Pharmaceutical Manufacturing Operator

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 bring 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.

About the role

This is a unique opportunity to be part of the team for the startup of a greenfield manufacturing site. The successful candidate will help start up the facility for both clinical and commercial supply at Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products, including Gene Therapy. The site will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance.

Initially, the Manufacturing Operator will support execution of equipment qualification, develop site operations procedures, and set up production areas. During this startup phase, roles will be fluid and dynamic. Once the plant is operational, the Manufacturing Operator will execute production activities on their shift under the leadership of the shift supervisor.

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, 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 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 other quality or regulatory requirements.
• Comply with cleanroom gowning requirements for completing specific work in drug substance and drug product.
• Work well in a fast-paced team environment.

Requirements

• High School diploma or equivalent.
• Direct manufacturing experience with automatic, manual, and semi-automated equipment, following operational procedures.
• 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.

Skills

• 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 communication skills (both oral and written).
• Understanding of Good Manufacturing Practices and strict adherence to GMP regulations.
• Adherence to all safety and environmental guidelines and promotion of safety and environmental compliance.
• Good organization skills.
• Ability to work with and learn new digital systems.
• Attention to detail.
• 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 performance of duties.

Schedule

• During the start-up phase, primarily day shift.
• As the site nears normal operation, shift work will be required (anticipated to be 4 x 10-hour rotating shifts).
• Some overtime required.

Pay

The anticipated wage for this position is $17.30 - $34.38 per hour. Full-time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• Comprehensive benefit program including medical, dental, vision, and prescription drug benefits.
• Eligibility to participate in a company-sponsored 401(k) and pension.
• Vacation benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and 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).