Associate Director - Extractables & Leachables - Technical Development

Job ID REQ-10085154 Aug 12, 2026 Switzerland Available in: English ### Summary ### WORK ARRANGEMENT: Onsite, \#Onsite LOCATION: Basel, Switzerland RELOCATION SUPPORT: This role is based in Basel, Switzerland. Novartis is unable to offer relocation support: please only apply if accessible. We are seeking a highly skilled and motivated Associate Director to support the local Extractables & Leachables (E&L) Specialty team, contribute to the development and be responsible for the implementation of E&L testing and assessment strategies in alignment with the global E&L community and wider organization within a multidisciplinary project team developing biological drugs. ### About the Role ### **ROLE PURPOSE** As Associate Director in the Extractables & Leachables (E&L) 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. **KEY RESPONSIBILITIES** * Provide expert support to a team of 4+ associates, including laboratory scientists and E&L experts (i.e. methods or analytical experts in the field of E&L). * Guide specialty team in alignment with business priorities and agreed strategies on technical, scientific and project management matters. * Act as Subject Matter Expert (SME) for E&L and lead relevant initiatives within the broader Organization. * Engage with stakeholders and partners (e.g. Drug Substance (DS) and Drug Product (DP) development, Manufacturing Science and Technology (MS&T), toxicologists) and manage interfaces as appropriate to ease workflows and satisfy partners. * Coordinate end-to-end project support on relevant E&L activities and ensure submission readiness for projects assigned to team. * Ensure 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) * Support integration of Data & Digital tools and Artificial Intelligence AI in E&L workflows and contribute or lead related initiatives. **ESSENTIAL REQUIREMENTS:** * University degree (preferably PhD) in Pharmacy, Biotechnology, Life Sciences or other relevant science discipline. * Minimum 10 years of proven experience in the pharmaceutical industry. * Minimum 5 years in a leadership position with successful performance and track record of leading teams. * Advanced knowledge in Extractables & Leachables (incl. Analytics/Regulation) as well as biotechnological CMC development. * Strong Leadership Skills: Proven ability to lead and inspire a team of scientists in a dynamic environment, with a -make-it-happen- spirit. * Solid business acumen with the ability to align scientific and technical decisions to organizational strategy and priorities. * Excellent communication and interpersonal skills. * Strategic thinking, high learning agility, solution oriented mindset. **Commitment 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. **Accessibility and Accommodation** Novartis 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 inclusion.switzerland@novartis.com and share the nature of your request along with your contact information. Please include the job requisition number in your message. **Why 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-culture **Benefits and Rewards:** Learn about all the ways we-ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) **Why 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-culture **Benefits and Rewards:** Learn about all the ways we-ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) Primary location salary range CHF126,000.00 - CHF234,000.00 Division Development Business Unit Development Location Switzerland Site Basel (City) Company / Legal Entity C028 (FCRS = CH028) Novartis Pharma AG Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Research & Development Development Switzerland Job ID REQ-10085154 ### Associate Director - Extractables & Leachables - Technical Development ### Apply to Job (link is external)