CSL Plasma
Principal Scientist, Regulatory Toxicology(m/w/x)
Full-timeOn-siteSenior
Opfikon
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CSCSL Behring
Principal Scientist, Regulatory Toxicology(m/w/x)
Glattbrugg
Full-timeOn-siteSenior
Nejo AI Summary
Toxicological risk assessments for biotherapeutics, applying SAR and read-across methodologies. Board Certification (ERT or DABT) and 5-8 years pharma/biotech experience required. Global project scope in biotherapeutics development.
Requirements
- Advanced degree in Toxicology, Pharmacology, Biomedical Sciences or related discipline
- Board Certification (ERT or DABT) or equivalent plus
- 5-8 years pharmaceutical or biotech industry experience
- Track record in nonclinical safety assessment and regulatory submissions
- Understanding of GLP regulations, ICH guidelines, and global regulatory requirements
- Excellent communication, leadership, and cross-functional collaboration skills
- Experience with CSL’s disease therapeutic areas
- Experience across multiple therapeutic areas and modalities
Tasks
- Prepare and peer-review toxicological risk assessments
- Apply advanced SAR and read-across methodologies
- Set health-based exposure limits like PDE and OEL
- Assess impurities, excipients, and extractables and leachables
- Evaluate manufacturing and stability deviations rapidly
- Analyze impacts on patient safety and product efficacy
- Collaborate with Global Clinical Safety and Pharmacovigilance
- Review product technical complaints and trend categories
- Represent toxicology on interdisciplinary global project teams
- Build a network of internal and external experts
- Monitor evolving toxicology guidelines and regulatory trends
Work Experience
- 5 - 8 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GLP regulations
- ICH guidelines
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring 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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CSCSL Behring
Principal Scientist, Regulatory Toxicology(m/w/x)
Glattbrugg
Full-timeOn-siteSenior
Nejo AI Summary
Toxicological risk assessments for biotherapeutics, applying SAR and read-across methodologies. Board Certification (ERT or DABT) and 5-8 years pharma/biotech experience required. Global project scope in biotherapeutics development.
Requirements
- Advanced degree in Toxicology, Pharmacology, Biomedical Sciences or related discipline
- Board Certification (ERT or DABT) or equivalent plus
- 5-8 years pharmaceutical or biotech industry experience
- Track record in nonclinical safety assessment and regulatory submissions
- Understanding of GLP regulations, ICH guidelines, and global regulatory requirements
- Excellent communication, leadership, and cross-functional collaboration skills
- Experience with CSL’s disease therapeutic areas
- Experience across multiple therapeutic areas and modalities
Tasks
- Prepare and peer-review toxicological risk assessments
- Apply advanced SAR and read-across methodologies
- Set health-based exposure limits like PDE and OEL
- Assess impurities, excipients, and extractables and leachables
- Evaluate manufacturing and stability deviations rapidly
- Analyze impacts on patient safety and product efficacy
- Collaborate with Global Clinical Safety and Pharmacovigilance
- Review product technical complaints and trend categories
- Represent toxicology on interdisciplinary global project teams
- Build a network of internal and external experts
- Monitor evolving toxicology guidelines and regulatory trends
Work Experience
- 5 - 8 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GLP regulations
- ICH guidelines
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring 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
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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