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CSCSL Behring

Senior Scientist, Regulatory Toxicology(m/w/x)

Opfikon
Full-timeOn-siteSenior

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

  • EnglishBusiness Fluent
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