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CSL Behring
2mo ago

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

Opfikon
Full-timeOn-siteSenior

Description

In this role, you will conduct risk assessments and toxicological evaluations while collaborating with cross-functional teams. Your expertise will help ensure product safety and efficacy, addressing any unexpected manufacturing deviations swiftly.

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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

Education

Doctoral / PhD

Work Experience

1 - 3 years

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

Languages

English – Business Fluent

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