Global Senior Toxicologist

Job Description

1886! We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in generics and bio-similars and is committed to playing a leading role in improving access to medicines worldwide. Quality is embedded in our daily work, shown by trust and respect of employees, patients and business partner. High quality standards are met in all work processes, in development and production of medicines as well as market supply with our highly qualified and experienced experts playing a key role. As part of our efforts to ensure the quality and safety of our medicines, we are looking for a Global Senior Toxicologist to join our teamYOUR KEY RESPONSIBILITIES:Your responsibilities include, but are not limited to:? Preparation of complex Toxicological (risk) assessments of impurities and excipients (determination of ADE/PDE and/or safety risk assessment) with usage of innovative approaches.? Complex genotoxicity hazard assessment for impurities using in vitro and in vivo data and in-silico SAR approaches, including determination of PDE/AI where applicable.? Interpretation of in-vitro and in-vivo preclinical studies to investigate the mutagenic/genotoxic and carcinogenic properties of impurities.? Planning, organization, management and supervision of preclinical programs (mainly studies to investigate the mutagenic/genotoxic and carcinogenic properties of impurities) in accordance with resources, timelines, regulatory and professional standards.? Proactive and ongoing functional area development / implementation of new methodologies and techniques.? Active collaboration with cross-functional partners (Product Development; Novartis/Sandoz Technical Operations) .Diversity & Inclusion / EEONovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum RequirementsWHAT YOU?LL BRING TO THE ROLE:? Suitably qualified individuals from a scientific background. Previous pharmaceutical or biopharmaceutical industry experience is of significant benefit. Academic degree in life sciences (pharmacy, biochemistry, medicine, biology, veterinary), with preferably specialization in toxicology (Certified European Registered Toxicologist (ERT) or equivalent).? Experienced (minimum 8 years) in toxicological (risk) assessments of impurities.? Experienced (minimum 8 years ) in preclinical studies, mainly studies to investigate the mutagenic/genotoxic and carcinogenic properties.? Experienced within the field of toxicology in pharmaceutical or biopharmaceutical industryUnderstanding of drug development and commercialization processes; knowledge of the regulatory environment; experience in overseeing or conducting pre-clinical studies; understanding of study design and methodology and have an understanding of the need to balance safety and efficacy concerns.? Experience being an active contributor to cross-functional teams and/or working in matrix organizations. Has strategic mind-set, with ability to see a broader picture; attention to detail; High quality, critical thinking, process and performance orientated; prioritizes activities and projects;? Exercises good judgment on regulatory, legal, quality and technical related compliance issues;? Positive and ?can-do? approach; biased towards finding solutions and win/wins; responsiveness and flexibility.High personal integrity; trustworthy; strong compliance and quality mind-set.? Collaborative, team oriented approach, capable of working cross-functionally, and in a matrixed and integrated wayWhy consider Sandoz?Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.Imagine what you could do at Sandoz!Commitment to Diversity & Inclusion:Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

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