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Intern – Radiopharmaceutical Manufacturing
Student
USA / Indiana
Published on 10/6/2025
Job reference : 2025-21706
Join Orano USA, where we're powering the future with innovation collaboration, and purpose. The Intern – Radiopharmaceutical Manufacturing will participate in the establishment of ATLab Indianapolis as a new commercial-scale manufacturing facility for therapeutic radiopharmaceuticals. The facility will be geared towards ramp up of activities to support Phase 3 clinical trials and commercial manufacturing. During Summer 2026, 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.
Key Responsibilities:
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.
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EHS Specialist Intern – Radiopharmaceutical Manufacturing
Student
USA / Indiana
Published on 10/2/2025
Job reference : 2025-21668
Join Orano USA, where we're powering the furture with innovation collaboration, and purpose. As a EHS Specialist Intern will provide hands-on experience in a radiopharmaceutical manufacturing environment, focusing on supporting and improving the facility’s waste management programs and other EHS initiatives.
Key Responsibilities:
Assist in the development, implementation, and improvement of radioactive and hazardous waste management programs.
Support environmental monitoring, documentation, and compliance activities in accordance with NRC, DOT, EPA, and state regulations.
Conduct inspections, surveys, and audits of EHS processes under supervision.
Help maintain records, prepare reports, and track EHS metrics.
Collaborate with the EHS team and manufacturing personnel to promote a culture of safety and regulatory compliance.
Participate in special EHS projects and continuous improvement initiatives.
Learning Opportunities:
Gain hands-on experience in a highly regulated pharmaceutical manufacturing environment.
Learn about radioactive and hazardous waste handling and regulatory compliance.
Develop professional skills in safety, problem-solving, and project management.
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Chemist I
Regular/Permanent
USA / Texas
Published on 9/26/2025
Job reference : 2025-21620
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 team as a Chemist l and play a vital role in safeguarding the integrity of raw materials and sterile drug products. Are you seeking your next challenge as a Chemist l? If so, this is your chance to grow within a dynamic, mission-driven organization that’s transforming oncology from the inside out.
The Chemist l role under moderate supervision, is responsible for manufacturing of products inside a traditional chemistry lab. These products support the business catalog, custom synthesis business, as well as the GMP business.
Key Responsibilities
Manufactures batches following a batch record.
Scales batches from bench scale to kilo scale.
Synthesizes custom compounds and documents process and procedures in formal filing.
Performs in process testing and evaluates results, specifically with HPLC.
Proposes solutions to typical chemistry problems.
Supports process development under guidance of senior chemists.
Acts as backup to lab technicians and lab specialists, 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.
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Intern - Radiopharmaceutical Manufacturing
Student
USA / Indiana
Published on 5/17/2025
Job reference : 2024-18574
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.
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Manager, Sterility Assurance
Regular/Permanent
USA / Indiana
Published on 9/23/2025
Job reference : 2025-21557
Orano Med is seeking a Manager, Sterility Assurance.
The Manager, 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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Senior Manager, Records Management
Regular/Permanent
USA / Texas
Published on 9/10/2025
Job reference : 2025-21397
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 Records Management team as a Senior Manager, Records Management and play a vital role in safeguarding the integrity of raw materials and sterile drug products. Are you seeking your next challenge as Senior Manager, Records Management, this is your chance to grow within a dynamic, mission-driven organization that’s transforming oncology from the inside out.
The Senior Manager, Records Management will be responsible for oversight of all study level Trial Master Files including set-up, periodic and final QC and final transfer and archival. The position will develop oversight and TMF archival SOPs and manage the TMF archival platform.
Key Responsibilities
Responsible for developing and implementing a comprehensive records management strategy that is GCP and GDP compliant including oversight and archival SOPs and set-up and management of a TMF archival platform.
Select and onboard/implement a TMF platform.
Ensure inspection readiness state for outsourced TMFs by conducting periodic quality control reviews and following up to ensure timely and appropriate resolution of findings.
Oversee the TMF archival process, ensuring that all documents are properly filed, indexed, and accessible.
Prepare for and support health authority inspections (trial master file QCs, pulling documents during inspections).
Stay current with regulatory requirements and industry best practices related to records management and TMF.
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Senior Manager, Clinical Supply Chain
Regular/Permanent
USA / Texas
Published on 9/10/2025
Job reference : 2025-21423
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 Clinical Supply Chain team as Senior Manager, Clinical Supply Chain and play a vital role in safeguarding the integrity of raw materials and sterile drug products. Are you seeking your next challenge as Senior Manager, Clinical Supply Chain? If so, this is your chance to grow within a dynamic, mission-driven organization that’s transforming oncology from the inside out.
The Senior Manager, Clinical Supply supports day-to-day drug supply operations for Orano Med clinical trials, reporting to the Director of Clinical Supply. Key responsibilities include coordinating production schedules, tracking shipments, and resolving site-level supply issues to ensure timely drug delivery and dosing.
Key Responsibilities
Production and Delivery Coordination:
Assist the Director of Clinical Supply with coordinating radiopharmaceutical production schedules to align with site-specific dosing timelines
Manage logistics planning for dose deliveries from manufacturing sites to clinical sites, considering half-life constraints, time zones, and customs clearance
Communicate regularly with manufacturing partners and courier vendors to confirm production status, pickup timing, and delivery confirmations
Order and Shipment Tracking:
Maintain and update internal tracking tools with real-time shipment status, from production through confirmed site receipt, including delivery confirmations and any delays
Proactively follow up with depots, clinical sites, courier vendors, and internal logistics stakeholders to ensure timely deliveries and address any in-transit issues or exceptions
Site and Vendor Communication Support:
Support the Director of Clinical Supply by assisting with site-facing logistics, including shipment tracking, drug availability, and receipt follow-up
Work closely with Clinical Operations, manufacturing, and vendor teams to help monitor schedule changes, resupply needs, and enrollment forecasts
Identify and document any shipment delays, temperature excursions, or discrepancies, and escalate to the Director for resolution
Cross-Functional Support:
Collaborate with cross-functional teams to align on enrollment projections, production scheduling, and logistics activities.
Join recurring supply calls to keep internal teams informed of upcoming shipments and constraints.
Support the Director in coordinating day-of dosing communications with manufacturers, couriers, and clinical sites