Careers

Orano Med is seeking a Facilities Engineer for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals. The Facilities Engineer will oversee the maintenance, optimization, and compliance of our state-of-the-art manufacturing facility. The ideal candidate will ensure that all facility systems operate efficiently, safely, and in alignment with regulatory standards pertinent to the pharmaceutical industry. Facility Maintenance & Optimization: Manage and perform preventive, corrective, and predictive maintenance on facility equipment and systems to ensure optimal performance. Assess and optimize facility layout and operational systems to enhance efficiency and safety. Develop and maintain a process for ongoing evaluation and upgrade of capital equipment. Regulatory Compliance: Ensure all facility operations comply with FDA cGMP regulations and other relevant standards. Develop and maintain Standard Operating Procedures (SOPs) related to facility operations. Project Management: Lead projects related to facility modifications, equipment installations, and system upgrades. Coordinate with internal teams and external contractors to ensure timely and compliant project execution. Safety & Environmental Stewardship: Implement and uphold safety protocols to maintain a secure working environment. Manage waste disposal and recycling systems in compliance with environmental regulations. Documentation & Reporting: Maintain accurate records of maintenance activities, inspections, and compliance reports. Prepare technical reports evaluating trends and facility performance data. Other responsibilities as needed.

Orano Med is seeking a Customer Service Manager for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals. The Customer Service Manager will take ownership of building out the customer service program within Orano Med. This role will contribute to the successful commercial launch of AlphaMedix in North America. The ideal candidate will possess a strong background in customer service systems implementation and cross-functional collaboration with internal and external stakeholders. Primary Responsibilities: Set up a customer service program for a new radio-pharmaceutical manufacturing operation from the ground up. Work with software developers to embed customer service functions into a new platform for online ordering and product tracking. Establish a communication protocol for external customers when shipment delays/disruptions occur. Develop customer service-oriented Key Performance Indicators to measure the success of the operation from the customer’s perspective. Communicate progress regularly to key stakeholders and escalate potential roadblocks when identified. Work with external partners to define roles and responsibilities for customer engagement in a contract manufacturing environment. Define customer complaint handling, communication, and feedback policies.

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.

Orano Med is seeking a Sterility Assurance Technician. The technician will be responsible for conducting routine viable and non-viable environmental monitoring, sampling, and testing. The ideal candidate will collaborate with cross-functional teams to execute bioburden reduction monitoring strategies, evaluation of monitoring data, and assist in identifying and evaluating microbiology-related issues. Technical Expertise Provide support in evaluating bioburden reduction methods, including aseptic techniques, cleaning, and disinfection practices. Perform routine environmental monitoring of controlled areas according to established Standard Operating Procedures (SOPs) and protocols. Collect and analyze samples for microbial enumeration and identification. Maintain proper documentation of all monitoring activities and results in accordance with Good Documentation Practices (GDP). Review and draft SOPs on an “as needed” basis. Collaborate with cross-functional teams to investigate and resolve quality events, deviations and non-conformances related to environmental monitoring. Assist in the validation and qualification of cleanroom facilities and equipment such as Media Fills or facility expansion projects. Stay updated on industry regulations and best practices to ensure compliance. Ability to confidently interact with regulatory bodies (such as the FDA), notified bodies, and customers. Assist in responding to microbiology related requests and audit findings. Risk Assessment and Root Cause Analysis Assist in gathering data and supporting documentation regarding microbiology or sterility assurance related investigations or risk assessments. Assist in root cause analyses for sterility assurance, environmental monitoring, and other microbiology-related issues. Assist in implementing corrective and preventive actions to address identified root causes and mitigate associated impact/risk assessments. Compliance & Standards Maintain compliance with relevant regulations (e.g. 21 CFR Part 210/211). Ensure adherence to industry standards and best practices. Collaborate with internal and external stakeholders to align processes with guidelines. Quality Control & Audits Regularly audit personnel and processes for bioburden control and sterility assurance. Manage and evaluate ISO classification activities, media fills, and gowning qualification processes. Assist in trending and analysis of environmental monitoring and other microbiological data for management review and identification of continuous improvement opportunities. Team Membership & Training Ability to adjust to unforeseen situations and provide recommendations as needed to achieve operational/business objectives. Assist in providing guidance, training, and support as needed to operators in support of as needed to operators in support of aseptic and sterile operations. Foster a culture of quality and compliance within the team.

Orano Med is seeking a Facilities Maintenance Engineer for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals. The Facilities Maintenance Engineer will oversee the maintenance, optimization, and compliance of our state-of-the-art manufacturing facility. The ideal candidate will ensure that all facility systems operate efficiently, safely, and in alignment with regulatory standards pertinent to the pharmaceutical industry. Facility Maintenance & Optimization: Manage and perform preventive, corrective, and predictive maintenance on facility equipment and systems to ensure optimal performance. Assess and optimize facility layout and operational systems to enhance efficiency and safety. Regulatory Compliance: Ensure all facility operations comply with FDA cGMP regulations and other relevant standards. Develop and maintain Standard Operating Procedures (SOPs) related to facility operations. Project Management: Support projects related to facility modifications, equipment installations, and system upgrades. Safety & Environmental Stewardship: Implement and uphold safety protocols to maintain a secure working environment. Manage waste disposal and recycling systems in compliance with environmental regulations. Documentation & Reporting: Maintain accurate records of maintenance activities, inspections, and compliance reports. Prepare technical reports evaluating trends and facility performance data. Other responsibilities as needed.

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.

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.

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.