Principal Scientist – TSMS Device Assembly

Role: The Device Assembly Technical Services / Manufacturing Science (TSMS) Principal Scientist leads device assembly technical development at Lilly's greenfield Kenosha site, focusing on establishing and supporting compliant manufacturing processes for parenteral drug products. Responsibilities include providing technical input during design, commissioning, tech transfer, process validation, and ongoing site support; ensuring regulatory compliance; and driving process consistency across the product lifecycle and network. The role entails developing process control strategies, supporting investigations, preparing technical documentation, leading risk management, and collaborating with upstream vendors and global teams. It also involves mentoring staff, supporting audits, and maintaining a strong safety culture. Qualifications: BS or MS in engineering or related scientific field; minimum 5 years supporting pharmaceutical or medical device manufacturing, with experience in device assembly, cGMP operations, tech transfer, and process validation. Preferred skills include knowledge of drug/device manufacturing, project management certification, and experience with greenfield site setup. High-Value: Focus on device assembly for injectable products, supporting start-up and validation activities in a regulated, cross-functional environment. Work setup: Monday–Friday, with flexibility for occasional extended hours and travel to other sites and corporate locations, primarily based in the U.S.