Senior Scientist, Analytical Development and Quality Control
Nurix Therapeutics
June 24, 2026
On-site
Brisbane, CA
Operations
Position: Senior Scientist, Analytical Development and Quality Control (onsite, Brisbane, CA)
Key Responsibilities:
- Lead analytical method development, validation, and lifecycle management for drug product formulations (including ASDs and lipid-based systems)
- Support PPQ, commercialization, commercial QC, and lifecycle management of analytical methods and control strategies
- Design/oversee DP development, registration batch, and commercial stability programs (protocol development and trend analysis)
- Author/review DP analytical development reports to support regulatory submissions and marketing authorization
- Oversee analytical activities (method development, validation, QC testing) at CDMOs and contract testing laboratories
- Support investigations (OOS/OOE/OOT), root cause analysis, and CAPAs
- Perform critical review of analytical data, protocols, reports, specifications, and related documentation
- Trend stability data; support retest period and shelf-life establishment (statistical methods)
- Contribute to material control strategies and specifications
- Author technical documents (reports, specifications, validation/stability protocols and reports, COAs, storage statements)
- Author/review regulatory submission analytical sections (IND/IMPD/NDA) and respond to health authority information requests
- Maintain analytical documentation/data for traceability, data integrity, and inspection readiness; follow cGMP and SOPs
- Travel up to 5%
Qualifications:
- Advanced degree (Chemistry/Pharmaceutics/related)
- Senior Scientist: BS/MS + 14+ years industrial CMC or PhD + 8+ years
- Strong drug product analytical development/validation experience
- Experience with ASDs and/or lipid-based formulations
- Experience overseeing CDMO/contract testing labs
- Experience supporting IND/IMPD/NDA and global regulatory filings
- Fluency with ICH, cGMPs, and pharmacopeial chapters
- Strong cross-functional collaboration and technical writing; manage multiple priorities
Key Responsibilities:
- Lead analytical method development, validation, and lifecycle management for drug product formulations (including ASDs and lipid-based systems)
- Support PPQ, commercialization, commercial QC, and lifecycle management of analytical methods and control strategies
- Design/oversee DP development, registration batch, and commercial stability programs (protocol development and trend analysis)
- Author/review DP analytical development reports to support regulatory submissions and marketing authorization
- Oversee analytical activities (method development, validation, QC testing) at CDMOs and contract testing laboratories
- Support investigations (OOS/OOE/OOT), root cause analysis, and CAPAs
- Perform critical review of analytical data, protocols, reports, specifications, and related documentation
- Trend stability data; support retest period and shelf-life establishment (statistical methods)
- Contribute to material control strategies and specifications
- Author technical documents (reports, specifications, validation/stability protocols and reports, COAs, storage statements)
- Author/review regulatory submission analytical sections (IND/IMPD/NDA) and respond to health authority information requests
- Maintain analytical documentation/data for traceability, data integrity, and inspection readiness; follow cGMP and SOPs
- Travel up to 5%
Qualifications:
- Advanced degree (Chemistry/Pharmaceutics/related)
- Senior Scientist: BS/MS + 14+ years industrial CMC or PhD + 8+ years
- Strong drug product analytical development/validation experience
- Experience with ASDs and/or lipid-based formulations
- Experience overseeing CDMO/contract testing labs
- Experience supporting IND/IMPD/NDA and global regulatory filings
- Fluency with ICH, cGMPs, and pharmacopeial chapters
- Strong cross-functional collaboration and technical writing; manage multiple priorities