Careers

Orano Med Theranostics Orano Med is seeking a detail-oriented GMP Manufacturing Technician III 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 Primary operator for release testing of cold vials/syringes and solutions Monitoring of materials stock, requesting orders, obtaining relevant documents and submitting for release Assist in troubleshooting process errors Suggest corrective actions in support of deviation investigations Assist in editing non-clinical process & equipment documents   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 Orano Med is seeking a detail-oriented GMP Production Associate This position is primarily responsible for manufacturing GMP clinical materials and products. This position is also responsible for maintaining the GMP production suite and GMP equipment, as well as ensuring that all necessary documentation is maintained accurately in accordance with all applicable regulations. The GMP Production Associate performs clinical product manufacturing as well as preparation for clinical product manufacturing. This position conducts cleaning and routine maintenance of areas and equipment, edits documents, and maintains accurate records of operations within GMP suite. Key Responsibilities All Production Associate levels: Follow written procedures for clinical and non-clinical manufacturing as primary operator or verifier Participate in release testing of cold vials and solutions Complete batch records, forms, equipment logs, and other production records as directed per company procedures and GMP guidelines Work concurrently with Quality Assurance (QA),Quality Control (QC), and Logistics personnel to deliver a high-quality product Adhere to production schedules and timelines Execute room and equipment preparation for manufacturing operations Perform room sanitization activities to maintain controlled environment conditions Participate in isolator and room monitoring Maintain stock of manufacturing raw materials and obtain necessary documentation to submit for release Identify and communicate common equipment/process failures and report to supervisor Participate in deviation investigations Clean, sanitize and sterilize equipment and components to support production operations Initiate cleaning procedures for the labs, perform daily checks and routine maintenance on equipment, restock labs. Maintain up-to-date training on all manufacturing records Assist in review of manufacturing documents Maintain gowning and production qualifications 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 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.  

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. 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 Schedule:  Monday - Friday: 12:00 P.M. - 8:30 P.M.

Orano Med Theranostics Orano Med is seeking a detail-oriented Pre-Clinical Scientist We are seeking a highly motivated Pre-Clinical Scientist with expertise in radiopharmaceutical development to join our Research and Development team. The successful candidate will design, execute, and analyze preclinical studies 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 and conduct in vivo and in vitro preclinical studies to evaluate the efficacy, safety, and pharmacokinetics of radiopharmaceutical compounds. Develop and optimize experimental protocols for radiopharmaceutical research, ensuring compliance with regulatory standards (e.g., GLP). Analyze and interpret complex datasets, preparing detailed reports and presentations for internal stakeholders and regulatory submissions. Collaborate with chemistry, and clinical teams to support IND-enabling studies and translate preclinical findings to clinical applications. 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. 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 EHS Specialist for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals. The EHS Specialist will be responsible for supporting safe, compliant, and efficient radiopharmaceutical manufacturing operations by implementing, monitoring, and improving Environmental Health & Safety programs. This role ensures compliance with NRC, FDA, DOT, OSHA, EPA, and state regulations, while fostering a strong safety culture in a highly regulated GMP environment. Key Responsibilities Develop, implement, and maintain EHS policies, procedures, and training tailored to radiopharmaceutical production. Monitor radiation safety programs, including dosimetry, contamination surveys, exposure tracking, and waste management. Support Radiation Safety Officer (RSO) activities and assist with maintaining compliance with RAM license conditions. Conduct safety inspections, risk assessments, and job hazard analyses; recommend corrective and preventive actions. Oversee proper handling, storage, transport, and disposal of radioactive and hazardous materials in accordance with NRC, DOT, and EPA requirements. Investigate EHS incidents, near misses, and deviations, document findings and lead root cause analysis. Partner with Quality, Operations, and Engineering to ensure compliance with FDA cGMP and ALARA principles. Maintain records and prepare reports for regulatory agencies (NRC, OSHA, EPA, state regulators). Provide EHS training and mentorship to manufacturing staff to promote a culture of continuous safety improvement. Schedule Monday through Thursday: 10:00AM-8:30PM

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.