Visual Inspection Scientist - Advanced Therapies Manufacturing

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters.

Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance.

This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.

Visual Inspection Scientist – Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support to achieve the reliable and compliant manufacture of gene therapy drug product to predetermined global quality standards via a detailed set of manufacturing instructions and procedures. In this role, the successful candidate provides day-to-day technical support to the visual inspection program, supporting inspection qualification, defect classification, and process monitoring while working cross-functionally with Operations, Quality Assurance, and Engineering.

This person interacts daily with a wide variety of stakeholders internally and externally. The mission of TS/MS is to provide scientific leadership and technical support for manufacturing to make medicine today and tomorrow.

• Understand the scientific and quality principles that govern the visual inspection of drug products, including how the product, equipment, aseptic processes, and container closure systems influence inspection outcomes and defect presentation.
• Provide day-to-day technical support to the visual inspection process so that inspection is performed reliably, consistently, and in compliance with applicable procedures and quality standards.
• Support the qualification and ongoing performance of inspection personnel and equipment, including inspector qualification, defect classification, and review of inspection results, escalating complex questions to Quality or senior TS/MS as needed.
• Support the maintenance of visual inspection tools and materials, such as test kits, practice kits, and defect libraries, in partnership with Quality Assurance.
• Help monitor visual inspection performance and quality metrics, identify trends, and support timely and appropriate responses to process variability.
• Prepare, review, and provide technical support for visual-inspection-related studies and documentation, such as procedures, work instructions, deviation investigations, change controls, and monitoring reports.
• Participate in continuous improvement, deviation investigations, and cross-functional projects related to visual inspection, and continue to develop visual inspection knowledge and technical capability over time.
• Train, coach, and mentor operators, statistical sorters, and inspectors on inspection technique and defect classification, and support the visual inspection…