Senior Manager, Drug Product Analytics & QC – Onsite Brisbane

Nurix, Inc.; California; On-site; USD 161,000 - 186,000; Full time

Job summary

Nurix Therapeutics in Brisbane, CA is seeking a Senior Manager to lead the Analytical Development and Quality Control of drug product formulations, including ASDs and lipid-based systems, and to oversee external CDMO testing.

The role supports regulatory submissions (IND/IMPD/NDA) and late-phase tech transfer, with collaboration across Development, Regulatory, and Quality groups. PhD with 8+ years of CMC experience preferred; onsite at Brisbane headquarters.

Qualifications

• PhD with 8+ years of industrial CMC experience.
• Experience in drug product analytical development and validation.
• Experience with amorphous solid dispersions and/or lipid-based formulations.
• CDMO oversight and contract testing lab experience.
• Regulatory submissions (IND/IMPD/NDA) and global filings experience.
• Fluency with ICH guidelines and cGMPs.

Responsibilities

• Lead analytical method development validation and lifecycle management for DP formulations.
• Support PPQ activities, commercialization, and lifecycle management for DP methods.
• Design and oversee DP development, registration batch, and stability programs.
• Author and review analytical development reports for regulatory submissions.
• Oversee analyses at CDMOs and contract testing labs and CAPAs investigations.
• Collaborate with cross-functional teams to ensure traceability and data integrity.

Skills

Analytical development

Cross-functional collaboration

Regulatory submissions

Education

PhD in Chemistry / Pharmaceutics or related field

Job description

Nurix Therapeutics in Brisbane, CA is seeking a Senior Manager to lead the Analytical Development and Quality Control of drug product formulations, including ASDs and lipid-based systems, and to oversee external CDMO testing.

The role supports regulatory submissions (IND/IMPD/NDA) and late-phase tech transfer, with collaboration across Development, Regulatory, and Quality groups. PhD with 8+ years of CMC experience preferred; onsite at Brisbane headquarters.