#R-234627
lity in this role will be to organize, prepare and review risk assessments supporting R&D projects and Quality, liaising closely with e.g., Project Toxicologists, CMC, Manufacturing Site Pharmacovigilance Responsible (MSPR)/Global Clinical Safety and Pharmacovigilance (GCSP)
You will be responsible to set exposure limits: PDE/ADE, AI, OEL, TE, and TTC
You will perform toxicological assessments on leachables/extractables
Another focus will be for you to assess the impact on safety and efficacy of the product in patients within its labeled use
Assessment of prospective impact of unexpected deviations from specified or usual quality during manufacture or release testing of the starting material, an intermediate or final product on the safety and efficacy of the product in patients within its labeled use will be part of your responsibilities
You will also evaluate prospective impact of unexpected deviations from the usual stability profile of the product on safety, tolerability, and efficacy of the product on the market, where appropriate, together with Global Clinical Safety and Pharmacovigilance (GCSP).
As expert in the field, you will apply state-of-the-art assessment methods based e.g. on literature available in freely accessible databases, use Structure/Activity Relationships (SAR), read-across methodologies, etc.
You will perform review of Product Technical Complaints, as needed, according to product trends and types of complaints
You will serve as function's representative across R&D projects across therapeutic areas and collaborate with global, cross-continental project teams
Another focus for you will be to actively establish and foster a high quality, global network with relevant experts 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 of advantage
At least 5 years as 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 of advantage
In depth knowledge of relevant regulatory guidelines.
Experience in in-vitro toxicology welcome
What we offer
For more information, please check out our global benefits below.
We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.
Our Benefits
We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 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 us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!