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  • Lead and manage Tech Transfer projects effectively and independently, ensuring deliverables are completed in time, at agreed costs and carefully balancing benefits & risks.
  • Define Project strategy, Project Team and create end-to-end Project Plan capturing project risks including mitigation strategy
  • Coordinate cross-functional Project Team across internal stakeholders /Project Management
  • Business case support: consolidate master documentation for BC calculation and provide technical expertise on the transfer feasibility at the target site.  
  • Prepare and lead Project related meetings
  • Provide scientific and technical expertise, e.g., in quality, technology transfer, regulatory
  • Generate master documentation for the transfer and preparation of Transfer Protocols
  • Check compliance of all GMP documents transfer related
  • Coordinate and support manufacturing sites to produce trial/validation batches and provide on-site production support
  • Analyze and evaluate data from the executed batches to make fact-based decisions
  • Define requirements for stability studies and review stability results
  • Prepare the updates of Dossiers according to technology transfer results and variation documentation in accordance with regulatory requirements of impacted countries.
  • Clarify and coordinate the submission slots with all subsidiaries
  • Coordinate the collection of data together with manufacturing and laboratories for the response to regulatory insufficiency reports and follow-up on variation status with all countries

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