Massachusetts General Physicians’ Organization
Pharmacist, Nuclear
Massachusetts General Physicians’ Organization, Boston, Massachusetts, us, 02298
Job Description
Under the direct supervision of the Director of the Institute for Innovation in Imaging, the Nuclear Pharmacist will be part of our growing radiopharmaceutical production program. In alignment with existing facilities, this radiopharmaceutical production facility focuses on fluorine-18, gallium-68 and copper-64 based radiopharmaceuticals, and also developing new theranostics. The Nuclear Pharmacist will lead this facility and collaborate with existing facilities across the MGB network.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Ensure compliance with all local and Federal, State, and Local regulations, USP
and
guidelines, Company Policies, Corporate Standards and Health and Safety rules related to area of responsibility. Supervise and assist with radiotracer preparation, aseptic manipulation, 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 documentation for IND and RDRC regulatory reviews. Oversee inventory management for all chemicals, materials, supplies and equipment necessary to meet cGMP criteria. Adjust par value inventory levels as necessary to meet future facility needs. Proactively identify backorder situations early enough in order to validate replacement components and as necessary, submit associated documentation to appropriate regulatory bodies if necessary. Monitor all certified cleanroom ISO parameters required for daily aseptic operations. Notify Engineering Department of any facility issues that are not meeting specifications and notify appropriate regulatory groups if necessary. Oversee annual calibrations, preventative maintenance, certifications, and repairs of all analytical and associated equipment involved with the preparation of radiopharmaceuticals. Facilitate, organize and document all daily temperature, humidity, differential pressure, and equipment checks to meet specifications. Initiate, review, and complete all documented deviations, investigations (General or Out of Specification), and CAPAs to ensure quality assurance. Provide training and supervision to employees to assure 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 daily radiation wipes and surveys on outgoing shipping containers, pharmacy supplies, incoming RAM packages, work spaces, and equipment. Identify and report any quality or compliance concerns and take immediate corrective action as required. Actively participate in maintaining a safe work environment by completing required training, providing suggestions for improving the health and safety program and bringing unsafe acts and/or conditions to the attention of management. Work with Institute for Innovation in Imaging leadership in establishing research relationships with biopharma. SKILLS & COMPETENCIES REQUIRED:
Ability to accommodate schedule changes based on user needs. Ability to communicate effectively and in a professional manner, both with co-workers and study staff. Ability to cultivate a positive and inclusive work environment. Ability to prioritize job duties (i.e. successfully balances proactive versus reactive tasks). Handles multiple tasks quickly without forfeiting quality. Excellent command of underlying theory (e.g. chromatography method development and radiotracer synthesis optimization). Strong organizational and communication skills. Excellent judgment and ability to interpret information and protocol requirements. Aptitude for technical problem solving. Ability to supervise and train staff effectively. Ability to make independent and effective decisions that are in the best interest of the lab. Ability to adapt to shifting priorities in response to changing deadlines and work requirements. Flexibility to deal positively with organizational changes. Ability to anticipate problems and develop contingency plans to deal with them. Ability to maintain high productivity in stressful situations. Ability to challenge proposed actions in a way that facilitates constructive discussion. Willingness to become an authorized user of radioactive materials. LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:
Licenses:
Nuclear Pharmacist in MA or eligible for reciprocation. Certifications: Preferred:
Quality Assurance / Board certification in nuclear pharmacy. Qualifications
EDUCATION:
Required:
Bachelor's Degree. Preferred:
Doctoral Degree. Field of Study/Additional Specialized Training:
B.S. or higher in a pharmacy program is required. EXPERIENCE:
Direct experience working with radiopharmaceuticals is required. Preferred to have 3-5 years of prior directly related experience. SUPERVISORY RESPONSIBILITY:
Direct: 2 (Laboratory Assistants, Technicians and Technologists). WORKING CONDITIONS:
Work is performed in the radiopharmaceutical facility of the Institute for Innovation in Imaging. Laboratory and office setting. Must be able to lift 50 pounds. Primary Location
MA-Charlestown-MGH 13th Street Work Locations
MGH 13th Street 149 13th Street Charlestown 02129 Job Organization
Massachusetts General Hospital (MGH) Schedule
Full-time Standard Hours: 40 Shift
Day Job Employee Status
Regular Recruiting Department: MGH Radiology Research
#J-18808-Ljbffr
Ensure compliance with all local and Federal, State, and Local regulations, USP
and
guidelines, Company Policies, Corporate Standards and Health and Safety rules related to area of responsibility. Supervise and assist with radiotracer preparation, aseptic manipulation, 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 documentation for IND and RDRC regulatory reviews. Oversee inventory management for all chemicals, materials, supplies and equipment necessary to meet cGMP criteria. Adjust par value inventory levels as necessary to meet future facility needs. Proactively identify backorder situations early enough in order to validate replacement components and as necessary, submit associated documentation to appropriate regulatory bodies if necessary. Monitor all certified cleanroom ISO parameters required for daily aseptic operations. Notify Engineering Department of any facility issues that are not meeting specifications and notify appropriate regulatory groups if necessary. Oversee annual calibrations, preventative maintenance, certifications, and repairs of all analytical and associated equipment involved with the preparation of radiopharmaceuticals. Facilitate, organize and document all daily temperature, humidity, differential pressure, and equipment checks to meet specifications. Initiate, review, and complete all documented deviations, investigations (General or Out of Specification), and CAPAs to ensure quality assurance. Provide training and supervision to employees to assure 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 daily radiation wipes and surveys on outgoing shipping containers, pharmacy supplies, incoming RAM packages, work spaces, and equipment. Identify and report any quality or compliance concerns and take immediate corrective action as required. Actively participate in maintaining a safe work environment by completing required training, providing suggestions for improving the health and safety program and bringing unsafe acts and/or conditions to the attention of management. Work with Institute for Innovation in Imaging leadership in establishing research relationships with biopharma. SKILLS & COMPETENCIES REQUIRED:
Ability to accommodate schedule changes based on user needs. Ability to communicate effectively and in a professional manner, both with co-workers and study staff. Ability to cultivate a positive and inclusive work environment. Ability to prioritize job duties (i.e. successfully balances proactive versus reactive tasks). Handles multiple tasks quickly without forfeiting quality. Excellent command of underlying theory (e.g. chromatography method development and radiotracer synthesis optimization). Strong organizational and communication skills. Excellent judgment and ability to interpret information and protocol requirements. Aptitude for technical problem solving. Ability to supervise and train staff effectively. Ability to make independent and effective decisions that are in the best interest of the lab. Ability to adapt to shifting priorities in response to changing deadlines and work requirements. Flexibility to deal positively with organizational changes. Ability to anticipate problems and develop contingency plans to deal with them. Ability to maintain high productivity in stressful situations. Ability to challenge proposed actions in a way that facilitates constructive discussion. Willingness to become an authorized user of radioactive materials. LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:
Licenses:
Nuclear Pharmacist in MA or eligible for reciprocation. Certifications: Preferred:
Quality Assurance / Board certification in nuclear pharmacy. Qualifications
EDUCATION:
Required:
Bachelor's Degree. Preferred:
Doctoral Degree. Field of Study/Additional Specialized Training:
B.S. or higher in a pharmacy program is required. EXPERIENCE:
Direct experience working with radiopharmaceuticals is required. Preferred to have 3-5 years of prior directly related experience. SUPERVISORY RESPONSIBILITY:
Direct: 2 (Laboratory Assistants, Technicians and Technologists). WORKING CONDITIONS:
Work is performed in the radiopharmaceutical facility of the Institute for Innovation in Imaging. Laboratory and office setting. Must be able to lift 50 pounds. Primary Location
MA-Charlestown-MGH 13th Street Work Locations
MGH 13th Street 149 13th Street Charlestown 02129 Job Organization
Massachusetts General Hospital (MGH) Schedule
Full-time Standard Hours: 40 Shift
Day Job Employee Status
Regular Recruiting Department: MGH Radiology Research
#J-18808-Ljbffr