Senior Packaging Design Lead, Late-Stage Pharma

Eli Lilly and Company; United States; Remote; USD 144,000 - 251,000; Full time

Job summary

Eli Lilly and Company is seeking a Senior Advisor, Manufacturing Package Design to drive primary and secondary packaging strategy for late-stage and commercial drug products. You will lead cross-functional teams with CMOs/CPOs, oversee design verification/validation, technology transfer, and extensive documentation aligned with cGMP.

The role requires strong leadership, a track record in packaging design for late-stage programs, and collaboration with Regulatory, Quality, and Clinical Supply

Qualifications

• Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or a related field; advanced degree preferred.
• 7+ years’ experience in sponsor-side manufacturing package design, with demonstrated leadership of packaging design programs.
• Significant experience supporting late-stage clinical and/or commercial packaging programs required.
• Strong knowledge of cGMP regulations and industry standards/trends pertaining to pharmaceutical packaging design, container closure systems, and manufacturing.
• Demonstrated experience leading packaging technical strategy and design for late-stage/commercial programs, including technology transfer to commercial manufacturing.
• Experience managing relationships with CMOs/CPOs and packaging component/material suppliers.
• Working knowledge of drug substance, drug product, and packaging principles, equipment, and processes across solid dosage and/or parenteral formats.
• Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred.

Responsibilities

• Lead design, development, and technical strategy for primary and secondary packaging components/systems for late-stage clinical and commercial manufacturing.
• Serve as packaging design lead on project teams with external CMOs/CPOs; manage packaging-related technical relationships.
• Direct packaging engineering activities including design verification/validation, transportation/shipping validation, stability packaging configurations.
• Lead technology transfer of packaging design and processes from development/clinical scale to commercial manufacturing.
• Develop and maintain technical documentation (design history files, packaging specs, risk assessments) per cGMP.
• Collaborate with Regulatory Affairs to author/review CMC packaging sections of regulatory submissions.
• Ensure packaging design supports launch readiness, supply continuity, and product lifecycle management.
• Identify and implement continuous improvement initiatives for packaging processes, equipment, and vendor performance.
• Manage packaging-related change controls, deviations, and CAPAs with Quality; support root cause investigations.
• Evaluate and select packaging materials, components, and equipment with CMOs/CPOs.
• Provide packaging design expertise for quality systems, processes, and procedures.
• Build and mentor a team supporting manufacturing package design activities.

Skills

Packaging design

Leadership

Cross-functional collaboration

Project management

Technical strategy

Education

Bachelor's degree in packaging engineering or related field

Tools

CMO management

Regulatory submissions experience

Job description

Eli Lilly and Company is seeking a Senior Advisor, Manufacturing Package Design to drive primary and secondary packaging strategy for late-stage and commercial drug products. You will lead cross-functional teams with CMOs/CPOs, oversee design verification/validation, technology transfer, and extensive documentation aligned with cGMP.

The role requires strong leadership, a track record in packaging design for late-stage programs, and collaboration with Regulatory, Quality, and Clinical Supply