Senior Packaging Design Lead for Late-Stage

Eli Lilly and Company; Indiana; On-site; USD 144,000 - 251,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision benefits

Pension plan

Paid time off

Job summary

Eli Lilly and Company in the United States is seeking a Senior Advisor for Manufacturing Package Design to lead primary and secondary packaging design for late-stage and commercial products. You will partner with CMOs/CPOs, oversee design verification/validation, and drive quality, regulatory readiness, and supply continuity.

The role requires 7+ years in sponsor-side packaging design, strong cGMP knowledge, and cross-functional collaboration across Manufacturing, Quality, Regulatory Affairs,

Qualifications

• Bachelor's degree in packaging engineering, mechanical engineering, life sciences or related field.
• 7+ years in sponsor-side manufacturing package design with late-stage programs.
• Strong knowledge of cGMP regulations and packaging standards.
• Experience leading packaging strategy and design for late-stage/commercial programs, incl. tech transfer to commercial manufacturing.
• Experience managing CMOs/CPOs and packaging supplier relationships.
• Experience authoring or reviewing CMC packaging sections of regulatory submissions.
• Domestic and international travel required (10–20%).

Responsibilities

• Lead design and strategy for primary and secondary packaging for late-stage clinical and commercial programs.
• Serve as packaging design lead on project teams with CMOs/CPOs; manage packaging-related relationships.
• Coordinate with CMC and Clinical Supply Chain on packaging for trials and production forecasts.
• Direct packaging engineering activities including design verification/validation and stability studies.
• Lead technology transfer from development to commercial manufacturing.
• Develop and maintain design history files, packaging specs, risk assessments/FMEAs per design control requirements.
• Collaborate with Regulatory Affairs to support regulatory submissions and health authority queries.
• Support launch readiness and product lifecycle packaging needs with cross-functional teams.
• Identify and implement continuous improvement in packaging processes and vendor performance.
• Travel 10–20% as needed.

Skills

Packaging design

cGMP knowledge

Leadership

Cross-functional collaboration

CMO/CPO management

Regulatory strategy

Education

Bachelor's degree in packaging engineering

Advanced degree preferred

Job description

Eli Lilly and Company in the United States is seeking a Senior Advisor for Manufacturing Package Design to lead primary and secondary packaging design for late-stage and commercial products. You will partner with CMOs/CPOs, oversee design verification/validation, and drive quality, regulatory readiness, and supply continuity.

The role requires 7+ years in sponsor-side packaging design, strong cGMP knowledge, and cross-functional collaboration across Manufacturing, Quality, Regulatory Affairs,