Senior Scientist, Analytical Development and Quality Control

Responsibilities

• Lead analytical method development, validation, and lifecycle management for drug product formulations including ASDs and lipid-based systems
• Oversee analytical activities, method development, and QC testing conducted at CDMOs and contract testing laboratories
• Design and oversee drug product development, registration batch, and commercial stability programs
• Author and review analytical development reports and regulatory submission sections (IND/IMPD/NDA)
• Contribute to investigations such as OOS, OOE, and OOT, including root cause analysis and CAPAs
• Collaborate with cross-functional teams including Chemical Development, Regulatory, Quality, and Supply Chain
• Maintain analytical documentation to ensure traceability, data integrity, and inspection readiness

Requirements

• Advanced degree in Chemistry, Pharmaceutics, or a related field
• For Senior Scientist: BS/MS 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 amorphous solid dispersions (ASDs) and/or lipid-based formulations
• Experience in CDMO and contract testing lab oversight
• Experience supporting regulatory submissions (IND, IMPD, NDA) and global regulatory filings
• Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters
• Strong technical writing skills for development reports and regulatory documents

About the Company

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines to improve treatment options for patients with cancer and inflammatory diseases.