Focus Diagnostics
Address: 5785 Corporate Ave, Cypress, CA 90630 Phone: (714) 220-1900: : Website: : Place name: : Category: : : Own this business?
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Focus Diagnostics Employees
Focus Diagnostics April 2013 - Present
Antech Diagnostics December 2010 - April 2013
Proteogenix Inc March 2008 - December 2010
Osmetech Molecular Diagnostics March 2004 - March 2008
University of Kansas Medical Center March 2003 - March 2004
Skills
Molecular Biology, Lifesciences, Cell Culture, Assay Development, Biotechnology, RT-PCR, PCR, ELISA, FDA, Flow Cytometry, qPCR, Immunology, Biomarkers, Microbiology, Validation, Antibodies, Immunoassays, Cell, In Vitro
Education
University of Kansas Medical Center 2000 — 2003
Postdoctoral Fellow, Molecular Virology
University of Madras 1994 — 2000
PhD, Virology, Molecular Biology
Focus Diagnostics February 2014 - Present
Focus Diagnostics February 2013 - February 2014
Clarient October 2011 - February 2013
Education
University of California, Riverside 2006 — 2010
Biological Science, Medical Biology, 3.5 GPA
Motion Industries October 2011 - Present
Le Cordon Bleu College July 2008 - October 2011
Focus Diagnostics August 2007 - March 2008
EG&G Technical Services May 2006 - August 2007
Bank of America September 2002 - May 2006
Skills
Higher Education, Customer Service, Hiring, Microsoft Office, Accounts Payable, Accounts Receivable, Cost Accounting, Inventory Management, Inventory Control, Financial Analysis, Account Reconciliation, Access, Account Management, Admissions, Budgets, Forecasting, Leadership, Marketing, Microsoft Excel, Microsoft Word, Negotiation, Outlook, Payroll, PowerPoint, Public Speaking, Purchasing, Training
Education
University of Phoenix-Las Vegas Campus 2008 — 2010
Master of Business Administration (M.B.A.)
University of Nevada-Las Vegas 2002 — 2006
Bachelor of Science Business Administration (B.S.B.A.), Business Administration and Management, General
Envigo ++++ September 2015 - Present
Huntingdon Life Sciences September 2013 - Present
Eurofins Global Central Laboratory April 2005 - August 2013
Focus Diagnostics April 2005 - June 2006
The Frank Hawkins Kenan Institute of Private Enterprise November 2001 - April 2005
quantumStream, Inc January 2000 - November 2001
The Frank Hawkins Kenan Institute of Private Enterprise March 1996 - January 2000
Skills
Biotechnology, Business Development, CRO, Drug Development, Competitive Analysis, Clinical Development, Market Research, Pharmaceutical Industry, Biopharmaceuticals, New Business Development, Strategic Planning, Clinical Trials, Infectious Diseases, Start-ups, Biomarkers, CRM, Lifesciences, Oncology, Cross-functional Team..., Business Strategy, GLP, Email Marketing, Mergers & Acquisitions, Fundraising, Mergers, Life Sciences, Strategy, Management
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2003 — 2005
Master of Business Administration (M.B.A.), Global Business; OneMBA
The George Washington University 1993 — 1997
Bachelor's Degree, Anthropological Linguistics
IntegenX. Inc. September 2014 - Present
Focus Diagnostics July 2013 - August 2014
path4ward, Inc. September 2011 - July 2013
JLH Consulting May 2011 - September 2011
Roche Molecular Systems, Inc. 2006 - 2011
Roche Molecular Systems, Inc. 2005 - 2006
JLH Consulting 2005 - 2005
Applied Imaging 2001 - 2005
Abbott Diagnostics 2000 - 2001
Abbott Diagnostics 1999 - 2000
Skills
Cross-functional Team..., Strategy, Medical Devices, Product Management, Biotechnology, Commercialization, Product Development, Product Launch, SaaS, Leadership, Management, Global Marketing, Sales, Marketing, Oncology, Market Development, Pharmaceutical Industry, Start-ups, Enterprise Software, Strategic Planning, Sales Operations, Team Building, Market Research, Molecular Diagnostics, FDA, Lifesciences, Strategy Development, Hardware Diagnostics, Strategic Partnerships, Competitive Analysis, Product Marketing, Team Leadership, Executive Management, Consulting, Global Business..., Life Science Industry, Mobile Enterprise, Virology, Genomics, Immunology, International Business, Infectious Diseases, Laboratory, Integration, Change Management, Venture Capital, Pricing, International Sales, Market Analysis, Commercial Management
Education
Purdue University 1984 — 1989
Bachelor of Science (BS)
Focus Diagnostics December 2014 - Present
Focus diagnostics, A Quest diagnostics subsidiary June 2014 - Present
ViiV Healthcare November 2009 - May 2014
GlaxoSmithKline 2001 - 2009
Marin County Specialty Clinic 1998 - 2001
Marin County Specialty Clinic 1998 - 2001
Santa Clara Valley Medical Center 1995 - 1997
Stanford University School of Medicine 1995 - 1997
Skills
Infectious Diseases, Medicine, HCV, Virology, Clinical Development, Clinical Research, Pharmaceutical Industry, Clinical Trials, Pharmacology, Medical Education, Vaccines, Medical Affairs, Healthcare, Medical Writing, Clinical Pharmacology, Therapeutic Areas, Lifesciences, Protocol Design, Scientific Analysis, Scientific Presentation, Neurology
Education
Stanford University
Infectious Disease Fellow
Stanford University
Internal Medicine Residency
University of California, San Francisco - School of Medicine
MD, Medicine
AstraZeneca September 2015 - Present
AstraZeneca August 2014 - September 2015
Advanced Testing Laboratory November 2013 - August 2014
Advanced Testing Laboratory May 2011 - November 2013
Amylin Ohio, LLC September 2009 - June 2011
Amylin Pharmaceuticals, Inc March 2007 - September 2009
Amylin Pharmaceuticals, Inc October 2005 - March 2007
Focus Diagnostics October 2004 - October 2005
Focus Diagnostics September 2002 - October 2004
Focus Diagnostics February 2001 - September 2002
Skills
Validation, Deviations, Change Control, FMEA, Product Complaints, Internal Audit, Quality Auditing, CAPA, Quality Investigations, Laboratory, Calibration, Quality Assurance Review, Analytical Method..., Sop, GMP, Employee Training, Microbiology, GLP, Quality Assurance, Quality Management, ISO, Pharmaceutical Industry, SOP, FDA, Quality System
Education
San Diego State University-California State University 2008 — 2009
Adv. Certificate, Biomedical Quality Systems
University of California, Santa Barbara 1992 — 1997
B.S., Zoology
Proove Biosciences, Inc. September 2014 - May 2015
Response Genetics April 2013 - September 2014
Response Genetics October 2011 - April 2013
Dendreon July 2011 - November 2011
Focus Diagnostics October 2007 - July 2011
Skills
GMP, Biotechnology, Sop, FDA, Aseptic Technique, ELISA, Molecular Biology, Assay Development, Quality Control, RT-PCR, qPCR, Laboratory, Microbiology, GLP, LIMS
Education
Rutgers University 2003 — 2007
BS, Biology
Rutgers University – Camden 2003 — 2007
BS, Biology
UCSF Medical Center July 2013 - Present
Dendreon November 2010 - November 2011
Focus Diagnostics July 2009 - October 2010
DDS LEGAL SUPPORT SYSTEMS, INC February 2003 - January 2010
California State University, Fullerton August 2007 - June 2008
Skills
Assay Development, FDA, Aseptic Technique, GMP, Biotechnology, Flow Cytometry, Cell, ELISA, Sop
Education
University of California, San Francisco 2012 — 2016
Doctor of Pharmacy (PharmD)
Jeanetics Laboratory Consulting, LLC November 2012 - Present
Berkeley HeartLab, a Quest Diagnostics service 2008 - November 2012
Sequenom 2007 - 2008
Focus Diagnostics 2005 - 2007
Specialty Laboratories 2000 - 2005
SmithKline Beecham Clinical Laboratories 1995 - 2000
Boston University School of Medicine 1989 - 1995
Skills
Diagnostics, Biotechnology, Life Sciences, Molecular Genetics, Laboratory Operations, Genetics, Laboratory, Human Genetics, Genetic Testing, Lifesciences, Biochemistry, Molecular Biology, Assay Development, Clinical Research, Sequencing, Biomarkers, Genomics, DNA sequencing, DNA, PCR, Personalized Medicine, Commercialization, qPCR, Technology Transfer, Product Launch, Science, Gel Electrophoresis, Molecular Diagnostics, Laboratory Medicine, LIMS, Validation, Sop, Clinical Development, FDA, Genotyping, GLP, Clinical Trials, Cell, Microbiology, Cancer, SNP genotyping, CLIA, DNA extraction, Oncology, Hematology, SOP, DNA Sequencing
Education
Harvard Medical School 1980 — 1983
Postodoctoral Fellowship, Human/Medical Genetics
The Ohio State University 1969 — 1977
B.S., M.Sc.,Phd., Genetics
Focus Diagnostics June 2015 - Present
LabCorp December 2012 - Present
454 Life Sciences (Roche) August 2006 - December 2012
Skills
HIPAA, Clinical Research, Clinical Trials, Process Improvement, GCP, Biotechnology, PCR, Flow Cytometry, Lifesciences, Analysis, Quality Assurance, 5S, Biochemistry, SAP, Assay Development, Life Sciences, SOP, Validation, EMR, GLP, GMP, Healthcare, Laboratory, Molecular Biology
Education
University of Saint Joseph 2011 — 2014
Master's Degree, Biochemistry
Merrimack College 2002 — 2006
Bachelor's of science, Health science
Gilead Sciences April 2015 - Present
Edwards Lifesciences September 2014 - April 2015
Dendreon August 2013 - August 2014
Dendreon July 2012 - August 2013
Dendreon March 2011 - July 2012
Focus Diagnostics November 2010 - March 2011
Focus Diagnostics August 2007 - November 2010
Boston Scientific May 2007 - August 2007
UC Davis June 2005 - July 2006
Skills
R&D, Validation, ELISA, Cell, Manufacturing, Assay Development, Protein Chemistry, V&V, GMP, Cross-functional Team..., Biopharmaceuticals, Sop, Technology Transfer, FDA, CAPA, Laboratory, Product Development, Biotechnology
Education
University of California, Berkeley 2006 — 2007
MS, Chemical Engineering
University of California, Davis 2002 — 2006
BS, Biochemical / Chemical Engineering
Bausch &Lomb Surgical, Valeant Pharmaceutical September 2013 - Present
Focus Diagnostics October 2014 - February 2015
Bausch + Lomb Surgical June 2013 - August 2013
University of Southern California August 2012 - May 2013
University of Southern California February 2007 - May 2013
Skills
Molecular Biology, Molecular Cloning, Immunohistochemistry, Confocal Microscopy, Cell Culture, Western Blotting, Cell Biology, PCR, Fluorescence Microscopy, Neuroscience, Statistics, Biochemistry, Genetics, Regulatory Affairs, IND, NDA, IDE, 510K, PMA, cGMP practices, cGLP, QSR, FACS analysis, Transfection, Electroporation, Lentivirus, Immunocytochemistry, Dissection, Perfusion, Cryosectioning, Chromatin..., ChIP-seq, RNAi, SDS-PAGE, Matlab, Technical Files, Medical Device Directive, CE marking, Design dossier, Medical devices, Quality Assurance, Animal Models, Medical Device Labeling, Class III Medical..., RT-PCR, Medical Devices, Quality System
Education
University of Southern California 2006 — 2013
Doctor of Philosophy (Ph.D.), Neuroscience
University of Southern California 2012 — 2013
Certificate in Regulatory and Clinical Affairs
Zhejiang University 2002 — 2006
Bachelor of Science (B.S.), Biological Sciences
PTS Diagnostics September 2015 - Present
Nanosphere March 2014 - September 2015
Focus Diagnostics July 2012 - March 2014
Focus Diagnostics February 2009 - June 2012
Panbio Ltd April 2003 - July 2008
Panbio Ltd April 2003 - November 2004
Skills
Biotechnology, New Business Development, Lifesciences, Medical Devices, Strategic Planning, Business Planning, Capital Equipment, Commercialization, Forecasting, Healthcare, Leadership, Life Sciences, Management, Marketing Management, Product Development, Product Launch, Sales, Sales Management, Sales Operations, Selling, Strategy, Training
Education
University of Phoenix 2010 — 2012
MBA, Business Administration and Management, General, 3.81
Southern Virginia University 1999 — 2002
Bachelor of Arts (B.A.), Business Administration and Management, General
Medtronic August 2015 - Present
Medtronic June 2015 - August 2015
USDA July 2013 - September 2014
Focus Diagnostics 2012 - February 2013
Image Quest Worldwide, Inc. September 2011 - June 2012
UC Irvine Ecology Department September 2010 - March 2012
Skills
Microsoft Office, Biology, Microsoft Excel, Data Analysis, Product Management, Communication Skills, Team Leadership, Customer Service, Leadership, Management, Marketing, Public Speaking, Social Media, Event Planning, Social Networking, PowerPoint, Communication, Conflict Resolution, Project Management
Education
University of California, Irvine - The Paul Merage School of Business 2014 — 2016
Master of Business Administration (M.B.A.), Marketing
University of California, Irvine 2008 — 2012
Bachelors of Science, Biology
University of Sussex 2010 — 2010
Physics
United States Navy, Bangor Kitsap Region, WA January 2015 - Present
Holy Trinity Parish August 2012 - June 2015
St. Agatha's Catholic Church September 2010 - March 2012
Diagnostic Hybrids, Inc. January 2009 - May 2010
Oregon Medical Labs 2006 - 2008
Focus Diagnostics 2004 - 2006
Dade Behring (Siemens) 2001 - 2006
Gen Probe 1996 - 2001
Skills
Sales, Healthcare, Training, Negotiation, Hospitals, Management, Cold Calling, Infectious Diseases, New Business Development, Account Management, Team Building, Competitive Analysis, Lifesciences, Public Speaking, Product Launch, Medical Devices, Capital Equipment, Leadership, Sales Operations, Sales Process, Recruiting, Program Management, B2B, Salesforce.com, Time Management, Business Planning, Networking, Team Leadership, Strategy, Cross-functional Team..., Teamwork, Sales Management, Social Networking, Business Development, Life Sciences
Education
University of Washington 1995 — 1996
Professional Certificate, Management Skills
Oregon State University 1979 — 1984
Bachelor of Science (BS), Microbiology
Focus Diagnostics June 2014 - Present
Focus Diagnostics August 2001 - June 2014
Focus Diagnostics August 2000 - July 2001
Focus Diagnostics August 1993 - July 2000
University of California, Irvine 1990 - 1993
Skills
Molecular Diagnostics, Infectious Diseases, Assay Development, qPCR, Clinical Trials, Technology Transfer
Education
University of California, San Diego 1984 — 1990
Ph.D., Molecular Biology
University of Oklahoma 1980 — 1984
B.S., Microbiology
The Suddath Companies February 2012 - April 2014
MDI January 2011 - June 2011
NACA March 2007 - October 2010
Focus Diagnostics October 2001 - February 2007
NACA May 1999 - September 2001
Pool Water Products January 1994 - February 1999
Skills
Microsoft Office, Microsoft Excel, SQL, Event Planning, Microsoft Word, Databases, PowerPoint, Visio, Outlook, Data Analysis, Access, Research, Oracle, Healthcare, Information Technology, Analysis, Microsoft SQL Server, Logistics, Budgets, Windows, Training, Customer Service, Team Building, Process Improvement
Education
Phillips Graduate Institute 1992 — 1994
AA, Computer Science
Tosoh Bioscience, Inc. February 2007 - Present
Focus Diagnostics October 2004 - February 2007
Wampole Laboratories November 2000 - October 2004
Skills
Diagnostics, Capital Equipment, Territory, Consultative Selling, Forecasting, Coaching, Healthcare, Hospitals, Sales Operations, Hardware Diagnostics, Market Development, Product Launch, Sales Management, Selling, Medical Devices, Cardiology, Sales, Competitive Analysis, Biotechnology, Life Sciences, Medical Diagnostics
Education
University of Kentucky
B.S., Biological Sciences, Chemistry
IntegenX. Inc. February 2015 - Present
Humana October 2013 - February 2015
Quest Diagnostics March 2012 - September 2013
Quest Diagnostics July 2009 - March 2012
Quest Diagnostics August 2006 - July 2009
Focus Diagnostics August 2005 - August 2006
Focus Diagnostics January 2005 - August 2005
Focus Diagnostics January 2001 - January 2005
Merck February 1998 - January 2001
Skills
Hospitals, Sales Management, Medical Diagnostics, Healthcare, Business Process..., Cross-functional Team..., Molecular Diagnostics, Sales Operations, Business Development, Capital Equipment, Sales Funnel..., Sales and marketing, Leadership..., Profit Margins, Organizational Agility, Organization Growth, Commercialization, Leadership, Hardware Diagnostics, Biotechnology, Product Launch, Market Development, Clinical Trials, Medical Devices, Immunology, Management, FDA, Cardiology, Managed Care, Oncology, Infectious Diseases, Laboratory, Lifesciences, Pharmaceutical Industry, Market Analysis, Diabetes, Cancer, Sales, Strategy, Life Sciences
Education
University of Nebraska Medical Center 1995 — 1997
BSN, Nursing
University of Nebraska-Lincoln 1992 — 1995
Bachelor of Science (B.S.), Biology/Biological Sciences, General
University of Nebraska-Lincoln 1988 — 1992
BS, Biology
Focus Diagnostics December 2011 - Present
Focus Diagnostics June 2011 - November 2011
Focus Diagnostics May 2009 - July 2011
Focus Diagnostics October 2007 - May 2009
Baxter Healthcare May 2006 - November 2006
Skills
Molecular Diagnostics, Six Sigma, Product Development, Miller-Heiman Strategic..., Instrumentation, Manufacturing Automation, Customer Service, qPCR, Lean/cGMP Manufacturing, Manufacturing Operations, Instructor-led Training, Microbiology, Lean Manufacturing, Supervisory Experience, Product Demonstration, Infectious Diseases, PCR, Validation, Protein Chemistry, Medical Devices, FDA, Molecular Biology, Biochemistry, Biotechnology, ELISA, CAPA, Lifesciences, Design Control, GMP, SOP
Education
University of Cape Town 2004 — 2005
BSc (Hons), Molecular & Cell Biology
University of Cape Town 2001 — 2004
BSc, Biochemistry, Biotechnology, Microbiology
Focus Diagnostics March 2013 - Present
Focus Diagnostics September 2012 - March 2013
Education
UC Irvine 2005 — 2009
Biology/Biological Sciences, General
Various- 2014 - 2014
IMA Institute of Management Accountants-Houston Chapter 2014 - 2014
Accelerated Production Services, Inc February 2013 - July 2013
Christie Digital Systems 2008 - 2012
Defense Contract Audit Agency 2006 - 2008
Focus Diagnostics 2005 - 2006
SportKat 2004 - 2005
County of San Diego 2001 - 2004
Skills
CMA, Managerial Finance, Financial Analysis, Financial Accounting, Auditing, Oracle 9i, JD Edwards, Hyperion Enterprise, Cognos, TM1, Sage MAS200, Financial Reporting
Education
Webster University
Master of Arts (M.A.), Finance, General
The College of Santa Fe
Bachelor of Arts (B.A.), Management
Berkeley HeartLab, Inc. Senior Director, Genetic ServicesSequenom. Inc.2007 - 2008
Focus Diagnostics 2005 - 2007
Specialty Laboratories 2000 - 2005
SmithKline Beecham Clinical Laboratories 1995 - 2000
Education
The Ohio State University 1972 — 1977
PhD, Genetics
Phenomenex July 2014 - Present
Johnson & Johnson January 2012 - January 2014
Johnson & Johnson August 2010 - January 2012
ProteoGenix, Inc. February 2009 - August 2010
Quest Diagnostics August 2005 - February 2009
Focus Diagnostics August 2005 - February 2009
Zymo Research Corp July 2002 - July 2005
University California, Irvine, Developmental Biology Center, Laboratory of Peter J. Bryant May 1998 - May 2002
Skills
Assay Development, Validation, FDA, ELISA, Quality System, GLP, Biotechnology, Molecular Biology, PCR, Lifesciences, Sop, Technology Transfer, GMP, Infectious Diseases, R&D, Protein Chemistry, Cross-functional Team..., Hardware Diagnostics, Quality Control, Pharmaceutical Industry, V&V, CAPA, Chemistry, 21 CFR Part 11, Commercialization, Design Control, Clinical Trials, Oncology, Clinical Development, Product Development, LIMS, Design of Experiments, Manufacturing, Biochemistry, SOP
Education
University of California, Irvine 1996 — 1999
Bachelor of Science, Biological Sciences, cum laude, Cell & Developmental Biology, Biochemistry, Genetics, Anthropology
University of California, Irvine 1996 — 1999
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Focus Diagnostics November 2012 - Present
Focus Diagnostics June 2010 - November 2012
Focus Diagnostics July 2008 - June 2010
Focus Diagnostics October 2005 - June 2008
University of California, Irvine 1999 - 2005
Skills
Molecular Biology, Product Development, Infectious Diseases, Diagnostics, qPCR, R&D, Patents, Genetics, Microbiology, Cell Culture, PCR, Immunology, ELISA, Hardware Diagnostics, Immunoassays, Assay Development, Validation, Medical Devices, FDA, Bioinformatics, DNA, Cell, In Vitro, GMP, Commercialization, Molecular Genetics, Design Control
Education
University of California, Irvine - College of Medicine 1991 — 1998
PhD, Molecular Biology
University of California, Los Angeles 1986 — 1990
BS, Biology
Caris Life Sciences 2012 - 2014
Predictive Biosciences 2010 - 2011
Orthofix 2010 - 2010
EraGen Biosciences 2008 - 2010
Philips Healthcare 2002 - 2008
Inovise Medical 2000 - 2002
Focus Diagnostics 1997 - 2000
Skills
Medical Devices, Clinical Research, EMEA, Biotechnology, Regulatory Affairs, Quality System, Clinical Trials, Cancer, Lifesciences, ISO 13485, Infectious Diseases, FDA, Design Control, Cross-functional Team..., CAPA, European Union, Oncology, Molecular Biology, Biochemistry, GMP, Pharmaceutical Industry, Hardware Diagnostics, Product Launch, R&D, Commercialization, Hospitals, Clinical Development, Market Development, Capital Equipment, Cardiology, Orthopedic, Validation, Global Marketing, Biomedical Engineering, Medical Diagnostics, Quality Control, Quality Assurance, Immunology, Technology Transfer, Biopharmaceuticals, In Vitro, Medicine, Genomics, Microbiology, IVD, GLP, Laboratory, 21 CFR Part 11, Sop, V&V
Education
San Diego State University-California State University
B.S., Biology
Nanosphere June 2014 - Present
Focus Diagnostics November 2013 - June 2014
QIAGEN September 2011 - November 2013
QIAGEN July 2007 - September 2011
Roche Diagnostics April 2005 - July 2007
Beckman Coulter January 2002 - April 2005
Skills
Life Science Technolog..., Molecular Oncology, Technology Workflow..., Clinical Laboratory..., Salesforce Training, Lifesciences, Biotechnology, Assay Development, Immunoassays, Molecular Diagnostics, Molecular Biology, Medical Devices, Market Development, Laboratory Automation, Laboratory Medicine, Commercialization, Hardware Diagnostics, Hematology, Immunology, Sales Operations, Laboratory, Business Development, Leadership, Infectious Diseases, Healthcare, Product Development, Medical Diagnostics, Oncology, Strategic Partnerships, Genomics, Clinical Trials, Capital Equipment, Urology, Life Sciences, Neurology
Education
The Johns Hopkins University 2012 — 2015
Masters of Science in Biotechnology Enterprise, Translational Medicine, Licensing and FDA Regulatory Affairs
Purdue University 1995 — 2000
MT(ASCP) BS, Medical Technology and Allied Health
Focus Diagnostics August 2009 - Present
Focus Diagnostics August 2009 - Present
Westcliff Medical Labs February 2008 - December 2009
Argent Mortgage 2004 - 2007
Skills
Illustrator, Maya, Microsoft Office, Photoshop
Education
Art Institute of California - Orange County 2010 — 2013
B.S., Media Arts and Animation
University of California, Riverside 1999 — 2004
B.A., Fine Arts
Lakewood High School
Natera February 2015 - Present
Focus Diagnostics January 2013 - February 2015
IVD Technologies January 2012 - October 2012
Tufts University April 2008 - September 2010
University of Queensland January 2004 - December 2007
UC San Diego October 2002 - December 2003
Center For Talented Youth (Johns Hopkins University) 2001 - 2003
IGEN International Incorporated June 2000 - August 2000
Skills
Molecular Biology, Cell Biology, Biochemistry, Microscopy, PCR, Fluorescence, Personnel Training, Tissue Culture, SDS-PAGE, HPLC, Western Blotting, Cell Based Assays, Imaging, Cell Culture, ELISA, Purification, Genetics, Protein Purification, DNA, Immunoprecipitation, UV-Vis, Immunohistochemistry, Immunofluorescence, Chromatography, Fluorescence Microscopy, qPCR, RT-PCR, Gel Electrophoresis, RNA isolation, DNA extraction
Education
The University of Queensland 2004 — 2009
PhD, Marine Studies - Applied Biochemistry
University of Massachusetts, Amherst 1999 — 2002
BSc, Biology
Medtronic August 2015 - Present
Focus Diagnostics October 2014 - Present
Edwards Lifesciences February 2011 - October 2014
NBTY October 2008 - December 2010
NBTY January 2008 - September 2008
Focus Diagnostics January 2007 - October 2007
Skills
GMP, Clinical Trials, FDA, CAPA, Quality Auditing, Quality Assurance, Medical Devices, Quality System, ISO 13485, GLP, Trackwise, FDA GMP, ISO 14971, Quality Control, Design Control, Root Cause Analysis
Education
ASQ 2015 — 2015
CQE, Certified Quality Engineer
University of California, Santa Barbara 2003 — 2006
B.S, Biochemistry
High school
Experimental Sciences
Forsyth-Wilson Enterprises April 2004 - June 2015
IBL International February 2010 - November 2010
Focus Diagnostics December 2005 - January 2010
Quest Diagnostics December 2005 - January 2010
Eli Lilly June 2004 - December 2005
Corporate Research International January 2003 - June 2004
CentraComm 2002 - 2003
Danka Office Imaging 1997 - 2002
Best Buy February 1996 - March 1997
Skills
Medical Devices, Infectious Diseases, Healthcare, Biotechnology, Commercialization, Pharmaceutical Industry, Product Launch, Laboratory, Orthopedic, Hospitals, Hardware Diagnostics, Capital Equipment, Molecular Diagnostics, FDA, Pharmaceutical Sales, Immunology, Market Research, Sales Effectiveness, Sales Force Development, Selling Skills, Microbiology, Genomics, Molecular Biology, Capital Equipment Sales, Business Development, Sales, Leadership, Customer Service, Management, Sales Management, Account Management, New Business Development, Life Sciences, Sales Operations, Cross-functional Team..., Strategic Planning
Education
The University of Findlay 1997 — 2002
BS Business Management, Business Management, International Business, Marketing
The Ohio State University 1993 — 1997
Business Management
MDxHealth August 2014 - Present
Focus Diagnostics June 2012 - August 2014
Focus Diagnostics April 2009 - June 2012
Focus Diagnostics April 2008 - April 2009
Focus Diagnostics May 2007 - March 2008
University of California Irvine Pharmacology September 2006 - May 2007
Rigshospitalet January 2006 - September 2006
Wilhelm Johannsen Centre February 2004 - July 2005
OHSU June 1994 - September 1998
Skills
Molecular Biology, qPCR, Immunoassays, Assay Development, Biotechnology, PCR, RT-PCR, ELISA, Validation, Lifesciences, Western Blotting, Infectious Diseases, FDA, Protein Purification, Cell Culture, Microbiology, Medical Devices, Sop, GMP, CAPA, Purification, DNA, Microscopy, Agarose Gel..., Protein Expression, Transfection, Cell, Antibodies, Technology Transfer, Laboratory, real-time PCR, R&D, Chemistry, Genotyping, Mammalian Cell Culture, Immunology, Protein Chemistry, Life Sciences, Medical Diagnostics, SOP
Education
University of Oregon 2000 — 2004
MS, Evolutionary Genetics
University of Oregon 1995 — 2000
BS, Biology Minor Physical Chemistry
Antech Diagnostics June 2014 - Present
Focus Diagnostics March 2014 - May 2014
UC San Diego 2011 - 2013
Skills
Grossing, Tissue Processing, Rodent husbandry, Bacterial Culture, Bacterial Transformation, DNA recombination, Restriction Digestion, Enzyme Assays, ELISA, Protein Electrophoresis, DNA electrophoresis, Agarose Gel..., SDS-PAGE, Northern Blotting, Southern blotting, Western Blotting, PCR, RT-PCR, Protein Crystallization, Protein Purification, TLC, Immunoblotting, Fluorescence..., IR spectroscopy, Mass Spectrometry
Education
University of California, San Diego 2010 — 2013
Bachelor of Science (BS), Human Biology
Epic Sciences August 2015 - Present
Focus Diagnostics April 2015 - July 2015
UC San Diego June 2013 - March 2015
Salem State University 2011 - 2013
Skills
Microsoft Office, Molecular Biology, Biotechnology, PCR, Microsoft Excel, PowerPoint, Research, Cell Culture, Microsoft Word, Matlab, Lifesciences, Biochemistry, Microbiology, Western Blotting, Teamwork, Gel Electrophoresis, C++, Customer Service, ELISA, SDS-PAGE, Protein Engineering, FPLC, GC-MS, Life Sciences
Education
University of California, San Diego 2013 — 2015
Master of Science (M.S.), Chemistry and Biochemistry
Salem State University 2010 — 2013
Bachelor of Science (BS), Biochemistry
Focus Diagnostics June 2013 - Present
Focus Diagnostics August 2011 - June 2013
Skills
Data Analysis, Editing, Microsoft Office, Public Speaking, Research, Clinical Research, Laboratory, Molecular Biology
Education
University of California, Los Angeles 2006 — 2010
Microbiology, Immunology, and Molecular Genetics, Microbiology and Immunology
Robert Half Finance & Accounting June 2015 - Present
CYK Accounting Services June 2012 - Present
HMS Host at The John Wayne Airport November 2011 - February 2013
Focus Diagnostics August 2006 - October 2010
Skills
Accounting, Financial Reporting, Financial Analysis, Project Management, Microsoft Excel, Microsoft Word, Budgets, Microsoft Office, Customer Service, Research, Sage MAS200, QuickBooks, Turbo Tax, Bookkeeping, Auditing, Account Reconciliation, Financial Statements, General Ledger, Payroll, Bank Reconciliation, Accruals, Variance Analysis, Analysis, Internal Audit, Accounts Receivable, Internal Controls, Financial Accounting, Financial Planning
Education
International Culinary Schools at The Art Institute of California 2010 — 2013
Culinary Management
Regis University 1984 — 1988
Bachelor of Applied Science (B.A.Sc.), Accounting
Ocean Media October 2006 - Present
PIHRA District 7 2003 - Present
Michelle Gustilo-Smithson, PHR September 2008 - July 2010
Focus Diagnostics October 2003 - September 2006
AppleOne January 2000 - September 2003
Mesa Energy Systems 1998 - 1999
Mesa Energy Systems 1998 - 1999
Mesa Energy Systems 1998 - 1999
Mesa Energy Systems 1998 - 1999
Skills
Training, Recruiting, Leadership Development, Deferred Compensation, Employee Relations, HR Consulting, Benefits Administration, System Administration, Temporary Staffing, Marketing, Applicant Tracking..., Performance Management, Talent Management, Marketing Strategy, Strategic Planning, Onboarding, Team Building, Human Resources, Start-ups, Personnel Management, Management, Account Management, Talent Acquisition
Education
Purdue University 1992 — 1997
Bachelor of Arts (B.A.), Organizational Communications, Minor in Supervision
Long Beach Polytechnic High School
Long Beach Polytechnic High School
Texas Biomedical Research Institute November 2014 - Present
Baylor Health Care System October 2012 - October 2013
Pima Community College February 2011 - December 2011
US Oncology September 2008 - August 2010
Kinetic Concepts January 2006 - November 2007
Focus Diagnostics March 2005 - September 2005
Cedars-Sinai Medical Center March 2000 - February 2005
Memorial Sloan-Kettering Cancer Center July 1997 - February 2000
Amgen October 1996 - July 1997
Skills
Clinical Trials, Oncology, Clinical Research, Strategic Planning, Clinical Development, Cancer, Healthcare, GCP, Hospitals, Regulatory Affairs, Pharmaceutical Industry, CTMS, Process Improvement, Biotechnology, Change Management, Quality Assurance, Quality Control, Quality Management, SOP, Drug Development, Laboratory, Medical Devices, Protocol, Life Sciences, GLP, GMP, Cell Culture, Research, FDA
Education
UCLA 2002 — 2004
MPH, Public Health
UCLA 1992 — 1996
BS, Biochemistry
Ambry Genetics 2015 - Present
Focus Diagnostics 2013 - 2015
UC Irvine Health 2012 - 2013
Skills
Laboratory Medicine, Clinical Research, Molecular Biology, Laboratory, Immunology, Hospitals, Microbiology
Education
University of California, Irvine 2007 — 2011
Bachelor of Science (BS), Biology/Biological Sciences
Blue Skies, LLC 2002 - Present
Allergan 2012 - 2014
Advanced Sterilization Products 2009 - 2014
Abbott Diabetes Care 2010 - 2010
MicroVention 2010 - 2010
Biomed Development Corporation 2009 - 2009
Ethicon Endo-Surgery 2007 - 2009
Biosense Webster 2003 - 2009
Focus Diagnostics 2007 - 2008
Cordis 2003 - 2004
Skills
ERP, SDLC, Process Improvement, Business Process..., Business Process, Requirements Analysis, Medical Devices, Integration, FDA, Cross-functional Team..., Quality Assurance, CRM Integration, Program Management, Project Management, Management Consulting, Operations Management, JD Edwards, ISO 13485, Supply Chain Management, SAP, Software Development, Enterprise Software, Strategy, Management, Testing, Consulting, Manufacturing, Supply Chain, Team Leadership
Education
The Institute of Technology at Linköping University 1993 — 1997
Master of Science, Industrial Engineering and Management
Skalby
Focus Diagnostics February 2015 - Present
Focus Diagnostics June 2014 - January 2015
UC Irvine June 2010 - December 2013
University of California, Riverside January 2008 - June 2010
Skills
Clinical Trials, Plaque Assay, Birds, Evolutionary Biology, Scientific Writing, Animal Behavior, Sexual selection, R, Animal Communication, Ecology, Experimental Design, Science, Mating behavior, Microscopy, PCR, DNA extraction
Education
University of California, Irvine 2010 — 2014
Master's degree, Biological Sciences
UC Riverside 2006 — 2010
Bachelor of Science (B.S.), Biology/Biological Sciences, Emphasis in Evolution & Ecology
Beth Israel Deaconess Medical Center March 2015 - Present
Focus Diagnostics June 2012 - September 2014
UCLA January 2012 - April 2012
Skills
Tissue Culture, Cell Culture, Hemaglutination..., Plaque Assay, Bacterial Culture, ELISA, PCR, in Situ Hybridization, Leadership, Pipetting, Laboratory Safety, Research, Science, Analysis, Data Analysis, Molecular Biology, Teaching, Customer Service
Education
University of California, Los Angeles 2006 — 2011
Bachelor of Science (B.S.), Cell/Cellular and Molecular Biology
LabCorp May 2011 - Present
LabCorp November 2003 - Present
LabCorp July 2002 - Present
Focus Diagnostics March 1998 - May 2002
National Institutes of Health July 1990 - March 1998
Hackensack University Medical Center November 1988 - July 1990
Mount Sinai Medical Center August 1986 - November 1988
Skills
Infectious Diseases, Laboratory Medicine, Immunology, Lifesciences, Microbiology, Biotechnology, Laboratory, Virology, Molecular Biology, Clinical Research, Pathology, Clinical Microbiology, Epidemiology, Healthcare, Molecular Diagnostics, Clinical Trials, Medical Devices, Cell Culture, Hospitals, Life Sciences
Education
The Ohio State University 1981 — 1986
Ph.D., Medical Microbiology and Immunology
University of Pennsylvania 1977 — 1981
B.A., Biology
The Bronx High School of Science 1974 — 1977
Regents Diploma
Focus Diagnostics April 2014 - Present
MicroVention March 2011 - Present
Edwards Lifesciences March 2006 - March 2011
Medtronic August 2002 - February 2006
Skills
Fixtures, Design Control, Design of Experiments, Medical Devices, ISO 13485, CAPA, Quality System, V&V, Validation, FDA, Lean Manufacturing, Six Sigma, Manufacturing, R&D, Engineering, Injection Molding, Manufacturing..., Minitab, Machining, ISO 14971, DMAIC, SPC
Education
The University of Connecticut
BSc., Mechancial Engineering/Materials Engineering
MDxHealth March 2012 - Present
Captek Holdings March 2011 - March 2012
Capstone Care, LLC May 2009 - March 2012
Jasmin Terrace at Montclair, Inc. November 2009 - December 2011
Agendia, Inc. February 2010 - March 2011
LiveOffice January 2009 - June 2009
Focus Diagnostics November 2001 - November 2008
Quad Research June 1997 - July 2001
Medtronic August 1990 - May 1997
Hewlett-Packard July 1978 - July 1990
Skills
Sales, ERP, Budgets, Pricing, Strategic Planning, Financial Analysis and..., Cost Accounting..., Corporate Finance, Forecasting, Business Development, Financial Analysis, Start-ups, Cross-functional Team..., Change Management, Mergers & Acquisitions, Process Improvement, Accounting, Data Analysis, Analysis, Medical Devices, Due Diligence, Management, Managerial Finance, Finance, Strategy, Business Planning, Strategic Financial..., Business Strategy, Portfolio Management, Financial Modeling, Private Equity, Leadership, Cost Accounting, Financial Planning
Education
University of California, Berkeley - Walter A. Haas School of Business 1976 — 1981
MBA, Finance
University of Colorado Boulder - Leeds School of Business 1970 — 1974
B.S., Finance & International Business
Quest Diagnostics February 2014 - July 2015
Quest Diagnostics May 2013 - February 2014
Genoptix Medical Laboratory (a Novartis Company) April 2012 - May 2013
Focus Diagnostics (a Quest Diagnostics Company) June 2008 - April 2012
Focus Diagnostics January 2002 - June 2008
Employer Beneifit Services (EBS) September 2000 - October 2001
Quest Diagnostics 1996 - 2000
PacifiCare Health Systems 1989 - 1996
Skills
Product Launch, Product Marketing, Strategic Planning, Marketing Strategy, Healthcare, Commercialization, Medical Devices, Business Planning, Product Development, Market Research, Cross-functional Team..., Leadership, Market Development, Forecasting, Biotechnology, Management, Pricing, Marketing, Hardware Diagnostics, Analytics, Pricing Strategy, Competitive Analysis, Marketing Management, Team Building, Market Analysis, Molecular Diagnostics, Sales, Contract Negotiations, New Business Development, Data Analysis, Sales Operations, Infectious Diseases, Business Management, Diagnostics, Business Strategy, Negotiation, Analysis, Hospital Marketing, Marketing Operations, Pricing Systems, Sales trainings, Customer Interaction, Customer Service...
Education
Tulane University - A.B. Freeman School of Business
Bachelor of Science (B.S.), Business Management
Gilead Sciences August 2015 - Present
Pacira Pharmaceuticals, Inc. March 2015 - July 2015
Allergan February 2011 - November 2014
Allergan June 2004 - February 2011
Allergan September 2002 - June 2004
Focus Diagnostics August 2000 - September 2001
Skills
FDA, Biotechnology, Pharmaceutical Industry, CAPA, Sop, Validation, GMP, Biopharmaceuticals, 21 CFR Part 11, GxP, Aseptic Processing, Change Control, LIMS, Technology Transfer, V, GLP, Quality System, V&V, SOP
Education
University of California, Riverside 2002 — 2003
M.S., Biochemistry and Molecular Biology
University of Southern California 1996 — 2000
B.S., Biomedical/Biochemical Engineering
Focus Diagnostics June 2015 - Present
CareDx, Inc March 2014 - May 2015
Novartis Vaccines and Diagnostics April 2011 - March 2014
Monogram Biosciences July 2007 - April 2011
Genentech September 2003 - June 2007
Johnson & Johnson August 1998 - September 2003
U.S. Army Europe May 1993 - May 1998
Skills
Sales Operations, Commercialization, Competitive Analysis, Product Marketing, Product Development, Biotechnology, Brand Management, Medical Devices, Leadership, Product Management, Global Marketing, Product Launch, Managed Care, Infectious Diseases, Cross-functional Team..., Competitive Intelligence, Assay Development, Integrated Marketing, Operations Management, Strategic Planning, Marketing, Sales, Pharmaceutical Sales, Pharmaceutical Industry, Marketing Strategy, Oncology, Strategy, Cardiology, Lifesciences, Market Development, Life Sciences
Education
University of Cincinnati College of Business 1999 — 2001
MBA, Marketing
University of Oklahoma 1995 — 1997
MA, Human Relations
United States Military Academy at West Point 1989 — 1993
Bachelor of Science (BS), French Studies
Vaxart Inc. March 2015 - Present
Allergan February 2014 - November 2014
Focus Diagnostics May 2004 - February 2014
Clarient February 2003 - May 2004
University of New Mexico 2001 - 2003
Unilever Research 1993 - 1996
Skills
Cell Based Assays, Clinical Trials, Vaccines, ELISA, Infectious Diseases, Cell Culture, Life Sciences, Diagnostics, Clinical Development, Immunology, Validation, Science, Pharmaceuticals, Virology, R&D, Research, Immunoassays, Tissue Culture, Cancer, FDA, Immunohistochemistry, Biopharmaceuticals
Education
University of California, Irvine 1996 — 2001
Ph.D., Virology
The Johns Hopkins University 1989 — 1993
B.A., Biology/Chemistry
Kinkaid School 1982 — 1989
Focus Diagnostics April 2007 - Present
PDL Biopharma 2002 - 2005
eos biotechnology 2000 - 2002
Wyeth 1989 - 2000
Skills
Biotechnology, Assay Development, FDA, ELISA, Molecular Biology
Education
Rochester Institute of Technology 1987 — 1999
Bachelor of Science (BS), Biotechnology
Focus Diagnostics April 2014 - Present
Focus Diagnostics August 2009 - April 2014
California Student Aid Commission April 2009 - July 2009
Genentech March 2008 - March 2009
Alembic Ltd, India October 2005 - December 2007
Charotar University of Science & Technology (Formerly Charotar Institute), India February 2004 - October 2005
Kadakia College of Management and Computer Studies August 2000 - February 2004
Skills
Biostatistics, SAS, Clinical Trials, SAS programming, Clinical Study Design, Survival Analysis, Statistical Modeling, R, Statistics, CRO, Clinical Research, Clinical Data Management, FDA, Data Analysis, Validation, Regulatory Submissions, 21 CFR Part 11, GCP, Lifesciences, Protocol
Education
The Maharaja Sayajirao University of Baroda 2004 — 2005
Post Graduate Diploma in Business Management, Business Administration and Management, General
Maharaja Sayajirao University of Baroda, vadodara 1998 — 2000
Master of Science, Statistics
Maharaja Sayajirao University of Baroda, vadodara 1995 — 1998
Bachelor of Science, Statistics
HERE, a Nokia company March 2012 - Present
Navteq November 2011 - March 2012
Focus Diagnostics December 2010 - December 2011
Microsoft July 2008 - January 2011
Rapt Inc. August 2005 - June 2008
Leica Geosystems HDS, LLC 2000 - 2005
Allstate Research & Planning Center 1993 - 2000
Skills
Machine Learning, Agile Methodologies, Computer Vision, Distributed Systems, Analytics, Software Engineering, C++, Strategy, Algorithms, Python, Big Data, Cloud Computing
Education
Stanford University 1990 — 1996
Ph.D.
University of California, Davis 1988 — 1990
MS
University of California, Berkeley 1984 — 1988
BS
DRM Associates April 2013 - Present
MicroPhage Inc. January 2011 - May 2013
ProteoGenix, Inc. February 2007 - September 2010
Focus Diagnostics 2003 - 2007
Bausch & Lomb 1999 - 2003
Johnson & Johnson 1996 - 1999
HealthNetwork Labs 1993 - 1995
HealthNetwork Labs 1993 - 1995
HealthNetwork Labs 1993 - 1995
Ciba Corning 1992 - 1995
Skills
FDA, Biotechnology, Lifesciences, Medical Devices, Infectious Diseases, Commercialization, Healthcare, Capital Equipment, Cross-functional Team..., Hardware Diagnostics, Start-ups, Technology Transfer, Hospitals, Venture Capital, Pharmaceutical Industry, Product Development, Marketing Strategy, Market Development, Product Launch, Validation, R&D, 21 CFR Part 11, ISO 13485, Biopharmaceuticals, Strategy, CAPA, Regulatory Affairs, Immunology, GLP, V&V, GMP, Quality System, Sop, Design Control, Change Control, Microbiology, Laboratory, Oncology, Genomics, Clinical Development, GCP, Clinical Trials, Strong Business Acumen, Team Management, Immunoassays, Molecular Biology, Medical Diagnostics, Assay Development, Biochemistry, Drug Development
Education
Southern Illinois University, Edwardsville 1970 — 1972
Bachelor of Science (BS), Blogy
Focus Diagnostics Senior ProgrammerQuest Diagnostics2006 - Present
Skills
Validation, SQL, Data Analysis, Software Development, 21 CFR Part 11, Business Intelligence
Education
University of California, Irvine
Dendreon November 2010 - Present
Biomerica Inc July 2009 - November 2010
Focus Diagnostics May 2008 - January 2009
Clontech February 2002 - April 2008
Skills
Biotechnology, Molecular Biology, Immunology, ELISA, Assay Development, Cell Culture, Immunoassays, GMP, PCR, Protein Chemistry, HPLC, Flow Cytometry, Validation, Cell, FDA, Sop, Western Blotting, Purification
Education
University of Guelph 1989 — 1994
Ph.D, Parasitic Molecular Dianogsis and Immunology and Molecular Biology
University of Guelph 1987 — 1989
M.Sc, Parasitic Immunology and Vaccination
MHS Biotech Consulting May 2014 - Present
North Amercian Science Associates (NAMSA) November 2012 - April 2014
Self Employed November 2010 - November 2012
Focus Diagnostics April 2008 - October 2010
Beckman Coulter November 1987 - March 2008
The Universtiy of Iowa July 1980 - October 1987
Skills
Assay Development, Molecular Biology, ISO, Biomarker Discovery, GMP, Protein Purification, Product R&D, Protein Function, HPLC, Immunoassays, Validation, Protein Chemistry, Biotechnology, Cell, Chemistry, Spectrophotometry, Infectious Diseases, Enzyme Assays, In Vitro, Lifesciences, GLP, Purification, Capillary..., Biochemistry, Proteomics, UV/Vis, V&V, Antibodies, Genomics, Biomarkers, Immunology, Commercialization, ELISA, Technology Transfer, DNA, R&D, Life Sciences
Education
University of Michigan
B.S., Zoology
University of Southern California
Ph.D., Biochemistry
Medtronic Minimed June 2015 - Present
Avrio Biopharmaceuticals December 2014 - June 2015
Edwards Lifesciences February 2008 - August 2014
Focus Diagnostics April 2005 - October 2007
Amgen September 2001 - April 2005
Baxter BioScience May 2000 - September 2001
Alpha Therapeutics November 1997 - May 2000
Skills
Flow Cytometry, Manufacturing, Laboratory, Sop, Validation, Engineering, V&V, UV/Vis, FTIR, Product Development, Gas Chromatography, Protein Chemistry, Medical Devices, Calibration, FMEA, Chemistry, FDA, Spectrophotometry, Testing, Training, Immunology, Software Documentation, Biochemistry, Troubleshooting, Analysis, Management, CAPA, ISO 14971, GMP, ISO 13485, SOP
Education
University of California, Los Angeles 1992 — 1997
BS, Biochemistry
Focus Diagnostics March 2007 - Present
Education
University of San Francisco 2001 — 2006
B.A., Psychology, German Studies
Homestead Clinical Corporation September 2005 - March 2007
Amgen July 2002 - July 2004
Immunex September 1990 - July 2002
Focus Diagnostics 1983 - 1990
Skills
Validation, Drug Discovery, Bioanalysis, ELISA, Assay Development, Medical Diagnostics, Biotechnology, Biomarkers, Biopharmaceuticals, Antibodies
Education
University of California, Santa Cruz 1979 — 1982
B.A., Biology
Hycor Biomedical May 2009 - Present
Focus Diagnostics July 2006 - February 2009
Focus Diagnostics November 2005 - July 2006
Diagnostic Products Corporation May 2004 - November 2005
Diagnostic Products Corporation June 1997 - May 2004
Alpha Therapeutic Corporation March 1993 - June 1997
Skills
Management, GMP, Manufacturing, Quality Control, Quality System, Testing, Validation, Leadership, Biotechnology, CAPA, Change Control, Cross-functional Team..., Data Analysis, Design Control, ELISA, FDA, ISO 13485, Immunoassays, Lean Manufacturing, Medical Devices, Pharmaceutical Industry, Process Improvement, Product Management, Project Management, Quality Assurance
Education
University of California, Los Angeles 1987 — 1991
M.S., Bioinorganic Chemistry
Northwestern University 1983 — 1987
B.A., Chemistry
Viracor-IBT Laboratories, Inc. February 2015 - Present
Focus Diagnostics July 1994 - January 2015
Skills
Immunology, Assay Development, Clinical Research, Infectious Diseases, ELISA, Immunoassays, Laboratory, Microbiology, Sop, Protein Chemistry, Cell Culture, Cell Biology, Lifesciences, Medical Diagnostics, Commercialization, Medical Devices, Biotechnology, Life Sciences, Western Blotting, Flow Cytometry, Technology Transfer, Clinical Trials
Education
University of North Carolina at Chapel Hill 1975 — 1979
PhD, Immunology
Edwards Lifesciences January 2015 - Present
Edwards Lifesciences September 2013 - January 2015
Focus Diagnostics November 2009 - August 2013
Focus Diagnostics August 2008 - November 2009
Beckman Coulter 1993 - July 2008
Skills
FDA, de novo, 510(k), EUA, Quality Systems, 21 CFR, ISO 13485, IVDD, Quality System, Design Control, Regulatory Submissions, Sop, Infectious Diseases, Medical Devices, Validation, ISO 14971, GMP, V&V, 21 CFR Part 11, CE marking, CAPA, Biotechnology, IVD, Change Control, GLP, Hardware Diagnostics, Regulatory Affairs, Cross-functional Team..., Clinical Trials, Biopharmaceuticals, Technology Transfer, Commercialization, PMA, Immunoassays, SOP
Education
University of California, Irvine 1987 — 1990
Bachelor's of Science, Biology, General
University of California, Santa Cruz 1986 — 1987
Biology/Biological Sciences, General
Focus Diagnostics September 2009 - Present
University of California, Irvine September 2002 - March 2011
University of California, Irvine September 1998 - September 2002
Education
University of California, Irvine - School of Medicine 2002 — 2011
Ph.D, Biological Sciences
University of California, Irvine 1997 — 2002
B.S., Biological Sciences
Focus Diagnostics May 2014 - Present
Planet Beach Franchising Corporation 2012 - Present
Franchise Consulting Associates, Inc December 2010 - Present
Roche Diagnostics January 2000 - May 2011
Christiana Care Health System 1990 - December 1999
Thomas Jefferson University 1985 - 1990
Johns Hopkins University 1986 - 1987
Skills
Selling Skills, Lifesciences, Pharmaceutical Industry, Market Development, Medical Devices, Sales Process, Competitive Analysis, Market Planning, Talent Acquisition, Franchising, Client Counseling, Career Counseling, Professional Counseling, Consulting, Biotechnology, Business, Genomics, Product Launch, Sales Effectiveness, Pharmaceutical Sales, Start-ups, Life Sciences, Sales, Oncology
Education
West Chester University of Pennsylvania 1990 — 1992
MS
University of Delaware
BA, Biology
Bio-Rad Laboratories April 2011 - Present
ProteoGenix, Inc. September 2008 - August 2010
Focus Diagnostics August 2006 - September 2008
Skills
Product Development, Assay Development, Infectious Diseases, ELISA, FDA, Instrument Validation
Education
University of Oklahoma
Focus Diagnostics February 2013 - Present
Focus Diagnostics November 2009 - Present
Third Wave Technologies 2002 - 2009
Skills
Biotechnology, Infectious Diseases, Molecular Biology, Medical Devices, Commercialization, Cross-functional Team..., Capital Equipment, Product Launch, Hardware Diagnostics, Lifesciences, Molecular Diagnostics, FDA, Validation, Healthcare, Life Sciences
Education
Radford University 1966 — 1970
Bachelor’s Degree, Chemistry
Radford University
Kaiser Permanente September 2014 - Present
Focus Diagnostics January 2013 - December 2014
Skills
Biotechnology, Cross-functional Team..., CAPA, Business Strategy, FDA, GMP, Infectious Diseases, Laboratory, Life Sciences, Lifesciences, Medical Devices, Microbiology, Molecular Biology, Quality Assurance, Quality System, R, Sop, Strategic Planning, Validation
Education
State University of New York College at Plattsburgh
None January 2012 - Present
Focus Diagnostics October 2004 - December 2011
Diamedix 1996 - 2004
Detroit Public Schools January 1983 - March 1987
Education
University of Maryland College Park 1970 — 1973
BS, Mathematics
Dendreon February 2015 - Present
Dendreon June 2012 - February 2015
Dendreon November 2010 - June 2012
Focus Diagnostics January 2008 - November 2010
Focus Diagnostics February 2005 - January 2008
Antech Diagnostics August 2004 - February 2005
Skills
Flow Cytometry, Assay Development, ELISA, Cell Culture, Protein Chemistry, Aseptic Technique, GLP, Bioassay, Immunoassays, Microbiology, Purification, Quality Control, LIMS, Biopharmaceuticals, Protein Purification, Gram Staining
Education
University of California San Diego 2000 — 2004
Bachelors of Science in Biochemistry and Cell Biology, Biochemistry and Cell Biology
University of California, San Diego 2000 — 2004
Bachelor's Degree, Biochemistry and Cell Biology
Claritas Genomics June 2015 - Present
Focus Diagnostics 2012 - December 2014
Focus Diagnostics 2010 - 2012
Focus Diagnostics 2006 - 2010
Focus Diagnostics 2000 - 2005
Meridian Bioscience Inc. 1995 - 2000
Meridian Bioscience Inc. 1995 - 2000
Skills
Medical Devices, Capital Equipment, Infectious Diseases, Product Launch, Cross-functional Team..., Team Leadership, Hardware Diagnostics, Biotechnology, Sales Management, Commercialization, Sales, Market Development, Immunology, Molecular Diagnostics, Market Analysis, Salesforce.com, Laboratory, FDA, Lifesciences, Global Marketing, Capital Equipment Sales, Sales Operations
Education
University of Oklahoma 1987 — 1992
Bachelor of Arts (B.A.), History, Political Science
Ultrafab February 2010 - Present
Lenel Systems International March 2008 - February 2010
Arnold Magnetic Technologies October 2006 - March 2008
Focus Diagnostics February 2005 - August 2006
Frontier Communications June 1995 - June 2000
Education
Rochester Institute of Technology
Bachelor of Applied Science (BASc)
Susquehanna University
Allergan April 2013 - Present
Dendreon August 2010 - March 2013
Focus Diagnostics March 2009 - July 2010
Skills
Aseptic Technique, Aseptic Processing, cGMP manufacturing, cGMP practices, Validation, GMP, FDA, Sop, Compounding, Biopharmaceuticals, CAPA, LIMS, Trackwise, GLP, Change Control, SOP, Biotechnology, Quality Assurance
Education
University of California, Irvine
B.S.
VA Medical Center August 2015 - Present
National Genetics Institute; a LabCorp subsidiary November 2013 - Present
National Genetics Institute September 2013 - November 2013
National Genetics Institute; a LabCorp subsidiary August 2011 - September 2013
Focus Diagnostics January 2011 - June 2011
Sylvan Learning Centers October 2010 - May 2011
Circuit City August 2008 - February 2009
Skills
Biochemistry, Microbiology, PCR, Social Media, Assay Development, DNA
Education
University of California, Riverside 2006 — 2010
BS, Biology
Amgen March 2006 - Present
Focus Diagnostics March 2005 - March 2006
Quest Diagnostics February 2002 - March 2005
Skills
CAPA, GMP, Quality Systems, Process Validation, SOP, cGMP
Education
University of California, Santa Barbara 1996 — 2001
Bachelor of Science (BS), Cell developmental biology
Puma Biotechnology November 2012 - Present
Genentech August 2011 - November 2012
Focus Diagnostics July 2008 - August 2011
Focus Diagnostics October 2007 - July 2008
Amgen October 2006 - October 2007
Focus Diagnostics October 2002 - October 2006
Skills
Molecular Biology, Clinical Trials, Infectious Diseases, Immunology, Drug Development, Oncology, Validation, Biotechnology, Clinical Research, Laboratory, Medical Devices, Microbiology, Lifesciences, Science, FDA
Education
University of California, Irvine
Bachelors of Science, Biological Sciences
Focus Diagnostics April 2006 - Present
Skills
ELISA, Immunoassays, Cell Culture, Infectious Diseases, Immunology, PCR, Molecular Biology, Biotechnology, Western Blotting, Cell Biology, RT-PCR, Assay Development, qPCR, Laboratory, Protein Purification, Lifesciences, Genomics, Microbiology, Biochemistry, Flow Cytometry, GLP, Protein Chemistry
Education
UCI 2002 — 2004
Master of Science (MS), Biotechnology
UCLA 1997 — 2002
Bachelor of Science (BS), Microbiology and Immunology
Taipei American School
Trinity Medical Center February 2015 - Present
QIAGEN January 2012 - February 2015
Cardinal Health March 2008 - January 2012
Siemens Healthcare August 2006 - March 2008
Focus Diagnostics February 2004 - August 2006
Wampole Laboratories October 2001 - February 2004
Skills
ELISA, Hardware Diagnostics, Microbiology, Infectious Diseases, Lifesciences, Capital Equipment, Hospitals, Cardiology, Healthcare, Selling, Laboratory Automation, Medical Devices, Chemistry, Medical Diagnostics, Hematology, Biotechnology, Immunology, Customer Satisfaction, Sales Operations, Assay Development
Education
The University of Akron
BS in Medical Technology, Medical Technology
Mingo High School
American Toxicology llc March 2014 - Present
Focus Diagnostics September 2001 - June 2011
Santa Paula Memorial Hospital September 2000 - August 2001
Advanced Clinical Lab April 2000 - August 2000
Pantox Laboratory March 1998 - June 2000
Mercy Medical, Nichols Institute November 1990 - June 1996
Toxicology, Nichols Institute July 1985 - June 1996
Education
California State
University of Phoenix
Master of Arts, Organizational Management
Siemens Healthcare April 2014 - Present
Siemens Healthcare November 2009 - March 2014
Siemens Healthcare August 2006 - November 2009
Focus Diagnostics January 2000 - August 2006
Meridian Bioscience January 1998 - December 2000
Skills
Capital Equipment Sales, Product Launch, Hospitals, Healthcare, Biotechnology, Sales Operations, Account Management, Sales Management, Market Development, Cross-functional Team...
Education
Rutgers University
BA, Biology and Psychology
Focus Diagnostics October 2011 - Present
Focus Diagnostics January 2010 - September 2011
BioPhase Solutions August 2010 - December 2010
Skills
Lifesciences, Microbiology, FDA, Biochemistry, qPCR, Immunology, Validation, Infectious Diseases, ELISA, Cell Culture, Biotechnology, PCR, Assay Development, GMP, Molecular Biology
Education
University of California, San Diego
Focus Diagnostics June 2012 - Present
Focus Diagnostics January 2007 - June 2012
Peregrine Pharmaceuticals August 2006 - November 2006
Valeant Pharmaceuticals September 2000 - July 2006
Skills
Lifesciences, Immunology, Cell Culture, Assay Development, Biotechnology, Molecular Biology, Infectious Diseases, ELISA, Immunoassays, Cell, FDA, Microbiology, Protein Purification, PCR, qPCR, RT-PCR, Protein Chemistry, Life Sciences
Education
University of Arizona 1995 — 1999
Bachelor of Science (B.S.), Biology, General
Quest Diagnostics November 2013 - Present
Quest Diagnostics October 2012 - October 2013
Focus Diagnostics January 2008 - October 2012
NAMSA March 2006 - November 2007
Focus Diagnostics May 1994 - March 2006
MRL, Inc. (Microbiology Reference Lab) December 1985 - May 1994
Skills
GLP, Microbiology, CAPA, Cell Culture, GMP, Biotechnology, Laboratory, Immunology, Agarose Gel..., Clinical Research, TLC, Validation, Antibodies, Life Sciences, Infectious Diseases, Medical Devices, ELISA, recombinant DNA..., Capillary..., real-time PCR, Molecular Biology, qPCR
Education
UC Irvine 1979 — 1981
Bachelor of Science (B.S.), Biology/Microbiology
Orange Coast College 1976 — 1979
Associate's degree, Biology, General
Passy-Muir May 2014 - Present
Focus Diagnostics March 2013 - May 2014
Medtronic April 2009 - February 2012
CoreValve November 2007 - April 2009
Skills
Validation, Medical Devices, FDA, CAPA, ISO 13485, GMP, V&V, 21 CFR Part 11, Quality System, SOP
Education
The Johns Hopkins University 2009 — 2011
Master of Science (M.S.), Regulatory Affairs
University of California, San Diego 2003 — 2007
Bachelor of Science (B.S.), Biology
Quality Consultant March 2013 - Present
Focus Diagnostics May 2012 - March 2013
Boston Scientific 2008 - 2012
Allergan 2006 - 2007
Valeant Pharmaceuticals 2001 - 2006
Horizon Medical Outsourcing 2000 - 2001
Beckman Coulter 1989 - 2000
Internation Medication Systems, Inc 1986 - 1989
DigiRad 1985 - 1986
Skills
Auditing, Clinical Trials, GLP, cGMP, GCP, FDA inspection, BIMO, IND, NDA, Quality systems, FDA, GMP, Regulatory Affairs, Quality System, CAPA, Validation, Quality Management
Education
University of California, Los Angeles 1982 — 1985
Master of Science (MS), Chemistry
University of La Verne 1978 — 1982
Bachelor of Science (B.S.), Chemistry, Physics, minor in Mathematics
Panda Restaurant Group January 2014 - Present
Focus Diagnostics May 2013 - September 2013
Boys and Girls Club of Cypress August 2012 - June 2013
Education
University of California, Irvine 2007 — 2012
Bachelor of Science (B.S.), Mathematics, Minor in Biological Science
Oxford Academy