Senior Scientist, Drug Product Analytics & CDMO Oversight

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

Job summary

Nurix Therapeutics seeks an experienced Senior Scientist to join the Analytical Development and Quality Control group. The Senior Scientist will oversee drug product analytical development, method development, CDMO validation, and lifecycle management in support of Nurix’s oncology and I&I programs.

The role requires expertise in chromatographic and dissolution method development, stability studies, and phase-appropriate validation.

Qualifications

• Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field).
• BS/MS degree 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 (e.g., IND, IMPD, NDA) and global regulatory filings.
• Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters.
• Ability to work effectively in a cross-functional environment.
• Strong technical writing skills and data integrity focus.

Responsibilities

• Lead analytical method development validation and lifecycle management for drug product formulations, including ASDs and lipid-based systems.
• Support PPQ activities, commercialization, commercial QC, and lifecycle management for drug product analytical methods and control strategies.
• Design and oversee DP development, registration batch, and commercial stability programs, including protocol development and trend analysis.
• Author and review DP analytical development reports to support regulatory submissions and marketing authorization.
• Oversee analytical activities at CDMOs and contract testing labs.
• Contribute to investigations (e.g., OOS, OOE, OOT), root cause analysis and CAPAs.
• Perform critical review of analytical data, protocols, reports, specifications, and related documentation.
• Trend stability data and establish retest periods and shelf life using statistical methods.
• Collaborate in development of material control strategies and specifications.
• Author technical documents including COAs, stability protocols/reports, and regulatory submissions.

Skills

Cross-functional collaboration

Analytical method development

Regulatory submissions

cGMP knowledge

Technical writing

Education

Advanced degree in Chemistry/Pharmaceutics/related field

Job description

Nurix Therapeutics seeks an experienced Senior Scientist to join the Analytical Development and Quality Control group. The Senior Scientist will oversee drug product analytical development, method development, CDMO validation, and lifecycle management in support of Nurix’s oncology and I&I programs.

The role requires expertise in chromatographic and dissolution method development, stability studies, and phase-appropriate validation.