Director Jobs

About The Position

Requirements

• 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%).
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)