New · posted Oct 15
Nurix Therapeutics · Biotechnology
Senior Manager, Analytical Development and Quality Control - Drug Product
- Brisbane, CA
- On-site
- Full-time
- Manager
Open until filled
The role
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.
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.
What you need
- 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
What you'll do
- 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
Pay
$161,100 – $185,600 a year
Employer providedSalary Range: $161,100 – $185,600
Where you'll work
Brisbane, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Brisbane, CA
From the posting
About Nurix
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
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 36% above the US median for Quality Control roles at this level.
This roleEmployer provided
Manager roles in California5 roles publishing pay
Manager roles in the US24 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $161,100 | — | $185,600 |
| California (middle half) | $128,500 | $140,000 | $171,000 |
| All US (middle half) | $108,500 | $127,250 | $143,500 |
This role: Nurix Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 275 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Nurix's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods16
- Documentation and SOPs8
- Collaboration and leadership8
- Validation and qualification7
- Regulatory submissions6
- GMP and compliance2
- Investigations and CAPA1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
Company hiring pulse
Nurix on Regulatory Jobs
- 11
- Open roles
- 11
- Distinct roles
- 1
- Locations
By discipline
- Quality6 55%
- Regulatory5 45%
By level
- Director7 64%
- Manager3 27%
- Senior & Principal1 9%
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Senior Manager, Analytical Development and Quality Control - Drug Product at Nurix
Open until filled. $161K–$186K a year, employer provided.