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

TN Germany; Marburg; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An innovative firm is seeking a Principal Toxicologist to lead risk assessments in a dynamic research environment. This pivotal role involves collaborating with global teams to ensure product safety and efficacy, while applying cutting-edge methodologies in toxicology. The ideal candidate will possess a strong background in immunology and toxicology, with at least five years of experience in the biotech or pharmaceutical sectors. Join a forward-thinking company that values professional growth and offers a supportive workplace, including childcare services and wellness days.

Leistungen

CSL-subsidized company bike leasing

Childcare at Kita Froschkönig

Access to gym facilities

Two wellness days per year

Family services including psychological support

Qualifikationen

• Advanced degree in Life Sciences or related fields required.
• At least 5 years as a non-clinical toxicologist in biotech or pharma.

Aufgaben

• Prepare risk assessments supporting R&D projects and Quality.
• Evaluate the impact of deviations during manufacture or testing.

Kenntnisse

Toxicology training

Immunology

Regulatory guidelines knowledge

In-vitro toxicology

Ausbildung

PhD in Life Sciences

MD or PharmD

Jobbeschreibung

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

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Client:

CSL

Location:

Marburg, Germany

Job Category:

Finance

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EU work permit required:

Yes

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Job Reference:

9e0ca434ced3

Job Views:

2

Posted:

30.04.2025

Expiry Date:

14.06.2025

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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. You will liaise closely with global cross-functional project teams. The successful candidate will also assess the impact of unexpected deviations during manufacture, release, or stability testing of starting material, intermediates, or final products within a short turnaround time.

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

The Role

• Organize, prepare, and review risk assessments supporting R&D projects and Quality, collaborating with 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
• Assess the impact on safety and efficacy of the product in patients within its labeled use
• Evaluate the prospective impact of deviations during manufacture or release testing on safety and efficacy
• Assess the impact of deviations from the stability profile on safety, tolerability, and efficacy of the product on the market
• Apply state-of-the-art assessment methods, including literature review, SAR, read-across methodologies
• Review Product Technical Complaints based on trends and complaint types
• Represent the function across R&D projects and collaborate with global teams
• Establish and foster a high-quality, global network with internal and external experts

Your Skills and Experience:

• Advanced degree (PhD, MD, PharmD) in Life Sciences or related fields
• Toxicology training, board certification
• Strong background in immunology
• Education in chemistry is a plus
• At least 5 years as a non-clinical toxicologist in biotech, pharma, or CRO
• Experience in biopharmaceutical development
• Experience with cell and gene therapy, monoclonal antibodies is advantageous
• Knowledge of regulatory guidelines
• In-vitro toxicology experience is welcome

What we offer

• Innovative work environment
• CSL-subsidized company bike leasing
• Childcare at “Kita Froschkönig” for children from 6 months to 3 years
• Access to gym facilities on campus
• Two wellness days per year (additional paid time off)
• Family services, including psychological support, legal advisory, and family care