Medarex Company
Industry: Biotech company
DescriptionMedarex was an American biopharmaceutical company based in Princeton, New Jersey, with manufacturing facilities in Bloomsbury and Annandale, New Jersey, and research facilities in Milpitas and Sunnyvale, California. In 2009, Medarex was purchased by Bristol Myers Squibb. Headquarters: Princeton, NJ Founder: Donald L. Drakeman Founded: 1987 Parent organization: Bristol-Myers Squibb Subsidiary: GenPharm International, Inc
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Medarex Employees
ERM: Environmental Resources Management July 2009 - Present
Laureate Pharma July 2007 - July 2009
Teva Pharmaceuticals January 2007 - July 2007
Medarex October 2005 - December 2006
Skills
Microbiology, Quality Assurance, Environmental Monitoring, Validation, GMP
Education
University of Alaska Anchorage 2012 — 2012
Fluid Mechanics/ Engineering
Temple University 2008 — 2010
Quality Assurance/ Regulatory Affairs
Ohio University 1999 — 2003
BS, Microbiology
AAIPharma Services Corp. April 2013 - Present
DPT Laboratories, August 2012 - April 2013
Dendreon April 2010 - January 2012
Medarex 2004 - April 2010
Medarex 2002 - 2004
Medarex 1999 - 2002
Medarex 1998 - 1999
Medarex 1996 - 1998
Medarex 1994 - 1996
Cytogen Corporation April 1991 - April 1994
Skills
Microbiology, Immunology, cGMP, GMP, LIMS, SOP, Cell Based Assays, QC, Aseptic Processing, Biotechnology, Pharmaceuticals, Life Sciences, Quality Systems, Aseptic Technique, Cell Culture, Pharmaceutical Industry, Sop, Lifesciences, Biologics, Cell, Quality Control, HPLC, FDA, Validation, ELISA, GLP, Vaccines, 21 CFR Part 11, Assay Development, Laboratory, Monoclonal Antibodies, Technology Transfer, GxP, CAPA, Quality Assurance, Quality System, Biopharmaceuticals, V&V, Chromatography, Purification, Antibodies, Protein Chemistry, Clinical Development, R&D, Clinical Trials, Gel Electrophoresis, DNA, Trackwise, Change Control
Education
University of Phoenix 2003 — 2005
MBA, HR management
Rutgers University-New Brunswick 1979 — 1982
B.S., Animal Science (Cook College)
Wagner College 1979 — 1981
M.S., Microbiology
Tottenville High School 1975 — 1978
HS, Academic
Kaplan IP Law, P.C. July 2011 - Present
Genencor January 2010 - July 2011
Medarex April 2007 - January 2010
Morrison & Foerster LLP 2003 - 2007
Fish & Neave July 1997 - May 2003
Skills
Patents, Patent Prosecution, Intellectual Property, Licensing, Patentability, Invention, Biotechnology, Start-ups, Registered Patent..., Patent Litigation, Biofuels, Prosecution, Due Diligence, Lifesciences, Pharmaceutical Industry, Patent Applications, Litigation, Molecular Biology, Biopharmaceuticals, Trade Secrets, Technology Transfer, Trademarks, Legal Opinions, Biochemistry, Joint Ventures, Legal Writing, Litigation Support, Client Counseling, Trademark Infringement, Copyright Law, Freedom to Operate, Intellectual Asset..., Patent Portfolio..., Intellectual Property..., IP, Commercialization, Corporate Law, Life Sciences, Patent Portfolio..., Medical Devices
Education
Fordham University School of Law 1997 — 2001
J.D., Law
Columbia University College of Physicians and Surgeons 1991 — 1997
Ph.D., Microbiology
California Polytechnic State University-San Luis Obispo 1986 — 1991
BS, Microbiology
Novartis September 2013 - Present
Robert Wood Johnson University Hospital Hamilton August 2008 - Present
LabCorp Clinical Trials May 2010 - August 2013
Esoterix, A LabCorp Company May 2008 - May 2010
Medarex February 2007 - May 2008
Esoterix January 2003 - February 2007
Monmouth Medical Center 2002 - 2002
Skills
Flow Cytometry, Life Sciences, Clinical Trials, Immunology, Hematology, Biotechnology, Blood Bank, Urinalysis, Coagulation, Medical Technology, Sop, Oncology, Laboratory, FACS, GCP, Validation, Immunoassays, Lifesciences, ELISA, GLP, SOP, Serology
Education
Monmouth University 1997 — 2002
B.S, Medical Technology
Kenyon & Kenyon 2007 - 2013
Medarex 2002 - 2004
Skills
Patents, Patent Litigation, Litigation, Biotechnology, Intellectual Property, Product Development, R&D, Drug Development
Education
Princeton University 1998 — 2002
B.S.E., Chemical Engineering
University of Notre Dame 2004 — 2007
J.D.
Mount St. Mary's University 2013 — 2014
Saint Ignatius High School 1994 — 1998
Covance October 2014 - Present
Celgene March 2011 - October 2014
Merck, Inc. 2009 - 2011
Medarex 2007 - 2009
Skills
Pharmacovigilance, Clinical Trials, GCP, Clinical Development, Oncology, CTMS, ICH-GCP, Pharmaceutical Industry, CRO, Regulatory Submissions, Regulatory Affairs, Sop, Medical Writing, Drug Safety, Clinical Monitoring, Clinical Research, FDA, EDC, Clinical Data Management, Life Sciences, Therapeutic Areas, Infectious Diseases, Protocol, SOP, Biotechnology, IND, 21 CFR Part 11, Cardiology, Data Management, Diabetes, Medical Affairs
Education
Rutgers, The State University of New Jersey-New Brunswick 1994 — 1998
Bachelor of Science (B.S.), Public Health
Yale University School of Medicine July 2011 - Present
University of Connecticut Health Center August 2006 - July 2011
Medarex September 2002 - August 2006
University of Medicine and Dentistry of New Jersey January 2000 - September 2001
Bayer Pharmaceuticals May 2000 - August 2000
Vion Pharmaceuticals June 1997 - August 1999
Skills
Immunology, Infectious Diseases, Autoimmune Diseases, Cancer, Cell, Genetics, Cell Culture, Western Blotting, Cell Biology, Molecular Biology, Flow Cytometry
Education
The University of Connecticut Health Center 2006 — 2011
Doctor of Philosophy (PhD), Immunology
Drew University 1997 — 2001
Bachelor's degree, Biology, General
Celldex Therapeutics July 2011 - Present
Shire Pharmaceuticals June 2010 - April 2011
Medarex August 2000 - December 2009
Bristol-Myers Squibb March 1990 - June 2000
Education
Georgetown University 1977 — 1982
PHD, Biology
Tufts University 1973 — 1977
BS, Biology
NBHS
Core Informatics March 2015 - Present
BioSero, LLC May 2013 - March 2015
Freeslate Inc. February 2011 - May 2013
Agilent Technologies March 2008 - February 2011
Medarex August 1998 - March 2008
Dade-Behring 1998 - 1999
Santa Cruz Biotechnology 1995 - 1998
Skills
Automation, Research, Biotechnology, R&D, Project Portfolio..., Process Improvement, Contract Management, Lifesciences, Access, Business Process..., Project Management, Requirements Analysis, Management, Leadership, Laboratory Automation, Drug Discovery, Sales, Cell Culture, ELISA, Cell Based Assays, Cell, Technology Transfer, Assay Development, High Throughput..., Commercialization, Protein Chemistry, Genomics, Biopharmaceuticals, Molecular Biology, Purification, Chromatography, DNA sequencing, FDA, LIMS, Life Sciences, Cross-functional Team..., Product Development
Education
North Carolina State University 1990 — 1993
BS, Biology
California State University-East Bay 1990 — 1991
Associate's degree, Accounting and Business/Management
Bristol-Myers Squibb 2009 - Present
Medarex 2002 - 2009
Corixa Corporation 2000 - 2002
Coulter Pharmaceuticals 1999 - 2000
Tanabe Research Laboratories U.S.A, Inc. 1990 - 1999
Immunetech Pharmaceuticals 1989 - 1990
The Burnham Institute 1985 - 1989
Skills
Cell Biology, Pharmacology, Drug Discovery, Biopharmaceuticals, Biotechnology, Drug Development, Biomarkers, Clinical Development, Immunology, Pharmaceutical Industry, Lifesciences, Life Sciences, Assay Development, Oncology, Molecular Biology, Technology Transfer, Clinical Trials
Education
Albany Medical College 1980 — 1985
Ph.D., Physiology
State University of New York College at Oswego
B.A, Biology
Cassie's Calendar October 2006 - Present
Johnson & Johnson August 2007 - August 2015
Pharmaceutical Consulting, Inc March 2003 - September 2006
NovaDel Pharma Inc. February 2002 - December 2002
NexMed, Inc. February 2001 - February 2002
Medarex January 1998 - February 2001
East Ohio Regional Hospital January 1988 - January 1989
Bell Nursing Home January 1987 - January 1988
Motion Picture and Television Hospital January 1985 - January 1986
Skills
Product Complaints, PQMS, Complaint Management, Pharmaceutical Industry, Internal Audit, GMP, Labeling, Investigations, Medical Devices, Software Documentation, Biologics, Packaging, Batch Record Review, FDA, Clinical Trail Material, Customer Service, Marketing, Quality Control, SOP, Training, Clinical Trials, Quality System, Microsoft Excel, Biotechnology, Process Improvement, Microsoft Office, PowerPoint, Marketing Strategy, Regulatory Affairs, Operations Management, Data Analysis, 21 CFR Part 11, GCP, Data Management, Inventory Management, Documentation, Materials, Community, cGMP, Pharmaceuticals, Microsoft Word, Compliance, Excel, Customer Relations, Quality Assurance, Public Speaking, Team Building
Education
Avtech 2007 — 2007
Belmont Technical College 1988 — 1989
Registered Nursing
University of Steubenville 1978 — 1983
Medical Technology and Psychology
Franciscan University of Steubenville 1978 — 1982
Medical Technology-Psychology
Avtech Institute
Belmont Technical College
University of Oregon September 2012 - Present
University of Oregon March 2010 - September 2012
National Girls Collaborative Project June 2012 - August 2012
National Girls Collaborative Project April 2012 - June 2012
Environmental Law Alliance Worldwide January 2012 - March 2012
Research!America June 2011 - August 2011
Genentech February 2008 - March 2010
Medarex September 2006 - February 2008
Skills
Policy Analysis, Strategic Planning, Program Evaluation, GIS, Molecular Biology, Biochemistry, Biotechnology, Lifesciences, Protein Purification, Cell Culture, PCR, Microscopy, Protein Expression, SDS-PAGE, Western Blotting, Transfection, Cell Biology, Tissue Culture, Gel Electrophoresis, qPCR
Education
University of Oregon 2010 — 2012
Master's, Public Administration
The University of Texas at Austin 2000 — 2003
Master's, Biochemistry
New Mexico State University 1996 — 2000
Bachelor's, Biochemistry
RVA Marketing and Media LLC August 2002 - Present
Ukrop's Homestyle Foods April 2011 - April 2012
Shenandoah Growers 2010 - 2011
Akin Gump Strauss Hauer & Feld LLP 2008 - 2010
Miles & Stockbridge P.C. 2007 - 2008
K&L Gates 2006 - 2007
U.S. Court of Appeals for the D.C. Circuit 2005 - 2006
Medarex 2001 - 2002
ABC Television 2000 - 2001
Time Inc. 1999 - 2000
Skills
Event Planning, Blogging, Product Development, Social Media, Research, Public Speaking, Non-profits, Editing, Mergers, Strategic Planning, Microsoft Office, Marketing, Public Relations, Spanish, Fundraising, Event Management, Advertising, Entrepreneurship, Marketing Communications, Business Development, Press Releases, Social Media Marketing
Education
University of Richmond School of Law 2002 — 2005
J.D., Law - Communications
Princeton University 1995 — 1999
A.B., Politics, African American Studies
Warren County ARTs Group January 2012 - Present
Asbury Carbons; Asbury Graphite Mills October 2010 - Present
Regional Personnel Services, Inc. February 2007 - October 2010
Foster Wheeler September 2010 - September 2010
Reagent Chemicals July 2010 - July 2010
Foster Wheeler AG April 2010 - July 2010
Medarex June 2009 - January 2010
Ikaria Holdings February 2008 - October 2008
Reagent Chemical Co. January 2008 - February 2008
Flemington Medical Group September 2007 - December 2007
Skills
Editing, Photoshop, Switchboard Operator, Microsoft Excel, Photography, Microsoft Word, Administrative..., Microsoft Office, Receptionist Duties, Pharmaceutical Industry, Microsoft Publisher, Proofreading, Event Planning
Education
Raritan Valley Community College 2008 — 2008
Graphic Design, HTML
Ortho Clinical Diagnostics September 2014 - Present
Otsuka January 2012 - Present
Otsuka April 2010 - December 2011
Medarex March 2009 - January 2010
Medarex, Inc. July 2005 - March 2009
Medarex, Inc. February 2003 - June 2005
Skills
Talent Management, Personnel Management, Performance Management, Compensation & Benefits, Pharmaceutical Industry, Human Resources, Employee Relations, Recruiting, Project Planning, HR Transformation, Organizational Design, Applicant Tracking..., HRIS, Lifesciences, FDA, GMP, HR Consulting, Workforce Planning, Clinical Trials, Employee Benefits, HR Policies, Program Management, Validation, Onboarding, Deferred Compensation, Internal Communications, Life Sciences, Biotechnology, Talent Acquisition, Clinical Development, Succession Planning, Sop, PeopleSoft, Employee Engagement, Change Management, Acquisition Integration
Education
Rutgers University-New Brunswick
BS, Finance
Villanova University
MS (In Progress), HR Development
Celldex Therapeutics March 2015 - Present
Tandem Labs November 2014 - February 2015
Avax-Technologies June 2009 - June 2014
Medarex May 2001 - March 2009
Molecular Discoveries, LLC (Formerly Immunotheraphy, Inc.) January 2000 - May 2001
Virtua Health June 1995 - December 1999
Virtua Health 1989 - 1995
Skills
Cell, ELISA, Biotechnology, Monoclonal Antibodies, Tissue Culture, GLP, IND, Protein Chemistry, Assay Development, FDA, Transfection, Sop, GMP, Validation, Western Blotting, Biopharmaceuticals, Flow Cytometry, Antibodies, Laboratory, Vaccines, Life Sciences
Education
Rutgers University-New Brunswick 1991 — 1995
Bachelor of Science, Biology
Alder Biopharmaceuticals Inc. (Nasdaq: ALDR) January 2015 - Present
Alder Biopharmaceuticals November 2011 - Present
Bayer Healthcare April 2010 - March 2011
Entelos October 2009 - March 2010
Medarex 2006 - 2008
UCSF 2003 - 2005
McGill University 1996 - 2003
UCSF 2002 - 2002
Skills
Immunology, Cell, Assay Development, Cancer, Clinical Development, In Vitro, Antibodies, Protein Chemistry, ELISA, Drug Development, In Vivo, Biomarkers
Education
University of California, San Francisco 2003 — 2005
Postdoctoral fellow, Tumor Immunology
McGill University 1997 — 2003
PhD, Immunology
Bristol-Myers Squibb April 2013 - Present
Bristol-Myers Squibb, BDC January 2009 - April 2013
Medarex September 2008 - November 2010
Medarex February 2008 - August 2008
Medarex January 2004 - 2008
Skills
Biotechnology, Laboratory Automation, Project Management, Process Engineering, Clean Rooms, Simplifying the Complex, Robotics, Multi Tasking, High Throughput..., Six Sigma, Lifesciences, Validation, Pharmaceutical Industry, R&D, GMP, Molecular Biology, Quality Assurance, 21 CFR Part 11, Biopharmaceuticals, Laboratory, Technology Transfer, Biochemistry, Automation, FDA, Analytical Chemistry, Drug Discovery, Cell Culture, Sop, Quality System, PCR, Commercialization, Purification, LIMS, Chemistry, Medical Devices, Microbiology, V&V, Change Control, ELISA, Process Simulation, GLP, Drug Development, Quality Auditing, Assay Development, Computer System..., Clinical Trials, Cell, Oncology, Life Sciences
Education
Purdue University 2012 — 2013
Green Belt, Lean Six Sigma, A+
Crimean State Industrial Pedagogical Institute, Simferopol 1993 — 1999
Master, Civil Engineer
MedImmune September 2011 - Present
Sabin Vaccine Institute June 2009 - September 2011
Medarex October 2006 - August 2008
Roche Molecular Systems August 2005 - September 2006
Education
Johns Hopkins Bloomberg School of Public Health 2008 — 2010
MHS, Global Disease Epidemiology and Control
Dickinson College 2001 — 2005
BS, Biology and English
Roche January 2010 - Present
IDBS, Inc. August 2005 - September 2009
Schering-Plough Research Institute May 2000 - July 2005
Hoffmann-La Roche July 1995 - April 2000
Medarex August 1993 - July 1995
Skills
Informatics, Biochemistry, Pharmacology, Project Planning, Project Management, Electronic Lab Notebooks, LIMS, Computer System..., Customer Engagement, Business Analysis, ADME, DMPK, Bioinformatics, Protein Chemistry, Lifesciences, GxP, Drug Development, Laboratory, Translational Medicine, Communication Skills, Clinical Development, Requirements Management, Bioanalysis, GCP, Assay Development, Biotechnology, GLP, Biomarkers, Biopharmaceuticals, In Vitro, Cheminformatics, High Throughput..., CRO, Biomarker Discovery, In Vivo, Genomics, Life Sciences, Pharmaceutical Industry, Drug Discovery, Validation
Education
Rutgers, The State University of New Jersey-New Brunswick 1989 — 1993
Bachelor's Degree, Biochemistry
Penn State University January 2010 - Present
De Novo DNA November 2012 - Present
University of California, San Francisco March 2007 - October 2009
Medarex June 2001 - August 2001
Skills
Metabolic Engineering, Synthetic Biology, DNA, Molecular Cloning, Genetics, Chemical Engineering, Protein Expression, Biophysics, Statistical Mechanics, Stochastic Processes, Dynamical Systems, Biotechnology, Cell Culture, Computational Biology, Genetic Engineering, Biochemistry, Systems Biology, Genomics, Molecular Biology, Optimizations, Flow Cytometry, Bioinformatics, Lifesciences, Optimization, Life Sciences, Laboratory, Biology, Protein Purification
Education
University of Minnesota-Twin Cities 2002 — 2007
PhD, Chemical Engineering
Rutgers University-New Brunswick 1998 — 2002
BS, Chemical Engineering
Lincoln Manufacturing December 2013 - Present
Lincoln Manufacturing June 2009 - December 2013
NEI Corporation January 2011 - December 2012
CCS Materials Inc. September 2010 - January 2011
Medarex December 2009 - June 2010
Parelec Inc February 2006 - June 2009
Parelec February 2006 - June 2009
Exxon Mobil Research and Engineering Co October 2005 - December 2005
L'Oreal, Inc July 2005 - August 2005
QTI Inc October 2004 - June 2005
Skills
Wet Chemistry, Chemistry, HPLC, Analytical Chemistry, UV/Vis, Polymers, Spectroscopy, FTIR, Chromatography, Sop, GLP, Quality System, Validation, Coatings, Product Development, CAPA, Characterization, GMP, Drug Development, Gas Chromatography, Raw Materials, Quality Control, Laboratory, Technology Transfer, LIMS, Formulation, R&D, Organic Chemistry, Materials, Design of Experiments, Manufacturing, Process Simulation, Materials Science, Chemical Engineering
Education
County College of Morris 1980 — 1983
AA, Chemical Technology
PAREXEL February 2012 - Present
Aerie Pharmaceuticals June 2011 - November 2011
LMS Logistics January 2011 - May 2011
Aerotek Scientific November 2010 - February 2011
Novartis June 2009 - October 2010
OraSure Technologies April 2007 - June 2009
Novartis Consumer Health March 2006 - January 2007
NPS Pharmaceuticals August 2004 - March 2006
Medarex 2004 - 2004
sanofi-aventis July 2000 - April 2003
Skills
ICH-GCP, Clinical Trials, CRO, GCP, CTMS, Validation, Clinical Research, Regulatory Affairs, Sop, FDA, Lifesciences, Biotechnology, Cross-functional Team..., Drug Development, EDC, Protocol, Quality Assurance, Pharmaceutical Industry, Clinical Development, Clinical Monitoring, Regulatory Submissions, Clinical Data Management, Clinical Operations, Oncology, Data Management, Regulatory Requirements, Infectious Diseases, Therapeutic Areas, Pharmacovigilance
Education
Cedar Crest College 2005 — 2015
BSN, RN, Nursing
Community College 1992 — 1998
Associates, Liberal Arts
Actinium Pharmaceuticals, Inc. June 2014 - Present
Bristol-Myers Squibb October 2011 - June 2014
Bristol-Myers Squibb August 2010 - October 2011
Medarex February 2001 - July 2010
Ortho Biotech, Johnson and Johnson May 1999 - February 2001
Skills
In-process Analytical..., Methods Development, Methods Validation, Analytical Chemistry, Analytical Support, Assay Development, Biopharmaceuticals, Biotechnology, 21 CFR Part 11, CAPA, CRO, Cell Culture, Chromatography, Clinical Development, Clinical Trials, Cross-functional Team..., Drug Development, ELISA, FDA, Formulation, GLP, GMP, HPLC, IND, In-process, LIMS, Laboratory, Lifesciences, Manufacturing, Monoclonal Antibodies, Oncology, Pharmaceutical Industry, Project Management, Protein Chemistry, Purification, Quality Assurance, Quality Control, Regulatory Affairs, Regulatory Submissions, Sop, Technology Transfer, V, Vaccines, Validation
Education
Rutgers, The State University of New Jersey-Newark 2004 — 2006
MBA, Finance
University of Notre Dame 1984 — 1989
PhD, Biochemistry
FlowMetric, Inc January 2010 - Present
Drexel University College of Medicine October 2011 - Present
Centocor R&D a Johnson & Johnson Co. June 1997 - December 2009
Medarex 1996 - 1997
Skills
Flow Cytometry, Immunology, Lifesciences, Biotechnology, Drug Discovery, Drug Development, Pharmaceutical Industry, Microbiology, Clinical Development, Biomarkers, Medical Devices, Cancer, Cell Biology, Clinical Research, Cell Culture, Molecular Biology, Oncology, Clinical Trials, Biopharmaceuticals, Cell, CRO, Pharmacology, Infectious Diseases, Technology Transfer, GLP, Science, Protein Chemistry, Commercialization, Biochemistry, Vaccines, Pharmaceutics, In Vitro, Genetics, FDA, Laboratory, PCR, Life Sciences, Assay Development
Education
University of Pennsylvania School of Medicine 1991 — 1996
Villanova University 1981 — 1985
BS, Biology
Muskingum College 1981 — 1983
upper dublin high school 1978 — 1980
Bristol-Myers Squibb August 2015 - Present
Bristol-Myers Squibb August 2013 - August 2015
Bristol-Myers Squibb March 2012 - August 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2010 - March 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2009 - December 2010
Medarex December 2007 - September 2009
Medarex June 2005 - December 2007
Medarex June 2004 - June 2005
Medarex June 2003 - June 2004
Medarex November 2001 - June 2003
Skills
Analytical Chemistry, Biopharmaceuticals, Monoclonal Antibodies, Formulation, GMP, Biotechnology, GLP, Technology Transfer, Assay Development, Clinical Development, LIMS, Sop, Protein Chemistry, Validation, HPLC, Chromatography, CRO, Life Sciences, Lifesciences, Analytical Method..., Project Management, ELISA, Outsourcing Management, Vendor Contracts, CMC development, Technical Writing, Regulatory Guidelines, Budget Process, Budget Forecasts, Risk Assessment, Analytical Methods..., Extractables &..., Procurement, Negotiation, Business Process..., Strategic Sourcing, Strategy, Operational Excellence
Education
Rutgers Business School 2011 — 2015
Master of Business Administration (M.B.A.), Supply Chain Management, 3.92
Columbia University in the City of New York 2000 — 2001
Master's Degree, Biotechnology, 3.90
Monmouth University 1995 — 1999
Bachelor's Degree, Biology (major), Chemistry (minor), 3.96
Bristol-Myers Squibb September 2005 - Present
Medarex January 2001 - August 2005
Schering-Plough July 1999 - January 2001
Dewey Ballantine LLP September 1996 - June 1999
Education
Columbia University in the City of New York 1993 — 1996
Doctor of Law (JD)
University of Notre Dame 1989 — 1993
Bachelor of Arts (BA), History
Mylan June 2015 - Present
Mylan February 2013 - June 2015
Kadmon Pharmaceuticals, LLC March 2009 - February 2013
University of Pittsburgh October 2008 - March 2009
Medarex January 2008 - October 2008
Phyton Biotech August 2007 - January 2008
Sanofi Pasteur May 2002 - August 2007
Skills
Lifesciences, Cell Culture, Biopharmaceuticals, Biotechnology, GMP, Sop, LIMS, Pharmaceutical Industry, GLP, Validation, Technology Transfer, HPLC, Vaccines, ELISA, FDA, Biochemistry, CAPA, Life Sciences, SOP
Education
Long Island University, Southampton Campus 1996 — 2000
Bachelors of Science, Biology
Lehigh University 2005 — 2006
Graduate Certificate, Regulatory Affairs
Bristol-Myers Squibb, New Jersey April 2010 - Present
Intertek Caleb Brett June 2006 - May 2010
Medarex August 2009 - April 2010
Roche Diagnostics June 2008 - August 2009
Skills
Protein Analysis, Protein Purification, IR/Raman Identity..., GMP, LIMS, Sop, FDA, Laboratory, Quality Control, Testing, GLP, Biotechnology, Spectrophotometry, Analytical Chemistry, Validation, Protein Chemistry, PCR
Education
Montclair State University 2005 — 2008
Bachelor of Science, BioChemistry
Middlesex County College
Stevens Institute of Technology
Stevens Institute of Technology
Stevens Institute of Technology
Bio-Gist Ventures, LLC 2010 - Present
Genmab 2005 - 2010
Medarex 1999 - 2005
Wildlife Conservation Society 1989 - 1999
Skills
Certified Licensing..., Biotechnology, Licensing, Entrepreneurship, Lifesciences, Immunology, Infectious Diseases, Commercialization, CTMS, Intellectual Property, Vaccines, FDA, Antibodies, Biochemistry, Biomarkers, Business Development, Biopharmaceuticals, Management, Patents, Regulatory Affairs, GCP, Venture Capital, Technology Transfer
Education
Princeton University 1984 — 1990
Ph.D., Biology, Population Biology
Yale University 1979 — 1983
B.S., Biology
Tegrant Corporation October 2011 - Present
medarex 2007 - 2010
Pfizer June 2004 - March 2007
Wrigley August 1987 - June 2004
Education
Middlesex County College 1985 — 1989
Fine Art Retail & Investment 2013 - Present
Bristol-Myers Squibb 2010 - Present
Medarex 2010 - 2010
Level Therapeutics 2010 - 2010
Skills
Strategy, Oncology, CAPA, Quality Assurance, Change Control, Product Development, Clinical Trials, Manufacturing, GMP, Research, Biotechnology, Drug Discovery, Biologics, GLP, Start-ups, Biopharmaceuticals, Quality Control, Management, Mergers & Acquisitions, FDA, Chemistry, Validation, Project Management, Business Strategy, Clinical Research, Training, Technology Transfer, Clinical Development, Pharmaceutical Industry, Cross-functional Team..., 21 CFR Part 11, Sop, GCP, Drug Development, Regulatory Affairs, GxP, CRO, IND, Regulatory Filings
Education
DeSales University
Master of Business Administration, Program Management with Highest Honors
Lehigh University
Bachelor of Science, Biochemistry with Honors
Lightspeed Research September 2005 - July 2008
Medarex October 2000 - April 2005
Education
Rutgers University-New Brunswick 1996 — 2000
B.S., Biological Sciences
Mersana Therapeutics 2014 - Present
Morphotek, Inc. 2005 - 2014
Medarex 2003 - 2005
Aventis Behring 2000 - 2002
Chiron Corporation 1990 - 1997
Skills
Biopharmaceuticals, Biotechnology, Monoclonal Antibodies, Drug Development, FDA, Technology Transfer, GMP, Assay Development, Validation, Protein Chemistry, IND, Drug Discovery, Pharmaceutical Industry, Project Management, 21 CFR Part 11, Life Sciences, CMC, Program Management, IMPD, Vaccines, Bioassay, Drug Product, Supply Chain Management, CMO management, Clinical Trials
Education
University of Chicago
MS, Molecular Genetics and Cell Biology
California Polytechnic State University-San Luis Obispo
BS, Microbiology
DOCS January 2015 - Present
PRA Health Sciences May 2013 - December 2014
Celgene Cellular Therapeutics April 2010 - September 2012
Medarex January 2006 - March 2010
Celgene October 2001 - January 2006
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Research, Windows, Outlook, Photoshop, Teaching, HTML, Clinical Research, CRO, Clinical Trials, CTMS, Biotechnology, GCP, FDA
Education
Rutgers, The State University of New Jersey-New Brunswick 1995 — 1998
Bachelor of Arts (BA), Clinical Psychology
Rutgers University October 2011 - Present
Pharmica Consulting LLC October 2010 - October 2011
Bristol-Myers Squibb, Princeton, New Jersey July 2009 - October 2010
Medarex April 2006 - October 2010
McGraw-Hill August 2003 - April 2006
Minotola National Bank May 1999 - July 2003
Skills
MBA, MCSE, SharePoint, Process Improvement, Data Analysis, Project Management, Vendor Management, Software Documentation, Change Management, Business Intelligence, Program Management, SDLC, Management, Technical Writing, Business Analysis, Troubleshooting, Strategic Planning, Team Leadership, Disaster Recovery, Data Management
Education
Pennsylvania State University-Great Valley Graduate Center 2010 — 2012
MBA
Wilmington University 1998 — 2002
B.S., Business Management
Medarex/Bristol Myers Squibb July 2005 - Present
Medarex July 2001 - June 2005
Medarex April 1999 - June 2001
Excell Biotech Ltd/Immutech 1997 - 1999
Dominion Biologicals Ltd 1995 - 1997
Dominion Biologicals Ltd. 1994 - 1995
Skills
Validation, Change Control, Technology Transfer, Pharmaceutical Industry, Cell Culture, Cell, FDA, Antibodies, Biotechnology, Regulatory Affairs, Monoclonal Antibodies, Purification, Sop, Protein Chemistry, Characterization, GMP, Molecular Biology, Assay Development, Drug Discovery, Microbiology, GLP, Oncology, Biopharmaceuticals, ELISA, Tissue Culture, Laboratory, Clinical Trials, LIMS, Formulation, Lifesciences, Bioreactor, Vaccines, Fermentation, 21 CFR Part 11, Manufacturing, CAPA, Drug Development, Clinical Development, Protein Purification, Immunology, Chromatography, Testing, HPLC
Education
Dalhousie University 1989 — 1993
B.Sc, Advanced Double Major in Chemistry and Biology.
Merck November 2014 - Present
Merck August 2012 - November 2014
ReSearch Pharmaceutical Services contracted to Merck January 2011 - August 2012
Cenduit November 2008 - January 2011
Fisher Clinical Services 2004 - 2010
Cenduit May 2007 - November 2008
Cenduit June 2004 - May 2007
Medarex August 2002 - June 2004
Skills
Customer Service, Requirements Analysis, Clinical Research, GCP, Vendor Management, Customer Relations, IVR, Problem Solving, SDLC, 21 CFR Part 11, Computer System..., Process Improvement, EDC, Project Management, Quality Assurance, Clinical Trials, Software Documentation, CRO, FDA, Data Management, Oncology, Protocol
Education
Kutztown University of Pennsylvania 1993 — 1997
BS, Education/Mathematics
ASR
Phillipsburg Catholic
Bristol-Myers Squibb October 2015 - Present
Earle A. Chiles Research Institute September 2008 - September 2015
Medarex October 2007 - September 2008
Cerus June 2002 - August 2007
La Jolla Institute for Allergy & Immunology May 2003 - May 2004
Cytomation Inc. July 2001 - July 2002
Northwestern University April 1996 - August 1997
South Bend Medical Foundation August 1993 - April 1996
Valley View Regional Hospital December 1992 - August 1993
Skills
Immunology, Infectious Diseases, Vaccines, Cancer, Flow Cytometry, Biotechnology, Oncology, In Vivo, Drug Discovery, Monoclonal Antibodies, Laboratory, Hematology, Cell, Lifesciences, Biomarker Discovery, Cancer Immunotherapy, Research, Cell Based Assays, Clinical Trials, Life Sciences, Virology, MT, Cancer Research, Breast Cancer, ELISPOT, Human Immunology, Mouse Models, Tumor Immunology, Biomarkers, Immunotherapy, Tissue Culture, Cell Biology, Immunohistochemistry, ELISA
Education
University of Florida 1997 — 2001
Ph.D., Immunology
University of Florida College of Medicine 1997 — 2001
Ph.D., Immunology
Oklahoma State University 1987 — 1993
B.S., Medical Technology
Sanofi Pasteur January 2014 - Present
Sanofi Pasteur September 2007 - January 2014
Medarex June 2005 - September 2007
PPD February 2005 - June 2005
Skills
Compliance, Validation, GCLP, GLP, GCP, Immunology, Immunoassays, Assay Development, Clinical Trials, Vaccines, Laboratory, FDA, 21 CFR Part 11, Project Planning, Clinical Development, ELISA, Cell Culture, Biopharmaceuticals, Infectious Diseases, Purification, Biotechnology, Protein Chemistry, GMP, Monoclonal Antibodies, LIMS, Sop, Pharmacokinetics, Technology Transfer, Lifesciences, Cell, Data Management, Clinical Research, Aseptic Technique, R&D, Molecular Biology, Pharmaceutical Industry, SOP, Life Sciences, Change Control, Regulatory Affairs, Quality Assurance, Protocol
Education
Lehigh University 1999 — 2003
B.S., Molecular Biology
NuvOx Pharma January 2013 - Present
Instant Bioscan December 2012 - Present
Desert Angels January 2012 - Present
Acorn Consulting June 2011 - Present
Advanced Biologics Co., Ltd. January 2009 - June 2011
Caris MPI July 2008 - December 2008
Medarex 2000 - 2008
Aviron January 1995 - December 1998
ImmuLogic 1990 - 1995
MAST Immunosystems (now Hitachi Medical) 1986 - 1990
Skills
Pharmaceuticals, Biotechnology, Diagnostics, Medical Devices, Clinical Research, Biologics, Pharmaceutical Industry, Vaccines, Lifesciences, Cleantech, Cross-functional Team..., Start-ups, Molecular Biology, Oncology, Regulatory Affairs, Drug Development, Product Development, Commercialization, Technology Transfer, FDA, Biopharmaceuticals, Clinical Development, Clinical Trials, Biomarkers, Assay Development, Mergers & Acquisitions, Drug Discovery, GMP, Immunology, CRO, Hardware Diagnostics, Biochemistry, Genomics, R&D, Due Diligence, Monoclonal Antibodies, Infectious Diseases, Validation, Cancer, Protein Chemistry, Pharmacology, IND, Sop, Cell, GLP, Regulatory Submissions, Cell Culture, GCP, Microbiology, CTMS
Education
Cornell University
Ph.D.
University of California, San Diego
BA
Wm. S. Hart High School
Eli Lilly and Company March 2003 - Present
Medarex July 2001 - January 2003
Skills
Biotechnology, 21 CFR Part 11, Antibodies, Biochemistry, Biopharmaceuticals, Cancer, Cell, Cell Biology, Cell Culture, Chromatography, Clinical Development, Drug Development, Data Analysis, Drug Discovery, Formulation, GLP, GMP, HPLC, Genomics, Immunology, Laboratory, Lifesciences, Monoclonal Antibodies, PCR, Pharmaceutical Industry, Protein Chemistry, R&D, Oncology, Statistics, Sop, Strategy, Validation, Toxicology, Technology Transfer, Vaccines, Molecular Biology, FDA
Education
University of North Carolina at Chapel Hill 1997 — 2001
Postdoc, Biochemistry
TIFR 1992 — 1997
Ph.D., Biochemistry
Banaras Hindu University 1990 — 1992
M.S., Chemistry
Novartis March 2014 - Present
Novartis March 2010 - March 2014
Novartis May 2007 - March 2010
Novartis December 2005 - May 2007
Merck August 2004 - November 2005
Medarex August 2002 - August 2004
DGI Biotechnologies May 2001 - August 2002
Skills
Clinical Development, GCP, Oncology, Clinical Research, Clinical Trials, CTMS, Medicine
Education
Monmouth University 1997 — 2001
BS, Biology
Gilead Sciences June 2015 - Present
Merck March 2010 - March 2015
Bristol-Myers Squibb June 2009 - March 2010
ID Business Solutions January 2008 - August 2008
Bristol-Myers Squibb July 2007 - January 2008
Hydromer June 2006 - January 2007
Medarex December 2004 - June 2006
Taxsimple June 1994 - December 2004
Massachusetts General Hospital May 2003 - September 2003
Center for Advanced Biotechnology at Boston University May 2002 - June 2003
Skills
Business Analysis, Electronic Lab Notebooks, BioBook, BioAssay, SDLC, ELN, IDBS E-Workbook, Cambridgesoft E-Notebook, Life Sciences, Template Building, Template Creation, Life Science Industry, Requirements Gathering, Requirements Analysis, Business Requirements, Functional Requirements, Deployment Strategies, Training, Data Management, Visio, Biotechnology, Management, Cross-functional Team..., Agile & Waterfall..., Spotfire, Protocol Design, User Acceptance Testing, End User Training, User-centered Design, Interviewing Subject..., Subject Matter Experts, Functional..., ELISA, Documentation, Technical Documentation, User Documentation, Assay Development, GLP, In Vitro, In Vivo, Clinical Development
Education
University of Pennsylvania 2003 — 2004
Masters, Biotechnology Engineering
Boston University 1999 — 2003
Bachelors, Biomedical Engineering
AstraZeneca August 2014 - Present
Bristol-Myers Squibb February 2013 - Present
Bristol Myers Squibb December 2011 - Present
Bloc, Inc. 2015 - 2015
Bloc, Inc. 2015 - 2015
University of Maryland University College 2011 - 2015
Dendreon April 2011 - November 2011
Huntingdon Life Sciences July 2010 - April 2011
International Technidyne Corporation December 2009 - July 2010
Medarex August 2009 - November 2009
Skills
LIMS, Flow Cytometry, Excel, Word, GLP, Cell Culture, bioreactors, Quality Control, Data Analysis, GMP, Validation, HPLC, Microsoft Excel, C++, Bioinformatics, R, Perl, Oracle SQL, ELISA
Education
University of Maryland University College 2012 — 2015
Master’s Degree, Bioinformatics, 3.08
Rutgers, The State University of New Jersey-New Brunswick 2004 — 2007
Bachelor Of Science, Biomedical Engineering
Sharjah Indian School 1997 — 2001
Diploma, High School
Biomirex, Inc. August 2011 - Present
MSM Protein Technologies, Inc. September 2005 - July 2011
Medarex 2002 - 2004
Praecis Pharmaceuticals 2000 - 2002
Harvard University 1996 - 1999
University of California, Los Angeles 1992 - 1996
Skills
Biotechnology, Lifesciences, Drug Discovery, Biopharmaceuticals, Assay Development, Drug Development, Oncology
Education
Lomonosov Moscow State University (MSU)
Ph.D., Biochemistry
Bristol-Myers Squibb March 2010 - Present
American Cancer Society September 2009 - August 2010
Medarex January 2001 - February 2010
American Cancer Society 2007 - 2009
Bethlehem Steel July 2000 - January 2001
Pocono Mountain School District August 1998 - July 2000
Skills
Pharmaceutical Industry, Biotechnology, FDA, GMP, Clinical Trials, Oncology, Biopharmaceuticals, Project Management, Technology Transfer, Drug Development, Aseptic Processing, Assay Development, Chromatography, 21 CFR Part 11, CTMS, HPLC, GLP, Quality Assurance, Therapeutic Areas, Purification, Immunology, Cross-functional Team..., Chemistry, ELISA, Commercialization, Formulation, Process Simulation, LIMS, Drug Discovery, Protein Chemistry, Protein Purification, GCP, SDS-PAGE, Vaccines, Change Control, CRO, Infectious Diseases, Cell, Laboratory, Microbiology, Pharmacology
Education
DeSales University 1999 — 2004
MBA, Management
Lebanon Valley College 1994 — 1998
BS, Chemistry, minor Secondary Education
Unilife Corporation March 2011 - Present
Bristol-Myers Squibb May 2010 - April 2011
Medarex February 1999 - May 2010
Kern McNeill International (CRO) January 1993 - January 1998
Hoffmann-La Roche January 1989 - January 1993
Skills
GMP, 21 CFR Part 11, Document Management, Software Documentation, Project Management, Management, Microsoft Office, Training, Troubleshooting, Budgets, Sop, Validation, FDA, Coaching, eDoc, Master Control, Internal Audit, Performance Reviews, Document Review, Project Planning, Requirements Analysis, Quality Assurance, Quality Management, Cross-functional Team..., Pharmaceutical Industry, CAPA, Biotechnology, GLP, LIMS, Change Control, Biopharmaceuticals, Technology Transfer, Clinical Development, Lifesciences, Regulatory Affairs, Computer System..., V&V, CRO, GxP, ISO 13485, Regulatory Submissions, Quality System, Process Improvement, SAP, Medical Devices, Quality Auditing, GCP, SOP, Design Control, Quality Control
Education
DeSales University 2004 — 2009
BA, Business Management
SCCC 1990 — 1995
AA, Biology
Cambria-Rowe Business College 1986 — 1988
AS, Business, Medical Secretarial
Advaxis, Inc. June 2015 - Present
Drais Pharmaceuticals August 2013 - June 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2007 - August 2013
ImClone Systems February 1996 - May 2007
Medarex 1994 - 1996
Regeneron Pharmaceuticals 1993 - 1994
Skills
GLP, Sop, Drug Development, Biopharmaceuticals, Biotechnology, Project Management, Monoclonal Antibodies, Project Portfolio..., Process Improvement, Immunology, Clinical Data Management, CTMS, Clinical Trials, Lifesciences, Clinical Development, Assay Development, Change Control, Cell, ICH-GCP, Cell Biology, GxP, Oncology, Drug Discovery, Pharmaceutical Industry, FDA, 21 CFR Part 11, R&D, CRO, Genomics, Regulatory Submissions, Clinical Monitoring, Validation, Biochemistry, Cell Culture, Technology Transfer, ELISA, Quality System, Clinical Research, GMP, Regulatory Affairs, EDC, Regulatory Requirements, Commercialization, Data Management, Cross-functional Team..., GCP, Molecular Biology, IND, Therapeutic Areas
Education
Rutgers University-New Brunswick 1990 — 1993
bs, biochemistry
MedGenesis Therapeutix January 2011 - Present
Biovail Technologies May 2010 - January 2011
Medarex September 2003 - May 2010
Medarex December 2002 - September 2003
Amarin Corporation March 2001 - November 2002
Pfizer September 1998 - March 2001
Warner Lambert May 1997 - August 1998
Warner Lambert April 1993 - April 1997
Ciba-Geigy November 1991 - March 1993
Croda June 1991 - November 1991
Skills
CMO Management, Technology Transfer, Biotechnology
Education
Rutgers University-New Brunswick 1992 — 1996
MS, Chemistry
St. Francis University 1987 — 1991
BS, Chemistry
Insmed, Inc. November 2013 - Present
Mirati Therapeutics July 2013 - November 2013
MethylGene Inc. June 2012 - July 2013
HCR America September 2010 - June 2012
Bristol-Myers Squibb January 2010 - September 2010
Medarex March 2008 - January 2010
Clinsys Clinical Research June 2007 - March 2008
Clinsys Clinical Research March 2006 - May 2007
Target Research Associates March 2005 - March 2006
Target Research Associates 2003 - 2005
Skills
Clinical Trials, GCP, Program Management, Pharmaceutical Industry, Clinical Development, Cross-functional Team..., CRO, FDA, Drug Development, Oncology, Clinical Monitoring, Process Improvement, SOP, Biotechnology, Clinical Research, Therapeutic Areas, CTMS, ICH-GCP, Infectious Diseases, EDC
Education
Mount Vernon Nazarene University 1999 — 2001
Columbus State Community College 1983 — 1987
ADN, Nursing
Hilliard High
Eli Lilly and Company February 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2009 - February 2014
HGS April 2007 - April 2009
Medarex November 2003 - April 2007
Skills
Oncology, Clinical Trials, Clinical Development, CRO, GCP, CTMS, Clinical Monitoring, Pharmaceutical Industry, ICH-GCP, Drug Development, EDC, Sop, Clinical Operations, Biotechnology, Biopharmaceuticals, Regulatory Affairs, Pharmacovigilance, Therapeutic Areas, FDA, Vaccines, Infectious Diseases, Immunology, Medical Affairs, Neurology, Hematology, IND, Lifesciences, Regulatory Requirements, Cardiology, Rheumatology, Diabetes
Education
Rutgers University-New Brunswick 2001 — 2003
MBA, Concentration: Pharmaceutical Management
Rutgers University-New Brunswick 1996 — 2001
BS, Public Health with MInor in Biology
medarex StudentPDA2008 - 2008
PDA 2008 - 2008
PDA 2008 - 2008
imclone systems 2002 - 2007
Education
Fairleigh Dickinson University 1998 — 2002
BS, Biology
Bristol-Myers Squibb January 2010 - Present
Medarex July 1992 - December 2009
Skills
Drug Discovery
Education
Dartmouth College 1984 — 1988
Ph.D., Biochemistry and Immunology
Allegheny College 1974 — 1978
Medarex August 2007 - Present
ImClone Systems November 2004 - July 2007
Lohmann Therapy Systems June 2000 - November 2004
Education
Pennsylvania State University-Great Valley Graduate Center 2000 — 2002
Eli Lilly and Company 2009 - Present
Medarex March 2008 - December 2008
ImClone Systems Incorporated December 2005 - February 2008
Noninvasive Technologies 2002 - 2005
Braton Biotech 1995 - 2001
Skills
Antibodies, Cell, ELISA, Assay Development, Technology Transfer, HPLC, Biotechnology, Pharmacokinetics, Monoclonal Antibodies, Validation, Clinical Development, Immunoassays, Molecular Biology, Protein Purification, Cell Biology, Protein Expression, Cancer, Protein Chemistry, Transfection, Cell Culture, In Vitro, Biochemistry, Lifesciences, GLP, Drug Discovery, Immunology, Flow Cytometry, Purification, SDS-PAGE, Biopharmaceuticals, Pharmaceutical Industry
Education
Indian Institute of Technology, Delhi 1983 — 1990
Ph.D., Biochemistry
Complementary Medicine & Healing Arts November 2008 - Present
Integrative Medicine Center November 2005 - Present
The Center June 2006 - November 2008
Cornell University May 1999 - August 2001
Medarex April 1998 - May 1999
Skills
Homeopathy, Wellness, Clinical Nutrition, Fertility, Herbal Remedies, Women's Health, Digestive Disorders, Detoxification, Naturopathy, Chronic Illness, Alternative Medicine, Herbal, Functional Medicine
Education
National College of Naturopathic Medicine 2001 — 2005
ND, Naturopathic Medicine
Lycoming College 1993 — 1997
BS, Biology, Chemistry
Bristol-Myers Squibb 2009 - Present
Medarex May 2003 - September 2009
Rigel January 2002 - February 2003
UCSF 1997 - 2001
Dartmouth College 1995 - 1997
Skills
Biotechnology, Cell, Lifesciences, Assay Development, Antibodies, Drug Discovery, Validation, Molecular Biology, Immunology, Life Sciences, Biochemistry, Cell Biology
Education
Geisel School of Medicine at Dartmouth 1990 — 1995
Ph.D., Biochemistry
Smith College 1986 — 1990
B.A., Chemistry
Novartis 2014 - Present
Huntingdon Life Sciences April 2012 - June 2014
ICON Central Laboratories July 2009 - August 2012
Medarex November 2005 - July 2009
Esoterix Clinical Trials Services 2000 - 2005
Skills
Flow Cytometry, Immunotoxicology, GLP, GCP, Immunology, Translational Research, Clinical Trials, Assay Development, Assay Validation, Regulatory Guidelines, Mentoring, Data Analysis, Interpretation Of Data, Biotechnology, Biopharmaceuticals, Validation, Quality Control, Clinical Development, FDA, R&D, Laboratory, GMP, CRO, Sop, Pharmaceutical Industry, Bioanalysis, Cell, Biomarkers, Lifesciences, Pharmaceutics, Biologics, GxP, ELISA
Education
Brunel University London 1983 — 1987
B.Sc, Hons
Celgene Cellular Therapeutics December 2009 - Present
Palatin Technologies July 2006 - December 2009
Medarex July 2003 - July 2006
Abbott 2001 - 2003
Knoll Pharmaceuticals 1993 - 2001
Lederle Laboratories 1991 - 1993
Skills
Oncology, Clinical Development, Pharmaceuticals, Clinical Trials, Biotechnology, Immunology, Clinical Research, Clinical, GCP, R&D, Cancer, Cellular Therapeutics, Rheumatology, Inflammatory Bowel..., Multiple Sclerosis, Stroke, Sexual Dysfunction, Cell, Pharmaceutical Industry, Drug Development, Regulatory Submissions, Medical Affairs, EDC, Monoclonal Antibodies, Drug Discovery, Lifesciences, Validation, Pharmaceutics, CRO, GLP, Biomarkers, FDA, Regulatory Affairs, IND, Inflammation, Therapeutic Areas, Vaccines, Medical Writing, Clinical Data Management, Clinical Pharmacology, Hematology, Pharmacology, Pharmacovigilance, Sop, Technology Transfer, Translational Medicine, 21 CFR Part 11, Protocol, Diabetes, Biopharmaceuticals
Education
NCI / Baltimore Cancer Research Center 1979 — 1982
Medical Oncology, Medical Oncology
NYU / Bellevue Medical Center 1976 — 1979
Internal Medicine, Internal Medicine
University of Pennsylvania School of Medicine 1972 — 1976
MD, Medicine
Queens College 1968 — 1972
BA, Chemistry
Genzyme, a Sanofi Company May 2010 - Present
Medarex July 2009 - June 2010
Roche Molecular Systems November 2007 - May 2009
Immunicon Corporation (Acquired by Veridex, LLC) February 2006 - November 2007
Roche Molecular Systems January 2003 - January 2006
Roche Molecular Systems June 1999 - January 2003
Skills
GMP, FDA, CAPA, Sop, Quality System, Biotechnology, V&V, Validation, Change Control, ISO 13485, Medical Devices, Quality Management, Aseptic Processing, Quality Assurance, Root Cause Analysis, HPLC, Quality Control, Cell Culture, 21 CFR Part 11, Variance Analysis, SOP
Education
Rutgers University-New Brunswick 1995 — 1999
B.A., Biology / Psychology (Double Major)
UC Davis Mouse Biology Program December 2012 - Present
UC Santa Cruz April 2006 - December 2012
Medarex October 2004 - April 2006
Tocatta Therapeutics August 2003 - October 2004
Deltagen July 1998 - June 2003
Skills
Animal Models, Cell Culture, Surgery, ELISA, Flow Cytometry, PCR, Transfection, Confocal Microscopy, Immunohistochemistry, In Vivo, Microscopy, Mutagenesis, Immunofluorescence, Stem Cells, Fluorescence Microscopy, Pharmacology, General Surgery, Lifesciences, Life Sciences
Education
Rockefeller University 2000 — 2001
Fellowship
Stanford University 1997 — 1998
Bachelor of Science (B.S.), Post Graduate Research
San Jose State University 1990 — 1994
BS, Physiology
Quintiles August 2014 - Present
Mitsubishi Tanabe Pharma Development America July 2010 - July 2014
INC Research August 2008 - July 2010
Medarex 2006 - 2008
Novartis July 2005 - February 2006
Bristol-Myers Squibb September 2003 - July 2005
ExxonMobil 1990 - September 2003
Skills
GCP, Auditing, GLP, Quality Assurance, Pharmaceutical Industry
Education
Longwood University
BS, Biology
Temple University
MS, Quality Assurance & Regulatory Affairs
DSI (Foster McKay) October 2012 - Present
GSK 2011 - 2012
Eisai 2010 - 2011
Sepracor October 2008 - September 2010
Azopharma June 2008 - April 2010
Bioheart Inc November 2006 - February 2008
ImClone Systems 2005 - 2006
Huntingdon Life Sciences 2002 - 2004
Medarex 2002 - 2004
Skills
FDA, GMP, Sop, GLP, Quality Assurance, Quality Control, ICH-GCP, V&V, GCP, Medical Devices, 21 CFR Part 11, Project Management, ISO 13485, Process Improvement, Gap Analysis, Risk Assessment, Clinical Trials, SOP, CRO, Pharmaceutical Industry
Education
Saint Joseph's University - Erivan K. Haub School of Business 2013 — 2015
Executive MBA - in progress, Pharmaceutical Marketing and Management
Rutgers, The State University of New Jersey-New Brunswick 1995 — 2000
Bachelor of Science (BSc), Biological Sciences
Bristol-Myers Squibb, Princeton, New Jersey August 2010 - Present
Medarex March 2003 - August 2010
Baxter 2001 - 2003
Johnson & Johnson 1999 - 2001
Validation and Process Associates 1997 - 1999
Skills
Manufacturing, Validation, Technology Transfer, GMP, FDA, Biotechnology, Change Control, Quality Assurance, CAPA, Quality Auditing, Sop, Pharmaceutical Industry, Biopharmaceuticals, Aseptic Processing, LIMS, V&V
Education
La Salle University - School of Business Administration 2000 — 2003
MBA, Business
Penn State University 1991 — 1996
BS, Chemical Engineering
Novartis December 2013 - Present
PAREXEL September 2013 - November 2013
Morphotek, Inc. May 2012 - September 2013
Novartis October 2009 - May 2012
Medarex 2007 - October 2009
Celgene 2005 - 2007
Organon Pharmaceuticals 2003 - 2005
Kendle International 2002 - 2003
Kendle International 2000 - 2002
Kendle International 1999 - 2000
Skills
Pharmaceuticals, Clinical Monitoring, Oracle Clinical, Clinical Data Management, EDC, CDISC, GCP, Oncology, Clinical Trials, Data Management, CRO, Clinical Research, Validation, SOP, ICH-GCP, Therapeutic areas, 21 CFR Part 11, CRF design, Biotechnology, Infectious Diseases, FDA, Documentation, Mentoring, Access, Process Improvement, Document Management, Hematology, Immunology, MedDRA, Cardiology, Team Leadership, Mentoring Of Staff, Project Manager..., Cross-functional Team..., Cross Functional Team..., Cross Functional..., Computer System..., Drug Development, Pharmaceutical Industry, Pharmacovigilance, Sop
Education
College of Saint Elizabeth
Kutztown University of Pennsylvania
Janssen, Pharmaceutical Companies of Johnson and Johnson 2010 - Present
sanofi-aventis 2005 - 2010
Medarex 2001 - 2005
Medtronic 1999 - 2000
Skills
Clinical Trials, Clinical Development, CTMS, CRO, Pharmaceutical Industry, Oncology, Clinical Research, GCP, Biotechnology, FDA, Therapeutic Areas, Infectious Diseases, Clinical Monitoring, EDC, Protocol, Immunology, Medical Devices
Education
Florida International University
MPH-HA, Public Health- Epidemiology
University of Miami
Bachelor Science, Chemistry
STEALTH BIOTHERAPEUTICS April 2014 - Present
Pearl Therapeutics February 2011 - April 2014
Ikaria July 2008 - March 2011
Medarex January 1998 - June 2008
Skills
Oncology, Clinical Operations, CTMS, Clinical Research, Clinical Trials, EDC, Clinical Development, Biotechnology, ICH-GCP, Therapeutic Areas, Drug Development, Pharmaceutical Industry, Lifesciences, GCP, Regulatory Submissions, Regulatory Affairs, Sop, CRO, Clinical Monitoring, FDA
Education
Montclair State University
Bachelor of Science (B.S.), Biology/Chemistry
Auxilium Pharmaceuticals March 2013 - May 2014
Auxilium Pharmaceuticals November 2011 - March 2013
Medarex September 2000 - 2010
Lehigh University June 1990 - June 2000
Skills
Subcloning, Cell Banking, Writing Skills, Organizational..., Team Leadership, Process Improvement, Detail Oriented, cGMP practices, Supervising, Upstream Development, HPLC, ELISA, Microscopy, Fermentation Process..., Bacterial Cell Culture, Mammalian Cell Culture, Upstream Process..., Bioreactor Operation, Technical Writing, Bioreactor, SDS-PAGE, Microplate Assays, Western Blotting, Cell Culture, Biotechnology, Lifesciences, Monoclonal Antibodies, Upstream, Assay Development, Protein Chemistry, Cell, Fermentation, Clinical Development, Genomics, LIMS, Biopharmaceuticals, Technology Transfer, Life Sciences
Education
Lehigh University
M.S., Bioscience & Biotechnology
Moravian College 1985 — 1989
B.S., Biology
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2011 - Present
Auxilium Pharmaceuticals February 2010 - June 2011
Medarex February 2007 - February 2010
Skills
HPLC, GLP, Sop, GMP, SDS-PAGE, Validation, Assay Development, Aseptic Technique, Chromatography, Quality Control, Biochemistry, Cell Culture, FDA, Spectrophotometry, Pharmaceutical Industry, 21 CFR Part 11, Protein Chemistry, LIMS, Laboratory, Lifesciences, Aseptic Processing, Purification, Biopharmaceuticals, Calibration, Monoclonal Antibodies, Biotechnology, ELISA, Technology Transfer, CAPA, Protein Purification, SOP
Education
Cedar Crest College 2003 — 2006
Bachelor of Science, Biochemistry
Bristol-Myers Squibb June 2010 - Present
Medarex February 2007 - June 2010
ICON Central Laboratories 2005 - 2007
Taro Pharmaceuticals 2004 - 2005
United Biomedical, Inc 1999 - 2004
Skills
LIMS, Sop, GMP, Validation, HPLC, FDA, GLP, Biotechnology, 21 CFR Part 11, Microbiology, Pharmaceutical Industry, Lifesciences, Biochemistry, SDS-PAGE, ELISA
Education
East Stroudsburg University of Pennsylvania 1996 — 1999
Bachelors, Biology
Northampton Community College August 2015 - Present
ERA One Source September 2011 - Present
Weichert Realtors September 2007 - September 2011
Weichert Realtors July 2005 - September 2011
Medarex July 2002 - November 2002
sanofi-aventis February 1999 - July 2002
sanofi-aventis October 1997 - July 2002
Allegheny University of the Health Sciences October 1997 - February 1999
East Stroudsburg University January 1997 - December 1997
Skills
First Time Home Buyers, Vacation Homes, Retirement Homes, Residential Homes, Relocation, Real Estate, Short Sales, Investment Properties, Sellers, REO, Referrals, Foreclosures, Selling, Investors, Listings, Real Estate Transactions, Acreage, Negotiation, Buyers, New Home Sales, Waterfront, Buyer Representation, Investments, Townhomes, e-PRO, Single Family Homes, New Homes, Condos, Sales
Education
Kings College, Wilkes-Barre, PA 2008 — 2012
Certificate, Education Certification
East Stroudsburg University of Pennsylvania 1996 — 1997
M.S., Biology
University of Scranton 1992 — 1996
B.S., Biology
Bristol-Myers Squibb January 2010 - Present
Medarex November 2005 - January 2010
Skills
CRO, Oncology, Clinical Development, Clinical Data Management, Data Management, EDC, Clinical Research, GCP, Oracle Clinical, CTMS, CRF design, Clinical Trials
Education
Northampton Community College
New York University January 2013 - May 2014
Celgene November 2010 - July 2012
Celgene February 2009 - November 2010
ISTA Pharmaceuticals April 2006 - July 2008
Bergen County College May 2005 - July 2005
Genta December 2001 - July 2002
Medarex June 1999 - August 2001
Novartis February 1992 - May 1999
Wallace Laboratories March 1984 - January 1992
Revlon Health Care Group October 1978 - February 1984
Skills
Protocol, Pharmacovigilance, Neurology, Clinical Social Work, Psychotherapy, Neuroscience, Pharmacology, Clinical Development, Clinical Research, Medicine, GCP, Medical Writing, CTMS, CRO, Clinical Trials, Oncology, Pharmaceutical Industry, Lifesciences, Biotechnology, Allergy, Anatomy, Autonomic nervous..., Cardiovascular Medicine, Dry eye syndrome, Endocrinology, Reproductive..., Experimental Design, Experimental Psychology, Experimental Research, Experimental Analysis, Immunology, Medical Research, Neurosurgery, Oncology Clinical..., Ophthalmology, Pharmaceutical Research, Pharmacokinetics, Physiology, Psychopharmacology, Respiratory Disease, Statistical Data..., Pharmaceutical Sciences, Scientific Writing, Life Sciences
Education
New York University 2013 — 2014
Master of Social Work (MSW), Clinical Social Work
Rutgers, The State University of New Jersey-Newark
Ph. D., Behavioral and Neural Science (Neuroscience)
Saint John's University
MS, Pharmaceutical Sciences (Pharmacology)
City University of New York-Brooklyn College
MA, Experimental Psycology
Miami University
BA, Psycology
Endo / Auxilium Pharmaceuticals, Inc. March 2012 - Present
Auxilium Pharmaceuticals April 2010 - June 2012
Medarex November 2005 - March 2010
Jet-care International August 2004 - November 2005
Skills
SOP, GMP, LIMS, Quality Assurance, TRACKWISE, SAP, Internal Audit, Regulatory Inspections, Regulatory Submissions, Change Control, Sop, Trackwise, Quality Control, Aseptic Technique, Biotechnology, 21 CFR Part 11, Regulatory Affairs, Document Management, Deviations, CAPA, Pharmaceutical Industry, Inspection, Technology Transfer, Biopharmaceuticals, Clinical Development, Vaccines, FDA, Clinical Research, Validation, GCP, Environmental Monitoring, Monoclonal Antibodies, Microbiology, Drug Development, Aseptic Processing, Lifesciences, GLP, GxP, Computer System..., Cleaning Validation, Clinical Trials, Immunology, Chromatography, HPLC, Quality System, V&V, Assay Development, Biochemistry, Purification
Education
Temple University 2010 — 2013
MS, Quality Assurance and regulatory Affairs
Muhlenberg College 2001 — 2004
BS, Natural Sciences
Bristol-Myers Squibb July 2010 - Present
Medarex May 1998 - July 2010
Biovest International January 1997 - May 1998
Education
Kean University 2000 — 2002
Master, Biotechnology
University of Wisconsin-River Falls 1991 — 1996
BS, Biotechnology
Bowler High 1987 — 1991
High School Diploma, General Studies
Thermo Fisher Scientific 2015 - Present
Bristol-Myers Squibb June 2014 - 2015
Bristol-Myers Squibb May 2010 - June 2014
Medarex January 2009 - May 2010
Medarex July 2005 - January 2009
Medarex October 2003 - July 2005
Aker Kværner March 2003 - October 2003
Foster Wheeler June 2002 - March 2003
Foster Wheeler USA 2002 - 2003
Skills
21 CFR Part 11
Education
Lehigh University 1998 — 2002
BS, Computer Engineering
Northeast Clinical Research October 2014 - Present
BRD July 2012 - October 2014
Medarex 2008 - 2010
Medarex 2002 - 2008
Skills
Regulatory Affairs, Clinical Trials, Clinical Research, Lifesciences, 21 CFR Part 11, Biotechnology, Data Management, Sop, GCP, FDA, CRO, Software Documentation, EDC, Clinical Development, CTMS, SOP, Life Sciences
Education
Northampton Community College
Bristol-Myers Squibb June 2014 - Present
Bristol-Myers Squibb, Inc. 2010 - November 2014
Medarex May 1999 - April 2010
Medarex 1999 - 2009
Merck Serono June 2002 - 2006
Stryker Biotech August 1996 - May 1999
Skills
Technology Transfer, Drug Discovery, Manufacturing, Biopharmaceuticals, GMP, Aseptic Processing, Sop, LIMS, HPLC, Cell Culture, Biotechnology, Chromatography, Process Simulation, CAPA, FDA, Pharmaceutical Industry, Management, Assay Development, Purification, GLP, Validation, 21 CFR Part 11, Microbiology, Monoclonal Antibodies, Lifesciences, IND, Protein Chemistry, Protein Purification, Clinical Development, Drug Development, Fermentation, ELISA, Change Control, Analytical Chemistry, Aseptic Technique, Cell, Oncology
Education
University of New Hampshire 1989 — 1992
Master's degree, Chemistry
Messiah College 1983 — 1987
BS, Chemistry, Biology
Novartis November 2011 - Present
Novartis October 2006 - March 2012
BD Medical 2005 - 2006
Medarex 2001 - 2005
Skills
Clinical Research, Clinical Trials, GCP, Clinical Development, Pharmaceutical Industry, CTMS, Oncology
Education
Rutgers University-New Brunswick 1997 — 2001
BA, Biology/italian
Gemmus Pharma Inc. July 2012 - Present
FirstString Research Inc. 2012 - Present
Galectin Therapeutics 2011 - Present
Curis 2010 - Present
Rogosin Institute 2009 - Present
Titan Pharmaceuticals Inc. 2007 - Present
Everybody Wins NY 2010 - 2012
Surface Logix 2005 - 2011
Medarex 2007 - 2009
Bayer HealthCare 2006 - 2007
Skills
Clinical Development, Pharmaceutical Industry, Biotechnology, Drug Development, Oncology, Clinical Trials, Infectious Diseases, Lifesciences, Drug Discovery, Clinical Research, Biopharmaceuticals, Regulatory Affairs, Pharmacology, Life Sciences, Neurology, R&D, Commercialization, Immunology, Medical Devices, FDA, Protocol, Regulatory Submissions, Clinical Pharmacology, CRO, Cardiology, Medicine
Education
Cornell University Medical College 1976 — 1980
MD, Neurobiology - accepted into medical school before obtaining undergrad degree
Cornell University
Cornell University
Little Red School House, Elizabeth Irwin, Dwight Englewood
Bristol-Myers Squibb Company February 2010 - Present
Medarex 2008 - 2010
Bristol-Myers Squibb January 2007 - July 2008
Skills
Clinical Data Management, EDC
Education
Osmania University 1991 — 1993
Masters, Genetics
Dendreon June 2010 - September 2012
Merck January 2010 - August 2010
Medarex October 2007 - January 2010
Benchmark Analytics May 2003 - September 2007
Skills
ELISA, GMP, LIMS, Protein Chemistry, Validation
Education
Lycoming College 1999 — 2003
BS, Biology
Northern Lehigh High School 1996 — 1999
Diploma, General
Bristol-Myers Squibb, Princeton, New Jersey January 2010 - Present
Medarex October 2007 - January 2010
Baxter Healthcare 2001 - 2007
Knoll/Abbott August 1997 - October 2001
Skills
Quality Assurance, Aseptic Processing, Microbiology, GMP, CAPA, Validation, Quality System, Biotechnology, Technology Transfer, Pharmaceutical Industry, FDA, CRO, Clinical Research, Clinical Development, GLP, Oncology, Biopharmaceuticals, Lifesciences, Quality Auditing, Clinical Trials, 21 CFR Part 11, Change Control, Sop, GxP, LIMS, Regulatory Affairs, SOP, Trackwise, ISO 13485, Life Sciences, GCP, V&V, Laboratory
Education
Centenary College
MBA, Business
Northwestern State University
BS, Microbiology
Schumpert School of Medical Technology
MT (ASCP), Medical Technology
IPH Consulting, LLC 2006 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2010 - 2012
Medarex 2006 - 2010
Celgene 2004 - 2006
Berlex (NJ) 2003 - 2004
PRA International 2000 - 2003
Skills
Oncology, Phase I, Clinical Trials, Clinical Monitoring, Clinical Development, Clinical Research, EDC, GCP, Clinical Research..., Gastroenterology, CRO, CTMS
Education
Penn State University
BS, Biology
Bristol-Myers Squibb, Princeton, New Jersey December 2011 - Present
Laureate Biopharmaceutical Services January 2011 - December 2011
Medarex February 2002 - January 2011
Aker Kvaerner February 1994 - February 2002
Honeywell May 1993 - November 1994
Jacobs Engineering September 1990 - May 1993
Skills
Project Planning, Commissioning, GMP, Engineering, Validation, Project Management, Biotechnology, Biopharmaceuticals, Operations Management, Pharmaceutical Industry, FDA, Clinical Development, GxP, LIMS, Sop, 21 CFR Part 11, Quality Assurance, Change Control, Engineering Management, Regulatory Affairs, CAPA, Six Sigma, GLP, Leadership, Lifesciences, R&D, Quality System, V&V, Computer System...
Education
Rutgers University-New Brunswick 1986 — 1990
BS, Electrical Engineering
Sanofi Pasteur November 2014 - Present
Bristol-Myers Squibb February 2013 - November 2014
Bristol-Myers Squibb August 2010 - February 2013
Medarex February 2005 - August 2010
Fisher Clinical Services July 2003 - August 2004
Skills
GMP, Organization, Technical Writing, LIMS, SAP, Microsoft Office, cGMP, SOP, CAPA, Sop, FDA, Biotechnology, Pharmaceutical Industry, Biopharmaceuticals, Quality Assurance, Purification, Aseptic Technique, UV/Vis, Deviations, Quality Control, Chromatography, Manufacturing, Microbiology, Change Control, 21 CFR Part 11, Filtration, Cleaning Validation, Laboratory, Aseptic Processing, GxP, HPLC, Vaccines, Technology Transfer, Monoclonal Antibodies, Clinical Development, GLP, Software Documentation, Validation, Lifesciences, Trackwise, Biochemistry, Drug Development
Education
Cedar Crest College 2000 — 2005
BS, Chemistry
Pfitech Business Solutions October 2014 - Present
Partners in IT Inc. July 2014 - August 2014
TEKsystems January 2014 - July 2014
SA IT Services November 2013 - December 2013
Self-employed October 2012 - October 2013
Modis January 2012 - August 2012
Six Flags May 2011 - October 2011
Apex Systems September 2010 - January 2011
The Genusys Group October 2004 - February 2007
Medarex October 2005 - April 2006
Skills
System Administration, Active Directory, Troubleshooting, Windows 7, Technical Support, Help Desk Support, Software Installation, Laptops, Networking, System Deployment, Hardware, Microsoft Office, Windows, XP, Servers, TCP/IP, Operating Systems, Printers, Customer Service, Information Technology, Windows Server, Training, Blackberry, Visio, Analysis, Computer Hardware, SharePoint, Disaster Recovery, VPN, Outlook, Databases, Windows Vista, Customer Relations, Excel, Administration, Problem Solving, Security, Vendor Management, Group Policy, Remote Desktop, VMware, Microsoft Exchange, A+ Certified, Network + Certified, Microsoft Technologies, HP, Switches, Citrix, SCCM, DHCP
Education
Georgian Court University 2007 — 2010
Bachelor's degree, Accounting and Business/Management, 3.8
Ocean County College 1994 — 1997
Associate of Arts (AA), Liberal Arts and Sciences/Liberal Studies, 3.7
Bristol-Myers Squibb June 2014 - Present
Bristol-Myers Squibb March 2010 - June 2014
Medarex June 2002 - March 2010
Skills
Validation, Technology Transfer, GMP, Purification, Protein Chemistry, Biopharmaceuticals, Lifesciences, Sop, Chromatography, Protein Purification, Pharmaceutical Industry, Biotechnology, Cell Culture, HPLC, GLP, FDA, Monoclonal Antibodies, LIMS, Assay Development
Education
Penn State University
Bachelor's degree, Chemical Engineering
North Carolina State University
Master's degree, Chemical Engineering
Consultant in Alliance and Program Management January 2013 - Present
Dr Reddys Laboratories December 2010 - September 2012
Independent Consultant 2010 - February 2011
Medarex 2004 - 2010
Abbott Laboratories Immunosciences Center 2002 - 2004
PPD Development, INC January 2001 - January 2002
Nycomed Amersham Imaging January 1996 - January 2000
Independent 2000 - 2000
Hoechst Roussel Pharmaceuticals, Inc. January 1977 - January 1996
Skills
Team Leadership, Clinical Development, CTMS, Clinical Trials, CRO, Pharmaceutical Industry, Oncology, GCP, Biotechnology, Clinical Research, Clinical Data Management, Sop, FDA, Regulatory Affairs, Regulatory Submissions, Protocol, Pharmacovigilance, Medical Devices, EDC, Drug Development, Infectious Diseases, Therapeutic Areas, Immunology, IND, Clinical Operations, R&D, Endocrinology, Biopharmaceuticals, Cardiology, Gastroenterology, Cross-functional Team..., Process Improvement, Rheumatology, Program Management, Clinical Pharmacology, Neurology, Phase I, GLP, Lifesciences, Technology Transfer, Vaccines, GMP, Quality Assurance, 21 CFR Part 11, Diabetes, Medical Writing, Clinical Monitoring, ICH-GCP, Pharmaceutics, Drug Discovery
Education
American Management Association
Certificate
BLOOMSBURG STATE COLLEGE
BA
Illinois State University
M.S.
REG Life Sciences September 2011 - Present
Geron Corporation March 2006 - August 2011
Medarex January 2000 - February 2006
Skills
Process Improvement, GMP, Biotechnology, SOP, Validation, FDA, Pharmaceutical Industry, Biopharmaceuticals
Education
Humboldt State University
Bristol-Myers Squibb September 2013 - Present
Bristol-Myers Squibb March 2010 - September 2013
Medarex July 2008 - March 2010
Skills
Biotechnology, Sop, GMP, LIMS, Biopharmaceuticals, Validation, CAPA, Technology Transfer, FDA, 21 CFR Part 11, Change Control, Microbiology, Cell Culture, ELISA, Assay Development, Trackwise, Immunology, Quality System, Biochemistry, Aseptic Technique, Immunoassays, Flow Cytometry, Regulatory Submissions, Monoclonal Antibodies, Cell Biology, Western Blotting, Antibodies, Lifesciences, GLP, Molecular Biology, Cell, HPLC, Protein Chemistry, Vaccines, Environmental Monitoring
Education
Kean University 1994 — 1998
B.S., Biology
Roselle Catholic 1990 — 1994
Novartis August 2014 - Present
Novartis January 2013 - Present
Dendreon 2010 - January 2013
Bristol-Myers Squibb 2009 - 2010
Medarex 2007 - 2009
Medarex 2005 - 2007
Skills
LIMS, Aseptic Technique, Microbiology, Environmental Monitoring, Aseptic Processing, Biopharmaceuticals, GMP, Monoclonal Antibodies, cGMP practices, Immunology, Quality Control, Biotechnology, Endotoxin, FDA, Validation, Assay Development, Bioburden, Bacterial Identification, Gram Staining, TOC, Vaccines, Sop, Cell, Antibodies, Drug Development, Pharmaceutical Industry, Technology Transfer, CAPA, ELISA, Cell Culture, Conductivity, HPLC, SDS-PAGE, Protein Chemistry, Purification, Chromatography, Sterility, Mycoplasma, FMEA, Gap Analysis, Risk Assessment, White Papers, Clean Rooms, ICH Guidelines, USP, 21 CFR Part 11, Code of Federal..., IND, R&D, Luminescence
Education
Rutgers, The State University of New Jersey-New Brunswick 1999 — 2003
Bachelor of Science (B.S.), Biology, General
Boehringer Ingelheim Pharmaceuticals May 2011 - Present
Enzon Pharmaceuticals July 2010 - May 2011
Independent Contractor April 2010 - May 2011
Medarex 2000 - March 2010
Roberts Pharmaceutical Corp. 1999 - 2000
Skills
Global Drug Development, Biotherapeutics, Regulatory Guidelines, Regulatory Interactions, Toxicology
Education
Rutgers University-New Brunswick
BA
University of Medicine and Dentistry of New Jersey
PhD
Merck (Contract Position with Spectrforce Technologies Inc.) August 2013 - August 2015
Bristol-Myers Squibb 2010 - 2013
Medarex/Bristol-Myers Squibb 2005 - 2010
Medarex 2001 - 2005
Medarex 1999 - 2001
Ortho Biotech 1994 - 1999
Skills
LIMS, Environmental Monitoring, Microbiology, Aseptic Processing, Sop, Quality Control, CAPA, GMP, Trackwise, Biopharmaceuticals, 21 CFR Part 11, Validation, FDA, Regulatory Requirements, Cleaning Validation, Laboratory, Assay Development, Change Control, Chemistry, Pharmaceutics, SOP
Education
Rutgers University-New Brunswick 1989 — 1992
BA, Biological Sciences
Bristol-Myers Squibb January 2010 - Present
Medarex September 2001 - January 2010
OraSure Technologies October 2000 - September 2001
Smithkline Beecham Clinical Laboratories August 1999 - August 2000
SmithKline Beecham Clinical Laboratories February 1989 - July 1999
Education
Cedar Crest College
BS, Biology, minor chemistry
Bristol-Myers Squibb, Princeton, New Jersey February 2010 - Present
Medarex June 1998 - February 2010
Education
Rutgers University-New Brunswick 1998 — 2002
BA, Political Science
Essex County College 1994 — 1996
AS, Business Administration
Medarex Office and Facilities CoordinatorMedarex2002 - 2010
Medarex, Princeton, NJ 2002 - 2010
Education
Middlesex County College 1975 — 1976
I took courses as part of a continuing education plan.
East Brunswick High School 1964 — 1968
High School
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - Present
Bristol-Myers Squibb, Princeton, New Jersey May 2010 - January 2011
Medarex March 2008 - April 2010
Medarex September 2006 - March 2008
Johnson & Johnson June 2003 - August 2006
Galderma December 2002 - June 2003
Galderma November 2000 - December 2002
Johnson & Johnson September 1999 - November 2000
Johnson & Johnson November 1998 - September 1999
Rutgers, The State University of New Jersey July 1997 - November 1998
Skills
Clinical Trials, GCP, Medical Affairs, Protocol, Clinical Operations, Pharmaceutical Industry, Clinical Monitoring, ICH-GCP, Biotechnology, Clinical Development, GMP, Regulatory Submissions
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (B.A.), Biology and Anthropology
Bristol-Myers Squibb May 2012 - Present
Laureate Pharma April 2011 - May 2012
Medarex August 2001 - December 2010
Koh-I-Noor, Inc. 1989 - August 2001
Education
Ramapo College of New Jersey 1977 — 1981
BA, Environmental Studies
EMR CPR August 2012 - Present
Indiana University School of Medicine April 2011 - July 2012
Kelley School of Business 2006 - 2011
Medarex 2005 - 2006
Genentech 2005 - 2006
Skills
Healthcare Information..., Hospitals, Lifesciences, Pharmaceutical Industry, Medicine, Healthcare, EMR, Oncology, Clinical Trials, Physicians, Program Management, Biotechnology, Team Leadership, Customer Service, Clinical Research, Data Analysis, Medical Education, Cancer, Molecular Biology
Education
Indiana University - Kelley School of Business 2010 — 2011
MBA
Indiana University School of Medicine 2006 — 2011
MD
California State University-East Bay 2000 — 2005
B.S., Biology
Bristol-Myers Squibb, Princeton, New Jersey March 2010 - Present
Medarex February 2002 - February 2010
Medarex February 2002 - February 2010
LabCorp 1999 - 2002
Skills
Aseptic Technique, Media optimization, Cell Culture, Cell, SMO, Microbiology, GLP, ELISA, GMP, Biopharmaceuticals, LIMS, Biotechnology, Assay Development, Purification, Monoclonal Antibodies
Education
Rutgers University-New Brunswick 1994 — 1998
B.S., Animal Science
Immaculata High School 1990 — 1994
Sartorius Stedim Biotech July 2010 - Present
Medarex May 1996 - July 2010
Skills
Biotechnology
Education
Ohio University 1991 — 1995
Medarex November 2001 - Present
JNJ PSGA October 2000 - October 2001
Garden State Cancer Center 1998 - 2000
Education
Lehigh University 2009 — 2010
Regulatory Affairs
Rutgers University-New Brunswick 2008 — 2009
mini-MBA, Biopharma Innovation
Montclair State University 1996 — 1998
BA, biology/chemistry
Ohio Wesleyan University 1994 — 1996
Pre-professional zoology
Bristol-Myers Squibb March 2010 - Present
Medarex November 2005 - March 2010
Sartorius 2002 - 2005
Skills
Biotechnology, 21 CFR Part 11, Pharmaceutical Industry, Lifesciences, LIMS, Vaccines, Quality Assurance, FDA, Materials Management, Regulatory Affairs, SAP, Biopharmaceuticals, CAPA, Technology Transfer, Change Control, GMP, Clinical Development, Validation, Sop, GLP, Drug Development, Regulatory Submissions, Aseptic Processing, Computer System..., V&V, Clinical Trials
Education
Lehigh University
BS, Business
Wilkes University
MBA, Management and Marketing
Bristol-Myers Squibb January 2010 - Present
Medarex September 2008 - January 2010
Celgene January 2008 - September 2008
Novartis November 2002 - 2008
Education
College of Saint Elizabeth 1997 — 2001
MA, Psychology
Centenary College 1993 — 1996
BA, Psychology
Bristol-Myers Squibb March 2010 - Present
Medarex March 1999 - February 2010
Interferon Sciences September 1995 - March 1999
Ethicon January 1995 - September 1995
Skills
Validation, GMP
Education
Rutgers University-New Brunswick
Bachelors of Arts, Biology
BioVision November 2012 - August 2014
MedImmune March 2008 - 2012
Maxygen September 2005 - April 2006
Medarex November 2004 - March 2005
Abmaxis October 2003 - February 2004
Skills
SDS-PAGE, ELISA, Gyros, Purification, FACS, Protein Characterization, Cell Based Assays, Protein Chemistry, Monoclonal Antibodies, Immunoassays, Cell, Protein Purification, Cell Culture, Western Blotting, Antibodies, Assay Development, GMP, RT-PCR
Education
Bharati Vidyapeeth 1991 — 1995
Foothill
Certificate of Proficiency
Pune University
Bachelor of Science; bachelor's degree in U.S
Medarex 2001 - 2010
Ingersoll-Dresser Pump Company/Flowserve 1999 - 2000
Ingersoll-Dresser Pump Company 1998 - 1999
Ingersoll-Dresser Pump Company 1996 - 1998
Ingersoll-Dresser Pump Company 1995 - 1996
Ingersoll Rand/Ingersoll-Dresser Pump Company 1992 - 1995
Ingersoll Rand 1988 - 1992
Skills
Financial Reporting, Payroll, Cost, Journal Entries, Accounting, Cost Accounting, Forecasting, Budgeting, Costing, Spreadsheets, Financial Analysis, Technology Transfer, Sop, Budgets, Auditing, 21 CFR Part 11, FDA, Finance, Vaccines, Target Costing, Regulatory Submissions, CAPA, Account Reconciliation, Microsoft Excel, SEC filings, CRO, Validation, Biotechnology, Change Control, Data Management, Clinical Development, CTMS, EDC, Software Documentation, Protocol, Oncology, Due Diligence, GCP, Analysis, Clinical Data Management, Biopharmaceuticals, SOP
Education
Bloomsburg University of Pennsylvania
Bachelor of Science-Business Administration, Accounting
Olympus October 2014 - Present
Olympus 2014 - 2015
Olympus 2014 - 2015
Olympus 2014 - 2015
Olympus 2014 - 2015
Charles River Laboratories January 2014 - October 2014
McNeil Consumer Healthcare August 2013 - December 2013
Sanofi Pasteur, Swiftwater PA December 2012 - July 2013
Medarex 2003 - 2004
Inolex Chemical 1996 - 1997
Skills
GMP, Manufacturing, Quality Assurance, Quality Control, Sop, CAPA, 21 CFR Part 11, LIMS, FDA, Change Control, Validation, Biotechnology, Pharmaceutical Industry, Vaccines, Microbiology, Cell Culture, Biopharmaceuticals, Aseptic Processing, GLP, Aseptic Technique, Laboratory, Purification, SDS-PAGE, Immunoassays, Protein Purification, V&V, Regulatory Submissions, Drug Discovery, Technology Transfer, Assay Development, Quality System, Regulatory Affairs, Monoclonal Antibodies, SOP, Clinical Trials, Lifesciences, ELISA, GxP, Trackwise, Computer System..., Chromatography, Protocol, HPLC, CRO, Protein Chemistry, GCP, Clinical Development, Drug Development
Education
East Carolina University 1991 — 1993
BS, Biochemistry
West Virginia University 1983 — 1987
BS, Secondary Science Education
Elements 5 Investment Management, LLC April 2013 - Present
Axiom August 2012 - Present
Dartmonkey Trading and Investment Capital Management January 2010 - December 2012
Medarex November 2001 - January 2010
Schering-Plough July 1999 - November 2001
Darby & Darby, P.C. August 1998 - July 1999
Merck June 1996 - June 1998
Skills
Financial Planning, Investment Management, Wealth Management, Portfolio Management, Investment Strategies, Asset Allocation, ETFs, Options Spread Trading, Due Diligence, Client Counseling
Education
College for Financial Planning
Accredited Wealth Management Advisor(SM), Wealth Management
Seton Hall University School of Law 1995 — 1998
JD
Rutgers University & UMDNJ 1991 — 1994
Master of Science (MS), Cell and Developmental Biology
Lafayette College 1987 — 1991
Bachelor of Arts (BA), Biology
Air Products and Chemicals, Inc. July 2011 - Present
Medarex September 2005 - December 2010
BASF February 1995 - September 2004
Education
Rutgers University-New Brunswick
HR Management Program
Medarex Staff BiologistMerck2001 - 2006
Education
Rutgers University-New Brunswick 1998 — 2001
University of Alaska Fairbanks 1997 — 1998
Synthes DePuy April 2014 - Present
ReSearch Pharmaceutical Services July 2011 - April 2014
Contracting August 2010 - July 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2009 - August 2010
Medarex December 2007 - July 2008
Icon Clinical November 2006 - July 2007
Phoenixville Hospital January 2001 - January 2006
IRB of Phoenixville Hospital 2004 - 2004
RHMC August 1999 - June 2001
Alcon Precision Device Facility March 1991 - August 1998
Skills
Pharmacovigilance, Drug Safety, Clinical Trials, MedDRA, Regulatory Submissions, Oncology, Regulatory Affairs, Clinical Research, Sop, Clinical Development
Education
Eastern University 2003 — 2004
BSN, Nursing
Alvernia College 1997 — 1999
ADN, Nursing
Reading Hospital School of Surgical Technology
Surgical technology, certificate
Celldex Therapeutics July 2012 - Present
Celldex Therapeutics February 2009 - August 2012
Celldex Therapeutics March 2006 - February 2009
Medarex July 2005 - March 2006
Medarex October 2001 - June 2005
BD Biosciences June 2000 - September 2001
Memorial Sloan-Kettering Cancer Center (MSKCC) August 1996 - June 2000
Skills
Hematology, Oncology, Immunology, Therapeutic antibodies, Cancer vaccine, Immunoassay, Target identification, Transgenic mouse model, Animal studies
Education
Fujian Medical University 1977 — 1982
medicine
SolarCity February 2012 - June 2013
Molecular Nanosystems July 2011 - December 2011
Molecular Nanosystems April 2011 - June 2011
Amyris Biotechnologies September 2009 - February 2011
BD October 2008 - June 2009
Medarex July 2007 - September 2008
Stanford University, Department of Bioengineering October 2005 - September 2007
Eksigent Technologies January 2007 - July 2007
Eksigent Technologies December 2005 - January 2007
Caliper Life Sciences March 2005 - December 2005
Education
University of California, Davis 1999 — 2002
Biological Systems, Engineering
Las Positas College 1996 — 1999
Transfer, General
UCLA Health System July 2014 - Present
UCLA Health System June 2013 - June 2014
UCLA Health System June 2010 - June 2013
Medarex September 2004 - June 2006
Education
Tufts University School of Medicine 2006 — 2010
M.D.
Princeton University 2000 — 2004
A.B.
The Commonwealth Medical College December 2013 - Present
The Commonwealth Medical College June 2008 - Present
Genaera Corporation October 2007 - June 2008
JK Associates 2004 - 2008
University of Florida March 2005 - September 2007
BioCentric, Inc. May 2003 - July 2004
Thomas Jefferson University December 2002 - May 2003
Medarex May 1996 - August 1997
Skills
Transfection, Protein Expression, Molecular Biology, Fluorescence Microscopy, Physiology, Molecular Cloning, Cell Biology, Genetics, Biochemistry, Lifesciences, Protein Purification, Gel Electrophoresis, Western Blotting, SDS-PAGE, DNA extraction, qPCR, DNA, Medical Writing, Immunohistochemistry, PCR, Protein Chemistry, Neuroscience, Cell Culture, Tissue Culture, Medical Education, Microscopy, ELISA, HPLC, Cell, Science, Drug Discovery, Cancer, Biotechnology, Mass Spectrometry, Animal Models, Pharmacology, Immunology, Assay Development, Cell Signaling, Genomics, Flow Cytometry, Infectious Diseases, Vaccines, Site-directed..., Scientific Writing, Signal Transduction, RT-PCR, Confocal Microscopy, X-ray crystallography, Proteomics
Education
Thomas Jefferson University 1997 — 2002
PhD, Biochemistry and Molecular Biology
Cedar Crest College 1992 — 1996
BS, Genetic Engineering
Instrumentation Laboratory October 2007 - Present
Medarex January 2004 - August 2007
Skills
Assay Development, R&D, Design Control, Protein Chemistry, Medical Devices, Immunoassays, FDA, ELISA, Enzyme Assays, Coagulation, Biochemistry, IVD, Biotechnology, Chromatography, HPLC, Lifesciences, GMP, Laboratory, Life Sciences
Education
University of Medicine and Dentistry of New Jersey 1996 — 1998
Master of Science (MS), Biochemistry, Biotechnology
Kean University 1992 — 1995
Bachelor of Science (B.S.), Biochemistry
Janssen July 2014 - Present
Bristol-Myers Squibb November 2012 - November 2013
Kelly Services February 2010 - December 2011
Jonson and Johnson 2010 - 2011
LifeCell Corp February 2008 - September 2009
Aerotek May 2006 - February 2007
Grunenthal USA May 2005 - April 2006
Medarex October 2003 - July 2004
Whiting-Turner Contracting Company May 2003 - July 2003
Pharmacia November 2001 - June 2002
Skills
Administration, Software Documentation, Research, Analysis, Budgets, Strategic Planning, Database Administration, Teamwork, Team Leadership, Customer Service, Process Scheduler
Education
Cittone Institute
Linden High School
Secretarial Science
Raritan Valley Community College
Business and Office Management
Celgene Corporation March 2009 - Present
Celgene Corporation March 2009 - Present
Celgene Corporation March 2008 - Present
Celgene Corporation March 2008 - March 2009
Medarex, Inc July 2005 - March 2008
Medarex June 2005 - March 2008
Integrium, LLC May 2004 - May 2005
Schering-Plough Research Institute November 2002 - January 2004
Schering-Plough Research Institute August 1999 - November 2002
Novartis Pharmaceutical Corporation November 1997 - August 1999
Skills
Clinical Research..., Computer Software, Clinical Trials, GCP, Oncology, Immunology, Drug Discovery, Biotechnology, Sop, Pharmaceutical Industry, Lifesciences, Regulatory Affairs, Clinical Research, Clinical Development, Protocol, Clinical Study Design
Education
Fairleigh Dickinson University
Bachelor of Science (BS), Medical Technology
Fairleigh Dickinson University
Master of Science (MS), Mathematics and Computer Science
Fairleigh Dickinson University
M.S, Mathematics; Computer Science
Fairleigh Dickinson University
B.S, Medical Technology
Medarex September 2006 - April 2008
Veridex June 2004 - June 2006
Roche Pharmaceuticals June 2002 - June 2004
Skills
Molecular Biology, Cell Culture, Assay Development, ELISA, Cell, Drug Discovery, qPCR, Life Sciences, Validation, Laboratory, Transfection, Antibodies
Education
William Paterson University of New Jersey 2000 — 2002
Master of Science (MS), Biotechnology
Mangalore University 1991 — 1994
Master of Science (MSc), Medical Microbiology and Bacteriology
B. Braun Medical Inc March 2009 - Present
Medarex October 2006 - March 2009
Veridex, LLC (a Johnson and Johnson Company) January 2004 - October 2006
ASSOCIATE SCIENTIST July 2003 - December 2003
University of Pennsylvania School of Medicine August 2000 - July 2003
OraSure Technologies August 1999 - December 1999
Skills
NDA, ANDA, Regulatory Submissions, eCTD, FDA, CMC Regulatory Affairs, Regulatory Requirements, Strategy, Technical Support, Product Development
Education
University of Pennsylvania 2001 — 2003
Master's degree (M.S.), Molecular Biotechnology
Lehigh University 2008 — 2009
Certificate in Regulatory Affairs, Regulatory Affairs in a Technical Environment
DeSales University 1996 — 2000
Bachelor of Science (B.S.), Biology, General
Bristol-Myers Squibb March 2014 - Present
Bristol-Myers Squibb June 2010 - Present
Medarex July 2002 - June 2010
Medarex January 1999 - July 2002
Skills
GMP, Biopharmaceuticals, Purification, Chromatography, Aseptic Processing, Manufacturing, Technology Transfer, Process Improvement, Continuous Improvement
Education
Rutgers, The State University of New Jersey-New Brunswick 1994 — 1998
Bachelor of Science (BS), Biochemistry
Celgene October 2007 - Present
Johnson & Johnson, Veridex, LLC April 2006 - October 2007
Medarex March 2004 - April 2006
Johnson & Johnson, NCS January 2003 - March 2004
Johnson & Johnson, NCS January 2002 - January 2003
Skills
CRO Oversight, Project Management, CRA Training..., IATA/ICAO Biological..., GCP Training, Basware, CTMS, Endpoint, Oracle, Ariba, Microsoft Word, Excel,..., CSFA/Access, CT.Gov, AmEx Travel/Concur
Education
Rutgers University-New Brunswick 2008 — 2014
Bachelor of Arts (BA), Communications/English, Scholarship Recipient, Dean's List