Lead Operator - Manufacturing

Eli Lilly and Company • Us, IN

13d • $26 - $41 • Onsite

About The Position

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 39,000 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. #WeAreLilly 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. Lilly 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. Position Summary: 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).

Requirements

• BS/BA degree in a science related field of study is preferred. Other degrees and certifications will be considered with a combination of relevant work experience.
• 5-10 years of relevant experience in a pharmaceutical manufacturing environment or similar field of work.
• Aseptic and/or cGMP manufacturing experience is preferred.
• Hours of work will require shift work on weekends as we progress into next phases. Flexibility is required.
• Currently the work week will be Monday-Friday 7am-3:30pm and transitioning to the 2-2-3, 7am-7pm or 7pm to 7 am (Spring of 2026) depending on selected shift
• 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 one or more team members during performance of duties
• Comfortable handling radioactivity and follow proper ALARA (As Low As Reasonably Achievable) technique
• Full range of motion and ability to use both hands mandated by machinery.
• High degree of manual dexterity.
• Regular lifting of 10 lb weights, occasional lifting of up to 50 lbs
• Excellent oral and written communication skills
• Very detail oriented and meticulous with execution of tasks and documentation
• Work collaboratively in a team environment
• Operate and execute with a sense of urgency
• Excellent organizational and interpersonal skills
• Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)

Nice To Haves

• Experience working with radiopharmaceuticals will be considered an asset but is not a requirement.

Responsibilities

• 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
• 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, efficiency, and compliance across the production environment
• Uphold and promote a culture of safety, compliance, and accountability in every task
• Flexibly adapt to changing priorities and shift schedules based on manufacturing needs
• Perform other duties as assigned to support operational readiness and delivery

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees