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121201 F. Hoffmann-La Roche AG

Analytical Expert for Trace & NDSRI Analytics and Mass Spectrometry(m/w/x)

Basel
Full-timeOn-siteExperienced

Qualitative/quantitative analysis of organic/elemental impurities, leading NDSRI development/validation with advanced chromatography. Master's/PhD in Natural Science and proven GC-MS/LC-HRMS experience, plus GxP application, required. Work in a large, global pharmaceutical environment with project coordination.

Requirements

  • Master’s or PhD in Natural Science or equivalent
  • Proven work experience with GC-MS and LC-HRMS
  • Experience in application of GxP requirements
  • Proven practical experience in impurity quantification
  • Development/validation of chromatographic and MS methods
  • Familiarity with MS software
  • Pragmatic, proactive, and solution-oriented mindset
  • Interest in continuous process improvement
  • Excellent team player
  • Strong communication skills
  • Curiosity and comfort in matrix environment
  • Very good knowledge of spoken and written English

Tasks

  • Perform qualitative and quantitative analysis of organic and elemental impurities
  • Utilize advanced MS and chromatography platforms for analysis
  • Lead development and validation of Nitrosamine Drug Substance Related Impurities
  • Ensure compliance with quality standards for NDSRI
  • Manage project requests and coordinate with Analytical Project Leaders
  • Facilitate communication with cross-functional stakeholders
  • Advise teams on control strategies and technical solutions for N-Nitrosamines and Trace Analytics

Work Experience

  • approx. 1 - 4 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • GC-MS
  • LC-HRMS
  • MS software
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