Advanced Tissue Sciences
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Advanced Tissue Sciences Employees
Artemis Institute for Clinical Research April 2015 - Present
Champions Oncology, Inc. February 2011 - March 2015
Metabolon 2008 - 2011
Rho, Inc. 2007 - 2008
Aviva Biosciences Inc. 2004 - 2007
Epicyte Pharmaceuticals 2000 - 2004
Advanced Tissue Sciences February 1997 - May 2000
Sulzer Medica Calcitek 1994 - 1997
Pacific Biotech, Inc. (Eli Lilly) 1989 - 1994
Skills
Market Research, Biotechnology, CRO, Life Sciences, Strategic Partnerships, Oncology, Drug Development, Pharmaceutical Industry, Biopharmaceuticals, Business Development, Lifesciences, Medical Devices, Infectious Diseases, Clinical Development, Strategy, Drug Discovery, Clinical Trials, Technology Transfer, Management
Education
United States International University, San Diego 2000 — 2003
MBA, International Business
University of California, Santa Barbara 1982 — 1986
BA, Biology
Independent Consultant May 2013 - Present
Amylin Pharmaceuticals - a wholly owned subsidiary of Bristol-Myers Squibb September 2008 - March 2013
Amylin Pharmaceuticals - a wholly owned subsidiary of Bristol-Myers Squibb November 2002 - September 2008
Advanced Tissue Sciences March 1990 - October 2002
Skills
Microsoft Excel, Microsoft Office, Microsoft Word, PowerPoint, Customer Service, GLP, Pharmaceutical Industry, GCP, 21 CFR Part 11, Biotechnology, FDA, GMP, GxP, Medical Devices, Quality Assurance, Quality System, SOP, Validation, Quality Auditing
Education
McGill University
Bachelor's degree, Zoology/Animal Biology
University of LaVerne
M. Sc Business Organizational Mgmt., Business Administration and Management, General
Gilead Sciences February 2015 - Present
Gilead Sciences September 2014 - February 2015
GMP Quality, LLC September 2014 - February 2015
Genzyme January 2012 - August 2014
Lonza October 2011 - December 2011
Dendreon March 2004 - September 2011
Amylin Pharmaceuticals October 2002 - March 2004
Advanced Tissue Sciences April 1997 - October 2002
Collagen Corp. 1995 - 1997
Hoffmann-La Roche 1994 - 1995
Skills
Validation, FDA, Change Control, Quality System, Quality Assurance, GMP, 21 CFR Part 11, Biotechnology, V&V, Pharmaceutical Industry, CAPA, Leadership, Management, Cancer Immunotherapy, Commercialization, Sterilization, Project Management, Computer System..., Aseptic Processing, Medical Devices, Regulatory Requirements, Technology Transfer, ISO 13485, Cleaning Validation, GCP, Calibration, Testing, Risk Management, GxP, Quality Control, Quality Auditing, Sop, LIMS, GLP, Biopharmaceuticals, Regulatory Submissions, Manufacturing, Process Simulation, Cross-functional Team..., Regulatory Affairs, Design Control, Quality Systems, GAMP, Lifesciences, Clinical Trials, Vaccines, Deviations, Life Sciences, Chromatography, SOP
Education
New Jersey Institute of Technology
BS, Electrical Engineering
New Jersey Institute of Technology - School of Management
MS, Engineering Management
Ajinomoto Althea Inc. April 2013 - Present
Optimer Pharmaceuticals March 2009 - March 2013
Pacira Pharmaceuticals August 2008 - March 2009
ACADIA Pharmaceuticals February 2006 - August 2008
Smith & Nephew Wound Management 2003 - 2006
Advanced Tissue Sciences 1995 - 2003
Wavetek Electronics 1980 - 1995
Skills
FDA, Microsoft Excel, Inventory Management, Accounts Payable, Software Documentation, Microsoft Word, Process Improvement, Customer Service, Microsoft Office, Leadership, Cross-functional Team..., Team Building, Financial Analysis, Accounting
Education
Grossmont College 1990 — 1992
certification, Orthopedic Technology
Allan Hancock College 1974 — 1976
general
Lompoc High School 1970 — 1974
yes, general
University of California, San Francisco July 2015 - Present
Children's Hospital of Philadelphia June 2012 - Present
The Children's Hospital of Philadelphia June 2009 - Present
The Scripps Research Institute June 2001 - June 2003
Advanced Tissue Sciences June 1999 - July 2000
Skills
Hospitals, Critical Care, Healthcare Management, Inpatient, Patient Safety, Clinical Research, EMR, Hospital Medicine, ICU, Healthcare, Emergency Medicine, Healthcare Information..., EHR, Medical Education
Education
Duke University School of Medicine 2003 — 2009
MD, PhD, Medicine, MD; Pharmacology and Cancer Biology, PhD
University of Notre Dame 1998 — 2002
Bachelor's degree, Biology
Self-employed 1994 - Present
Qualcomm 1997 - 2001
Advanced Tissue Sciences 1994 - 1997
Skills
Published Author, Oil Painting, Japanese maples
Education
San Diego State University-California State University 1967 — 1976
Bachelor's degree, Mechanical Engineering, Art, English, Comparitive Literature
Polynoma April 2012 - Present
UCSD CONNECT Springboard October 2011 - April 2012
Self-employed CFO consultant June 2011 - April 2012
Pure Bioscience June 2005 - April 2011
CardioNet August 2003 - June 2005
Advanced Tissue Sciences March 2000 - May 2003
BAX Global March 1998 - March 2000
Burkert Contromatic September 1996 - March 1998
United Parcel Service April 1991 - June 1996
Bristol-Myers Squibb October 1986 - April 1991
Skills
Corporate Finance, Corporate Development, International Business, International Accounting, US GAAP, UK GAAP, Strategic Planning, Financial Planning, Budgeting, SEC reporting, SOX, NASDAQ, Capital Raises, Private Placements, Audit Committee, Joint Ventures, Warrants, Options, Treasury, Private Equity, Venture Capital, Licensing Agreements, Strategic Partnerships, M&A due diligence, Acquisition Integration, Business Reorganizations, Risk Management, Activity Based..., Process Manufacturing, Microsoft Dynamics, Tax, Life Sciences, Biotechnology, Medical Devices, Pharmaceuticals, Logistics, Supply Chain Management
Education
University of California, Irvine - The Paul Merage School of Business 2002 — 2004
MBA, Finance, 3.95
Chartered Institute of Management Accountants 1987 — 1989
Stage 3, Accounting, Tax and Company Law
University of the West of England 1982 — 1986
B.A. (Hons), Business Studies / Finance
Martini Communications Consulting 2008 - Present
WeissComm Partners 2006 - 2008
Porter Novelli 2004 - 2006
Edelman 2002 - 2004
Noonan/Russo Communications 1996 - 2002
Acorda Therapeutics 1994 - 1996
Advanced Tissue Sciences 1990 - 1994
Skills
Corporate Communications, Investor Relations, Writing, Crisis Communications, Public Relations, Management, Strategic Communications, Biotechnology, Media Relations, Strategy, Internal Communications, Message Development, Marketing, Public Affairs, Press Releases, Reputation Management, Lifesciences, Marketing Communications, Communication Training, Strategic Counsel, Leadership, Integrated Marketing, Communications Planning, Thought Leadership, Life Sciences
Education
Franklin & Marshall College 1984 — 1988
B.A.
The Aspen Institute 2015 - Present
Genentech 2013 - Present
Association for Women in Science 2011 - Present
Genentech 2009 - 2012
Genentech 2002 - 2009
Eli Lilly and Company June 2001 - October 2002
UBS Investment Bank 2000 - 2000
Advanced Tissue Sciences January 1997 - July 1999
Skills
Lifesciences, Team Leadership, Project Management, Leadership, Clinical Development, Biotechnology, Portfolio Management, Oncology, Technology Transfer, Pharmaceutical Industry, Research, Immunology, Drug Discovery, Cross-functional Team..., Biopharmaceuticals, FDA, Clinical Trials, Life Sciences
Education
Stanford University Graduate School of Business
MBA
University College London
Postdoctoral Fellow
University of California, Berkeley
BS
University of California, San Diego
PhD
CnA Consulting Group January 2013 - Present
Jet Lasik 2013 - 2013
Shire Regenerative Medicine January 2012 - December 2012
Advanced BioHealing 2010 - 2012
Advanced BioHealing 2008 - 2010
Advanced Biohealing 2006 - 2008
Smith and Nephew 2002 - 2006
Advanced Tissue Sciences 1992 - 2002
Skills
Biotechnology, Medical Devices, FDA, GMP, Lifesciences, ISO 13485, Validation, CAPA, Technology Transfer, Quality System, Pharmaceutical Industry, Aseptic Processing, Biopharmaceuticals, Biologics, Cross-functional Team..., Manufacturing, Strategic Planning, Change Control, Due Diligence, Real Estate, Facilities Management, Organizational Design, Operations Management, Product Launch, Project Management, Operating Budgets, Capital Projects, Production Budgeting, Capital Budgeting, Oncology, Real Estate Transactions, Real Estate Development, Commercialization, Start-ups, Strategy, Mergers & Acquisitions, Continuous Improvement
Education
National University of Ireland, Galway
B.Sc, H.D.E., Science, Education
Webster University
MA, Management
DARÉ Bioscience May 2015 - Present
Calibr - California Institute for Biomedical Research May 2015 - Present
WomanCare Global Trading October 2014 - May 2015
WomanCare Global International July 2013 - October 2014
Sabrina Johnson Consulting September 2011 - June 2013
Cypress Bioscience January 2008 - August 2011
Cypress Bioscience April 2002 - August 2011
Cypress Bioscience August 1998 - August 2011
Advanced Tissue Sciences March 1994 - August 1998
Clonetics Corporation January 1993 - February 1994
Skills
Biotechnology, Pharmaceutical Industry, Medical Diagnostics, Chief Financial Officer, Chief Operating Officer, Strategic Planning, Capital Formation, Investor Relations, Business Development, Mergers, Acquisitions, Commercialization, Marketing Strategy, Sales Management, Mergers & Acquisitions, Lifesciences, Leadership, Clinical Development, Strategic Partnerships
Education
Thunderbird School of Global Management 1991 — 1992
Master of International Management, with honors, International Business
UCL 1988 — 1989
Master of Science, Biochemical Engineering
Tulane University 1984 — 1988
Bachelor of Science, Magna Cum Laude, Biomedical Engineering
Epic BioVentures, LLC August 2010 - Present
Neurobiology Foundation January 2012 - Present
Anthem Biotechnologies January 2011 - Present
Chamberlin Associates December 2004 - Present
Kennesaw State University August 2005 - June 2012
Aurazyme Pharmaceuticals, Inc January 2000 - January 2004
CryoLife, Inc. January 1995 - January 2004
Advanced Tissue Sciences January 1993 - January 1994
EPIX Pharmaceuticals Corporation January 1990 - January 1993
UC Irvine January 1978 - January 1990
Skills
Product Development, Research, Venture Capital, Due Diligence, Strategic Planning, Pharmaceutical Industry, Medical Devices, Immunology, Tissue Engineering, Biotechnology, Biomaterials, Medical Diagnostics, Venture Management, Start-up Ventures, University Teaching, Medical Education, Acoustic Guitar, Private Equity, Start-ups, Clinical Trials, Strategy, Mergers & Acquisitions, Regulatory Affairs
Education
University of California, Irvine 1986 — 1990
PhD, Immunology/cell biology
University of California, Los Angeles 1972 — 1976
BSME, bioengineering
Anam Arts March 2014 - Present
Art Smarts Inc September 2012 - Present
Michaels Arts and Crafts / Grumbacher September 2014 - December 2014
The Gate Project March 2009 - August 2012
CHCDC 2009 - 2011
Celula Inc May 2005 - April 2006
Arena Pharmaceuticals February 1999 - December 2003
Dr Paul Farrell Mission Chiropractic December 1988 - February 2000
Advanced Tissue Sciences March 1997 - September 1998
Skills
Molecular Biology, Lifesciences, Research, Non-profits, Teaching, Biotechnology, Genetics, Cell Culture, Cell Biology, Biochemistry, Science, Adobe Photoshop, Healing Nutrition, Massage Therapy, Fine Art Portraiture, Fine Art Drawing, Digital Photography, Figurative Sculpture, Photoshop, Portrait Photography, Cell, Therapeutic Massage, In Vitro, Fine Art, Assay Development, Drug Discovery, Figurative Art, Chemistry, High Throughput..., Transfection, R&D, Pharmaceutical Industry, Drawing, Social Networking, Art Education, Arts, Photography, Music Education, Civil Rights, Civil Society, Painting, Contemporary Art, Nonprofits, Neuroscience, Creativity, Life Drawing, Acrylic Painting, Multi Media, Expressionistic Art, Singing
Education
Tufts University 1978 — 1982
BFA, Fine Arts World Religions
School of the Museum of Fine Arts 1978 — 1982
BFA, Fine Art, World Religions
Pacific College of Oriental Medicine 1988 — 1990
MT, Massage Therapy Alternative Medicine
San Diego City College
Molecular Biology
Texas Heart Institute June 2014 - Present
Texas Heart Institute September 2013 - June 2014
University of Louisville September 2011 - May 2013
University of Louisville September 2005 - September 2011
MD Anderson Cancer Center May 2003 - August 2005
Advanced Tissue Sciences 2003 - 2003
Rice University 1998 - 2003
Skills
Biomedical Engineering, Tissue Engineering, Bioengineering, Biomaterials, Confocal Microscopy, Cell Culture, Microscopy, Stem Cells, Nanoparticles, Microfluidics, Tissue Culture, Nanotechnology, Fluorescence Microscopy, Immunohistochemistry, Scanning Electron..., Flow Cytometry, AFM, Labview, Molecular Biology, Spectroscopy, Nanomaterials, Regenerative Medicine, Laboratory, Cell, Microfabrication, LabVIEW
Education
Rice University 1997 — 2003
Ph.D., Bioengineering
Rensselaer Polytechnic Institute 1994 — 1996
BS, Biomedical Engineering
Cornell University 1988 — 1990
Advance
Miltenyi Biotec 2014 - Present
Intrexon Corporation 2013 - 2014
Intrexon Corporation 2011 - 2013
Cyntellect 2007 - 2010
Cyntellect 2004 - 2007
Cyntellect 2000 - 2004
Cyntellect 1998 - 2000
Advanced Tissue Sciences 1997 - 1998
Aastrom Biosciences 1992 - 1997
Baxter Healthcare 1989 - 1992
Skills
Lifesciences, Biotechnology, R&D, Molecular Biology, Genomics, Drug Discovery, Product Development, Stem Cells, ELISA, Start-ups, Biopharmaceuticals, Tissue Culture, Flow Cytometry, Cancer, Cell Culture, Confocal Microscopy, Immunology, Commercialization, Life Sciences
Education
Northwestern University
Ph.D., Biochemical Engineering
BioImaging Solutions, Inc. December 2003 - Present
BioImaging Solutions, Inc. December 2003 - Present
Advanced Tissue Sciences 1990 - 1997
Skills
Digital Imaging, Medical Devices, Business Modeling, Turn Around Management, Competitive Analysis, Forecasting, Funding, Alternative Energy, Product Management, Mergers & Acquisitions, Start-ups, Biotechnology, Strategic Planning, Strategic Partnerships, Marketing Strategy, Team Building, Business Development, New Business Development, Management, Product Development, Life Sciences
Education
California Polytechnic State University-San Luis Obispo 1980 — 1984
Bachelor of Science (B.Sc.), Biology/Anatomy & Physiology
eFFECTOR Therapeutics, Inc. June 2012 - Present
Lumena Pharmaceuticals, Inc. (now Shire) March 2012 - August 2014
Excaliard Pharmaceuticals, Inc. (now owned by Pfizer) September 2011 - March 2012
AM Consulting 2011 - September 2011
BrainCells, Inc. 2004 - March 2011
AM Consulting 2003 - 2004
Elitra Pharmaceuticals 1998 - 2003
Advanced Tissue Sciences 1991 - 1998
Bear Stearns 1986 - 1988
Skills
Biotechnology, Pharmaceuticals, Diagnostics, Public and Private..., Mergers & Acquisitions, Business Development, Debt Financing, Strategic Planning, Operations, General Management, Financial Modeling, Financial Planning, Market Analysis, Project Management, Investor and Public...
Education
UCLA Anderson School of Management 1989 — 1991
MBA, Finance & Marketing
University of California, Santa Barbara 1981 — 1986
Bachelors, Biology and Genetics
Greenbrae Dermatology 2009 - Present
American Board of Dermatology 2009 - Present
Loma Linda University Medical Center 2009 - 2010
Massachusetts General Hospital Dermatolopathology Unit 2004 - 2005
Brigham and Women's Hospital Angiogenesis & Wound Healing Clinic 2003 - 2004
Massachusetts General Hospital Laboratory for Tissue Engineering & Organ Function 2001 - 2004
Johns Hopkins School of Medicine Brain Tumor Laboratory 1998 - 2000
Advanced Tissue Sciences 1997 - 1997
Skills
Skin Cancer, Board Certified, Dermatology, Plastic Surgery, Mohs Surgery, Botox Cosmetic, Dermatopathology, Juvederm, Clinical Research, Aesthetics, Oncology, Healthcare, Medicine, Cosmetics, Physicians, Medical Devices, Restylane, Skin Care, Medical Education, Medical Research, Psoriasis, Skin, Fillers, Family Medicine, Reconstructive Surgery, Treatment, Internal Medicine, Public Health, EMR, Liposuction, Facelift, Laser Surgery, Cancer, Clinical Trials, Surgery, Hospitals, Chemical Peels, Pediatrics
Education
University of California, Davis - School of Medicine 2006 — 2009
Dermatology Residency
Harvard Medical School 2000 — 2005
MD
Massachusetts Institute of Technology 2000 — 2005
MD
The Johns Hopkins University 1996 — 2000
BS, Biomedical Engineering
Shire October 2010 - Present
Cypress Bioscience March 2009 - October 2010
Vical February 1999 - November 2008
Advanced Tissue Sciences, Inc. April 1996 - February 1999
Advanced Tissue Sciences December 1989 - March 1996
Skills
Clinical Development, Immunology, Flow Cytometry, Cell Culture, ELISA, GMP, Pharmaceutical Industry, In Vitro, Biotechnology, Cell, Technology Transfer, Molecular Biology, FDA, Lifesciences, Assay Development, Validation, Clinical Trials, qPCR, Stem Cells
Education
University of Montana 1977 — 1982
BA, Biology, Botany
MiMedx April 2014 - Present
MiMedx Group October 2012 - Present
MiMedx Group 2011 - October 2012
MiMedx Group March 2011 - August 2011
CryoLife, Inc. April 2009 - March 2011
Histogen Inc. April 2008 - March 2009
W.L. Gore & Associates June 2006 - March 2008
J&J 2001 - 2006
Smith & Nephew October 1997 - April 2000
Advanced Tissue Sciences October 1991 - March 1997
Skills
Marketing Strategy, Marketing, Advertising, Medical Devices, Surgery, Strategic Planning, Market Research, Forecasting, Product Marketing, Market Development, Product Launch, Market Analysis, Competitive Analysis, Product Development, Product Management, Marketing Management, New Business Development, Business Development, Market Planning, Leadership, Global Marketing, Wound Care, Surgeons, Pharmaceutical Industry, Disposables
Education
Saint Michael's Medical Center 2004 — 2005
EMT, Emergency Medicine
University of La Verne 1995 — 1997
MBA, Marketing & Advertising
Point Loma Nazarene University 1986 — 1990
BA, Marketing
RETIRED July 2014 - Present
AgonOx, Inc. March 2012 - July 2014
Providence Health and Services August 2009 - March 2012
Hemcon Medical Technologies October 2007 - August 2009
USGS August 2002 - March 2007
VitaGen, Inc. August 1996 - August 2001
Advanced Tissue Sciences November 1992 - August 1996
Houghten Pharmaceuticals August 1989 - November 1992
Clonetics Corporation June 1988 - August 1989
Cytotech, Inc. August 1985 - 1987
Skills
Immunology, Cell Culture, Molecular Biology, Medical Devices, Biology, Bioassay, in Vitro Toxicology, Cancer Research, Infectious Diseases, Clinical Trials, Lifesciences, Microbiology, Biotechnology, ELISA, Genetics, Antibodies, In Vitro, Science, Laboratory, Drug Discovery, Assay Development, Validation, Cell, R&D, Biochemistry, Flow Cytometry, Oncology, FDA, GMP, Cross-functional Team..., Cell Biology, Cancer, Vaccines, Western Blotting, Clinical Development, Immunohistochemistry, Drug Development, Tissue Culture, Biopharmaceuticals, Genomics, DNA, Animal Models, Technology Transfer, Protein Chemistry, PCR, Biomarkers, Monoclonal Antibodies, Translational Research, Protein Purification, Clinical Research
Education
City University of New York-Hunter College 1976 — 1979
Master's, Biology
Fordham University 1971 — 1975
Bachelor's, Biology
Organovo, Inc. October 2014 - Present
Organovo, Inc. September 2012 - October 2014
Tengion July 2007 - August 2012
Carolinas Healthcare System December 1996 - June 2007
Desmos, Inc. 1994 - 1996
Advanced Tissue Sciences June 1991 - October 1994
Skills
Cell, Biomaterials, Regenerative Medicine, Tissue Engineering, Cell Biology, Biotechnology, Life Sciences, Cell Therapy, Product Development, Process Development, Animal Models, Molecular Biology, Microscopy, DNA, Process Simulation, FDA, Validation, Technology Transfer, ELISA, Biochemistry, Fluorescence Microscopy, Stem Cells, Tissue Culture, Lifesciences, Cell Culture, Biomedical Engineering, Flow Cytometry, Medical Devices, Clinical Development, GMP, GLP, Commercialization, Protein Purification, Biopharmaceuticals, Drug Discovery, Assay Development, R&D
Education
University of Michigan 1986 — 1991
PhD, Bioengineering
University of Michigan 1983 — 1986
Masters, Bioengineering
University of Michigan 1979 — 1983
BS, Microbiology
Technicolor Home Entertainment Services March 2006 - Present
Nalge Nunc International August 2003 - March 2006
Advanced Tissue Sciences November 1997 - December 2001
Bio-Rad Laboratories January 1996 - November 1997
Millipore Corp May 1979 - January 1996
Skills
SAP, QAD, BPCS, Oracle, Supply Chain, Supply Chain Management, Supply Chain..., Warehouse Management, Inventory Management, Warehousing, 3PL, Materials Management, Business Process..., Continuous Improvement, Demand Planning, Distribution Center..., Forecasting, Inventory Control, Leadership, Logistics, Management, Operations Management, Process Improvement, Procurement, Project Planning, Purchasing, Supply Chain Operations, Budgets, Shipping, Strategy, Reverse Logistics, MRP, Logistics Management, Strategic Sourcing, Cross-functional Team...
Education
Lesley University 1990 — 1991
MS, Management
Stonehill College 1984 — 1988
BA, Business Administration
Gradalis, Inc. February 2014 - Present
Prometheus Laboratories Inc., A Nestlé Health Science Company July 2011 - March 2014
Prometheus Laboratories Inc. October 2001 - July 2011
Sorrento Networks 2000 - 2001
Advanced Tissue Sciences 1997 - 2000
Cytel 1992 - 1997
Frazee Industries 1990 - 1992
KPMG, PWC 1983 - 1990
Skills
Finance, Strategy, Biotechnology, Acquisition Integration, Mergers & Acquisitions, Due Diligence, Strategic Planning, Pharmaceutical Industry, Commercialization, Corporate Development, Investor Relations, Mergers, Cross-functional Team..., SEC filings, Start-ups, Financial Modeling, Sarbanes-Oxley Act, Forecasting, Venture Capital, Clinical Development, Medical Devices, Lifesciences, Product Launch, IPO, Business Planning, Business Strategy, Executive Management, Managed Care, Oncology, Technology Transfer, Life Sciences, Strategic Alliances, Financial Planning, Medical Diagnostics, Infectious Diseases, Molecular Diagnostics, Strategic Finance, Financial Transactions, Debt & Equity Financing, Acquisiton, Hyperion Enterprise
Education
New Mexico State University 1979 — 1983
Bachelor of Accountancy, Accounting
San Diego State University-California State University
University of Northern Iowa
Arena Pharmaceuticals November 2012 - Present
(Self-employed) January 2008 - October 2012
Genentech, Inc. / Tanox, Inc. January 2005 - December 2007
Cell Genesys / Chiron Corporation October 1997 - December 2004
Advanced Tissue Sciences November 1995 - September 1997
IDEC Pharmaceuticals March 1992 - December 1994
Skills
GMP, FDA, Biotechnology, Validation, Technology Transfer, 21 CFR Part 11, CAPA, Sop, Change Control, Quality System, Pharmaceutical Industry, Aseptic Processing, GxP, Lifesciences, Biopharmaceuticals, V&V, IND, Quality Control, Quality Assurance, Regulatory Affairs, Facility Start-up, Software Documentation, Clinical Trials, External Audit, GLP, Quality Management, Project Management, Microbiology, CRO, FDA GMP, Life Sciences, SOP
Education
University of California, San Diego 2010 — 2012
Professional Certificate, Project Management
San Diego State University-California State University 1998 — 2002
Minor, Cellular & Molecular Biology
University of California, Berkeley 1987 — 1991
Comparative Literature and Spanish
Henry M. Gunn High School
American Peptide Company September 2008 - Present
American Peptide Company April 2007 - September 2008
N/A December 2005 - March 2007
Santarus, Inc November 2002 - December 2005
Advanced Tissue Sciences February 2002 - October 2002
Alliance Pharmaceuticals February 1998 - January 2002
Chemical Waste Management February 1994 - February 1998
Beckman Instruments June 1992 - September 1993
Skills
Sales Management, Product Development, Market Research, Management, Cross-functional Team..., Market Analysis, Manufacturing, New Business Development, HPLC, Chromatography, Regulatory Affairs, Quality System, Protein Chemistry, Product Launch, LC-MS, Drug Discovery, Sop, Medical Devices, Purification, Life Sciences, SOP, Biotechnology, Biochemistry, Biopharmaceuticals
Education
University of California, Irvine 1988 — 1991
BS, Biological Sciences
University of California San Diego Extension Courses 2000 — 2013
Porterville High School 1982 — 1986
Boulder Country Day School August 2013 - Present
Boulder Country Day School May 2013 - July 2013
First Lutheran church April 2009 - July 2013
Decked Out Home and Business Maintenance, Inc January 2004 - June 2013
Semtech June 2000 - July 2002
Advanced Tissue Sciences 1989 - 1998
Skills
Construction Management, Horticulture, Inventory Management, Facilities Management, Building Relationships, Property Management, Contract Negotiation, Residential Homes, Construction, Renovation, Team Building, Strategic Planning, Management, Leadership
Education
San Diego Mesa College 1989 — 1992
Orange Coast College 1986 — 1987
Wagenknecht IP Law Group, PC April 2015 - Present
Sughrue Mion PLLC November 2010 - March 2015
DLA Piper February 2004 - October 2010
Diversa Corporation July 2002 - February 2004
Burstein Technologies September 2001 - June 2002
The Brotman Group June 2000 - August 2001
Presseisen & Reidelbach February 1998 - July 1999
DepoTech 1995 - 1997
Advanced Tissue Sciences November 1992 - March 1995
Skills
Patents, Patent Prosecution, Patentability, Trademarks, Biotechnology, Life Sciences, Intellectual Property, Licensing, Molecular Biology, Litigation
Education
California Western School of Law 1997 — 2000
Juris Doctor
University of California, San Diego 1989 — 1994
BS, Biochemistry
Brentwood School 1986 — 1989
Bachelor of Science (BS), Biochemistry
GIA 2013 - February 2015
Mitchell International 2012 - 2013
Callaway Golf January 2007 - September 2011
Life Technologies January 2005 - December 2006
Life Technologies October 2002 - December 2004
Advanced Tissue Sciences July 2002 - October 2002
Wingcast January 2000 - June 2002
Ford September 1995 - January 2000
SAIC 1989 - 1995
Relevant Keywords 1989 - 1989
Skills
Strategic Planning, P&L Management, M&A experience, Profitability..., Strategic Financial..., Market Assessments, Profitable Growth, Re-organization, Forecasting Models, Budgeting, Corporate Finance, Budgets, Business Planning, Business Strategy, CO-PA, Competitive Analysis, Finance, Financial Analysis, Financial Modeling, Forecasting, Management, Mergers, Mergers, Reorganisation, Start-ups, Strategy, Mergers & Acquisitions
Education
University of California, Berkeley - Walter A. Haas School of Business 1993 — 1995
MBA, Finance and Strategy
University at Buffalo 1987 — 1989
MS, Engineering
COHU - consultant April 2013 - Present
BBH West - Corporate Communications 2009 - June 2015
Alphatec Spine 2008 - 2009
Artes Medical (currently Suneva) 2006 - 2008
CryoCor, Inc. 2001 - 2006
Advanced Tissue Sciences 1999 - 2000
Ligand Pharmaceuticals 1994 - 1998
Skills
Start-ups, Investor Relations, Medical Devices, Mergers, Strategic Planning, Biotechnology, Cross-functional Team..., Financial Modeling, Marketing Strategy, Competitive Analysis, Business Development, Product Development, Risk Management, Project Management, Financial Analysis, Due Diligence, Venture Capital, Budgets, Entrepreneurship, IPO, Marketing, Product Launch, Business Planning, Business Strategy, Finance, Forecasting, Market Analysis, Mergers, Market Research, New Business Development, Strategy, Product Management
Education
San Diego State University-California State University 1992 — 1996
MBA, Finance
University of California, San Diego 1984 — 1988
B.A.
Chatsworth High School 1981 — 1984
DianaPlantSciences July 2013 - August 2015
TE Connectivity September 2010 - July 2013
AVI BioPharma, Inc June 2007 - August 2009
Cascade Biologics April 2005 - July 2007
MedImmune Vaccines August 2001 - February 2004
IntraBiotics August 1999 - July 2001
Dendreon October 1997 - August 1999
Advanced Tissue Sciences November 1994 - August 1997
Skills
Quality Assurance, Quality Auditing, cGMP, GMP, Quality System, SOP, Document Management, FDA, Documentation, Continuous Improvement, CAPA, Validation, Quality Management, ISO 13485, V&V, Software Documentation, Compliance, GxP, Biotechnology, Quality Control, Laboratory, Quality Systems, GLP, Lifesciences, Six Sigma, Manufacturing, Technology Transfer, Design of Experiments, ISO, 21 CFR Part 11, 5S, Testing, Calibration, Supplier Quality, Iso 9000, Medical Devices, Change Control, Aseptic Processing, Auditing, DMAIC, Regulatory Affairs, Root Cause Analysis, LIMS, SPC, Lean Manufacturing, Regulatory Requirements, Minitab, R&D, FMEA
Education
San Diego State University-California State University 1994 — 1997
Bachelors of Science, Biology
Aarop Technologies January 1998 - Present
Aarop Tech August 1998 - December 2013
Aarop Technologies August 1998 - November 2013
Advanced Tissue Sciences March 1990 - October 1992
Skills
pre-clinical drug..., in-vivio pharmacologist, Biotechnology, Life Sciences, Product Development, Medicine, Pharmacovigilance in..., problem identification..., Drug Development, Clinical Trials, Pharmaceutical Industry, Technology Transfer, R&D, Start-ups, Commercialization, Clinical Development, Oncology, Biopharmaceuticals, Drug Discovery, Management, Entrepreneurship, Strategic Planning, Strategy, Business Development, Medical Devices, Due Diligence
Education
Small Business Developed Center, SBA San Diego, CA 1994 — 1996
Smal Business Management Trainee, Biotechnology Business Development, N/A
University of California, San Diego - School of Medicine 1986 — 1990
Ph.D., Drug Delivery systems
University of Mumbai 1980 — 1986
Doctor of Philosophy (Ph.D.), Veterinary Biomedical and Clinical Sciences
Illumina August 2013 - Present
Naval Facilities Engineering Command February 2011 - August 2013
Biogen Idec January 2003 - January 2011
Advanced Tissue Sciences April 1999 - September 2002
MEDTRONIC AVE August 1998 - April 1999
Skills
FDA, Biotechnology, Technology Transfer, Aseptic Processing, V&V, Pharmaceutical Industry, GMP, 21 CFR Part 11, Validation, Sop, Change Control, Engineering, CAPA, Quality System, Process Simulation, Biopharmaceuticals, GLP, Lifesciences, Medical Devices, GxP, Management, Chromatography, R&D, Computer System..., Manufacturing, SOP, Life Sciences
Education
San Diego State University-California State University 2001 — 2004
MS, Mechanical Egineering
Wayne State University 1979 — 1982
Bachelor's Degree, Civil Engineering
Labyrinth Regulatory Consulting February 2008 - Present
VitalTherapies June 2012 - September 2015
Vital Therapies March 2010 - January 2012
PRA International February 2004 - 2008
Angiotech 2006 - 2007
SkyePharma January 2003 - December 2003
Advanced Tissue Sciences April 2001 - November 2002
Skills
Regulatory Submissions, Regulatory Affairs, Clinical Trials, Clinical Research, Protocol, Sop, Biotechnology, Medical Devices, Regulatory Requirements, FDA, GCP, Clinical Development, IND, Strategy, Therapeutic Areas, Oncology, Informed Consent, Pharmaceutical Industry, ICH-GCP, CRF design, Clinical Monitoring, Clinical Compliance, EDC, CRO
Education
Kalamazoo Valley Community College
RN, Nursing
San Diego State University-California State University
Master of Science, Regulatory Affairs
University of Phoenix
BS, Business Administration
EdgeWave! March 2007 - Present
Tensys Medical 2006 - 2007
Advanced Tissue Sciences 2003 - 2006
Skills
Networking, Network Security, Routing, Network Administration, Security, TCP/IP, Firewalls, Cloud Computing, VPN, DNS, Windows Server, Linux, System Administration, Virtualization, Active Directory, Servers, Internet Security, VMware ESX, SaaS, Troubleshooting, ePrism, iPrism
Education
California State University-San Marcos - College of Business Administration 2000 — 2002
Coleman College 1983 — 1993
BSCS
Grossmont College 1986 — 1989
Grossmont High School
Grossmont High School
University of San Diego July 2015 - Present
Veridiam April 2013 - January 2015
Shire Regenerative Medicine January 2012 - August 2012
Advanced BioHealing July 2011 - January 2012
Advanced BioHealing January 2008 - January 2011
Advanced Biohealing, La Jolla Ca January 2006 - January 2008
Smith and Nephew Wound Management December 2001 - March 2006
Advanced Tissue Sciences January 2001 - January 2006
Avail Medical Products January 1994 - January 2001
Pacific Device 1998 - 1999
Skills
FDA, Medical Devices, Engineering, ISO 13485, Manufacturing, Product Development, Change Control, GMP, Validation, Biotechnology, Quality System, Manufacturing..., CAPA, Design Control, Biopharmaceuticals, V&V, Lifesciences, Technology Transfer, Cross-functional Team...
Education
San Diego State University-California State University 1988 — 1991
Bachelors of Science, Mechanicl Engineering
Ronnda L Bartel Consulting LLC January 2014 - Present
Aastrom Biosciences 2010 - 2013
Aastrom Biosciences 2006 - April 2010
MicroIslet, Inc. 2004 - 2006
SRS Capital 2001 - 2002
StemCells Inc 1998 - 2001
Advanced Tissue Sciences 1995 - 1998
Becton Dickinson 1992 - 1995
Advanced Tissue Sciences 1989 - 1992
University of Kansas, Department of Pharmaceutical Chemistry 1986 - 1989
Skills
Life Sciences, Regenerative Medicine, Tissue Engineering, Biotechnology, Product Development, Research, cGMP, GMP, Lifesciences, Clinical Development, Technology Transfer, Sop, Drug Discovery, Molecular Biology, Biochemistry, Cell Culture, Drug Development, FDA, Medical Devices, Validation, Pharmaceutical Industry, ELISA, R&D, ISO 13485, Immunology, Assay Development, Cell, Biopharmaceuticals, Microbiology, Clinical Trials, Science, CAPA, Cell Biology, Commercialization, GLP, Flow Cytometry, Cell Therapy, Stem Cells, In Vitro, Regulatory Submissions, Biomarkers
Education
University of Kansas 1980 — 1984
PhD, Biochemistry
Tunnell Consulting 2002 - Present
Breite Consulting Associates 2000 - Present
Advanced Tissue Sciences 1994 - 2000
Hybritech Inc. 1985 - 1994
Beckman Coulter 1980 - 1985
Education
University of California, Santa Barbara 1970 — 1974
BA, Biochemistry
Inovio Pharmaceuticals February 2007 - Present
CancerVax 2004 - 2005
Advanced Tissue Sciences 1996 - 2002
Pacific Device 1990 - 1996
Hughes Aircraft Company, Space and Communications Group 1985 - 1990
Skills
Vaccines, Biotechnology, Lifesciences, FDA, GMP
Education
San Diego State University-California State University 1999 — 2003
MBA
University of California, Berkeley 1980 — 1985
BSME
Vital Therapies, Inc. September 2014 - Present
Organogenesis Inc. April 2014 - September 2014
Shire Regenerative Medicine October 2012 - April 2014
Shire Regenerative Medicine January 2011 - October 2012
Advanced BioHealing February 2010 - January 2011
Advanced BioHealing August 2007 - February 2010
Advanced Tissue Sciences 1999 - 2002
Advanced Tissue Sciences 1998 - 2002
Advanced Tissue Sciences 1994 - 1998
Advanced Tissue Sciences 1990 - 1994
Skills
Biopharmaceuticals, Molecular Biology, Commercialization, Tissue Engineering, V&V, Protein Purification, Biomaterials, Flow Cytometry, GMP, ELISA, Process Simulation, PCR, Assay Development, Biotechnology, GLP, Biologics, Microbiology, Change Control, R&D, Manufacturing, Cell, Regenerative Medicine, Medical Devices, Clinical Development, Bioengineering, Lifesciences, Technology Transfer, Project Management, Biochemistry, Bioreactor, Cell Signaling, Validation, FDA, Aseptic Processing, Quality System, Sop, Pharmaceutical Industry, Drug Discovery, Cell Culture, Research
Education
University of California, San Diego
PhD, bioengineering, physiology
University of Arizona
Master of Science (MS), Microbiology, General
University of Arizona
Bachelor of Science (BS), Microbiology, General
Tecellact LLC CSOHistogen Inc2008 - 2009
Advanced Tissue Sciences 1993 - 2002
Biophase 1995 - 1995
Skills
Drug Delivery, Biotechnology, Pharmaceutical Industry, Regulatory Submissions, Product Development, Lifesciences, Medical Devices, Immunology, FDA, Regulatory Affairs, Tissue Engineering, Clinical Trials, Technology Transfer, R&D, Biomaterials, Cell Therapy, Validation, Stem Cells, Biopharmaceuticals, Life Sciences, Protein Chemistry, GMP, Clinical Research, ISO 13485, CAPA, Regenerative Medicine, Biochemistry, Animal Models, Cell, Cell Culture, Oncology, Molecular Biology, Cell Biology, GLP, Hardware Diagnostics, Sop
Education
University of Cambridge 1958 — 1963
Exponent Failure Analysis Associates September 2005 - Present
Advanced Tissue Sciences 2001 - 2001
AlliedSignal June 1998 - September 1998
Lucent Technologies May 1997 - August 1997
Skills
Finite Element Analysis, Biomedical Engineering, Mechanical Engineering, Matlab, Dynamics, Engineering, Failure Analysis, Biomechanics
Education
Georgia Institute of Technology 2001 — 2005
Doctor of Philosophy (Ph.D.), Mechanical Engineering
Georgia Institute of Technology 1998 — 2001
Master of Science (M.S.), Mechanical Engineering
Lehigh University 1994 — 1998
B.S., Mechanical Engineering
Symbiotix, Inc October 1998 - Present
Symbiotix 1998 - 2015
Meda 1998 - 2015
Meda 1998 - 2015
Symbiotix 1998 - 2015
Advanced Tissue Sciences September 1996 - September 1998
Rhone-Poulenc Rorer 1994 - 1996
Genentech August 1987 - August 1994
Glaxo Pharmacuticals August 1981 - August 1987
Skills
Pharmaceutical Industry, Biotechnology, Oncology, Infectious Diseases, Neurology, Managed Care, Medical Education, Cardiology, Diabetes, Clinical Development, Medical Devices, Dermatology, Market Access, Pharmaceutical Sales, Lifesciences, Immunology, Product Launch, Life Sciences
Education
Eastern Kentucky University 1976 — 1979
BS, Microbiology/Chemistry
Heron Therapeutics, Inc. 2015 - Present
V2 Bio-Consulting 2008 - 2015
Novartis Vaccines & Diagnostics 2010 - 2012
Alza Corporation (Johnson & Johnson) 2006 - 2008
AMEC 2004 - 2005
Phoenix Imperative, Inc 2002 - 2005
Integrated Validation Services 2000 - 2003
Accumetrics 1998 - 2000
Advanced Tissue Sciences 1993 - 1997
Viagene 1991 - 1993
Education
San Diego State University-California State University
BA, Business
Senomyx, Inc. January 2009 - Present
Senomyx, Inc. January 2001 - January 2009
Genomics Institute of the Novartis Research Foundation August 1999 - July 2001
Chimeric Therapies February 1999 - July 1999
Dura Pharmaceuticals August 1998 - January 1999
Advanced Tissue Sciences December 1996 - August 1998
Wyeth Research 1990 - 1996
Skills
Facilities Management, Biotechnology, Budgets, Manufacturing, Construction, Lifesciences, Sop, Project Management, Software Documentation, Research, Validation, GMP, Pharmaceutical Industry, CMMS, Building Management..., AutoCAD, Biopharmaceuticals, Cross-functional Team..., FDA, Life Sciences, R, SOP, Training
Education
University of California, San Diego
Facilities Management
Ambit Biosciences June 2008 - Present
Nikkiso April 2014 - April 2015
Shire Regenerative Medicine March 2012 - April 2014
MiraCosta College March 2012 - April 2014
Waterman Challenge Paddleboard Race 1999 - 2011
Favrille 2005 - June 2008
Eaton's La Jolla Paddleboard Race 2001 - 2007
Biogen Idec 2001 - 2005
Advanced Tissue Sciences 1999 - 2001
Chiron Corporation 1995 - 1999
Education
University of California, San Diego 1992 — 1997
San Diego Social Venture Partners March 2014 - Present
Santarus, Inc. 2004 - 2014
UCSD Extension 2009 - 2013
Quidel 2000 - 2003
Advanced Tissue Sciences 1991 - 2001
Skills
Personnel Management, Human Resources, Performance Management, Deferred Compensation, Training, Succession Planning, Talent Management, Employee Relations, Employee Benefits, Recruiting, Leadership Development, Pharmaceutical Industry, Benefits Administration, Management, Public Speaking, Business Development, Strategic Planning, Onboarding, Leadership, HRIS, Team Building
Education
San Diego State University-California State University
Master of Business Administration (MBA), Human Resources
University of San Diego
Bachelor of Science (B.S.), Business Management
CareFusion August 2011 - Present
Kaz, Inc. June 2008 - August 2011
Cardinal Health September 2001 - June 2008
Abbott Ambulatory Infusion Systems 1998 - 2001
Advanced Tissue Sciences 1996 - 1998
Winfield Industries 1991 - 1993
Skills
Pro Engineer, Solidworks, Sheet Metal, Finite Element Analysis, Injection Molding, Mechanical Engineering, AutoCAD, R&D, Medical Devices, Product Development
Education
San Diego State University-California State University 1988 — 1990
MS, Mechanical Engineering
Princeton University 1976 — 1980
BS, Mechanical Engineering
Winston Churchill High School
Advanced Bionics July 2014 - Present
Advanced Bionics April 2012 - July 2014
Advanced Bionics July 2008 - April 2012
Amgen December 2002 - 2007
Advanced Tissue Sciences 2001 - 2002
Dura Pharmaceuticals 1997 - 2001
Skills
Experimental Design, V&V, CAPA, Validation, FDA, Medical Devices, Protocol, Biotechnology, Design Control, R&D, Manufacturing
Education
University of Rochester 1992 — 1996
BS, Chemical and Biomedical Engineering
Shire Regenerative Medicine May 2012 - Present
Advanced BioHealing May 2006 - May 2012
Smith & Nephew 2002 - 2005
Advanced Tissue Sciences 1995 - 2003
Skills
FDA, Pharmaceutical Industry, Facilities Management, Validation, Medical Devices, 21 CFR Part 11, Sop, Quality System, Biotechnology, GMP, CAPA, Microbiology, Manufacturing, Aseptic Processing, Technology Transfer, Strategic Planning, Clean Rooms, GLP, Change Control, Biopharmaceuticals
Education
Beloit College 1982 — 1986
Bachelor of Science
Druh USA, LLC September 2014 - Present
Peace & Love Doing A World of Good July 2008 - September 2014
Advanced Tissue Sciences February 2001 - October 2002
Xerox June 1984 - February 2001
Skills
Public Speaking, Retail, Strategic Planning, New Business Development, Microsoft Excel, Customer Service, Marketing, Motivational Speaking, Sales, Marketing Strategy, Managerial Finance, Marketing Communications, Coaching, Leadership Development, Marketing Management, Sales Management, Team Building, PowerPoint, Microsoft Office, Leadership, Business Strategy, Entrepreneurship, Business Planning, Management
Education
University of Rochester - William E. Simon Graduate School of Business Administration 1994 — 1996
MBA
Indiana University Bloomington 1981 — 1985
BS, Business
EVV Consulting, LLC 2007 - Present
Elan Pharmaceuticals 2002 - 2007
Advanced Tissue Sciences 1998 - 2002
PAREXEL 1993 - 1998
Skills
Biotechnology, GCP, Clinical Data Management, Regulatory Submissions, Clinical Trials, SAS, Biostatistics, Statistics, Pharmaceutical Industry
Education
Bowling Green State University 1990 — 1992
MS, Applied Statistics
University of the Philippines 1985 — 1989
BS, Math
ACADIA Pharmaceuticals September 2013 - Present
Ardea Biosciences August 2012 - Present
Ardea Biosciences December 2011 - August 2012
Spectrum Pharmaceuticals January 2009 - February 2010
Favrille Inc. September 2006 - June 2008
Elan Pharmaceuticals 2005 - 2006
La Jolla Pharmaceutical Company October 2002 - March 2005
Advanced Tissue Sciences June 1999 - October 2002
Idec Pharmaceuticals April 1998 - June 1999
Parexel 1994 - 1998
Skills
FDA, CRO, EDC, Software Documentation, Validation, Oncology, Sop, GCP, SOP, Biotechnology
Education
University of New Hampshire 1988 — 1992
BA, Zoology/PreMed
Vital Therapies, Inc. November 2012 - Present
Favrille, Inc. January 2005 - May 2008
Advanced Tissue Sciences 1999 - 2002
Education
University of Colorado Denver
B.A., Political Science
University of San Diego 2014 - Present
Advanced Test Equipment Rentals 2013 - 2014
Intellectual Property Professionals Connection 2010 - 2012
McDermott Will & Emery April 2010 - October 2010
Foley & Lardner LLP November 2008 - April 2009
Fish & Richardson P.C. 2004 - 2007
Heller Ehrman 1998 - 2004
Brown Martin Haller & McClain 1997 - 1998
Advanced Tissue Sciences 1990 - 1997
Skills
Illustrator, Lifesciences, Dreamweaver, Intellectual Property, Graphic Design, Licensing, Biotechnology, Patents, InDesign, Adobe Acrobat, Photoshop, Web Development, Flash, Adobe Creative Suite, Layout, Mac, WordPress, Web Design
Education
University of California, San Diego – Extension 2011 — 2012
Professional Certificate, Graphic Design
San Diego State University-California State University
BS, Biology
Arena Pharmaceutical April 2007 - March 2011
Synteract, Inc. 2002 - 2007
Advanced Tissue Sciences 1999 - 2001
PAREXEL International 1995 - 1999
Skills
EDC, CRO, Data Management, Clinical Development, Clinical Data Management, CRF design, Phase I, Clinical Research, Databases, Clinical Trials, ICH-GCP, Sop, GCP, Pharmaceutical Industry, SAS, Inform
Education
University of Phoenix 1999 — 2009
Illumina June 2008 - Present
Aptera February 2007 - May 2008
Illumina 2000 - 2007
Aurora Biosciences April 1998 - February 2000
Advanced Tissue Sciences June 1997 - April 1998
Education
University of California, San Diego 1994 — 1999
Camino International, LLC December 2013 - Present
Amylin Pharmaceuticals - a wholly owned subsidiary of Bristol-Myers Squibb 2005 - January 2014
RSF Consulting 2003 - 2005
Advanced Tissue Sciences 2000 - 2002
Braun Thermoscan 1995 - 2000
Hybritech, Inc. 1990 - 1995
Microgenics 1986 - 1990
Skills
Biotechnology, Technology Transfer, Business Development, Pharmaceutical Industry, Management, Corporate Development, Cross-functional Team..., Lifesciences, Infectious Diseases, Commercialization, Diabetes, Medical Devices, Drug Development, Start-ups, Managed Care, Biopharmaceuticals, Clinical Development, Product Launch, CRO, Strategic Planning, FDA, Relationship Management, GMP, Product Development, Licensing, Clinical Trials, Bus Dev, Strategy, Drug Delivery, Oncology, Competitive Intelligence, Pharmaceutical Sales, Drug Discovery, Regulatory Affairs, Validation, Sales Effectiveness, Regulatory Submissions, Medical Affairs, IND, CTMS, Vaccines, 21 CFR Part 11, Biomarkers, Sop, Endocrinology, GCP, Therapeutic Areas, Immunology, Neurology, Rheumatology
Education
Pepperdine University 1983 — 1985
MBA
Shire Regenerative Medicine (formerly Advanced BioHealing) 2010 - 2014
Biotech Industry 2006 - 2009
Favrille, Inc. 2002 - 2006
IDEC Pharmaceuticals 2002 - 2002
Advanced Tissue Sciences 1995 - 2002
Molecular Biosystems 1993 - 1995
Biosurface Technology / Genzyme Tissue Repair 1990 - 1993
Skills
GMP, Aseptic Processing, Manufacturing, Clean Rooms, Validation, Cell Culture, Aseptic Technique, Medical Devices, FDA, Operations Management, Biotechnology, Tissue Culture, DMAIC, Biologics, V&V, Biopharmaceuticals, Tissue Engineering, Operational Excellence, Media Preparation, Lean Process Improvement, CAPA, 21 CFR Part 11, Quality System, Technology Transfer, Technical Writing, Mentoring, coaching, ISO 13485, Process Simulation, Sop, Change Control, Coaching, SOP
Education
University of Massachusetts Boston
Bachelor of Science (BS), Biology
Malden Catholic High School
College prep
Taconic May 2013 - Present
Lonza April 2009 - April 2013
Mediatech 2007 - 2009
MicroIslet, Inc. 2004 - 2007
Telos Pharmaceuticals 2002 - 2004
Advanced Tissue Sciences 1997 - 2002
Trega Biosciences 1996 - 1997
Skills
Biotechnology, Lifesciences, Flow Cytometry, Molecular Biology, Immunology, ELISA, Western Blotting, Cell Culture, Cell Biology, Tissue Culture, Biopharmaceuticals, Purification, Biochemistry, PCR
Education
University of California, San Diego 1995 — 1999
Inova Diagnostics September 2015 - Present
Ultimate Labs Inc. June 2014 - September 2015
Ultimate Labs February 2013 - June 2014
Histogen Inc. December 2009 - November 2012
Stemedica Cell Technologies 2012 - 2012
Prometheus Labs March 2009 - November 2009
Histogen Inc. October 2008 - January 2009
Genentech Inc. February 2006 - April 2008
Smith & Nephew Wound Management (Formerly Advanced Tissue Sciences) November 2002 - January 2006
Advanced Tissue Sciences April 1992 - November 2002
Skills
CAPA, Quality System, Validation, Quality Assurance, Six Sigma, ISO 13485, Medical Devices, Regulatory Affairs, Quality Control, Continuous Improvement, FDA, GMP, Lean Manufacturing, Cleaning Validation, Sop, Manufacturing, Root Cause Analysis, Design Control, Biotechnology, Clinical Trials, Analytical Chemistry, IND, Change Control, GLP, Design of Experiments, Microbiology, Cross-functional Team..., 21 CFR Part 11, Quality Auditing, Regulatory Requirements, Chemistry, Quality Management, Regulatory Submissions, Biopharmaceuticals, Calibration, GxP, LIMS, Pharmaceutical Industry, Technology Transfer, R&D, Aseptic Processing, Lifesciences, ISO, Trackwise, ELISA, Assay Development, SPC, Laboratory, Deviations, Computer System...
Education
Pamantasan ng Lungsod ng Maynila 1979 — 1984
BS, Chemical Engineering
BioLogical Conclusions January 2013 - Present
Stryker Orthopaedics February 2011 - March 2012
Stryker Orthopaedics February 2008 - February 2011
Stryker Orthopaedics June 2005 - February 2008
Hackensack University Medical Center January 2003 - June 2005
Advanced Tissue Sciences January 2002 - October 2002
Advanced Tissue Sciences August 1996 - June 2001
Skills
Biomaterials, Bioengineering, Project Management, Medical Devices, Orthopedic, Research, Clinical Development, Biomechanics, Product Development, FDA
Education
University of California, San Diego 1995 — 2001
PhD, Bioengineering
University of Florida 1989 — 1995
BS, Chemical Engineering
Advanced BioHealing MFG SupervisorSmith & Nephew1996 - 2006
Advanced Tissue Sciences 1996 - 1998
Education
University of California, San Diego 1990 — 1995
Bachelors, Biology, Minor Psychology
Mira Mesa High School 1986 — 1990
High School
BioAustin July 2013 - Present
Law Offices of John Burns, PLLC April 2013 - Present
Life Technologies May 2011 - April 2013
Life Technologies Corporation November 2008 - July 2011
Applied Biosystems March 2006 - November 2008
Applied Biosystems December 2002 - March 2006
Advanced Tissue Sciences March 2001 - December 2002
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 1998 - 2001
U.C. Davis School of Law August 2000 - December 2000
Fenwick & West October 1997 - March 1998
Skills
Technology Transfer, Licensing, Patents, Intellectual Property, Patent Litigation, Patent Prosecution, Biotechnology, Lifesciences, Trademarks, Contract Negotiation, Contract Management, Molecular Virology, miRNA, siRNA, Molecular Biology, Medical Diagnostics, Team Leadership, Teamwork, Leadership, Corporate Law, Virology, Mergers, Patentability, Mergers & Acquisitions, Legal Writing, Commercialization, Due Diligence, Joint Ventures, Start-ups, Commercial Litigation, Prosecution, Trade Secrets, Litigation Support, Medical Devices, Biopharmaceuticals, Copyright Law, Employment Law, Genomics, Regulatory Affairs, FDA, Document Review, Pharmaceutical Industry, Drug Development, Corporate Governance, DNA, Courts, DNA sequencing, Drug Discovery, Litigation Management, Protein Chemistry
Education
University of California, Davis - School of Law 1995 — 1997
J.D., Law
Santa Clara University School of Law 1994 — 1995
Baylor College of Medicine 1982 — 1988
Ph.D., Virology & Epidemiology
San Diego State University-California State University 1980 — 1982
M.S., Microbiology
The Ohio State University 1971 — 1975
B.S., Microbiology
Retrophin October 2012 - Present
Retrophin October 2012 - Present
BioMarin Pharmaceutical Inc 2005 - October 2012
APT Pharmaceuticals 2009 - 2011
Renwood 1994 - 2010
Cell Therapeutics, Inc 2004 - 2005
SangStat Medical 1998 - 2003
SangStat Medical Corporation/Genzyme 1997 - 2002
SangStat 1997 - 2002
Advanced Tissue Sciences 1995 - 1997
Skills
Oncology, FDA, Pharmaceutical Industry, Biotechnology, Pharmaceutical Sales, Business Development, Sales Management, Lifesciences, Cross-functional Team..., Managed Care, Marketing Strategy, GMP, Medical Devices, Strategy, Product Launch, Commercialization, Clinical Trials, Start-ups, Strategic Planning, Regulatory Affairs, Product Development, Cardiology, Sales, Hematology, Sales Effectiveness, Infectious Diseases, Drug Development, Vaccines, Technology Transfer, Immunology, Validation
Education
University of Notre Dame 1969 — 1973
BS, Biology
DLH Biomedical Consulting LLC April 2013 - Present
Numerof & Associates, Inc. January 2014 - Present
Johnson & Johnson Diabetes Institute November 2008 - April 2013
LifeScan, a Johnson & Johnson Company 2000 - 2008
Johnson & Johnson (LifeScan) 2000 - 2006
Advanced Tissue Sciences January 1998 - July 2000
SciClone Pharmaceuticals February 1992 - December 1997
Baxter Healthcare 1982 - 1992
University of Illinois at Chicago 1979 - 1992
University of Chicago 1968 - 1979
Skills
Medical Devices, Pharmaceutical Industry, Regulatory Affairs, Clinical Trials, FDA, Clinical Research, Diabetes, Medical Education, Product Launch, ISO 13485, Healthcare, Design Control, Cross-functional Team..., R&D, Product Development, Managed Care, Clinical Development, GCP, Start-ups, Medicine, Medical Affairs, Endocrinology, Hardware Diagnostics, Biomedical Engineering, Commercialization, Biotechnology, Lifesciences, Internal Medicine, Quality Assurance, Life Sciences
Education
University of Chicago - The Pritzker School of Medicine 1963 — 1967
M.D.
Harvard University 1960 — 1963
B.A., Chemistry & Physics
Lake Forest Graduate School of Management
MBA, Business Administration and Management, General
The University of Chicago
PhD, Physiology
Organogenesis Inc. April 2014 - Present
Shire Pharmaceuticals 2006 - 2013
Smith & Nephew 2000 - 2006
Advanced Tissue Sciences 1998 - 2003
Skills
Team Leadership, Coaching, Training & Development, Manufacturing, Employee Training, Biotechnology, Process Improvement, FDA, Aseptic Technique, ISO 13485, CAPA, 21 CFR Part 11, Change Control, Aseptic Processing, Sop, GMP, Biopharmaceuticals, GLP, Medical Devices, Cell Culture, Cell, V, Validation, SOP
Education
UCSD 1990 — 1995
Bachelor of Science, Biology
Advanced Tissue Sciences 1998 - 2000
Skills
Biopharmaceuticals, Biotechnology, Vaccines, Validation, Lifesciences, Molecular Biology, Biochemistry, Clinical Development, Medical Devices, R&D, Clinical Research, Drug Discovery, Oncology, Regulatory Affairs, Cell Culture, Technology Transfer, GMP, Clinical Trials, Pharmaceutical Industry, GCP, Drug Development, Protein Purification, FDA
Education
University of California, San Diego 1990 — 1994
Post doc
University of San Diego
MaxSynergy Consulting, LLC 2014 - Present
Esperion Therapeutics, Ann Arbor, MI 2014 - 2015
Esperion Therapeutics, Ann Arbor, MI 2014 - 2015
Aastrom Biosciences February 2011 - 2014
EyeCyte Inc. October 2007 - February 2011
MicroIslet, Inc. July 2004 - February 2008
Aastrom Biosciences 2007 - 2008
Forest Life Sciences November 2002 - July 2004
MorphoGen Pharmaceuticals Inc. July 2000 - November 2002
Advanced Tissue Sciences June 1992 - July 2000
Skills
Coaching, Team Building, Leadership, Consulting, FDA, Biotechnology, Assay Development, GMP, GLP, Cell, Life Sciences, R&D, Validation, Technology Transfer, Biopharmaceuticals, Lifesciences, Stem Cells, In Vitro, Cross-functional Team..., Antibodies, Project Management, Management, Protein Chemistry, Processes Development, Culture Development, Tissue Engineering, Stem Cell Technology, Cross Functional Team..., Mentoring, Team Leadership, Team Development, Performance Motivation, Team Motivation, Leadership Mentoring, Program Management, Strategic Planning
Education
University of California, San Diego 1988 — 1992
B.S., Bioengineering
University of California, San Diego
CMC ICOS Biologics November 2007 - Present
ICOS November 2001 - November 2007
Advanced Tissue Sciences November 1995 - September 2001
Hyclone Laboratories December 1993 - September 1995
Skills
Quality Control, Biopharmaceuticals, GMP, GLP, Biotechnology, Validation, CAPA, FDA, Sop, HPLC, Analytical Method..., Quality System, 21 CFR Part 11
Education
University of California, Santa Barbara 1986 — 1990
BA, Aquatic Biology
Prometheus Laboratories Inc. June 2005 - Present
Prometheus Laboratories Inc June 2005 - Present
Smith and Nephew Wound Management October 2002 - January 2005
Advanced Tissue Sciences November 1996 - October 2002
Hybritech 1987 - 1996
Skills
Biotechnology, Customer Relations, Diagnostics, Customer Service, Operations Management, Hardware Diagnostics, Oncology, FDA, Medical Devices, Cross-functional Team..., Healthcare, Pharmaceutical Industry, Logistics, Managed Care, Product Launch, Sales, Clinical Trials, Hematology, Lifesciences, Infectious Diseases
Education
University of Dayton 1969 — 1973
B.S., Medical Technology
St. Agustine Academy, Lakewood, OH
Therapeutics Inc. December 2014 - Present
Therapeutics Inc. January 2011 - December 2014
Therapeutics Inc. January 2006 - January 2011
Prometheus Laboratories Inc., A Nestlé Health Science Company 1999 - 2005
Trega Biosciences, Inc 1993 - 1998
Advanced Tissue Sciences 1990 - 1993
Omega Marine 1986 - 1989
Skills
Pharmaceutical Industry, Biotechnology, Medical Devices, Lifesciences, Oncology, Managed Care, Clinical Development, Commercialization, CRO, FDA, Life Sciences, Management, Biopharmaceuticals, Clinical Trials, Cross-functional Team...
Education
University of Phoenix 1992 — 1995
BSBA, Accounting
Youngstown State University 1984 — 1986
Accounting
Independent Consultant Cabana Home July 2009 - October 2013
Ross Valley Mother's Club April 2010 - April 2011
Celera Corporation 2000 - 2003
Cyanotech 1997 - 2000
Desmos, Inc 1994 - 1996
Viagene (Chiron) 1994 - 1995
Advanced Tissue Sciences 1992 - 1994
Skills
Molecular Biology, Assay Development, Cell Culture, ELISA, Lifesciences, RNAi, RT-PCR, Protein Purification, Graphic Design, Laboratory, PCR, Western Blotting, Southern Blot, FPLC, Bioreactor, Quality Control, Graphics Layout, Small Business, Social Media Marketing, Database Admin, AutoCAD, Plasmid Isolation, Vector Cloning, Aquaculture, Nutraceuticals, Proficient in InDesign, Studio Webware, Studio Showroom, Studio Designer, Biotechnology, Furnishings, R&D, Cell Biology, HPLC, Purification, Adobe Creative Suite
Education
UC San Diego
BS Physiology and Neuroscience
UC Berkeley Extension
Interior Design and Architecture
UC San Diego Extension
Graphic Design
PPD July 2012 - Present
Regulatory Affairs Consulting and Medical Writing Services February 2008 - June 2012
Cadence Pharmaceuticals 2006 - 2008
Maxim Pharmaceuticals 2004 - 2006
PAREXEL Interntional 2002 - 2004
Innercool Therapies 2001 - 2002
Hollis-Eden Pharmaceuticals 1999 - 2000
Advanced Tissue Sciences 1998 - 1999
Advanced Tissue Sciences 1995 - 1998
Advanced Tissue Sciences 1992 - 1995
Skills
Regulatory Affairs, FDA, Regulatory Submissions, Clinical Trials, Sop, Validation, GCP, Biotechnology, IND, Medical Devices, Medical Writing, Technology Transfer, Clinical Research
Education
University of California, San Diego 1986 — 1990
BA, Communication, Biology
Honeywell Aerospace March 2013 - Present
Honeywell Aerospace 2005 - March 2013
HP 2001 - 2003
Advanced Tissue Sciences 1994 - 1999
Skills
Supply Chain, Demand Planning, Production Planning, Supply Chain Management, Six Sigma, Process Improvement, Forecasting, SAP, Strategic Sourcing, Inventory Management, Planning, Operations Management, ERP, Change Management, Strategic Planning, Access, Excel, MRP, Lean Manufacturing, Program Management, Microsoft Office, Supplier Management, Continuous Improvement, Procurement, Cross-functional Team..., Cost Reduction, Materials Management, Demand Forecasting, Aerospace, Manufacturing, Analysis, Project Planning, Supply Management, Kaizen, Logistics, Supply Chain...
Education
Arizona State University, W. P. Carey School of Business
MBA, Supply Chain Management
aTyr Pharma July 2010 - Present
Mark Long Capital October 2007 - December 2010
Unisys June 2005 - October 2007
California Skin Research Institute (CSRI) January 1995 - October 1998
Self Employed 1995 - 1998
Douglas Allred Company 1995 - 1995
Advanced Tissue Sciences 1992 - 1995
Russell Reynolds Associates 1990 - 1992
R.J. Watkins & Company 1985 - 1990
Skills
Microsoft Office, Research, Administrative..., Calendaring, Executive Support, Travel Arrangements, Biotechnology, Spreadsheets, Office Management, Lotus Notes, Microsoft Excel, Outlook, Concur, Calendars, CRO, Clinical Development, Lifesciences, Oncology, Administrative..., Life Sciences
Education
San Diego Mesa College
Associate’s Degree, Professional, Technical, Business, and Scientific Writing
Pacific Coast Trade School 1984 — 1985
Diploma, Executive Assistant/Executive Secretary