Massimo Mannini has worked at the Rosia site Italy since 1988 where he started as Formulation Supervisor, Blood Fractionation Derivates for Sclavo. He held positions of increasing responsibility with Bayer (including a 1 year assignment in Clayton, NC US) until joining Chiron in 1998 where he took over responsibility for Filling and Inspection. Massimo was appointed Aseptic Operations Manager for the Rosia Site in 2000 and Head of Aseptic Manufacturing with the Novartis acquisition in 2006 in-conjunction with the start-up of new Building 42 dedicated to Aseptic Operations. He led the team there thru 3-FDA PAI’s, and 1-FDA Team Bio inspection between 2007 and 2009. He held the position of SME, Sterile Technologies Rosia Site starting in 2010 and then in Global Secondary Manufacturing Team as Aseptic Process Expert, with several collaboration in foreign countries (China, Saudi, US) Since 2011 covering MS&T Aseptic Engineering Manager position with a group of Engineers taking care of Tech Transfer, internal and to External NVD Sites or CMOs, Process improvements and Troubleshooting.