Senior Director Glass Science

Experteer Overview

In this role you will act as the enterprise technical authority on pharmaceutical glass for parenteral products, shaping glass science strategy across Lilly’s global manufacturing network. You will lead investigations into glass-related deviations, collaborate with suppliers, and influence regulatory and industry standards. You’ll work cross-functionally to ensure container closure integrity and glass-drug compatibility at scale, driving continuous improvement and scientific excellence.

This position offers a unique opportunity to impact patient outcomes by advancing glass packaging technologies and standards.

Retribuzione / Benefits

• Serve as the global technical authority on borosilicate glass (Type I vials, cartridges, syringes) for parenteral products
• Provide expert guidance on glass composition, surface chemistry, delamination, and glass-drug interactions
• Apply first-principles knowledge of glass drawing, converting, coatings, and leaching to troubleshoot manufacturing issues
• Lead complex deviations/investigations involving glass packaging across Lilly sites
• Utilize advanced analytical techniques (ToF-SIMS, XPS, SEM-EDX, FTIR, ICP-MS) to characterize glass surfaces and interpret data
• Engage and challenge glass supplier experts to drive material quality and performance
• Advise on new glass components and CCS design, qualification plans, and reports
• Incorporate parenteral processing requirements into CCS design and qualification
• Perform process capability assessments, FMEA, and root cause analyses for glass-related events
• Represent Lilly in technical interactions with suppliers and drive continuous improvement
• Lead or contribute to supplier audits with deep technical input on glass manufacturing and quality systems
• Translate glass knowledge into Lilly control strategies across the network
• Auth/submit regulatory modules and papers on primary packaging and CCS with minimal guidance
• Engage with regulators on glass packaging topics and inspections
• Maintain knowledge of ICH, USP, Ph. Eur., FDA guidance for container closure and E&L
• Develop global standards for glass components and influence industry groups (BioPhorum Fill Finish)
• Balance science and compliance in technical recommendations with Regulatory, Quality, and HSE partners
• Foster network-level collaboration and knowledge transfer across manufacturing sites and disciplines
• Mentor scientists to build glass science capabilities across the network
• Leverage industry trends and external expertise to improve Lilly strategies

Responsabilità

• Advanced degree (PhD preferred) in a related field
• Minimum 10 years in pharmaceutical/biotech manufacturing with substantial focus on glass packaging or container closure systems
• Willingness to travel internationally up to 25%
• Experience at multiple manufacturing sites and with US/European regulatory environments (preferred)
• Active participation in industry consortia or equivalent (preferred)
• Strong publication/presentation track in glass science or related areas (preferred)
• Knowledge of borosilicate glass chemistry, surface treatments, and delamination mechanisms
• Experience with CCIT, E&L, and particulate matter considerations for parenteral products
• Proficiency in advanced analytical characterization techniques and data interpretationRegulatory inspection experience and ability to author CTD modules related to primary packaging
• GMP/compliance mindset with familiarity with ICH, USP, Ph. Eur., FDA guidance
• Strong problem-solving, RCA/FMEA/DoE skills
• Excellent communication and cross-functional leadership abilities
• Collaborative leadership across Quality, Regulatory, R&D, and Engineering

Requisiti fondamentali

• bonus program
• 401(k) retirement plan
• pension
• medical/dental/vision coverage
• flexible benefits (FSAs)
• life insurance and disability benefits