Shu-Chen Chen

I have over 25 years of diversified experience in product and process design and development, quality control, and manufacturing for medical device, biological, and chemical industries. I hold a BS, MS and Ph.D. degree in Chemical Engineering focusing on Computational Fluid Dynamics. I am a certified quality engineer, biomedical auditor and 6-sigmal black belt from American Society for Quality. I was in charge of the container closure integrity (CCI) test method development for therapeutic proteins in various types of containers ranging from vial, syringe, cartridge, drug delivering device, glass and plastics containers in the last 7 years at Amgen. I have worked with different leak detection technologies - including microbial challenge, dye ingress, vacuum decay, high voltage leak detection, helium mass spectrometer, and headspace analyzer. My experience in the area will provide insights on the challenges of developing physical CCI test method, particularly for the combination product with therapeutic proteins.