Senior Scientist, Drug Product Analytics & QC

Nurix; 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, focusing on DP analytical development, method development, and CDMO oversight. The role supports oncology and I&I programs with lifecycle management and regulatory submission contributions.

The ideal candidate has expertise in ASDs and lipid-based formulations, strong cross-functional collaboration, and robust technical writing skills for IND/IMPD/NDA sections.

Qualifications

• Advanced degree in Chemistry, Pharmaceutics, or related field.
• Senior Scientist: BS/MS 14+ years or PhD with 8+ years 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.
• Strong technical writing skills for development reports and regulatory documents.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Lead analytical method development validation and lifecycle management for DP formulations.
• Support PPQ activities, commercialization, commercial QC, and lifecycle management for DP methods.
• Design and oversee DP development, registration batch, and stability programs.
• Author and review DP analytical development reports to support regulatory submissions.
• Oversee analytical activities at CDMOs and contract testing labs.
• Contribute to investigations and CAPAs like OOS/OOE/OOT.
• Review analytical data, protocols, and certificates of analysis.
• Trend stability data and establish retest periods and shelf life.
• Collaborate on material control strategies and specifications.
• Author regulatory submission sections and health authority responses.
• Maintain traceability and data integrity per cGMP.
• Follow cGMP requirements and SOPs; travel up to 5%.

Skills

Analytical development

Regulatory submissions

Cross-functional collaboration

Technical writing

Data integrity practices

Education

Advanced degree in Chemistry/Pharmaceutics or related field

PhD with 8+ years industrial CMC experience

Job description

Nurix Therapeutics seeks an experienced Senior Scientist to join the Analytical Development and Quality Control group, focusing on DP analytical development, method development, and CDMO oversight. The role supports oncology and I&I programs with lifecycle management and regulatory submission contributions.

The ideal candidate has expertise in ASDs and lipid-based formulations, strong cross-functional collaboration, and robust technical writing skills for IND/IMPD/NDA sections.