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The Associate Director, Quality will be responsible for driving technical excellence and regulatory compliance at ATLab Indianapolis, a next-generation commercial-scale facility for sterile radiopharmaceutical manufacturing. This position plays a critical cross-functional role in ensuring the facility operates with maximum reliability, safety, and regulatory readiness, contributing directly to the timely and compliant delivery of life-saving therapies. The Associate Director, Quality supports the company’s short- and long- term goals for maintaining Quality Systems and Compliance. This position 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 Theranostics Orano Med is seeking a detail-oriented CMC Scientist We are seeking a highly motivated CMC Scientist with expertise in radiopharmaceutical development to join our CMC team. The successful candidate will design, execute, and analyze studies and create reports for R&D CMC to support the development of novel radiopharmaceutical compounds. This role offers an opportunity to contribute to groundbreaking therapies and collaborate with cross-functional teams to advance our pipeline toward clinical trials. Key Responsibilities Design, conduct and optimize R&D studies to characterize radiopharmaceutical compounds. Analyze, interpret and troubleshoot complex datasets. Prepare summary reports to support tech transfer and regulatory filings. Review and further develop & refine existing processes. Collaborate with cross-functional teams review protocols, batch records, formulation records, and other related documents. Maintain accurate records of experiments and ensure data integrity in accordance with company policies. Stay current with advancements in radiopharmaceutical science and contribute to the development of innovative research strategies. Other duties, as needed. Orano strives to provide a total compensation package that brings value to our employees. We also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.

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 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 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. Key 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 practice 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 Work hours vary, start times possible as early as 12AM.

Orano Med Theranostics Orano Med is seeking a detail-oriented Logistics Specialist We are seeking a detail-oriented and proactive Logistics Specialist to join our fast-paced dynamic team. In this role, you will be responsible for management and oversight of all logistics and transportation operations for the Orano Med Theranostics facility in Plano, TX. Key Responsibilities Oversee all incoming/outgoing shipping activities for the Plano, TX site including providing applicable support to the Warehouse and Shipping Attendant Develop and implement logistics strategies and procedures to enhance operational efficiency Collaborate with internal teams to align logistics operations with overall business objectives. Ensure a timely and cost-efficient delivery of a variety of packages/shipments, to include: Clinical doses Raw materials Lab supplies R&D samples Empty Type A package returns Used generator returns for recycling Manage vendor relationships and contracts with selected couriers Facilitate site and process audits/inspections for all shipping activities Formulate audit and inspection responses Coordinate audit and inspection activities with vendors Manage FedEx platform and other relevant accounts for Plano, TX facility Coordinate deliveries with our carriers, recipients and Plano Team (Clinical Supply, GMP, Quality and R&D). Validate best delivery option for each shipment based on pre-determined criteria Confirm delivery option selection with appropriate teams Create bookings within courier platforms Reconcile invoices with booking estimates Act as primary shipper and consignee for hazardous materials and international shipments Prepare and manage logistics documents, correspond with carriers to ensure accuracy and compliance with all relevant regulations and industry standards Manage customs clearance process for international shipments Operate as primary contact for all shipping communications, including emergency response Communicate with carriers to resolve any issues or delays that arise during the logistics process Schedule work hours around clinical shipments to provide on-time support Generate and maintain site shipping records and logs to ensure traceability Manage inventory of Type A packages and shipping supplies. Maintain accurate records. Support Radiation Safety Officer for incoming/outgoing radioactive material shipments and maintaining inventory Orano strives to provide a total compensation package that brings value to our employees. We also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.

Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. The top priority for the Production Operator II will be routine production. This position presents the opportunity to help establish a new facility that will meet high standards for quantity, speed, and reliability. A competitive candidate will be energetic and motivated. Key Responsibilities Work with Production Supervisor and Management team to improve the process Collaborate with the shift supervisor to ensure the shift is running efficiently while leading by example Collaborate with the shift supervisor to train other members of the team Writing and reviewing relevant SOPs Help ensure the site is in an audit ready state Perform routine cleaning/disinfection of the cleanroom suites Complete: reading SOPs, gowning qualification, media fills, process training, bioburden runs, PV runs, tech transfer Top priority: Daily routine productionFollow 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, communicate failures/near misses Quality/continuous improvementAdhere to SOPs, company policies, regulatory requirements, laws Work closely with QC/QA to deliver quality products Assist with deviations, OOT/OOS, CAPAs, change controls, audits, inspections Collaborate with MS&T and process engineers to identify process improvements and help execute development work needed to implement change Cross-train and performCleanrooms: cleaning, EM, restocking Routine radiation surveys, wipe tests OtherMaintain paper/electronic batch records, equipment logs, other records Equipment: maintain, qualify, calibrate, prepare, report problems, troubleshooting Maintain stock of materials/supplies; obtain documentation for raw material release

Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. The top priority for the Senior Manager, Production is to provide strategic and operational leadership for all GMP radiopharmaceutical manufacturing activities at ATLab Indianapolis. This role is accountable for ensuring the reliable, compliant, and efficient execution of clinical and commercial production, while developing the long-term capabilities, systems, and culture needed to support site growth. Key Responsibilities Leadership & Oversight Provide strategic direction, coaching, and performance management for Supervisors, Operators, and technical production staff. Drive operational excellence and accountability by setting clear departmental strategies, goals, and KPIs aligned with site and corporate objectives. Build and develop organizational capability through succession planning, training programs, and leadership development. Serve as a key member of the Site Leadership Team, providing input into site-wide strategy, planning, and resourcing decisions. Production Operations Oversee end-to-end production operations to ensure reliable supply to clinical and commercial customers. Direct planning, scheduling, and resource allocation to meet short- and long-term production needs. Ensure production readiness, including equipment qualification, material availability, facility readiness, and operator certification. Provide oversight and technical leadership during complex operations, atypical events, and high-risk activities. Quality, Compliance & Safety Ensure all operations adhere to cGMP, NRC, ALARA, OSHA, EPA, and state regulations. Elevate quality culture by driving excellence in documentation, investigations, change management, and audit readiness. Serve as a senior point of escalation for deviations, CAPAs, and risk assessments; ensure timely and effective closure. Partner with QA, QC, EHS/ RSO, and Regulatory Affairs to support inspections, license management, and site certifications. Continuous Improvement Lead cross-functional initiatives to improve yield, reduce cycle time, strengthen process capability, and optimize resource utilization. Apply Lean, Six Sigma, and Operational Excellence methodologies to eliminate waste and reduce variability. Drive introduction and governance of new technologies, systems, and digital tools to enhance operational efficiency. Other Responsibilities Provide leadership and input into site-level strategy, expansion projects, and long-range planning Oversee departmental budget planning and financial stewardship. Support hiring, onboarding, and organizational plan

Orano Med Theranostics Orano Med is seeking a detail-oriented GMP Manufacturing Technician We are seeking a highly motivated GMP Manufacturing Technician who will be responsible for non-clinical GMP manufacturing, maintaining the GMP suite and GMP equipment, as well as ensuring that all necessary documentation is maintained accurately in accordance with all applicable regulations. The GMP Manufacturing Technician assists with clinical material manufacturing as well as preparation for clinical product manufacturing. This position conducts routine maintenance of areas and equipment and maintains accurate records of operations within GMP suite. Key Responsibilities Follow written procedures for non-clinical manufacturing Complete batch records, forms, equipment logs, and other production records as directed per company procedures and GMP guidelines Work concurrently with Quality Assurance (QA) and Quality Control (QC) personnel to deliver a high-quality product Follow and adhere to production schedules and timelines Execute room and equipment preparation for manufacturing operations Perform room sanitization activities as needed to maintain controlled environment conditions Participate in isolator and room monitoring Participate in room and isolator preparation for manufacturing Stocking materials in the GMP labs Identify and communicate process and equipment failures during manufacturing to supervisor and equipment team Identify process errors and report to supervisor Participate in deviation investigations and follow management guidance for corrective and preventive actions Clean, sanitize and sterilize equipment and components to support production operations Initiate cleaning procedures for the labs, perform routine maintenance on equipment, restock labs. Demonstrate ability to perform tasks with minimal guidance once trained Complete training on Master Batch Records, Formulation Records, and Protocols related to non-clinical manufacturing Complete on the job training for cleaning, gowning, GMP suite access, and equipment Orano strives to provide a total compensation package that brings value to our employees. We also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.

Orano Med is seeking a detail-oriented Technology Transfer Lead for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals. The Technology Transfer Lead will define the strategy and implement the framework for technology transfers of radiopharmaceutical products developed within Orano Med. Lead technology transfer projects between Orano Med sites, overseeing activities for both sending and receiving sites, in collaboration with all involved departments (Chemistry, Manufacturing, and Controls, Quality, Regulatory, MS&T and Operations) including: Responsibilities Project scoping: formation of the project team, timeline definition, specific cost assessment, and establishment of prerequisites and deliverables. Drafting and approval of technology transfer protocols (including analytical method transfer) as well as defining the validation strategy for implementing new processes. Conducting risk analyses and developing mitigation strategies, including cleaning validation and cross-contamination risk management. Monitoring project timelines and deliverables, reviewing generated documentation to ensure completeness and compliance with project needs. Assessing facility readiness and operational preparedness. Providing technical support and troubleshooting during site transfers, including root cause analysis of process deviations or anomalies. Ensuring full documentation traceability and robustness to guarantee regulatory compliance and industrial reproducibility. Addressing radiological safety risks in coordination with local Health, Safety, and Environment representatives. Manage outsourcing projects to Contract Manufacturing Organization/Contract Development and Manufacturing Organization partners for Active Pharmaceutical Ingredient (peptide or other) manufacturing, defining, and overseeing Chemistry, Manufacturing, and Controls requirements with external suppliers or partners. Prepare for and support audits and inspections (including health authorities’ inspections) related to technology transfers. Implement and promote best practices in technology transfer, capturing, and sharing lessons learned across the organization.