Tom Bryant Email & Phone Number

Daly City, CA, US

Brisbane, California, United States

Alameda, CA

• Promoted three times. Tested manufactured cGMP medical devices (US IVD, RUO, CE), raw materials, and in-process samples. Trained new analysts, performed investigations for non-conforming product and deviations. Proven.
• Analytical lab lead – Successfully took over oligonucleotide analytical chemistry lab independently with only two weeks training and no prior experience.
• Geographic Equivalence – Chosen to learn Ligase Activity assay and transfer assay from Abbott, Chicago to the Alameda site. Completed transfer MQ, wrote and updated associated documents.
• Functional Assay Lead – Took over as lead assay analyst. Also trained new analytical chemists.
• Environmental Monitoring Lead – Took over maintenance of environmental monitoring system. Streamlined and improved system through spreadsheet creation and procedure revision.
• Method Qualification - Involved in successful Method Qualifications of multiple product lines: HIV BDT version update, ligase assay geographical transfer, HLA site qualification, HLA DRB version update.

Alameda

• Promoted twice before moving to QC department. Manufactured medical devices in cGMP environment following procedural documents. Performed batch record review and training of new manufacturing chemists. Guided other.
• CE Process Validation - Lead chemist for CE marking project for Cystic Fibrosis Assay.
• Instrument Validation - Dibipack shrink-wrap IOQ, Monobloc Tube filling apparatus validation.
• Chosen to help oligonucleotide manufacturing site during ramp-up. Learned manufacturing and QC processes involved in cGMP oligonucleotide production.
• Developed excel based time tracking utilities to help streamline manufacturing activities.
• Method Qualification (with Product Transfer and Product development) - Involved in Luminex project development and transfer. Worked independently, and with direction on experimental manufacturing scale up.