<p>Employment Classification : Student</p> <p>Job details :</p> <p>Position Summary The Intern - Radiopharmaceutical Manufacturing will participate in the establishment of ATLab Indianapolis as a new commercial-scale manufacturing facility for therapeutic radiopharmaceuticals. During Summer 2024, the facility will be concluding construction and qualification, so the Intern should focus efforts on: safety and occupational training, completing an assigned project, helping with basic tasks, growing in technical understanding, developing workplace skills, and building a professional network. Safety and Compliance Read and follow all assigned relevant SOPs Safety: Reading/on-the-job training in radiation safety, hazardous materials, occupational safety. Assist with submissions and compliance for RAM license and environmental compliance. Production, QC, Shipping Observe/assist with qualification of spaces: IQ/OQ/PQ of cleanrooms and aseptic spaces Assist with qualification (IQ/OQ/PQ) of new equipment and instrumentation. Observe and understand: function of all instrumentation; chemistry behind production of Pb-212 and radiolabeled final drug product; science behind all QC methods. Assist with implementation of new software: inventory management, chemical inventory, eBR, LIMS, dose ordering, shipping software, etc. Consumable supplies: assist with inventory management, including planning, purchasing, inspecting, and accepting incoming supplies. Assist with design and implementation of shipping equipment and procedures. Quality Assurance Embody and promote a culture of quality and continuous improvement. Adhere to all applicable procedures, cGMP, company policies, and any other quality or regulatory requirements. Learn about and gain comfort with cGMP and QMS. Assist with preparing and reviewing documents: SOPs, vendor qualification forms, material acceptance forms, instrument qualification forms, etc. Project In consultation with the supervisor, the Intern is expected to identify and complete a project with reasonable scope during the period of the internship. Travel Amount: 1-3 optional travel opportunities The intern may receive other tasks and responsibilities as assigned.</p> <p>Position Summary The Intern - Radiopharmaceutical Manufacturing will participate in the establishment of ATLab Indianapolis as a new commercial-scale manufacturing facility for therapeutic radiopharmaceuticals. During Summer 2024, the facility will be concluding construction and qualification, so the Intern should focus efforts on: safety and occupational training, completing an assigned project, helping with basic tasks, growing in technical understanding, developing workplace skills, and building a professional network. Safety and Compliance Read and follow all assigned relevant SOPs Safety: Reading/on-the-job training in radiation safety, hazardous materials, occupational safety. Assist with submissions and compliance for RAM license and environmental compliance. Production, QC, Shipping Observe/assist with qualification of spaces: IQ/OQ/PQ of cleanrooms and aseptic spaces Assist with qualification (IQ/OQ/PQ) of new equipment and instrumentation. Observe and understand: function of all instrumentation; chemistry behind production of Pb-212 and radiolabeled final drug product; science behind all QC methods. Assist with implementation of new software: inventory management, chemical inventory, eBR, LIMS, dose ordering, shipping software, etc. Consumable supplies: assist with inventory management, including planning, purchasing, inspecting, and accepting incoming supplies. Assist with design and implementation of shipping equipment and procedures. Quality Assurance Embody and promote a culture of quality and continuous improvement. Adhere to all applicable procedures, cGMP, company policies, and any other quality or regulatory requirements. Learn about and gain comfort with cGMP and QMS. Assist with preparing and reviewing documents: SOPs, vendor qualification forms, material acceptance forms, instrument qualification forms, etc. Project In consultation with the supervisor, the Intern is expected to identify and complete a project with reasonable scope during the period of the internship. Travel Amount: 1-3 optional travel opportunities The intern may receive other tasks and responsibilities as assigned.</p> <p>Adress : Brownsburg</p>