Senior Scientist, Analytical Development and Quality Control - Early Phase
About The Position
Nurix Therapeutics seeks an experienced Senior Scientist to join its Analytical Development and Quality Control group. The role leads analytical and QC activities for IND-enabling and early-phase clinical studies, including analytical method development, characterization of drug substance and drug product attributes, identification and characterization of technical risks, and collaboration on risk mitigation. The Senior Scientist oversees and performs analytical development, validation, and testing internally and through external CDMO/CRO partners, and authors relevant sections of regulatory filings. The ideal candidate has expertise in chromatographic method development, stability studies, and phase-appropriate validation and control, with contributions to first-in-human INDs and experience overseeing vendors. The position is onsite at Nurix headquarters in Brisbane, California. The stated salary range is $162,000–$186,000.
Requirements
- Advanced degree in a relevant discipline such as Chemistry, Pharmaceutics, or a related field.
- For Senior Scientist: BS/MS degree with 14+ years or PhD with 8+ years of industrial CMC experience.
- Expertise in HPLC method development.
- Experience in analytical method development and validation.
- Experience managing analytical activities at CDMOs/CROs.
- Solid understanding of control strategy, method validation, and retest/expiry.
- Experience managing stability programs, reference standards, and retest/expiry.
- Familiarity with ICH guidelines, cGMPs, and pharmacopeial chapters.
- Familiarity with 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 the organization.
- Ability to travel domestically and internationally.
- Strong team orientation and highly collaborative approach.
- Solutions- and results-oriented focus.
- Hands-on approach; resourceful and open to diverse points of view.
Nice To Haves
- Experience with gas chromatography, NMR, mass spectrometry, particle size analysis, solid-state characterization, dissolution, ICP-MS/OES, and/or FTIR.
- A record of contribution to first-in-human INDs.
- Experience in vendor oversight.
Responsibilities
- Characterize drug substance and drug product attributes, identify technical risks, and collaborate on risk mitigation strategies.
- Develop methods for and analytically characterize drug substances, drug products, and product stability.
- Manage and/or execute method development internally and at CDMOs/CTLs.
- Manage method validation, QC testing, and reference standards at CDMOs/CTLs.
- Manage forced degradation, long-term stability, and predictive stability studies.
- Contribute to OOS/OOE/OOT investigations.
- Critically review data, protocols, reports, specifications, and other documentation.
- Trend stability data and establish retest periods and shelf life using statistical methods.
- Collaborate in developing material control strategies and specifications.
- Follow cGMP requirements and internal SOPs.
- Oversee and execute analytical development, validation, and testing internally and at external CDMO/CRO partners.
- Author relevant sections of regulatory filings.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
