Senior Toxicology Specialist, Risk Evaluation
vor 3 Wochen
For our Research division, we are seeking a
Senior Toxicology Specialist, Risk Evaluation (m/f/x)R
Fulltime / permanent / non-tariff
The Opportunity
As a Senior Toxicology Specialist, you will play a pivotal role in conducting risk evaluations (medical/pharmacological/toxicological) that support R&D, production, and marketing across all therapeutic domains of CSL Behring, CSL Seqirus; CSL Vifor, and CSL Plasma. You will collaborate closely with global cross-functional project teams. The ideal candidate will also assess the implications of unforeseen deviations during the manufacturing, release, or stability testing of starting materials, intermediates, or final products within a swift turnaround time.
This position carries global responsibilities, including participation in international teams and assessment meetings.
The Role
- Your primary duty will be to organize, prepare, and review risk evaluations that support R&D initiatives and Quality, working closely with Project Toxicologists, CMC, Manufacturing Site Pharmacovigilance Responsible (MSPR)/Global Clinical Safety and Pharmacovigilance (GCSP).
- You will establish exposure limits: PDE/ADE, AI, OEL, TE, and TTC.
- Your responsibilities will include performing toxicological evaluations on leachables/extractables.
- A key focus will be to evaluate the impact on safety and efficacy of products in patients within their labeled use.
- You will assess the prospective impact of unexpected deviations from specified or usual quality during manufacturing or release testing on the safety and efficacy of products in patients within their labeled use.
- Additionally, you will evaluate the potential impact of unexpected deviations from the usual stability profile of products on safety, tolerability, and efficacy in the market, where appropriate, in collaboration with Global Clinical Safety and Pharmacovigilance (GCSP).
- As an expert in the field, you will utilize state-of-the-art assessment methodologies based on literature available in accessible databases, applying Structure/Activity Relationships (SAR), read-across methodologies, etc.
- You will review Product Technical Complaints as necessary, based on product trends and types of complaints.
- You will represent the function across R&D projects in various therapeutic areas and collaborate with global, cross-continental project teams.
- Another focus will be to actively build and maintain a high-quality, global network with relevant experts both internally and externally.
Your Skills and Experience:
- Advanced degree (PhD, MD, PharmD) in Life Sciences or closely related fields.
- Toxicology training, board certification.
- Strong background in immunology.
- Education in chemistry is advantageous.
- At least 5 years of experience as a non-clinical toxicologist in a biotechnology, pharmaceutical, or CRO environment.
- Relevant experience in biopharmaceutical development.
- Additional experience in the development of cell and gene therapy and monoclonal antibodies is a plus.
- In-depth knowledge of pertinent 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.
- Childcare services for up to 14 children (from 6 months to 3 years old).
- Access to gym facilities on campus.
- Two wellness days per year (additional paid time off).
- Family services such as psychological support, legal advisory, family care services, and more for you and your immediate family.
For more information, please check out our global benefits below.
We look forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectations.
Our BenefitsWe encourage you to prioritize your well-being. It's important, and so are you. Learn more about how we care at CSL.
About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat individuals with rare and serious diseases. Our treatments provide hope for people in over 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around usAs a global organization with employees in over 35 countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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