Senior Director Glass Science

Lilly • Sesto Fiorentino, Indiana

7d • $151,500 - $264,000 • Hybrid

About The Position

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.

Requirements

• Advanced degree (PhD preferred) in Materials Science, Chemical Engineering, Glass Science, Pharmaceutical Sciences, Chemistry, Biomedical Engineering, or a related field.
• Minimum 10 years of experience in pharmaceutical or biotechnology manufacturing with substantial focus on glass primary packaging, parenteral drug products, or container closure systems.
• Preferred: Experience at multiple pharmaceutical manufacturing sites, ideally with both US and European regulatory environments.
• Willingness to travel internationally to Lilly manufacturing sites and supplier facilities (up to approximately 25%).
• Recognised industry expert in pharmaceutical glass science with a demonstrated track record of resolving complex deviations and influencing glass suppliers at a technical level.
• Deep knowledge of borosilicate glass chemistry, glass tube drawing/converting processes, surface treatment technologies (silicone coating, ammonium sulfate treatment), and delamination mechanisms.
• Expertise in container closure system integrity (CCIT), extractables and leachables (E&L), and glass-drug product compatibility for parenteral applications.
• Proficient in advanced analytical characterisation techniques applied to glass surfaces (ToF-SIMS, XPS, SEM-EDX, FTIR, ICP-MS) and able to critically interpret third-party analytical reports.
• Experience representing a pharmaceutical company at regulatory inspections and authoring CTD modules related to primary packaging and CCS.
• Strong GMP compliance background and understanding of regulatory expectations (ICH Q8/Q9/Q10/Q11, USP <1>, <660>, <661>, Ph. Eur. 3.2.1).
• Excellent problem-solving capability; proficient with root cause analysis tools (RCA, FMEA, fishbone), statistical analysis, and design of experiments (DoE).
• Exceptional written and verbal communication skills in English, with proven ability to engage diverse audiences from manufacturing operators to executive leadership and regulatory authorities.
• Demonstrated collaborative leadership across functions — Quality, Regulatory, Research & Development, Engineering — and across manufacturing sites.

Nice To Haves

• Active participation in industry consortia (BioPhorum Fill Finish, ASTM, PDA, USP Expert Committee) as a company representative or contributor.
• External publications or presentations in pharmaceutical glass science, container closure integrity, or particulate matter in injectable products.
• Experience with glass fractography, failure analysis of glass components, or mechanistic investigation of glass particulate formation.
• Knowledge of prefilled syringe systems (PFS) and combination products, including needle-based delivery systems.
• Familiarity with biologic drug product formulations (mAbs, ADCs, peptides) and their specific sensitivity to glass container interactions.
• Black belt or equivalent Six Sigma / structured problem-solving certification.
• Experience in a global or network role, working across multiple manufacturing sites and time zones.

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.
• 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 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.
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree