Pharmaceutical Manufacturing Operator

About the role

Lilly is seeking a Manufacturing Operator to join the team at the Lebanon Advanced Therapies, LP2 site. This role involves performing routine manufacturing activities in a cleanroom environment, coordinating with various departments, and adhering to strict GMP regulations.

Responsibilities

• Perform routine manufacturing activities in cell culture, downstream purification, and fill & finish areas.
• Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to ensure timely release of advanced therapies.
• Participate in equipment commissioning and qualification, as well as process validation activities.
• Safely work with BSL-2 materials and follow the site's biologics safety program.
• Conduct and document production of advanced therapies according to digital manufacturing batch records and associated Standard Operating Procedures (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 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 any other quality or regulatory requirements.
• Comply with cleanroom gowning requirements for 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.
• Minimum of 3+ years pharmaceutical cleanroom experience or equivalent comparable manufacturing experience.
• Drug substance experience; hands-on expertise working with bioreactors, filters, TFFs, and similar processes.
• Technical problem-solving skills.
• Good communications skills (oral and written).
• Learning and understanding of Good Manufacturing Practices and strict adherence to GMP regulations.
• Ability to work with and learn new digital systems.
• Ability to demonstrate attention to detail.

Qualifications

• Authorized to work in the United States on a full-time basis.
• No visa sponsorship provided.

Skills

• Attention to detail.
• Fast-paced environment adaptability.
• Clear verbal communication.
• Collaborative teamwork.

Benefits

• Company-sponsored 401(k)
• Pension
• Vacation benefits
• Medical, dental, vision, and prescription drug benefits
• Flexible benefits (healthcare and/or dependent day care flexible spending accounts)
• Life insurance and death benefits
• Time off and leave of absence benefits
• Well-being benefits (employee assistance program, fitness benefits, and employee clubs and activities)