Associate Director, Chemical Development & CMC

Initial Therapeutics, Inc.; Brisbane (CA); On-site; USD 243,000 - 257,000; Full time

Job summary

Nurix Therapeutics, Inc. in Brisbane, CA, is seeking an Associate Director, Chemical Development to lead cGMP manufacturing and DS/RSM program execution. You will oversee CMOs, drive process development, and ensure regulatory submissions meet ICH and FDA requirements.

The role requires a PhD in a related field and 5+ years in pharma/biotech CMC/cGMP, with experience in scale-up, QbD, and IND/NDAs. Up to 50% travel may be required.

Qualifications

• PhD in a related field plus 5 years of industry experience in a pharmaceutical/biotechnology CMC/cGMP environment.
• Development of safe, scalable, phase-appropriate routes of synthesis to drug substance targets.
• Oversight of US and international CMOs for cGMP manufacture of drug substances.
• Authoring Module 3 sections for IND/IMPD and/or NDA/MAA filings; familiarity with ICH Q7 and FDA/EU GMP guidelines.

Responsibilities

• Responsible for regulatory starting materials (RSMs) and Drug Substance cGMP manufacturing activities, including scale-up to support candidate selection.
• Identify, select, and manage CMOs for process optimization and cGMP manufacture of DS for clinical programs.
• Deliver robust, scalable manufacturing of DS meeting quality and regulatory requirements; implement process characterization and DS Control Strategy.

Education

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

Job description

Nurix Therapeutics, Inc. in Brisbane, CA, is seeking an Associate Director, Chemical Development to lead cGMP manufacturing and DS/RSM program execution. You will oversee CMOs, drive process development, and ensure regulatory submissions meet ICH and FDA requirements.

The role requires a PhD in a related field and 5+ years in pharma/biotech CMC/cGMP, with experience in scale-up, QbD, and IND/NDAs. Up to 50% travel may be required.