Scientist, Analytical Development and Quality Control

Nurix•Brisbane, CA

2d•Onsite

About The Position

Nurix Therapeutics seeks an experienced Scientist to join the Analytical Development and Quality Control group. The Scientist will conduct analytical method development and material characterization studies to inform drug substance and drug product development. They will also provide operational oversight at external CDMO/CTL partners, manage reference standards and impurity markers, collaborate in CMC risk management, and author technical reports. In Nurix’s laboratories, the Scientist will characterize material attributes and impurities by high resolution mass spectrometric and multidimensional chromatographic techniques. They will determine impurity structures, characterize material stability, and elucidate mechanisms of degradation. They will employ state of the art QbD approaches to develop and troubleshoot chromatographic test methods to accelerate and derisk QC activities performed externally at CDMOs and CTLs. The Scientist will critically evaluate characterization data and communicate results in multidisciplinary teams.

Requirements

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
Strong 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 Haves

Hands-on experience with two-dimensional liquid chromatography is a plus.
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

Responsibilities

Conduct analytical method development and material characterization studies to inform drug substance and drug product development.
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, and elucidate mechanisms of degradation.
Employ state of the art QbD approaches to develop and troubleshoot chromatographic test methods to accelerate and derisk QC activities performed externally at CDMOs and CTLs.
Critically evaluate characterization data and communicate results in multidisciplinary teams.
2D-LC for impurity profiling of complex samples, derisking HPLC test procedures, and 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, stability 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, Bioanalytical, DMPK, and Preclinical departments.
Compliance with cGMP quality standards and internal SOPs.