially validated targets and addressing unmet medical needs, including an oral IL-17 antagonist peptide, anti-obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin discovery programs.

More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at .Position 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 our synthetic peptide drugs. The successful candidate will handle chemical process research, large scale laboratory production and process and related technology transfer to CDMOs and management of partnering CDMOs.

The candidate will be heading and managing the API group.

We are committed to a thriving in-office culture. This role requires being on-site at our office in Newark, CA 4 days a week.

Responsibilities Foster a collaborative culture interacting with Drug Discovery and Pre-clinical Development team during preliminary stages of drug development. Analyze the first enabling procedures and develop phase-appropriate routes to efficient and scalable manufacturing of peptides, non-canonical amino acids and small molecules to support pre-clinical and clinical trials.

Use analysis of data to evaluate and compare chemicals syntheses using both Solid (SPPS) and Liquid
- Phase Peptide Synthesis (LPPS) for therapeutic peptides.

Communicate results clearly and rapidly to internal and external teams to drive execution and delivery of APIs.Develop and execute manufacturing and supply strategies of raw materials, regulatory starting materials, and drug substances that meet global regulatory expectations. Work with multiple CDMOs in sourcing amino acids, peptide fragments for large scale manufacturing of APIs; effectively manage outsourced PR&D and production activities.

Lead the evaluation and choice of global third-party contractors and suppliers for process development and manufacturing activities.

Collaborate closely with analytical scientists to monitor and understand the impact of process changes on the yield and impurity profile during development of peptide APIs.Interface between analytical and toxicology departments in identification and qualification of impurities. Contribute to Quality and CMC-related regulatory correspondence.

Maintain a current understanding of peptide and organic process R&D literature.

Maintain a current understanding of global regulatory health care requirements, ICH and FDA guidelines, and filing strategy.

Effectively document both laboratory and scale up activities.

Take the initiative and actively drive creative and innovative solving of problems, both technical, managerial and timing.

Required

Skills & Qualifications

PhD in synthetic organic chemistry, with at least 15 years of process research and…