Technical Transfer Lead

Due to a recent successful phase III trials, the client is now in a position to fit out the new facility ready for the production of the new vaccine with GMP batches to be manufactured by Jan 2025.  This will include transferring over to a new paperless digital system.

You will be required to manage a team of scientists and deliver the technical transfer, scale up, process optimisation and GMP manufacture of new and existing Bulk Drug Product manufacturing processes.

To be successful for this role we are looking for the following skills & experience:

•  10+ years  working within the Vaccine or Biologics Health Science Industrial sector, in Process / Assay Development, Manufacture or Analytical functions, particularly viral products
• Science based Degree qualification or additional relevant experience in Vaccines / Biotech discipline
• Proven track record in leadership of major, complex, multi-disciplinary projects involving diverse departmental teams
• Proven Line Management capabilities of experienced Senior Scientists (5+ years)
• Strong GMP understanding and experience
• Strong commercial awareness
• Excellent understanding of protein chemistry and characterisation and their application to clinical manufacture processes
• Good understanding of working with Biological systems, equipment and environments
• Experience managing capital expenditure projects
• Strong experience of New Product Introduction and/or Technology Transfer
• Good experience of statistical data analysis and process trending
• Experience of change management, lean systems and risk analysis
• Excellent communication at all levels of business, and team management
• Lean Six Sigma Green Belt or above
• Concern for delivery and ability to effectively prioritise, plan and execute delivery
• Ability to work in fast paced environment with changing business priorities, managing conflicting to priorities