Senior Director, Quality Control
Nurix Therapeutics · Brisbane, CA
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Role summary
Nurix Therapeutics seeks an Associate Director of Chemical Engineering to provide end-to-end chemical engineering oversight for bexobrutideg drug substance from late-stage development through commercial launch. The role involves leading process optimization, technology transfer to contract manufacturers, and ensuring regulatory compliance across manufacturing operations.
What they're looking for
- Advanced degree in chemical engineering or related discipline
- Extensive experience in small-molecule drug substance process development and scale-up
- Demonstrated expertise in unit operations, process modeling, and equipment selection
- Knowledge of cGMP, FDA, EMA, and ICH regulatory requirements
- Experience leading technology transfer and manufacturing at contract development organizations
- Strong project management and cross-functional collaboration skills
What you'll be doing
- Design, develop, and optimize scalable manufacturing routes for small-molecule drug substance
- Oversee equipment qualification, maintenance, and operations at external contract manufacturers
- Lead technology transfer and process scale-up demonstrations at development and commercial facilities
- Review and approve batch records, deviation investigations, and change controls for regulatory compliance
- Author and review CMC sections of regulatory filings including INDs and NDAs
Privacy & handoff
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