Director - Measurement Systems Leader - Advanced Characterization & Metrology

Lilly • Indianapolis, IN

15h • Onsite

About The Position

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:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position 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.
The Measurement Systems Leader plays a pivotal technical leadership role in establishing and operating a state-of-the-art Center of Excellence for critical measurement capabilities supporting container closure systems (CCS) and device development across DDCS. This leader is responsible for developing and executing a strategic capability build-up roadmap aligned with DDCS portfolio priorities, serving both the innovation and commercialization verticals. A key differentiator for this role is championing digital transformation and laboratory automation, 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
• 15+ years of progressive experience in pharmaceutical/biotechnology or medical device development
• 3+ years of team leadership experience
• Demonstrated expertise in advanced characterization techniques such as microscopy, X-ray CT, surface analysis, container closure integrity testing (CCIT), and device functionality evaluation.
• Track record of building laboratory automation and/or AI/Machine Learning-based data workflows in a regulated environment.
• Computational-experimental collaboration mindset; translating data to model validation
• Digital transformation and laboratory automation leadership

Nice To Haves

• Data-driven decision making and clear communication of complex technical results
• Master's degree in relevant technical discipline with 13+ years of experience as listed above, OR PhD in relevant discipline with 10+ years of experience as listed above
• Experience with pharmaceutical primary packaging and container closure systems qualification.
• 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.
• Scientific depth and breadth in advanced analytical and characterization techniques
• Technical leadership and people development across multidisciplinary laboratory teams
• Regulatory and compliance acumen in GxP/GMP environments

Responsibilities

• Strategic Capability Development & Center of Excellence Leadership
• Develop and execute a comprehensive strategic roadmap for measurement sciences capabilities aligned with DDCS innovation priorities and portfolio needs.
• Establish the Measurement Sciences team as the recognized Center of Excellence for critical characterization capabilities across DDCS and PRD.
• Conduct technology horizon scanning to identify emerging measurement techniques and analytical innovations relevant to CCS, devices, and combination products.
• Partner with DDCS leadership to prioritize capability investments based on portfolio value, technical risk mitigation, and strategic differentiation.
• Evaluate new technologies through pilot studies and feasibility assessments; drive adoption of novel characterization approaches.
• Team Leadership & Organizational Development
• Build, lead, and mentor a high-performing team of analytical scientists, imaging specialists, materials characterization experts, and combination product test method scientists.
• Establish clear roles, responsibilities, and career development pathways for team members with diverse technical specializations.
• Foster a culture of scientific excellence, innovation, continuous learning, and collaborative problem-solving.
• Develop KPIs to measure team effectiveness, utilization, turnaround time, and scientific impact.
• 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 & Laboratory Automation
• Champion 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.
• Data Integrity, Compliance & Inspection Readiness
• Ensure rigorous data integrity practices aligned with ALCOA+ principles.
• Develop data governance framework; implement robust data systems and controls.
• Maintain HSE compliance and inspection readiness in all laboratory environments.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Director