Lead, Chemical Development & Drug Substance Strategy

NURIX; San Francisco (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 for drug substances and coordinate with CMOs for scalable production.

The role supports early to late-stage programs, ensuring quality and regulatory compliance across DS manufacturing and related CMC activities. The position requires a PhD in a related field and at least five years of industry experience, with readiness to travel up to 50%.

Qualifications

• PhD in a relevant scientific discipline plus 5 years in pharma/biotech CMC/cGMP.
• Experience leading CMOs for cGMP drug substance manufacture.
• Experience with IND/NDA/MAA filings and ICH/FDA guidelines.

Responsibilities

• Oversee regulatory starting materials (RSMs) and Drug Substance (DS) cGMP manufacturing.
• Manage CMOs for DS manufacturing and process optimization.
• Lead QS/QbD initiatives to establish DS control strategy for NDAs/MAAs.
• Prepare CMC sections for regulatory filings and support INDs/NDAs.

Skills

cGMP manufacturing

CMO oversight

Regulatory submissions

Process characterization

DOE

QbD

Education

PhD in Chemical Engineering/Pharmaceutical Science

Job description

Nurix Therapeutics, Inc. in Brisbane, CA is seeking an Associate Director, Chemical Development to lead cGMP manufacturing for drug substances and coordinate with CMOs for scalable production.

The role supports early to late-stage programs, ensuring quality and regulatory compliance across DS manufacturing and related CMC activities. The position requires a PhD in a related field and at least five years of industry experience, with readiness to travel up to 50%.