Orano USA · 1 month ago
Technology Transfer Lead
Brownsburg, IN
Full-time
Onsite
Senior LevelOrano Med is a company specializing in radiopharmaceutical manufacturing, and they are seeking a detail-oriented Technology Transfer Lead for their new facility at ATLab Indianapolis. The role involves defining the strategy for technology transfers of radiopharmaceutical products, overseeing projects between different sites, and ensuring compliance with regulatory standards.
Utilities
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
Qualification
Required
Detail-oriented
Experience in technology transfer for radiopharmaceutical manufacturing
Ability to define strategy and implement frameworks for technology transfers
Experience leading technology transfer projects between sites
Collaboration skills with departments such as Chemistry, Manufacturing, and Controls, Quality, Regulatory, MS&T and Operations
Project scoping skills including formation of project teams, timeline definition, specific cost assessment, and establishment of prerequisites and deliverables
Ability to draft and approve technology transfer protocols including analytical method transfer
Experience in defining validation strategies for implementing new processes
Conducting risk analyses and developing mitigation strategies
Experience in cleaning validation and cross-contamination risk management
Monitoring project timelines and deliverables
Reviewing documentation for completeness and compliance
Assessing facility readiness and operational preparedness
Providing technical support and troubleshooting during site transfers
Conducting root cause analysis of process deviations or anomalies
Ensuring documentation traceability and robustness for regulatory compliance
Addressing radiological safety risks in coordination with Health, Safety, and Environment representatives
Managing outsourcing projects to Contract Manufacturing Organization/Contract Development and Manufacturing Organization partners
Defining and overseeing Chemistry, Manufacturing, and Controls requirements with external suppliers or partners
Preparing for and supporting audits and inspections related to technology transfers
Implementing and promoting best practices in technology transfer
Company
Orano USA
U.S. advanced reactor services, uranium enrichment, uranium sales, used nuclear fuel management, federal services, and nuclear medicine.
Founded in 2017
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase