Senior Manager, Analytical Development and Quality Control - Drug Product

Regulatory Jobs; Brisbane (CA); On-site; USD 161,000 - 186,000; Full time

Job summary

Nurix Therapeutics, a clinical-stage biopharmaceutical company, seeks a Senior Manager to lead drug product analytical development and QC. You will oversee method development, validation at CDMOs, and lifecycle management to support oncology and inflammation programs.

The role emphasizes cross-functional collaboration, regulatory submissions, and late-stage transfer activities. Based onsite at the Brisbane, CA headquarters, you will author development reports, manage stability programs, and

Qualifications

• Advanced degree in Chemistry, Pharmaceutics, or related field.
• PhD with 8+ years of industrial CMC experience preferred.
• Strong experience in drug product analytical development and validation.
• Experience with ASDs and/or lipid-based formulations.
• Oversight of CDMO/contract testing labs.
• Experience supporting IND/IMPD/NDA submissions.
• Knowledge of ICH, cGMPs, pharmacopeial chapters.

Responsibilities

• Lead analytical method development, validation, and lifecycle management for DP formulations.
• Design and oversee DP development, registration batches, and stability programs.
• Author and review analytical development reports for regulatory submissions.
• Support late-phase tech transfer and validation activities.
• Coordinate with CDMOs and CTLs for analytical testing.
• Investigate OOS/OOE/OOT issues and drive CAPAs.
• Review data, protocols, reports, and COAs for traceability and GMP compliance.
• Contribute to material control strategy development and specifications.
• Prepare regulatory documentation sections (IND/IMPD/NDA).
• Collaborate with cross-functional teams across development stages.

Education

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

PhD with 8+ years of industrial CMC experience

Strong experience in drug product analytical development and validation

Analytical development for amorphous solid dispersions (ASDs) and/or lipid-based formulations

CDMO and contract testing lab oversight

Experience supporting regulatory submissions (e.g., IND, IMPD, NDA)

Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters

Cross-functional collaboration

Technical writing skills

Ability to manage multiple priorities in a fast-paced environment

Excellent communication and cross-functional collaboration skills

Job description

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 & 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