Senior Director, API Development

Protagonist Therapeutics • Newark, NJ

12d • Onsite

About The Position

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.

Requirements

• PhD in synthetic organic chemistry, with at least 15 years of process research and development experience in peptides and small molecules.
• Experience with DoE method 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 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.

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.

Benefits

• Health Care benefits
• Protagonist covers 100% of the premium cost for medical, dental, and vision coverage for all full-time employees and their dependents.
• Flexible Spending Accounts – Healthcare FSA, Dependent Care FSA, Commuter Benefits
• 401(k) Plan
• Flexible Vacation Policy
• Life Insurance (Basic, Voluntary & AD&D)
• Short Term & Long Term Disability
• Company paid lunch and snacks

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree