Group Leader, Packaging & Distribution Development

Eli Lilly and Company • Us, IN

21h • $130,500 - $211,200 • Onsite

About The Position

The Group Leader leads Lilly’s Secondary Packaging and Product Distribution team within the Delivery, Device, and Connected Solutions organization. The team develops secondary packaging and product distribution solutions—including cold-chain and ambient shipping qualification—to protect clinical and commercial products from development through delivery to patients. The role covers drug products and drug-device combination products, and integrates packaging and shipping deliverables into drug and combination product design control. The leader sets strategy, develops talent and technical capability, and guides patient-centered packaging design and cross-functional alignment with Device Development, CMC, Quality, Regulatory, Manufacturing, and other partners.

The role establishes long-term strategies for secondary packaging and distribution platforms, directs development and qualification of packaging and shipping systems, and ensures product stability and performance under distribution hazards. It also oversees combination product packaging design control, risk assessments, technical documentation, stability studies, and regulatory submission readiness. The leader maintains inspection readiness, laboratory safety and data integrity, and effective collaboration with internal and external stakeholders. The position is located at Lilly Technology Center – North in Indianapolis, Indiana, with 5–15% travel.

Requirements

• Bachelor’s degree in packaging, materials, mechanical, chemical, or biomedical engineering, or a related scientific discipline.
• 10 or more 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 or more years of experience, or PhD with 3 or more 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 and career paths, and manage workload, capacity, and succession planning.
• Set team strategy and priorities aligned with Lilly PR&D and enterprise portfolio goals, and represent the team in cross-functional governance and portfolio planning.
• Promote technical excellence, continuous improvement, patient-centered thinking, and team fluency in combination product design control.
• Set long-term strategies for secondary packaging and product distribution platforms, including cold-chain and ambient shipping solutions.
• Integrate shipping and secondary packaging deliverables into product design, process development, verification, and validation for clinical and commercial portfolios.
• Champion technologies and design innovations that improve product protection, sustainability, and patient experience; develop innovative packaging for devices, sterile components, container platforms, and new drug modalities.
• Develop and implement AI and automation technologies to improve efficiency in packaging design, documentation, testing, and distribution qualification workflows.
• Define and verify product stability requirements against shipping hazards, including vibration, shock, vacuum, and thermal stress.
• Develop secondary packaging solutions and distribution processes; guide qualification of shipping containers, packing processes, and cold-chain solutions.
• 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, and ensure complete, audit-ready design documentation in Design History Files and Device Master Records.
• 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 evidence, and author or oversee platform rationale and technical submission content for global regulatory filings.
• Monitor regulatory requirements and partner with Regulatory Affairs on global strategy and submission planning.
• Design and coordinate combination product stability studies aligned with ICH guidelines; analyze data to inform shelf life, storage conditions, and fit-for-use rationale.
• Ensure documentation supports technology transfer, knowledge transfer, and regulatory submissions.
• Maintain regulatory inspection readiness and ensure work meets applicable standards and combination product 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 team members and suppliers.
• Oversee shipping simulation laboratory operations, including safety, ALCOA+ data integrity, equipment maintenance, and testing capacity.
• Build partnerships with Device and Drug-Device Combination Product Development, CMC, Clinical Development, Regulatory Affairs, Quality, Manufacturing, and Commercial teams.
• Align with Regulatory Affairs on global submission and post-approval packaging and shipping content, balancing scientific rigor, quality, and development speed.
• Work with Manufacturing and Technical Services/Manufacturing Sciences on 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 teams, Global Packaging, manufacturing sites, and commercial distribution centers.
• Explore and implement AI/ML applications, digital tools, and data analytics for 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 forums and use external learning to inform internal strategy and innovation.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• 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 employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

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