Associate Director, API Development

Associate Director, API Development

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 API pipeline candidates. The successful candidate will be responsible for chemical process research, large scale laboratory production and process and related technology transfer to CDMOs and management of partnering CDMOs.

Expectations

• Foster a collaborative culture interacting with Drug Discovery and Pre-clinical Development team during early stages of drug development.Analyze the initial enabling procedures and develop phase appropriate routes to efficient and scalable manufacturing of peptides, noncanonical amino acids and small molecules to support pre-clinical and clinical trials.
• Use analysis of data to evaluate and compare chemicals syntheses utilizing 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 selection of global third-party contractors and suppliers for process development and manufacturing activities.
• Work closely with analytical scientists to monitor and understand the impact of process

changes on the yield and impurity prole during developmental of peptide APIs.

• Interface between analytical and toxicology departments in identication and qualication 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.

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

Experience/Qualications

• PhD in synthetic organic chemistry, with >7 years, or MS in organic synthesis, with 10+ years, of process research and development experience in peptide or small molecule.
• Experience with DoE methodology applied to process development.
• Strong understanding of FDA/ICH/cGMP guidance.
• Demonstrated ability to effectively lead projects with internal and external resources.
• Experienced with regulatory CMC lings in IND, NDA, IMPD, PAS covering all phases of pre- clinical and clinical development in both the US and global markets, knowledge of relevant FDA and EMA regulations and able to work within regulatory agency requirements.
• Strategic thinker and problem-solver capable of identifying risks and risk mitigation strategies.
• Strong teamwork, negotiation and inuencing skills, able to work in a team setting and establish clear and consistent goals and objectives.
• Must be hands on, detailed oriented, self-driven and goal-oriented, and able to multi-task to achieve results.
• Must be able to adhere to strict project timelines and budgets advise teams and management on impacts and changes in project timelines.
• Inventivethinker, able to assess and take calculated risks to move project forward, and champion new ideas and approaches.

The base pay range for this position at commencement of employment is expected to be between $165,000 and $190,000/ year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides, icotrokinra and rusfertide, derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA expected in 2025. Icotrokinra (JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including the IL-17 oral peptide antagonist PN-881, an oral hepcidin program, and an oral obesity program.