Senior Manager, Drug Product Analytics & QC (Onsite)

Regulatory Jobs; Brisbane (CA); On-site; USD 161,000 - 186,000; Full time

Job summary

Nurix Therapeutics, a clinical-stage biopharmaceutical company, seeks a Senior Manager to lead drug product analytical development and QC. You will oversee method development, validation at CDMOs, and lifecycle management to support oncology and inflammation programs.

The role emphasizes cross-functional collaboration, regulatory submissions, and late-stage transfer activities. Based onsite at the Brisbane, CA headquarters, you will author development reports, manage stability programs, and

Qualifications

• Advanced degree in Chemistry, Pharmaceutics, or related field.
• PhD with 8+ years of industrial CMC experience preferred.
• Strong experience in drug product analytical development and validation.
• Experience with ASDs and/or lipid-based formulations.
• Oversight of CDMO/contract testing labs.
• Experience supporting IND/IMPD/NDA submissions.
• Knowledge of ICH, cGMPs, pharmacopeial chapters.

Responsibilities

• Lead analytical method development, validation, and lifecycle management for DP formulations.
• Design and oversee DP development, registration batches, and stability programs.
• Author and review analytical development reports for regulatory submissions.
• Support late-phase tech transfer and validation activities.
• Coordinate with CDMOs and CTLs for analytical testing.
• Investigate OOS/OOE/OOT issues and drive CAPAs.
• Review data, protocols, reports, and COAs for traceability and GMP compliance.
• Contribute to material control strategy development and specifications.
• Prepare regulatory documentation sections (IND/IMPD/NDA).
• Collaborate with cross-functional teams across development stages.

Education

Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)

PhD with 8+ years of industrial CMC experience

Strong experience in drug product analytical development and validation

Analytical development for amorphous solid dispersions (ASDs) and/or lipid-based formulations

CDMO and contract testing lab oversight

Experience supporting regulatory submissions (e.g., IND, IMPD, NDA)

Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters

Cross-functional collaboration

Technical writing skills

Ability to manage multiple priorities in a fast-paced environment

Excellent communication and cross-functional collaboration skills

Job description

Nurix Therapeutics, a clinical-stage biopharmaceutical company, seeks a Senior Manager to lead drug product analytical development and QC. You will oversee method development, validation at CDMOs, and lifecycle management to support oncology and inflammation programs.

The role emphasizes cross-functional collaboration, regulatory submissions, and late-stage transfer activities. Based onsite at the Brisbane, CA headquarters, you will author development reports, manage stability programs, and