Senior Scientist, Analytical Development and Quality Control (Drug Product)

CompanyNurix 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.PositionNurix Therapeutics seeks an experienced Senior Scientist to join the Analytical Development and Quality Control group. The Senior Scientist 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 Scientist 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 Scientist 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.Key Responsibilities IncludeLead analytical method development validation and lifecycle management for drug product formulations, including amorphous solid dispersions (ASDs) and lipid-based systemsSupport PPQ activities, commercialization, commercial QC, and lifecycle management for drug product analytical methods and control strategiesDesign and oversee DP development, registration batch, and commercial stability programs, including protocol development and trend analysisAuthor and review DP analytical development reports to support regulatory submissions, and marketing authorizationOversee 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 CAPAsPerform critical review of analytical data, protocols, reports, specifications, and related documentationTrend stability data and support establishment of retest periods and shelf life using statistical methodsCollaborate in the development and justification of material control strategies and specificationsAuthor technical documents, including analytical development reports, specifications, validation and stability protocols/reports, certificates of analysis (COAs), and storage statementsAuthor and review analytical sections of regulatory submissions (e.g., IND/IMPD/NDA)Collaboratively author responses to health authority requests for informationAct as a key contributor to multidisciplinary teams, including Chemical Development, Pharmaceutical Development, Regulatory, Quality, Preclinical, Supply Chain, Medicinal Chemistry, and DMPKMaintain and organize analytical documentation and data to ensure traceability, data integrity, and inspection readinessFollow cGMP requirements and internal SOPsTravel up to 5%, as requiredQualificationsAdvanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)Senior Scientist: BS/MS degree with 14+ years or PhD with 8+ years of industrial CMC experienceStrong experience in drug product analytical development and validationExperience with analytical development for amorphous solid dispersions (ASDs) and/or lipid-based formulationsExperience in CDMO and contract testing lab oversightExperience supporting regulatory submissions (e.g., IND, IMPD, NDA) and global regulatory filingsFluency with ICH guidelines, cGMPs, and pharmacopeial chaptersAbility to work effectively in a cross-functional environmentStrong technical writing skills (e.g., development reports, regulatory documents)Ability to manage multiple priorities in a fast-paced environmentExcellent communication and cross-functional collaboration skillsSalary RangeSenior Scientist -- $161,110 – 185, 618Application ProcessNurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).