Wellstat Biologics
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Wellstat Biologics Employees
University of Maryland Greenebaum Cancer Center (UMGCC) June 2013 - Present
University of Maryland School of Medicine; Human Research Protections Office (HRPO) March 2011 - June 2013
Siemens Healthcare Diagnostics June 2010 - February 2011
Baxter Bioscience September 2005 - October 2009
George Washington University January 2004 - September 2005
VA Maryland Health Care System January 2003 - January 2004
Wellstat Biologics April 2000 - January 2003
Skills
GLP, Sop, GMP, Biotechnology, Vaccines, FDA, Regulatory Affairs, Purification, Lifesciences, Clinical Trials, Microbiology, SDS-PAGE, ELISA, Protein Purification, Cell Culture
Education
Johns Hopkins School of Medicine 2009 — 2010
Masters of Science, Regulatory Affairs
Morgan State University 1994 — 1999
Bachelors of Science, Biology
Vaxin Inc. January 2015 - Present
Vaxin Inc. November 2013 - December 2014
Wellstat Biologics April 2010 - November 2013
Wellstat Biologics January 2008 - April 2010
The Henry M. Jackson Foundation for the Advancement of Military Medicine January 2006 - January 2008
The Henry M. Jackson Foundation for the Advancement of Military Medicine July 2003 - January 2006
Skills
Assay Development, Molecular Biology, ELISA, Purification, SDS-PAGE, Biotechnology, Cell Culture, GLP, Virology, GMP, Cell Biology, Gel Electrophoresis, Immunology, Lifesciences, Vaccines, Tissue Culture, Protein Purification, Microbiology, Flow Cytometry, Immunoassays, Cell, Biochemistry, Life Sciences
Education
University of Maryland College Park 1999 — 2003
Bachelor of Science, General Biology
Medtronic April 2004 - Present
Wellstat Biologics April 2002 - September 2003
Skills
Medical Devices, Operating Room, Surgeons, New Business Development, Market Development, Capital Equipment
Education
The Johns Hopkins University 1997 — 2001
Bachelor's degree, Biology, General
Amplimmune, Inc. May 2015 - Present
Amplimmune, Inc. August 2008 - May 2015
Wellstat Biologics March 2001 - August 2008
Panacos Pharmaceuticals February 1999 - March 2001
Genetic Therapy, Inc. August 1996 - November 1998
Skills
ELISA, Assay Development, GMP, HPLC, Gel Electrophoresis, SOP authoring, Cell Culture, SDS-PAGE, Biotechnology, GLP, Cell, Western Blotting, Biopharmaceuticals, Immunology, Technology Transfer, SOP, Validation, Life Sciences, Molecular Biology, Monoclonal Antibodies, Analytical Chemistry, Cell Biology, Protein Chemistry
Education
Rochester Institute of Technology 1990 — 1994
BS, Biotechnology
Sanofi Pasteur July 2015 - Present
Novartis Vaccines 2013 - July 2015
GSK Vaccines 2011 - 2013
MedImmune 2008 - March 2011
Wellstat Biologics 2005 - 2008
Sanofi Pasteur (Aventis, RRI, CANVAC) 2001 - 2005
National Research Council - Biotechnology Research Institute 1997 - 2001
Skills
Vaccine Production, Cell Culture, Quality by Design, Biotechnology, Vaccines, Molecular Biology, Cell, Biochemical Engineering, Characterization, Monoclonal Antibodies, Biopharmaceuticals, GLP, Technology Transfer, GMP, Life Sciences, PCR, Drug Discovery, Cell Based Assays, Protein Expression, SDS-PAGE, Cell Biology, Virology, Transfection, In Vitro, Flow Cytometry, qPCR, SOP, Clinical Trials, FDA, R&D, Tissue Culture, Lifesciences, Pharmaceutical Industry, Assay Development, Managerial Skills
Education
Laval University (Biotechnology Research Institute) 1997 — 2001
PhD, Biochemical Engineering
Université Laval 1994 — 1997
MSc., Molecular Biology
University of Ottawa / Université d'Ottawa 1989 — 1992
BSc., Biochemistry (minor Biochemical Engineering)
WuXi AppTec June 2014 - Present
WuXi AppTec August 2012 - June 2014
Life Technologies April 2011 - July 2012
Epic States April 2009 - April 2011
Amgen May 2003 - June 2008
Wellstat Biologics March 2002 - April 2003
Kelly Services October 2000 - January 2002
Skills
Market Research, Data Analysis, Project Management, Process Simulation, Pharmaceutical Industry
Education
UCLA Anderson School of Management 2005 — 2008
MBA
Oklahoma State University 1998 — 2000
MS, Chemical Engineering
Mark W Thompson Biopharma Consulting 2014 - Present
MedImmune 2003 - 2013
Wellstat Biologics 2000 - 2003
DynCorp/Novavax 1998 - 2000
Natl Inst of Health 1991 - 1998
Community Practice 1981 - 1984
Skills
Vaccines, Biotechnology, Biopharmaceuticals, Monoclonal Antibodies, Immunology, Technology Transfer, Clinical Trials, Drug Development, Lifesciences, GMP, Virology, Purification, Validation, Infectious Diseases, Protein Purification, Assay Development, Pharmaceutical Industry, Protein Chemistry, Drug Discovery, Chromatography, GLP, Aseptic Technique, IND, Western Blotting, Life Sciences, Cell Culture, ELISA, Biochemistry, R&D, HPLC, In Vitro, Antibodies, Sop, FDA, Immunoassays, Molecular Biology, Cancer, Cell, SDS-PAGE, Aseptic Processing, Biomarkers, Clinical Development, Oncology, Flow Cytometry, Cell Biology, Microbiology
Education
Purdue University
BS Pharm, Pharmacy
The Ohio State University
PhD, Biochemistry
Independent Contractor May 2015 - Present
MedImmune January 2013 - October 2014
Mediatech, Inc Cellgro January 2011 - January 2013
Medimmune, Inc May 2009 - August 2010
TraumaCure, Inc February 2008 - April 2009
Wellstat Biologics November 2000 - August 2005
Skills
Technical Writing, GMP, Administrative Work, FDA, GLP, Sop, Biotechnology, Quality Assurance, Medical Devices, CAPA, Biopharmaceuticals, Pharmaceutical Industry, Validation, Regulatory Affairs, 21 CFR Part 11, Quality Auditing, Microbiology, Drug Development, Quality Control, SOP, Aseptic Processing, V&V, Technology Transfer
Education
University of Maryland College Park 1997 — 2000
Loreto Convent Valley Road, Nairobi 1990 — 1992
Kenya Certificate of Secondary Education, General Studies
Wellstat Biologics June 2008 - Present
Phyton Biotech November 2005 - June 2008
Curagen Co August 2004 - November 2005
Bristol-Myers Squibb Co December 2002 - August 2004
Human Genome Sciences, Inc September 2000 - December 2002
BD-Pharmingen Inc July 1998 - September 2000
Education
The Scripps Research Institute 1997 — 1998
Hoechst Postdoc Fellow, Protein Biochemistry
University of Delaware 1990 — 1996
Ph.D, Biochemistry
Shanghai Inst. of Pharmaceutical Industry 1986 — 1989
MS, Biochemistry
Fudan University 1980 — 1984
BS, Medicinal Chemistry
NIH December 2010 - Present
Wellstat Biologics June 2000 - December 2010
Nabi Biopharmaceuticals 1991 - June 2000
NABI 1991 - 2000
Skills
Facilities Management, cGMP, Word, Contract Negotiation, MS Project, IFMA CFM, GMU Certificate of..., Contract Management, GMP, Project Management, Microsoft Word
Education
George Mason University 2004 — 2006
None, Facilities Management
BD September 2012 - Present
BD January 2012 - September 2012
Shire Pharmaceuticals August 2003 - December 2011
Shire Pharmaceuticals September 2005 - July 2008
Shire Pharmaceuticals August 2003 - September 2005
Wellstat Biologics 2002 - 2003
Alpharma 1998 - 2002
Skills
LIMS, Microbiology, Quality Control, GLP, Cleaning Validation, FDA, 21 CFR Part 11, Pharmaceutical Industry, Change Control, Validation, Sop, Quality Assurance, Regulatory Affairs, HPLC, CAPA, Aseptic Processing, Software Documentation, GMP, USP, Regulatory Submissions, Technology Transfer, Biotechnology
Education
Salisbury University
Bachelor of Science (B.S.), Biology/Biological Sciences, General
CBER, FDA July 2008 - Present
Wellstat Biologics July 2006 - July 2008
Nabi Biopharmaceuticals 2003 - 2006
Palatin Technologies 2000 - 2003
ImClone Systems 1995 - 2000
Ortho Biotech 1981 - 1994
Skills
CAPA, cGMP, Biopharmaceuticals, FDA, Pharmaceuticals, Biotechnology, GMP, Quality Management, Change Control, Validation, GLP, Sop, Pharmaceutical Industry, Biologics, 21 CFR Part 11, Quality Assurance, Technology Transfer, Regulatory Affairs, Vaccines, Regulatory Requirements, V&V, Quality System, Regulatory Submissions, Drug Development, Clinical Trials, Clinical Development, Lifesciences, IND, Microbiology, ISO 13485, Analytical Chemistry, Life Sciences
Education
Seton Hall University 1980 — 1990
MS, Biology/Microbiology
QIAGEN Gaithersburg November 2009 - Present
QIAGEN Inc 2007 - Present
Wellstat Biologics January 2005 - November 2007
Education
University of Maryland University College
BS, Biology
United Therapeutics September 2012 - Present
QIAGEN October 2008 - September 2012
Wellstat Biologics July 2001 - October 2008
Life Technologies 1999 - 2001
Oncor, Inc 1990 - 1998
Digene Corporation 1985 - 1990
Skills
FDA, GMP, GLP, Biotechnology, Lifesciences, Biopharmaceuticals, Sop, Validation, CAPA, Technology Transfer, Quality Control, Quality Assurance, R&D, 21 CFR Part 11, LIMS, Change Control, Life Sciences, SOP
Education
University of Maryland Baltimore County 1980 — 1985
BA, Biochemistry
QIAGEN March 2014 - Present
QIAGEN April 2011 - March 2014
Wellstat Management Company June 2006 - April 2011
Wellstat Biologics 2006 - 2011
Skills
Microsoft Office, HTML, cGMP, Customer Service, Excel, Word, PowerPoint, Editing, English, Writing, Documentation, Access, Public Speaking, Problem Solving, Document Management, Administration, Brazilian Portuguese, Microsoft Word, MasterControl(TM), FDA, Software Documentation, GMP, Technical Writing, Sop, Microsoft Excel, GLP, Assay Development, Biopharmaceuticals, Change Control
Education
Montgomery College
Associate of Science (AS), Life Sciences
MedImmune December 2005 - Present
MedImmune March 2005 - December 2005
MedImmune August 2004 - March 2005
MedImmune November 2003 - August 2004
Osiris Therapeutics July 2001 - November 2003
ReSearch Pharmaceutical Services (Ostuka) July 1999 - July 2001
Guilford Pharmaceuticals April 1997 - April 1999
Wellstat Biologics June 1996 - April 1997
Otsuka America Pharmaceutical, Inc. February 1995 - June 1996
Skills
Biotechnology, Clinical Development, Clinical Trials, GCP, Vaccines, Biopharmaceuticals, CRO, Clinical Operations, Infectious Diseases, Sop, Drug Development, CTMS, Clinical Monitoring, ICH-GCP, Clinical Research, Oncology, Regulatory Submissions, IND, Therapeutic Areas
Education
The Johns Hopkins University 1996 — 2000
Master of Public Health, Clinical Investigation and Biostatistics
Loyola College in Maryland 1990 — 1994
BS, Biology
Minitab July 2014 - Present
Minitab January 2011 - June 2014
Minitab July 2007 - December 2010
Minitab August 2006 - July 2007
Restek Corporation October 2005 - July 2006
Wellstat Biologics October 2002 - September 2005
Wellstat Biologics July 2001 - October 2002
Life Technologies April 2000 - June 2001
Life Technologies April 1999 - April 2000
National Institutes of Health July 1997 - April 1999
Skills
SQL, Microsoft SQL Server, Databases, C#, T-SQL, Agile Methodologies, XML, .NET, Visual Studio, TFS, ASP.NET, Scrum, Software Development, ASP.NET MVC
Education
University of Maryland University College 2001 — 2006
BS, Computer and Information Technology
St. Mary's College of Maryland 1993 — 1997
BA, Biology
RAPID Laboratories Inc. June 2011 - Present
Wellstat Biologics February 2005 - December 2010
GEORGETOWN UNIVERSITY, SCHOOL OF MEDICINE, Washington, DC June 2004 - February 2005
NATIONAL CANCER INSTITUTE, Fort Detrick, Frederick, MD May 2001 - May 2004
Nationa Institute of Infectious and Parasitic diseases 1996 - 2001
Skills
Virology, Cell Culture, Assay Development, Molecular Biology, Cell, Lifesciences, ELISA, Cell Biology, Laboratory, Proteomics, Drug Discovery, Immunoassays, Cancer Research, Biotechnology, Clinical Development, Purification, SDS-PAGE, Tissue Culture, Immunology, Life Sciences
Education
National Institute of Infectious and Parasitic Diseases
Doctor of Philosophy (PhD), Virology
Sofia University St. Kliment Ohridski
B.S., Biology/Biological Sciences, General
Wellstat Diagnostics July 2011 - Present
Wellstat Biologics February 2006 - July 2011
Sanaria Inc June 2004 - February 2006
Calypte Biomedical August 2002 - June 2004
Skills
Biotechnology, GLP, Assay Development, GMP, Immunoassays, FDA, Validation, CAPA, Lifesciences, Biopharmaceuticals, Product Development, ISO 13485, Microbiology, Sop, Medical Devices, Quality System, Cell Culture, Pharmaceutical Industry, R&D, Aseptic Processing, Biochemistry, Technology Transfer, Virus Culture, PCR, Molecular Biology, Plaque Assay, ELISA, SDS-PAGE, nasba, hybridomas, DNA Extraction, DNA Sequencing, Western Blotting, Life Sciences, SOP
Education
Penn State University
Wayne State University
Cropperhoppers Stuff on Etsy.com January 2012 - Present
George Junior Republic July 2006 - January 2007
VisionQuest January 2004 - June 2005
Wellstat Biologics January 2001 - November 2003
Skills
Customer Service, Windows, Research, Outlook, Teaching, Strategic Planning, Negotiation, Editing, Team Building, Leadership, Fundraising, Event Planning, Social Media, Public Speaking, Blogging, Microsoft Office
Education
Indiana State University 1999 — 2001
Master's degree, Neuroscience
Slippery Rock University of Pennsylvania 1995 — 1999
Bachelor's degree, Psychology