Manager Global Technology Transfer - (I-182)

- 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#J-18808-Ljbffr