Process Chemistry Director

1 week ago


California USA, United States HireMinds Full time
Associate Director, Process Chemistry & API Development

HireMinds is partnering with a biotech company focused on peptide drug development to find an experienced Associate Director, Process Chemistry & API Development. This role will support the development of peptide drugs and manage partnerships with contract development and manufacturing organizations (CDMOs).

Key Responsibilities:

  • Analyze medicinal chemistry procedures to identify efficient and scalable manufacturing routes for peptides and amino acids.
  • Develop and execute manufacturing and supply strategies for raw materials, regulatory starting materials, and drug substances.
  • Collaborate with CDMOs to source amino acids and peptide fragments for large-scale API manufacturing.
  • Lead the evaluation and selection of 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 yield and impurity profiles.
  • Interface between analytical and toxicology departments to identify and qualify impurities.
  • Contribute to quality and CMC-related regulatory correspondence.
  • Stay current with the latest scientific literature related to peptide and process R&D.
  • Effectively document laboratory and scale-up activities.

Requirements:

  • PhD in organic/peptide chemistry with 7+ years, or MS in organic/peptide synthesis with 10+ years, industry pharmaceutical, biotech, or contract lab process chemistry experience.
  • Experience with process performance qualification and early commercial manufacturing is preferred.
  • Knowledge of QbD principles including DoE methodology applied to process development.
  • Strong understanding of FDA/ICH/cGMP guidance.
  • Proven ability to effectively lead projects with internal and external resources.
  • Experience with regulatory CMC filings (IND, NDA, IMPD, PAS) across all phases of pre-clinical and clinical development in both the U.S. and global markets.
  • Strategic thinker and problem-solver capable of identifying risks and developing mitigation strategies.
  • Strong teamwork abilities related to negotiation and influencing skills.
  • Ability to adhere to strict project timelines and budgets, and advise teams and management on project impacts and changes.

Compensation:

Salary: $175,000 to $190,000

Bonus: 10-15%

Stock considerations, health, dental, and 401k plan



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