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Judith A Blunt

from Shingle Springs, CA
Age ~72

Judith Blunt Phones & Addresses

  • 2871 Shingle Springs Dr, Shingle Spgs, CA 95682 (510) 794-5691
  • Shingle Springs, CA
  • Union City, CA
  • Grants Pass, OR
  • Fremont, CA
  • 33487 Caliban Dr, Fremont, CA 94555

Work

Company: 23andme Nov 2011 Address: Mountain View, CA Position: Director of regulatory affairs and quality assurance

Education

Degree: M.S. School / High School: University of California, San Francisco 1983 to 1986 Specialities: Clinical Science

Skills

Fda • Biotechnology • Medical Devices • Lifesciences • Clinical Trials • Iso 13485 • Regulatory Affairs • Clinical Research • Design Control • Quality System • Pharmaceutical Industry • Clinical Development • Validation • Oncology • Sop • Ivd • R&D • Molecular Diagnostics • Capa • Ctms • Gmp • Regulatory Submissions • Laboratory • Quality Assurance • Hardware Diagnostics • V&V • Assay Development • Gcp • Biopharmaceuticals • Regulatory Requirements • Glp • 21 Cfr Part 11 • Product Launch • Technology Transfer • Drug Development • Gxp • Commercialization • Personalized Medicine • Medical Diagnostics • Life Sciences

Interests

Transfusion Medicine • Molecular Diagnostics • Personalized Medicine • Ivds • Direct To Consumer Genetic Testing

Emails

Industries

Medical Devices

Resumes

Resumes

Judith Blunt Photo 1

Principal Consultant

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Location:
2871 Shingle Springs Dr, Shingle Springs, CA 95682
Industry:
Medical Devices
Work:
23andMe - Mountain View, CA since Nov 2011
Director of Regulatory Affairs and Quality Assurance

XDx Aug 2010 - Nov 2011
Director of Regulatory Affairs and Quality Assurance

Novartis Diagnostics May 2006 - Aug 2010
Assoc. Dir., Clinical Operations

Cepheid Apr 2005 - May 2006
Director of Clinical Affairs

InSite Vision Aug 2004 - Apr 2005
Dir. of Regulatory Affairs
Education:
University of California, San Francisco 1983 - 1986
M.S., Clinical Science
California State Polytechnic University-Pomona 1972 - 1976
BS, Microbiology
Skills:
Fda
Biotechnology
Medical Devices
Lifesciences
Clinical Trials
Iso 13485
Regulatory Affairs
Clinical Research
Design Control
Quality System
Pharmaceutical Industry
Clinical Development
Validation
Oncology
Sop
Ivd
R&D
Molecular Diagnostics
Capa
Ctms
Gmp
Regulatory Submissions
Laboratory
Quality Assurance
Hardware Diagnostics
V&V
Assay Development
Gcp
Biopharmaceuticals
Regulatory Requirements
Glp
21 Cfr Part 11
Product Launch
Technology Transfer
Drug Development
Gxp
Commercialization
Personalized Medicine
Medical Diagnostics
Life Sciences
Interests:
Transfusion Medicine
Molecular Diagnostics
Personalized Medicine
Ivds
Direct To Consumer Genetic Testing

Publications

Us Patents

Self-Corrected Assay Device

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US Patent:
51716887, Dec 15, 1992
Filed:
Aug 23, 1989
Appl. No.:
7/396326
Inventors:
Gary E. Hewett - Los Altos Hills CA
Steven T. Mielke - Fremont CA
Judith A. Blunt - Fremont CA
Assignee:
Cholestech Corporation - Hayward CA
International Classification:
C12M 136
C12Q 160
G01N 2100
US Classification:
435289
Abstract:
An assay device and method for determining the concentration of an analyte in a fluid sample. The device includes a porous-matrix reservoir which receives the sample to be assayed, and at least two reaction zones into which sample fluid is drawn from the reservoir. In an embodiment containing two reaction zones, a single-point standard curve which corrects for reduced-signal effects related to loss of reagent activity and linear inhibition effects, is used to determine analyte concentration. In an embodiment containing three reaction zones, a two-point standard curve which corrects for reduced-signal effects related loss of reagent activity and non-linear inhibition effects, is used to determine analyte concentration. Also disclosed is an apparatus which uses the device for automated or semi-automated analyte assay.

Non-Human Primate Monoclonal Antibodies And Methods

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US Patent:
47772450, Oct 11, 1988
Filed:
Aug 19, 1985
Appl. No.:
6/767213
Inventors:
Steven K. H. Foung - San Francisco CA
Judith A. Blunt - Fremont CA
Linda B. Rabin - Alameda CA
F. Carl Grumet - Stanford CA
Edgar G. Engleman - Atherton CA
Assignee:
Genelabs Incorporated - Redwood City CA
International Classification:
C07K 1500
C12N 500
A61K 3942
A61K 3944
US Classification:
530387
Abstract:
A stable trioma cell line capable of secreting a non-human primate monoclonal antibody specific against a selected antigen. An exemplary cell line secretes chimpanzee monoclonal antibody specific against an antigen associated with hepatitis nonA/nonB infection. The cell line is produced, in the method of the invention, by isolating lymphocytes from a primate immunized with the selected antigen, and immortalizing the lymphocytes by fusion with a stable, non-antibody-secreting murine myeloma/human hybridoma cell line having selected-for human characteristics. The trioma fusion products are selected for secretion of the desired antibody, which has a variety of diagnostic and/or therapeutic uses.
Judith A Blunt from Shingle Springs, CA, age ~72 Get Report