Senior Manager, Analytical Development and Quality Control - Drug Product

Senior Manager, Analytical Development and Quality Control - Drug Product

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Position:

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.

This position provides technical oversight of analytical method development, validation, and testing conducted at external CDMO/CRO partners. The Senior Manager will author analytical development reports and IND/IMPD/NDA sections and support late-phase tech transfer and validation activities. This role will also contribute to analytical development for new drug products and dosage forms. The Senior Manager will work closely in cross-functional teams to ensure alignment and integration of analytical and QC strategies across development stages.

The ideal candidate will have 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.

This position is onsite at Nurix headquarters in Brisbane, CA.

Responsibilities:

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

Qualifications:

Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)

Senior Manager: 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 (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

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

Salary Range: $161,100 – $185,600

Location: Brisbane, CA - Onsite