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Analytical Expert for Trace & NDSRI Analytics and Mass Spectrometry(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- GC-MS
- LC-HRMS
- MS software
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Analytical Expert for Trace & NDSRI Analytics and Mass Spectrometry(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- GC-MS
- LC-HRMS
- MS software
About the Company
1201 F. Hoffmann-La Roche AG
Industry
Healthcare
Description
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
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