Senior Director Glass Science

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

This is an opportunity for an industry-recognized pharmaceutical glass subject matter expert (SME) to serve as the technical authority on glass primary packaging for Lilly's parenteral drug products - including vials, cartridges, and prefillable syringes.

The Senior Director – TSMS Glass Science will advise on complex deviations, challenging glass supplier experts, and influencing both internal strategies and external industry standards. At this level, the individual is expected to sustain network-level results, drive multi-site influence, and serve as a reference point across functions — including Technical Development & Manufacturing Sciences, Quality, Regulatory, Drug Delivery & Chemistry Sciences, and Research & Development — for all matters pertaining to glass container science, glass-drug product compatibility, and container closure system integrity.

• Serve as the enterprise-level technical authority on pharmaceutical glass (borosilicate Type I vials, cartridges, syringes) across the global manufacturing network.
• Provide expert technical guidance on glass composition, surface chemistry, delamination, particulate formation mechanisms (silica, lamellar particles), and glass-drug product interactions.
• Apply first-principles understanding of glass tube drawing, converting processes (dehydrogenation, washing), PDMS/silane coating behavior, and ionic leaching to investigate and resolve manufacturing issues.
• Advise on complex deviations and out-of-specification investigations involving glass primary packaging at Lilly manufacturing sites globally.
• Leverage advanced analytical techniques (ToF-SIMS, XPS, SEM-EDX, FTIR, ICP-MS) to characterize glass surface phenomena and interpret data from contract analytical laboratories.
• Challenge and technically engage glass supplier experts (Schott, BD, Ompi, and others) with scientific rigor; drive supplier accountability for material quality and performance.

• Advise programs for new glass components and container closure systems (CCS), including design, specification development, and generation of qualification plans and reports.
• Integrate parenteral processing requirements (filling, stoppering, capping, lyophilization) into CCS design selection and qualification.
• Perform process capability assessments, FMEA, and root cause analyses for glass component-related quality events.
• Represent Lilly TSMS in technical interactions and partnerships with glass packaging material suppliers; drive continuous improvement activities.
• Lead or support supplier audits, providing deep technical input on glass manufacturing processes, control strategies, and quality systems.
• Maintain a comprehensive understanding of glass supplier manufacturing processes, failure modes, and capability limits; translate this knowledge into Lilly control strategies.

• Author major papers, presentations, and regulatory submission modules (CTD sections) related to primary packaging and CCS with minimal guidance.
• Represent Lilly during regulatory inspections and engage with regulatory agencies on topics related to glass packaging and CCS integrity.
• Maintain and apply current knowledge of ICH, USP, Ph. Eur., and FDA guidance related to container closure systems, extractables/leachables, and particulate matter.
• Write and review global standards and strategies for glass primary packaging components; influence industry working groups including Bio Phorum Fill…