Lead Operator - Manufacturing

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. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

Eli Lilly and Company is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Eli Lilly and Company aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry‑leading pipeline, in‑house manufacturing capabilities, and secured supply for medical isotopes including actinium‑225 and lutetium‑177.

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.
• 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 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 curriculums.
• 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.
• Perform aseptic manufacturing of radiopharmaceutical drug products and radioisotopes in strict compliance with batch records, SOPs, and cGMP standards.
• Operate, monitor, and maintain production equipment to ensure performance, safety, and compliance with calibration and preventative maintenance schedules.
• Hand…