Manager Global Technology Transfer

Select how often (in days) to receive an alert:
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