07 ago - Italia
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Overview In this role you act as the enterprise expert for polymer primary packaging in parenteral products, guiding material science across Lilly's global network. You will shape strategies on polymer formulation, surface treatments and processing to ensure container closure integrity and product safety. You lead E&L; and CCS programs, influence regulatory submissions, and engage cross‐functionally to manage deviations and supplier performance. This is a high‐impact position that drives science‐driven decisions for life‐changing medicines. You will collaborate with R&D;, Quality, Regulatory, and Manufacturing to advance polymer packaging science at scale.
Key Responsibilities Serve as the global technical authority on polymer primary packaging components across the manufacturing network.
Provide expert guidance on polymer formulation, surface treatments and polymer‐drug interactions.
Apply first‐principles polymer processing understanding to assess material properties and extractables.
Lead deviations investigations related to polymer components at Lilly sites.
Leverage advanced analytical techniques (ToF‐SIMS, XPS, GC‐MS, LC‐MS/MS, FTIR, NMR, TGA, DSC, SEM‐EDX) for surface characterization and E&L; data.
Challenge supplier experts to ensure material quality and performance.
Lead and oversee E&L; programs in line with BioPhorum, ICH Q3E, USP, and risk‐based frameworks.
Assess polymer‐drug product compatibility with focus on adsorption and degradation.
Establish Lilly's scientific stance on E&L; qualification and CCS testing strategies.
Lead qualification programs for new polymer components and CCS design.
Integrate parenteral processing requirements into CCS design and qualification.
Perform risk analyses (FMEA, RCA) for polymer‐related quality events.
Represent Lilly in supplier interactions and audits with deep technical input.
Maintain an understanding of supplier manufacturing processes and translate to control strategies.
Author and review regulatory submissions an
08 ago - Italia
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08 ago - Italia
WAICO
08 ago - Italia
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08 ago - Italia
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