Senior Director - Polymer Science

Job SummaryThis 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, plastic containers, film bags, 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 across the global manufacturing network; provide expert guidance on polymer formulation, surface treatment technologies, and the physicochemical interactions between polymers and parenteral drug products; apply first-principles understanding of polymer processing and its impact on material properties; advise on complex deviations and out-of-specification investigations involving polymer components at Lilly manufacturing sites worldwide. Extractables, Leachables & Polymer-Drug Product Compatibility Lead and oversee extractables and leachables (E&L) programs for polymer primary packaging components in accordance with BioPhorum, ICH Q3E, USP , , and relevant risk-based frameworks; assess polymer–drug product compatibility for parenteral formulations; evaluate the toxicological risk profile of identified leachables in collaboration with Safety Assessment and Regulatory; establish Lilly's scientific position on polymer E&L qualification strategies; provide technical guidance on container closure integrity testing (CCIT) strategies. Container Closure Systems & Supplier Management Lead qualification programs for new polymer components and container closure systems; integrate parenteral processing requirements into polymer CCS design selection and qualification; perform process capability assessments, FMEA, and root cause analyses for polymer component-related quality events; represent Lilly in technical interactions and partnerships with polymer packaging material suppliers; lead or support supplier audits; maintain a comprehensive understanding of polymer supplier manufacturing processes and incorporate this knowledge into Lilly control strategies and supplier agreements. Regulatory, Compliance & Standards Author major papers, presentations, and regulatory submission modules related to polymer primary packaging, E&L, and CCS with minimal guidance; represent Lilly during regulatory inspections and engage with regulatory agencies on polymer packaging topics; write and review global standards and strategies for polymer primary packaging components; influence industry working groups including BioPhorum Fill Finish. Network Leadership & Knowledge Transfer Drive sustained network-level results, influencing global network leaders, functional leaders, and site heads across multiple manufacturing sites; collaborate across disciplines to advance complex, multi-stakeholder technical programs; mentor and coach scientists across the manufacturing network; leverage industry trends and external expertise to improve Lilly strategies and positions on polymer materials; establish and maintain effective working relationships with Pharmaceutical R&D on new product and platform development involving polymer CCS. Required Qualifications Advanced degree (PhD preferred) in Materials Science, Polymer Science, Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related field; minimum 10 years of experience in pharmaceutical or biotechnology manufacturing with substantial focus on polymer primary packaging, container closure systems, or extractables and leachables; willingness to travel internationally to Lilly manufacturing sites and supplier facilities (up to approximately 25%). Preferred Qualifications Experience at multiple pharmaceutical manufacturing sites, ideally with both US and European regulatory environments; active participation in industry consortia (BioPhorum Fill Finish, PDA, USP Expert Committee on Packaging); external publications or presentations in pharmaceutical polymer science, extractables/leachables, container closure integrity, or particulate contamination from polymer components; experience with drug-device combination products involving polymer CCS interfaces; familiarity with biologic drug product formulations and their sensitivity to polymer-derived leachables; knowledge of process contact materials in aseptic filling and their E&L implications; black belt or equivalent Six Sigma / structured problem-solving certification; experience in a global or network role; excellent problem-solving capability; exceptional written and verbal communication skills in English. Benefits and Compensation Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $264,000. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. #J-18808-Ljbffr 100 Eli Lilly and Company