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

TN Switzerland; Bern; Vor Ort; CHF 100’000 - 160’000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen sucht einen Principal Toxicologist mit umfangreicher Erfahrung in der Risikobewertung. In dieser spannenden Rolle sind Sie verantwortlich für die Durchführung von Risikoanalysen, die Unterstützung von F&E-Projekten und die enge Zusammenarbeit mit globalen Projektteams. Sie werden die Auswirkungen unerwarteter Abweichungen bewerten und sicherstellen, dass die Produkte den höchsten Sicherheitsstandards entsprechen. Diese Position bietet Ihnen die Möglichkeit, in einem dynamischen Umfeld zu arbeiten, in dem Ihre Expertise einen direkten Einfluss auf die Produktentwicklung hat. Wenn Sie leidenschaftlich an Toxikologie interessiert sind und in einem globalen Team arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Leistungen

Innovatives Arbeitsumfeld

Unterstützte Firmenfahrradleasing

Kinderbetreuung für bis zu 14 Kinder

Zugang zu Fitnessstudio auf dem Campus

2 Wellness-Tage pro Jahr

Familienservices

Qualifikationen

• Fortgeschrittene Kenntnisse in Toxikologie und Immunologie erforderlich.
• Mindestens 5 Jahre Erfahrung als nicht-klinischer Toxikologe.

Aufgaben

• Vorbereitung und Überprüfung von Risikoanalysen für R&D-Projekte.
• Bewertung unerwarteter Abweichungen während der Herstellung.

Kenntnisse

Toxikologie

Immunologie

Chemie

Biopharmazeutische Entwicklung

In-vitro-Toxikologie

Ausbildung

PhD in Lebenswissenschaften

MD

PharmD

Jobbeschreibung

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

Client:

CSL

Location:

Bern

Job Category:

Finance

Job Reference:

7c0ec50eba20

Job Views:

4

Posted:

25.04.2025

Expiry Date:

09.06.2025

Job Description:

For our Research department, we are looking for a Principal Toxicologist, Risk Assessment (m/f/x) (R-234627).

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 the 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 Project Toxicologists, CMC, Manufacturing Site Pharmacovigilance Responsible (MSPR)/Global Clinical Safety and Pharmacovigilance (GCSP).
• You will be responsible for setting exposure limits: PDE/ADE, AI, OEL, TE, and TTC.
• You will perform toxicological assessments on leachables/extractables.
• Another focus will be to assess the impact on safety and efficacy of the product in patients within its labeled use.
• Assessment of the 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 the 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 an expert in the field, you will apply state-of-the-art assessment methods based on literature available in freely accessible databases, use Structure/Activity Relationships (SAR), read-across methodologies, etc.
• You will perform a review of Product Technical Complaints, as needed, according to product trends and types of complaints.
• You will serve as the 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 is an advantage.
• At least 5 years as a non-clinical toxicologist in a biotechnology, pharmaceutical, or CRO setting.
• Relevant experience in biopharmaceutical development.
• Additional experience in the development of cell and gene therapy and monoclonal antibodies is an advantage.
• In-depth knowledge of relevant regulatory guidelines.
• Experience in in-vitro toxicology is welcome.

What we offer:

• Innovative work environment.
• CSL-subsidized company bike leasing.
• Childcare “Kita Froschkönig” for up to 14 children (from 6 months to 3 years old).
• Access to gym facility on campus.
• 2 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 direct family.