Ray Ohhashi Email & Phone Number

Redwood City, Ca, Us

Newark, California, United States

Novato, California, United States

• Skilled in performance of various analytical methods and molecular biology assays including Immunoassays (e.g., ELISA, BLI), qPCR, ddPCR, UV-Vis Spectroscopy, cell-based methods (e.g. In vitro Cell-Based Potency Assays), adherent mammalian tissue culture, and aseptic technique.• Executed Method Establishment (Transfer/Qualification/Validation) studies in GxP Laboratory Environment for AAV Gene Therapy Clinical Program in accordance to cGMP and 21CFR guidelines.• Authored new SOPs and served as SME for Analytical Methods for AAV Gene Therapy Clinical Program.• Designed and executed Method Optimization and Method Feasibility studies in Lab Notebook studies.• Authored Method Validation Protocols/Reports in accordance with ICH Q2(R2) guidelines.• Authored Technical Reports in response to GMP Deviation Investigations.• Initiated and owned various QMS Records: GMP Deviations, VDRs, CAPAs, LIRs, OOS Investigations.• Contributed as QC Document and Test Record Reviewer.• Managed reagents, data and inventory in Laboratory Information Management System.• Mentored and trained new hires and junior analysts in areas of expertise to improve technical knowledge and GxP acumen.

Santa Barbara, California, United States

• Led QC testing effort during initial product release of Asymmetric-Flow Field Flow Fractionation (AF4) product to market.• Performed routine QC Testing across different product lines (MALS, RI, DLS, FFF).• Performed independent analysis of instrument issues and developed solutions in Manufacturing, Service, and Quality Control processes.• Performed validations of various hardware and software changes.• Performed method development of QC tests and protocol writing during pilot phase.• Performed mining of historical QC data and prepared reports on failures and trends.

Santa Barbara, California, United States

Santa Barbara, California Area

Neuroscience Research Institute, Craig Montell Lab• Performed In-fusion cloning, E. coli Transformation, Colony Picking, Colony PCR, Plasmid Prep (Mini and Midi scale), and Gel Extraction to support research projects.• CRISPR plasmid design SnapGene for gene knockout lines in individual project.• Maintained transgenic lines of Aedes aegypti mosquitoes.• Refer to Honors and Awards Section for information on research project.

Pleasanton, Ca

• Assay development for the detection of infectious agents in the cobas Liat System.• Examined qPCR Assay performance (e.g., sensitivity, specificity, LOD).• Tested new reagent formulations and handled clinical samples.