Senior Director - Polymer Science

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
** Job Summary
** This is an opportunity for an industry-recognized pharmaceutical polymer materials subject matter expert (SME) to serve as the technical authority on polymer-based primary packaging components for Lilly's parenteral drug products - including elastomeric closures (stoppers, plungers, tip caps), plastic containers (COP/COC vials, prefillable syringes), film bags, plastic caps, and polymer-based process contact materials used in aseptic filling processes. The Senior Director - Polymer Science Materials Expert will advise on complex deviations, challenge polymer component supplier experts, and influence 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 polymer container closure system science, polymer-drug product compatibility, extractables/leachables (E&L), and container closure integrity.

** Key Responsibilities*
* ** Polymer Materials Science & Technical Authority** + Serve as the enterprise-level technical authority on pharmaceutical polymer primary packaging components (elastomeric closures, COP/COC containers, prefillable plastic syringes, film bags, PTFE/FEP process tubing) across the global manufacturing network. + Provide expert technical guidance on polymer formulation (compounding, vulcanization, cross-linking), surface treatment technologies (siliconization, fluorination, barrier coatings), and the physicochemical interactions between polymers and parenteral drug products.

+ Apply first-principles understanding of polymer processing (injection molding, compression molding, extrusion) and its impact on material properties, dimensional consistency, and extractable profiles. + Advise on complex deviations and out-of-specification investigations involving polymer components at Lilly manufacturing sites globally, including particulate contamination, closure integrity failures, visible foreign matter, and functionality issues. + Leverage advanced analytical techniques (ToF-SIMS, XPS, GC-MS, LC-MS/MS, FTIR, NMR, TGA, DSC, SEM-EDX) to characterize polymer surfaces, identify extractable/leachable compounds, and interpret data from contract analytical laboratories.

+ Challenge and technically engage polymer component supplier experts with scientific rigor; drive supplier accountability for material quality and performance.
** Extractables, Leachables & Polymer-Drug Product Compatibility** + Lead and oversee extractables and leachables (E&L) programs for polymer primary packaging components in accordance with Bio Phorum, ICH Q3E, USP , , and relevant risk-based frameworks. + Assess polymer-drug product compatibility for parenteral formulations, including biologics (mAbs, ADCs, peptides) and small molecules, with particular attention to adsorption, absorption, and chemical degradation driven by polymer interactions.

+ Evaluate the toxicological risk profile of identified leachables in collaboration with Safety Assessment and Regulatory; provide scientifically defensible safety thresholds. + Establish and maintain Lilly's scientific position on polymer E&L qualification strategies; author and review internal standards and regulatory submission modules with minimal guidance. + Provide technical guidance on container closure integrity testing (CCIT) strategies for polymer-based CCS, including probabilistic leak detection and package integrity qualification.

** Container Closure Systems & Supplier Management** + Lead qualification programs for new polymer components and container closure systems (CCS), including design, specification development, and generation of qualification plans and reports. + Integrate parenteral processing requirements (filling, stoppering, lyophilization, terminal sterilization, EtO/gamma/e-beam/X-ray sterilization) into polymer CCS design selection and qualification. + Perform process capability assessments, FMEA, and root cause analyses for polymer component-related quality events, including visible particulates, subvisible particles, and functional defects.

+ Represent Lilly in technical interactions and…