Radiopharmaceutical Production Technologist
Duties and Responsibilities:
• Operates, maintains and calibrates automated and semi-automated radiopharmaceutical manufacturing equipment.
• Lead and execute the qualification of manufacturing processes, validation protocols and manufacturing validation of clinical-grade and commercial-grade radiopharmaceuticals.
• Prepares SOPs for manufacturing/production activities and validation protocols for production processes and equipment including final reports.
• Conduct regular production of radiopharmaceuticals for clinical and commercial use according to cGMP standards.
• Initiate and author Investigations, CAPAs, Deviation and Change Control documentation as related to manufacturing and testing of radiopharmaceuticals.
• Follow and observe all radiation safety procedures. Provide related training to other staff members as required.
• Maintain a clean and safe working environment in compliance with safety and pharmaceutical regulation.
• Perform radiation safety duties in compliance with regulations.
• Efficiently comply with waste management rules and regulations.
• Ability to work various shifts
• Other duties as assigned
• Bachelor’s degree in a scientific related discipline (e.g. Chemistry, microbiology)
Technical Skills Required:
• 3+ year experience in a commercial pharmaceutical development or manufacturing settings
• Knowledge of GMP/GLP principles
• Experience with the production of I-131 or PET radiopharmaceuticals and experience with GMP production using automated synthesis units for radiopharmaceuticals is a huge plus!
• Knowledge of safety procedures for hazardous environment (chemical and radioactive)
• Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification required.
• Knowledge of gamma spectroscopy, liquid scintillation and gas-proportional counting instrumentation.
• Understands CMC documentation for novel compounds consistent with requirements for IND, NDA, ANDA, RDRC or other regulatory pathways.
• Experience in an environmental testing laboratory is a plus.
• Knowledge of Current Good Manufacturing Practice (21 CFR 211)
• Knowledge and experience with quality assurance oversight of aseptic manufacturing processes
• Knowledge and experience with pharmaceutical quality systems and quality assurance concepts
• Radiopharmaceutical experience a plus.
• Excellent communication skills both verbal and written.
• Strong problem- solving skills.
• Effective interpersonal skills.
• Must be able to manage multiple priorities.