Senior Manager/Associate Director, Analytical Development and Quality Control

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Job description

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 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%

Required Qualifications

• 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

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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