Senior Scientist: Drug Product Analytics & QC (Onsite)

Nurix Therapeutics; Brisbane (CA); On-site; USD 162,000 - 186,000; Full time

Job summary

Nurix Therapeutics seeks an experienced Senior Scientist to lead analytical development and QA for drug product programs at the Brisbane, CA headquarters. You will oversee method development, validation, and lifecycle management across late-stage programs and author regulatory submissions.

The role requires expertise in ASDs, lipid-based formulations, and cross-functional collaboration with Regulatory, QC, and CDMO partners to ensure cGMP compliance and data integrity throughout development.

Qualifications

• Advanced degree in Chemistry, Pharmaceutics, or related field.
• BS/MS with 14+ years or PhD with 8+ years of industrial CMC experience.
• Strong experience in drug product analytical development and validation.
• Experience with analytical development for ASDs and/or lipid-based formulations.
• Experience in CDMO and contract testing lab oversight.
• Experience supporting regulatory submissions (IND, IMPD, NDA) and global filings.
• Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters.
• Ability to work effectively in a cross-functional environment.

Responsibilities

• Lead analytical method development, validation, and lifecycle management for DP formulations.
• Oversee PPQ activities, commercialization, and stability programs.
• Design and oversee DP development, protocol creation, and trend analysis.
• Author and review analytical development reports for regulatory submissions.
• Coordinate activities with CDMOs and external testing labs.
• Investigate OOS/OOE/OOT findings and drive CAPAs.

Skills

Analytical Development

Validation

CDMO Oversight

Regulatory Submissions

ICH cGMP

Technical Writing

Cross-Functional Collaboration

Data Integrity

Education

Advanced degree in Chemistry/Pharmaceutics

BS/MS with 14+ years or PhD with 8+ years CMC experience

Job description

Nurix Therapeutics seeks an experienced Senior Scientist to lead analytical development and QA for drug product programs at the Brisbane, CA headquarters. You will oversee method development, validation, and lifecycle management across late-stage programs and author regulatory submissions.

The role requires expertise in ASDs, lipid-based formulations, and cross-functional collaboration with Regulatory, QC, and CDMO partners to ensure cGMP compliance and data integrity throughout development.