Manager/Senior Manager, Analytical Development and Quality Control

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 Manager/Senior Manager to join the Analytical Development and Quality Control group. The Manager/Senior Manager 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 Manager/Senior Manager 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:

• Method development for and analytical characterization of drug substances, drug substance starting materials and synthetic intermediates, impurities, and product stability
• Management of key activities internally and at CDMO/CTLs including method development, method validation, QC testing, and reference standard management
• Management and execution of in-house analytical laboratory activities
• Management of forced degradation and predictive stability studies
• Evaluation, implementation, and administration of statistical and data analysis software
• Contribution to OOS/OOE/OOT investigations
• Critical review of data, protocols, reports, specifications, and other documentation
• Trending stability data and establishing retest periods/shelf life using statistical methods
• Collaboration in the development of material control strategies and specifications
• Authorship of technical documents including test procedures, development reports, specifications, protocols, COAs, stability reports, and storage statements
• Authorship of relevant IND/IMPD and NDA/MAA sections
• Collaboration in multidisciplinary teams that include Chemical Development, Formulation Development, Regulatory, Quality, Supply Chain, Medicinal Chemistry, and DMPK
• Management and organization of documentation and data
• Ensuring compliance to cGMP quality standards and internal SOPs
• Travel up to 15%

Required Qualifications

• Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, Chemical Engineering or related field)
• Manager: BS/MS degree with 5+ years, or PhD with 2+ years of industrial experience in small molecule pharmaceutical development
• Sr. Manager: BS/MS degree with 8+ years or PhD with 4+ years of industrial experience in small molecule pharmaceutical development
• Demonstrated expertise in HPLC method development is essential
• Additional experience in one or more techniques such as gas chromatography, NMR, MS, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, and/or FTIR
• Experience in analytical development and validation for drug substances, starting materials, synthetic intermediates, and solid oral drug products
• 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
• Familiarity with 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.

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