Senior Manager/Associate Director, Analytical Development and Quality Control Specialist
4 weeks ago
Nurix 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, 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.
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%
Requirements
- Advanced 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 development
- Associate Director: BS/MS degree with 12+ years, or PhD with 8+ 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
Fit with Nurix Culture and Values
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view
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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 SummaryNurix 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 ResponsibilitiesIndependent management of key...
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