Group Leader, Packaging & Distribution Development
Lilly · United States, Indianapolis IN
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
The Delivery, Device, and Connected Solutions (DDCS) organization at Eli Lilly designs, develops, and commercializes drug delivery systems, devices, and packaging that bring medicines to patients around the world. DDCS enables nearly $4 billion in pharmaceutical sales and continues to grow.
Position Overview:
This role leads our Secondary Packaging and Product Distribution team, which owns packaging, shipping qualification, and cold-chain distribution solutions that protect Lilly's clinical and commercial portfolio from development through patient delivery — including drug product and drug-device combination products.
We're looking for an experienced packaging and distribution leader with strong combination product development expertise to build and grow a high-performing team responsible for secondary packaging design (cartons, trays, labels, printed components) and product distribution systems (cold-chain and ambient shipping qualification). This role integrates packaging and shipping deliverables directly into drug and combination product design control, giving this leader the technical depth to represent packaging within the broader device-drug development lifecycle. It's a strategic leadership role with the influence to shape patient-centered packaging design, drive cross-functional alignment with Device Development, CMC, Quality, and Regulatory, and elevate the technical capability of the team.
Key Responsibilities:
Team Leadership & Talent Development
- Lead, coach, and grow a team of packaging and distribution engineers, building deep technical bench strength and clear career paths. Set team strategy and priorities that align with Lilly PR&D and enterprise portfolio goals.
- Foster a culture of technical excellence, continuous improvement, and patient-centered thinking.
- Manage workload, capacity planning, and succession planning across the team.
- Represent DDCS packaging and distribution capabilities in cross-functional governance and portfolio planning forums.
- Coach team members on combination product design control principles, building the team's fluency in device-drug integration alongside core packaging engineering skills.
Technical Strategy — Packaging & Distribution Innovation
- Set the long-term strategy for secondary packaging and product distribution platforms, including cold-chain and ambient shipping solutions. Ensure "full-process" integration of shipping and secondary packaging deliverables to inform and derisk product design, process development, and verification and validation for Lilly's clinical portfolio (both drug product and drug-device combination products).
- Champion new technologies and design innovations that improve product protection, sustainability, and the patient experience. Design and develop innovative, technically sound packaging solutions for new devices (including sterile device components), container platforms, and new drug modalities.
- Develop and implement AI and automation technologies to scale the team's work and gain efficiency across packaging design, documentation, testing, and distribution qualification workflows.
- Define and verify product stability requirements against shipping hazards such as vibration, shock, vacuum, and thermal stress. Develop robust secondary packaging solutions (including cold chain packaging) and distribution processes.
- Guide the development and qualification of shipping containers, packing processes, and cold-chain solutions for clinical and commercial distribution.
- Guide root cause analysis and corrective action for packaging- and distribution-related investigations and excursions.
Combination Product Packaging Design Control & Submission Readiness
- Integrate packaging and distribution deliverables into combination product design control, in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
- Direct molecule-specific risk assessments for packaging and shipping systems per ISO 14971, incorporating drug product safety profiles, device failure modes, and patient use scenarios.
- Ensure secondary packaging and distribution content is complete and audit-ready within Design History Files (DHF) and Device Master Records (DMR), including design inputs, design outputs, verification protocols, and traceability matrices.
- Develop integrated control strategies that connect packaging and shipping specifications with device and drug product specifications and combination product performance attributes.
- Direct the generation of data packages and evidence demonstrating product stability under shipping and distribution conditions, and author or oversee platform rationale and technical submission content (IND, NDA, BLA, MAA) supporting global regulatory filings.
- Monitor the regulatory landscape for combination product packaging and distribution requirements; partner with Regulatory Affairs on strategy and submission planning across regions (FDA, EMA, PMDA, NMPA).
- Design and coordinate combination product stability studies aligned with ICH guidelines, analyzing data to inform shelf-life, storage conditions, and fit-for-use rationale.
- Ensure robust documentation supporting technology transfer, knowledge transfer, and regulatory submissions.
Laboratory Leadership, Compliance & Right to Operate
- Maintain the team's work in a state of regulatory inspection readiness. Ensure work products meet applicable standards (USP, EP, JP, CFR, ASTM, ISTA, GDP) as well as combination product design control requirements (21 CFR Part 820, ISO 13485, ISO 14971).
- Ensure timely review and approval of methods, protocols, procedures, and change controls.
- Partner with Quality to define and uphold packaging and distribution control strategies, and to maintain audit and inspection readiness.
- Champion safe work practices across the team and with suppliers.
- Oversee shipping simulation laboratory operations to ensure a safe working environment, data integrity (ALCOA+) in test execution and records, and well-maintained equipment and capacity that enable the clinical portfolio's testing needs.
Cross-Functional Influence and Collaboration
- Build strong partnerships with Device and Drug-Device Combination Product Development, CMC functions, Clinical Development, Regulatory Affairs, Quality, Manufacturing, and Commercial teams.
- Align with Regulatory Affairs on packaging and shipping content for global submissions and post-approval changes, balancing scientific rigor, quality, and development speed.
- Work closely with Manufacturing and Technical Services/Manufacturing Sciences to ensure smooth technology transfer.
- Serve as a trusted advisor to Device Development, Business Unit, and Human Factors teams on patient-centered packaging requirements.
- Maintain close collaboration with New Product Planning, Clinical Trial Manufacturing/Packaging/Distribution, Global Packaging, manufacturing sites, and commercial distribution centers.
- Explore and implement AI/ML applications, digital tools, and data analytics to improve packaging and combination product development processes.
External Oversight and Scientific Presence
- Engage in corporate procurement strategy and supplier/CMO due diligence for packaging and distribution partners.
- Maintain presence in external scientific and industry consortium forums to establish Lilly's leade