Barry Garfinkle Email and Phone Number

Over 30 years of experience in the development and manufacture of vaccines, biologicals and sterile pharmaceuticals. Extensive experience in Technical Operations,. Quality, and Regulatory Affairs in support of vaccines and biolgics. Designed facilities for the manufacture of bulk and filling of vaccines, biologics and sterile pharmaceuticals including lyophilization. Goals: Continue to advance the technologies associated with the manufacture of sterile pharmaceuticals, biologics and vaccines. Improve the manufacturing processes to achieve six sigma.Specialties: Facility Design, Validation and Startup for Sterile Processing including sterile pharmaceuticals, vaccines and biologics. Regulatory Affairs experience with FDA/CBER/EU/AustraliaTroubleshooting of biological processesProductivity Improvements for Sterile and Vaccine ManufactureAseptic Processing / Sterility Assurance Problem Solving