The Production Technician plays an active role in daily production of targeted radioligand therapy products in a new state-of-the-art facility in Indianapolis, Indiana. Due to the nature of the process (sterile radioactive drug products) this role requires attention to detail, ownership of the process and understanding of safety and quality standards.
General responsibilities will include, but are not limited to the following:
• Supports all technical aspects related to production readiness including cleaning and performing sterilization of the isolators using vaporized hydrogen peroxide.
• Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
• Performs detailed setup and preparation of instruments and automated equipment.
• Performs production of each individual customer product vial in a highly classified isolator cell while ensuring the sterility of the injectable drug product. This includes dispensing vials, removing those vials using a delivery system and preparing vials for shipment.
• Accurately record data in the batch record and ERP system.
• Maintains and prepares equipment/environment for use
• Participation in qualification/validation activities
• Assist on deviation investigations, audits, and inspections
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