Associate Director, Chemical Development
Nurix Therapeutics · Brisbane, CA
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What they're looking for
- PhD in Chemical Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, or related discipline
- 5+ years pharmaceutical or biotechnology industry experience in CMC/cGMP environments
- Demonstrated experience developing scalable synthetic routes to drug substances
- Experience overseeing US and international contract manufacturing organizations for cGMP new chemical entities
- Experience authoring Module 3 sections for IND/IMPD and NDA/MAA regulatory filings
- Knowledge of ICH Q7, FDA 21 CFR Parts 210 and 211, EU GMP guidelines
What you'll be doing
- Manage regulatory starting materials and drug substance cGMP manufacturing and scale-up activities
- Select, identify, and oversee contract manufacturing organizations for process optimization and cGMP manufacture
- Lead process characterization, quality attribute identification, and control strategy implementation using QbD principles
- Prepare and review CMC sections of regulatory submissions; represent company before regulatory authorities
- Develop and execute stability registration and process validation programs supporting commercialization
Compensation$243,410.16 to $256,800 per year
Privacy & handoff
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