Scientist ADQC - Drug Substance

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix's dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine's next chapter with a new script to outmatch disease.

Position

Nurix Therapeutics seeks an experienced Scientist to join the Analytical Development and Quality Control group. The Scientist will execute drug substance analytical and QC activities, primarily to support late phase clinical studies. The Scientist will develop and troubleshoot analytical test methods, characterize product attributes, collaborate in risk mitigation activities, and author technical reports. The Scientist will oversee and execute analytical development, validation, and testing 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, stability studies, and method validation. The ideal candidate should have a record of contribution to late phase CMC analytical development and experience in vendor oversight.

This position is based at Nurix headquarters in San Francisco, CA.

Key responsibilities

• Method development for and analytical characterization of drug substances, drug products, and product stability
• Management and/or execution of method development internally and at CDMOs/CTLs
• Management of method validation, QC testing, and reference standards 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
• Authorship of technical documents including test procedures, analytical development reports, specifications, validation and stability protocols, COAs, stability reports, and storage statements
• Authorship of relevant IND/IMPD and NDA/MAA sections
• Collaboration in multidisciplinary teams that include Chemical Development, Pharmaceutical Development, Regulatory, Quality, Preclinical, Supply Chain, Medicinal Chemistry, and DMPK
• Management and organization of documentation and data
• Ensuring compliance with cGMP quality standards and internal SOPs
• Travel up to 10%
• Additional responsibilities as required

Qualifications

• Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)
• BS degree with 10+ years, MS degree with 6+ years, or PhD with 2+ years of industrial CMC experience
• 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
• Experience in analytical method development and validation
• Experience managing stability programs, reference standards, and retest/expiry
• Familiarity with ICH guidelines, cGMPs, and pharmacopeial chapters
• Ability to critically interpret data and articulate technical concepts in multidisciplinary settings
• Ability to ensure assigned activities are completed to the 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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