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 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 stability
• Management of method development, method validation, QC testing, and reference standard management activities internally and at CDMOs/CTLs
• Management of forced degradation, long term stability, and predictive stability studies
• 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, analytical development reports, product specifications, validation and stability protocols, COAs, stability reports, and storage statements
• Authorship of relevant IND/IMPD sections
• Collaboration toward responses to health authority requests for information
• 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, or related field)
• BS/MS degree with 12+ years or PhD with 6+ years of industrial experience in small molecule pharmaceutical development
• Expertise in HPLC method development is essential
• Additional experience in techniques such as gas chromatography, NMR, mass spectrometry, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, and/or FTIR
• Solid understanding of phase-appropriate approaches to control strategy, method validation, and retest/expiry
• 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
• 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 critically interpret data and articulate technical concepts in multidisciplinary settings
• 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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