Associate Director, Chemical Development — Strategy & CMOs

Nurix, Inc.; Northern (KY); Hybrid; USD 243,000 - 257,000; Full time

Job summary

Nurix Therapeutics, Inc. in Brisbane, CA seeks an Associate Director of Chemical Development to lead DS/cGMP manufacturing and CMO oversight. The role covers scale‑up, regulatory alignment, and supplier management to support clinical programs.

The candidate will drive phase‑appropriate process characterization, QbD elements, and DS control strategies for NDAs/MAAs, with travel up to 50%. Requires a PhD and 5+ years in pharma CMC/cGMP environments.

Qualifications

• PhD in Chemical Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related field with at least 5 years in pharma/biotech CMC/cGMP.
• Experience selecting and managing CMOs for DS manufacture and process development.
• Ability to author regulatory submissions (Module 3) and work with regulatory agencies.

Responsibilities

• Regulatory starting materials (RSMs) and Drug Substance (DS) cGMP manufacturing; scale‑up for candidate selection.
• Identify, select and manage CMOs for process optimization and cGMP DS manufacture.
• Deliver robust, scalable phase‑appropriate DS manufacturing meeting regulatory requirements.
• Implement phase‑appropriate process characterization and controls; select regulatory starting materials.
• Lead DS risk assessment, DOEs, QbD concepts, and DS control strategy for NDAs/MAAs.
• Manage RSMs and DS supply chain for clinical and commercial demand.
• Plan primary stability, validation batches per cGMP, ICH, FDA guidelines; lead process validation.
• Prepare/review CMC sections for INDs/NDAs/MAAs; represent DS before authorities.
• Prepare, review or approve cGMP batch records and technical reports; present at meetings.
• Domestic and international travel up to 50% as needed.

Skills

CMC/cGMP experience

Education

PhD in Chemical Engineering or related

Job description

Nurix Therapeutics, Inc. in Brisbane, CA seeks an Associate Director of Chemical Development to lead DS/cGMP manufacturing and CMO oversight. The role covers scale‑up, regulatory alignment, and supplier management to support clinical programs.

The candidate will drive phase‑appropriate process characterization, QbD elements, and DS control strategies for NDAs/MAAs, with travel up to 50%. Requires a PhD and 5+ years in pharma CMC/cGMP environments.