Join Isotopia USA as a Radiopharmaceutical Production Specialist to play a crucial role in the manufacturing of cGMP isotope products for U.S. and global customers.
Requirements
- Prepare, dispense, and synthesize radiopharmaceutical compounds in accordance with established protocols and procedures.
- Operate and maintain specialized production equipment, including radiation detectors, autoclaves, and synthesis modules, in accordance with safety protocols and manufacturer guidelines.
- Accurately document all production activities, including materials used, equipment settings, test results, and deviations, in compliance with cGMP requirements.
- Identify and troubleshoot equipment issues, process deviations, and quality concerns, and implement corrective actions as necessary.
- Work closely with cross-functional teams, including chemists, quality assurance personnel, and regulatory experts, to ensure seamless production operations and regulatory compliance.
- Participate in process optimization initiatives to enhance production efficiency, product quality, and regulatory compliance.
- Stay current with new developments in radiopharmaceutical production techniques, safety practices, and regulatory requirements. Train and mentor junior technicians as needed.
- Perform routine and scheduled cleaning and sanitization of the ISO 7 cleanroom and controlled areas in accordance with approved SOPs, cGMP requirements, and contamination control procedures.
Benefits
- 401k Retirement Program with 5% of Salary Company Contribution
- Individual and Dependent Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-term Disability Insurance
- Long-term Disability Insurance