Junior Radiochemist

Junior Radiochemist

The Radiochemistry Lab at Banner Alzheimer's Institute (BAI) is a unit that performs daily production of various imaging agents for Positron Emission Tomography (PET) scans. These scans are used to study the cause and progression of Alzheimer's disease, a neurodegenerative disorder that affects tens of millions of people worldwide. BAI is a Banner Health Center of Excellence whose mission is to end Alzheimer's disease without losing another generation.

The Radiochemistry team takes pride in timely and reliable supply of imaging agent doses to its customers (BAI PET Imaging department and fellow PET imaging facilities in Phoenix, in Arizona, and in neighboring states) while being fully compliant with FDA and USP regulations.

The Radiochemistry Lab is currently seeking an experienced Junior Radiochemist who will be responsible for performing quality control (QC) of the daily batches of imaging agents manufactured by the Lab and who will participate in developing of QC procedures for new products. The quality control process involves more than a dozen of rigorous tests using sophisticated techniques such as High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), gamma-spectrometry, etc.

An integral part of this role is also maintenance, calibration, and troubleshooting of the analytical instruments.

This role will not have any interaction with clinical patients. All of your time will be dedicated working in the laboratory or research setting.

Schedule:

Monday-Friday 6AM – 2:30PM with limited schedule flexibility

Location:

901 E Willetta St Phoenix, AZ

POSITION SUMMARY

This position, under the direction of radiochemistry senior staff, this position is responsible for the manufacture of radiotracers for human and animal research and for performing their quality control using established procedures in compliance with protocols, current Good Manufacturing Practices, applicable FDA regulations, and the United States Pharmacopeia standards. Maintains accurate written records of radiopharmaceutical production and quality control according to procedures and regulatory requirements.

Participants in operation of the cyclotron and associated equipment in compliance with protocols and ALARA radiation safety practices. Performs a wide variety of laboratory, inventory, and equipment maintenance, preparation procedures, and distribution activities associated with the manufacturing of radiotracers.

CORE FUNCTIONS

• Under the supervision of radiochemistry senior staff, operates cyclotron and radiochemistry equipment to perform routine production and quality control of radiotracers in accordance with established SOP's and regulatory guidelines, such as USP 823 and/or 21 CFR 212. Performs troubleshooting of the production and quality control equipment. Investigates root causes of deviations and out-of-specification (OOS) events and assists in developing and implementing of corrective actions/preventive actions (CAPA).
• Routinely handles radioisotopes and radiotracers in a safe & compliant manner. Under the supervision of the Radiochemistry manager(s), performs packaging and shipment of radiotracers to remote sites in accordance with DOT regulations. Performs radiation surveys using standard radiation monitoring equipment.
• Responsible for maintaining inventory of laboratory supplies including ordering, receipt, and approval using the radiochemistry Laboratory Information System. Responsible for storage and disposal of chemical waste and maintaining the necessary regulatory documentation.
• Responsible for maintenance and calibration of a variety of chemistry and scientific instrumentation used in the production of PET radiopharmaceuticals such as analytical TLC, HPLC, GC, and bacterial endotoxin testing systems. Collects and documents quality control data on existing equipment at scheduled intervals.
• Cleans and maintains sterile preparation rooms, anteroom, and Laminar flow hoods in accordance with standard operating procures (SOP's) and USP 797 guidelines. Performs routine environmental testing as required. Performs periodic checks of sterility and environmental monitoring media at scheduled…