Associate Director, Chemical Development & DS Manufacturing

nurix

Brisbane (CA)

On-site

USD 243,000 - 257,000

Full time

9 days ago
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Job summary

Nurix Therapeutics, Inc. in Brisbane, CA is hiring an Associate Director, Chemical Development to lead cGMP manufacturing of drug substance and to manage CMOs for scale‑up and process validation. The role supports regulatory submissions and quality compliance across programs.

The candidate will drive process characterization, set controls, and ensure readiness for NDAs/MAAs, with significant travel as needed. This is a high‑impact scientific leadership position.

Qualifications

  • PhD in Chemical Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related field.
  • At least 5 years of industry experience in a pharmaceutical/biotechnology CMC/cGMP environment.
  • Experience with development of safe, scalable, phase‑appropriate routes of synthesis to drug substance targets.
  • Experience overseeing US and international CMOs for cGMP manufacture of drug substances.
  • Familiarity with ICH Q7 and FDA 21 CFR Part 210, 211 and EU GMP guidelines.

Responsibilities

  • Oversee regulatory starting materials (RSMs) and Drug Substance (DS) cGMP manufacturing, including scale‑up for candidate selection.
  • Identify, select, and manage CMOs for process optimization and cGMP DS manufacture.
  • Deliver robust, scalable, and cost‑effective phase‑appropriate DS manufacturing meeting regulatory requirements.
  • Lead DS process characterization, identify critical quality attributes and control strategies, and justify regulatory starting materials.
  • Support NDAs/MAAs with DS regulatory submissions; interact with US and European authorities.
  • Up to 50% domestic and foreign travel may be required.

Education

PhD in Chemical Engineering/Pharmaceutical Chemistry/Organic Chemistry/Pharmaceutics/Pharmaceutical Science or related field

Job description

Nurix Therapeutics, Inc. in Brisbane, CA is hiring an Associate Director, Chemical Development to lead cGMP manufacturing of drug substance and to manage CMOs for scale‑up and process validation. The role supports regulatory submissions and quality compliance across programs.

The candidate will drive process characterization, set controls, and ensure readiness for NDAs/MAAs, with significant travel as needed. This is a high‑impact scientific leadership position.

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