Orano USA is establishing a new commercial-scale manufacturing facility for therapeutic radiopharmaceuticals (ATLab Indianapolis) to support Phase 3 clinical trials and commercial manufacturing. The intern will contribute to the facility's ramp-up, focusing on safety, training, project completion, and gaining technical and workplace skills.
Requirements
- Safety: Reading/on-the-job training in radiation safety, hazardous materials, occupational safety.
- Assist with submissions and compliance for RAM license and environmental compliance.
- 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.
- Proficiency with Microsoft Office applications (Word, Excel, Outlook).
Responsibilities
- 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.
- Assist with preparing and reviewing documents: SOPs, vendor qualification forms, material acceptance forms, instrument qualification forms, etc.
Other
- Read and follow all assigned relevant SOPs
- 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.
- In consultation with the supervisor, the Intern is expected to identify and complete a project with reasonable scope during the period of the internship.
