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 solutions, including environmental monitoring and USP testing for sterility, endotoxin, bioburden and subvisible particulates.• 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 qualification of aseptic facility expansion.

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 Stiefel branded OTC and cosmetic products.-Provided microbiological expertise for audits of vendors and outsourcing partners.-Justified and oversaw introduction of MicroSeq sequencing identification system as a cost-effective regional resource for the company. -Earned GSK R&D Exceptional Science Award for development of protocols for assessing integrity of ophthalmic device for non-preserved formulations.-Earned GSK R&D Gold Award for managing seamless transfer of RTP site projects to other GSK Product Development sites, due to decommissioning of the RTP site.

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 Award for development of calibrated procedure for container closure integrity (both microbial and dye intrusion). -Supervised up to five team members.

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 Preservative Efficacy) and environmental monitoring. -Used Vitek identification system, gel-clot and kinetic LAL, as well as Bactometer.

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 Investigations-Autoclave validation and D-value studies-Performed microbial identification by API system-Nonviable particulate monitoring of air in aseptic facility-Particulate Matter testing of injectable products. Validation of Particulate Matter instrument. -HEPA filter testing and repair in the aseptic facility.-New facility validation and start-up activities (Puerto Rico site).