Organization Overview:
Delivery, Devices, and Connected Solutions (DDCS) sits within Lilly's Product Research & Development organization. We're a team of scientists and engineers who discover, design, and develop patient-centered drug delivery solutions across many modalities - from injection devices to new routes of administration and nanomedicines. DDCS drives drug delivery innovation across early and late development for a growing portfolio of small molecules, biologics, and nucleic acid therapeutics.
DDCS uses a matrix model, with strong functional teams supporting innovation and commercialization work. Our vision is to get medicines to more people, faster, guided by three pillars: Delivery Systems, Robust & Sustainable, and Patient Experience + Outcomes.
Position Overview:The Measurement Science & Advanced Characterization team is a Center of Excellence within DDCS. The team generates the experimental data that validates computational models, informs device and container closure system design, supports regulatory submissions, and solves technical problems across the portfolio. This team is the experimental engine behind data-driven decisions in DDCS.
The Group Leader, Measurement Science & Advanced Characterization sets the vision and builds the roadmap for measurement science capability across DDCS. This leader grows and runs a Center of Excellence that generates the experimental foundation for understanding how medicines, devices, and the body work together - from injection physiology and drug delivery mechanics to the performance of delivery devices as complete systems.
This role expands the team's technical reach into new areas, including molecular device characterization and nanoparticle analytics, and champions tight collaboration between measurement science, modeling, and AI/data science. A core part of this role is transforming how the lab runs - using AI and automation to move the team into its next era of operation - while keeping full compliance with data integrity requirements (FDA 21 CFR Part 11, GxP, ALCOA+).
Key Responsibilities:
Vision, Strategy, & Team Leadership- Set the vision and strategy for the DDCS Measurement Science team, and build and lead the roadmap to get there.
- Build, grow, and lead a high-performing team of diverse analytical scientists, imaging specialists, materials characterization experts, and container closure, device, and combination product test method scientists.
- Own the team's budget, headcount planning, and capital equipment strategy in line with DDCS portfolio priorities and business plan development.
- Build a culture of scientific excellence, curiosity, growth mindset, and collaborative problem-solving; coach and develop team members' careers.
- Set and maintain a high quality standards and ensure data integrity, safety, and other compliance requirements. Maintain rigorous data integrity (ALCOA+) and HSE compliance, and keep the lab inspection-ready at all times.
- Represent measurement science in DDCS business strategy, leadership forums and portfolio governance.
Foundational Science & New Capability Development - Establish new capabilities to characterize and understand the foundational physical and chemical processes behind injection physiology, drug delivery, and delivery devices as one continues system. Ensure the measurements are meaningful, accurate, and well grounded in patient safety and product efficacy.
- Expand team scope into molecular device characterization and nanoparticle analytics, identifying and building capability and/or establishing external collaboration and sourcing strategy to enable internal scientific development.
- Scan the field for emerging measurement techniques and analytical innovation relevant to new modalities, drug delivery science, container closure systems, devices, and combination products; run pilot studies to test and adopt promising new approaches.
- Guide investment decisions on new instrumentation and techniques based on portfolio need and scientific return.
Cross-Functional Integration: DDCS capability (Modeling & AI/Data Science) and functional teams - Champion close collaboration between measurement science, computational modeling (e.g. FEA, CFD, SciML), and AI/data science teams. Use data to enable and verify physics/data driven model performances.
- Direct experimental study design that feeds model development and validation - examples include material inputs, injection simulation data, CFD validation, and dimensional data for CAD verification.
- Enable model-informed drug/medicine development (MIDD) by pairing computational predictions with targeted experimental testing, building toward regulatory-grade models suitable for health authority submissions.
- Fully integrate measurement sciences into DDCS and PRD. Enable data driven decision making across DDCS - ranging from formulation and device design, container closure selection, novel drug delivery technologies, to combination product development and commercialization projects.
- Act as the escalation point for complex technical troubleshooting across drug delivery, device and container closure system, and combination product development programs.
- Direct advanced characterization work (imaging, surface characterization, CCIT, nanoparticle and materials characterization) to find failure mechanisms and degradation pathways.
- Lead root cause investigations into device failures, CCS integrity issues, and material problems, and provide rapid-response support when clinical or commercial timelines are at risk.
Method Development & Regulatory Support - Oversee development, validation, and lifecycle management of analytical methods for containers, closures, devices, and combination products, in line with ICH, 21 CFR Part 11, and GxP requirements. Deliver validation methods to enable the control strategy of drug/combination products.
- Accountable for tech transfer to commercial manufacturing sites to enable product and process validation and product launch.
- Build method libraries and knowledge repositories so the team's learning compounds over time.
- Direct authoring of technical sections for regulatory submissions related to test methods, characterization studies, and device testing.
Lab Transformation: AI & Automation - Lead the transformation of lab operations into a new era, using AI and automation to change how the team works - not just to improve existing steps - to drive speed and productivity gains. Identify, co-develop, and deploy AI and automation solutions into all lab operations.
- Direct laboratory automation and digitalization efforts: robotic testing, automated data capture and processing, workflow management systems, and real-time equipment monitoring.
- Direct the use of AI/ML across image analysis, anomaly detection, data visualization, and workflow design. Build centralized data repositories with shared data structures and analytics platforms across the team.
Basic Qualifications - Earned Master's degree in measurement science, metrology, analytical sciences, materials science, or a related technical field, with a minimum of 15+ years of progressive experience in pharmaceutical, biotechnology, or medical device development, including 5+ years directly leading or managing a scientific team
- Experience with CMC development, drug delivery, RoA physiology, and/or molecular device (e.g. nanoparticle, cell encapsulation) characterization techniques.
- Experience in analytical control strategy development in collaboration with clinical/PD/PK and/or tox studies
- Working knowledge in drug product formulation, container closure and delivery devices, and/or combination produce development and submissions.
Preferred Qualifications: - Earned PhD in related field above and 12+ years of progressive experience in pharmaceutical, biotechnology, or medical device development, including 5+ years directly leading or managing a scientific team
- Track record setting technical vision and strategy for a scientific team, not just executing an existing plan.
- Hands-on expertise in advanced characterization: microscopy, X-ray CT, surface analysis, container closure integrity testing (CCIT), and device functional testing.
- Experience building pharmaceutical primary packaging or container closure system qualification programs.
- Track record building lab automation and AI/ML data workflows in a regulated environment.
- Experience authoring regulatory submission sections (IND, BLA, NDA) tied to analytical characterization.
- Working knowledge of FDA 21 CFR Part 11, GxP, ICH guidelines, and ALCOA+ data integrity principles.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$153,000 - $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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