Associate Director/Director, Analytical Development and Quality Control

2 months ago

San Francisco, California, United States Nurix Therapeutics Full time

Company

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix's drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.

Nurix's wholly owned pipeline comprises targeted protein degraders of Bruton's tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.

Position

Nurix Therapeutics seeks an experienced Associate Director/Director to join the CMC Analytical Development and Quality Control group. The Associate Director/Director will drive analytical development and testing operations internally and at external CDMO/CRO partners, author relevant sections of regulatory filings, and collaborate cross-functionally to develop and justify control strategies. The ideal candidate should have a track record of innovation in analytical chemistry and technical decision-making using sound scientific judgment and critical data interpretation. The Associate Director/Director will contribute to programs at all phases of development, from IND-enabling activities to commercialization and lifecycle management. This position is based at Nurix headquarters in San Francisco, CA.

Key responsibilities include:

Leading the development of technical control strategy in collaboration with Chemical Development and Formulation Development functionsServing as a subject matter expert, interpreting data, evaluating technical risk, and communicating scientific and operational concepts across functionsCharacterization of drug substance and drug product, impurities, and product stabilityMethod development, validation, and continuous improvementOversight of analytical tech transfer, testing operations, and stability programs at external partnersManagement of OOS/OOE/OOT investigations and documentationReview of protocols, reports, specifications, and other documents generated by external partnersAuthorship of technical documents including specifications, storage statements, protocols, COAs, test procedures, development reports, and stability reportsAuthorship and review of relevant IND/IMPD and NDA/MAA sections and responses to health authority information requestsCo-authorship of internal SOPs and work instructionsSupporting supplier selection, qualification, site visits, and auditsCollaboration in multidisciplinary teams that include Chemical Development, Formulation Development, Regulatory, Quality, Supply Chain, Medicinal Chemistry, and DMPKManaging supplier relationships and sustaining CMO/CRO engagementManagement and organization of development data and documentationTraining and mentorship of internal analytical staffEnsuring compliance to cGMP quality standards and internal SOPsTravel up to 20%
Required QualificationsAdvanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)Master's degree with 15+ years or PhD with 10+ years of relevant industrial experience in pharmaceutical analytical developmentStrong background in instrumentational analytical method development. Proven expertise in HPLC method development and troubleshooting is imperativeExperience in analytical development for solid oral drug products. Expertise in dissolution method development is essentialAdditional expertise in one or more methodologies such as GC, MS, NMR, microbiology, XRD, particle size analysis, or CEExperience in management of analytical projects at CDMOs/CROs including technical leadership, cost management, and coordination with project objectives and timelinesAbility to critically interpret data and communicate technical concepts in multidisciplinary settingsExperience in authorship of regulatory submissions and responses to health authority information requestsExperience managing stability programs, reference standards, and retest/expiry using statistical approachesDesire to stay current with technical advancements in analytical chemistry, industry best practices, and the constantly evolving regulatory environmentThorough understanding of ICH guidelines, cGMPs, and pharmacopeial chaptersStrong interpersonal skills that foster collaboration within and outside of the organizationAbility to travel domestically and internationally
Fit with Nurix Culture and ValuesStrong team orientation; highly collaborativeSolutions and results-oriented focusHands-on approach; resourceful and open to diverse points of view
Application Process

Nurix 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 ).

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