Lead Operator - Manufacturing

Role 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.

Responsibilities

• 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).

Responsibilities (continued)

• 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.

Qualifications

• Required: 5-10 years of relevant experience in a pharmaceutical manufacturing environment or similar field of work.
• Preferred: BS/BA degree in a science related field; other degrees and certifications considered with relevant experience.
• Preferred: Aseptic and/or cGMP manufacturing experience.
• Preferred: Experience working with radiopharmaceuticals is an asset but not required.
• Hours of work will require shift work on weekends as we progress into next phases. Flexibility is required. Currently the work week is Monday-Friday 7am-3:30pm, transitioning to a 2-2-3 schedule (7am-7pm or 7pm-7am) depending on shift.

Skills

• Ability to maintain focus on a complex task for 4-6 hours at a time
• Adaptable to a fast-paced and evolving environment
• Clear, verbal communication with team members during performance of duties
• Comfortable handling radioactivity and following ALARA guidelines
• Full range of motion and high manual dexterity; regular lifting of 10 lb; occasional lifting up to 50 lbs
• Excellent oral and written communication skills
• Detail-oriented and meticulous with tasks and documentation
• Team collaboration and sense of urgency in execution
• Excellent organizational and interpersonal skills
• Proficiency in Microsoft Office (Outlook, Word, PowerPoint, Excel)

Education

• BS/BA degree in a science related field (preferred; other degrees considered with relevant experience)