Careers

The Assoc Dir/Dir of Clinical Operations will service the Clinical Program Director for assigned Global Development Team(s) (GDT); overseeing clinical trial execution and operational strategy.  This role will have line management responsibilities for Clinical Operations team members including but not limited to Clinical Project Managers and Sr. CRAs and will foster a collaborative and high-performing environment while maintaining oversight of CROs, study execution, ensuring data integrity, regulatory compliance and adherence to budget parameters and timelines.   Key Responsibilities Clinical Program Management: lead the planning, execution, and monitoring of clinical trials, ensuring that trials are conducted in accordance with clinical development planning, regulatory guidelines, and Good Clinical Practice (GCP). Clinical Trial Oversight: Oversee the clinical trial life cycle, from study design to study completion. This includes strategy development, trial progress monitoring, and risk management. Provide guidance and support to clinical teams on trial execution, risk mitigation and problem-solving.   Risk Mitigation: Identify and address any operational risks, implementing corrective and preventative actions as necessary to keep trials on track. Vendor Management: Oversee the selection and maintain oversight of external vendors such as CROs and/or other service providers, ensuring adherence to timelines and quality standards. Manage assigned CRO relationships; serve as an escalation point for study teams (e.g. performance challenges, timeline delays etc) and drive resolution with CRO counterpart(s). Contribute to development of governance charters and participate in governance meetings.  Collaboration: Work closely with cross-functional teams, including Regulatory, Safety, and Clinical Development to ensure alignment on clinical development strategy and execution. Budget & Resource Management: Monitor budgets and resource allocation for clinical trials, ensuring that trials are conducted efficiently and within budget. Responsible for annual (and quarterly updates) for assigned Clinical Program(s). Clinical Trial Reporting: Support the preparation of clinical trial reports, regulatory submissions, and other documents required for clinical trial progress or regulatory review. Process Development and Continuous Improvement: Contribute to process development and improvement initiatives, ensuring that clinical operations remain efficient, scalable, and adaptable to the evolving needs of the organization. Will be assigned as process owner for sub-set of department processes.   Line Management: Will have line management responsibilities for Clinical Operations team members including but not limited to Clinical Project Managers and Sr. CRAs.

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

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 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 

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.  

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.

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.