Senior Scientist, Regulatory Toxicology

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

The Senior toxicologist will prepare risk assessments (toxicological / pharmacological/ medical) supporting R&D, production and marketing in all therapeutic areas of CSL Behring, CSL Seqirus; CSL Vifor and CSL Plasma. This role 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.

The Senior toxicologist will liaise closely with global cross-functional project teams and interact with external experts.

The Role:

• 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)

• Set exposure limits: PDE/ADE, AI, OEL, TE, and TTC

• Perform toxicological assessments on leachables/extractables

• Assessment of prospective impact of unexpected deviations from 1.) specified or usual quality profile 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 and 2.) 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).

• Use 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.

• Perform review of Product Technical Complaints, as needed, according to product trends and types of complaints

• Serve as function’s representative across R&D projects across therapeutic areas

• Actively establish and foster a high quality, global network with relevant experts internally and externally

Your Skills and Experience:

• University Degree in Life Sciences or closely related fields (e.g. PhD, MD, PharmD)

• Toxicology training (board certification preferred)

• 1-3 years of relevant experience as non-clinical toxicologist in a biotechnology, pharmaceutical or CRO setting

• Additional experience in biopharmaceutical development.

• In depth knowledge of relevant regulatory guidelines.

• Strong scientific background in at least one of the following therapeutic areas: hematology, immunology, transplantation, cardiovascular disease, pulmonology

• Fluent in English (Proficient written, verbal and presentation skills)

Was wir bieten

Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, was wir bei CSL bieten .

Über CSL Behring

CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring .

CSL soll so vielfältig sein wie die Welt, in der wir leben

Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über Vielfalt, Fairness & Inklusion bei CSL.

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