Senior Manager/Associate Director, Analytical Development and Quality Control
3 weeks ago
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 Senior Manager/Associate Director to join the CMC Analytical Development and Quality Control group. The Senior Manager/Associate Director will oversee and execute analytical development, tech transfer, and testing operations internally and at external CDMO/CRO partners, evaluate and implement new analytical and data management technologies, and author relevant sections of regulatory filings. The ideal candidate should have a track record of accomplishment in analytical method development and vendor oversight/communication. The Senior Manager/Associate Director will contribute to programs at all phases of development, from IND-enabling activities to commercialization. This position is based at Nurix headquarters in San Francisco, CA.
Key responsibilities include:
Independent management of key activities at CDMO/CTLs including method development, validation/tech transfer, QC testing, and reference standard managementManagement or execution of in-house analytical laboratory activities including method development/troubleshooting and material characterizationAnalytical characterization of drug substance and drug product, impurities, and product stabilityManagement of OOS/OOE/OOT investigations, deviations, and associated documentationCritical review of data, protocols, reports, specifications, and other CDMO/CTL documentsCollaborative development of product control strategy and specificationsAuthorship of technical documents including specifications, protocols, COAs, test procedures, development reports, stability reports, and storage statementsAuthorship of relevant IND/IMPD and NDA/MAA sectionsTrending stability data and establishing retest periods and shelf life using statistical methodsCollaboration in multidisciplinary teams that include Chemical Development, Formulation Development, Regulatory, Quality, Supply Chain, Medicinal Chemistry, and DMPKSupporting supplier qualification, site visits, and auditsManagement and organization of documentation and dataEnsuring compliance to cGMP quality standards and internal SOPsTravel up to 20%Required QualificationsAdvanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)Sr. Manager: BS degree with 8+ years, MS degree with 6+ years, or PhD with 4+ years of relevant industrial experience in small molecule pharmaceutical analytical developmentAssociate Director: BS/MS degree with 12+ years, or PhD with 8+ years of relevant industrial experience in small molecule pharmaceutical analytical developmentDemonstrated expertise in HPLC and dissolution method development is essentialAdditional experience in one or more techniques such as particle size analysis, solid state characterization, gas chromatography, KF, NMR, MS, ICP-MS/OES, and/or FTIR is requiredExperience in analytical development for solid oral drug products from method development and characterization to development and justification of control strategyExperience in management of analytical activities at CDMOs/CROsAbility to critically interpret data and communicate technical concepts in multidisciplinary settingsExperience managing stability programs, reference standards, and retest/expiryExperience in authoring IND/IMPD and NDA/MAA sectionsSolid understanding of ICH guidelines, cGMPs, and pharmacopeial chaptersExperience in OOT/OOE/OOS management, deviation management, and change controlAbility to ensure assigned activities are completed in satisfaction of project timelinesStrong 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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San Francisco, California, United States Nurix Therapeutics Full timeCompanyNurix 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,...
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