
Pharmacist, Nuclear
4 weeks ago
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, we are launching a new radiopharmaceutical production facility focused on fluorine-18, gallium-68, and copper-64 based radiopharmaceuticals, and also developing new theranostics. The pharmacist will help to establish and lead this facility and collaborate with existing facilities across the MGB network.
Education
Doctor of Pharmacy required
Licenses and Credentials
Pharmacist [MA or eligible for reciprocation License]
PREFERRED: Nuclear pharmacist in MA
PREFERRED: Board certification in nuclear pharmacy.
Massachusetts Controlled Substances Registration [MCSR - Massachusetts] - Massachusetts Department of Public Health preferred
PRINCIPAL DUTIES AND RESPONSIBILITIES:- Ensure compliance with all local and Federal regulations, Company Policies, Corporate Standards, and Health and Safety rules related to area of responsibility.
- Actively participate in the joint Quality Assurance Program for PET radiotracer production of MGH and BWH.
- 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 the preparation of documentation for IND and RDRC regulatory reviews.
- Oversee inventory management systems for chemicals and other materials necessary to meet cGMP criteria.
- Adjust par value inventory levels as necessary to meet future facility needs as backorder situations present.
- 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.
- Assist in designing a facility life schedule.
- 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.
- Participate in maintaining a safe work environment by completing required training, suggesting improvements, and reporting unsafe acts or conditions.
- Work with Institute for Innovation in Imaging leadership to establish research relationships with biopharma.
- Ability to accommodate schedule changes based on user needs.
- Effective and professional communication skills with co-workers and study staff.
- Ability to cultivate a positive and inclusive work environment.
- Prioritization skills to balance proactive and reactive tasks.
- Handling multiple tasks efficiently without compromising quality.
- Strong knowledge of chromatography method development and radiotracer synthesis optimization.
- Organizational and communication skills.
- Judgment and interpretation skills for information and protocols.
- Technical problem-solving aptitude.
- Effective supervision and training abilities.
- Ability to make independent, well-informed decisions.
- Flexibility to adapt to shifting priorities and organizational changes.
- Problem anticipation and contingency planning skills.
- High productivity in stressful situations.
- Constructive challenge of proposed actions for improvement.
- Willingness to become an authorized user of radioactive materials.
Direct supervision of 2 Laboratory Assistants, Technicians, and Technologists.
Working Conditions:- Work is performed in the radiopharmaceutical facility of the Institute for Innovation in Imaging, in a laboratory and office setting.
- Must be able to lift 50 pounds.
The General Hospital Corporation is an Equal Opportunity Employer. We embrace diverse skills, perspectives, and ideas and are committed to providing reasonable accommodations for individuals with disabilities throughout the application and employment process.
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