Lead TSMS Scientist - Device Assembly (Greenfield)

100 Eli Lilly and Company; Wisconsin; On-site; USD 68,000 - 174,000; Full time

Job summary

Eli Lilly and Company is seeking a Principal Scientist for Device Assembly TSMS at the Kenosha County site to establish and lead the technical program for device assembly, aligning equipment, process design, tech transfer, and validation to enable compliant startup and manufacturing.

The role requires owning the technical agenda, guiding cross-functional teams, and ensuring robust documentation, deviation handling, and regulatory readiness across the product lifecycle.

Qualifications

• BS or MS in engineering, or related scientific discipline.
• Minimum of 5 years directly supporting pharmaceutical or medical device manufacturing.
• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills in a startup environment.
• Clear oral and written communication across all levels of the organization.
• Authorized to work in the United States full-time.
• Lilly will not sponsor work authorization or visas.

Responsibilities

• Understand principles for manufacturing parenteral drugs and device assembly.
• Serve as technical SME during design, build, commissioning at a greenfield site.
• Provide technical support for start-up activities (tech transfer, equipment qualification, process validation).
• Support non-routine investigations related to device assembly (deviations, complaints).
• Prepare, review and provide support for technical documents (change controls, regulatory submissions, validation reports).
• Own the technical agenda for assigned device assembly product, platform, or validation process.

Skills

Parenteral manufacturing

Tech transfer experience

Equipment qualification

Process validation

Deviations handling

Cross-functional leadership

Regulatory understanding

Education

BS or MS in engineering/science

Job description

Eli Lilly and Company is seeking a Principal Scientist for Device Assembly TSMS at the Kenosha County site to establish and lead the technical program for device assembly, aligning equipment, process design, tech transfer, and validation to enable compliant startup and manufacturing.

The role requires owning the technical agenda, guiding cross-functional teams, and ensuring robust documentation, deviation handling, and regulatory readiness across the product lifecycle.