1201 F. Hoffmann-La Roche AG
Project Toxicologist with large molecule experience(m/w/x)
Full-timeOn-siteSenior
Basel
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RORoche
Expert Toxicologist for Impurity Safety Assessment and Risk Management(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
Risk assessment of genotoxic impurities per ICH M7 and E&L profiles for pharmaceutical safety dossiers. PhD/MSc in Toxicology and profound ICH guidelines knowledge required. Work in global pharmaceutical company with 100,000+ employees.
Requirements
- PhD and MSc in Toxicology
- 5–10 years in pharmaceutical toxicology
- Working knowledge of genetic toxicology
- Profound knowledge of ICH guidelines
- Broad understanding of drug development
- Strong communication and interpersonal skills
Tasks
- Serve as the main contact for impurity and E&L risk assessments.
- Conduct risk assessments of genotoxic impurities per ICH M7.
- Perform toxicological evaluations of E&L profiles for various components.
- Provide guidance on toxicological concern thresholds for safety dossiers.
- Design and interpret in silico (Q)SAR analyses and propose studies.
- Draft scientifically justified TBLs for impurities and leachables.
- Apply risk assessment methodologies according to ICH and EMA/FDA guidelines.
- Support integration of TBLs into product specifications and validation.
- Collaborate with teams to ensure compliant control strategies.
- Work closely with chemists, scientists, and regulatory affairs teams.
- Evaluate data for the release of new manufacturing batches.
- Represent Roche in industry consortia and regulatory discussions.
- Advise project teams on regulatory requests regarding impurities.
Work Experience
- 5 - 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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RORoche
Expert Toxicologist for Impurity Safety Assessment and Risk Management(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
Risk assessment of genotoxic impurities per ICH M7 and E&L profiles for pharmaceutical safety dossiers. PhD/MSc in Toxicology and profound ICH guidelines knowledge required. Work in global pharmaceutical company with 100,000+ employees.
Requirements
- PhD and MSc in Toxicology
- 5–10 years in pharmaceutical toxicology
- Working knowledge of genetic toxicology
- Profound knowledge of ICH guidelines
- Broad understanding of drug development
- Strong communication and interpersonal skills
Tasks
- Serve as the main contact for impurity and E&L risk assessments.
- Conduct risk assessments of genotoxic impurities per ICH M7.
- Perform toxicological evaluations of E&L profiles for various components.
- Provide guidance on toxicological concern thresholds for safety dossiers.
- Design and interpret in silico (Q)SAR analyses and propose studies.
- Draft scientifically justified TBLs for impurities and leachables.
- Apply risk assessment methodologies according to ICH and EMA/FDA guidelines.
- Support integration of TBLs into product specifications and validation.
- Collaborate with teams to ensure compliant control strategies.
- Work closely with chemists, scientists, and regulatory affairs teams.
- Evaluate data for the release of new manufacturing batches.
- Represent Roche in industry consortia and regulatory discussions.
- Advise project teams on regulatory requests regarding impurities.
Work Experience
- 5 - 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Roche
Industry
Pharmaceuticals
Description
Roche is dedicated to advancing science and ensuring access to healthcare for millions of people globally. With over 100,000 employees, the company fosters creativity and ambition to deliver life-changing healthcare solutions.
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