Senior Manager, Analytical Development and Quality Control - Drug Product
Nurix · Brisbane · $161,100–$185,600 (stated in the posting)
Senior Manager, Analytical Development and Quality Control – Drug Product
Lead drug product analytical development for Nurix’s oncology and inflammation & immunology programs, from method development through late-phase tech transfer, validation, and regulatory filings. You will guide CDMO and CRO partners and shape analytical and QC strategy for complex formulations, including amorphous solid dispersions and lipid-based systems, in close partnership with cross-functional teams.
Position Description
Nurix Therapeutics seeks an experienced Senior Manager to join the Analytical Development and Quality Control group. The Senior Manager will be responsible for drug product (DP) analytical development, including method development, oversight of method validation at CDMOs, and lifecycle management in support of Nurix’s oncology and inflammation & immunology (I&I) programs. The role provides technical oversight of analytical method development, validation, and testing at external CDMO/CRO partners, authors analytical development reports and IND/IMPD/NDA sections, supports late-phase tech transfer and validation activities, and contributes to analytical development for new drug products and dosage forms. The ideal candidate has expertise in chromatographic and dissolution method development, stability studies, and phase-appropriate validation and control strategies, along with demonstrated experience supporting late-phase development and regulatory submissions.
The Opportunity
- Lead analytical method development, validation, and lifecycle management for drug product formulations, including amorphous solid dispersions (ASDs) and lipid-based systems
- Support PPQ activities, commercialization, commercial QC, and lifecycle management for drug product analytical methods and control strategies
- Design and oversee DP development, registration batch, and commercial stability programs, including protocol development and trend analysis
- Author and review DP analytical development reports to support regulatory submissions and marketing authorization
- Oversee and support analytical activities, including method development, validation, and QC testing conducted at CDMOs and contract testing laboratories (CTLs)
- Contribute to investigations (e.g., OOS, OOE, OOT), root cause analysis, and CAPAs
- Perform critical review of analytical data, protocols, reports, specifications, and related documentation
- Trend stability data and support establishment of retest periods and shelf life using statistical methods
- Collaborate in the development and justification of material control strategies and specifications
- Author technical documents, including analytical development reports, specifications, validation and stability protocols/reports, certificates of analysis (COAs), and storage statements
- Author and review analytical sections of regulatory submissions (e.g., IND/IMPD/NDA)
- Collaboratively author responses to health authority requests for information
- Act as a key contributor to multidisciplinary teams, including Chemical Development, Pharmaceutical Development, Regulatory, Quality, Preclinical, Supply Chain, Medicinal Chemistry, and DMPK
- Maintain and organize analytical documentation and data to ensure traceability, data integrity, and inspection readiness
- Follow cGMP requirements and internal SOPs
- Travel up to 5%, as required
What You’ll Bring
- PhD in Chemistry, Pharmaceutics, or a related field 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 (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 (e.g., development reports, regulatory documents)
- Ability to manage multiple priorities in a fast-paced environment
- Excellent communication and cross-functional collaboration skills
Salary Range: $161,100 - $185,600
The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.
Location: Onsite – Brisbane, CA
Fit with Nurix Culture and Values
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view