Senior Scientist, Drug Product Analytics & QC

Nurix Therapeutics

Brisbane (CA)

On-site

USD 162,000 - 196,000

Full time

14 days+

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Job summary

Nurix Therapeutics seeks an experienced Senior Scientist to join the Analytical Development and Quality Control group. The Senior Scientist will be responsible for drug product analytical development, including method development, oversight of method validation at CDMOs, and lifecycle management in support of Nurix’s oncology and inflammation & immunology programs.

This position provides technical oversight of analytical method development, validation, and testing conducted at external CDMO/CRO

Qualifications

PhD with 8+ years of industrial CMC experience.
Experience in drug product analytical development and validation.
Experience with analytical development for 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.

Responsibilities

Lead analytical method development validation and lifecycle management for drug product formulations, including amorphous solid dispersions 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, 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.