Pharmaceutical Manufacturing Operator

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. It 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 part of the team for the startup of a green‑field manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

Engineering the startup of a state‑of‑the‑art facility and building a manufacturing supply chain from ground up.

The Manufacturing Operator 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.

During the initial project delivery / startup phase, the operator will support equipment qualification, develop site operations procedures, and set up production areas. Once the plant is operational, the Manufacturing Operator will execute production activities on their shift under the leadership of the shift supervisor.

• Work in a cleanroom environment to produce advanced therapies safely and with quality.
• Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on‑time release of advanced therapies.
• Participate in equipment commissioning, qualification testing, and process validation activities in collaboration with other departments.
• Safely work with BSL‑2 materials, following the 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 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.
• Follow cleanroom gowning requirements required for completing specific work in drug substance and drug product.
• Work well in a fast‑paced team environment.

• High School diploma or equivalent.
• Direct manufacturing experience with automatic, manual, and semi‑automated equipment, following operational procedures.
• Qualified applicants must be authorized to work in the United States on a full‑time basis (no visa sponsorship).

• 3+ years pharmaceutical cleanroom experience or equivalent comparable manufacturing experience.
• Drug Substance experience: hands‑on expertise working with bioreactors, cells, TFFs, purification, and similar processes.
• Technical problem‑solving skills.
• Good oral and written communication skills.
• Strong understanding and adherence to Good Manufacturing Practices and GMP regulations.
• Commitment to safety and environmental guidelines and self‑promotion of compliance.
• Good organizational skills.
• Ability to work with and learn new digital systems.
• Attention to detail.

• During the start‑up phase, the shift will be primarily day shift; as the site nears normal operation, shift work will be required. Anticipated to be 4 x 10‑hour rotating shifts.
• Ability to maintain focus on a complex task for 4–6 hours at a time.
• Adaptable to work in a fast‑paced and evolving environment.
• Maintain clear, consistent, and constant verbal communication with team members during duties.
• Some overtime required.

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