Experience

Kedrion Biopharma

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project Planning Manager

  • Mar 2016 - Present

  Lead and coordinate the interdisciplinary team in order to meet the objectives in plasma-derived project, develop and commercialize a new plasma product. In this role I lead all the project workstream, clinical, regulatory, process and product development, process and method Tech transfer to clinical manufacturing facility and Tech transfer to commercial manufacturing planning and monitoring all the activities ensuring that the project meet the given objectives. As a planning manager I am also involved in the building of e new system for the company to manage the R&D resources required for the program portfolio. Moreover I also have the responsibility to implement a company system of Toll gating and to introduce the project management tools applied to R&D project.



GSK Vaccines

• Siena Area, Italy

• Technical Project Manager

  • Mar 2015 - Feb 2016

  Technical Progect Manager Project development Lead and coordinate the interdisciplinary teams in order to meet project objectives in biopharmaceutical projects Lead and coordinate Tech transfer in a industrializable way of biopharmaceutical project and process from Research to Technology Department, Manufacturing and fand contract manufacturing/CMOs. Lead and coordinate validation and tech transfer of the in-house analytical methods (i.e. Capillary electroforesis, Dionex, Reverse phase methods immunoassay, Antigen contect) from technology department to quality control and/or CMO Lead coordinate and manage operational activities (upstream, downstream processes and drug product processes) to manufacture bulks and clinical trial material to be used in clinical stuidies Phase I, II and III ) Lead and coordinate GMP readiness of Technical development upstream and downstream facility to be ready for PhIII manufacturing.



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Development Project Manager

  • Apr 2007 - Mar 2015

  Project development Lead and coordinate the interdisciplinary teams in order to meet project objectives Lead and coordinate Tech transfer of very early projects from Research Siena to TD in a industrializable way and from TD to manufacturing/CMOs.Manage operational activities to manufacture pivotal DSs and PhIII DS readiness

• QC Compliance Manager

  • Jan 2002 - Apr 2007

  Lead and coordinate Compliance in Quality Control with the international guidelines (FDA, ICH, cGMP) Lead and coordinate writing of SOPs and guidelines in Quality control based on the International and global guidelines (i.e. Novartis Quality Manual). Lead and manage methods validation (strategy definition, protocols and reports approval).Responsible for Sample managementExpert in LIMS System Manage specification of new oand old products based on the international and development guidelines

• Downstream Process development Scientist

  • Jun 2000 - Dec 2001

  Downsteram Process development for vaccine proteins.GMP lots documents preparation and production. Process transfer to manufacturing

• Junior Research

  • May 1994 - Jun 2000

  I has been involved in the pertussis project and I gained experience in resolving patent problems for the Pertussis Acellular Vaccine that contributed to present a report to the High court of Justice, Chaney Division Patent Court. I also contribute to study the structure and function of H. pylori toxin. The results obtained in H. pylori have been included in PhD thesis for Molecular and Cellular Biology “Study of Structure and Function of Toxin Helicobacter pylori for the development of a Molecular Vaccine