Radiopharmaceutical Production Specialist

3 days ago

Karachi, Sindh, Pakistan beBeeNuclearPharmacist Full time $120,000 - $160,000

Our growing radiopharmaceutical production program seeks an experienced professional to join our team as a Nuclear Pharmacist. The successful candidate will be part of our new radiopharmaceutical production facility focused on fluorine-18, gallium-68, and copper-64 based radiopharmaceuticals.

This is an exciting opportunity for someone who wants to contribute to the development of theranostics and make a difference in patient care. As a Nuclear Pharmacist, you will have the chance to work with a talented team of professionals who share your passion for innovation and excellence.

The ideal candidate will have strong clinical knowledge and experience in radiopharmaceutical production. They will also have excellent communication skills and be able to lead a team of professionals to ensure compliance with regulations and quality standards.

Key Responsibilities:
  • Ensure compliance with local and Federal regulations, company policies, corporate standards, and health and safety rules related to area of responsibility.
  • Participate in the joint Quality Assurance Program for PET radiotracer production.
  • 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.

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