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1201 F. Hoffmann-La Roche AG
15d ago

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

Basel
Full-timeOn-siteExperienced

Description

In this role, you will engage in hands-on analysis of impurities in drug substances, lead the validation of critical components, and serve as a key analytical coordinator. You will ensure effective communication across teams and provide expert guidance on control strategies.

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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

Education

Master's degree
OR
Doctoral / PhD

Work Experience

approx. 1 - 4 years

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

Tools & Technologies

GC-MSLC-HRMSMS software

Languages

English – Business Fluent

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