Sr. Principal Scientist - TS/MS Device & Packaging

Role Summary

Sr. Principal Scientist - TS/MS Device & Packaging at Lilly. A pivotal technical leadership role in the Device and Packaging Manufacturing division, providing oversight for new and existing medicines, supporting technical transfer, and optimizing control and capacity to maintain reliable supply across the site.

Responsibilities

• Demonstrate ownership and stewardship for medical device design, manufacturing, labeling, and/or packaging processes.
• Collaborate with regulatory function to align strategies for new products, packaging, platform changes, and technical change agendas.
• Engage externally to stay current in risk management, technology, regulatory and compliance environments; apply insights to design transfer and manufacturing processes.
• Prepare, review, and approve study designs, protocols, technical reports, and related documentation; oversee qualification and validation strategy for device and packaging processes.
• Independently identify engineering questions/issues and develop solutions to advance business objectives.

Qualifications

• Minimum: Bachelor‚Äôs degree in Science, Engineering, or related field.
• 5+ years of experience in pharmaceutical and/or medical device manufacturing or regulated industry.
• Strong understanding of cGMPs and pharmaceutical or regulated industry manufacturing.
• Ability to lead complex technical projects and make informed decisions.
• Preferred: Prior experience in packaging and/or device assembling operations; familiarity with commercialization process and process control requirements; strong technical leadership and communication skills; ability to work independently and in teams; analytical and problem-solving abilities; project management experience and basic statistical skills; working knowledge of equipment and facility qualification processes; familiarity with PPE requirements; travel 0-50%.

Skills

• Technical SME oversight; cross-functional collaboration; data analysis; first principles thinking; regulatory and compliance navigation; problem-solving; CAPA management; process optimization; Lean tools.

Education

• Bachelor‚Äôs degree in Science, Engineering, or related field.

Additional Requirements

• Variable travel may be required to support business needs, 0-50%.