Nurix
Senior Manager, Analytical Development and Quality Control - Drug Product
Brisbane, CA . Posted 6 months ago
The role
This person will lead drug product analytical development for oncology and inflammation & immunology programs. They will oversee method development, validation, and lifecycle management at CDMO and CRO partners.
What you will do
- Lead analytical method development, validation, and lifecycle management for drug product formulations
- Support PPQ activities, commercialization, commercial QC, and lifecycle management
- Design and oversee DP development, registration batch, and commercial stability programs
- Author and review DP analytical development reports to support regulatory submissions
- Oversee analytical activities conducted at CDMOs and contract testing laboratories
- Contribute to investigations including OOS, OOE, OOT, root cause analysis, and CAPAs
- Perform critical review of analytical data, protocols, reports, specifications, and documentation
- Trend stability data and support establishment of retest periods and shelf life
- Collaborate in the development and justification of material control strategies and specifications
- Author and review analytical sections of regulatory submissions and responses to health authority requests
Required qualifications
- PhD in Chemistry, Pharmaceutics, or a related field
- 8+ years of industrial CMC experience
- Strong experience in drug product analytical development and validation
- Experience in CDMO and contract testing lab oversight
- Experience supporting regulatory submissions (e.g., IND, IMPD, NDA) and global regulatory filings
- Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters
- Ability to work effectively in a cross-functional environment
- Strong technical writing skills
- Ability to manage multiple priorities in a fast-paced environment
- Excellent communication and cross-functional collaboration skills
- Travel up to 5%, as required
Nice to have
- Experience with analytical development for amorphous solid dispersions (ASDs) and/or lipid-based formulations
About the company
Nurix Therapeutics seeks an experienced Senior Manager to join the Analytical Development and Quality Control group.