Principal software engineer Jobs in Cölbe

For our Research department, we are looking for a

Principal Toxicologist, Risk Assessment (m / f / x)

R-234627

Fulltime / permanent / non-tariff

The Opportunity

As Principal Toxicologist you will be responsible for preparing risk assessments (medical / pharmacological / toxicological) supporting R&D, production and marketing in all therapeutic areas of CSL Behring, CSL Seqirus; CSL Vifor and CSL Plasma and liaise closely with global cross-functional project teams. The successful candidate will also be responsible for the assessment of impact of unexpected deviations during manufacture, release or stability testing of starting material, an intermediate or final product within a short turnaround time.

This role has global responsibilities, including participation in global teams and assessment meetings.

The Role

• Your main responsibility 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 :

What we offer