Measurement Science – Advanced Characterization & Metrology

Eli Lilly and Company • Indianapolis, IN

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About The Position

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).

Requirements

• 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

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees