Group Leader, Packaging & Distribution Development

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. The role is a strategic leadership position 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. Travel: 5–15%. Location: Indianapolis, IN; Lilly Technology Center – North (LTC-N).

Responsibilities

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; Set the long-term strategy for secondary packaging and product distribution platforms, including cold-chain and ambient shipping solutions; Champion new technologies and design innovations that improve product protection, sustainability, and the patient experience; Develop and implement AI and automation technologies to scale the team's work; Define and verify product stability requirements against shipping hazards such as vibration, shock, vacuum, and thermal stress; Guide the development and 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 FDA 21 CFR Part 820, ISO 13485, and ISO 14971; Direct molecule-specific risk assessments for packaging and shipping systems per ISO 14971; Ensure secondary packaging and distribution content is complete and audit-ready within DHF and DMR; Develop integrated control strategies connecting packaging and shipping specifications with device and drug product specifications; Direct the generation of stability data packages and author or oversee technical submission content (IND, NDA, BLA, MAA); Monitor the regulatory landscape and partner with Regulatory Affairs on strategy and submission planning across regions; Design and coordinate combination product stability studies aligned with ICH guidelines; Maintain the team's work in a state of regulatory inspection readiness; Ensure timely review and approval of methods, protocols, procedures, and change controls; Partner with Quality to define and uphold packaging and distribution control strategies; Champion safe work practices across the team and with suppliers; Oversee shipping simulation laboratory operations, including data integrity (ALCOA+); Build strong partnerships with Device, CMC, Clinical Development, Regulatory Affairs, Quality, Manufacturing, and Commercial teams; Serve as a trusted advisor on patient-centered packaging requirements; Explore and implement AI/ML applications, digital tools, and data analytics to improve packaging and combination product development processes; Engage in corporate procurement strategy and supplier/CMO due diligence for packaging and distribution partners; Maintain presence in external scientific and industry consortium forums

Requirements

Earned Bachelor's degree in packaging, materials, mechanical, chemical, or biomedical engineering, or a related scientific discipline, with 10+ years of relevant industry experience; 1+ year of experience leading and developing technical teams; Direct experience with drug development, drug-device combination product development, and/or consumer product packaging & distribution design and development; Track record partnering effectively with Quality, Regulatory, Manufacturing, and/or Device Development stakeholders; Strong executive communication with the ability to adapt to shifting priorities and timelines

Nice to have

Earned 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 (DHF) content, integrated control strategies, or technical regulatory submission sections for combination products; Secondary packaging design (cartons, trays, labels, printed components) experience; Experience with product distribution systems (cold-chain and ambient shipping qualification); Experience designing or coordinating stability studies for combination products 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

Benefits

Company bonus (depending, in part, on company and individual performance); Company-sponsored 401(k); Pension; Vacation benefits; 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; Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)