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 BioPhorum, ICH Q3E, USP <1663>, <1664>, 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 partnerships with polymer packaging material suppliers; drive continuous improvement activities and material change management.
• Lead or support supplier audits, providing deep technical input on polymer manufacturing processes, compounding formulas, control strategies, and quality systems.
• Maintain a comprehensive understanding of polymer supplier manufacturing processes, failure modes, and capability limits; translate this knowledge into Lilly control strategies and supplier agreements.

Regulatory, Compliance & Standards

• Author major papers, presentations, and regulatory submission modules (CTD sections) related to polymer primary packaging, E&L, and CCS with minimal guidance.
• Represent Lilly during regulatory inspections and engage with regulatory agencies on topics related to polymer packaging, container closure integrity, and E&L risk assessments.
• Maintain and apply current knowledge of ICH, USP, Ph. Eur., and FDA guidance relevant to polymer materials, including USP <661>, <381>, <382>, <1663>, <1664>, Ph. Eur. 3.2.2, 3.2.9, and ISO 11607.
• Write and review global standards and strategies for polymer primary packaging components; influence industry working groups including BioPhorum Fill Finish.
• Ensure science and compliance are appropriately balanced in all technical recommendations; serve as a true partner with Regulatory, Quality, and HSE functions.

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 — Drug Product Technical Sciences, Device, Quality, and Pharmaceutical R&D — to advance complex, multi-stakeholder technical programs related to polymer CCS to resolution.
• Mentor and coach scientists across the manufacturing network; build organisational capability in polymer materials science and parenteral packaging.
• Leverage industry trends and external expertise (trade associations, scientific consortia, peer-reviewed literature) to improve Lilly strategies and positions on polymer materials.
• Challenge others, including management, when conclusions are not supported by data; demonstrate scientific courage in technical forums.
• Establish and maintain effective working relationships with Pharmaceutical R&D on new product and platform development efforts involving polymer CCS, prefilled syringes, and drug-device combination products.

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) as a company representative or contributor.
• 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 (autoinjectors, wearable injectors, pen systems) involving polymer CCS interfaces.
• Familiarity with biologic drug product formulations (mAbs, ADCs, peptides) and their specific sensitivity to polymer-derived leachables, silicone oil, and surface adsorption phenomena.
• Knowledge of process contact materials in aseptic filling (PTFE/FEP tubing, single-use systems, platinum-cured silicone, gaskets) and their E&L implications.
• Black belt or equivalent Six Sigma / structured problem-solving certification.
• Experience in a global or network role, working across multiple manufacturing sites and time zones.
• Excellent problem-solving capability; proficient with root cause analysis tools (RCA, FMEA, fishbone), statistical analysis, and design of experiments (DoE).
• Exceptional written and verbal communication skills in English, with proven ability to engage diverse audiences from manufacturing operators to executive leadership and regulatory authorities.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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). In addition, 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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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