Nurix Therapeutics
biopharmaceutical
Scientist,AnalyticalDevelopmentandQualityControl
“Scientist, Analytical Development and Quality Control at Nurix Therapeutics. Skills: mass spectrometry, liquid chromatography, analytical method development, material characterization. Conduct analytical method development and material characterization studies. Provide operational oversight at external CDMO/CTL partners”
What You'll Achieve.
inform drug substance and drug product development; accelerate and derisk QC activities performed externally at CDMOs and CTLs; ensure assigned activities are completed to the satisfaction of project timelines
Industry & Context.
troubleshoot chromatographic test methods; derisking HPLC test procedures; Solutions and results-oriented focus
Travel up to 5%
What They're Looking For.
Must Have
Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field). BS with 10+ years, MS degree with 6+ years, or PhD with up to 4 years of relevant experience, Expertise in operation and maintenance of mass spectrometers, Experience in HPLC operation and method development, Ability to critically interpret data and articulate technical concepts in cross functional teams, Ability to ensure assigned activities are completed to the satisfaction of project timelines, interpersonal skills that foster collaboration within and outside of the organization, Applicants should be legally entitled to work for any employer in the US
Nice to Have
Experience with accurate mass instrumentation such as Orbitrap Tribrid mass spectrometers, Experience in operation of 2D-LC, Experience in the determination of structures of small molecule impurities and/or metabolites, Experience protein and/or ADC characterization by mass spectrometry, Familiarity with gas chromatography, NMR, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, and/or FTIR, Experience with reference standard management, stability programs, and/or method validation, Familiarity with ICH guidelines, cGMPs, and pharmacopeial chapters
What You'll Do.
Conduct analytical method development and material characterization studies
Provide operational oversight at external CDMO/CTL partners
Manage reference standards and impurity markers
Collaborate in CMC risk management
Author technical reports
Characterize material attributes and impurities by high resolution mass spectrometric and multidimensional chromatographic techniques
Determine impurity structures
Characterize material stability
Elucidate mechanisms of degradation
Employ state of the art QbD approaches to develop and troubleshoot chromatographic test methods
Accelerate and derisk QC activities performed externally at CDMOs and CTLs
Critically evaluate characterization data
Communicate results in multidisciplinary teams
2D-LC for impurity profiling of complex samples
derisking HPLC test procedures
adaptation of incompatible methods to mass spectrometry
Structural elucidation by high resolution Orbitrap Tribrid Mass Spectrometry
QbD HPLC method development using multivariate DOE software
Forced degradation and elucidation of degradation mechanisms
Accelerated predictive stability studies and modeling of packaging configurations and long term stability
Authorship of technical documents such as analytical development reports
and storage statements
Management of reference standards and impurity markers
Manage and organize documentation and data
Contribute to protocol development and oversight/troubleshooting of method transfers
Liaise with Medicinal Chemistry
and Preclinical departments
Compliance with cGMP quality standards and internal SOPs
How You'll Work.
Team & Collaboration
communicate results in multidisciplinary teams; Ability to ensure assigned activities are completed to the satisfaction of project timelines; interpersonal skills that foster collaboration within and outside of the organization; Liaise with Medicinal Chemistry, Bioanalytical, DMPK, and Preclinical departments; team highly collaborative
Communication Scope
articulate technical concepts in cross functional teams
Process & Methodology
operational oversight at external CDMO/CTL partners, CMC risk management, protocol development and oversight/troubleshooting of method transfers
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