Manufacturing Associate - Advanced 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 is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products  will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, 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 start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up.

The Manufacturing Associate will be responsible for performing routine manufacturing activities across GMP manufacturing areas, including:
Cell Culture, Downstream Purification, and Fill & Finish at the Lebanon Advanced Therapies, LP2 site.

Initially, the Manufacturing Associate will be responsible for supporting execution of equipment qualification, developing site operations procedures and setting up production areas. During this initial project delivery/startup phase of the project, roles will be fluid and dynamic. Once the plant is operational, the Manufacturing Associate will be responsible for execution of production activities on their shift under the leadership of the shift supervisor.

• Work cross functionally with TSMS and Engineering to develop procedures, MES records, and establish operational controls.

• Work in a cleanroom environment to produce advanced therapies in a safe and quality manner.

• Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of advanced therapies.

• Participate in equipment commissioning and qualification testing and process validation activities in collaboration with other departments.

• Safely work with BSL-2 materials, following site biologics safety program.

• Conduct and appropriately document production of advanced Therapies via strict adherence to digital manufacturing batch records and affiliated SOPs.

• Utilize and monitor manufacturing equipment to ensure performance and safety standards are met.

• Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure that all production equipment is in good working order and is validated for use.

• Provide verbal and written reports to supervisors and other teams in a clear and concise manner.

• Maintain accurate and complete electronic records and logbooks as per cGLP and/or cGMP, as appropriate.

• Adhere to all applicable procedures, cGLP, cGMPs, company policies, and any other quality or regulatory requirements.

• Compliance with cleanroom gowning requirements required for completing specific work in drug substance and drug product.

• Work well in a fast-paced team environment.

• Bachelor's degree in a…