Global Senior Toxicologist
Location
Andhra Pradesh | India
Job description
About the role
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!
Job Purpose:
Responsible for toxicological/ecotoxicological risk assessments supporting impurity qualifications and to plan, execute and monitor the preclinical studies needed for product development.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
1. Planning, organization, oversight and interpretation of outsourced in vitro and in vivo preclinical studies in accordance with resources, timelines, regulatory and professional standards.
2. 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.
3. Genotoxicity hazard assessment for impurities using in-vitro and in-vivo data and in-silico (Q)SAR approaches (according to ICH M7 guideline).
4. Determination of Harmful dose for children for selection of blister packaging for US market. Peer review of different types of toxicological (risk) assessments.
5. Interpretation of health hazard assessments for occupational safety and cleaning validation. implementation of GLP and other GXP standards.
6. Active knowledge sharing within the Product Development and Sandoz.
7. Active collaboration with cross-functional partners, including, but not restricted to other functions within Product Development, Novartis Technical Operations, Novartis Business Services. Active participation in development project teams. Collaboration with external experts as indicated by project/product requirements.
8. Other tasks, as directed by the supervisor, or based on specific appointment, or determined during the annual objectives setting process, or by relevant key performance indicators.
Role Requirements
What you’ll bring to the role:
Education Requirements:
Minimum – Academic degree in life sciences (pharmacy, veterinary, medicine, biology, (bio)chemistry...), with specialization in toxicology
Desired – Certifications in Toxicology
Languages: Fluent in English
Experience/Professional: Requirements 7–8 years' experience in toxicology or preclinical research.
You’ll receive:
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art 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 and entrepreneurial spirit 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 encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Job tags
Salary
