10 дней назад
Project Toxicologist (Biopharma)
54 400 - 72 533€
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Project Toxicologist (Biopharma): Developing safety strategies and conducting toxicology assessments for vaccines, adjuvants, monoclonal antibodies, and other biopharmaceutical products with an accent on integrated risk assessment, GLP/non-GLP studies, and regulatory documentation. Focus on evaluating toxicological findings, coordinating cross-functional project teams, answering Health Authority questions, and applying New Approach Methodologies.
Location: Marcy-l'Etoile, France; hybrid work with remote working up to 2 days per week
Salary: €54,400–€72,533 per year
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines to improve patient safety and health outcomes.
What you will do
- Provide safety strategies and conduct toxicology evaluations and risk assessments for vaccine and biopharmaceutical projects.
- Assess the safety of new components, excipients, and process residues, including their potential impact on human health.
- Evaluate study findings and advise project teams on product development and progression.
- Manage and monitor GLP and non-GLP toxicity studies, ensuring timely delivery, compliance, and reporting quality.
- Compile safety data for internal, clinical, and regulatory documentation, including IB, IND, IMPD, CTA, CTD, RMP, PBRER, labelling, and pediatric plans.
- Communicate integrated risk assessments to project teams and partners, support Health Authority meetings, and contribute to operational excellence and NAM adoption.
Requirements
- Experience in vaccine toxicology and/or biopharmaceuticals, including experience as a toxicology study director and project representative.
- Understanding of vaccine and biopharmaceutical development in an R&D or pharmaceutical industry environment, including animal models.
- Broad expertise in human and animal pathophysiology, pharmacology, and toxicology.
- Toxicology-certified background, such as a PhD, Pharmacist, DVM, MD, or toxicology certification.
- Fluent English and French, written and spoken, are required.
- Knowledge of regulatory standards and New Approach Methodologies, with strong communication and workload-management skills.
Culture & Benefits
- 31 days of paid leave plus RTT days depending on employment status.
- Quality health insurance and public transport coverage of up to 80%.
- Maternity leave of 18 weeks and parental welcome leave of 14 weeks.
- Savings and retirement plans with employer contributions, profit-sharing, and incentive schemes.
- Internal and international mobility opportunities, structured career paths, and personalized training.
- Collaboration across scientific, clinical, and digital teams, including AI, data, and digital platforms.
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