Associate Director, Analytical Development and Quality Control

CompanyNurix 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.PositionNurix Therapeutics seeks an experienced Associate Director to join the Analytical Development and Quality Control group to lead IND-enabling and early phase analytical development. The Associate Director will develop analytical testing and characterization methods to evaluate drug substance and drug product attributes, identify and characterize technical risk, and collaborate toward risk mitigation strategies. The Associate Director will oversee and execute analytical development, validation, and testing operations both internally and at external CDMO/CRO partners and author relevant sections of regulatory filings.The ideal candidate must have expertise in chromatographic method development, impurity and stability characterization, and phase-appropriate control strategy. The candidate must have a record of contribution to Phase 1 INDs, and experience in vendor oversight.This position is based at Nurix headquarters in San Francisco, CA.Key responsibilities include:Chemical and physical characterization of drug substance and drug product attributes, identification of technical risks, and collaboration on risk mitigation strategy.Method development for and analytical characterization of drug substances, drug products, and product stabilityManagement of method development, method validation, QC testing, and reference standard management activities internally and at CDMOs/CTLsManagement of forced degradation, long term stability, and predictive stability studiesContribution to OOS/OOE/OOT investigationsCritical review of data, protocols, reports, specifications, and other documentationTrending stability data and establishing retest periods/shelf life using statistical methodsCollaboration in the development of material control strategies and specificationsAuthorship of technical documents including test procedures, analytical development reports, product specifications, validation and stability protocols, COAs, stability reports, and storage statementsAuthorship of relevant IND/IMPD sectionsCollaboration toward responses to health authority requests for informationCollaboration in multidisciplinary teams that include Chemical Development, Formulation Development, Regulatory, Quality, Supply Chain, Medicinal Chemistry, and DMPKManagement and organization of documentation and dataEnsuring compliance to cGMP quality standards and internal SOPsTravel up to 15%Required QualificationsAdvanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)BS/MS degree with 12+ years or PhD with 6+ years of industrial experience in small molecule pharmaceutical developmentExpertise in HPLC method development is essentialAdditional experience in techniques such as gas chromatography, NMR, mass spectrometry, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, and/or FTIRSolid understanding of phase-appropriate approaches to control strategy, method validation, and retest/expiryExperience in analytical development and validation for drug substances, starting materials, synthetic intermediates, and solid oral drug productsExperience in management of analytical activities at CDMOs/CROsExperience managing stability programs, reference standards, and retest/expiryFamiliarity with ICH guidelines, cGMPs, and pharmacopeial chaptersExperience in OOT/OOE/OOS management, deviation management, and change controlAbility to critically interpret data and articulate technical concepts in multidisciplinary settingsAbility 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 internationallyFit with Nurix Culture and ValuesStrong team orientation; highly collaborativeSolutions and results-oriented focusHands-on approach; resourceful and open to diverse points of viewApplication 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/).