Associate Director, Active Pharmaceutical Ingredient Development (API)
Full-time onsite position
Newark Office, Newark, CA, US
Protagonist Therapeutics is recruiting for Associate Director, Active Pharmaceutical Development. As an API process research and development chemist experienced in the biopharmaceutical industry, you will support the Chemistry, Manufacturing and Control organization in advancing the peptide-based and other organic molecules pipeline from Discovery to late-stage development. Responsibilities include technical oversight of route of synthesis scouting and selection for multiple drug substances and starting materials, scale-up and supply for preclinical activities, and phase-appropriate manufacturing process development and technology transfer to CDMOs for clinical supply. This role is pivotal in ensuring successful IND-enabling studies, supply of human clinical trials, and global regulatory submissions across a portfolio of Protagonist products. Strong emphasis on the understanding of peptide manufacturing and challenges, isolation and purification along with solid-form engineering done in a regulatory environment.
Responsibilities
- During early stages ensure a seamless transfer of knowledge and responsibilities from Discovery to the pre-clinical development team. You will analyze the enabling procedures and develop phase appropriate routes for efficient and scalable manufacturing of synthetic peptides, non-canonical amino acids and small molecules therapeutics.
- Lead the evaluation and choice of global third-party contractors and suppliers for process development and manufacturing activities. Ensure in a timely and efficient manner the uninterrupted supply of clinical and commercial drug substances for all programs. Communicate status clearly and rapidly to internal and external teams to drive execution and delivery of APIs.
- Lead technology transfer, scale-up and process performance validation of drug substance commercial manufacturing at multiple CDMOs.
- Generate and analyze process metrics to develop or select safe, scalable, robust, sustainable and economical syntheses for both Solid (SPPS) and Liquid- Phase Peptide Synthesis (LPPS) methods.
- Develop and execute manufacturing and supply strategies for raw materials, regulatory starting materials, and drug substances that meet global regulatory expectations. Work with multiple global CDMOs to achieve the goal of a robust drug substance supply chain. Effectively manage outsourced process research, development and production activities.
- Collaborate cross-functionally with CMC API development, formulation development, toxicology supply, Regulatory Affairs, Quality, supply chain, and clinical teams to ensure robust end-to-end process support.
- 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.
- Maintain a current understanding of the peptide and organic process R&D literature. Stay current with global regulatory health care requirements, ICH and FDA guidelines, and global filing strategies.
- Contribute to Quality and CMC-related regulatory correspondence. Author and review CMC regulatory submissions (INDs, NDAs, IMPDs, etc.), including process descriptions, validation strategies, and control strategies.
- Effectively document laboratory and scale up activities.
- Initiate and actively drive creative and innovative solving of problems, both technical, managerial and schedule.
Qualifications
- Advanced degree preferred. Ph.D. 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 synthesis.
- Experience with DoE methodology as applied to process development.
- Strong understanding of FDA/ICH/cGMP guidelines and the ability to apply these guidelines appropriately in context of the stage of drug development.
- Demonstrated ability to effectively lead multiple projects with internal and external resources. Demonstrated success in technology transfer, clinical and commercial scale-up, and process validation.
- Experienced with regulatory CMC filings 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.
- Analytical thinker and problem-solver capable of identifying risks and risk mitigation strategies.
- Strong teamwork, negotiation and influencing skills, able to work in a team setting and establish clear and consistent goals and aims.
- Must be direct, detailed oriented, self-driven and purposeful, and able to multi-task to achieve results.
- Must be able to adhere to strict project timelines and budgets recommend teams and management on impacts and changes in project timelines.
- Inventive thinker, able to assess and take calculated risks to move project forward, and champion innovative ideas and approaches.
The base pay range for this position at commencement of employment is expected to be between $165K and $190K / 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.
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