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 Records Management team as a Senior Manager, Records Management and play a vital role in safeguarding the integrity of raw materials and sterile drug products. Are you seeking your next challenge as Senior Manager, Records Management, this is your chance to grow within a dynamic, mission-driven organization that’s transforming oncology from the inside out. The Senior Manager, Records Management will be responsible for oversight of all study level Trial Master Files including set-up, periodic and final QC and final transfer and archival. The position will develop oversight and TMF archival SOPs and manage the TMF archival platform. Key Responsibilities Responsible for developing and implementing a comprehensive records management strategy that is GCP and GDP compliant including oversight and archival SOPs and set-up and management of a TMF archival platform. Select and onboard/implement a TMF platform. Ensure inspection readiness state for outsourced TMFs by conducting periodic quality control reviews and following up to ensure timely and appropriate resolution of findings. Oversee the TMF archival process, ensuring that all documents are properly filed, indexed, and accessible. Prepare for and support health authority inspections (trial master file QCs, pulling documents during inspections). Stay current with regulatory requirements and industry best practices related to records management and TMF.

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 Clinical Supply Chain team as Senior Manager, Clinical Supply Chain and play a vital role in safeguarding the integrity of raw materials and sterile drug products. Are you seeking your next challenge as Senior Manager, Clinical Supply Chain? If so, this is your chance to grow within a dynamic, mission-driven organization that’s transforming oncology from the inside out. The Senior Manager, Clinical Supply supports day-to-day drug supply operations for Orano Med clinical trials, reporting to the Director of Clinical Supply. Key responsibilities include coordinating production schedules, tracking shipments, and resolving site-level supply issues to ensure timely drug delivery and dosing. Key Responsibilities Production and Delivery Coordination: Assist the Director of Clinical Supply with coordinating radiopharmaceutical production schedules to align with site-specific dosing timelines Manage logistics planning for dose deliveries from manufacturing sites to clinical sites, considering half-life constraints, time zones, and customs clearance Communicate regularly with manufacturing partners and courier vendors to confirm production status, pickup timing, and delivery confirmations Order and Shipment Tracking: Maintain and update internal tracking tools with real-time shipment status, from production through confirmed site receipt, including delivery confirmations and any delays Proactively follow up with depots, clinical sites, courier vendors, and internal logistics stakeholders to ensure timely deliveries and address any in-transit issues or exceptions Site and Vendor Communication Support: Support the Director of Clinical Supply by assisting with site-facing logistics, including shipment tracking, drug availability, and receipt follow-up Work closely with Clinical Operations, manufacturing, and vendor teams to help monitor schedule changes, resupply needs, and enrollment forecasts Identify and document any shipment delays, temperature excursions, or discrepancies, and escalate to the Director for resolution Cross-Functional Support: Collaborate with cross-functional teams to align on enrollment projections, production scheduling, and logistics activities. Join recurring supply calls to keep internal teams informed of upcoming shipments and constraints. Support the Director in coordinating day-of dosing communications with manufacturers, couriers, and clinical sites  

Orano Med is seeking a detail-oriented QC Analyst to join our Quality Control team. In this role, you will conduct cGMP testing of final products, in-process materials, raw materials, and stability samples. You will maintain laboratories, assist in writing and optimizing methods, perform method validation, and qualify lab equipment as needed. Responsibilities Perform comprehensive testing on final products, in-process materials, raw materials, and stability samples. Execute a variety of testing methods including chromatography, spectroscopy, wet chemistry, and radionuclide assays Complete and review test records with accuracy and attention to detail Report any quality anomalies according to established protocols Perform deviation and laboratory investigations as needed Draft data summaries including Certificates of Analysis (CofA) and stability summary tables Update methods, technical reports, and investigations documentation Prepare testing reagents and maintain laboratory supplies and chemicals Conduct environmental monitoring (EM) sampling, incubation, and testing Assist in validation and/or development of analytical methods and techniques Participate in the qualification of QC laboratory equipment Package and send samples to contract laboratories Additional responsibilities as assigned

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.

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.