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, with 39,000 employees worldwide that discover, develop, and bring life‑changing medicines to patients and improve disease understanding and management.

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. The role also serves as backup to the Team Leader as 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.

• BS/BA degree in a science‑related field is preferred. Other degrees and certifications will be considered with relevant work experience.
• 5‑10 years of relevant experience in a pharmaceutical manufacturing environment or similar field.
• Aseptic and/or cGMP manufacturing experience is preferred.
• Experience working with radiopharmaceuticals is considered an asset.
• Work requires shift work, including weekends. Current schedule Monday‑Friday 7am‑3:30pm with future transition to 2‑2‑3 or 7am‑7pm or 7pm‑7am shifts.

• 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.
• Comfortable handling radioactivity and follow proper ALARA technique.
• Full range of motion and manual dexterity; regular lifting up to 50 lbs.
• Excellent oral and written communication skills.
• Very detail oriented and meticulous with documentation.
• Work…