Aastrom Biosciences
Industry: Company
DescriptionVericel Corporation is a public, American biopharmaceutical company which was known prior to October 2014 as Aastrom Bio. Aastrom Bio was formed in 1989 in Ann Arbor, Michigan. Headquarters: Cambridge, MA CEO: Nick Colangelo (Nov 2014–) Founded: 1989 Subsidiaries: Aastrom Biosciences, Sl, Zellera AG, Genzyme Biosurgery ApS, Aastrom Biosciences Ltd Ireland
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Aastrom Biosciences Employees
NeuMoDx April 2015 - Present
Elanco February 2014 - April 2015
Wayne State University February 2013 - November 2013
Aastrom Biosciences May 2012 - August 2012
Michigan State University August 2008 - May 2011
Michigan State University January 2010 - May 2010
Pfizer June 2007 - July 2008
Michigan State University May 2006 - March 2007
Skills
Cell Culture, Molecular Biology, PCR, Biochemistry, Cell, Microbiology, Microsoft Office, Research, Cell Biology, Immunohistochemistry, Western Blotting, qPCR, Biotechnology, Molecular Cloning, Experimental Design, Data Analysis, Protein Expression, Life Sciences, Microscopy, Fermentation, Cell Based Assays, Gel Electrophoresis, DNA, Media Preparation, Cell Signaling, SDS-PAGE, Fluorescence Microscopy, Genetics, RT-PCR, Transfection, Lifesciences, Science, Laboratory, Molecular Genetics, Cancer Research, Brain Tumors, Managing Database, Protocol Design, Written & Oral..., Scientific Writing, Mouse Handling, DNA extraction, Assay Development, Biology, Tissue Culture, RNA isolation, Lyophilization, DNA Extraction
Education
Michigan State University 2008 — 2011
Masters of Science, Cell and Molecular Biology
Michigan State University 2005 — 2007
Bachelors of Science, Biochemistry & Molecular Biology/Biotechnology
Macomb Community College 2003 — 2005
Associate of Science (A.S.), Molecular Biotechnology
Genzyme, a Sanofi company May 2015 - Present
Sanofi Oncology July 2013 - May 2015
MCPHS University Fellows' Network July 2013 - May 2015
MCPHS University July 2013 - May 2015
Aastrom Biosciences November 2012 - December 2012
Eli Lilly and Company October 2012 - November 2012
Arbor Communications May 2012 - June 2012
Skills
Oncology, Medical Communications, Medical Writing, Medical Affairs, Teamwork, Pharmaceutical Industry, Fellowships
Education
University of Michigan College of Pharmacy 2009 — 2013
Doctor of Pharmacy (PharmD)
University of Michigan 2006 — 2009
Biology, General
BioImaging Solutions, Inc. June 2014 - October 2014
Aastrom Biosciences November 2012 - June 2014
International Stem Cell Corporation May 2011 - September 2012
The Scripps Research Institute April 2009 - May 2011
Histogen Inc. June 2007 - January 2009
Orion Biosolutions June 2004 - June 2007
United States Marine Corps June 2000 - June 2004
Skills
Stem Cells, Cell Culture, Tissue Engineering, Cell, Cell Biology, Molecular Biology, Differentiation, Lifesciences, Tissue Culture, PCR, Immunocytochemistry, Immunohistochemistry, DNA, Western Blotting, ELISA, qPCR, Biochemistry, Biotechnology, RNA isolation, Protein Expression
Education
Cal State San Marcos 2011 — 2016
Bachelor's degree, Cellular and Molecular Biology
Palomar College
Associate of Arts (A.A.), Math and Science
Palomar College
Associate of Arts (A.A.), Arts and Humanities
General Mills June 2014 - Present
Michigan State University June 2011 - May 2014
Unilever May 2013 - August 2013
University of Massachusetts Amherst June 2012 - August 2012
Aastrom Biosciences June 2011 - August 2011
Skills
Research, Mathematical Modeling, Laboratory, Mathematica, Matlab, Statistics, Chemistry, Assay Development, Nanoparticles, Project Management, Fluorescence, ELISA, Cell, Flow Cytometry
Education
Michigan State University 2010 — 2014
Bachelor of Science (B.S.), Chemical Engineering
Accenture 2011 - Present
Shepherd Advisors June 2010 - August 2010
Aastrom Biosciences February 2010 - April 2010
Adoption & Foster Care Mentoring (AFC) January 2009 - August 2009
University of Massachusetts January 2008 - January 2009
Biosite Diagnostics / Inverness Medical November 2002 - October 2007
Skills
Management Consulting, Strategy, Financial Modeling, Mergers & Acquisitions, Research, Management, Cross-functional Team..., Business Strategy, Finance, Fundraising, Program Management, Competitive Analysis, Analytics, Entrepreneurship, Leadership
Education
University of Michigan - Stephen M. Ross School of Business 2009 — 2011
M.B.A, Concentrations in Finance & Strategy
Northeastern University 1997 — 2002
B.S., Chemical Engineering, magna cum laude
Vericel Corporation October 2014 - Present
Aastrom Biosciences June 2014 - September 2014
Genzyme May 2013 - June 2014
Pen and Anvil Press September 2012 - December 2012
MIT Haystack Observatories June 2009 - August 2012
Westford Historical Society and Museum June 2011 - August 2011
Tyngsborough Public Schools January 2010 - January 2010
Education
Endicott College 2008 — 2012
Bachelor of Arts (B.A.), English
Mallinckrodt Pharmaceuticals (formerly Covidien) September 2011 - Present
Washington University School of Medicine January 2011 - September 2011
Pfizer Pharmaceuticals 1999 - 2010
Aastrom Biosciences February 1994 - June 1999
Wayne State University 1992 - 1994
Skills
Drug Discovery, Cell Biology, Drug Development, Laboratory Research, Biomarker Discovery, Biochemistry, Cell Signaling, Immunoassays, Cell Based Assays, Fluorescence Microscopy, Immunofluorescence, Confocal Microscopy, Cell Culture, Biotechnology, Pharmaceuticals
Education
Wayne State University 1990 — 1992
MS, Cell Biology
Eastern Michigan University 1987 — 1989
BS, Biology
BD November 2013 - Present
Unemployed Biopharmaceutical Professional April 2013 - November 2013
Aastrom Biosciences March 2007 - April 2013
Pfizer August 2006 - March 2007
Genzyme October 2001 - March 2006
Skills
Biotechnology, FDA GMP, Environmental Monitoring, Cell Culture, Technical Writing, Project Management, Pharmaceutical..., Cell Viability Assays, Medical Devices, Aseptic Technique, Data Entry, Cell Therapy, Quality System, Quality Control, Document Management, Document Drafting, Process Optimization, Adult Stem Cells, Process Improvement, FDA, Batch Records, SOP authoring, SOP development, Iso 9000, Cross Functional Team..., Bioreactor, Process Qualification, Regulatory Submissions, Start-ups, Deviations, Aseptic Processing, Mammalian Cell Culture, Biopharmaceuticals, Technology Transfer, GMP, Sop, Laboratory, cGMP manufacturing, Clinical Trials, 21 CFR Part 11, cGMP practices, Lifesciences, Cell, IND, Stem Cells, Drug Development, Protocol, Validation, Biomaterials, Drug Discovery
Education
Boston University 1992 — 1997
Bachelor of Science (B.S.), Biology, with specialization in Marine Science
Litchfield High School
Vericel Corporation February 2014 - Present
Aastrom Biosciences December 2013 - February 2014
Aastrom Biosciences November 2010 - December 2013
Birchwood Genetics July 2009 - April 2010
Skills
Cell Culture, PCR, GMP, Biotechnology, GLP, FDA, Aseptic Technique, SOP, Validation, Change Control, Communication Skills, Highly detail oriented, SOP authoring, Protocol Design, Microscopy, Scientific Analysis, Batch Records, Technical Training, Specifications, Gel Electrophoresis, Managing Meetings, Technical Presentations, Root Cause Analysis, Problem Solving, Human Physiology, Dissection, Leadership, 21 CFR Part 211, Clean Rooms, Quality by Design, Process Development
Education
Eastern Michigan University 2001 — 2006
Bachelor of Science (BS), Biology, General
Siemens Healthcare October 2014 - Present
Aastrom Biosciences March 2014 - September 2014
Genzyme Biosurgery November 2011 - March 2014
Genzyme Biosurgery June 2007 - November 2011
University of Connecticut September 2004 - May 2007
YMCA March 2002 - January 2005
Skills
cGMP, SOP, Cell Culture, Biotechnology, Process Development, Gel Electrophoresis, PCR, Western Blotting, ELISA, Cell Based Assays, GMP, Microsoft Office, PowerPoint, Word, Excel, Documentation, Outlook, Microsoft Word, Microsoft Excel, Software Documentation, Cell, Sop, Process Simulation, FDA, qPCR, GLP, Aseptic Technique, Trackwise, Training, Scientific Writing, Clean Rooms, cGMP practices, Manufacturing, Technical Writing, Data Analysis, CAPA, SDS-PAGE, Cross-functional Team..., Quality Assurance, Laboratory, Validation, Assay Development, Aseptic Processing, Technology Transfer, Microbiology, Tissue Culture, Deviations, Cell Biology, cGMP manufacturing, GxP
Education
Northeastern University 2009 — 2013
Master of Public Health, Urban health
The University of Connecticut 2003 — 2007
Bachelor of Science, Animal Science
King Philip High School 1999 — 2003
High school diploma
King Philip High School
Smith&Nephew, Inc., Biotherapeutics February 2013 - Present
Emergent BioSolutions August 2012 - February 2013
Aastrom Biosciences July 2007 - May 2012
Schoolcraft College June 2007 - May 2012
Pfizer Global R & D January 2000 - June 2007
Parke Davis 1992 - 2000
The Upjohn Company September 1986 - June 1992
Skills
Microbiology, Biotechnology, Infectious Diseases, Molecular Biology, Validation, cGMP, ELISA, Vaccines, Technology Transfer, SOP, Drug Discovery, Cell Culture, Cell Based Assays, PCR, Teaching, Scientific Writing, Virology, Sop, GMP, High Throughput..., Assay Development, Cell, Clinical Trials, Cell Biology, Protein Purification, Biochemistry, Analytical Chemistry, Stem Cells, Laboratory, Science, Sequencing, CAPA, Pharmacology, Lifesciences, Immunology, Protein Chemistry, Drug Development, Biomarkers, Biopharmaceuticals, GLP, Flow Cytometry, Life Sciences
Education
Purdue University 1984 — 1985
MS, Biology
The University of Chicago 1973 — 1977
AB, Biological Sciences
Aastrom Biosciences July 2010 - April 2013
Aastrom Biosciences April 2010 - June 2010
OptumInsight August 2009 - April 2010
Metabasis Therapeutics February 2008 - April 2009
Pfizer June 2006 - February 2008
Pfizer September 2003 - May 2006
Pfizer August 2001 - August 2003
Parke - Davis February 2000 - August 2001
Parke Davis August 1999 - January 2000
Parke-Davis January 1998 - August 1999
Skills
GMP, Pharmaceutical Industry, Clinical Development, Oncology, Drug Development, Clinical Trials, CRO
Education
Madonna University - Graduate Studies 1984 — 1989
MSA, Administration
Madonna University 1980 — 1983
BSA, General Business
re:3D January 2013 - Present
Mississippi Air National Guard July 2010 - Present
Open Innovation Program at NASA 2012 - 2013
Wyle Integrated Science and Engineering Group 2009 - 2012
BioFlow Technology 2006 - 2009
Aastrom Biosciences 2003 - 2006
Skills
Research, Fundraising, Public Speaking, International..., Program Management, Strategic Planning, Team Leadership, Project Management, Teaching, Proposal Writing, Business Development, Business Strategy, Government, Leadership, Analysis, Entrepreneurship, Leadership Development, Strategy, Social Media, Team Building, Project Planning, Training, Management, Public Relations, Data Analysis, Management Consulting, Event Planning, Nonprofits, Budgets, Systems Engineering
Education
The University of Texas at Austin
Research Affiliate, Digital Media Collaboratory, Center for Agile Technology
University of Michigan-Dearborn
MBA, Supply Chain Management, International Business
University of Michigan-Dearborn
BA, BS, Biology, International Studies, Hispanic Studies
Einstein Healthcare Network August 2014 - Present
Einstein Healthcare Network October 2013 - July 2014
PinnacleHealth System May 2012 - June 2013
PinnacleHealth System October 2011 - May 2012
Children's Hospital of Philadelphia July 2009 - July 2010
PinnacleHealth System October 2008 - June 2009
Aastrom Biosciences March 2006 - April 2008
University of Michigan Health System November 1999 - March 2006
Skills
Process Improvement, Leadership, Operations Management, Change Management, Healthcare, Healthcare Management, Financial Analysis, Hospitals, Healthcare Information..., EMR, Quality Improvement, Clinical Research, Public Health, Healthcare Consulting, EHR
Education
University of Michigan 2006 — 2008
M.H.S.A, Health Management
Ash Stevens Inc. October 2013 - Present
Aastrom Biosciences August 2011 - October 2013
Home Acres Building Supply August 2010 - July 2011
Education
Lansing Community College 2008 — 2010
Fire Science/Fire-fighting
Michigan State University 2006 — 2008
Construction Management
Abbott Vascular August 2014 - Present
Abbott Vascular October 2011 - Present
Abbott Vascular January 2011 - October 2011
Abbott Laboratories January 2009 - December 2010
Aastrom Biosciences June 2007 - December 2007
Skills
Medical Devices, FDA, Validation, Quality System, Technology Transfer, Solidworks, PMP, MS Project, Project Management, Facilities Engineering, Facilities Operations, Utility Systems, R&D, AutoCAD, Microsoft Project, GMP, Project Planning, Manufacturing
Education
University of Michigan 2007 — 2008
M.S., Biomedical Engineering
University of Michigan 2004 — 2007
B.S., Mechanical Engineering
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
University Of Michigan November 2013 - Present
Pharmacision January 2007 - March 2014
Aastrom Biosciences February 2012 - March 2013
RetroSense Therapeutics December 2009 - December 2010
Talecris Biotherapeutics April 2005 - November 2006
Bayer Biological Products January 2002 - March 2005
Bayer Biological Products January 2001 - December 2001
Glaxo/ Glaxo Wellcome August 1987 - December 2000
Skills
Strategic Planning, Product Development, Business Planning, Business Strategy, Positioning, Pharmaceutical Industry, Biotechnology, Commercialization, Oncology, Competitive Intelligence, Lifesciences, Biopharmaceuticals, Managed Care, Cell Therapy, Immunology, Marketing, Marketing Strategy, Market Research, Strategy, Start-ups, Drug Development, Strategic Partnerships, Business Development, Clinical Development, Technology Transfer, Medical Devices, Pharmaceutics, Due Diligence, Entrepreneurship, Market Planning, Drug Discovery, Leadership, Global Marketing, Licensing, Venture Capital, Corporate Development, Clinical Trials, Diabetes, FDA, Neurology, Life Sciences
Education
University of Rochester - William E. Simon Graduate School of Business Administration 1991 — 1993
MBA, Finance
State University of New York at Buffalo 1984 — 1987
BS, Medicinal Chemistry
Zoetis January 2013 - Present
Emergent BioSolutions November 2012 - January 2013
Aastrom Biosciences May 2011 - September 2012
Charles River Laboratories (formerly MIR Preclinical Services) 2007 - May 2011
Pfizer, Inc. February 1997 - April 2007
Boehringer Ingelheim June 1994 - January 1997
Regeneron Pharmaceuticals 1987 - 1995
Skills
Biochemistry, Biotechnology, Molecular Biology, Cell Biology, Assay Development, Drug Discovery, High Throughput..., Pharmacology, Enzyme Assays, Enzyme Kinetics, Ligand Binding, Receptor Binding Assays, ELISA, Biomarkers, Binding Assays, Cellular Assays, Cell Culture, In Vitro, Lifesciences, Infectious Diseases, Immunology, Purification, Immunohistochemistry, In Vivo, Microbiology, RT-PCR, Life Sciences, Western Blotting, Cell, Vaccines, Oncology, Pharmaceutical Industry
Education
Michigan State University
Bachelor of Science, Biochemistry
Aspire Pharmaceutical Consulting, LLC April 2013 - Present
YourEncore 2013 - Present
Aastrom Biosciences 2012 - 2013
Aastrom Biosciences 2011 - 2012
Somanetics Corporation 2009 - 2011
University of Michigan 2008 - 2009
University of Michigan 2006 - 2008
Skills
Biotechnology, Pharmacology, FDA, Clinical Research, Medical Devices, Pharmaceutical Industry, GLP, Cross-functional Team..., Sop, Science, Research, Laboratory, Clinical Trials, Biochemistry, Drug Discovery, GCP, Immunology, CRO, Toxicology, Cell, Protocol, Clinical Development, Microbiology, Chemistry, Lifesciences, Life Sciences, Data Quality, Data Review, SOP
Education
University of Michigan 2003 — 2006
PhD, Pharmacology
University of Michigan 2001 — 2003
MS, Pharmacology
University of Michigan 1995 — 2000
BS, Microbiology
Depuy Synthes - Johnson & Johnson July 2013 - Present
Project MedTech, Inc. 1998 - Present
Terumo Cardiovascular Systems May 2013 - July 2013
Terumo Heart, Inc. November 2010 - December 2012
MRC, Inc. July 2010 - August 2011
AlvaMed, LLC 2005 - 2010
Baxter Healthcare 2006 - 2009
QPharma, Inc. 2003 - 2006
Quintiles Consutling December 1988 - June 1999
Aastrom Biosciences 1994 - 1998
Skills
FDA, CAPA, Validation, Medical Devices, ISO 13485, Quality System, Quality Assurance, GMP, V&V, Regulatory Affairs, Cross-functional Team..., R&D, Biotechnology, Design Control, Testing, Engineering, Commercialization, Product Launch, ISO 14971, Manufacturing, Product Development, Quality Management, Risk Management, Quality Control, FMEA, Software Documentation, Lifesciences, Clinical Trials, Technology Transfer, Biomedical Engineering, Regulatory Requirements, Root Cause Analysis, Regulatory Submissions, Computer System..., Six Sigma, Clinical Development, Quality Auditing, ISO, 21 CFR Part 11, Change Control, GxP, Process Simulation, Sop, Electrical Engineering, 60601-1 3rd Edition, Functional Requirements, Requirements Management, Requirements...
Education
Rutgers University-New Brunswick
BA, English
University of Miami
MSBE, Biomedical Engineering
Vanderbilt University
Electrical and Biomedical Engineering
Aastrom Biosciences September 2013 - Present
Remmers Research LLC March 2009 - Present
Aegis Creative June 2011 - July 2012
CBR International, Inc August 2009 - June 2011
Array BioPharma August 2007 - January 2009
PFIZER INC (formerly Parke-Davis) February 2003 - January 2007
Pfizer January 2001 - January 2003
Parke-Davis (now Pfizer) January 2000 - January 2001
Parke-Davis (now Pfizer) January 1999 - January 2000
THE UNIVERSITY OF MICHIGAN MEDICAL SCHOOL January 1990 - January 1999
Skills
Medical Writing, Protocol Development, Pain, Regulatory Submissions, Clinical Development, Biotechnology, Clinical Research, Translational Medicine, Drug Development, Clinical Trials, Pain Management, Biomarkers, Pharmaceutical Industry, Protocol, Regulatory Affairs, Clinical Operations, CTMS, Neuroscience, Biopharmaceuticals, Molecular Biology, FDA
Education
University of Michigan 1984 — 1990
PhD
University of Michigan
MS
Wellesley College 1980 — 1984
BA
University of Michigan Medical School July 2013 - Present
University of Michigan August 2011 - July 2013
ProNAi Therapeutics, Inc. December 2011 - October 2012
Aastrom Biosciences April 2007 - September 2010
Esperion Therapeutics, Division of Pfizer Global R&D January 2005 - April 2007
Osiris Therapeutics 1998 - 2005
Skills
Lifesciences, Biotechnology, Drug Discovery, Business Development, Medicine, Commercialization, Technology Transfer, Medical Devices, Clinical Trials, Product Development, Clinical Development, Hardware Diagnostics
Education
University of Michigan 1988 — 1993
PhD, Physiology (Cardiac)
University of Dayton 1982 — 1986
B.S., Biology
The Bode Technology Group August 2012 - March 2013
The Bode Technology Group June 2003 - July 2012
Igen International March 2002 - April 2003
Biowhittaker September 2000 - December 2001
Pfizer July 1999 - September 2000
Aastrom Biosciences August 1997 - July 1999
Aastrom Biosciences September 1992 - August 1997
Skills
Biotechnology Industry, Stem Cells, Supervisory Experience, Team Management, Cell Culture, DNA fingerprinting, DNA sequencing, Process Simulation, Commercialization, Laboratory, Cell Biology, Drug Discovery, Medical Devices, Private Investigations
Education
Latvijas Universitate / University of Latvia 1984 — 1990
Master of Science (MS), Biochemistry
Medtronic - Peripheral Vascular March 2013 - Present
Medtronic Spinal and Biologics June 2008 - March 2013
Aastrom Biosciences May 2007 - February 2008
Skills
Product Development, Design Control, Medical Devices, FDA, Biomaterials, Design of Experiments, V&V, R&D, FMEA, Commercialization
Education
University of Michigan 2007 — 2008
M.S.E., Biomedical Engineering
University of Michigan 2003 — 2007
B.S.E., Biomedical Engineering
RoosterBio, Inc January 2013 - Present
Entrepreneur and Independent Consultant January 2013 - July 2013
Lonza September 2011 - January 2013
Lonza March 2008 - August 2011
Aastrom Biosciences July 2005 - February 2008
BD Technologies May 2001 - June 2005
Reprogenesis 1998 - 1998
Skills
Cell Therapy..., Tissue Engineering..., Process Development, Tissue Engineering, Bioprocessing, Cell Therapy, Biomaterials
Education
University of Michigan 1990 — 2001
BSE, MS, PhD, Materials Science & Engineering, Biomedical Engineering
California Institute for Regenerative Medicine January 2011 - Present
Food and Drug Administration October 2008 - November 2010
U.S. House of Representatives January 2008 - October 2008
US House of Representatives September 2006 - December 2007
Booz Allen Hamilton May 2006 - September 2006
Aastrom Biosciences December 2005 - May 2006
National Academy of Sciences September 2005 - November 2005
Northwestern University September 1999 - August 2005
National Institutes of Health January 1998 - August 1999
National Institutes of Health August 1996 - December 1997
Skills
Molecular Biology, Biotechnology, Science, Regenerative Medicine, Lifesciences, Science Policy, Biomaterials, Tissue Engineering, Regulatory Policy, Public Policy, Science Communication, Cell Therapy, Biochemistry, Federal Government..., Governmental Affairs, Spinal Cord Injury, Research Funding, R&D funding, Product Development, Drug Delivery, Gene Delivery, Regulatory Affairs, CMC Regulatory Affairs, FDA, Regulatory Submissions, Stem Cells
Education
Northwestern University 1999 — 2005
PhD, Biological Sciences
Occidental College 1992 — 1996
B.A., Biochemistry
Esperion Therapeutics, Plymouth, MI December 2012 - Present
DeNovo Sciences June 2012 - Present
Esperion Therapeutics, Inc. December 2009 - Present
Lycera Corporation 2007 - Present
kaleo 2006 - Present
Wolverine Venture Fund 2006 - Present
ElMa Advisors January 2005 - Present
Aastrom Biosciences 2005 - March 2013
Aastrom Biosciences December 2009 - December 2012
NightHawk Radiology Services January 2007 - March 2008
Skills
Start-ups, Team Building, Finance, Licensing, Capital Raising, Business Formation, Lifesciences, Venture Capital, Mergers, Strategic Planning, Medical Devices, Biotechnology, Business Strategy, Product Development, Business Development, Healthcare, Business Planning, Project Management, New Business Development, Cross-functional Team..., Corporate Development, Drug Discovery, Mergers & Acquisitions, Strategy, Market Analysis, Competitive Analysis, Pharmaceutical Industry, Strategic Partnerships, Management Consulting, Entrepreneurship, Leadership, Due Diligence, Drug Development, Executive Management, Commercialization, Biopharmaceuticals
Education
Northwestern University - Kellogg School of Management 1995 — 1997
MM, Business, finance
University of Michigan - Stephen M. Ross School of Business 1982 — 1984
Bachelor of Business Administration (B.B.A.), Accounting and Finance
Hemostemix October 2014 - Present
Forstbetrieb Burchardt (Burchardt Forestry Company) December 2003 - Present
Pfizer Inc. May 2010 - October 2014
Aastrom Biosciences May 2006 - May 2010
Miltenyi Biotec June 2000 - May 2006
Bayer AG December 1993 - May 2000
Skills
Clinical Research, Immunology, Biotechnology, Clinical Development, Clinical Trials, Regenerative Medicine, Pharmaceutical Industry, Oncology, Molecular Biology, Lifesciences, Stem Cells, Biochemistry, Pharmacology, Clinical Pharmacology, Drug Discovery, Drug Development, Cell, Toxicology, Biomarkers, FDA, Biopharmaceuticals
Education
Universität Witten/Herdecke 2000 — 2004
Ph.D. (Habilitation), Clinical Pharmacology
Medizinische Hochschule Hannover 1994 — 1999
D.Sc. (Dr. rer. biol. hum.), Pharmacology
Medizinische Hochschule Hannover 1985 — 1993
M.D. (Dr. med.), Medicine
Leibniz Universität Hannover 1986 — 1992
M.Sc. (Diplom-Biochemiker), Biochemistry
Yale University School of Medicine 1989 — 1990
Medicine, MB&B
Viveve Medical, Inc. June 2012 - Present
Aastrom Biosciences June 2010 - October 2011
Prescient Medical April 2004 - May 2010
Lehman Brothers June 1998 - December 2002
Biotronic NeuroNetwork February 1993 - July 1997
Skills
Private Equity, Mergers, Corporate Development, Investor Relations, Start-ups, Medical Devices, Finance, Strategic Planning, Restructuring, Pharmaceutical Industry, Biotechnology, Mergers & Acquisitions, Equities, Commercialization, Venture Capital, Divestitures
Education
Yale University 1997 — 1999
MPH, Health Management
University of Michigan 1989 — 1993
BS, Biopsychology & Pre-Med
Metrex August 2014 - Present
FDA May 2011 - June 2014
Aastrom Biosciences 2010 - 2011
Wayne State University June 2010 - September 2010
Detroit Bio-Medical Laboratories May 2009 - April 2010
Allen County Coroner's Office May 2008 - July 2008
Skills
PCR, Laboratory, Assay Development, Aseptic Technique, Protein Chemistry, Biology, Chemistry, Toxicology, Electrophoresis, Quality Control, Analysis, Microsoft Excel, PowerPoint, Molecular Biology, Cell Culture, Lifesciences, Microbiology, Biochemistry, ELISA, Western Blotting
Education
Tri-State University 2005 — 2009
Bachelor of Science, Biology and Chemistry
Trine University 2005 — 2009
BS, Biology, Chemistry, Forensics
MMS Holdings Inc. August 2015 - Present
YourEncore June 2013 - January 2015
Aastrom Biosciences November 2012 - July 2014
Accumed Systems January 2014 - April 2014
University of Michigan, Department of Biostatistics June 2008 - July 2013
i3 Statprobe August 2007 - May 2008
Pfizer Global Research and Development, Clinical Biostatistics February 2004 - August 2007
Parke-Davis Pharmaceutical Research (became Pfizer Global Research and Development in June 2000), Bi November 1998 - January 2004
Parke-Davis Pharmaceutical Research, Biometrics Department. Senior Statistician II September 1995 - October 1998
Parke-Davis Pharmaceutical Research, Biometrics Department September 1992 - August 1995
Skills
Bayesian statistics, Bioequivalence, Assay validation, Noncompartmental..., Familiarity with..., Proof of concept studies, Single- and..., Drug interaction studies, Linear and nonlinear..., Sample sizing of..., Statistics, Logistic Regression, Clinical Study Design, Clinical Development, Assay Development, Experimental Design, Clinical Trials, Biotechnology, Oncology, GCP, Life Sciences, CRO, Data Review, Statistical Programming, Drug Development, Survival Analysis, Data Quality, Pharmaceutical Industry, Biostatistics, Phase I, FDA, Clinical Pharmacology, Clinical Research
Education
The Ohio State University
Ph.D, Statistics
The Ohio State University
M.S, Statistics
Miami University
B.A, Zoology
Boston Scientific September 2014 - Present
Aastrom Biosciences February 2014 - September 2014
St. Jude Medical July 2013 - December 2013
Aastrom Biosciences July 2012 - March 2013
Aastrom Biosciences June 2011 - July 2012
Skills
Biomedical Engineering, FDA, Labview, Matlab, Quality System, Solidworks, COMSOL, ADINA, CAPA, PTC Pro/Engineer, Pro Engineer, Minitab, V&V, Engineering, Biotechnology, GMP, Medical Devices, PTC Creo
Education
University of Michigan 2012 — 2013
Master of Science (M.S.), Biomedical Engineering, Graduate Student
University of Michigan 2008 — 2012
Bachelor of Science (BS), Biomedical Engineering
Covance June 2015 - Present
SARC December 2012 - February 2015
inVentiv Health September 2007 - November 2012
Aastrom Biosciences September 2005 - September 2007
Skills
Clinical Trials, Drug Safety, Regulatory Affairs, Data Management, Clinical Monitoring, Medical Writing, Regulatory Submissions, Clinical Development, Oncology, Sop, GCP, CTMS, Clinical Research, Pharmacovigilance, FDA, Pharmaceutical Industry, CRO
Education
Eastern Michigan University
Bachelor of Science (B.S.), Biology, General
General Motors December 2010 - Present
Ford Motor Company June 2005 - November 2010
NetPlus, Inc. 1998 - 2005
Aastrom Biosciences 1997 - 1998
Telebit 1989 - 1997
Education
Bangladesh University of Engineering and Technology
BSc, Electrical & Electronics Engineering
University of Detroit Mercy
MS, Computer Science
INSP, LLC July 2012 - May 2014
The Inspiration Networks November 2011 - July 2012
Aastrom Biosciences April 2010 - January 2011
Aastrom Biosciences June 2006 - April 2010
Aastrom Biosciences January 2005 - June 2006
Aastrom Biosciences July 2002 - January 2005
Skills
Public Relations, Press Releases, Event Planning, Blogging, Editing, Corporate Communications, Newsletters, Public Speaking, Project Management, Marketing Communications, Social Media, Social Media Marketing, Marketing, Strategic Communications, Social Networking, Non-profits, Event Management, PowerPoint, Promotions, Media Relations, Microsoft Office, Marketing Strategy, Trade Shows, Email Marketing, Facebook, Copywriting, Digital Media, Marketing Management, Affiliate Marketing, Online Marketing, Management
Education
Siena Heights University 2007 — 2009
Bachelors, Multi-Disciplinary Studies
Eastern Michigan University 2002 — 2006
Communications
Illinois State University 1999 — 2002
Mass Communication
University of Michigan Health System June 2011 - Present
University of Michigan Medical School June 2008 - July 2011
Aastrom Biosciences January 2005 - May 2008
University of Toledo April 2002 - May 2008
Skills
Cell Culture, Molecular Biology, Cell Biology, Clinical Research, Manuscript, Biotechnology, PCR, Laboratory, in Situ Hybridization, Fluorescence, Genetics, Western Blotting, Cell, Biochemistry, Lifesciences, Transfection, DNA, In Vitro, Stem Cells, IVF, Embryology, Andrology, Fertility, Trophectodermal Biopsy, Tissue Culture, Flow Cytometry, Cancer Research, Life Sciences
Education
Eastern Virginia Medical School 2006 — 2008
Masters, Biomedical Science - Clinical Embryology and Andrology
University of Findlay 1992 — 1997
Bachelor of Science, Equine Science
Boston Scientific August 2011 - Present
Boston Scientific September 2006 - August 2011
Aastrom Biosciences 2006 - 2006
University of Michigan 2004 - 2006
Kawamura Institue of Chemical Research May 2003 - June 2004
Skills
Medical Devices, FDA, Regulatory Affairs, ISO 13485, Design Control, GMP, Quality System, CAPA, PMA, 21 CFR, Regulatory Requirements, Biocompatibility, Technical Files, Clinical Trials, Biomedical Engineering, Validation, Life Sciences, Polymer Characterization, Japanese MHLW & PMDA, 510(k), Regulatory Submissions, Biotechnology, Medical Device Directive, Combination Products, Post Market Surveillance, 21 CFR Part 11, Class III Medical..., FDA GMP, Catheters, IDE, Cultural Awareness, Adobe Creative Suite
Education
Rutgers University 2011 — 2014
Master of Science (MS), Clinical Trial Sciences, Magna Cum Laude
University of Michigan 2000 — 2006
Molecular Cellular and Developmental Biology, Material Science, Japanese Language
inVentiv Health Clinical August 2013 - Present
Aastrom Biosciences July 2010 - May 2013
Cerenis Therapeutics December 2008 - July 2010
Metabasis Therapeutics June 2007 - November 2008
Pfizer, Inc. January 1997 - June 2007
i3 Statprobe 1995 - 1997
Skills
Clinical Development, Clinical Trials, Clinical Research, GCP, CTMS, CRO, Oncology, Biotechnology, Pharmaceutical Industry, Drug Development, Clinical Monitoring, Lifesciences, FDA, Protocol, EDC, Regulatory Submissions, Sop, Diabetes, CRF design
Education
University of Michigan 1988 — 1995
M.S., Biology and Human Nutrition
3M Health Care July 2011 - Present
Aastrom Biosciences August 2009 - July 2011
Skills
GLP, Validation, CAPA, FDA, Quality System, Medical Devices, Teamwork, 21 CFR Part 11, GMP, Sop
Education
University of Florida
ARIAD Pharmaceuticals, Inc. November 2014 - Present
Aastrom Biosciences July 2012 - November 2014
Genzyme sanofi May 2009 - July 2012
Genzyme October 2007 - May 2009
Gregg International School March 2005 - August 2007
Abbott June 2003 - October 2004
Skills
Sop, Quality Assurance, Software Documentation, Root Cause Analysis, Trackwise, Manufacturing, Deviations, CAPA, GMP, FDA, Biotechnology, Regulatory Affairs, Regulatory Submissions, Validation, Pharmaceutical Industry, LIMS, Technology Transfer, GLP, V&V, Regulatory Requirements, Lifesciences
Education
University of Massachusetts, Amherst 1999 — 2003
Bachelor's degree, Japanese Language and Literature
Aastrom Biosciences August 2010 - Present
Dr. Brian Love's Research Group October 2009 - August 2010
Ugo's C-Store - University of Michigan Unions July 2008 - August 2010
Skills
Biotechnology, Technology Transfer, R&D, FDA, FMEA, Process Simulation, Cell Culture, Validation, Medical Devices, Design of Experiments, Materials Science, Chemistry, JMP, Microsoft Excel, Microsoft Office, Access, Stem Cells, Cellular Manufacturing, cGMP practices, cGMP manufacturing, Project Management, GMP, Manufacturing, Biomedical Engineering, Commercialization, Laboratory
Education
University of Michigan 2006 — 2010
B.S.E., Materials Science and Engineering
AlixPartners February 2007 - Present
Mercer August 2002 - February 2007
Mercer March 2001 - February 2002
Mercer April 2000 - March 2001
Aastrom Biosciences August 1997 - April 2000
Krug Life Sciences Inc & University Space Research Association July 1995 - May 1997
Skills
Customer Service, Microsoft Excel, Handle Confidential..., Business Objects, Elite Webview, Monthly Close, Teamwork, Accounts Receivable, Financial Analysis, Sarbanes-Oxley Act, Revenue Recognition, Project Estimation, Multi-currency..., Consulting Agreements, Written Communication, Verbal Communication, Time Management, Ad Hoc Reporting, Reporting & Analysis, Accounting, Professional Services, Hyperion HFM, Financial Audits, Continuous Improvement
Education
University of Michigan-Dearborn 1991 — 1995
BS, Environmental Science, Biology
BloodCenter of Wisconsin January 2009 - Present
BloodCenter of Wisconsin September 2007 - January 2009
GE Healthcare December 2006 - August 2007
Abbott Laboratories September 2006 - December 2006
Abbott Laboratories January 2005 - September 2006
Abbott Laboratories March 2002 - January 2005
Abbott Laboratories April 2000 - March 2002
Caltag Laboratories November 1998 - April 2000
Aastrom Biosciences July 1998 - November 1998
Karmanos Cancer Institute May 1994 - July 1998
Skills
ISO 13485, Validation, Root Cause Analysis, Process Monitoring, CAPA, V&V, FDA, Regulatory Affairs, Biotechnology, GMP, Medical Devices, Design Control, Quality System, Six Sigma, Change Control, Quality Assurance, Quality Management, Pharmaceutical Industry, Process Improvement, Sop, Value Stream Mapping, 21 CFR Part 11, Regulatory Requirements, Hardware Diagnostics, GLP, Cross-functional Team..., Operational Excellence, Clinical Trials, Continuous Improvement, Clinical Research, 21 CFR, FDA GMP, Healthcare, Quality Auditing, Lifesciences, ISO, Biopharmaceuticals, DMAIC, Laboratory, GxP, Manufacturing, Computer System..., Leadership, Management, Strategic Planning, Quality Control, Hospitals, Life Sciences
Education
University of Michigan-Dearborn 1996 — 1997
MBA (Incomplete), Economics
University of Detroit Mercy 1992 — 1996
BS, Biochemistry
Algal Scientific Corporation May 2012 - July 2013
Apolife, Inc. September 2011 - January 2012
Western Michigan University August 2009 - August 2011
Working Bugs LLC February 2008 - June 2009
Pfizer May 1999 - September 2007
Aastrom Biosciences January 1997 - November 1998
Skills
Fermentation, HPLC, GC, Cell Culture, Biotechnology, Purification, Protein Purification, Ethanol, Biofuels, Biomass, Column Chromatography, GC/MS, LC-MS, Microbiology, Fermentation Technology, Aseptic Technique
Education
University of Michigan 1997 — 1999
MS
Western Michigan University 1991 — 1995
BS
Washtenaw Community College
Washtenaw Community College
Washtenaw Community College
Washtenaw Community College
VWR International February 2011 - Present
Enzo Life Sciences International, Inc. August 2009 - February 2011
Assay Designs (an Enzo Life Sciences Company) August 2008 - August 2010
Ypsilanti Area Jaycees January 2008 - December 2009
Aastrom Biosciences June 2007 - May 2008
Pfizer Inc October 2001 - June 2007
Skills
Event Planning, Immunoassays, Volunteer Management, Tissue Culture, Biotechnology, Lifesciences, Pharmaceutical Industry, Molecular Biology, Cell Culture, Cell Biology, PCR, Biochemistry, Western Blotting, ELISA, GLP, Cell, R&D, FDA, Validation, Sop, Medical Devices, GMP, Quality Assurance, Biopharmaceuticals, Laboratory, Drug Discovery, Oncology, Immunology, Assay Development, Microbiology, Genomics, Chromatography, Infectious Diseases, Life Sciences
Education
University of Phoenix 2004 — 2006
Masters, Business Administration
Eastern Michigan University 1996 — 2001
Bachelors, Biochemistry/Communication
Boston Medical Center November 2013 - Present
MatriExtend Technologies, SP June 2009 - Present
Excelimmune, Inc. May 2012 - August 2013
Strategic Health Care, Inc. January 2011 - October 2012
Organogenesis, Inc. November 2006 - May 2009
Aastrom Biosciences 2003 - 2005
Brown University January 1993 - June 2003
ExoAssist, Inc January 1999 - January 2003
Skills
Biotechnology, Cell, Assay Development, Protein Chemistry, Clinical Trials, Clinical Development, FDA, Stem Cells, Regulatory Affairs, Biopharmaceuticals, Strategy, Tissue Engineering, Immunology, Lifesciences, Medical Devices, Life Sciences, Cell Culture, Clinical Research, Pharmaceutical Industry, Molecular Biology, Research, Technology Transfer
Education
Boston University 2007 — 2009
Certificate in PM, Project Management
Regis University 2003 — 2005
MBA, General
University of Pennsylvania 1980 — 1982
Post-doctoral Fellow- Reproductive Biology
Queen's University 1975 — 1980
PhD, Biochemistry
McGill University 1972 — 1975
B.Sc., Biochemistry
Virtusa August 2013 - Present
Trinity Health November 2012 - May 2013
Aastrom Biosciences September 2010 - July 2011
University of Michigan May 2006 - August 2010
University of Pittsburgh May 2002 - May 2005
Council of Scientific and Industrial Research June 2000 - May 2002
Skills
Data Analysis
Education
University of Madras 2001 — 2006
Doctor of Philosophy (Ph.D.), Biology
University of Madras 2000 — 2002
Master of Science (MS), Biology
University of Madras 1995 — 1998
Bachelor of Science (BS), Biochemistry
Pfizer March 2014 - Present
Covance August 2010 - March 2014
Covance August 2008 - August 2010
Aastrom Biosciences 2005 - 2008
Pfizer November 2001 - October 2005
Pfizer November 2001 - March 2003
Terre Clinical Research Services November 2000 - November 2001
Hartford Research Group September 1999 - November 2000
Phoenix International Life Sciences December 1998 - September 1999
Skills
GCP, Clinical Development, Clinical Trials, Clinical Research, Biotechnology, Pharmaceuticals, Clinical Trial..., CRO, Phase I, Research Project..., Clinical Monitoring, Change Management, Patient Recruitment, Customer Relations, Protocol Development, ICH-GCP, Documentation, Pharmaceutical Industry, Software Documentation, Sop, CTMS, Data Management, Protocol
Education
Project Management Institute 2009 — 2009
CPM, Project Management
Ohio University 1991 — 1994
Bachelor of Arts (B.A.), Psychology
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
National Institutes of Health October 2010 - Present
SoloHill Engineering October 2008 - June 2010
Aastrom Biosciences September 1996 - May 2008
University of Pittsburgh September 1993 - September 1996
Skills
Stem Cells, Cell Culture, Cell, Biotechnology, Cell Biology, Clinical Development, Science, Life Sciences, Lifesciences, In Vitro, Protein Expression, Molecular Biology, Protein Chemistry, Medical Devices, Research, GLP, GMP, Tissue Culture
Education
Northwestern University 1986 — 1991
Ph.D., Cell Biology
University of Illinois at Urbana-Champaign 1982 — 1986
B.S., Biology
Capricor Therapeutics, Inc. January 2012 - Present
Capricor, Inc. December 2010 - January 2012
Aastrom Biosciences March 2010 - November 2010
Aastrom Biosciences 2008 - 2010
Aastrom Biosciences 2006 - 2008
Aastrom Biosciences 2005 - 2006
Skills
Tissue Engineering, Cell Culture, GMP, FDA, Biotechnology, Stem Cells, Cell Biology, Clinical Development, Drug Development, Assay Development, Technology Transfer, Lifesciences, GLP, Biomedical Engineering, Immunology, Fluorescence Microscopy, PCR, Medical Devices, Drug Discovery, R&D, Bioprocessing, Regenerative Medicine, Cell, Molecular Biology, Biomaterials, ELISA, Biochemistry, Flow Cytometry, Cell Therapy, Western Blotting, Validation, Tissue Culture, Commercialization, Design Control, Microbiology, Biologics, CAPA, Sop, Biopharmaceuticals, Protein Purification, Clinical Trials, IND, Mammalian Cell Culture, Purification, High Throughput..., Vaccines, Life Sciences
Education
Virginia Polytechnic Institute and State University 2000 — 2005
PhD, Chemical Engineering
Arizona State University 1996 — 2000
BSE, Biomedical Engineering
PCT, a Caladrius company February 2014 - Present
Progenitor Cell Therapy June 2013 - January 2014
Aastrom Biosciences 2006 - 2013
Aastrom Biosciences 2000 - 2006
Aastrom Biosciences 1993 - 2000
Charles River Laboratories 1987 - 1993
Corning Incorporated 1979 - 1986
Skills
Product Development, Regulatory Submissions, Regulatory Requirements, Mammalian Cell Culture, Process Control, Aseptic Processing, Process Automation, Cell Therapy, Embedded Systems, Fluidics, Sterility Assurance, Strategic Planning, Budgets, Subcontractor..., Functional Requirements, System Requirements, Requirements Management, Software Requirements, Disposables, Manufacturing..., Design for Manufacturing, Bioreactor, Medical Devices, Stem Cells, FDA, ISO 13485, Technology Transfer, GMP, Validation, Regenerative Medicine, Biomedical Engineering, Tissue Culture, FMEA, Design Control, Start-ups, R&D, Biotechnology, Cell Biology, Biopharmaceuticals, Cell, Process Simulation, Pharmaceutical Industry, Biomaterials, Quality System, CAPA, Cross-functional Team..., Commercialization, Project Management
Education
Cornell University 1978 — 1979
Master of Engineering (M.Eng.)
Cornell University 1974 — 1978
Bachelor of Science (B.S.), Electrical Engineering, 3.75
Liberty Tax Service Norwood January 2012 - Present
Middle Management, Limited July 2008 - January 2013
Aastrom Biosciences March 2006 - May 2008
Skills
Cross-functional Team..., Biotechnology, Data Analysis, Process Improvement, Pharmaceutical Industry, Medical Devices, Strategic Planning, Project Management, Business Strategy, Lifesciences, Validation, Microsoft Office, Product Development, Program Management, Microsoft Excel, Manufacturing, Quality Assurance, Forecasting, Customer Service, Microsoft Word, Competitive Analysis
Education
Walsh College of Accountancy and Business Administration 2000 — 2002
University of Michigan-Flint 1997 — 2000
Bachelor of Business Administration (B.B.A.), Accounting
Aastrom Biosciences September 2008 - Present
Pfizer April 1999 - August 2007
Education
Eastern Michigan University
BSN, nursing
Aastrom Biosciences June 2014 - Present
Vericel Corporation 1996 - 2015
Vericel Corporation 1996 - 2015
Genzyme Biosurgery March 1996 - May 2014
AVANT Immunotherapeutics 1992 - 1995
bioMerieux 1987 - 1992
Kraft General Foods 1979 - 1987
Skills
Biotechnology, GMP, Aseptic Processing, FDA, Sop, Quality Control, CAPA, Change Control, LIMS, Validation, Microbiology, Biopharmaceuticals, GLP, 21 CFR Part 11
Education
State University of New York College at Geneseo 1977 — 1979
Bachelor's degree, Biology, General
State University of New York College of Agriculture and Technology at Morrisville 1974 — 1976
Associate of Science (A.S.), Natural Resources/Conservation, General
Essen BioScience February 2011 - Present
Aastrom Biosciences 2009 - March 2011
Pfizer Global Research and Development 1997 - 2007
Skills
Drug Discovery, Cell Biology, Assay Development, High Throughput..., Cell Culture, In Vitro, Biochemistry, ELISA, Lifesciences, Biotechnology, Cell, Molecular Biology, Sop, GMP, Pharmacology, Western Blotting, Laboratory Automation, Life Sciences
Education
University of Michigan 1992 — 1996
Bachelor of Science (B.S.), Cellular & Molecular Biology
Aastrom Biosciences August 2007 - Present
Education
Eastern Michigan University
Aastrom Biosciences August 2009 - April 2013
Kforce July 2008 - August 2009
PGRD-Pfizer Global R & D 2002 - June 2006
PGRD 1998 - 2002
Parke-Davis 1998 - 1999
Skills
Clinical Trials, Biotechnology, Clinical Research, Clinical Development, Clinical Data Management, GCP, Oncology, CTMS, Medical Devices, Clinical Study Design, Pharmaceutics, Regulatory Affairs, Clinical Monitoring, Drug Development
Education
Eastern Michigan University
BSN, Nursing
Eastern Michigan University
BS, Health Care Administration
Terumo Cardiovascular Systems October 2014 - Present
Terumo Cardiovascular Systems April 2013 - September 2014
Aastrom Biosciences April 2012 - April 2013
Terumo Cardiovascular Systems March 2008 - April 2012
Terumo Cardiovascular Systems March 2005 - 2008
Unisys March 2000 - March 2005
Packard Bell NEC 1997 - 1998
Skills
Medical Devices, Quality System, Cross-functional Team..., FDA, Manufacturing, Supply Management, Product Development, Continuous Improvement, Strategic Sourcing, Lean Manufacturing, Process Improvement, ISO 13485, Root Cause Analysis, Sourcing, Supply Chain Management, Design Control, Quality Assurance, FMEA, Validation, Purchasing
Education
New Mexico State University 1989 — 1992
Bachelor, Production and Operations Management
Oslo and Akershus University College 1983 — 1985
Associate's, Math & Physics
Ventana Medical Systems October 2013 - Present
Ventana Medical Systems April 2012 - Present
Ventana Medical Systems June 2010 - April 2012
Roche Tissue Diagnostics at F. Hoffmann-La Roche AG, Roche Tissue Diagnostics 2008 - April 2012
Ventana Medical Systems April 2008 - 2010
Ventana Medical Systems June 2006 - April 2008
Aastrom Biosciences November 2005 - June 2006
University of Arizona 1998 - 2002
Skills
Molecular Biology, Biotechnology, Lifesciences, Oncology, Assay Development, Genomics, Drug Discovery, Immunoassays, Immunohistochemistry, FDA, Commercialization, Cross-functional Team..., Medical Devices, Biomarkers, Immunology, Infectious Diseases
Education
Northeastern University 1992 — 1997
Ph.D., Immunology/Biochemistry
Hylant April 2013 - Present
Aastrom Biosciences September 2010 - April 2013
University of Michigan April 2007 - August 2010
Skills
PowerPoint, Customer Service, Microsoft Office, Public Speaking, Microsoft Excel, Microsoft Word, Outlook, Process Improvement, Data Analysis, Research, Event Planning, Data Entry, Nonprofits, Technical Writing, Training, Event Management, Social Networking, Project Planning, Management, Photoshop, Human Resources, Fundraising, Marketing, Leadership, Teaching, Employee Relations, Public Relations, Budgets, Program Management
Education
Eastern Michigan University
Washtenaw Community College
Associate of Arts and Sciences (AAS)
Commissioning Agents, Inc May 2013 - Present
Aastrom Biosciences November 2010 - March 2013
Terumo Cardiovascular Systems January 2007 - October 2010
Pfizer Global Research and Development November 2002 - January 2007
Skills
Design Control, Medical Devices, Validation, FDA, CAPA, ISO 13485, ISO 14971, Quality System, R&D, Technology Transfer, Biomaterials, GMP, Biotechnology, FMEA, Tissue Engineering
Education
Wayne State University 2008 — 2009
Masters of Engineering, Biomedical/Medical Engineering
University of Michigan 1996 — 2000
Bachelor of Science, Chemistry
MMS Holdings Inc. June 2014 - Present
MMS Holdings Inc. July 2013 - May 2014
Aastrom Biosciences August 2011 - April 2013
LabCorp September 2008 - July 2011
University of Michigan Medical Center May 2000 - September 2008
Skills
Biotechnology, Lifesciences, Molecular Biology, Cell Culture, PCR, ELISA, Clinical Trials, Clinical Research, Microscopy, FDA, Assay Development, GMP, Pharmaceutical Industry, SOPs, Controlled Documents, Quality Investigations, Quality Auditing, Change Control, Technical Documentation, Document Review, Technology Transfer, Technical Writing, Manufacturing Operations, Sop, GLP, Quality Assurance, Microbiology, Laboratory, SOP, Life Sciences
Education
Madonna University 1999 — 2003
B.S., Biology
Gabriel Richard H.S.
DePuy Synthes May 2010 - Present
Synthes Biomaterials July 2006 - April 2010
Aastrom Biosciences May 2002 - June 2006
Siecor 1996 - 1998
Skills
Design of Experiments, Six Sigma, R&D, Medical Devices, V&V, Biomedical Engineering, Design Control, Labview, FDA, Biotechnology, ISO 13485, Project Management, CAPA, Commercialization, Product Launch, Technical Writing, Validation, Biomaterials, GMP, Quality System, ISO 14971, GLP, Cell Culture, Polymers, Cell, Orthopedic, Technology Transfer
Education
Clemson University 2000 — 2002
Master’s Degree, Bioengineering
Virginia Polytechnic Institute and State University 1995 — 2000
Bachelor’s Degree, Materials Science and Engineering
Aastrom Biosciences December 2013 - Present
Aastrom Biosciences August 2011 - Present
Three Birds Jewelry May 2010 - Present
Cayman Chemical January 2006 - July 2011
Michigan Biotechnology Institute International April 2000 - April 2002
BioPort Corporation August 1999 - February 2000
Skills
Molecular Biology, Assay Development, Protein Expression, ELISA, Cell Culture, Protein Purification, Cell Biology, Cell, Biochemistry, Lifesciences, Biotechnology, Chromatography, PCR, Western Blotting, Drug Discovery, Flow Cytometry, Assay Transfer, cGMP practices, Life Sciences, Stem Cells, Processes Development, cGMP manufacturing, cGCP, Cell Therapy, BMNCs, Validation, Clinical Research, Clinical Trials, Cell Based Assays, Molecular Cloning, Commercialization, Baculovirus, SDS PAGE, Coomassie, Dot Blot, AKTA FPLC, Yeast Expression
Education
Michigan State University 2002 — 2005
Bachelor's, Biochemistry & Biotechnology
Garden City Hospital April 2015 - Present
Vericel Corporation March 2014 - February 2015
Pall Corporation April 2011 - July 2013
Pall Corporation August 2009 - March 2011
Pall Corporation May 2008 - July 2009
Aastrom Biosciences March 2007 - May 2008
Pall Corporation October 1996 - March 2007
PepsiCo November 1995 - October 1996
Pall Corporation August 1993 - November 1995
Skills
Microbiology, FDA, Validation, CAPA, Lifesciences, GLP, GMP, Sop, Biotechnology, Molecular Biology, Quality Assurance, R&D, Technology Transfer, Biopharmaceuticals, Laboratory, Aseptic Technique, Immunoassays, V&V, Aseptic Processing, ISO 13485, Change Control, 21 CFR Part 11, Medical Devices
Education
Adrian College 1988 — 1992
Bachelor of Science, Biology
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
Thermo Fisher Scientific February 2014 - Present
Life Technologies February 2008 - February 2014
Opexa Therapeutics 2002 - 2008
Baylor College of Medicine 1997 - 2002
Beckman Coulter 1996 - 1997
Aastrom Biosciences 1993 - 1994
Skills
Biotechnology, Technology Transfer, Biopharmaceuticals, Cell Culture, Lifesciences, Vaccines, Commercialization, Stem Cells, Molecular Biology, FDA, Microbiology, Cell Biology, Immunology, Pharmaceutical Industry, Cell, Assay Development, Flow Cytometry
Education
Texas A&M University - Mays Business School 2007 — 2009
MBA
Texas Tech University 1988 — 1992
BS, Microbiology
ATCC September 2008 - Present
Aastrom Biosciences 2005 - 2008
Skills
Stem Cells, Cell, Protein Engineering, Cell Biology, Assay Development, DNA, Biotechnology, Cell Culture, ELISA, Tissue Culture, Molecular Biology, Life Sciences, Flow Cytometry, Drug Discovery, Lifesciences, Transfection
Education
CAU/BAU
CAU/BAU
CAU/BAU
CAU/BAU
Penn State University
TPS Pharmaceutical Consulting 2007 - Present
Aastrom Biosciences August 2010 - July 2012
PAREXEL International September 2009 - April 2010
Metabasis Therapeutics 2007 - 2009
metabasis therapeutics 2007 - 2009
Pfizer 2003 - 2007
Pfizer 2002 - 2003
Parke Davis 1998 - 2002
Skills
Pharmaceutical Industry, Clinical Development, GCP, Statistics, Oncology, CRO, Biotechnology, GMP, Clinical Trials, Drug Development, FDA, Clinical Research, Data Quality, Data Review
Education
The Ohio State University 1991 — 1997
PhD, Statistics
West Virginia University 1987 — 1991
BS, Math
Aastrom Biosciences December 2010 - Present
Pall Corporation September 2003 - February 2010
Picometrix, Inc December 2000 - August 2003
Instrumentation Laboratory March 1995 - September 2000
Federal-Mogul March 1993 - March 1995
Midwest Microwave January 1991 - March 1993
Transidyne General January 1987 - November 1990
Education
Eastern Michigan University 1993 — 1995
Master of Business Administration, Strategic Quality Leadership
Eastern Michigan University 1986 — 1988
Bachelor, Business Administration Management major
Loras College 1983 — 1985
Undergrad Work, Business Management
EnvisionTEC, Inc. September 2013 - Present
Aastrom Biosciences October 2011 - August 2013
Aastrom Biosciences July 2010 - October 2011
PricewaterhouseCoopers August 2000 - July 2010
Education
Michigan State University 1996 — 2000
BA, Accounting
Terumo Cardiovascular Systems October 2014 - Present
Terumo Cardiovascular Systems January 2014 - October 2014
Aastrom Biosciences May 2011 - January 2014
Skills
Chemical Engineering, Aspen Plus, Process Simulation
Education
University of Michigan 2010 — 2011
Masters of Engineering, Pharmaceutical Engineering
University of Michigan 2006 — 2010
Bachelor of Science and Engineering, Chemical Engineering
WuXi AppTec July 2010 - Present
Charles River Laboratories/Surpass, Inc 2004 - 2010
St. Jude Medical 1999 - 2001
Aastrom Biosciences 1996 - 1999
Education
University of Minnesota-Twin Cities 1992 — 1995
PhD, Microbiology, Immunology and Cancer Biology
University of Minnesota-Twin Cities 1989 — 1992
MS, Nutrition
Augsburg College 1976 — 1980
BS, Medical Technology
Aastrom Biosciences June 2011 - Present
Sun Pharmaceutical Industries Ltd July 2010 - June 2011
Skills
GMP, Biotechnology, CAPA, Sop, FDA
Education
Adrian College 2006 — 2010
Bachelor of Arts, Chemistry, Biology
Life Science Investment Bank Executive 2010 - Present
Auxol Capital, LLC 2010 - Present
TyraTech, Inc. January 2007 - January 2010
Aastrom Biosciences 1991 - 2006
Sanford Burnham Research Institute 1987 - 1991
Education
Medical College of Virginia 1978 — 1981
Doctor of Philosophy (PhD), Pharmacology and Toxicology
University of Richmond 1973 — 1997
Bachelor of Arts (B.A.), Chemistry
Terumo Cardiovascular Systems July 2013 - Present
Domino's Farms Fitness Center November 2009 - Present
Team Beachbody November 2008 - Present
Enzo Life Sciences International, Inc. August 2012 - July 2013
Enzo Life Sciences International, Inc. June 2011 - August 2012
Enzo Life Sciences International, Inc. August 2010 - June 2011
Arbor Fit Club April 2010 - April 2011
Aastrom Biosciences 2001 - 2010
Skills
Biotechnology, Cross-functional Team..., Lifesciences, Inventory Management, GMP, Strategic Planning, Process Improvement, Operations Management, Logistics, Procurement, Supply Chain, Sales Management, Supply Chain Management, Microsoft Excel, Sop, Negotiation, Forecasting, Microsoft Office, Product Management, Purchasing, Budgets, Project Management, FDA, Continuous Improvement, Manufacturing, Leadership
Education
Eastern Michigan University 2008 — 2012
Bachelor of Business Administration (B.B.A.), Supply Chain Management
The Bottle Crew May 2014 - Present
Aastrom Biosciences December 2011 - May 2014
PwC January 2003 - December 2011
Skills
Sarbanes-Oxley Act, Auditing, SEC filings, US GAAP, CPA, Internal Controls, Accounting, Financial Reporting, GAAP, Big 4, Technical Accounting..., External Audit, Finance, SEC Filings
Education
Clemson University - College of Business and Behavioral Science 1998 — 2002
Accounting
The Ohio State University
Executive Business Management
Philips Healthcare May 2011 - Present
Baxter Healthcare June 2006 - May 2011
ITC September 2002 - June 2006
Aastrom Biosciences November 1997 - September 2002
Sanofi Diagnostics Pastuer May 1994 - November 1997
Baxter Anesthesia Division June 1992 - May 1994
Skills
Six Sigma, CQA, ASQ, CAPA, CQE, Continuous Improvement, Cross-functional Team..., Design Control, FDA, ISO, ISO 13485, Manufacturing, Medical Devices, Process Improvement, Quality Assurance, Quality System, V, Validation, DMAIC
Education
Rice University
BS, EE
Southern Methodist University
MS, Engineering Management / Operations Research
University of Texas at Dallas - Naveen Jindal School of Management
MBA, Accounting
Aastrom Biosciences June 2014 - Present
Genzyme Biosurgery July 1993 - May 2014
MGH Institute of Health Professions 1991 - 1993
MGH Institute of Health Professions 1991 - 1993
Mass General Hospital 1987 - 1993
Skills
Lifesciences, GLP, Validation, Microbiology, FDA, Vaccines, Assay Development, SDS-PAGE, Protein Purification, Protein Chemistry, Immunoassays, Aseptic Processing, R&D, Tissue Culture, Cell Culture, GMP, Process Improvement, PCR, Change Control, Cellular Assays, Cellular Analysis, Dendritic Cells, PBMC isolation, Cell Counting, Cell Viability Assays, Primary Cell Isolation, Cell Cycle Analysis, Small Animal Models, real-time PCR, Thermocycler, Life Sciences
Education
Framingham State College 1983 — 1986
Bachelor of Science (BS), Biomedical Sciences, General
Simmons College 1981 — 1983
LSNE Contract Manufacturing April 2015 - Present
Aastrom Biosciences June 2014 - April 2015
Genzyme Biosurgery October 2011 - April 2015
Pfizer June 2002 - August 2011
Pfizer May 2001 - April 2002
University of New Hampshire August 1999 - May 2001
Skills
Process Improvement, Design Control, Process Control, Project Management, Risk Assessment, process developement, Cell Culture, Assay Development, Cell, Aseptic Technique, Gel Electrophoresis, Microbiology, qPCR, In Vitro, Mammalian Cell Culture, Molecular Biology, PCR, RT-PCR, Western Blotting, DNA, Laboratory, Protein Purification, Purification, Genomics, Biopharmaceuticals, real-time PCR, Southern Blot, Northern Blotting, Primer Design, Tissue Culture, Monoclonal Antibodies, GLP, GMP, Scientific Writing, DNA extraction, Technology Transfer, Plasmid Isolation, Restriction Digestion
Education
University of New Hampshire 1998 — 2002
Bachelor's, Cellular, Molecular and Developmental Biology
Salem High School 1994 — 1998
Terumo Cardiovascular Systems November 2010 - Present
Factotem, Inc 2005 - Present
Terumo Cardiovascular Systems April 2009 - November 2010
Aastrom Biosciences January 2004 - July 2005
Bauer Controls July 2000 - January 2004
Sarns/3M Healthcare January 1989 - July 2000
Ethicon Endo-Surgery January 1987 - December 1988
Skills
Medical Devices, Business Analysis, FDA, ISO 13485, Validation, Quality Assurance, Quality System, Product Development, Process Improvement, Testing, Engineering, Manufacturing, Analysis, Cross-functional Team...
Education
Northwestern University 2012 — 2015
Master of Science (MS), Predictive Analytics
University of Michigan 1982 — 1986
Bachelor of Science (BS), Materials Science Engineering
Home Based Independent Contractor; medical transcription November 2009 - Present
Pfizer April 2000 - June 2004
Pfizer September 1997 - April 2000
Aastrom Biosciences September 1994 - September 1997
Wayne State University November 1992 - September 1994
Education
Bowling Green State University 1990 — 1992
Master of Science (M.S.)
Hillsdale College 1986 — 1990
Bachelor of Science (B.S.), Biology and Psychology
Novo Nordisk November 2014 - Present
Aastrom Biosciences May 2012 - November 2014
Aastrom Biosciences July 2011 - May 2012
Aastrom Biosciences September 2010 - July 2011
The University of Toledo 2005 - 2010
Skills
Cell, Western Blotting, Cell Biology, Molecular Biology, ELISA, In Vitro, qPCR, RT-PCR, Cell Culture, Protein Purification, PCR, Microscopy, Immunology, Regenerative Medicine, Cardiovascular..., Cytokines, GLP, Transfection, Biochemistry, Biotechnology, Assay Development, Pharmacology, Pre-clinical Studies, GMP, Clinical Research, Potency, SoftMax Pro, Pharmaceutical Industry, Stem Cells, Tissue Culture, Immunohistochemistry, Fluorescence Microscopy
Education
University of Toledo 2005 — 2010
Doctor of Philosophy (Ph.D.), Biomedical sciences, Cardiovascular and Metabolic Diseases
Grand Valley State University 2001 — 2005
Bachelor of Science (B.S.), Biomedical sciences
MMS Holdings Inc. August 2013 - February 2014
Aastrom Biosciences February 2011 - August 2013
Scientific Consulting, Inc. 2009 - 2011
INC Research (Formerly Kendle International) 2007 - 2009
CDI Corporation (Consultant to Pfizer, Inc.) 2005 - 2007
CCE Consulting Services, Inc. 2003 - 2005
Pfizer 2002 - 2003
Pfizer 1999 - 2002
Pfizer (Formerly Warner Lambert/Parke-Davis) 1995 - 1999
Pfizer (Formerly Warner Lambert/Parke-Davis) 1989 - 1995
Skills
CTMS, GCP, Clinical Monitoring, Oncology, Technology Transfer, Validation, Lifesciences
Education
Eastern Michigan University 1984 — 1989
Bachelor of Science (BS), Health/Health Care Administration/Management
Amgen September 2014 - February 2015
Aastrom Biosciences October 2013 - September 2014
Genzyme Biosurgery May 2013 - September 2013
Cell Signaling Technology December 2012 - March 2013
Charles River Laboratories October 2012 - November 2012
Skills
Cell Culture, Microsoft Office, TrackWise, SOP, Biotechnology, CRM, Public Speaking, Management, Organic Chemistry, cGMP manufacturing, Bilingual, Biology, Market Research, Public Relations, POE, cGMP practices, Technical Writing, GMP, Life Sciences, Quality Assurance, FDA, Pharmaceutical Industry, Laboratory, Biopharmaceuticals, CAPA
Education
University of North Carolina at Wilmington
Biology, Organic Chemistry, Polymer Chemistry
Universidad San Francisco de Quito
Bio-Chemistry, Zoology/Animal Physiology
Aastrom Biosciences June 2014 - Present
Genzyme sanofi July 2013 - June 2014
Education
UMass Boston 2011 — 2013
Bachelor of Science (B.S.), Exercise and Health Science
Aastrom Biosciences June 1999 - Present
Skills
Medical Devices
Education
University of Houston 1984 — 1987
Bachelor of Science (BS), Accounting and Finance
Aastrom Biosciences April 2014 - Present
UBCR LLC October 2012 - April 2014
UBCR January 2009 - October 2012
UBCR May 2007 - January 2009
Skills
Accounts Payable, Accounts Receivable, Accounting, Financial Accounting, ADP Payroll, Payroll, Transportation Safety, Human Resources, Fixed Asset Depreciation, Depreciation, Month End Close, Bank Reconciliation, Balance Sheet, Income Statement, Budget Monitoring, Planning Budgeting &...
Education
Michigan State University 2002 — 2006
Bachelor of Arts (B.A.), Accounting and Finance
Aastrom Biosciences 2013 - 2013
Aastrom Biosciences 2011 - 2013
Aastrom Biosciences 2009 - 2011
Aastrom Biosciences 2007 - 2009
Aastrom Biosciences 2006 - 2007
Aastrom Biosciences 2001 - 2006
Skills
Project Management, Change Management, Technology Transfer, Training, Instructional Design, Internal Communications, Organizational..., Lean Manufacturing, Operational Excellence, FDA GMP, ICH guidelines, Quality System, Quality by Design, Root Cause Analysis, Workflow Management, Value Stream Mapping
Education
University of Michigan
Bachelor's Degree