Senior Toxicology Specialist, Risk Management

vor 2 Wochen


Bern, Bern, Schweiz CSL Vollzeit

Job Opportunity

CSL is seeking a highly skilled Principal Toxicologist to join our Research department. As a key member of our team, you will be responsible for preparing risk assessments supporting R&D, production, and marketing in all therapeutic areas.

Key Responsibilities

  1. Organize, prepare, and review risk assessments supporting R&D projects and Quality, liaising closely with cross-functional project teams.
  2. Set exposure limits: PDE/ADE, AI, OEL, TE, and TTC.
  3. Perform toxicological assessments on leachables/extractables.
  4. Assess the impact on safety and efficacy of products in patients within their labeled use.
  5. Evaluate prospective impact of unexpected deviations from specified or usual quality during manufacture or release testing of starting materials, intermediates, or final products.
  6. Collaborate with Global Clinical Safety and Pharmacovigilance (GCSP) to assess the impact of unexpected deviations on product safety and efficacy.
  7. Apply state-of-the-art assessment methods, including literature reviews, Structure/Activity Relationships (SAR), and read-across methodologies.
  8. Review Product Technical Complaints as needed, according to product trends and types of complaints.
  9. Serve as a function's representative across R&D projects across therapeutic areas and collaborate with global, cross-continental project teams.

Requirements

  • Advanced degree (PhD, MD, PharmD) in Life Sciences or closely related fields.
  • Toxicology training, 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 development of 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

  • Innovative work environment.
  • CSL-subsidized company bike leasing.
  • Childcare services for up to 14 children (from 6 months till 3 years old).
  • Access to gym facilities on campus.
  • 2 wellness days per year (additional paid time off).
  • Family services, including psychological support, legal advisory, family care services, and more.


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