Careers

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

Job Description: Orano Med is seeking an HR Generalist for its Plano, TX location. This position requires applicable work experience in the radiopharmaceutical, pharmaceutical, or biotechnology industry. The ideal candidate must be hands-on with strong recruitment and sourcing experience. Under limited supervision, this role performs varied human resources activities across several HR functional areas for Orano Med Theranostics in the US. Major Duties and Responsibilities The HR Generalist will perform a variety of tasks including but not limited to: Serves as primary HR contact for managers and employees on corporate policies and procedures Implements best practices supporting Orano Med's mission Partners with Corporate HR on employee relations, investigations, and strategic programs Provides performance management guidance to line management Leads recruitment efforts, including sourcing and selection of qualified candidates Extends offers and coordinates relocation as needed Develops accountable leadership focused on employee engagement and performance Builds work relationships, morale, productivity, and retention Facilitates Performance Development and People Review processes Provides workforce planning and succession planning guidance Engages with external resources to benchmark HR best practices Liaises with Orano USA HR department on policy alignment

Orano Med is seeking a Project Manager- Radiopharmaceutical Equipment for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals. The Project Manager Radiopharmaceutical Equipment will manage technical projects related to radiopharmaceutical hot cells and other critical production equipment, from user requirements definition to qualification and operational follow-up.   Key Responsibilities Draft user requirements and specifications (URS) for hot cells and other critical systems (fluidic transfer systems, purification systems, radiation protection equipment). Participate in technical procurement: prepare tender documentation, analyze proposals, support supplier selection. Supervise design studies, fabrication, and commissioning, ensuring compliance with technical, regulatory, and operational standards. Lead qualification phases (IQ, OQ, PQ) in close collaboration with Orano Med quality and production teams. Manage all aspects of project execution: scheduling, budgeting, risk management, reporting, stakeholder coordination. Support equipment lifecycle and operational readiness: establish service contracts and maintenance plans, organize logistics for critical spare parts. Act as the primary contact for internal users and external service providers. Lead knowledge capitalization efforts and coordinate a user network for these equipment systems. Projects may also involve other strategic equipment used by Orano Med.

Job Description: The Associate Director, Quality Assurance supports the Company's short- and long-term goals for maintaining Quality Systems and Compliance. Provides direct oversight for the evaluation, implementation, execution and follow-up on quality systems in support of GMP compliance and release of finished product. This role oversees quality assurance of the manufacturing and packaging processes and procedures, the final review of investigations, and appropriate implementation of corrective actions to prevent recurrence. This role also provides input into the overall decision-making process pertaining to quality problems, internal and external, that can have far reaching results in terms of rejected batches, stock withdrawals, quarantined goods, revised production and marketing schedules and added manufacturing costs. Job Duties: Provides daily oversight of the QA teams responsible for supporting all production/processing areas. Develops and monitors appropriate KPI's for batch documentation review, Right First Time (RFT) and support of timely batch release. Responsible for department resource planning, talent development, and budget administration with regards to QA personnel. Directs investigations of product complaints and manufacturing discrepancies for manufactured products and ensures completion of appropriate documentation. Performs review of root-cause analysis and other problem-solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures. Provides QA review and approval of Investigations, CAPAs, SOPs, Change Controls, and protocols/reports. Ensures completeness, accuracy and compliance of all documentation. Coordinates the preparation, review, and approval of the Annual Product Quality Reports and any established metrics / KPIs. Participates in Regulatory/FDA inspections and audits by providing information or expediting/obtaining information required by the inspectors/auditors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.

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.