Technology Transfer Lead

Orano-posted about 1 month ago

Full-time • Mid Level

Indiana, PA

5,001-10,000 employees

Utilities

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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:

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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