Nuclear Pharmacist BWH

Principal Duties and Responsibilities

• Independently operates the Radiopharmacy and supports BICOR manufacturing units during operating hours, with schedules and responsibilities adapting to clinical, research, and staffing needs.
• Prepares, performs quality control, and dispenses SPECT radiopharmaceuticals.
• Performs PET radiopharmaceutical compounding, manufacturing, quality control, and distribution.
• Reviews manufacturing and compounding batch records against established product specifications and releases products when requirements are met.
• Manages inventory of SPECT radiopharmaceuticals and other materials needed to support daily operations.
• Performs and/or oversees equipment maintenance, system suitability testing, and required documentation.
• Verifies daily cleanroom parameters and ensures required environmental and operational standards are met.
• Maintains facility cleanliness in accordance with established cleaning procedures and schedules.
• Partners with Engineering to address out-of-specification results involving cleanrooms and associated equipment.
• Performs or oversees required radiation wipes and surveys of shipping containers, supplies, incoming packages, and workspaces.
• Collaborates with the Quality Systems Administration team to support the integrity and compliance of cGMP manufacturing processes.
• Supports preparation of documentation for ANDA, IND, and RDRC regulatory reviews.
• Provides training, guidance, and direction to staff as needed.
• Identifies and escalates quality or compliance concerns and implements corrective actions as appropriate.
• Supports the education of pharmacy students, nuclear medicine technology students, and medical residents on radiopharmaceutical production, quality control, and radiation safety.
• Serves as a resource for pharmacies, physicians, researchers, and other external partners seeking information about radiopharmaceuticals.

Qualifications

• Graduate of an Accreditation Council for Pharmacy Education (ACPE)-accredited pharmacy program and licensed or eligible for licensure with the Massachusetts Board of Pharmacy.
• Completion of a nuclear pharmacy program with coursework in radiation safety, radiopharmacy techniques, health physics, and instrumentation, or equivalent experience.
• Experience with computer-based data entry, ordering, and data compilation.
• Working knowledge of applicable regulations and standards governing radiopharmacy operations, including those of the Nuclear Regulatory Commission (NRC), Department of Transportation (DOT), Food and Drug Administration (FDA), Massachusetts Board of Pharmacy, Environmental Protection Agency (EPA), and Occupational Safety and Health Administration (OSHA).