Lead Operator - Manufacturing

Lead Operator – Manufacturing

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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana, with 39,000 employees worldwide.

Reporting to the Supervisor of Manufacturing, the Manufacturing Process Specialist (B4) supports daily production and inspection activities, contributes to process improvements, and ensures compliance with cGMP and safety requirements. This role also serves as backup to the Team Leader when needed to ensure operational continuity.

• Aseptic production of radiopharmaceutical drug product and radioisotopes in accordance with established manufacturing batch records.
• Support the technical transfer, development, and validation of production methods associated with finished dosage form (FDF) drug products and radioisotope products.
• Investigate, resolve, and mitigate deviations, non-conformances, and OOS (Out of Specification) events associated with product manufacturing at the Lilly RLT GMP facility.
• Monitor production-related equipment to ensure proper function and compliance with the established calibration / PM equipment schedule.
• Continuous process improvement of existing manufacturing methods via Current Good Manufacturing Practices (cGMP).
• Produce drug products following cGMP guidelines and resolve all production-related quality events in a timely manner.
• Coordinate production activities with Quality Control, Quality Assurance, and FUME or Engineering to facilitate on-time release of drug product and radioisotopes.
• Participate in technical transfer and process validation activities in collaboration with other departments.
• Safely work with radioactive materials following ALARA principles and NRC guidelines.
• Utilize and monitor all manufacturing-related equipment.
• Conduct and appropriately document aseptic production of radiopharmaceutical drug product and radioisotopes via strict adherence to manufacturing batch records and affiliated SOPs.
• Safely handle and participate in the transfer of radioactive materials throughout the facility.
• Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure all production equipment is good working order and validated for use.
• Provide verbal and written reports to supervisors in a clear and concise manner.
• Provide feedback to leadership on production team member performance, including attendance, engagement, and adherence to expectations.
• Adhere to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements.
• Oversee new hire training curricula.
• Initiate and document deviations, CAPAs, and related quality events in the electronic Quality Management System (QMS).
• Embody and promote a quality culture and due diligence approach as part of all activities.
• Work well in a fast-paced team environment.
• Perform other duties as assigned.
• Operate, monitor, and maintain production equipment to ensure performance, safety and compliance with calibration and preventative maintenance schedules.
• Handle and transfer radioactive materials safely and compliantly throughout the facility in accordance with ALARA principles and NRC guidelines.
• Accurately document production activities in real time, ensuring data integrity and traceability.
• Identify, initiate, and document deviations, CAPAs, and non-conformances within the Electronic Quality Management System (QMS).
• Partner with Quality Assurance and Quality Control to resolve quality events and support on-time product release.
• Support process development, technical transfer, and validation activities for new or modified production methods.
• Collaborate cross-functionally with Maintenance, Engineering, and Supply Chain to ensure seamless batch execution.
• Train and mentor new technicians, supporting onboarding through structured curricula and on-the-floor guidance.
• Facilitate shift huddles to communicate critical updates and ensure seamless handoff between teams.
• Contribute to continuous improvement initiatives that enhance safety,…