Senior Scientist, Analytical Development and Quality Control
Nurix Therapeutics
August 19, 2026
On-site
Brisbane, CA
Operations
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 for analytical methods and control strategies.
- Design and oversee DP development, registration batch, and commercial stability programs (protocol development and trend analysis).
- Author and review DP analytical development reports to support regulatory submissions and marketing authorization.
- Oversee analytical work (method development, validation, QC testing) performed at CDMOs and contract testing labs (CTLs).
- Contribute to investigations (OOS/OOE/OOT), root cause analysis, and CAPAs.
- Critically review analytical data, protocols, reports, specifications, and related documentation.
- Trend stability data; support retest period/shelf-life establishment using statistical methods.
- Collaborate on material control strategies and specifications.
- Author technical documents (analytical development reports, specifications, validation/stability protocols & reports, COAs, storage statements).
- Author/review analytical sections of regulatory submissions (IND/IMPD/NDA) and contribute to health authority information responses.
- Maintain analytical documentation for traceability, data integrity, and inspection readiness; follow cGMP and internal SOPs.
- Travel up to 5% as required.
Qualifications:
- Advanced degree in Chemistry, Pharmaceutics, or related field.
- PhD with 8+ years of industrial CMC experience (Senior Scientist).
- Strong drug product analytical development and validation experience.
- Experience with ASD and/or lipid-based formulation analytical development.
- Experience overseeing CDMOs and contract testing labs.
- Experience supporting regulatory submissions (IND/IMPD/NDA) and global filings.
- Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters.
- Strong technical writing, communication, cross-functional collaboration; ability to manage multiple priorities.
Onsite: Brisbane, CA.
Application Instructions:
- Applicants must be legally entitled to work in the US.
- 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 for analytical methods and control strategies.
- Design and oversee DP development, registration batch, and commercial stability programs (protocol development and trend analysis).
- Author and review DP analytical development reports to support regulatory submissions and marketing authorization.
- Oversee analytical work (method development, validation, QC testing) performed at CDMOs and contract testing labs (CTLs).
- Contribute to investigations (OOS/OOE/OOT), root cause analysis, and CAPAs.
- Critically review analytical data, protocols, reports, specifications, and related documentation.
- Trend stability data; support retest period/shelf-life establishment using statistical methods.
- Collaborate on material control strategies and specifications.
- Author technical documents (analytical development reports, specifications, validation/stability protocols & reports, COAs, storage statements).
- Author/review analytical sections of regulatory submissions (IND/IMPD/NDA) and contribute to health authority information responses.
- Maintain analytical documentation for traceability, data integrity, and inspection readiness; follow cGMP and internal SOPs.
- Travel up to 5% as required.
Qualifications:
- Advanced degree in Chemistry, Pharmaceutics, or related field.
- PhD with 8+ years of industrial CMC experience (Senior Scientist).
- Strong drug product analytical development and validation experience.
- Experience with ASD and/or lipid-based formulation analytical development.
- Experience overseeing CDMOs and contract testing labs.
- Experience supporting regulatory submissions (IND/IMPD/NDA) and global filings.
- Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters.
- Strong technical writing, communication, cross-functional collaboration; ability to manage multiple priorities.
Onsite: Brisbane, CA.
Application Instructions:
- Applicants must be legally entitled to work in the US.