Job Title:
Nuclear Pharmacist
About the Role:
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 supports the safe and efficient production and use of radioactive drugs for research and clinical diagnostic purposes at MGH.
The incumbent is involved in all aspects of the day-to-day operation of the PET Production and Nuclear Pharmacy radiopharmaceutical facilities. Additionally, the nuclear pharmacist offers consultation regarding the use of radiopharmaceuticals and non-radioactive imaging medications, as well as health and safety issues in patient care.
Duties and Responsibilities:
1. Assuming overall responsibility for quality oversight of the FDA-regulated, cGMP PET manufacturing facility and PET nuclear pharmacy, including manufacturing, compounding, quality control testing, dispensing, and packaging of PET radiopharmaceuticals.
2. Serving in a quality assurance (QA) role to ensure compliance with departmental procedures, FDA guidance, and regulatory filings.
3. Reviewing and releasing batches of PET radiopharmaceuticals manufactured under 21 CFR 212, cGMP PET drug manufacturing regulations.
4. Ensuring compliance with all applicable state, federal, and local regulations.
5. Maintaining inventory and ensuring the suitability of all raw materials and components used in production.
6. Performing setup, operation, and documentation of computer-controlled automated synthesis devices dedicated to PET radiopharmaceutical production.
7. Performing complex analytical testing, including TLC, HPLC, GC, radionuclide identity and purity testing, sterility, and pyrogen testing.
8. Collaborating with PET radiochemistry staff to troubleshoot production issues and optimize yields.
9. Working with cyclotron staff to ensure the quality and availability of PET radionuclides.
10. Maintaining detailed records of operations and validations.
11. Ensuring all shipments of radioactive materials meet regulatory requirements.
12. Working with radiation safety staff to ensure compliance with safety principles and regulations.
Requirements:
* Licensed pharmacist in Massachusetts or eligible for reciprocation.
* Licensure as a nuclear pharmacist is required.
* Board certification in nuclear pharmacy is encouraged but not required.
* B.S. or higher in pharmacy required.
* 1-2 years of relevant nuclear pharmacy experience preferred.