Johnny Kwan Email & Phone Number

Extensive experience in the biopharmaceutical industry involving; process development, pilot, clinical and commercial process transfer and manufacturing. Clinical and Commercial plant startup, Contract Manufacturing Person in the Plant, technology transfer to and from partner companies, and Regulatory filing and inspection support. Past experiences included; Developed purification processes for proteins, in the areas of research through clinical scale, for recombinant proteins from E. Coli., yeast, and mammalian cells. Performed operations under cGMP conditions in class ISO 5 to ISO 8 purification suites. Performed viral clearance studies. Created, executed and summarized process validation protocols and reports. Created and supervised purification clinical manufacturing operation and supported IND / MA applications. Scaled-up and transferred manufacturing processes to commercial scale plants, both internal and external. Designed, built, and supported licensure of commercial plants. Lead commercial plant commissioning activities and ran commissioning war room. Created inspection playbooks and supported inspections on-site. Technology transfer and scale up of externally acquired products to internal plants. Lead technical day to day CMO operations. Selection of CMO for Drug Substance and Drug Product.

Listed skills include Technology Transfer, Biotechnology, Biopharmaceuticals, Gmp, and 13 others.