Lead Toxicologist in Risk Evaluation
vor 4 Wochen
For our Research division, we are looking for a talented professional to join us as a Lead Toxicologist, focusing on Risk Evaluation (m/f/x). This role is a full-time, permanent position with no tariff restrictions.
About the Role and Company:
As the Lead Toxicologist, you will be instrumental in performing risk evaluations to support various operations of CSL Behring, CSL Seqirus, CSL Vifor, and CSL Plasma across multiple therapeutic domains. You will work closely with global project teams, playing a crucial role in assessing the implications of unexpected deviations during the manufacturing process and ensuring swift actions to uphold product quality standards.
This position has a global focus, requiring active engagement in international teams and assessment discussions.
Key Responsibilities:
- Organize, prepare, and review risk evaluations to support R&D and Quality operations
- Establish exposure limits such as PDE/ADE, AI, OEL, TE, and TTC
- Conduct toxicological evaluations on leachables/extractables
- Assess safety and efficacy implications for patients within the indicated product usage
- Evaluate potential impacts of deviations on product safety and efficacy
- Utilize advanced assessment techniques and remain informed about the latest scientific literature and methodologies
- Review Product Technical Complaints and identify trends and patterns
- Collaborate with cross-functional teams across therapeutic areas
- Build and maintain a robust global network of industry experts
Requirements:
- Advanced degree (PhD, MD, PharmD) in Life Sciences or related disciplines
- Toxicology training and board certification
- Strong background in immunology
- Knowledge of chemistry is advantageous
- Minimum 5 years of experience as a non-clinical toxicologist in biotech, pharma, or CRO environments
- Prior experience in biopharmaceutical development
- Familiarity with cell and gene therapy and monoclonal antibodies is a plus
- Proficiency in regulatory guidelines and in-vitro toxicology
Why Join Us:
- Dynamic work environment with opportunities for innovation
- Company-sponsored bike leasing program
- On-site childcare services for children aged 6 months to 3 years
- Access to campus gym facilities
- Two additional paid Wellness days annually
- Family support programs including psychological assistance, legal counseling, and more
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