Careers

Orano Med Theranostics Are you passionate about ensuring the highest standards in pharmaceutical manufacturing? Do you thrive in a fast-paced, detail-oriented environment where your work directly impacts clinical trial success? Join our Quality Assurance team as a QA Specialist II and play a vital role in safeguarding the integrity of raw materials and sterile drug products. Whether you're beginning your QA journey or seeking your next challenge, this is your chance to grow within a dynamic, mission-driven organization that’s transforming oncology from the inside out. The QA Specialist II supports GMP manufacturing operations by reviewing documentation, inspecting materials, and ensuring compliance with SOPs and regulatory standards. This role plays a key part in maintaining quality systems, supporting sterile manufacturing, and driving continuous improvement across QA processes. Key Responsibilities Review and inspect documentation for incoming raw materials and packaging components Release/disposition GMP products for Macrocyclics and OM Conduct thorough reviews of production batch records, logbooks, and associated documentation Perform area release for manufacturing operations Oversee sterile manufacturing processes and provide instruction on sterile gowning and aseptic techniques Review equipment and instrumentation documentation supporting GMP operations Scan and archive manufacturing documentation (e.g., batch records, audits, investigations, CAPAs, change controls) Follow up on investigations, CAPAs, and change controls to ensure timely and compliant resolution Participate in internal audits of GMP labs and non-GMP processes Assist in updating Quality SOPs and perform secondary documentation reviews Support documentation review related to technology transfer from R&D Work hours vary, start times possible as early as 12AM.

Orano Med is seeking a detail-oriented Quality Assurance Specialist for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals. The Quality Assurance Specialist will be responsible for supporting GMP manufacturing of raw materials and sterile drugs for clinical trials. The individual in this role will review documentation related to raw materials, components, and completed batch records followed by giving a disposition of each. Assist with quality systems improvements.  Responsibilities Inspect, review documentation, and release incoming raw materials and packaging components. Update Quality SOP’S and perform secondary review of documentation. Perform area release for manufacturing, as needed. Oversee sterile manufacturing process, provide sterile gowning and practices instruction. Review production batch records, logbooks, and associated documentation to assess completeness, accuracy, and compliance with SOPs. Review of equipment and instrumentation documentation in support of GMP manufacturing and testing operations. Scanning manufacturing documentation such as batch records, raw materials, audits, investigations, CAPA, and change control. Release/disposition GMP products for Macrocyclics and OM. Follow up on investigations, CAPAs and change controls for time completion. Review of documentation related to technology transfer from R&D for manufacturing activities. Perform Internal audits of GMP labs and other non-GMP processes as directed. Additional responsibilities as assigned Schedule Sunday - Thursday Hours: 3:00pm - 11:30pm 

Orano Med is seeking an Instrumentation Specialist for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals. The Instrumentation Specialist will be responsible for maintaining, calibrating, and ensuring the accurate operation of critical laboratory instrumentation. This position presents the opportunity to help establish a new facility that will meet high standards for quantity, speed, and reliability. Responsibilities Perform routine maintenance, calibration, and troubleshooting of HPLC systems, lab balances, particle counters, viable air samplers, BMS, and various sensors. Ensure all instrumentation operates within specified parameters and maintains accurate records of maintenance and calibration activities. Conduct temperature mapping for storage areas, equipment, and facilities to ensure compliance with regulatory requirements. Ensure all instrumentation activities comply with relevant regulatory standards (e.g., FDA, GMP, ISO). Diagnose and resolve technical issues with instrumentation, working with vendors and service providers as necessary. Remote work may be possible when the facility is under construction. Production Top priority: Daily routine production. Follow EHS regulations/guidelines: NRC (ALARA), OSHA, EPA, chemical, waste disposal, state/local regulations, etc. Manufacturing activities following SOPs, using proper aseptic technique. Setup production; line clearance; clean/VPHP. Troubleshoot urgent problems. Identify, document, and communicate failures/near misses. Quality/continuous improvement. Adhere to SOPs, company policies, regulatory requirements, and laws. Quality/continuous improvement Physical: Stand for 6+ hours, lift/move 50 lbs., and wear cleanroom PPE

At Orano, we are committed to providing safe, innovative nuclear and environmental solutions worldwide. This role manages Radiation Safety, Chemical Safety, and Environmental Health & Safety (EHS) programs at Orano’s DDPU facility. Serving as the subject matter expert for safety regulations, this position develops policies and procedures in compliance with OSHA, EPA, NRC, Texas DSHS, TCEQ, and company directives. Primary Job Duties: Radiation Safety  Develop and implement radiation safety policies, procedures, and training programs. Oversee employee radiation protection and maintain exposure records. Manage radiation exposure badges and dosimeters. Maintain radioactive materials (RAM) inventory and ensure compliance with equipment checks. Conduct facility inspections and audits; address safety issues promptly. Maintain certifications for domestic and international RAM shipments. Manage required forms and documentation for RAM use. RAM Logistics Coordinate packaging, labeling, and shipment of RAM per DOT, NRC, and IATA regulations. Document RAM receipts, shipments, and usage logs. Inspect shipments for compliance and maintain secure chain-of-custody. Oversee RAM waste segregation, packing, and disposal through licensed vendors.   Chemical Safety  Develop and implement the Chemical Hygiene Plan and safety programs. Oversee chemical inventory, labeling, storage, and disposal. Maintain spill response preparedness and emergency equipment. Conduct chemical safety inspections and respond to incidents. Analyze incident reports and recommend corrective actions. Maintain and audit SDS (Safety Data Sheet) binders.   Environmental Health & Safety  Develop and maintain the facility’s Environmental Protection, Safety, and Health Plan. Conduct hazard analyses and integrate controls into planning and operations. Monitor work areas, address safety concerns, and support continuous improvement. Lead safety incident reporting, investigations, and corrective actions. Track safety performance metrics and support a strong safety culture. Develop facility emergency plans and participate in required trainings and meetings.  

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.