Technology Transfer Lead
Listed on 2026-01-01
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Quality Assurance - QA/QC
Quality Engineering
About the role
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, leading projects between Orano Med sites and overseeing activities for both sending and receiving sites in collaboration with all involved departments (Chemistry, Manufacturing and Controls, Quality, Regulatory, MS&T and Operations).
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) and 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.
- Managing 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.
- Preparing for and supporting audits and inspections (including health authorities’ inspections) related to technology transfers.
- Implementing and promoting best practices in technology transfer, capturing and sharing lessons learned across the organization.
Entry level
Employment TypeFull‑time
Job FunctionResearch, Analyst, and Information Technology
IndustriesNuclear Electric Power Generation
LocationIndianapolis, IN
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