Senior Scientist, Analytical Development and Quality Control - Drug Product

Role: Senior Scientist leading analytical development for drug products in Nurix's oncology and inflammation programs, focusing on method development, validation, lifecycle management, and support for regulatory submissions. Responsibilities: oversee analytical method validation and lifecycle management for formulations like amorphous solid dispersions and lipid-based systems; author reports and regulatory documents; support late-phase validation, tech transfer, and commercialization; manage external CDMO/CRO testing; contribute to investigations and stability studies; ensure compliance with cGMP and regulatory standards; collaborate cross-functionally across development, QC, regulatory, and supply chain teams. Requirements: advanced degree in Chemistry, Pharmaceutics, or related; 14+ years BS/MS or 8+ years PhD industrial CMC experience; strong expertise in drug product analytical development, validation, and oversight of CDMO activities; experience with formulations such as ASDs/lipids; supporting IND/IMPD/NDA submissions; fluency in ICH, cGMPs, pharmacopeial standards; excellent technical writing and collaboration skills. Preferred: experience supporting late-stage development, regulatory filings, and stability studies. HighValue: biologics/ small molecules, drug product formulation, analytical validation, IND/IMPD/NDA, CDMO oversight, cGMP, regulatory support. WorkSetup: onsite Brisbane, CA, with travel up to 5%.