Joanne O'Dea Email & Phone Number

Greater San Diego Area

Greater San Diego Area

Greater San Diego Area

Sailing Events Association San Diego (SEA SD) is an organization which promotes major sailboat racing events in San Diego for the benefit of the local economy. Recently elected to the Board of Directors.

Greater San Diego Area

Promote J/Boat ownership, support local racing fleets, plan and encourage participation in J/Boat Regatta events.

Contract positions with responsibilities that included, but were not limited to, review and generation of Quality System procedural, policy, and QC test method Standard Operating Procedures (SOPs) in support of assay development and QC activities associated with start-up of GMP stem cell manufacturing operations and in preparation for inspection and successful licensure by CA FDB.

Established Quality Control dept. Developed, implemented, maintained Quality Systems, including analytical method development, writing STMs and SOPs, grew dept to 10 analysts supporting PhIII pivotal clinical trial in which over 400 patient specific immunotherapy lots were manufactured, tested, released. Managed scheduling, analysis of final product/in-process testing; supported process development. Oversight, audit of contract laboratory testing activities, Developed departmental goals, and procedures. Involved in design, equipping, and maintenance of the QC laboratory for GMP facility manufacturing autologous active immunotherapies. Responsible for technical writing including CMC, Annual Report, IND, and BLA. Implemented, managed Stability program for Phase III and commercial product. Managed Access database of stability testing results, supported Process and Analytical Method Validation. Successfully represented QC dept through CA FDB inspection and member of PAI prep team

Chiron Technologies, Center for Gene Therapy.Integral part of continuing configuration, optimization of large-scale cell culture systems, generating high titer, high quality retroviral vector.Responsible for operation of large scale retroviral vector production including scheduling, preparation, and maintenance of cell culture systems to support in vivo preclinical studies.Supported large scale alphaviral vector production exploring flat vs.suspension cell infection, infection times, volumes, inoculation cell density, incubation temperatures.Responsible for troubleshooting, evaluating production and processing procedure for retroviral vector preparations using in vitro functional assays; analyzing parameters, conditions, data collected. Successfully transferred process to Clinical Manufacturing.Performed clone selection for alphavirus packaging cell line including testing characteristics (MOI vs. titer, harvest times vs. titer, growth characteristics).

Generated recombinant retroviral vector-producing cell lines from stable transfected cells and cloning by limiting dilution. Selected highest titer potential clone (measuring transfer of expression by assaying for expression of gene of interest) used in the manufacture of high titer purified vector for pre-clinical studies.Demonstrated through cell-based assays that recombinant retroviral mediated expression of HBV core and e antigens induce potent antigen-specific cytotoxic T lymphocyte (CTL) responses in mice and macaques.Identified a CTL epitope in macaques immunized by direct in vivo administration of nonreplicating retroviral particles encoding the HBV core antigen (peptide loading of CTL targets).