Group Leader, Packaging & Distribution Development

Lilly • Indianapolis, IN

7d • $130,500 - $211,200 • Onsite

About The Position

The Group Leader, Packaging & Distribution Development leads Lilly’s Secondary Packaging and Product Distribution team within the Delivery, Device, and Connected Solutions organization. The team is responsible for secondary packaging, shipping qualification, and cold-chain and ambient distribution solutions that protect clinical and commercial products from development through delivery to patients, including drug products and drug-device combination products.

This strategic leadership role sets team priorities and long-term technical strategy, develops talent and team capabilities, and integrates packaging and distribution deliverables into drug and combination product design control. The leader drives patient-centered packaging design, technical innovation, regulatory readiness, and cross-functional alignment across Device Development, CMC, Quality, Regulatory, Manufacturing, Clinical Development, and Commercial teams. The position also oversees shipping simulation laboratory operations and supplier engagement, and explores AI, automation, and digital tools to improve development and qualification workflows.

The role is based at Lilly Technology Center – North in Indianapolis, Indiana, with 5–15% travel. The anticipated wage is $130,500–$211,200. Full-time equivalent employees are eligible for a company bonus, subject to applicable conditions, and a comprehensive benefits program that includes retirement, insurance, time-off, and well-being benefits.

Requirements

• Bachelor’s degree in packaging, materials, mechanical, chemical, or biomedical engineering, or a related scientific discipline, and 10+ years of relevant industry experience.
• At least 1 year of experience leading and developing technical teams.
• Direct experience with drug development, drug-device combination product development, and/or consumer product packaging and distribution design and development.
• Track record of effective partnership with Quality, Regulatory, Manufacturing, and/or Device Development stakeholders.
• Strong executive communication skills and ability to adapt to shifting priorities and timelines.

Nice To Haves

• Master’s degree in a related scientific discipline with 8+ years of experience, or PhD with 3+ years of experience.
• Experience authoring or reviewing Design History File content, integrated control strategies, or technical regulatory submission sections for combination products.
• Experience in secondary packaging design, including cartons, trays, labels, and printed components.
• Experience with product distribution systems, including cold-chain and ambient shipping qualification.
• Experience designing or coordinating combination product stability studies aligned with ICH guidelines.
• Working knowledge of ISTA and ASTM simulated distribution testing standards.
• Familiarity with serialization, child-resistance and senior-adult usability, compliance, tamper-evidence, and anti-counterfeiting requirements.
• Experience influencing global category or platform strategy across a matrixed organization.

Responsibilities

• Lead, coach, and develop packaging and distribution engineers; build technical capability, career paths, and succession plans.
• Set team strategy, priorities, workload, and capacity in alignment with Lilly PR&D and enterprise portfolio goals.
• Foster technical excellence, continuous improvement, and patient-centered thinking; coach the team on combination product design control and device-drug integration.
• Represent DDCS packaging and distribution capabilities in cross-functional governance and portfolio-planning forums.
• Set long-term strategy for secondary packaging and cold-chain and ambient distribution platforms, integrating deliverables into product design, process development, verification, and validation.
• Champion technologies and design innovations that improve product protection, sustainability, and patient experience; develop packaging for new devices, sterile device components, container platforms, and drug modalities.
• Develop and implement AI and automation technologies for packaging design, documentation, testing, and distribution qualification workflows.
• Define and verify product stability requirements against shipping hazards, and develop secondary packaging solutions and distribution processes.
• Guide 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.
• Integrate packaging and distribution deliverables into combination product design control in compliance with applicable FDA and ISO requirements.
• Direct molecule-specific packaging and shipping risk assessments, incorporating drug product safety profiles, device failure modes, and patient-use scenarios.
• Ensure secondary packaging and distribution documentation is complete and audit-ready in Design History Files and Device Master Records, including design inputs and outputs, verification protocols, and traceability matrices.
• Develop integrated control strategies connecting packaging and shipping specifications with device and drug product specifications and combination product performance attributes.
• Direct generation of shipping and distribution stability data packages; author or oversee platform rationales and technical submission content for global regulatory filings.
• Monitor combination product packaging and distribution regulations and partner with Regulatory Affairs on regional strategy and submission planning.
• Design and coordinate combination product stability studies aligned with ICH guidelines, using results to inform shelf life, storage conditions, and fit-for-use rationale.
• Ensure documentation supports technology transfer, knowledge transfer, and regulatory submissions.
• Maintain inspection readiness and ensure work meets applicable pharmacopeial, regulatory, testing, distribution, and design-control requirements.
• Ensure timely review and approval of methods, protocols, procedures, and change controls; partner with Quality on control strategies and audit readiness.
• Champion safe work practices with the team and suppliers.
• Oversee shipping simulation laboratory operations, including workplace safety, ALCOA+ data integrity, equipment upkeep, and testing capacity.
• Build partnerships across Device and Drug-Device Combination Product Development, CMC, 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.
• Work with Manufacturing and Technical Services/Manufacturing Sciences to support technology transfer.
• Advise Device Development, Business Unit, and Human Factors teams on patient-centered packaging requirements.
• Collaborate with New Product Planning, clinical trial manufacturing, packaging and 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.
• Engage in procurement strategy and supplier/CMO due diligence for packaging and distribution partners.
• Participate in external scientific and industry consortium forums and apply external learning to internal strategy and innovation.

Benefits

• Company bonus eligibility, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits eligibility.
• Flexible benefits, including 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, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

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