Experience
FDA  July 2015 - Present
Wellstat Diagnostics  June 2007 - January 2015
BioVeris Corporation  February 2004 - June 2007
Igen International, Inc.   November 1986 - February 2004

Skills
Research and Analysis, In-vitro Diagnostic..., Product Development, Technical Writing, Quality Systems, Medical Devices, CLIA regulations, Immunoassays, Assay Development, Biotechnology, Regulatory Affairs, FDA submissions, R&D, Electrochemistry, Validation, Electrochemiluminescence, Surface Chemistry, Analytics, Fluid Dynamics, Life Sciences, Process Engineering, Filtration, Sensors, Materials, Design of Experiments, Statistics

Education
The University of Texas at Austin   1982 — 1986
Doctor of Philosophy (Ph.D.), Chemistry

University of Wyoming   1976 — 1980
Bachelor's Degree, Chemistry

Experience
Meso Scale Discovery  May 2008 - Present
Eyemaginations  2006 - 2007
MediTech Media  June 2004 - June 2005
Igen International Inc   August 2002 - August 2003
Careywood Design   February 2001 - March 2002
Aston Entertainment   August 1999 - July 2001

Skills
Animation, 3D, Computer Animation, Character Animation, Maya, 3D Studio Max, Illustration, Compositing, Special Effects

Education
Full Sail University   1997 — 1999
Associate of Science (A.S.), Digital Communication and Media/Multimedia

Indian River State College

Experience
U.S. Pharmacopeia   August 2015 - Present
U.S. Pharmacopeia   March 2010 - August 2015
Maura Kibbey, Ph.D., Sole Proprietorship   July 2007 - December 2009
Poolesville High School Educational Foundation   December 2008 - August 2009
BioVeris Corporation  July 2005 - June 2007
Self-employed  2003 - 2005
IGEN International Inc   1995 - 2003
NIH- National Inst. Dental Research   1989 - 1995

Skills
Cross-functional Team..., Biotechnology, Drug Development, Lifesciences, Assay Development, Product Development, Leadership, Project Management, Drug Discovery, Program Management, Marketing, Training, Pharmaceutical Industry, FDA, CRO, Technology Transfer, Life Sciences

Education
Albany Medical College   1985 — 1990
Ph.D.

University at Albany, SUNY   1982 — 1983
B.S.

University of Rochester   1980 — 1982

Experience
The JBG Companies  May 2003 - Present
IGEN International, Inc.   March 2000 - May 2003

Skills
Real Estate, Real Estate Development, Event Planning, Office Management, Executive..., Investment Properties, Commercial Real Estate, Project Coordination, Outlook, Microsoft Excel, Organization &..., Administrative..., Herding Cats, Administrative..., Microsoft Office

Education
The University of Texas at San Antonio

Experience
Meso Scale Discovery  2004 - Present
IGEN International, Inc.   1986 - 2003
Celltech Group plc   1983 - 1986

Skills
Antibodies, Biotechnology, Intellectual Property, Immunoassays, Lifesciences, Molecular Biology, Validation, R&D, Cancer, Protein Chemistry, Biomarkers, Technology Transfer, Assay Development, Biochemistry, Immunology, Proteomics, Pharmaceutical Industry, Drug Discovery, Genomics, DNA, recombinant DNA..., ELISA, Biopharmaceuticals, Hardware Diagnostics, Purification, Monoclonal Antibodies, Cell, Life Sciences, PCR, Medical Devices, Commercialization, Cell Culture, Oncology

Education
King's College London   1979 — 1983
PhD, Biochemistry

University of Surrey   1975 — 1979
BSc 1st Class, Biochemistry

Experience
Cummins Consulting Services   January 2013 - May 2013
CSC  October 2005 - July 2012
LEADS Corporation  June 1997 - October 2005
IGEN International, Inc  1995 - 1997
Hekimian Laboratories   1989 - 1995
Computer Entry Systems   1983 - 1989
Jeffrey Shy and Associates   1982 - 1983

Skills
PMP, Project Planning, SDLC, MS Project, IT Service Management, Project Implementation, Earned Value Management, Project Management, Project Management Tools, Workflow, Communication Processes, Quality Management, Technical Resource..., Risk Management, Federal Projects, Federal Government..., Federal Program..., Proposal Writing, Cost-containment, Problem Management, Technology Change..., Large Scale Change..., Budgets, Budget Monitoring, Budget Proposals, Budget Constraints, Outstanding..., Interpersonal Skill, Project Turn-around, IT Project & Program..., Turnaround Strategy, ITIL Certified, Service Delivery, Program Management, PMO, Resource Management, Service Management, Requirements Analysis, Project Management..., Contingency Planning, Cross-Functional Teams, Management, Business Process..., Leadership, ITIL, Enterprise Architecture, IT Management, IT Strategy, IT Operations, Cross-functional Team...

Education
University of Maryland College Park   1989 — 1992
MBA, Business

The College of William and Mary   1978 — 1982
BS, Computer Science/Math

Experience
Wellstat Diagnostics  August 2007 - January 2015
BioVeris Corporation  February 2004 - June 2007
Igen International, Inc.   March 2001 - February 2004
ElectroCorr Consulting   March 1995 - June 2001
Upscale Water Company   1995 - 1999
Telectronics Pacing Systems  1984 - 1995

Skills
Technology Transfer, Team Building, Electrochemistry, Statistics, Data Analysis, Systems Integration, Integration, Cross-functional..., Materials Science, Sensors, Tenacious Work Ethic, Microsoft Office, Problem Solving, Patents, Publications, Device Design, Test Methodologies, Scientist, Technology, Analytical, Planning, Scheduling, Budgets, Electrochemical..., Electrochemical..., Electrodeposition, Biosensors, Analysis, New Business Development, Business Planning, Microsoft Excel, Entrepreneurship, Cross-functional Team..., Process Improvement, Program Management, Team Leadership, Management, Microsoft Word, Networking, Outlook, PowerPoint, Project Planning, Leadership, Medical Devices, Project Management, R&D, Biotechnology, Engineering, Life Sciences, Product Development

Education
Eindhoven University of Technology, Eindhoven, the Netherlands
Master of Science (MSc), Electrochemical Engineering

Experience
NantOmics LLC   August 2014 - Present
Fisher BioServices, part of Thermo Fisher Scientific   March 2009 - July 2014
KPL Inc   May 2005 - March 2009
World Wildlife Fund  January 2004 - April 2005
IGEN International Inc   October 1997 - January 2004
IGEN International Inc   September 1996 - October 1997
IGEN International Inc   October 1994 - September 1996
Bell Atlantic Meridian Systems  January 1993 - October 1994
FerriShield, Inc.   October 1989 - January 1993

Skills
Process Improvement, Logistics, Data Analysis, Client Retention, Negotiation, Client Relationship..., Team Building, Staff Development, CRM, Customer Service, Coaching, Lifesciences, Biotechnology, Management, Molecular Biology, Technology Transfer, Validation, Budgets, Commercialization, Cross-functional Team..., New Business Development, Strategic Partnerships, FDA, Pharmaceutical Industry, Training, Medical Devices, Sop, GLP, Life Sciences

Education
University of Maryland University College

Experience
Viavi Solutions  August 2015 - Present
JDSU  February 2008 - July 2015
SAIC Defense Solutions Group   May 2006 - February 2008
BioVeris Corporation  January 2004 - March 2006
IGEN International, Inc.   September 2001 - December 2004
Acterna formally TTC   February 1987 - August 2001
TTC  February 1987 - August 2001
Acterna  1987 - 2001
Vitro Corporation  May 1986 - February 1987
MaCom  September 1983 - May 1986

Skills
Microsoft Office, Visio, Solidworks, AutoCAD, CAD, Adobe Illustrator, Microsoft Project, Pro-Engineer, SDRC I-DEAS, Corel Draw, Windchill, Sheet Metal, Product Design, Solid Modeling, Injection Molding, Pro Engineer, MS Project, Illustrator, Orcad, AutoCAD Mechanical, Electro-mechanical, Manufacturing, Bill of Materials, Electronics, Tolerance Analysis, PCB design, Systems Engineering, Lean Manufacturing, Assemblies, Engineering, Machining, Plastics, Product Lifecycle..., GD&T, Mechanical Engineering, Schematic Capture, Engineering Management, Design for Manufacturing, Product Development, Rapid Prototyping, Manufacturing..., Test Equipment, Electronics Packaging

Education
Montgomery College   1983 — 1991
AA, Electro-Mechanical Drafting and Design

Damascus High School   1980 — 1983
General, Mechanical design and Drafting

Experience
CalAmp Corp.  March 2013 - Present
Wireless Matrix  March 2012 - March 2013
MITRE Corporation  May 2004 - March 2012
IGEN International Inc.  February 2001 - May 2004
Lifeminders  1997 - 2000
Fantasy Sports Properties   1997 - 1999
Alta Software   1997 - 1998
Cigital  1997 - 1998
Systex  1991 - 1993

Skills
Software Development, Agile Methodologies, Java, Software Engineering, System Architecture, XML, Python, Cross-functional Team..., Enterprise Architecture, Java Enterprise Edition, Enterprise Software, REST, Software Project..., Integration, SOA, Team Leadership, Architecture, MySQL, Software Design, Project Management, Team Management, Requirements Analysis, Scalability, Distributed Systems, Team Building, Simulations, Databases, Cloud Computing, Linux, .NET, Architectures

Education
Johns Hopkins University   1993 — 1998
M.S., Computer Science

Rensselaer Polytechnic Institute   1985 — 1989
B.S., Computer Science

Eastside High School

Experience
Primatics Financial, LLC   October 2006 - Present
Meso Scale Diagnostics, LLC  January 2004 - October 2006
IGEN International, Inc.   June 2001 - January 2004
zGraffiti, Inc.   January 2000 - June 2001
SRA International  June 1995 - January 2000

Skills
Spring, Hibernate, Ant, SOA, Java Enterprise Edition, Tomcat, Web Services, Software Development, Agile Methodologies, UML, Java, SQL, Software Project..., Struts, XML, JBoss Application Server, Integration

Education
Virginia Polytechnic Institute and State University   1995 — 1997
MS, Computer Science

Rensselaer Polytechnic Institute   1990 — 1994
BS, Computer and Software Engineering

Experience
United states patent and tradmark office   July 2012 - Present
United States Patent and Trademark Office  November 2007 - June 2012
BioVeris Corp.   January 2007 - June 2007
BioVeris Corporation  January 2005 - December 2006
BioVeris Corporation  August 2003 - December 2004
IGEN International  2001 - 2003
IGEN International Inc   August 1996 - July 2001
Microbiological Associates (BioReliance)   March 1994 - July 1996

Skills
Assay Development, Lifesciences, PCR, Molecular Biology, Validation, DNA, Organic Chemistry, Sop, Medicinal Chemistry, Pharmacology, Quality Assurance, Biotechnology, Technology Transfer, Biochemistry, Patents, Cell, Drug Discovery, Life Sciences

Education
University of Mississippi Medical Center   1992 — 1994
MS, Pharmacology and Toxicology

Bangalore University   1987 — 1989
MS, Medicinal Chemistry

Experience
Consumer Financial Protection Bureau  August 2014 - Present
DC Living Real Estate, LLC   October 2004 - Present
Bureau of Indian Affairs  August 2005 - August 2014
GovLoop  2014 - 2014
GovLoop  2014 - 2014
Aspen Systems  October 2000 - August 2005
IGEN International Inc   August 1998 - October 2000

Skills
Business Analysis, Web Design, Federal Government, Project Management, Program Management, Strategic Planning, FISMA, Communication, IT Strategy, Information Architecture, Strategic Communications, HTML, Weblogic, Leadership, Government, Software Project..., Usability, Marketing Communications, Oracle Applications, JavaScript, Information Assurance, User Interface Design, Management, Internal Communications, Video Editing, Web Development, CSS, Solution Architecture, Web Logic, Business Strategy, Training Delivery, Teacher Training, Hands-on Training, User Experience, User-centered Design, Commercials, Video Production, HD Video, Flash Animation, 3D Studio Max, 3D Modeling, Java, Creative Direction, Art Direction, iPad, Android Development, Solutions Marketing, Solution Development, Technology Solutions, Google Apps

Education
National Defense University (AMP 41)   2010 — 2010
CIO Certificate, Information Technology Management and Leadership

Georgetown University   2001 — 2004
Master of Arts (M.A.), Communication, Culture and Technology

Stanford University   1993 — 1998
BS, Symbolic Systems

Experience
Clym Environmental Services, LLC   December 2001 - Present
Life Technologies  1999 - 2001
BioVeris Corporation  1995 - 1999
IGEN International Inc   1994 - 1999
Genetic Therapy, Inc.   1988 - 1994

Skills
Environmental..., Environmental Awareness, Program Management, Biotechnology, Inspection, Management, Waste Management, Chemistry, Compliance, Training, Hazardous Materials, EHS, PCR, Environmental Consulting, Recycling, Safety Training, GMP, DNA extraction, Waste, Sop, Lifesciences, Workplace Safety, Analytical Chemistry, Biopharmaceuticals, Purification, GLP, Vaccines, Life Sciences

Education
University of Maryland Baltimore County   1986 — 1988
Master of Science (MS), Applied Molecular Biology

Frostburg State University   1978 — 1982
Bachelor of Science (BS), Biology

Experience
NeStar-1, Inc.   January 2008 - Present
Communication Technologies  September 2006 - August 2007
WebMethods, Inc.   January 2000 - September 2002
Net2000, Inc.   June 1998 - October 2001
webMethods, Inc. (acquired by Software AG)   1999 - 2001
Net2000 Communications  1998 - 2001
IGEN International Inc   1995 - 1997

Education
Ball State University   1967 — 1972
BS & MA, Education

Experience
Northrop Grumman Information Systems (NGIS) - Cyber Division   February 2015 - Present
Northrop Grumman Information Systems (NGIS) - Health Division   January 2014 - February 2015
KEYW Corporation  April 2013 - August 2013
Invertix Corporation (an Altamira Company)   March 2012 - April 2013
Northrop Grumman Aerospace Systems (NGAS)   September 2009 - November 2011
Northrop Grumman Space Technology (NGST)   April 2008 - September 2009
Northrop Grumman Mission Systems (NGMS)   September 2005 - April 2008
Dynamic Animation Systems  October 2004 - September 2005
SAIC  May 2002 - October 2004
IGEN International Inc.  May 2000 - May 2001

Skills
Amazon Web Services..., Splunk, Hadoop, Apache Spark, Accumulo, Ambari, Graph / NoSQL DB, Big Data, Dynamic Distributed..., pMatlab / MatlabMPI, Matlab / Octave, Natural Language..., Systems Engineering, Artificial Intelligence, Machine Learning, Software Design, UML, Analytics, Applied Mathematics, Operations Research, Computational..., Digital Signal..., Simulations, System Architecture, System Design, Algorithm Development, Distributed Systems, Information Retrieval, Integration, Java, SOA, Artificial Neural..., Ballistic Missile..., Cybernetics, Data Fusion, Digital Signal..., Mathematical Programming, Ontology Engineering, Defense, Decision Science, Geospatial Intelligence..., Imagery Intelligence..., Measurement and..., Optimal Control, Response Surface..., Scientific Programming, Signals Intelligence..., Surrogate Modeling, UML Unified Profile for...

Education
Muhlenberg College   1985 — 1989
Bachelor of Science (BSc) Mathematics, Bachelor of Science (BSc) Physics, Mathematics and Physics

Experience
K. Sprague Consulting LLC   January 2011 - Present
iba molecular  2008 - 2010
NIH - (PRSS/MIB/NIMH)   2005 - 2008
Nabi Biopharmaceuticals  2004 - 2005
BioVeris Corporation  2001 - 2004
IGEN International Inc   1998 - 2001

Skills
GMP, GLP, Validation, Quality Systems, Process Development, HPLC, cGMP, Analytical Chemistry, Chemistry, Technology Transfer, Documentation, Compliance, Research, CAPA, ISO, Quality Assurance, Purification, Science, In Vitro, Diagnostics, Auditing, Problem Solving, Microsoft Office, Chromatography, Biotechnology, FDA, Protein Chemistry, Manufacturing, Biochemistry, Life Sciences, Pharmaceuticals, SOP, Process Validation, IND, 21 CFR Part 11, UV-Vis, ISO 13485, LC-MS, IR, QC, Change Control, Biopharmaceuticals, GC/MS, Regulatory Affairs, Validations, UV, Mass Spectrometry, Immunoassays, Wet Chemistry, GxP

Education
Florida International University   1995 — 1997
MS, Chemistry

Woodlawn Program

Experience
YROC Inc.   July 2013 - Present
Jefferson County Homeschool Co-op, Shafer Academy   September 2002 - Present
Lonza  February 2012 - May 2012
IGEN International Inc.  December 1995 - August 2002
BioWhittaker Inc  March 1987 - November 1995

Skills
ELISA, Aseptic technique, Buffer Preparation, Kinetic assays, Mammalian cell culture, Developed immunoassays, Stability studies, In-vitro diagnostic..., Clinical studies, DNA isolation, DNA quantification, Cloning/PCR, RNA isolation, DNA electrophoresis, RNA electrophoresis, Protein isolation, BCA protein assay, Western blot, Antibody purification, Antibody labeling, Antigen Processing, Bacterial cell culture, Plant cell culture, Solution chemistry, Quality Control testing, BL3 experience, •Microsoft Office..., •cGLP, cGMP, ISO 9000..., •Design Expert, Aseptic Technique, Laboratory, Agarose Gel..., Western Blotting, Mammalian Cell Culture

Education
Hood College
M.S, Biomedical Science (Immunology)

Hood College
B.S, Food and Nutrition (Biochemistry)

Hagerstown Community College
Biotechnology Certificate