Objective

The RadiopharmaceuticalProduction Technician will be expected to perform all tasks associated with formulation, preparation, assembling, and packaging of components, according to cGMP Guidelines to meet production demands. Reporting to the Manager, Radiopharmaceutical Production, the Production Technician will have responsibility for aseptic production of radiopharmaceutical drug product and radioisotopes in accordance with established manufacturing batch records; will support the technical transfer, development, and validation of production methods associated with finished dosage form (FDF) drug products and radioisotope products; will investigate, resolve, and mitigate deviations, non-conformances, and OOS (Out of Specification) events associated with product manufacturing at the GMP facility; will monitor production-related equipment to ensure proper function and compliance with the established calibration / PM equipment schedule; and support continuous process improvement of existing manufacturing methods via Current Good Manufacturing Practices (cGMP).

*** Please note: must be flexible to work both the day and night shift ***
Essential Functions

• Produce radioisotopes and drug products following cGMP guidelines and resolve all production-related quality events in a timely manner.
• Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of drug product and radioisotopes.
• Participate in technical transfer and process validation activities in collaboration with other departments.
• Safely work with radioactive materials following ALARA principles and NRC guidelines.
• Utilize and monitor all manufacturing-related equipment.
• Conduct and appropriately document aseptic production of radiopharmaceutical drug product and radioisotopes via strict adherence to manufacturing batch records and affiliated SOPs.
• Safely handle and participate in the transfer of radioactive materials throughout the facility.
• Monitor manufacturing equipment to ensure performance and safety standards are met.
• Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure that all production equipment is in good working order and is validated for use.
• Preparation of packages for distribution as per the regulations for the Transportation of Dangerous Goods (TDG), Packaging and Transport of Nuclear Substances (PTNS), as well as International Air Transport Association (IATA)
• Provide verbal and written reports to supervisors in a clear and concise manner.
• Maintain accurate and complete lab data notebooks as per cGLP and/or cGMP, as appropriate.
• Adhere to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements.
• Embody and promote a quality culture and due diligence approach as part of all activities.
• Work well in a fast-paced team environment.
• Perform batch record calculations and maintain all documentation according to cGMP guidelines.
• Performs the maintenance and cleanliness of department, premises, and equipment on a daily basis.

• Associate degree or equivalent military experience. College level course work with a scientific background is highly desired. A bachelor’s degree (or higher) in scientific discipline is preferred.
• One or more years of relevant work experience is required, preferably in a pharmaceutical or cGMP manufacturing industry.
• Aseptic processing and technique experience preferred.
• Experience working with radiopharmaceuticals will be considered an asset but is not a requirement.

• Must be willing to work overnight shifts to support a small-sized team.  Typical shifts run Monday to Friday, with shifts spanning 10pm - 6am, 12am - 8am, 4am - 12pm and 9am - 5pm.
• Must be capable of providing front line troubleshooting of manufacturing equipment and process issues, properly elevating concerns, and issues to appropriate personnel.
• Full range of motion and ability to use both hands mandated by machinery. High degree of manual dexterity.
• Must be able to regularly lift 10 lb. weights, occasional lifting of up to 50 lbs.
• Ability to maintain focus on a complex task for 4-6 hours at a time.
• Excellent communications, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations, internal and external.
• Ability to work independently with minimal direction, and drive deliverables through to completion by deadlines provided.
• Highly organized with strong attention to detail and commitment to high quality work.
• Good interpersonal skills and ability to communicate information in a timely manner.
• Takes ownership and accountability for the production process, assigned production area, and associated documentation.

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