Senior Expert Technical Transfers/Višji strokovni tehnični prenosi
Core
Oversees clinical manufacturing site activities for drug substance and product process transfers, leading technical transfer teams and coordinating between transferring and receiving sites.
Role type
Senior Expert Technical Transfers (Clinical Manufacturing)
Builds
Drug substance and product processes for clinical manufacturing
Domain
Pharmaceutical manufacturing / Biopharma
Required skills
Technology transfer strategy, change control management, stakeholder management, regulatory compliance (GMP/GLP), project management, risk mitigation, knowledge transfer, documentation, cross-functional team leadership
Preferred skills
Advanced degree in technical/scientific discipline, coaching skills, technical writing, adaptability, problem-solving
Technologies
GMP, GLP, Novartis regulations, change control software, project management tools
Responsibilities
Initiate technology transfer activities upon Supply Point Decision, lead process transfer teams at receiving sites, develop technical transfer strategies aligned with CMC, ensure knowledge transfer between sites, monitor project progress, identify risks and develop mitigation plans, draft key transfer documents
Seniority
Senior, hands-on IC with leadership responsibilities
