Associate Director - Impurity Safety Expert

Associate Director – Impurity Safety ExpertJob ID REQ-10054887United KingdomSummaryAre you passionate about advancing pharmaceutical research and ensuring drug safety at Novartis? The Preclinical Safety (PCS) department at Novartis BioMedical Research (BR) is seeking an experienced Impurity Safety scientist to join our dynamic team.More than 100,000 people across 140 countries are working for Novartis to discover, develop, and successfully market innovative products to prevent and cure diseases, ease suffering, and enhance the quality of life. As an Impurity Safety expert at Novartis, you will play a key role in supporting non-clinical safety assessment throughout drug discovery and development, as well as for established medicines, with state-of-the-art regulatory compliance. Utilizing your expertise, you will collaborate with cross-functional teams to ensure the delivery of high-quality and compliant research. The position can be located in the US (Cambridge, MA or East Hanover, NJ) or UK (London).We are unable to offer permit support for this role.About the RoleKey Responsibilities:Conduct safety assessment of impurities in drug substances and medicinal products spanning all therapeutic modalities and disease indications (including extractable and leachables, elemental impurities, degradation products, and excipients)Perform ICH M7 in silico assessments to evaluate the presence of potential mutagenic impuritiesProvide expertise to support Nitrosamine impurity evaluationsProvide expert opinions on impurity safety assessments to support drug discovery and development project teams, regulatory submissions, due diligences, and life-cycle management of established medicines.Develop innovative interdisciplinary approaches to advance the field of impurity safety assessment across all therapeutic areas and advanced modalities (e.g. Bx, GTx, xRNA, RLT)Maintain state-of-the-art scientific and regulatory expertise in Impurity Safety.Lead cross-functional teams; represent the PCS line function on internal and external boards; actively share and communicate information back to the Impurity Safety teamEngaging and collaborating with key internal and external customer partnersEnsure compliance with relevant regulatory guidelines and standards.PhD, DVM or equivalentBroad knowledge in toxicology and chemistryKnowledge of the drug development processMinimum of 5 years of experience in regulatory impurity safety assessmentExperience in health authority interactionsKnowledge of design and application of impurity safety databases, experience in the area of QSARsStrong analytical skills and a commitment to scientific excellence.Excellent communication and team collaboration skills.Strong data exploration and analysis skills.Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureCommitment to Diversity and Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams\’ representative of the patients and communities we serve.Join our Novartis Network:If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networkHelping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureJoin our Novartis Network:Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/networkWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureJoin our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/networkUniversal Hierarchy Node Innovative MedicinesLocation United KingdomSite London (The Westworks)Company / Legal Entity GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.Novartis is committed to building an outstanding, inclusive work environment and diverse teams\’ representative of the patients and communities we serve.Job ID REQ-10054887Associate Director – Impurity Safety Expert #J-18808-Ljbffr