Packaging Design Lead — Late-Stage Pharma

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 129,000 - 231,000; Full time

Job summary

Lilly is seeking an Associate Director, Manufacturing Package Design to lead the design, development, and strategic packaging efforts for late‑stage clinical and commercial drug products in the US. This role partners with Manufacturing, Quality, Regulatory Affairs, and Supply Chain to ensure packaging readiness and launch success.

The position requires a Bachelor's in a packaging/engineering field and at least 7 years of sponsor‑side packaging design leadership, with strong cGMP knowledge and

Qualifications

• Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or related field.
• 7+ years’ experience in sponsor-side manufacturing package design with leadership of packaging design programs.
• Strong knowledge of cGMP regulations and industry standards in pharmaceutical packaging design and container closure systems.
• Demonstrated experience leading packaging technical strategy and design for late-stage/commercial programs including technology transfer.
• Experience managing relationships with CMOs/CPOs and packaging component/material suppliers.
• Working knowledge of drug substance, drug product, and packaging principles across solid dosage and/or parenteral formats.
• Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred.
• Experience with combination products/device packaging preferred.
• Strong leadership, project management, and cross-functional collaboration skills.

Responsibilities

• Lead design, development, and technical strategy for primary and secondary packaging for late-stage clinical and commercial programs.
• Represent the company on packaging-related activities with CMOs/CPOs and manage external relationships.
• Ensure clinical trial packaging aligns with production forecasts and product demand.
• Direct packaging engineering activities including design verification/validation and stability studies.
• Lead technology transfer of packaging design to commercial manufacturing with line trials and scale-up.
• Develop and maintain design history files, packaging specifications, and risk assessments in line with design control requirements.
• Collaborate with Regulatory Affairs to support CMC packaging sections of submissions.
• Support packaging readiness for launch, supply continuity, and product lifecycle management.
• Identify and drive continuous improvement in packaging processes, equipment, and supplier performance.
• Oversee change controls, deviations, and CAPAs related to packaging and QA investigations.
• Evaluate and qualify packaging materials, components, and equipment with CMOs/CPOs.

Skills

Packaging design leadership

Project management

Cross-functional leadership

cGMP knowledge

CMO/CPO management

Technology transfer

Regulatory awareness

Education

Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or a related field

Job description

Lilly is seeking an Associate Director, Manufacturing Package Design to lead the design, development, and strategic packaging efforts for late‑stage clinical and commercial drug products in the US. This role partners with Manufacturing, Quality, Regulatory Affairs, and Supply Chain to ensure packaging readiness and launch success.

The position requires a Bachelor's in a packaging/engineering field and at least 7 years of sponsor‑side packaging design leadership, with strong cGMP knowledge and