Project Management – University of Akron

Expertise:   Program management Research & Development – medical device concept design & development, registration, launch and global scale-up.  Small molecule and biologic development from pre-clinical to phase 4 studies.  Program leadership to coordinate clinical, medical, CMC, regulatory and quality teams to execute global clinical trials, complete regulatory filings and commercialization. Sterile, single-use drug and solution container design and process technology (sterile fill, frozen, glass containers).  

Experience:    Headed design, manufacturing, and international operations functions for Baxter International and Amgen.  Program Manager Baxter-Alliance Pharmaceuticals joint venture  

Other:  Global regulatory insight (FDA, EMEA, CFDA, Health Canada, TGA, Japan MOH, ANVISA).  Global manufacturing (sterile fill/finish), API sourcing, international drug importation, controlled substance and cold-chain transport. 

Email Lousi Meeuwen CV