Nuclear Pharmacist

4 weeks ago

Boston, Massachusetts, United States Massachusetts General Hospital Full time
Nuclear Pharmacist Job Summary

Under the direction of the Senior Operations Manager, PET Production and Cyclotron, the nuclear pharmacist provides a variety of services to ensure compliance in the procurement, preparation, compounding, manufacturing, quality control testing, dispensing, distribution, and monitoring of radiopharmaceuticals.

The nuclear pharmacist also provides support for the safe and efficient production and use of radioactive drugs for research and clinical diagnostic use at Massachusetts General Hospital.

The incumbent is involved in all aspects of the day-to-day operation of the PET Production and Nuclear Pharmacy radiopharmaceutical facilities.

In addition, the nuclear pharmacist provides consultation regarding all aspects of the use of radiopharmaceuticals and non-radioactive adjunct imaging medications, as well as health and safety issues in patient care.

Duties and Responsibilities
  • Assumes overall responsibility for quality oversight of the FDA regulated, cGMP PET manufacturing facility and PET nuclear pharmacy for the manufacturing, compounding, quality control testing, dispensing and packaging of PET radiopharmaceuticals.
  • Serves in a quality assurance (QA) role to ensure compliance with all departmental procedures, FDA guidance and regulatory filings.
  • Reviews and releases batches of PET radiopharmaceuticals manufactured under 21 CFR 212, cGMP PET drug manufacturing regulations.
  • Ensures compliance with all state, federal, and local regulations concerning these activities.
  • Maintains inventory and ensures suitability of all raw materials and components used in the production of PET radiopharmaceuticals.
  • Performs set up, operation, and documentation of computer controlled automated synthetic devices dedicated to the production of PET radiopharmaceuticals.
  • Performs complex analytical testing on manufactured and/or compounded radiopharmaceutical including, thin layer chromatography (TLC), high performance liquid chromatography (HPLC), gas chromatography (GC), radionuclide identity and purity testing with high purity germanium solid state detectors, sterility and pyrogen testing.
  • Works with PET radiochemistry staff to troubleshoot radiopharmaceutical production and optimize yields.
  • Works with cyclotron facility staff to ensure quality and availability of PET radionuclides for manufacturing and compounding of PET radiopharmaceuticals.
  • Maintains detailed records of operation and validation of all processes taking place in the nuclear pharmacy and PET production facility.
  • Ensures that all shipments of radioactive material meet all regulatory requirements.
  • Works with Massachusetts General Hospital radiation safety staff to ensure that all tasks are performed in the PET nuclear pharmacy are in compliance with regulatory and prudent radiation safety principles.
Qualifications
  • Must be a licensed pharmacist in Massachusetts or eligible for reciprocation.
  • Licensure as a nuclear pharmacist is required.
  • Board certification in nuclear pharmacy is encouraged but not preferred.
  • B.S. or higher in pharmacy is required.
  • 1-2 years of prior directly related nuclear pharmacy experience is preferred.

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