Quick overview
SeniorityMid Senior
Employment typeFull Time
Work modeOn Site
LocationSan Antonio, United States
ComplianceFDA RegulationsPharmacy
Job description
The PET Radiochemist is responsible for the daily production and quality control of routine PET radiopharmaceuticals for clinical and research studies. The PET radiochemist will also be responsible for completing and maintaining the appropriate documentation required by federal and state agencies associated with the production and distribution of the PET drug products/radioisotopes.
- Handle radioactive material for radiochemical synthesis in compliance with standard operating protocols and good ALARA radiation safety practices.
- Operation of laboratory instruments including automated chemistry modules, purification, and analytical instrumentation for radiopharmaceutical production.
- Preparation of radiopharmaceuticals in compliance with FDA regulations and 21CFR Part 212 - Current Good Manufacturing Practice for Positron Emission Tomography Drugs.
- Troubleshoot laboratory equipment using mechanical, electrical, and basic science skills.
- Develop and perform new processes or protocols for validation, manufacturing, and quality control of radiopharmaceuticals.
- Assist the facility director in developing, improving, and maintaining protocols, various applications, and licenses as required for routine radiopharmaceutical production.
- Assist in packaging and shipping of radioactive material in compliance with all state and federal regulations. Assist with the return and cleaning of shipping containers as assigned.
- Assist in preparing regulatory documents for submission to the FDA and other regulatory agencies.
- Maintain training records, instrument operation logs, repair, and maintenance records.
- Conduct periodic safety evaluations and internal laboratory audits
- Other duties as assigned.
- Higher education credentials and prior experience in handling radioactive material is desirable but not essential.
- Higher education credentials and prior experience in handling radioactive material is desirable but not essential.
- Higher education credentials and prior experience in handling radioactive material is desirable but not essential.
Education:
- Required Bachelor's Degree degree in chemistry, Physics, nuclear medicine technology, engineering, pharmacy, or related field.
Experience:
- 0-2 years experience is required.
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