Scientist, Analytical Development and Quality Control

Key Responsibilities

• • 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, stability reports, and storage statements.
• Management of reference standards and impurity markers.
• Management and organization of documentation and data.
• Contribution to protocol development and oversight/troubleshooting of method transfers.
• Liaison with Medicinal Chemistry, Bioanalytical, DMPK, and Preclinical departments.
• Compliance with cGMP quality standards and internal SOPs.
• Travel up to 5%.

Required Qualifications

• 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.
• Strong interpersonal skills that foster collaboration within and outside of the organization.

Bonus Qualifications

• 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.

Fit with Nurix Culture and Values

• Strong team orientation; highly collaborative.
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