Advanced Therapies Manufacturing Operator

BioSpace; Lebanon (IN); On-site; USD 24,000 - 47,000; Full time

Job summary

Lilly Manufacturing is building a state-of-the-art facility in Lebanon, Indiana, to deliver advanced therapies and support a growing pipeline. The Manufacturing Operator will join a fast-paced team responsible for GMP manufacturing activities across Cell Culture, Downstream Purification, and Fill & Finish.

Initial focus includes equipment qualification support, setting up production areas, and developing site operations procedures, with shift work transitioning to full production as the plant

Qualifications

• 3+ years pharmaceutical cleanroom experience or equivalent manufacturing experience
• Drug Substance experience; hands-on expertise with bioreactors, sums, TFFs, purification
• Technical problem-solving skills
• Good communications skills (oral and written)
• Adherence to GMP and regulatory requirements
• Ability to learn new digital systems
• 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.
• Safely work with BSL-2 materials following site biologics safety program.
• Document production of advanced therapies per batch records and SOPs.
• Utilize and monitor manufacturing equipment to ensure performance and safety standards.
• Collaborate with maintenance, equipment manufacturers, and QA to ensure equipment is in good working order and validated.
• Provide reports to supervisors and other teams clearly.
• Maintain electronic records and logbooks per cGMP and cGLP.
• Adhere to procedures, cGLP, cGMPs, and company policies.
• Compliance with gowning requirements for drug substance and drug product.
• Work well in a fast-paced team environment.

Skills

Pharma cleanroom experience

Bioreactors experience

Technical problem-solving

Good communications

Attention to detail

GMP knowledge

Digital systems literacy

Team player

Education

High School diploma or equivalent

Job description

Lilly Manufacturing is building a state-of-the-art facility in Lebanon, Indiana, to deliver advanced therapies and support a growing pipeline. The Manufacturing Operator will join a fast-paced team responsible for GMP manufacturing activities across Cell Culture, Downstream Purification, and Fill & Finish.

Initial focus includes equipment qualification support, setting up production areas, and developing site operations procedures, with shift work transitioning to full production as the plant