Under direction of the Senior Operations Manager, PET Production and Cyclotron, the nuclear pharmacist provides a variety of services, ensuring compliance in the procurement, preparation, compounding, manufacturing, quality control testing, dispensing, distribution, and monitoring of radiopharmaceuticals. The nuclear pharmacist also must provide support for the safe and efficient production and use of radioactive drugs for research and clinical diagnostic use at MGH. 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 for Nuclear Pharmacists in the MGH PET Nuclear Pharmacy include but are not limited to:

1. 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.
2. Serves in a quality assurance (QA) role to ensure compliance with all departmental procedures, FDA guidance and regulatory filings.
3. Reviews and releases batches of PET radiopharmaceuticals manufactured under 21 CFR 212, cGMP PET drug manufacturing regulations.
4. Ensures compliance with all state, federal, and local regulations concerning these activities.
5. Maintains inventory and ensures suitability of all raw materials and components used in the production of PET radiopharmaceuticals
6. Performs set up, operation, and documentation of computer controlled automated synthetic devices dedicated to the production of PET radiopharmaceuticals.
7. 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.
8. Works with PET radiochemistry staff to troubleshoot radiopharmaceutical production and optimize yields.
9. Works with cyclotron facility staff to ensure quality and availability of PET radionuclides for manufacturing and compounding of PET radiopharmaceuticals.
10. Maintains detailed records of operation and validation of all processes taking place in the nuclear pharmacy and PET production facility.
11. Ensures that all shipments of radioactive material meet all regulatory requirements.
12. Works with MGH 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.

Skills:

• Knowledge of federal and state laws and regulations as they relate to nuclear pharmacy.
• Understanding of universal precautions and infection control.
• Knowledge of pharmacoeconomics.
• Effective interpersonal, writing, and communication skills.
• Attention to detail.
• Must be able to lift 60 lbs.
• Must have the ability to handle multiple tasks simultaneously and to work in high-pressure situations.
• Must demonstrate appropriate knowledge of the principles of growth and development of the neonate, adolescent, adult, and geriatric patient.
• Must possess the ability to assess patient specific data relative to age-specific needs and provide appropriate care.

Qualifications

Licenses, Certifications, and/or Registrations:

• Must be a licensed pharmacist in Massachusetts or eligible for reciprocation, required.
• Licensure as a nuclear pharmacist is required.
• If incumbent is not a licensed nuclear pharmacist upon hire, incumbent must become licensed as a nuclear pharmacist within 6 months of employment. At departmental discretion, an additional extension of up to 6 months for a total of 12 months may be allowed.
• Board certification in nuclear pharmacy is encouraged but not preferred.

Education:

• B.S. or higher in pharmacy is required.

Experience:

• 1-2 years of prior directly related nuclear pharmacy experience is preferred.

Supervisory Responsibility:

• Pharmacist is responsible for indirectly supervising employees while performing pharmacy duties.

EEO Statement

Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.