Process Chemistry Director
1 week ago
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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