Senior Scientist, Analytical Development and Quality Control
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines. We aim to improve treatment options for patients with cancer and inflammatory diseases through our fully AI-integrated discovery engine and unparalleled ligase expertise.
About the role
We seek an experienced Senior Scientist to join the Analytical Development and Quality Control group. This role focuses on 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 Senior Scientist will provide technical oversight of analytical activities conducted at external CDMO/CRO partners, author analytical development reports, and support late-phase tech transfer and validation activities. 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.
Requirements
- Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field).
- PhD with 8+ years of industrial CMC experience for the Senior Scientist role.
- 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.
Pay
Salary Range: $162K - $196K