Careers

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. Key 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

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.

Orano Med Theranostics LLC is seeking a Senior Accountant to support day-to-day accounting functions and contribute to the growth of its U.S. operations. Reporting to the Director of Financial Operations, this role will serve as a key member of the Accounting/Finance team, working collaboratively within a dynamic, mission-driven environment. Job Responsibilities: Perform daily accounting operations, including accounts payable (AP), accounts receivable (AR), journal entries, and general ledger maintenance, including intercompany transactions. Lead and execute monthly, quarterly, and year-end close processes to ensure timely and accurate financial reporting. Assist in cash management processes, including payment processing and AR collections tracking. Support budgeting and financial planning processes by preparing schedules and variance analyses. Ensure compliance with internal controls, financial policies, and accounting standards. Review and analyze financial statements, prepare account reconciliations, and validate subledger activity with a strong focus on accuracy and completeness. Collaborate with external auditors, tax consultants, and other service providers during audits and tax filings. Assist with compliance requirements for federal, state, and local taxes, including sales and use tax, payroll tax, and related filings. Contribute to process improvement initiatives to enhance efficiency and accuracy within the accounting function.

Orano Med: Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells. Job Summary: Orano Med is seeking an Instrumentation Specialist, CQV or Sr. Instrumentation Specialist, CVQ for ATLab Indianapolis, a new, state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability. Job Responsibilities: Oversee IQ/OQ/PQ for new instruments Draft/review/approve documents related to CQV (SOPs, calibration certificates, IQ/OQ/PQ protocols, completed IQ/OQ/PQ reports) Equipment/service logs: establish, review, maintain URS for equipment: Assist with drafting/review/approval Responsible for a variety of cGMP and non-cGMP instruments including:Production: preparatory LC, fluid transfer, dispensing, weighing, EM QC: LC, HPGe, gamma counter, sterility, analytical balances, pipettes Hot cells: VPHP, EM, fill/finish, other sensors/controls Safety: radiation detectors for personnel, surfaces, air General: refrigerators/freezers, incubators Assist with cGMP aspects of facilities equipment/sensors/controls: hot cells/cleanrooms/HVAC, temperature/RH, particle counters, fume hoods, access control, etc. Work with instrument operators to develop robust protocols for system suitability checks for equipment Assist with vendor qualifications Top Priority: On-Time Production/Release of Product Batch Release All tasks from the Setup Phase that continue into Production Phase. Carrying out/supervising calibration procedures and equipment maintenance to ensure that instruments maintain their qualified status. Preparation of calibration certificates and data reports using appropriate Quality documentation. Ensuring that the equipment is calibrated as per specifications and industry standards. Oversee warranties, PMs, scheduled recalibration/requalification Scheduling appointments for equipment maintenance and servicing. Troubleshooting and repairing equipment and/or supervise outside contractors performing these tasks Testing repaired equipment to verify qualified status Ensuring a complete stock of backup instruments, spare parts, calibration equipment, other supplies. Expert on instrumentation: liaison to management/inspectors Write protocols for in-house calibrations/qualifications Analyze/suggest equipment upgrades and software Study industry guidelines and perform Change Controls to bring Orano Med SOPs into alignment (FDA, USP/EP, ICH, PDA, etc.) Oversee investigations to resolve deviations/OOS/recalls/complaints/FMEAs related to equipment.

The Project Manager (PM) works with members of the Global Development Team (GDT) to develop, track and report on cross-functional, integrated clinical development planning, timelines and risks. The role ensures that the program moves forward at the expected cadence and in accordance with company goals and is a key member of the GDT leadership team.  Job Responsibilities: Partner with Global Development Team (GDT) technical leads to identify key deliverables and activities to be completed, identifies dependencies, and optimizes the sequence of project activities. Manage GDT meetings including developing agendas, documenting decisions and tracking/following up on action items. Ensure cross-functional alignment through the integration of interdependent activities and through the communication of plans and timelines, with specific emphasis on critical path activities. Assist GDT technical leads with anticipating and tracking the execution of required deliverables and assists with navigating project teams through corporate governance. Build out project management tools to support internal program level anticipating, tracking and reporting. Capture project risks, develop mitigation plans and communicates project status clearly internally and externally as appliable. May include supervision of 1-2 junior project planners.

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

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.