Senior Manager/Associate Director, Analytical Development and Quality Control
4 weeks ago
Nurix Therapeutics is seeking an experienced Senior Manager/Associate Director to join the CMC Analytical Development and Quality Control group. The ideal candidate will oversee and execute analytical development, tech transfer, and testing operations internally and at external CDMO/CRO partners.
Key Responsibilities- Independent management of key activities at CDMO/CTLs including method development, validation/tech transfer, QC testing, and reference standard management
- Management or execution of in-house analytical laboratory activities including method development/troubleshooting and material characterization
- Analytical characterization of drug substance and drug product, impurities, and product stability
- Management of OOS/OOE/OOT investigations, deviations, and associated documentation
- Critical review of data, protocols, reports, specifications, and other CDMO/CTL documents
- Collaborative development of product control strategy and specifications
- Authorship of technical documents including specifications, protocols, COAs, test procedures, development reports, stability reports, and storage statements
- Authorship of relevant IND/IMPD and NDA/MAA sections
- Trending stability data and establishing retest periods and shelf life using statistical methods
- Collaboration in multidisciplinary teams that include Chemical Development, Formulation Development, Regulatory, Quality, Supply Chain, Medicinal Chemistry, and DMPK
- Supporting supplier qualification, site visits, and audits
- Management and organization of documentation and data
- Ensuring compliance to cGMP quality standards and internal SOPs
- Travel up to 20%
- Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)
- Sr
- BS degree with 8+ years, MS degree with 6+ years, or PhD with 4+ years of relevant industrial experience in small molecule pharmaceutical analytical development
- Demonstrated expertise in HPLC and dissolution method development is essential
- Additional 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 required
- Experience in analytical development for solid oral drug products from method development and characterization to development and justification of control strategy
- Experience in management of analytical activities at CDMOs/CROs
- Ability to critically interpret data and communicate technical concepts in multidisciplinary settings
- Experience managing stability programs, reference standards, and retest/expiry
- Experience in authoring IND/IMPD and NDA/MAA sections
- Solid understanding of ICH guidelines, cGMPs, and pharmacopeial chapters
- Experience in OOT/OOE/OOS management, deviation management, and change control
- Ability to ensure assigned activities are completed in satisfaction of project timelines
- Strong interpersonal skills that foster collaboration within and outside of the organization
- Ability to travel domestically and internationally
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.
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San Francisco, California, United States BioSpace, Inc. Full timeNurix 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...
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San Francisco, California, United States BioSpace, Inc. Full timeJob OverviewNurix Therapeutics, a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule therapies, is seeking an experienced Senior Manager/Associate Director to join its CMC Analytical Development and Quality Control group. The ideal candidate will oversee and execute analytical development, tech transfer,...
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