Michael Mcbride Email & Phone Number

Florida, United States

Rochester, Minnesota, US

Brooksville, Florida, US

Built and managed Quality Control department for manufacturer of sterile vials and prefilled syringes during new company/facility startup.

Bethlehem, PA, US

• Managed a team of nine analysts and one supervisor across two shifts providing microbiological services through new facility startup, for a large-scale manufacturing site for terminally sterilized intravenous.
• Oversaw microbiological execution of WFI system qualification.
• Designed and oversaw execution of new facility EMPQ and implementation of environmental monitoring program.
• Oversaw major expansion of existing microbiology laboratory, including specifying, qualifying and implementing new equipment for bacterial endotoxin, subvisible particulate, autoclave, incubators.
• Oversaw activities surrounding selection, installation, validation and implementation of sterility testing isolator.

Shelton, Connecticut, US

Oversaw team providing microbiological testing support for OTC and cosmetic sun care products, including microbial content and preservative efficacy testing, environmental and water system monitoring.

Cambridge, Massachusetts, US

- Managed team responsible for Environmental Monitoring, microbiological testing and media fill support for aseptic manufacturing facility, producing gene therapy products.- Provided microbiological trending reports and expertise to senior management.- Oversaw introduction of in-house bacterial endotoxin and bioburden testing, as well as environmental.

Brentford, Middlesex, GB

Managed a team of three R&D microbiologists supporting Product Development and Quality Control for clinical manufacture of oral, inhaled, sterile and topical products. -Directly oversaw microbiological support through launch of successful products such as Advair, Ventolin, Tykerb, Treximet, Duodart, Potiga, Tafinlar, Duac, Toctino, Fabior, and numerous.

Brentford, Middlesex, GB

-Oversaw outsourced testing in support of sterile and non-sterile clinical trial products in R&D, within the Quality Assurance organization. -Coordinated and conducted in-house testing. -Validated autoclaves, sterility testing isolator/sterilization system, BAX PCR system, Vitek and Sherlock (GC) identification systems. -Earned GSK R&D Exceptional Science.

Raritan, New Jersey, US

Provided microbiological support to both Janssen and McNeil organizations (divisions of Johnson and Johnson) which shared the site. -Performed release testing of sterile and non-sterile finished products (USP Sterility, Bacterial Endotoxin, Microbial Limit Tests) and raw materials, as well as testing in support of formulation development (Antimicrobial.

Provided microbiological testing and support for manufacturer of Small Volume Parenteral pharmaceutical products.Performed activities including:-Water, Environmental Monitoring-Bacterial Endotoxin testing and validation by Gel-Clot-Sterility testing for product release-Review of microbiology documentation for product release-Action level.