Associate Director - Extractables & Leachables - Technical Development

**Salary Range:** CHF126,000.00 - CHF234,000.00   **Job Description 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.   **Job Description** **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 [[email protected]](mailto:[email protected]) 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](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)](https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf)    **Skills Desired** Budget Management, Data Science, Process Simulation, Waterfall Model