02 ago
|
Experteer Italy
|
Trentino-Alto Adige
02 ago
Experteer Italy
Trentino-Alto Adige
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
premio program
401(k) retirement plan
pension
medical/dental/vision coverage
flexible benefits (FSAs)
life insurance and disability benefits
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📌 Senior Director Glass Science (Trentino-Alto Adige)
🏢 Experteer Italy
📍 Trentino-Alto Adige