Lead Technician - Production

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.

About POINT Biopharma:

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Recently acquired by Eli Lilly and Company, POINT 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. POINT is a wholly owned subsidiary of Eli Lilly and Company.
 
Position Summary:
Reporting to the Supervisor of Manufacturing, the Lead Technician - Production will have responsibility for: 
 

• 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 POINT 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). 

Roles and Responsibilities of the Position:

• 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