Measurement Science – Advanced Characterization & Metrology

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview: Delivery, Devices, and Connected Solutions (DDCS) sits within Eli Lilly's Product Research & Development organization. We are a diverse team of scientists and engineers responsible for discovering, designing, and developing patient-centric drug delivery solutions across a broad range of modalities — from injection devices to novel routes of administration and nanomedicines. DDCS drives the drug delivery innovation agenda across early and late development to meet the needs of an expanding portfolio that spans small molecules, biologics, and nucleic acid therapeutics. DDCS is organized around a matrix model with strong disciplinary and functional horizontals supporting innovation and commercialization verticals. Our vision is to get our medicines to more patients faster by accelerating reach and scale, guided by three strategic pillars: Delivery Systems, Robust & Sustainable, and Patient Experience + Outcomes. The Measurement Sciences & Advanced Characterization team functions as a Center of Excellence within the DDCS horizontal structure, providing critical experimental data that validates computational models, informs device and container closure system design, supports regulatory submissions, and drives technical troubleshooting across innovation and commercialization verticals. This team is the experimental engine that enables data-driven development decisions across the DDCS matrix. Position Overview: The Measurement Systems Leader plays a pivotal technical leadership role in a state-of-the-art Center of Excellence for enabling critical measurement capabilities supporting container closure systems (CCS) and device development across DDCS. This leader is responsible for building key characterization capabilities and driving its integration with modeling and data science functions to guide and enable DDCS portfolio priorities, serving both the innovation and commercialization verticals. A key differentiator for this role is championing experimental data-model integration, implementing AI/ML solutions to improve operational efficiency, while ensuring full compliance with data integrity requirements (FDA 21 CFR Part 11, GxP, ALCOA+ principles). Key Responsibilities: Strategic Testing Capability Development & Cross Functional Integration Develop and build measurement sciences capabilities aligned with DDCS innovation priorities and portfolio needs. Conduct technology horizon scanning to identify emerging measurement techniques and analytical innovations relevant to CCS, devices, and combination products. Evaluate new technologies through pilot studies and feasibility assessments; drive adoption of novel characterization approaches. Drive seamless integration among measurement science, modeling, and data science to enable scientific insights, model validation for regulatory submissions, and improving prediction and decision-making.  Build, lead, and mentor a high-performing team of analytical scientists, imaging specialists, materials characterization experts, and combination product test method scientists. Foster a culture of scientific excellence, innovation, continuous learning, and collaborative problem-solving. Computational Model Enablement Partner closely with the DDCS computational simulation team (FEA, CFD, SciML) to provide high-quality experimental data for model development and validation. Design and execute experimental studies specifically to inform computational models: FEA material inputs, injection simulation data, CFD validation, dimensional data for CAD verification. Validate computational predictions through targeted experimental testing; enable development of regulatory-grade models suitable for health authority submissions. Collaborate on design space exploration using integrated computational-experimental approaches; support model-informed drug development (MIDD) initiatives. Device & CCS Design Support, Troubleshooting & Problem Solving Serve as technical expert for complex troubleshooting across device and CCS development programs; generate data that enables data-driven design decision making. Apply advanced characterization techniques (imaging, surface characterization, CCIT, material characterization) to identify failure mechanisms and degradation pathways. Lead root cause investigations into device failures, CCS integrity issues, and material-related problems; design experimental studies to isolate contributing factors. Provide rapid-response support for critical technical issues impacting clinical or commercial timelines. Method Development, Validation & Transfer Develop and validate fit-for-purpose analytical methods for characterization of containers, closures, devices, and combination products. Manage method lifecycle to ensure validation level commensurate with development phases; ensure ICH, 21 CFR Part 11, GxP compliance. Establish method libraries and knowledge repositories for organizational learning. Author technical sections for regulatory submissions related to test methods, characterization studies, and device testing. Digital Transformation & Data Integrity, Compliance  Support laboratory automation and digitalization initiatives: robotic testing automation, automated data acquisition/processing, workflow management systems, real-time equipment monitoring. Implement AI/ML solutions across image analysis, anomaly detection, data visualization, and workflow improvement. Drive data integration and analytics; establish centralized data repositories with harmonized data structures and analytics platforms. Ensure rigorous data integrity practices aligned with ALCOA+ principles; implement robust data systems and controls. Maintain HSE compliance and inspection readiness in all laboratory environments.   Basic Qualifications: Bachelor's degree in measurement science, metrology, analytical sciences, materials science, or related technical discipline, and 10+ years of progressive experience in pharmaceutical/biotechnology or medical device development 3+ years of team leadership experience   Additional Preferences: Master's degree in a related field and 8+ years of experience as listed above, OR PhD in a related field and 5+ years of experience as listed above Demonstrated expertise in advanced characterization techniques: microscopy, X-ray CT, surface analysis, container closure integrity testing (CCIT), and device functionality evaluation. Experience with pharmaceutical primary packaging and container closure systems qualification. Track record of building laboratory automation and AI/ML-based data workflows in a regulated environment. Experience authoring regulatory submissions (IND, BLA, NDA) sections related to analytical characterization. Familiarity with FDA 21 CFR Part 11, GxP, ICH guidelines, and ALCOA+ data integrity principles. 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is $126,000 - $204,600 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. #WeAreLilly