Senior Toxicology Specialist

Vor 5 Tagen


Bern, Bern, Schweiz skybris Vollzeit

At skybris, we are seeking a highly skilled Senior Toxicology Specialist to join our Research department. The successful candidate will be responsible for preparing risk assessments supporting R&D, production and marketing in all therapeutic areas.

This role has global responsibilities, including participation in global teams and assessment meetings. As Principal Scientist in Risk Assessment, you will 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 perform toxicological assessments on leachables / extractables and set exposure limits: PDE / ADE, AI, OEL, TE, and TTC. Additionally, you will assess the impact on safety and efficacy of the product in patients within its labeled use.

This role requires expertise in immunology and strong background in non-clinical toxicology, with at least 5 years of experience in a biotechnology, pharmaceutical or CRO setting. Relevant experience in biopharmaceutical development is also necessary.

The ideal candidate will have advanced degree (PhD, MD, PharmD) in Life Sciences or closely related fields, as well as toxicology training and board certification. Experience in in-vitro toxicology is welcome.



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