Nurix Therapeutics
Senior Manager, Analytical Development and Quality Control - Drug Product
Brisbane, CA · Senior
Sponsorship not specified$161k-$186kDetected 10 days ago
Supply ChainPatient CareGMPAnimal StudiesCommunicationCollaborationWriting
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odds of building a lasting career here
59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
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About the role
- 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.
- This role will also contribute to analytical development for new drug products and dosage forms.
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)
- 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
- Maintain and organize analytical documentation and data to ensure traceability, data integrity, and inspection readiness
Requirements
- 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
- Ability to work effectively in a cross-functional environment
- Travel up to 5%, as required
- Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters
- 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
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view
Compensation
- $161,100 - $185,600
Benefits
- Collaboratively author responses to health authority requests for information
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