Protagonist Therapeutics
Associate Director, API Development
Protagonist Therapeutics, Newark, California, United States, 94560
Associate Director, API DevelopmentProtagonist is seeking an experienced API process research and development chemist to support route scouting and scale up of our peptides in development pipeline. The successful candidate will be responsible for peptide process research, large scale laboratory production and process and related technology transfer to CDMOs and management of partnering CDMOs.
Expectations
Analyze the Medicinal Chemistry procedure and identify routes to enable efficient and scalable manufacturing of peptides and amino acids using both Solid and Solution-Phase Peptide Synthesis; communicate results clearly and rapidly to internal and external teams.
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 new 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 profile during developmental of peptide APIs.
Interface between analytical and toxicology departments in identification and qualification of impurities.
Contribute to Quality and CMC-related regulatory correspondence.
Current with the peptide and process R&D scientific literature.
Effectively document both laboratory and scale up activities.
Creative and innovative problem solver.
Experience/Qualifications
PhD in organic/peptide chemistry, with >7 years, or MS in organic/peptide synthesis, with 10+ years, of process research and development experience.
Experience in process performance qualification and early commercial manufacturing is desired.
Experience with QbD including 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 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.
Strategic 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 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.
“Out of the box” thinker, 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 $175,000 and $200,000/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 biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced Phase 3 stages of clinical development, both derived from the Company's proprietary technology platform.
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Expectations
Analyze the Medicinal Chemistry procedure and identify routes to enable efficient and scalable manufacturing of peptides and amino acids using both Solid and Solution-Phase Peptide Synthesis; communicate results clearly and rapidly to internal and external teams.
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 new 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 profile during developmental of peptide APIs.
Interface between analytical and toxicology departments in identification and qualification of impurities.
Contribute to Quality and CMC-related regulatory correspondence.
Current with the peptide and process R&D scientific literature.
Effectively document both laboratory and scale up activities.
Creative and innovative problem solver.
Experience/Qualifications
PhD in organic/peptide chemistry, with >7 years, or MS in organic/peptide synthesis, with 10+ years, of process research and development experience.
Experience in process performance qualification and early commercial manufacturing is desired.
Experience with QbD including 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 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.
Strategic 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 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.
“Out of the box” thinker, 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 $175,000 and $200,000/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 biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced Phase 3 stages of clinical development, both derived from the Company's proprietary technology platform.
#J-18808-Ljbffr