Sandoz
Website:
sandoz.com
Job details:
Your Key Responsibilities
Your responsibilities include, but not limited to:
- Planning, organization, oversight and interpretation of outsourced in vitro and in vivo preclinical studies in accordance with resources, timelines, regulatory and professional standards.
- Preparation of Toxicological (risk) assessments for various impurities and excipients (determination of ADE/PDE and/or safety risk assessment), impurity qualification support for drug substance and drug product (small molecules) for residual solvents, elemental impurities, degradation product, extractable and leachable.
- Genotoxicity hazard assessment for impurities using in-vitro and in-vivo data and in-silico (Q)SAR approaches (according to ICH M7 guideline).
- Preparation of health hazard assessments and environmental risk assessments
- Implementation of GLP and other GXP standards.
- Active knowledge sharing within the Product Development
- Active collaboration with cross-functional partners, including, but not restricted to other functions within Product Development, Sandoz Technical Operations, Active participation in development project teams.
- Collaboration with external experts as indicated by project/product requirements
Essential Requirements
What you’ll bring to the role:
- Minimum 2-3 years of experience in drafting toxicological risk assessments
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
Join us!
Click on Apply to know more.