345205BR
May 30, 2022
Switzerland

Job Description

6000! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. The Pre-Clinical Safety (PCS) group in NIBR provides world class preclinical safety profiling and assessment for optimal drug discovery, development and commercialization, with state-of-the-art regulatory compliance.

The Preclinical Safety (PCS) department at Novartis Institutes for BioMedical Research (NIBR) is looking for a PhD-qualified scientist with advanced knowledge in toxicological impurity assessments and in-silico methodologies to independently conduct safety and in-silico assessments. The successful candidate will contribute to the effective operation of project teams to ensure efficient safety assessments in drug development and successful approval by Health Authorities. Work location will be Basel, Switzerland.

As part of an interdisciplinary team of scientists, you will be responsible for safety and in-silico assessments of intermediates, impurities (including new modalities), extractable & leachables, elemental impurities, degradations products and more.

Furthermore, you will conduct safety evaluations of new excipients used in formulations of our drug candidates.

Your responsibilities will include:

• Performs ICH M7 in silico assessments to evaluate the presence of potential mutagenic impurities
• Assessment of (new) excipients used in formulations
• Safety evaluations of impurities, extractable and leachables, elemental impurities and more
• Derivation of permitted daily exposure (PDE) and acceptable intake limits (AI)
• Supports technical functions in setting of specifications
• Provides input into study design of toxicological qualification studies
• Participate in safety sub-teams and line function teams; represent the PCS line function on internal boards and with third-party organizations such as partners and scientific organizations
• Maintain scientific and regulatory expertise in the fields of drug development and safety assessment

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Minimum: DVM, MSc or PhD.
• Broad knowledge in toxicology, in particular genetic toxicology
• Work experience in the impurity field is preferred
• Knowledge in chemistry is an asset
• Team player behavioral attributes
• Self-motivated and able to operate independently


Why consider Novartis?

766 million. That’s how many lives our products touched in 2021. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
NIBR
Translational Medicine
Switzerland
Basel
Research & Development
Full Time
Regular
No
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345205BR

Senior Impurity Scientist – Impurity Safety

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