Pharmaceutical Manufacturing Operator

Eli Lilly and Company • Lebanon, IN

6d • $17 - $34 • Onsite

About The Position

Lilly is 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 at Lilly. 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 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. 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. Initially, the Operator 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 Operator will be responsible for execution of production activities on their shift under the leadership of the shift supervisor.

Requirements

• 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. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• 3+ years pharmaceutical cleanroom experience or equivalent comparable manufacturing experience
• Drug Substance experience; hands-on expertise working with bioreactors, sums, TFFs, purification, and similar processes
• Technical problem-solving skills.
• Good communications skills (both oral and written).
• Requires learning and understanding Good Manufacturing Practices and strict adherence to GMP regulations.
• Will be expected to adhere to all safety and environmental guidelines and to promote safety and environmental compliance in all areas.
• Good organization skills.
• Ability to work with and learn new digital systems
• Ability to demonstrate attention to detail

Responsibilities

• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical benefits
• dental benefits
• vision benefits
• prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance
• death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED