Nuclear Radiopharmacist Specialist

Role Summary:

The successful candidate will join our team to establish and lead a new radiopharmaceutical production facility focused on fluorine-18, gallium-68, and copper-64 based radiopharmaceuticals. This individual will work closely with the Quality Assurance team to monitor overall integrity of the cGMP manufacturing process.

Key Responsibilities:

• Ensure compliance with local and Federal regulations, Company Policies, Corporate Standards, and Health and Safety rules related to area of responsibility.
• Supervise and assist with radiotracer manufacturing and quality control.
• Work with the Quality Assurance team to monitor overall integrity of the cGMP manufacturing process.
• Coordinate cGMP documentation review and facilitate process documentation.
• Assist in preparing documentation for IND and RDRC regulatory reviews.
• Oversee inventory management systems for chemicals and other materials necessary to meet cGMP criteria.
• Identify backorder situations early enough to validate replacement components and submit associated documentation to appropriate regulatory bodies.
• Monitor all cleanroom parameters required for daily operation.
• Notify Engineering Department of any OOS cleanroom specifications and appropriate regulatory groups as necessary.
• Oversee preventative maintenance and repairs to cleanroom facility and associated equipment.
• Facilitate and organize equipment maintenance and system suitability checks, and manually record results.
• Provide training and supervision to employees to ensure all lab activities are performed in compliance with regulations and initiatives, Company Policies, and Health and Safety rules.
• Supervise and maintain cleanliness of lab in accordance with the facility housekeeping schedules.
• Supervise and/or perform radiation wipes and surveys on shipping containers, pharmacy supplies, incoming packages, workspaces, and vehicles.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.

Requirements:

• Doctor of Pharmacy degree is mandatory.
• Pharmacist licensed in MA or eligible for reciprocal licensure is essential.
• PREFERRED: Nuclear pharmacist in MA.
• PREFERRED: Board certification in nuclear pharmacy.
• Massachusetts Controlled Substances Registration is preferred.

Working Conditions:

• Work is performed in the radiopharmaceutical facility, in a laboratory and office setting.
• Must be able to lift 50 pounds.

Supervisory Responsibility:

Direct supervision of Laboratory Assistants, Technicians, and Technologists.