Junior Radiochemist

Banner Health; Tucson (AZ); On-site; USD 70,000 - 100,000; Full time

Job summary

Banner Alzheimer’s Institute (BAI) in Phoenix/Tucson area seeks a Junior Radiochemist to manufacture radiotracers for research and perform quality control of daily batches. You will work under senior staff, maintain equipment, and ensure compliance with FDA, USP, and GMP guidelines.

The role covers operating cyclotron facilities, QC testing, inventory management, instrument calibration, and environmental safety, withday shifts and potential early mornings or evenings as needed.

Qualifications

• BS degree in chemistry, nuclear science or related discipline.
• At least two years' experience in PET/SPECT radiochemistry production.
• Strong analytical, organizational and communication skills; able to work with minimal supervision.
• Knowledge of regulatory guidelines (FDA, USP) and GMP practices.

Responsibilities

• Operate cyclotron and radiochemistry equipment to produce radiotracers per SOPs.
• Perform routine quality control and troubleshoot equipment.
• Package and ship radiotracers to remote sites in compliance with DOT.
• Maintain inventory using the Laboratory Information System.
• Calibrate and maintain analytic instruments (HPLC, GC, TLC) and perform endotoxin testing.
• Maintain clean rooms and perform environmental monitoring.
• Draft and review SOPs and related documents; participate in lab meetings.
• Ensure safety and regulatory compliance; coordinate with staff and vendors.

Skills

Analytical skills

Multitasking

Communication skills

Regulatory compliance knowledge

Microsoft Office

Education

BS in Chemistry or related discipline

Preferred BS in Science/Chemistry

Tools

HPLC

GC

TLC

Radiation monitoring equipment

Job description

## Junior RadiochemistApplylocations: Banner Alzheimer's Institute (901 E Willetta St)time type: Full timeposted on: Posted Todayjob requisition id: R4448638**Primary City/State:**Phoenix, Arizona**Department Name:**Radiochemistry Research**Work Shift:**Day**Job Category:**Clinical CareTucson is set in a Sonoran Desert valley surrounded by five mountain ranges. Boasting an average 350 sunny days a year and warm dry air, the climate is ideal for year-round outdoor recreation. Tucson offers one-of-a-kind experiences for those interested in outdoor adventure and nature, heritage and culture, arts and attractions, golf and original Southwest-inspired dining.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.Schedule: Monday-Friday 6AM – 2:30PM with limited schedule flexibilityLocation: 901 E Willetta St Tucson, AZBanner Alzheimer's Institute (BAI) was established in 2006 as Banner Health's first Center of Excellence. Banner Sun Health Research Institute (BSHRI) was founded in 1986. Our team is uniquely, passionately, and strategically committed to ending Alzheimer's disease and other neurodegenerative disorders without losing another generation, advancing oncology research to improve cancer prevention and treatment outcomes, and providing an unparalleled model of care for families facing these devastating diseases. Banner Research is committed to improving people's lives through comprehensive patient care and advances that capitalize on the best biomedical research. We intend to make a transformational difference in Alzheimer's disease, other neurodegenerative disorders, and oncology research and care.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 1. 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). 2. 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. 3. 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. 4. 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. 5. 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 intervals. 6. Disinfects and sterilizes glassware in preparation for radiotracer compounding. Performs cleaning procedures of radiosynthesis modules prior to their use in radiotracer production. 7. Participates in regularly scheduled lab meetings in order to receive and provide information. Assists in the drafting and review of standard operating procedures, forms, material specification sheets or other laboratory documents. 8. Resolves a variety of problems using established alternatives. Department level responsibility. Must be able to interact with all staff and external contacts, e.g., product and service vendors. Must be available to work early mornings and evenings if necessary. 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 two 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. Must have a strong working knowledge of Microsoft Office Suite especially Word, Excel, Access, OneNote, and PowerPoint. Must have sufficient knowledge and understanding of chemical/pharmacy terminology in order to read, identify, and extract pertinent data from laboratory records and information. PREFERRED QUALIFICATIONS Bachelor's degree in Science, Chemistry, or related field. At least 2 years of prior experience in using radiation monitoring equipment, handling radioactive materials, including DOT training in the packaging and shipment of radioactive materials and performing radiosyntheses and quality control of radiopharmaceutical products per current FDA guidelines. Additional related education and/or experience preferred.