Senior Director Glass Science

Key Responsibilities

• 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.

Container Closure Systems & Supplier Management

• Advises 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.

Regulatory, Compliance & Standards

• 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 BioPhorum Fill Finish.
• Ensure science and compliance are appropriately balanced in all technical recommendations; serve as a true partner with Regulatory, Quality, and HSE functions.

Network Leadership & Knowledge Transfer

• Drive sustained network-level results, influencing global network leaders, functional leaders, and site heads across multiple manufacturing sites.
• Collaborate across disciplines — Drug Product Technical Sciences, Device, Quality, and R&D — to advance complex, multi-stakeholder technical programs to resolution.
• Mentor and coach scientists across the manufacturing network; build organizational capability in glass science and parenteral packaging.
• Leverage industry trends and external expertise (trade associations, scientific consortia, peer-reviewed literature) to improve Lilly strategies and positions.
• Challenge others, including management, when conclusions are not supported by data; demonstrate scientific courage in technical forums.
• Establish and maintain effective working relationships with Research & Development on new product and platform development efforts involving glass container closure systems.