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Sr. Production Operator
Regular/Permanent
USA / Indiana
Published on 12/19/2025
Job reference : 2025-22526
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 Production Operator 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, Management and MS&T 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 and mentor other members of the team
Writing/Reviewing/Executing relevant SOPs, Qualifications, and internal studies
Implement new equipment, materials, software, systems
Environmental qualifications of new cleanrooms
Complete: reading SOPs, gowning qualification, media fills, process training, bioburden runs, PV runs, tech transfer
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
Mentor and cross-train new employees
Identify, document, communicate failures/near misses\
Quality/continuous improvement
Adhere 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
Cleanrooms: cleaning, EM, restocking
Packaging/labelling/driving/shipping of radioactive product
Routine radiation surveys, wipe tests
Maintain 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
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Production Operator II
Regular/Permanent
USA / Indiana
Published on 12/19/2025
Job reference : 2025-22525
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
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Sr. Production Manager
Regular/Permanent
USA / Indiana
Published on 12/19/2025
Job reference : 2025-22524
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
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Supervisor, Sterility Assurance
Regular/Permanent
USA / Indiana
Published on 12/15/2025
Job reference : 2025-21557
Orano Med is seeking a Supervisor, Sterility Assurance.
The Supervisor, Sterility Assurance will be responsible for developing, implementing, and maintaining contamination control strategies. Ensuring compliance with global regulatory standards and managing sterility assurance initiatives across the site. The ideal candidate will be a strong leader with proven experience in building and guiding high-performing teams, collaborating with cross-functional groups, and driving a culture of compliance and continuous improvement.
Key Responsibilities
Provide overall leadership and direction for sterility assurance and contamination control programs within a radiopharmaceutical GMP manufacturing environment.
Develop and implement long-term sterility assurance strategies, aligned with regulatory expectations and business objectives.
Serve as the site subject matter expert (SME) in sterility assurance, aseptic processing, and environmental monitoring.
Represent sterility assurance during internal and external audits, including with regulatory bodies (e.g., FDA, EMA) and customers.
Collaborate with executive leadership to establish clear sterility assurance metrics, continuous improvement initiatives, and site-level risk reduction strategies.
Oversee the design, implementation, and execution of robust contamination control programs (cleanroom qualification, media fills, aseptic techniques, gowning qualification, cleaning/disinfection programs, etc.).
Lead and approve sterility assurance risk assessments, deviation investigations, and root cause analyses for aseptic and microbiology-related events.
Ensure corrective and preventive actions (CAPA) are effectively implemented and tracked to completion.
Partner with Quality Assurance, Quality Control, Manufacturing, and Engineering teams to align sterility assurance practices with site quality objectives.
Act as the sterility assurance lead during regulatory inspections, audits, and customer visits, ensuring the site is always in a state of inspection readiness.
Manage, coach, and develop the sterility assurance team to build technical expertise and leadership capabilities.
Provide aseptic training and mentorship for manufacturing and quality staff to reinforce contamination control practices.
Foster a culture of compliance, accountability, and continuous improvement across the site.
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EHS Specialist
Regular/Permanent
USA / Indiana
Published on 10/9/2025
Job reference : 2025-21756
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
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Associate Director, Quality Assurance
Regular/Permanent
USA / Indiana
Published on 12/15/2025
Job reference : 2024-18313
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.
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GMP Manufacturing Technician
Regular/Permanent
USA / Texas
Published on 11/24/2025
Job reference : 2025-22264
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.
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Technology Transfer Lead
Regular/Permanent
USA / Indiana
Published on 11/18/2025
Job reference : 2025-22211
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.
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QC Analyst
Regular/Permanent
USA / Indiana
Published on 11/3/2025
Job reference : 2025-22087
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.
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Pre-Clinical Scientist
Regular/Permanent
USA / Texas
Published on 10/29/2025
Job reference : 2025-22057
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.