Practice Manager, Nuclear Pharmacy

Mass General Brigham•Boston, MA

1d•$118,435 - $172,234•Onsite

About The Position

The Practice Manager, Nuclear Pharmacy is a member of the pharmacy management staff working in the BWH/BICOR facility, a dual-registered nuclear pharmacy and PET drug manufacturing facility located at the BWH main campus. The mission of the BICOR/Nuclear Pharmacy program is to meet the clinical need for radiopharmaceuticals utilized in the nuclear medicine & molecular imaging department at BWH and affiliated institutions while supporting radiotracer development for researchers throughout the Mass General Brigham system. Reporting to the Operations Manager, BWH Nuclear Pharmacy & PET Production, the Nuclear Pharmacy Coordinator provides a heightened level of oversight, practice expertise, and cross-functional leadership for daily operation of the nuclear pharmacy and is a leading voice in the quality management program for the cGMP PET drug manufacturing plant. This role serves as an operational liaison between Nuclear Pharmacy / BICOR leadership and other institutional departments, including Nuclear Medicine clinic operations, Interventional Radiology, and Radiation Safety. The coordinator ensures routine procedures are harmonized with institutional policy and industry best practice standards and is central to scheduling routine and specialized training to nuclear medicine professionals throughout the department. The incumbent assists departmental leadership with maintaining regulatory compliance throughout the nuclear pharmacy practice in an intensely controlled operational environment.

Requirements

Graduate of an AACP accredited pharmacy program and a registered pharmacist with the Massachusetts Board of Pharmacy, or Board eligible. (Required)
Recognized as an Authorized Nuclear Pharmacist on a license issued by the Nuclear Regulatory Commission or an Agreement State. (Required)
Can demonstrate expertise and experience in the following practice areas: sterile preparation and compounding of SPECT and radiotherapeutic drugs or medical devices under USP <825> practice standards, PET drug manufacturing and quality management under 21 CFR part 212, federal and state regulatory requirements for the operation of a nuclear pharmacy, and NRC-compliant training of nuclear medicine professional staff (NMTs, Pharmacy, Physicians). (Required)

Nice To Haves

Five or more years as Authorized Nuclear Pharmacist in an academic or commercial setting. (Preferred)
Certification from the Board of Pharmaceutical Specialties as a Nuclear Pharmacist, or certification eligible. (Preferred)

Responsibilities

Responsible for operating the Radiopharmacy independently and staffing BICOR manufacturing units during operating hours as needed. Shifts and responsibilities are subject to change according to clinical, research, and staffing needs.
Oversees and performs SPECT radiopharmaceutical preparation, quality control, and dispensing.
Performs PET compounding, manufacturing, quality control, and distribution.
Compares handwritten results documented on manufacturing and compounding batch records with product specifications. Releases product when handwritten results are within specifications.
Oversees inventory management systems for SPECT radiopharmaceuticals and other materials necessary to meet dispensing needs.
Completes and/or oversees maintenance and system suitability for equipment used daily and verifies or records results.
Verifies all cleanroom parameters required for daily operation.
Responsible for cleanliness of facility in accordance with the documented cleaning schedules.
Notifies the Engineering Department of any Out of Specification results within cleanrooms and associated equipment.
Performs or ensures that radiation wipes and surveys on shipping containers, supplies, incoming packages, and workspaces are completed.
Works with the Quality Systems Administration team to monitor overall integrity of the cGMP manufacturing process.
Assists in the preparation of documentation for ANDA, IND and RDRC regulatory reviews.
Provides training and direction to staff as needed.
Identifies and reports to management any quality or compliance concerns and takes immediate corrective action as required.
Assists with the instruction of students (pharmacy and nuclear medicine technologists) and medical residents on practical aspects of radiopharmaceutical production, quality control and radiation safety.
Provides information on radioactive pharmaceuticals to outside inquiries including pharmacies, physicians and researchers.
Daily oversight of all nuclear pharmacists, pharmacists, support staff, and students working in the nuclear pharmacy.
Ensures that all practice requirements for a sterile nuclear pharmacy cleanroom environment are met.
Coordinates complex workflows across the nuclear pharmacy practice and cGMP quality management system.
When necessary, provides operations leadership support in nuclear pharmacy practice areas throughout the Mass General Brigham system.