Principal Toxicologist, Risk Assessment Specialist

vor 1 Woche

Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit
Job Summary

We are seeking a highly skilled Principal Toxicologist, Risk Assessment to join our Research department at CSL Behring. As a key member of our team, you will be responsible for preparing risk assessments to support R&D, production, and marketing across various therapeutic areas.

Key Responsibilities
  • Organize, prepare, and review risk assessments for R&D projects and Quality, collaborating closely with cross-functional teams.
  • Set exposure limits, including PDE/ADE, AI, OEL, TE, and TTC.
  • Perform toxicological assessments on leachables/extractables.
  • Assess the impact on safety and efficacy of products in patients within their labeled use.
  • Evaluate the prospective impact of unexpected deviations from specified or usual quality during manufacture or release testing on product safety and efficacy.
  • Collaborate with Global Clinical Safety and Pharmacovigilance to assess the impact of unexpected deviations on product stability profiles.
  • Apply state-of-the-art assessment methods, including literature reviews, Structure/Activity Relationships (SAR), and read-across methodologies.
  • Review Product Technical Complaints, as needed, to identify trends and types of complaints.
  • Represent the function across R&D projects and collaborate with global project teams.
Requirements
  • Advanced degree (PhD, MD, PharmD) in Life Sciences or closely related fields.
  • Toxicology training and board certification.
  • Strong background in immunology.
  • Education in chemistry is an advantage.
  • At least 5 years of experience as a non-clinical toxicologist in a biotechnology, pharmaceutical, or CRO setting.
  • Relevant experience in biopharmaceutical development.
  • Additional experience in cell and gene therapy and monoclonal antibodies is an advantage.
  • In-depth knowledge of relevant regulatory guidelines.
  • Experience in in-vitro toxicology is welcome.
What We Offer
  • An innovative work environment at our R&D campus.
  • CSL-subsidized company bike leasing.
  • Access to a gym facility on campus.
  • 2 wellness days per year (additional paid time off).
  • Family services, including psychological support, legal advisory, family care services, and more.

We are committed to creating a diverse and inclusive work environment. If you are passionate about making a difference in the lives of patients, we encourage you to apply for this exciting opportunity.

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