Associate Director, Chemical Development
Nurix Therapeutics
September 03, 2026
On-site
Brisbane, CA
Operations
Job Duties:
- Responsible for regulatory starting materials (RSMs) and Drug Substance (DS) cGMP manufacturing activities, including scale-up to support drug discovery candidate selection through commercialization.
- Identify, select, and manage Contract Manufacturing Organizations (CMOs) for process optimization and cGMP DS manufacture for clinical programs.
- Deliver robust, scalable, cost-effective, phase-appropriate DS manufacturing meeting quality and regulatory requirements.
- Implement phase-appropriate process characterization, identify critical quality attributes (CQAs) and controls, including RSM selection/justification to ensure CRO/CMO compliance and DS quality consistency.
- Lead late-phase program characterization using QbD (mapping studies, DOEs) to define CQAs and critical process parameters, including edge of failure and proven acceptable ranges; implement DS Control Strategy to support NDAs/MAAs.
- Support RSM/DS supply chain and logistics for clinical and commercial demand.
- Develop/execute plans for primary stability registration and validation batches of DS per cGMP/ICH/FDA.
- Lead process validation programs supporting commercialization.
- Prepare/review CMC sections of INDs, CTAs, NDAs, MAAs and other regulatory submissions; serve as DS expert to U.S. and European regulators.
- Prepare/review/approve cGMP batch records and CMC/Quality documents; prepare technical reports/publications/presentations.
- Travel up to 50% (domestic and foreign).
Requirements:
- PhD in Chemical Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related field.
- 5+ years industry experience in pharmaceutical/biotechnology CMC/cGMP with experience in:
- Safe, scalable, phase-appropriate synthesis route development.
- Oversight of U.S./international CMOs for cGMP NCE DS.
- Authoring Module 3 sections for IND/IMPD and/or NDA/MAA.
- ICH Q7; FDA 21 CFR Parts 210/211; EU GMP Volume 4 Part I/II.
Application Instructions:
- Send resume to HR@nurixtx.com; reference Position ID No NUR-028 in the email.
- Responsible for regulatory starting materials (RSMs) and Drug Substance (DS) cGMP manufacturing activities, including scale-up to support drug discovery candidate selection through commercialization.
- Identify, select, and manage Contract Manufacturing Organizations (CMOs) for process optimization and cGMP DS manufacture for clinical programs.
- Deliver robust, scalable, cost-effective, phase-appropriate DS manufacturing meeting quality and regulatory requirements.
- Implement phase-appropriate process characterization, identify critical quality attributes (CQAs) and controls, including RSM selection/justification to ensure CRO/CMO compliance and DS quality consistency.
- Lead late-phase program characterization using QbD (mapping studies, DOEs) to define CQAs and critical process parameters, including edge of failure and proven acceptable ranges; implement DS Control Strategy to support NDAs/MAAs.
- Support RSM/DS supply chain and logistics for clinical and commercial demand.
- Develop/execute plans for primary stability registration and validation batches of DS per cGMP/ICH/FDA.
- Lead process validation programs supporting commercialization.
- Prepare/review CMC sections of INDs, CTAs, NDAs, MAAs and other regulatory submissions; serve as DS expert to U.S. and European regulators.
- Prepare/review/approve cGMP batch records and CMC/Quality documents; prepare technical reports/publications/presentations.
- Travel up to 50% (domestic and foreign).
Requirements:
- PhD in Chemical Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related field.
- 5+ years industry experience in pharmaceutical/biotechnology CMC/cGMP with experience in:
- Safe, scalable, phase-appropriate synthesis route development.
- Oversight of U.S./international CMOs for cGMP NCE DS.
- Authoring Module 3 sections for IND/IMPD and/or NDA/MAA.
- ICH Q7; FDA 21 CFR Parts 210/211; EU GMP Volume 4 Part I/II.
Application Instructions:
- Send resume to HR@nurixtx.com; reference Position ID No NUR-028 in the email.