Radiopharmaceutical Production Technician I

$55,000 - $75,000/Yr

Unclassified - Coralville, IA

Full-time - Entry Level

Coralville, IA

About the position

The Radiopharmaceutical Production Technician I is responsible for the formulation, preparation, assembling, and packaging of radiopharmaceutical components in compliance with cGMP guidelines. This entry-level position involves working with radioactive materials, ensuring quality control, and supporting the technical transfer and validation of production methods. The technician will collaborate with various departments to facilitate the timely release of drug products and radioisotopes while adhering to safety and regulatory standards.

Responsibilities

• Produce radioisotopes and 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 Plant Maintenance 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.
• Preparation of packages for distribution as per the regulations for the Transportation of Dangerous Goods (TDG), Packaging and Transport of Nuclear Substances (PTNS), as well as International Air Transport Association (IATA).
• Provide verbal and written reports to supervisors in a clear and concise manner.
• Maintain accurate and complete lab data notebooks as per cGLP and/or cGMP, as appropriate.
• Adhere to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements.
• Embody and promote a quality culture and due diligence approach as part of all activities.
• Work well in a fast-paced team environment.
• Perform batch record calculations and maintain all documentation according to cGMP guidelines.
• Perform the maintenance and cleanliness of department, premises, and equipment on a daily basis.

Requirements

• Associate degree or equivalent military experience.
• College level course work with a scientific background is highly desired.
• A bachelor's degree (or higher) in scientific discipline is preferred.
• One or more years of relevant work experience is required, preferably in a pharmaceutical or cGMP manufacturing industry.
• Aseptic processing and technique experience preferred.
• Experience working with radiopharmaceuticals will be considered an asset but is not a requirement.

Nice-to-haves

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