Stellenbeschreibungph3Summary /h3pWORK ARRANGEMENT: Onsite, #Onsite /ppLOCATION: Basel, Switzerland /ppRELOCATION SUPPORT: This role is based in Basel, Switzerland. Novartis is unable to offer relocation support: please only apply if accessible. /ppWe are seeking a highly skilled and motivated Associate Director to support the local Extractables Leachables (EL) Specialty team, contribute to the development and be responsible for the implementation of EL testing and assessment strategies in alignment with the global EL community and wider organization within a multidisciplinary project team developing biological drugs. /ph3About The Role /h3h3ROLE PURPOSE /h3pAs Associate Director in the Extractables Leachables (EL) Specialty CH within Process Analytical Sciences (PAS), you will be part of a small team of 4+ associates, including laboratory scientists, methods and analytical experts. You will be directly responsible for managing Extractables Leachables activities primarily related to late phase assets, with focus on complex and innovative medicines (i.e. Antibody-oligonucleotide conjugates (AOCs), Cell Gene Therapy (CGT)). This includes guiding and driving activities within specialty and cross-functional project teams, shaping risk assessment and analytical strategies, developing concepts in line with internal and external regulatory standards while driving Data Digital initiatives within the specialty. /ph3Key Responsibilities /h3ulliProvide expert support to a team of 4+ associates, including laboratory scientists and EL experts (i.e. methods or analytical experts in the field of EL). /liliGuide specialty team in alignment with business priorities and agreed strategies on technical, scientific and project management matters. /liliAct as Subject Matter Expert (SME) for EL and lead relevant initiatives within the broader Organization. /liliEngage with stakeholders and partners (e.g. Drug Substance (DS) and Drug Product (DP) development, Manufacturing Science and Technology (MST), toxicologists) and manage interfaces as appropriate to ease workflows and satisfy partners. /liliCoordinate end-to-end project support on relevant EL activities and ensure submission readiness for projects assigned to team. /liliEnsure compliance with regulatory requirements applying principles described in relevant guidelines e.g. from Food Drug Administration (FDA), International Conference on Harmonization (ICH), United States Pharmacopeia (USP), International Organization for Standardization (ISO) /liliSupport integration of Data Digital tools and Artificial Intelligence AI in EL workflows and contribute or lead related initiatives. /li /ulh3Essential Requirements /h3ulliUniversity degree (preferably PhD) in Pharmacy, Biotechnology, Life Sciences or other relevant science discipline. /liliMinimum 10 years of proven experience in the pharmaceutical industry. /liliMinimum 5 years in a leadership position with successful performance and track record of leading teams. /liliAdvanced knowledge in Extractables Leachables (incl. Analytics/Regulation) as well as biotechnological CMC development. /liliStrong Leadership Skills: Proven ability to lead and inspire a team of scientists in a dynamic environment, with a “make-it-happen” spirit. /liliSolid business acumen with the ability to align scientific and technical decisions to organizational strategy and priorities. /liliExcellent communication and interpersonal skills. /liliStrategic thinking, high learning agility, solution oriented mindset. /li /ulh3Commitment to Diversity and Inclusion /h3pNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. /ph3Accessibility and Accommodation /h3pNovartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or to receive more detailed information about the essential functions of a position, please email and share the nature of your request along with your contact information. Please include the job requisition number in your message. /ph3Why Novartis /h3pHelping 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? /ph3Benefits And Rewards /h3pLearn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) /ph3Why Novartis: /h3pHelping 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? /ph3Benefits and Rewards: /h3pLearn about all the ways we’ll help you thrive personally and professionally. /ppRead our handbook (PDF 30 MB) /p /p #J-18808-Ljbffr
