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Senior Scientist, Regulatory Toxicology(m/w/x)
Risk assessments for R&D biotherapeutic projects at a global firm, setting exposure limits (PDE/ADE, OEL). 1-3 years non-clinical toxicology experience, board certification preferred. Direct influence on patient safety and product efficacy.
Requirements
- University Degree in Life Sciences or closely related fields
- Toxicology training, board certification preferred
- 1-3 years of relevant experience as non-clinical toxicologist
- Additional experience in biopharmaceutical development
- In-depth knowledge of relevant regulatory guidelines
- Strong scientific background in therapeutic areas: hematology, immunology, transplantation, cardiovascular disease, pulmonology
- Fluency in English, proficient written, verbal and presentation skills
Tasks
- Prepare and review risk assessments for R&D projects and Quality
- Set exposure limits: PDE/ADE, AI, OEL, TE, and TTC
- Perform toxicological assessments on leachables and extractables
- Assess impact of unexpected deviations on product safety and efficacy
- Evaluate stability profile effects on product safety and tolerability
- Utilize state-of-the-art assessment methods and literature databases
- Review Product Technical Complaints based on trends and complaint types
- Represent the function across R&D projects in various therapeutic areas
- Establish and maintain a global network with relevant internal and external experts
Work Experience
- 1 - 3 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
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Senior Scientist, Regulatory Toxicology(m/w/x)
Risk assessments for R&D biotherapeutic projects at a global firm, setting exposure limits (PDE/ADE, OEL). 1-3 years non-clinical toxicology experience, board certification preferred. Direct influence on patient safety and product efficacy.
Requirements
- University Degree in Life Sciences or closely related fields
- Toxicology training, board certification preferred
- 1-3 years of relevant experience as non-clinical toxicologist
- Additional experience in biopharmaceutical development
- In-depth knowledge of relevant regulatory guidelines
- Strong scientific background in therapeutic areas: hematology, immunology, transplantation, cardiovascular disease, pulmonology
- Fluency in English, proficient written, verbal and presentation skills
Tasks
- Prepare and review risk assessments for R&D projects and Quality
- Set exposure limits: PDE/ADE, AI, OEL, TE, and TTC
- Perform toxicological assessments on leachables and extractables
- Assess impact of unexpected deviations on product safety and efficacy
- Evaluate stability profile effects on product safety and tolerability
- Utilize state-of-the-art assessment methods and literature databases
- Review Product Technical Complaints based on trends and complaint types
- Represent the function across R&D projects in various therapeutic areas
- Establish and maintain a global network with relevant internal and external experts
Work Experience
- 1 - 3 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
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.
Not a perfect match?
- CSL Behring
Principal Scientist, Regulatory Toxicology(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Plasma
Principal Scientist, Regulatory Toxicology(m/w/x)
Full-timeOn-siteSeniorOpfikon - CSL Behring
Principal Scientist, Toxicology(m/w/x)
Full-timeOn-siteSeniorOpfikon - La Prairie
Cosmetic Product Safety Assessor(m/w/x)
Full-timeOn-siteNot specifiedZürich - CSL Plasma
Senior Scientist, Non-clinical External Study Management(m/w/x)
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