Senior Manager, Analytical Development and Quality Control - Drug Product

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