Senior Manager, Analytical Development and Quality Control

3 days ago

San Francisco, California, United States Nurix, Inc. Full time
Job Title: Manager/Senior Manager, Analytical Development and Quality Control

Nurix Therapeutics is a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative small molecule therapies for cancer and immune disorders.

We are seeking an experienced Manager/Senior Manager to join our Analytical Development and Quality Control team. The successful candidate will oversee and execute analytical development, tech transfer, and testing operations, evaluate and implement new analytical and data management technologies, and author relevant sections of regulatory filings.

Key Responsibilities:
  • Develop and validate analytical methods for drug substances, starting materials, and synthetic intermediates
  • Manage key activities internally and at CDMO/CRO partners, including method development, method validation, QC testing, and reference standard management
  • Execute in-house analytical laboratory activities, including forced degradation and predictive stability studies
  • Evaluate, implement, and administer statistical and data analysis software
  • Contribute to OOS/OOE/OOT investigations and critical review of data, protocols, reports, specifications, and other documentation
  • Trend stability data and establish retest periods/shelf life using statistical methods
  • Collaborate in the development of material control strategies and specifications
  • Author technical documents, including test procedures, development reports, specifications, protocols, COAs, stability reports, and storage statements
  • Author relevant IND/IMPD and NDA/MAA sections
  • Collaborate in multidisciplinary teams, including Chemical Development, Formulation Development, Regulatory, Quality, Supply Chain, Medicinal Chemistry, and DMPK
  • Manage and organize documentation and data, ensuring compliance to cGMP quality standards and internal SOPs
  • Travel up to 15%
Requirements:
  • Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, Chemical Engineering, or related field)
  • BS/MS degree with 5+ years, or PhD with 2+ years of industrial experience in small molecule pharmaceutical development
  • Demonstrated expertise in HPLC method development
  • 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
What We Offer:

Nurix Therapeutics 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.

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