Person
Cylia Chen-Ooi, MA
Cylia brings over 25 years of experience in the biopharmaceutical industry. She currently serves as Sr. Director at Amgen, where she and her team provide oversight of the Contract Manufacturing Operations. Since joining Amgen in 2006, she has held various roles across Quality, Manufacturing, Strategic Planning, and Process Development.
Earlier in her career, Cylia supported process validation and startup of new fill-finish facilities while consulting with Baxter and Watson. She holds a Master of Science in Regulatory Sciences and a Bachelor of Science in Biomedical Engineering, both from the University of Southern California.
Within PDA, Cylia has demonstrated a long-standing commitment to advancing industry practices. She led the PDA task force on Quality Metrics and Culture, spearheading the development of the PDA Quality Culture Assessment Tool—resources that US FDA inspectors and MHRA have been trained on. She also contributed to the ANSI Quality Culture standards initiative and served for six years on PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB).