Associate Director, Chemical Engineering — Drug Substance

BioSpace; Brisbane (CA); Vor Ort; USD 190.000 - 217.000; Vollzeit

Zusammenfassung

Nurix Therapeutics seeks an experienced Associate Director, Chemical Engineering to lead end-to-end bexobrutideg drug substance manufacture from late-stage development through commercial launch. You will oversee CDMO operations, tech transfer, and process optimization, reporting to the Director, Chemical Development.

The role requires strong GMP know-how, CDMO management, and regulatory familiarity, with up to 25% travel. Salary range is disclosed and location is Brisbane, CA onsite.

Qualifikationen

• PhD in chemical engineering with 5+ years of industrial drug substance experience or MS with 10+ years.
• Extensive GMP drug substance manufacturing and process development experience.
• Experience with tech transfer, CDMO management, QbD and DoE studies.

Aufgaben

• Provide engineering leadership for scalable DS manufacturing routes and process tech transfer.
• Review CDMO equipment, qualification packages and maintenance to ensure performance.
• Oversee DS CDMO scale-up, troubleshooting and batch support across development to PPQ batches.
• Coordinate with QA, supply chain and CMC to ensure timely manufacture and release of DS.
• Define process understanding via DoE/QbD and drive lifecycle and cost of goods improvements.
• Author/review CMC sections of regulatory filings and respond to health authority queries.

Kenntnisse

GMP knowledge

Process development

Tech transfer

DoE / QbD

Leadership

Cross-functional collaboration

Ausbildung

PhD in chemical engineering

Jobbeschreibung

Nurix Therapeutics seeks an experienced Associate Director, Chemical Engineering to lead end-to-end bexobrutideg drug substance manufacture from late-stage development through commercial launch. You will oversee CDMO operations, tech transfer, and process optimization, reporting to the Director, Chemical Development.

The role requires strong GMP know-how, CDMO management, and regulatory familiarity, with up to 25% travel. Salary range is disclosed and location is Brisbane, CA onsite.