Senior Toxicology Specialist, Risk Management
vor 2 Wochen
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
- Organize, prepare, and review risk assessments supporting R&D projects and Quality, liaising closely with cross-functional project teams.
- Set exposure limits: 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 prospective impact of unexpected deviations from specified or usual quality during manufacture or release testing of starting materials, intermediates, or final products.
- Collaborate with Global Clinical Safety and Pharmacovigilance (GCSP) to assess the impact of unexpected deviations on product safety and efficacy.
- Apply state-of-the-art assessment methods, including literature reviews, Structure/Activity Relationships (SAR), and read-across methodologies.
- Review Product Technical Complaints as needed, according to product trends and types of complaints.
- 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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