Careers

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 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