Junior Radiochemist

Primary location: Phoenix, Arizona – Banner Alzheimer’s Institute, 901 E Willetta St.

About the role

Under the direction of radiochemistry senior staff, this position manufactures radiotracers for human and animal research and performs their quality control using established procedures in compliance with protocols, current Good Manufacturing Practices, applicable FDA regulations, and United States Pharmacopeia standards. The role maintains accurate written records of radiopharmaceutical production and quality control, operates cyclotron and associated equipment following ALARA radiation-safety practices, and supports laboratory maintenance, inventory, and distribution activities.

Responsibilities

• Operate cyclotron and radiochemistry equipment to perform routine production and quality control of radiotracers in accordance with established SOPs and regulatory guidelines (USP 823 and/or 21 CFR 212).
• Perform troubleshooting of production and quality-control equipment; investigate root causes of deviations and out-of-specification events and assist in developing and implementing corrective/preventive actions (CAPA).
• Handle radioisotopes and radiotracers safely and compliantly.
• Package and ship radiotracers to remote sites in accordance with DOT regulations.
• Conduct radiation surveys using standard radiation-monitoring equipment.
• Maintain inventory of laboratory supplies, including ordering, receipt, and approval via the radiochemistry Laboratory Information System.
• Manage storage and disposal of chemical waste and maintain required regulatory documentation.
• Maintain and calibrate chemistry and scientific instrumentation used in PET radiopharmaceutical production (analytical TLC, HPLC, GC, bacterial endotoxin testing systems).
• Collect and document quality-control data on existing equipment at scheduled intervals.
• Clean and maintain sterile preparation rooms, anteroom, and laminar-flow hoods in accordance with SOPs and USP 797 guidelines.
• Perform routine environmental testing and periodic checks of sterility and environmental-monitoring media.
• Disinfect and sterilize glassware in preparation for radiotracer compounding.
• Clean radiosynthesis modules prior to radiotracer production.
• Participate in regularly scheduled lab meetings to receive and provide information.
• Assist in drafting and reviewing standard operating procedures, forms, material-specification sheets, and other laboratory documents.

Requirements

• BS degree in chemistry, nuclear science, or related discipline.
• At least two years of experience in a facility that produces PET and/or SPECT radioisotopes.
• Strong analytical skills and ability to work with minimal supervision.
• Organizational ability to prioritize and handle multiple tasks.
• Excellent human-relations and communication skills.
• Proficiency in Microsoft Office Suite (Word, Excel, Access, OneNote, PowerPoint).
• Sufficient knowledge of chemical/pharmacy terminology to read, identify, and extract pertinent data from laboratory records.

Preferred Qualifications

• Bachelor’s degree in Science, Chemistry, or related field.
• At least two years of prior experience using radiation-monitoring equipment and handling radioactive materials, including DOT training in packaging and shipment of radioactive materials.
• Experience performing radiosyntheses and quality control of radiopharmaceutical products per current FDA guidelines.

Schedule

Monday–Friday, 6:00 AM – 2:30 PM, with limited schedule flexibility.