Associate Director, Chemical Development — cGMP & DS Expert

BioSpace; Brisbane (CA); On-site; USD 243,000 - 257,000; Full time

Job summary

Nurix Therapeutics, Inc. in Brisbane, CA seeks an Associate Director, Chemical Development to lead cGMP manufacturing activities for drug substance and RSMs. You will oversee CMOs, drive scalable processes, and ensure regulatory compliance across preclinical to clinical program stages.

The role requires a PhD in a relevant field and 5+ years in pharma/biotech CMC/cGMP, with experience in IND/IMPD and NDA/MAA filings and ICH/EU guidelines. Domestic travel up to 50% is possible.

Qualifications

• PhD in Chemical Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related field required.
• 5+ years of industry experience in a pharmaceutical/biotech CMC/cGMP environment.
• Experience with developing scalable synthesis routes and managing CMOs for cGMP drug substances.
• Experience preparing Module 3 sections for IND/IMPD and/or NDA/MAA filings; familiarity with ICH/Q7 and FDA EU GMP guidelines.

Responsibilities

• Oversee regulatory starting materials and drug substance cGMP manufacturing activities, including scale‑up for candidate selection.
• Identify, select, and manage CMOs for process optimization and cGMP DS manufacture.
• Deliver robust, scalable manufacturing meeting quality and regulatory standards; implement phase‑appropriate controls.
• Lead DS characterization studies and DS control strategy to support regulatory submissions and NDA/MAA work.
• Prepare or review CMC sections of regulatory filings and represent DS expertise to authorities.

Skills

cGMP knowledge

CMO management

IND/CTA filings

Regulatory submissions

Education

PhD in Chemical Engineering or related field

Job description

Nurix Therapeutics, Inc. in Brisbane, CA seeks an Associate Director, Chemical Development to lead cGMP manufacturing activities for drug substance and RSMs. You will oversee CMOs, drive scalable processes, and ensure regulatory compliance across preclinical to clinical program stages.

The role requires a PhD in a relevant field and 5+ years in pharma/biotech CMC/cGMP, with experience in IND/IMPD and NDA/MAA filings and ICH/EU guidelines. Domestic travel up to 50% is possible.