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Radiochemist

Company: Banner Health
Location: Phoenix
Posted on: May 16, 2022

Job Description:

Primary City/State:Phoenix, ArizonaDepartment Name:Radiochemistry ResearchWork Shift:DayJob Category:Clinical CareHealth care is constantly changing, and at Banner Health, we are at the front of that change. We are leading health care to make the experience the best it can be. We want to change the lives of those in our care - and the people who choose to take on this challenge. If changing health care for the better sounds like something you want to be part of, we want to hear from you.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 a Radiochemist who will be responsible for performing quality control (QC) of the daily batches of imaging agents manufactured by the Lab and for developing and setting up 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. The typical schedule for this role is Monday-Friday 6 AM - 3 PM with limited schedule flexibility. The primary location for this role will be at Banner Alzheimer's Institute (901 E Willetta St, Phoenix, AZ 85054) and will be on-site with occasional remote capabilities.Your pay and benefits (Total Rewards) are important components of your Journey at Banner Health. Banner Health offers a variety of benefit plans to help you and your family. We provide health and financial security options, so you can focus on being the best at what you do and enjoying your life.Banner Alzheimer's Institute (BAI) was established in 2006 as Banner Health's first Center of Excellence. Banner Health is one of the largest nonprofit health care systems in the United States. Our team is uniquely, passionately and strategically committed to ending Alzheimer's without losing another generation and to providing an unparalleled model of care for families facing this devastating disease. BAI is committed to improving people's lives through excellent patient care and advances that capitalize on the best biomedical research. We intend to make a transformational difference in Alzheimer's research and care.POSITION SUMMARY
This position is responsible for the manufacture of PET and SPECT radiotracers for human and animal research using established procedures. Works collaboratively with research investigators to produce and validate existing research compounds developed by external entities and works closely with any other contracted parties as needed to manufacture and perform quality control on routine and research radiotracers in compliance with protocols, current Good Manufacturing Practices, other FDA regulations, and the United States Pharmacopeia standards. Supports all aspects of daily production of clinical and research manufacturing. Operates cyclotron and associated equipment in compliance with protocols and good ALARA radiation safety practices. Assists in the development, maintenance and operation of automated radiochemistry to synthesis equipment in compliance with all protocols and regulatory guidelines. Maintains accurate written records of radiopharmaceutical production and quality control according to procedures and regulatory requirements. Maintains, calibrates and is responsible for a variety of chemistry and scientific instrumentation used in the production of PET radiopharmaceuticals.

CORE FUNCTIONS
1. Operates cyclotron and automated/manual radiochemistry synthesis equipment in the manufacturing of routine clinical and research PET radiopharmaceuticals in compliance with all protocol and regulatory guidelines. Responsibilities include, but are not limited to: Setup and preparation of chemicals and reagents, Operation of automated radiochemistry synthesis units, Cleaning of automated radiochemistry synthesis units, Maintenance of automated radiochemistry synthesis units.

2. Performs quality control procedures on radiotracers used in routine clinical and research procedures. Maintains accurate written records of radiopharmaceutical production and quality control according to procedures and regulatory requirements. Maintains, calibrates and is responsible for a variety of chemistry and scientific instrumentation used in the production of PET radiopharmaceuticals.

3. Assists in the design and development of synthetic strategies for the production of new radiotracers for research imaging. May assist senior radiochemist to produce and validate existing research compounds developed by external entities. Creates Standard Operating Procedures to formally document the manufacturing and quality control procedures.

4. Provides chemistry, manufacturing, and controls data to the Radioactive Drug Research Committee (RDRC) and, when indicated, the FDA to enable that committee to evaluate new tracers for research usage.

5. Routinely handles radioisotopes and radiotracers in a safe & compliant manner. Coordinates the acquisition and disposal of radioactive substances per state and federal regulations.

6. Uses and assists with the maintenance of the computerized lab information system including inventory control, standard operating procedures, batch records, and training.

7. Must be able to interact with all staff, physicians, and external contacts. Must be available to work a rotating schedule of various days/shifts including early morning, evenings, weekends if necessary. Customers are patients, visitors, researchers, physicians and other staff, vendors.

MINIMUM QUALIFICATIONS
BS degree in chemistry, nuclear science or related discipline.

Must be knowledgeable in implementing systems to ensure manufacturing processes meet regulatory guidelines with at least three years of experience in a facility that produces PET and/or SPECT radioisotopes. Must have strong analytical skills, work with minimal supervision and the ability to prioritize projects; must be organized and able to handle multiple tasks. Excellent human relations and communication skills are required.

PREFERRED QUALIFICATIONS
Experience with a clinical research facility, as well as, with United States Pharmacopeia regulations.

Additional related education and/or experience preferred.

Keywords: Banner Health, Phoenix , Radiochemist, Other , Phoenix, Arizona

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