Human Genome Sciences
Industry: Biotechnology company
DescriptionHuman Genome Sciences was a biopharmaceutical corporation founded in 1992 by Craig Venter, Alan Walton and Wally Sternberg. It uses the human DNA sequence to develop protein and antibody drugs. Founder: Craig Venter Founded: 1992 CEO: Andrew Witty (1 Aug 2012–) Headquarters: Rockville, Maryland, United States Parent organization: GlaxoSmithKline Subsidiaries: Human Genome Sciences Pacific Pty Ltd,
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Human Genome Sciences Employees
Pro Football Zone LLC September 2010 - Present
Human Genome Sciences August 2005 - January 2012
GEICO November 2004 - July 2005
GEICO October 2003 - November 2004
Consolidated Delivery and Logistics June 2002 - September 2003
Skills
Football, Sports, Blogging, NFL, Sports Marketing, Sports Management, Sponsorship, Athletics, Sports Writing, Event Management, Social Media, Sports Coaching, Event Planning, Soccer, Public Relations, Social Media Marketing, Scouting, Coaching, Facebook, Media Relations, Marketing Communications, Social Networking
Education
St. Agnes Boys High School 1999 — 2001
High School Diploma, N/A
Ramapo High School 1997 — 1999
tranferred to St. Agnes
Towson University
A plus and Network plus certification, Information Technology
AstraZeneca October 2012 - Present
Human Genome Sciences October 2007 - October 2011
Skills
GMP, GLP, Validation, Biopharmaceuticals
Education
Université de Nantes
Master's degree, Quality Control Management in Agro-Food Enterprises
Université de La Rochelle
Janssen Biotech February 2015 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson 2012 - Present
Human Genome Sciences October 2010 - 2012
Bristol-Myers Squibb March 1999 - October 2010
Skills
Rheumatology, Managed Care, Buy & Bill, Biologics, Immunology, Gastroenterology, Neuroscience, Pharmaceutical Sales, Neurology, Cardiology, Dermatology, Pulmonology, Selling Skills, Pharmaceutics, Infectious Diseases, Biotechnology, Oncology, Lupus, Product Launch, Sales Effectiveness, Pharmaceutical Industry, Nephrology, Therapeutic Areas, Osteoporosis, Clinical Development, Rheumatoid Arthritis, Monoclonal Antibodies, Diabetes, Hospitals, Reimbursement, Psychiatry, Market Access, Sales Force Development, OB/GYN, Hematology, Medical Devices, Vaccines, Account Management, Mentoring, Strategic Planning, Contract Negotiation, Biopharmaceuticals, Product Launches, Consultative Selling, Plastic Surgery, Surgery, Anesthesiology, Respiratory Products, Hospital Sales, Endocrinology
Education
The University of Connecticut
BS, Microbiology
University of New Haven
MBA, Finance
Self-employed 2011 - Present
Human Genome Sciences January 2008 - December 2010
Human Resources International (HRI) January 2006 - December 2007
Skills
Human Rights, Human Computer..., Human Factors, Human Capital
Education
Texas State Technical College Harlingen 2003 — 2005
Master of Business Administration (MBA)
Texas State Technical College Harlingen 2000 — 2003
bba
Genentech March 2009 - Present
Genentech August 2007 - March 2009
Genentech January 2005 - August 2007
Genentech September 2002 - January 2005
Human Genome Sciences March 2001 - September 2002
Skills
Biotechnology, Cell Culture, JavaScript, Node.js, Puppet, Ruby, Sinatra, jQuery, CSS, HTML, Git, Test Driven Development, Google Search Appliance, Continuous Integration, SQL, ASP.NET, C#, VB.NET, VBA, Linux, Certified Scrum Master..., Oracle, Microsoft SQL Server, Process Control, Protein Purification, Fermentation Process..., JMP, Validation, Data Analysis, Agile Methodologies, Product Management
Education
Webb School of California 1983 — 1987
UC Davis
Bachelor of Science (BS), Environmental Toxicology
InHouse Patent Counsel, LLC January 2013 - Present
Human Genome Sciences 1998 - 2012
Finnegan Henderson 1995 - 1998
Skills
Intellectual Property, Litigation, Biotechnology, Technology Transfer, Biopharmaceuticals, Lifesciences, Patent Prosecution, Patents, Pharmaceutical Industry, Patent Litigation, Immunology, Licensing, Drug Discovery, Molecular Biology, FDA
Education
The George Washington University Law School 1994 — 1997
Doctor of Law (J.D.)
Johns Hopkins School of Medicine 1989 — 1994
Doctor of Philosophy (Ph.D.), Human Genetics and Molecular Biology
The University of Connecticut 1985 — 1989
Bachelor of Science (B.S.), Cell/Cellular and Molecular Biology
MacroGenics, Inc. July 2014 - Present
Questcor Pharmaceuticals, Inc. September 2013 - July 2014
Emergent BioSolutions (TechUSA) 2013 - September 2013
Human Genome Sciences 2011 - 2013
PAREXEL 2010 - 2011
Spring Grove State Hospital 2007 - 2010
National Institutes of Health 2005 - 2005
Skills
GCP, Auditing, Internal Audit, Vendor Audit, Gel Electrophoresis, MS Office Suite, Phlebotomy, FDA, Microsoft Office, Oncology, Quality Assurance, Clinical Research, CAPA
Education
The Johns Hopkins University 2012 — 2016
Master's degree, Biotechnology
The Johns Hopkins University - Carey Business School 2012 — 2016
Master of Business Administration (M.B.A.)
University of Maryland Baltimore County 2006 — 2010
Bachelor of Science (B.S.), Biology, General
Genentech 2006 - 2009
Human Genome Sciences 2001 - 2003
Skills
Biotechnology, Change Control, GMP, Biopharmaceuticals, Pharmaceutical Industry, Validation, Drug Development, 21 CFR Part 11, FDA, Technology Transfer, Sop, Clinical Development, Computer System..., Aseptic Processing, GxP, GLP, V&V, CAPA, IND, Regulatory Submissions
Education
University of California, Berkeley 2007 — 2010
Post-Bac Pre-Med
The Johns Hopkins University
Leidos May 2015 - Present
National Institutes of Health November 2010 - April 2015
University of Delaware 2005 - 2010
PolyLC, Inc. June 2004 - January 2005
Human Genome Sciences 2003 - 2003
Skills
Cell Biology, Molecular Biology, PCR, Assay Development, Protein Chemistry, Western Blotting, Cell Culture, Fluorescence Microscopy, Protein Expression, DNA, Purification, Biochemistry, Gel Electrophoresis, Tissue Culture, Cell, Transfection, qPCR, RT-PCR, Protein Purification, Microscopy, Immunofluorescence, Confocal Microscopy, Molecular Cloning, RNA isolation, Flow Cytometry, Blogging, Cancer
Education
University of Delaware 2005 — 2010
Ph.D., Biological Sciences
Susquehanna University 2001 — 2005
B.S., Biology
Shire January 2015 - Present
Shire HGT January 2011 - December 2014
Pfizer October 2009 - January 2011
Wyeth September 2005 - September 2009
Testa, Hurwitz & Thibeault, LLP/ K&L Gates November 2002 - September 2006
Hogan & Hartson, LLP August 2000 - September 2002
Human Genome Sciences February 1997 - January 1999
Skills
Patents, Patent Prosecution, Biotechnology, Patentability, Lifesciences, Intellectual Property, Due Diligence, Pharmaceutical Industry, Technology Transfer, Licensing, Trademarks, Patent Litigation, Litigation, Corporate Law, Biopharmaceuticals, Life Sciences, Legal Writing, Trade Secrets
Education
University of Maryland College Park 1992 — 1996
Bachelor of Science (BS), Molecular Biology
The Catholic University of America, Columbus School of Law
Juris Doctor, Law, Magna Cum Laude
GlaxoSmithKline December 2012 - Present
Human Genome Sciences October 2010 - Present
Human Genome Sciences May 2008 - October 2010
University of Maryland February 2008 - June 2008
NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY GAITHERSBURG October 2007 - May 2008
CVS Pharmacy June 2003 - April 2008
HOWARD HUGHES MEDICAL INSTITUTE BETHESDA, MARYLAND August 2005 - June 2007
Skills
Cell Culture, Biotechnology, GMP, Lifesciences, PCR, HPLC, Aseptic Technique, Pharmaceutical Industry, Sop, Validation, Purification, Chromatography, Molecular Biology, SDS-PAGE, ELISA, Biopharmaceuticals, Gel Electrophoresis, GLP, Biochemistry, Microbiology
Education
The Johns Hopkins University
Masters of Science, ZANVYL KRIEGER ARTS AND SCIENCES; Advance Biotechnology, 4.0
University of Maryland College Park 2004 — 2008
Bachelor's of Science, Cell Biology and Molecular Genetics, 3.7
GSK November 2013 - Present
GSK December 2012 - November 2013
Human Genome Sciences January 2012 - December 2012
Human Genome Sciences October 2005 - January 2012
Human Genome Sciences May 2004 - October 2005
Novozymes November 2001 - August 2003
Skills
Cleaning Validation, Validation, GMP, Aseptic Processing, Biopharmaceuticals, Fermentation, Technology Transfer, Biotechnology, CAPA, V&V, Sop, FDA, Change Control, GLP, LIMS, Purification, Filtration, 21 CFR Part 11, Chromatography, Aseptic Technique, Downstream Processing, Pharmaceutical Industry, Ultrafiltration, Protein Purification, Trackwise, Cell Culture, Deviations, Process Simulation, GxP, Monoclonal Antibodies, Quality System, Sterilization, CIP, cGMP manufacturing, Bioreactor, Contract Manufacturing, Chemical Engineering, Six Sigma, Process Engineering, SOP
Education
Universidade Federal de Santa Catarina 1996 — 2000
BS, Food/Chemical Engineering
DaVita 2011 - 2013
Human Genome Sciences 2010 - 2011
Eisai, Inc. 2008 - 2010
Amgen 2004 - 2008
Amgen 2000 - 2004
Amgen 2000 - 2002
Amgen 1996 - 2000
Amgen 1992 - 1996
Amgen 1990 - 1992
GlaxoSmithKline 1987 - 1990
Skills
Executive Leadership, Cross Functional Teams, New Product Launch, Branding Strategy, Brand Development, Mergers & Acquisitions, Strategic Partnerships, Organizational..., Oncology, Nephrology, Rheumatology, Advocacy & Access Groups, Contract Negotiation, Legal & Regulatory..., Government Affairs &..., Budgeting & Forecasting, Cross-functional Team..., Hospital Sales, Leadership, Product Development, Sales Operations, Managed Care, Marketing Strategy, Team Leadership
Education
The Ohio State University
BS, Science, Clinical Nutrition
GlaxoSmithKline July 2013 - Present
Human Genome Sciences July 2010 - July 2013
Montgomery County Department of Police 2007 - 2010
Skills
Security, Private Investigations, Physical Security, Security Operations, Surveillance, Security Management, Emergency Management, Investigation, Risk Assessment, Executive Protection, Homeland Security, Counterterrorism, Security Clearance, Supervisory Skills, Government, Military, DoD, Workplace Violence, Information Security, Risk Management, emergency, Background Checks
Education
The Johns Hopkins University 2004 — 2006
Master's Degree, Management
University of Maryland University College 1979 — 1980
Bachelor of Science (BS), Criminal Justice/Police Science
GlaxoSmithKline September 2012 - Present
Human Genome Sciences July 2012 - August 2012
Genentech October 2001 - June 2012
Roche October 1996 - October 2001
Marion Merrill Dow, Inc. (Aventist) April 1985 - December 1995
Skills
Mac, HP, Outlook, Microsoft Office, Buy & Bill, Goal Oriented, Cardiology, Biotechnology, Managed Care, Oncology, Infectious Diseases, Pharmaceutical Industry, Pharmaceutical Sales, Endocrinology, Immunology, Rheumatology, Hospital Sales, Gastroenterology, Allergy, Neurology, Sales Force Development, Pulmonology, Osteoporosis
Education
University of Central Florida - College of Business Administration 1981 — 1984
BS, Marketing
FDA December 2012 - Present
Woodrow Wilson International Center for Scholars September 2011 - December 2012
Regulatory Affairs Professionals Society (RAPS) 2012 - 2012
Circuit Court for Worcester County February 2006 - February 2007
Financial Industry Regulatory Authority October 2005 - February 2006
Dreschler Larkin & Walters LLP October 2004 - October 2005
U.S. District Court District of Columbia January 2005 - June 2005
Office of Counsel to Inspector General, HHS June 2004 - August 2004
K&L Gates June 2003 - August 2003
Human Genome Sciences February 2001 - July 2002
Skills
Rule Of Law, Legal Research and..., Policy Analysis, FDA Regulations, Regulatory Affairs, FDA, Writing, ELISA, GMP, Clinical Development, Budgets, Data Analysis, Intellectual Property, Criminal Law, Biotechnology, Public Policy, Policy, Lifesciences, Legal Writing, Statistics, Litigation, Product Development, Government, Cell Culture, Legal Research, Nonprofits, Administrative Law, Courts, Synthetic Biology, Research, Biopharmaceuticals, International Relations, Medical Devices, Molecular Biology, Grant Writing, Science, Patents, Life Sciences
Education
The Johns Hopkins University 2010 — 2012
MS, Bioscience Regulatory Affairs
Widener University School of Law (PA) 2002 — 2005
Juris Doctorate, Law, Concentration in Intellectual Property Law
University of Maryland College Park 1998 — 2002
Bachelors, Cell Biology and Molecular Genetics
MedImmune October 2014 - Present
Teva Pharmaceuticals January 2006 - October 2014
Human Genome Sciences 2000 - 2006
Skills
Biotechnology, GLP, GMP, Lifesciences, Sop, Cell Culture, Drug Development, Biopharmaceuticals, Validation, LIMS, Pharmaceutical Industry, FDA, Technology Transfer, Regulatory Affairs, Aseptic Processing
Education
The Johns Hopkins University 2001 — 2005
MS, Biotechnoloty
University of North Carolina at Wilmington 1996 — 2000
BS, Biology and Environmental Studies
MacroGenics, Inc. May 2013 - Present
Human Genome Sciences 2007 - 2012
Human Genome Sciences 2001 - 2006
Human Genome Sciences 1998 - 2001
Skills
Biotechnology, ELISA, Assay Development, SDS-PAGE, Cell Culture, Monoclonal Antibodies, Antibodies, Western Blotting, Molecular Biology, PCR, Electrophoresis, Sample Analysis, GLP, DNA, DNA sequencing, Tissue Culture, DNA extraction, Sequencing, In Vitro
Education
The Johns Hopkins University
Master of Science, Biotechnology
Virginia Polytechnic Institute and State University
Bachelor of Science, Biochemistry
Virginia Polytechnic Institute and State University
Bachelor of Science, Biology
CEB May 2013 - May 2015
Focus Investment Banking March 2013 - April 2013
George Washington University December 2012 - March 2013
Human Genome Sciences July 2011 - December 2012
Johns Hopkins University June 2005 - August 2008
Skills
Biotechnology, Biomedical Engineering, Technology Transfer, Biomaterials, Lifesciences
Education
University of Pennsylvania - The Wharton School
MBA, Healthcare Management
The Johns Hopkins University 2008 — 2010
M.S.E, Biomedical Engineering
The Johns Hopkins University 2002 — 2005
B.S, Biomedical Engineering, Electrical Engineering
Chalant Health April 2015 - Present
HealthyWomen.org April 2013 - Present
Booz Allen Hamilton 2007 - 2015
Johns Hopkins University Carey Business School 2007 - 2007
National Cancer Institute/NIH 2004 - 2007
BioVenture LLC 2004 - 2007
Human Genome Sciences 2000 - 2004
National Institutes of Health 2000 - 2001
National Center for Biotechnology Information (NCBI/NLM/NIH) 1997 - 2000
Skills
Business Development, Drug Development, Genomics, Lifesciences, Management Consulting, Pharmaceutical Industry, Strategic Alliances, Strategic Planning, Strategy, Technology Transfer, Biotechnology, Program Management, Oncology, Nonprofits, Bioinformatics, Drug Discovery, Genetics, Molecular Biology, Life Sciences, Commercialization, Clinical Trials
Education
The Johns Hopkins University 2002 — 2005
MBA
The Johns Hopkins University 1997 — 2000
Ph.D.
Pro Bono Consulting Program at the Montgomery County Volunteer Center November 2010 - July 2012
Integrated Project Services June 2005 - December 2009
Eli Lilly June 2003 - June 2005
Human Genome Sciences June 2001 - June 2003
Merck June 1997 - June 2001
Skills
Validation, Pharmaceutical Industry, GMP, FDA, CAPA, Six Sigma, Process Engineering, Biotechnology, Change Control, 21 CFR Part 11, Project Management, V&V, Process Improvement, Sop, Cross-functional Team..., Vaccines, Medical Devices, Computer System...
Education
Temple University 2006 — 2009
MBA, Business Administration
Villanova University 1993 — 1997
BS, Chemical Engineering
Maryland Spine and Brain Specialists, LLC October 2012 - Present
Towson University June 2010 - August 2012
Human Genome Sciences January 2007 - May 2010
Applied Cell Sciences June 2006 - January 2007
Skills
Central line placement, Venipuncture, Suturing, H&P, Surgical assisting (1st..., Sterile technique, Ear Irrigation, Incision & Drainage, Vaccination, Splinting, Pelvic exam with..., BLS, ACLS, Ultrasound
Education
Towson University 2010 — 2012
MS, Physician Assistant
University of Maryland College Park
BS, Biology
U.S. House of Representatives February 2001 - Present
Software Productivity Strategist Inc, April 2000-Feb 2001 Rockville, MD April 2000 - February 2001
Johns Hopkins University January 1999 - February 2000
Johns Hopkins University January 1997 - December 1999
Floor Rio and Carpets Inc January 1997 - January 1998
Human Genome Sciences January 1995 - January 1997
Walter Reed Army Medical Center February 1991 - January 1995
Skills
SNMP, TCP/IP, Network Management..., Network Monitoring Tools, Network Performance..., Network Design, Network Architecture, Network Engineering, Wireless Networking, Computer Network..., DNS, HP Network Node Manager, CA Spectrum, Network Monitoring..., WhatsUp Gold IT and..., IT Alerting (x)..., Statseeker Network..., Maintaining a..., Linux, Teaching, Cross-functional Team..., Team Building, Team Management, Teamwork, Team-oriented, Self-starter, Self-driven, Works well individually, Cisco Technologies, Windows Server, Network Administration, Networking, Integration, Troubleshooting, Switches, Servers
Education
The Johns Hopkins University 1998 — 2000
Master's degree, Information Technology
University of Maryland College Park 1990 — 1994
Bachelor's degree, Biochemistry and Computer Science
Rheumatology Associates March 2013 - Present
Human Genome Sciences November 2010 - January 2013
Amgen December 2004 - November 2010
Accredo Healthcare - a Medco Company July 2003 - December 2004
Skills
Rheumatology, Cardiology, Managed Care, Pharmaceutical Sales, Biotechnology, Pharmaceutical Industry, Immunology, Hospitals, Dermatology, Nursing Education, IV, Critical Care, Diabetes, Nursing, Medical Affairs, Healthcare
Education
Tennessee Technological University 1983 — 1985
Bachelor of Science (BS), nursing
University of Tennessee-Knoxville 1981 — 1983
Roane County High School
PPD August 2012 - Present
Human Genome Sciences January 2007 - January 2012
Human Genome Sciences January 2006 - January 2007
Human Genome Sciences January 2004 - January 2006
Human Genome Sciences July 1998 - January 2004
Boehringer Mannheim July 1997 - May 1998
Amgen May 1996 - June 1997
Cortech January 1994 - May 1997
Procter & Gamble January 1989 - January 1994
Procter & Gamble January 1988 - January 1989
Skills
Regulatory Submissions, Regulatory Affairs, Clinical Research, Clinical Trials, Clinical Development, Clinical Monitoring, Clinical Supervision, NDA, IND
Education
The University of Connecticut Health Center
Bachelor of Science, Pharmacy
Osiris Therapeutics May 2015 - Present
ProMetic BioTherapeutics, Inc. March 2013 - May 2015
Human Genome Sciences June 2011 - December 2012
MedImmune 2010 - 2010
Meso Scale Discovery 2010 - 2010
The George Washington University July 2008 - October 2009
Skills
Regulatory Affairs, Project Management, Assay Development, ELISA, GLP, Cell Culture, Immunoassays..., GMP, Immunogenicity, Technical Writing, GraphPad Prizm, SoftMax, Biotechnology, FDA, SOP, Validation
Education
The George Washington University 2008 — 2010
MS, Biochemistry and Molecular Biology
Luhansk TS State Pedagogical University 1990 — 1995
BS, Chemistry, Biology
Regulatory Affairs Professional Society (RAPS) 2014 — 2014
Certificate, Regulatory Affairs Certificate: Pharmaceuticals
Project Management Institute (PMI) 2012 — 2013
Certificate: Certified Associate in Project Management (CAPM)®, Project Management
Office of Research & Development, US Department of Veterans Affairs August 2013 - Present
URS Corporation October 2012 - August 2013
Parenteral Drug Association 2009 - 2013
PwC PRTM Management Consulting March 2011 - October 2012
American Red Cross September 2005 - March 2011
BioVeris Corporation August 2004 - September 2005
Human Genome Sciences August 2003 - August 2004
Baxter International Inc. April 1999 - August 2003
BioReliance November 1997 - April 1999
George Washington University June 1992 - November 1997
Skills
Life Sciences, Quality Assurance, GMP, Vaccines, Quality Systems, Medical Devices, Validation, Compliance, Logistics, Process Improvement, Biotechnology, Strategic Planning, Process Development, Supply Chain Management, Product Development, Problem Solving, Healthcare, Supply Chain, cGMP, Pharmaceuticals, FDA, SOP, ISO, Documentation, Six Sigma, Team Building, Program Management, CAPA, Risk Management, Testing, HPLC, QC, Sop, Pharmaceutical Industry, Lifesciences, Technical Writing, Quality Control, Leadership, Assay Development, Laboratory, Software Documentation, Quality System, Clinical Trials, Analysis, Project Management
Education
The George Washington University 1993 — 1998
MS, Analytical Chemistry
Tunnell Government Services January 2012 - Present
Human Genome Sciences March 2011 - January 2012
Career Connection, Inc. November 2010 - March 2011
Life Technologies January 2010 - October 2010
Career Connection, Inc. 1999 - January 2010
QIAGEN March 2006 - August 2008
Otsuka 1997 - 1999
Boehringer Mannheim 1992 - 1997
NRI 1987 - 1992
Skills
Talent Acquisition, Workforce Planning, Applicant Tracking..., Biotechnology, Pharmaceutical Industry, Recruiting, Technical Recruiting, Onboarding, Sourcing, Medical Devices, Lifesciences, Internet Recruiting, Human Resources, Employee Engagement, Temporary Placement, Staffing Services, Clinical Research, Executive Search, Pharmaceutics, Deferred Compensation, Performance Management, Talent Management, Benefits Negotiation, College Recruiting, Employer Branding, Regulatory Affairs, HRIS, Employee Benefits, Quality Assurance, Organizational..., Screening, Employee Relations, Interviews, Training, Personnel Management, Screening Resumes, Strategy, Biopharmaceuticals, Management, Taleo, Leadership, Hiring, Contract Recruitment, Employee Training, Succession Planning, Permanent Placement, Government Contracting..., Proposal Recruitment, Salary Negotiation, Temporary Staffing
Education
Towson University 1983 — 1985
B.S., Business Administration
Towson University
Bachelor of Applied Science (B.A.Sc.), Marketing
Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates September 2015 - Present
University of Maryland School of Law July 2013 - May 2015
Financial Industry Regulatory Authority June 2010 - August 2011
Cheatham Tax Service January 2007 - March 2011
Human Genome Sciences June 2007 - March 2009
Skills
Income Tax, Legal Research, Legal Writing, Corporate Tax, IP Tax, Analysis, Statistics, Due Diligence, Project Management, Process Improvement, Financial Analysis, Data Analysis, Microsoft Excel
Education
University of Maryland School of Law 2011 — 2015
Juris Doctor
University of California, San Diego 2002 — 2006
Bachelor of Arts, Political Science
FDA September 2008 - Present
Human Genome Sciences June 2004 - August 2008
Human Genome Sciences June 2003 - August 2003
Skills
FDA, Biotechnology, Lifesciences, GMP, Regulatory Affairs, Validation, Cell Culture, Pharmaceutical Industry, Engineering, Technology Transfer, CAPA, Medical Devices, Sop, Data Analysis, Quality System, V&V, Biopharmaceuticals
Education
The Johns Hopkins University 2007 — 2010
MS, Biotechnology
The Johns Hopkins University - Carey Business School 2007 — 2010
MBA, Business Administration
University of Virginia 2000 — 2004
BS, Chemical Engineering
TESARO 2013 - Present
Dyax Corp. 2007 - 2013
Histogenics 2006 - 2007
Genentech 2004 - 2006
Human Genome Sciences 2001 - 2004
Gene Logic, Inc. 1998 - 2001
KPL 1988 - 1994
Skills
Quality Assurance, GMP, Biotechnology, FDA, Quality System, Sop, CAPA, Compliance, Trackwise, Quality Systems, cGMP, PAI, Master Control, Biopharmaceuticals, GLP, Technology Transfer
Education
The Johns Hopkins University
MS, Biotechnology
PRA Health Sciences November 2014 - Present
AstraZeneca / MedImmune May 2013 - October 2014
Human Genome Sciences, Inc. 2011 - 2013
Human Genome Sciences, Inc. 2009 - 2011
Human Genome Sciences 2007 - 2009
Human Genome Sciences 2005 - 2007
Human Genome Sciences 2003 - 2005
Human Genome Sciences 2002 - 2003
Human Genome Sciences 1999 - 2002
Skills
Clinical Development, Clinical Trials, Global Clinical..., Strategic Planning, Team Building, Resource..., Budget Development,..., Cross-functional Team..., Timeline Development..., Process Development and..., Vendor Performance..., Biotechnology, CRO, EDC, Team Building, Pharmaceutical Industry, GCP, ERP, Drug Development, CTMS, Regulatory Submissions, Management, Analysis, Oncology, Clinical Operations, GMP, Supplier Performance, Clinical Research, Clinical Data Management, Lifesciences, FDA, Clinical Study Design, Immunology, Pharmacovigilance, Sop, Infectious Diseases, Medical Affairs, Vaccines, Regulatory Affairs, IND, 21 CFR Part 11, Therapeutic Areas, ICH-GCP, Clinical Monitoring, GLP, Medical Writing, Life Sciences
Education
The Johns Hopkins University
MS
University of Maryland College Park
BS
Amgen March 2012 - Present
Amgen March 2008 - June 2012
Amgen November 2005 - March 2008
MedImmune May 2003 - November 2005
Human Genome Sciences January 1998 - May 2003
Skills
Molecular Pharmacology, Animal Models, Imaging Systems, Pharmacodynamics, Angiogenesis, Cell Signaling, Monoclonal Antibodies, Biomarker Discovery, Apoptosis, Flow Cytometry, ELISPOT, Immunofluorescence, Transfection, Vector NTI, Primer Design, Agarose Gel..., Project Team Leader, Drug Discovery, Drug Development, Western Blotting, Cell Culture, qPCR, In Vivo, Immunohistochemistry, Confocal Microscopy, Immunology, Stem Cells, Translational Research, Target Identification
Education
The Johns Hopkins University 1997 — 1999
MS, Biotechnology
William & Mary 1992 — 1996
BS, Biology
Takeda PharmaceuticalsQ October 2013 - Present
Endo Health Solutions October 2012 - July 2013
Human Genome Sciences September 2010 - October 2012
Centocor April 2001 - September 2010
Amgen January 1992 - July 1998
Key Pharmaceuticals 1982 - 1992
Skills
Oncology, Biotechnology, Rheumatology, Urology, Managed Care, Nephrology, Biologics, Pharmaceutical Sales, Gastroenterology, Dermatology, Buy & Bill, Endocrinology, Infectious Diseases, Neurology, Cardiology, Pharmaceutical Industry, Clinical Research, Pharmaceutics, Hospital Sales, Medical Devices, Pulmonology, Sales Effectiveness, Diabetes, Market Access, Hematology, Immunology, Product Launch, Biopharmaceuticals, Therapeutic Areas, Clinical Development, Commercialization, Medical Affairs, Vaccines, Clinical Trials, CRO, Regulatory Affairs, FDA, Osteoporosis, Sales Force Development, Drug Development, Medical Writing, Pharmacovigilance, Lifesciences, Selling Skills, Market Development, OB/GYN, Allergy, Sop, Capital Equipment, Business Acumen
Education
University of Delaware 1977 — 1981
BS, Business Administration
Foundation Fighting Blindness 2011 - Present
Section on Cellular Differentiation, PDEGEN, NICHD, NIH 1992 - Present
Correlogic Systems, Inc. 2005 - 2010
Correlogic Systems, Inc. 2004 - 2005
Human Genome Sciences 1997 - 2001
Massey University 1993 - 1997
Georgetown University 1992 - 1997
Massey University 1986 - 1997
Massey University 1986 - 1993
Skills
Molecular Genetics, Biotechnology, Cell Biology, Pharmaceutical Industry, Protein Chemistry, Biochemistry, Lifesciences, Technology Transfer, Biopharmaceuticals, Molecular Biology, Genomics, Immunology, Assay Development, Drug Discovery
Education
The Johns Hopkins University School of Medicine 1982 — 1985
Post-doctoral studies
University of Otago 1978 — 1982
PhD
University of Canterbury 1975 — 1977
B.Sc.(Hons)
SMR Bio Consulting January 2011 - Present
Celera Corporation April 2003 - December 2010
Human Genome Sciences November 1992 - March 2003
Roche Institute of Molecular Biology November 1988 - November 1992
Skills
Proteomics, Assay Development, Drug Discovery, Biomarkers, Bioinformatics, Lifesciences, Genomics, Cell, Biotechnology, Cancer, Genetics, Protein Expression, Cell Biology, Validation, Protein Chemistry
Education
University of Cincinnati 1980 — 1988
Ph.D. M.S., Molecular/Cell Biology
The Ohio State University 1974 — 1979
Bachelor of Science (B.S.), Biochemistry
Affiliated Computer Services, A Xerox Company May 2009 - Present
Human Genome Sciences March 2005 - May 2009
Resources Global Professionals April 2004 - March 2005
Astrolink / Lockheed Martin July 1999 - March 2004
Computer Sciences Corporation August 1992 - June 1999
Ernst & Young June 1988 - April 1992
Skills
Accounting, Business Intelligence, Auditing, Business Process..., Cross-functional Team..., Executive Management, Financial Reporting, Financial Analysis, Internal Audit, Leadership, Internal Controls, Management, Management Consulting, Program Management, Revenue Recognition, SEC Filings, SEC filings, Sarbanes-Oxley, Sarbanes-Oxley Act, Strategic Planning, Process Improvement
Education
The Catholic University of America 1984 — 1988
B.S., Accounting
Forrest BioServices, LLC September 2015 - Present
GSK June 2014 - September 2015
GlaxoSmithKline December 2012 - June 2014
Human Genome Sciences July 2010 - December 2012
Aeras Global TB Vaccine Foundation January 2007 - July 2010
Lonza (formerly Cambrex Bioscience) July 2006 - December 2006
Bioprocess Scale-Up Facility (MTECH) August 2002 - May 2006
Skills
Engineering, Fermentation, Cell Culture, Aseptic Processing, GMP, Technology Transfer, CAPA, Manufacturing, Purification, Biotechnology, Vaccines, Laboratory, Process Simulation, cGMP manufacturing, Biopharmaceuticals, FDA, Sop, V&V
Education
The Johns Hopkins University 2011 — 2014
Technical Management, Engineering, 4.0
University of Maryland College Park 2001 — 2006
Bachelors of Science, Biological Resources Engineering
GlaxoSmithKline December 2012 - Present
Human Genome Sciences January 2009 - December 2012
Human Genome Sciences August 2007 - January 2009
BioMarin July 2005 - July 2007
BioMarin June 2003 - July 2005
BioMarin February 2003 - June 2003
BioMarin October 2001 - February 2003
BioMarin October 1999 - October 2001
Skills
Lean Manufacturing, Column Chromatography, Operational Excellence, Six Sigma, Strategic Planning, Contract Manufacturing, Continuous Improvement, Change Management, Quality Auditing, Protein Purification, Cell Culture, Project Management, Risk Management, Leadership, Team Building, Safety Management..., Perfusion, Batch Processing, Validation, Process Simulation, GMP, Biopharmaceuticals
Education
Villanova University 2012 — 2012
Master Black Belt
Villanova University 2011 — 2011
Six Sigma Black Belt
UCLA 1994 — 1999
BS, Physiological Science
Law Office of Arabelle Malinis March 2015 - Present
Housing and Economic Rights Advocates April 2010 - January 2014
Bay Area Legal Aid Contra Costa Office October 2009 - December 2009
Human Genome Sciences May 2008 - August 2008
HIV and AIDS LEGAL SERVICES ALLIANCE January 2008 - May 2008
Bay Area Legal Aid May 2007 - August 2007
Chiron Corporation January 2003 - July 2005
Onyx Pharmaceutical October 2004 - December 2004
BioMarin August 2000 - September 2002
Skills
Legal Writing, Legal Research, Intellectual Property, Civil Rights, Litigation, Research, Civil Litigation, Westlaw, Contract Negotiation, Consumer Law, Public Speaking, Microsoft Office, Microsoft Excel, Housing Discrimination, Advocacy, Estate Planning, Preparation of Wills, Revocable Trusts, Special Needs Trusts, Probate Administration
Education
University of California, Davis
Bachelor of Science
Western State University College of Law
Juris Doctor
GlaxoSmithKline December 2012 - Present
Human Genome Sciences May 2010 - December 2012
Baxter Healthcare October 2007 - May 2010
Skills
GMP, LIMS, Validation, FDA, Sop, Biopharmaceuticals, Aseptic Processing, Change Control, SOP
Education
American University of Rome
Italian Studies
The Johns Hopkins University School of Medicine
Pain Medicine- Implantable Therapies/Clinical Research
Towson University
Biology
University of Maryland College Park
Microbiology
Amplimmune, Inc., a subsidiary of AstraZeneca\MedImmune April 2013 - Present
Human Genome Sciences 1999 - December 2012
Micros Systems 1996 - 1999
Skills
SEC Financial Reporting, US GAAP, Internal Financial..., Cost Accounting, Department Budgeting, Enterprise Systems..., Process Improvement, SOX 404, Financial Analysis, Accounting, Financial Reporting, Internal Controls, Auditing, Sarbanes-Oxley Act
Education
The George Washington University
MBA, Finance
University of Virginia
B.S., Accounting
QIAGEN 2012 - 2013
Catalyst Health Solutions March 2012 - July 2012
Human Genome Sciences January 2009 - March 2012
MedImmune April 2004 - December 2008
Dragonfly Capital Partners 2003 - 2004
Wachovia Securities, Inc. 1997 - 2002
Skills
Investor Relations, Lifesciences, Biotechnology, Pharmaceutical Industry, Mergers, Commercialization, Due Diligence, Clinical Development, Competitive Analysis, Biopharmaceuticals, Oncology, Technology Transfer, Medical Devices, Corporate Development, Financial Analysis, Investments, Capital Markets, SEC Financial Reporting, Regulation Fair..., Equities, Finance, Venture Capital, Corporate Finance, Mergers & Acquisitions, Corporate Communications
Education
The University of Connecticut School of Business 1990 — 1992
MBA, Finance/Accounting
University of Connecticut
B.S., Chemistry
OSU Injury Biomechanics Research Center May 2014 - Present
The Ohio State University Wexner Medical Center January 2014 - April 2014
Wake Forest University May 2013 - August 2013
Human Genome Sciences June 2012 - August 2012
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Research, Teamwork, Social Media, Public Speaking, English, Statistics, Data Analysis
Education
The Ohio State University 2011 — 2015
Bachelor of Science (B.S.), Biomedical Engineering
Illumina December 2013 - Present
Integral Molecular June 2010 - June 2013
University of Pennsylvania School of Medicine July 2006 - June 2009
Philadelphia University 2007 - 2007
Human Genome Sciences June 1996 - August 1998
Walter Reed Army Institute of Research April 1993 - May 1996
Skills
High Throughput..., Assay Development, Cell Biology, Tissue Culture, Molecular Cloning, Monoclonal Antibodies, Immunoassays, Biopharmaceuticals, Biotechnology, Flow Cytometry, Marketing, Cancer Biology, Cell Culture, Genetics, Technical Sales..., Cancer, Antibodies, Cancer Stem Cells, Colorectal, Mammalian Cell Culture, Pancreas, Fluorescence Microscopy, DNA sequencing, Animal Models, recombinant DNA..., Bioinformatics, Protein Expression, Molecular Genetics, Protein Purification, Project Management, Genomics, Cancer Research, Cell-based Assays, Colorectal Cancer, Pancreatic Cancer, Colon, Next Generation...
Education
Thomas Jefferson University 1998 — 2006
PhD, Genetics
University of Maryland College Park 1991 — 1996
BS, Cellular and Molecular Biology, and Genetics
The Johns Hopkins University School of Medicine
Obermayer Rebmann Maxwell & Hippel LLP September 2013 - Present
U.S. Department of Justice May 2012 - August 2012
Human Genome Sciences June 2011 - August 2011
Wolf Trap Foundation for the Performing Arts May 2008 - August 2008
Skills
Legal Writing, Legal Research, Public Speaking, Westlaw, Research, Litigation, Civil Litigation, Commercial Litigation, Courts, Arbitration, Mediation, Appeals, Trials
Education
The University of Texas School of Law 2010 — 2013
J.D., Law
Virginia Polytechnic Institute and State University 2007 — 2010
Bachelor of Arts (B.A.), Communication
Loudoun Valley High School 2003 — 2007
MockV Solutions September 2013 - Present
Human Genome Sciences 2007 - 2012
Skills
Purification, Protein Chemistry, Technology Transfer, Monoclonal Antibodies, GMP, Validation, Filtration, FDA, Column Chromatography, Ion Exchange, Laboratory, Design of Experiments, Characterization, cGMP manufacturing, Biophysics, Protein Purification
Education
The Johns Hopkins University 2008 — 2013
Master of Science (M.S.), Biotechnology
University of Maryland College Park 2002 — 2006
Bachelor of Science (B.S.), Cellular, Molecular Biology and Genetics
MedImmune August 2012 - Present
Human Genome Sciences September 2007 - August 2012
Genentech 2003 - 2007
Carpenter Co. 2002 - 2002
Skills
Lyophilization, Protein Purification, Technology Transfer, GMP, Biopharmaceuticals
Education
The Johns Hopkins University 2008 — 2012
Master of Science (MS), Biotechnology
Virginia Commonwealth University 2000 — 2003
BS, Chemical Engineering
GSK June 2014 - Present
GlaxoSmithKline January 2013 - June 2014
Human Genome Sciences June 2010 - January 2013
Virginia Tech January 2009 - May 2010
Skills
GMP, Purification, Chromatography, FDA, Biotechnology, HPLC, Protein Purification, Lifesciences, Cell Culture, Microbiology, UV/Vis, Sop, Monoclonal Antibodies, Trackwise, Aseptic Technique, Spectrophotometry, Column Chromatography, LIMS, Quality Assurance, Technical Writing, Downstream Processing
Education
Virginia Polytechnic Institute and State University 2005 — 2010
B.S., Biological Systems Engineering
University College Dublin 2007 — 2008
Incyte August 2015 - Present
Teva Biopharmaceuticals USA March 2008 - July 2015
Cegenesys, Inc 2007 - March 2008
Human Genome Sciences July 1999 - 2005
Skills
CMC development of..., Biological drug..., Mammalian Cell Culture, Regulatory Submissions, Technology Transfer, Protein Chemistry, Biopharmaceuticals, Life Sciences, Pharmaceutical Industry, Cell
Education
The Johns Hopkins University 2005 — 2012
Master of Business Administration (M.B.A.), Business Administration and Management, General
University of Calcutta 1982 — 1988
Doctor of Philosophy (Ph.D.), Biochemistry and Molecular Biology
University of Calcutta 1980 — 1982
Master's Degree, Biochemistry, 1st class
Presidency College 1975 — 1979
Bachelor's Degree, Chemistry major, 1st Class
Armstrong World Industries July 2015 - Present
Cognitus Consulting January 2002 - Present
Carhartt June 2011 - June 2015
Nebraska Public Power District - Vignon May 2011 - May 2011
Weidmann Electrical Technology / WICOR USA & Mexico September 2009 - May 2011
Huntsville Utilities January 2009 - May 2011
Manuli Rubber Industries September 2008 - December 2010
Gainesville Regional Utilities October 2008 - January 2009
Deloitte Consulting 1993 - 2009
Human Genome Sciences March 2008 - September 2008
Skills
Project Implementation, Mergers, SAP, SAP R/3, FI/CO, Costing, CO-PA, ABAP, SAPScript, ERP, Integration, Manufacturing, Business Process, Materials Management, Data Migration, Business Analysis, Change Management, Business Process..., Management Consulting, Business Process Design, Inventory Management, co-pc, costing co-production, costing active..., Sales order costing, New GL, Sales Order, Target Costing, Requirements Analysis, SAP Implementation, SAP ERP, SAP PS, SD, Process Improvement, Business Intelligence, SAP FI, Analysis, SAP FICO, Legacy Systems, SAP BW, Outsourcing, Master Data, Testing, IDOC, SAP SD, Software Documentation, SAP MM, Master Data Management, ECC, Requirements Gathering
Education
Tilburg University 1982 — 1988
DRs
Rijksscholengemeenschap 1975 — 1981
Rijksscholengemeenschap Den Bosch 1975 — 1981
TSA September 2012 - Present
US Department of Homeland Security September 2010 - September 2012
Human Genome Sciences October 2007 - September 2010
FDA February 2007 - October 2007
United States Marine Corps February 1999 - June 2004
Education
The Johns Hopkins University 2008 — 2010
Master of Science (MS), Biotechnology
University of Maryland College Park 2004 — 2007
Bachelor of Science (B.S.), Microbiology and Immunology
Sodexo April 2011 - Present
Kelly Services November 2010 - March 2011
U.S. Department of Energy September 2009 - November 2010
Sparks May 2009 - November 2010
Human Genome Sciences October 2004 - March 2009
Human Genome Sciences August 2002 - October 2004
Human Genome Sciences April 1998 - August 2002
AT&T Solutions October 1995 - March 1998
Footwear Industries of America 1991 - 1994
Skills
Cross-functional Team..., Microsoft Office, Training, Project Management, Biotechnology, Public Speaking, Research, Event Planning, Policy, Office Management, Proposal Writing, Project Planning, Budgets, Management, Team Building, Strategy, Program Management, Human Resources
Education
University of Connecticut 1984 — 1988
B.A., Communications
GlaxoSmithKline May 2014 - Present
GlaxoSmithKline January 2013 - May 2014
Human Genome Sciences December 2009 - January 2013
Skills
Biopharmaceuticals, Biotechnology, GMP, Aseptic Technique, Purification, Technology Transfer, Sop, Aseptic Processing, GLP, Validation, Fermentation, LIMS, Protein Purification, FDA, Life Sciences, Pharmaceutical Industry, Chromatography, Microsoft Office, SOP
Education
University of Virginia 2005 — 2009
Bachelor of Science (B.S.), Biology, General
The University of Glasgow 2007 — 2007
National Institute of Allergy and Infectious Diseases (NIAID) March 2013 - Present
InnoSico LLC June 2012 - Present
DME Alliance Inc. November 2012 - March 2013
Kymanox March 2011 - November 2012
Novavax October 2010 - March 2011
Novavax July 2007 - October 2010
Emergent February 2006 - June 2007
Biogen/Idec August 2004 - October 2005
Human Genome Sciences April 2001 - May 2004
MedImmune September 1997 - April 2001
Skills
Entrepreneurship, New Business Development, Government Contracting, Process Validation, Process Development, Technology Transfer, Validation, Business Analysis, Risk Assessment, GMP, Process Engineering, Project Execution, V&V, Process Simulation, Protein Chemistry, Project Management, Biopharmaceuticals, Purification, Biotechnology, Cell Culture, Lifesciences
Education
John's Hopkins and UMBC 2012 — 2012
Innovate Program
The Johns Hopkins University - Carey Business School 2008 — 2010
MBA, Business Administration
University of Maryland Baltimore County 1993 — 1996
ChemE, Chemical Engineering
Biogen Idec July 2003 - January 2011
Biogen Idec July 2003 - January 2011
Human Genome Sciences July 2001 - June 2003
Education
University of California, San Diego 1997 — 2001
B.S., Bioengineering: biotechnology
Epitomics, Inc Founding PresidentChinese Biopharmaceutical Association1995 - Present
Mendel Biotechnology, Inc. 1998 - 2002
Human Genome Sciences 1993 - 1998
Education
University of California, Berkeley
Lancaster Laboratories October 2013 - Present
GlaxoSmithKline December 2012 - June 2013
Human Genome Sciences October 2007 - June 2013
Human Genome Sciences January 2005 - October 2007
MedImmune July 2002 - January 2005
Skills
GMP, GLP, Biotechnology, Protein Chemistry, HPLC, Chromatography, ELISA, Sop, Assay Development, Technical Reports, LIMS, Cell Culture, Purification, Biopharmaceuticals, Validation, Protein Purification, Microbiology, Technology Transfer, SDS-PAGE, FDA, Pharmaceutical Industry, Lifesciences, Immunology, Antibodies, Western Blotting, Quality Assurance, Six Sigma, Product Matrix Analysis, Process Qualification, Quality Control, Cell, Immunoassays, Vaccines, Gel Electrophoresis, qPCR, DNA extraction, Empower, Separations, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, QUMAS, Size Exclusion, Reverse Phase, Green Belt, Process Improvement
Education
Stockton University 1998 — 2002
B.S., Biology
AstraZeneca December 2013 - Present
MedImmune February 2007 - December 2013
Human Genome Sciences August 2006 - February 2007
Human Genome Sciences February 2005 - August 2006
GlaxoSmithKline October 2001 - February 2005
Merck August 2000 - October 2001
Merck June 1998 - August 2000
DuPont May 1994 - December 1996
Skills
Biotechnology, Validation, Biopharmaceuticals, Pharmaceutical Industry, Technology Transfer, GMP, Drug Development, Process Simulation, FDA, Cross-functional Team..., R&D, Regulatory Submissions, Lifesciences, Vaccines, Cell Culture, Clinical Development
Education
The Johns Hopkins University - Carey Business School 2006 — 2010
MBA, MBA
University of Pennsylvania 1999 — 2003
MS, Chemical Engineering
Virginia Polytechnic Institute and State University 1993 — 1998
BS, Chemical Engineering and Biochemistry
AztraZeneca July 2015 - Present
AstraZeneca (MedImmune) March 2014 - July 2015
GlaxoSmithKline December 2012 - February 2014
Human Genome Sciences February 2011 - December 2012
Sanofi Pasteur February 2007 - February 2011
Sanofi Pasteur 2007 - February 2011
MedImmune 2001 - 2007
Skills
Aseptic Processing, GMP, GLP, FDA, Sop, Quality Assurance, CAPA, Change Control, 21 CFR Part 11, LIMS, Biopharmaceuticals, Trackwise, Biotechnology, Vaccines, Quality System, Aseptic Technique, Deviations, Microbiology, FDA GMP, Quality Auditing, USP, Quality Control, cGMP practices, Sterilization, Fermentation, Environmental Monitoring, Contract Manufacturing, Cell Culture, Purification, Analytical Chemistry, Regulatory Submissions, Regulatory Affairs, Cleaning Validation, Validation, Computer System..., V&V
Education
Universidad de Puerto Rico 1992 — 1996
Bachelor of Applied Science (B.A.Sc.), Microbiology, General
Novartis June 2015 - Present
Novartis August 2014 - May 2015
Novartis Pharmaceuticals January 2012 - August 2014
Novartis August 2008 - December 2011
Novartis July 2005 - July 2008
Novartis May 2003 - July 2005
Schering Plough 1997 - 2003
Schering Plough 1997 - 2003
Human Genome Sciences April 1993 - August 1995
Skills
Cross-functional Team..., Pharmaceutical Industry, Change Management, Stakeholder Management, Training, Process Improvement, Project Management, Clinical Trials, Leadership, Business Process, Clinical Development, CRO, Quality Assurance, GCP, 21 CFR Part 11, Sop
Education
Tulane School of Public Health and Tropical Medicine 1995 — 1997
MS
University of Maryland College Park 1988 — 1992
BS
BioReliance June 2011 - Present
BioReliance June 2010 - June 2011
BioReliance April 2008 - June 2010
BioReliance May 2007 - April 2008
BioReliance August 2006 - May 2007
MedImmune September 2005 - August 2006
Human Genome Sciences May 2001 - August 2005
Skills
Validation, Quality Assurance, Compliance, Software Documentation, Quality System, GMP, Cleaning Validation, Quality Control, GLP, V&V, FDA, Sop, Biotechnology, Computer System..., Pharmaceutical Industry, Lifesciences, LIMS, GxP, 21 CFR Part 11, Biopharmaceuticals, CAPA
Education
The Johns Hopkins University 2002 — 2005
M.S.
University of Pittsburgh 1999 — 2001
B.S.
Human Genome Sciences June 2012 - Present
Novavax December 2010 - June 2012
LASD Search and Rescue September 2009 - December 2010
Keck Graduate Institute September 2007 - December 2010
Amgen June 2006 - August 2006
Amgen 2003 - 2005
Skills
Monoclonal Antibodies..., Bioreactor engineering, Search and Rescue, Biotechnology, Cell Culture, Lifesciences, Purification, Biochemistry, Technology Transfer, Protein Purification, Biopharmaceuticals, Molecular Biology, Assay Development, Chromatography, Western Blotting, PCR, Protein Chemistry, ELISA, Cell, Microbiology, Immunoassays, HPLC, Bioprocessing
Education
Keck Graduate Institute 2007 — 2010
PhD, Applied Life Sciences, Bioprocessing
Keck Graduate Institute 2005 — 2007
MBS, Master's of Bioscience business
University of California, Santa Barbara 1999 — 2003
Bachelor of Science, Biochemistry
NIAID/NIH April 2009 - Present
NIAID/NIH April 2007 - April 2009
CoGenesys, Inc 2006 - 2007
Human Genome Sciences 2000 - 2006
Skills
Clinical Development, ELISA, Biotechnology, Lifesciences, Monoclonal Antibodies, GLP, Pharmacokinetics, HPLC-MS
Education
The George Washington University School of Medicine and Health Sciences 1993 — 1997
Ph.D., Pharmacology
The George Washington University 1986 — 1988
M. Sc, Biological Science
GlaxoSmithKline December 2012 - Present
Human Genome Sciences April 2009 - December 2012
Human Genome Sciences July 2006 - April 2009
Human Genome Sciences March 2003 - July 2006
Celera Genomics September 2001 - March 2003
Celera Genomics August 2000 - September 2001
Skills
GMP, Biopharmaceuticals, Biotechnology, FDA, Change Control, Trackwise, Deviations, Quality Auditing, GxP, cGMP practices, Regulatory Submissions, Sop, Pharmaceutical Industry, Quality Control, Aseptic Processing, CQA, GLP, Quality Assurance, CAPA, Regulatory Affairs, LIMS
Education
The Johns Hopkins University 2002 — 2004
MS, Biotechnology
University of Mary Washington 1996 — 2000
BS, Biology
St Pauls
Baylor College of Medicine April 2015 - Present
Baylor College of Medicine 2015 - 2015
Shanghai Chempartner April 2013 - October 2013
Frontier BioSciences, Inc. September 2012 - April 2013
Human Genome Sciences April 2008 - January 2012
Covance Inc January 2005 - April 2008
NeoPharm, Inc. April 2003 - November 2004
NeoPharm March 2001 - April 2003
Skills
GLP, CRO, Toxicology, IND, Biotechnology, Pharmaceuticals, Animal Models, Drug Discovery, Pharmacokinetics
Education
University of Calcutta 1980 — 1986
PhD, Biochemistry, Immunology
MacroGenics May 2009 - Present
Self-employed December 2007 - April 2009
Cambridge Antibody Technology/AstraZeneca December 2005 - December 2007
Genencor International 2005 - 2006
Human Genome Sciences 1995 - 2005
Regeneron 1989 - 1995
Education
University of Connecticut
MedImmune June 2014 - Present
Dynport Vaccine Company April 2007 - June 2014
Bridge Global Pharmaceutical Services 2006 - 2007
Gene Logic Laboratories 2004 - 2006
Human Genome Sciences February 2002 - December 2003
University of Maryland at Baltimore June 2000 - February 2002
Skills
GLP, Toxicology, Immunology, Vaccines, In Vivo, Validation, Infectious Diseases, Technology Transfer, Project Management, Biotechnology, Lifesciences, Biopharmaceuticals, ELISA, In Vitro, Cell
Education
The Johns Hopkins University 2003 — 2007
MS, Biotechnology
Virginia Polytechnic Institute and State University 1996 — 2000
BS, Animal and Poultry Sciences
MedImmune November 2012 - Present
Quality Agents, LLC April 2012 - November 2012
Teva Biopharmaceuticals USA February 2008 - December 2011
CoGenesys June 2005 - February 2008
Teva 2008 - 2008
Human Genome Sciences 1993 - 2006
HGS 1993 - 2006
National Cancer Institute August 1991 - March 1993
Skills
Biotechnology, Lifesciences, Biopharmaceuticals, GMP, GLP, Validation, Cell Culture, ELISA, Technology Transfer, Molecular Biology, FDA, PCR
Education
The Johns Hopkins University 1994 — 1997
MS, Biotechnology
University of Colorado at Boulder 1987 — 1990
Bachelor of Science (BS), Environmental, Population & Organismic Biology
Qiagen December 2010 - Present
QIAGEN July 2007 - December 2010
Digene Corporation May 2004 - July 2007
Human Genome Sciences June 1999 - December 2003
AstraZeneca August 1997 - June 1999
Skills
Genotyping, Assay Development, PCR, Molecular Biology, qPCR, Cell Biology, DNA, Purification, ELISA, Cell, DNA sequencing, Immunoassays, Genomics, RT-PCR, Sequencing, Laboratory Automation, Molecular Diagnostics, Protein Purification, Immunology, Monoclonal Antibodies, DNA Sequencing
Education
University of Delaware 1992 — 1997
BS, Biology
Johnson & Johnson September 2014 - Present
Amgen April 2006 - September 2014
Human Genome Sciences September 2002 - March 2006
National Institute of Standards and Technology January 1997 - August 2002
Education
The Johns Hopkins University
Doctor of Philosophy (Ph.D.), Chemical Engineering
UCSF Medical Center September 2013 - Present
Johns Hopkins Hospital June 2009 - August 2013
GlaxoSmithKline September 2012 - April 2013
Human Genome Sciences April 2012 - August 2012
Education
University of California, San Francisco 2013 — 2017
Doctor of Philosophy (PhD), Health Policy
The Johns Hopkins University 2010 — 2011
Master of Public Health/Master of Nursing, Public Health Nursing
The Johns Hopkins University 2007 — 2009
Bachelor of Science, Nursing
Wellesley College 2002 — 2006
Bachelor of Arts (B.A.), Sociology
Amplimmune, cell culture & process development November 2010 - Present
Human Genome Sciences October 2008 - November 2010
Macrgenics April 2002 - October 2008
Skills
Purification, Antibodies, Biotechnology, ELISA, Protein Chemistry, Lifesciences, Assay Development, Molecular Biology, GMP, Monoclonal Antibodies, Process Simulation, Technology Transfer, Protein Purification, Biopharmaceuticals, Cell Culture, Fermentation, Cell
Education
Texas A&M University 1993 — 1998
Ph. D, Biochemistry
Human June 2010 - Present
Human Genome Sciences 2008 - 2009
Education
The Johns Hopkins University 2005 — 2007
MS, Regulatory Affairs
Virginia Polytechnic Institute and State University 1998 — 2002
National Institutes of Health 2007 - Present
Human Genome Sciences April 2000 - April 2003
Education
University of Maryland College Park 2005 — 2011
Ph.D., Molecular and Cell Biology
The Johns Hopkins University 2000 — 2003
M.S., Biotechnology
The George Washington University 1997 — 1999
B.S., Biology
Clorox September 2013 - Present
CSA-Soliance July 2011 - August 2013
Tunnell Consulting, Inc. August 2008 - June 2011
Human Genome Sciences May 2003 - October 2007
Diosynth April 2001 - April 2003
GlaxoSmithKline July 1992 - March 2001
GlaxoWellcome 1992 - 2001
Abbott Laboratories July 1985 - June 1992
Skills
Biopharmaceuticals, GMP, Process Validation, Process Management, Protein Chemistry, Method Validation, Technology Transfer, Project Management, Process Characterization, Compliance, HPLC, Validation, Biotechnology, Operational Excellence, Process Simulation, FDA, GLP, Sop, Pharmaceutical..., Quality Management, 21 CFR Part 11, Pharmaceutical Industry, Drug Development, Change Control, Regulatory Submissions, V&V, IND, Quality Assurance, CAPA, Quality System, GxP, SOP
Education
University of Wisconsin-Madison
BS, Bacteriology
The University of Texas at Austin
Certificate, Process Management
GlaxoSmithKline December 2012 - Present
Human Genome Sciences January 2010 - December 2012
Human Genome Sciences, Inc. July 2003 - January 2010
Skills
GLP, Biotechnology, GMP, ELISA, Protein Purification
Education
The Johns Hopkins University 2004 — 2006
Masters, Biotechnology
University of Wisconsin-Madison 1999 — 2003
BS, Molecular Biology
Edell, Shapiro & Finnan LLC May 2013 - Present
Foley & Lardner LLP November 2012 - April 2013
Human Genome Sciences March 2008 - September 2012
Johns Hopkins University School of Medicine September 2007 - March 2008
ASIC International May 2000 - May 2002
Eastman Kodak 1997 - 1998
Skills
Biochemistry, Patent Prosecution, Intellectual Property, Patents, Genomics, Technology Transfer, Prosecution, Patent Litigation, Patentability, Molecular Biology, Lifesciences, Biotechnology, Licensing, Pharmaceutical Industry, Medical Devices, Biomedical Engineering, Registered Patent..., Client Counseling, Life Sciences
Education
The Johns Hopkins University 2002 — 2007
Ph.D., Electrical and Computer Engineering
University of Tennessee-Knoxville 1992 — 1997
B.S., Chemistry and Biochemistry
Genenech 2008 - Present
Genentech 2008 - Present
Genentech, A Member of the Roche Group 2008 - Present
Genentech August 2004 - Present
Genentech August 2004 - February 2008
Human Genome Sciences 1998 - 2004
Ben Venue Laboratories 1990 - 1994
Education
The University of Akron 1983 — 1987
Bachelors of Science in Biochemistry
Medstar Harbor Hospital July 2015 - Present
University of Maryland August 2010 - December 2014
University Student Government Association April 2011 - April 2012
Human Genome Sciences October 2005 - September 2010
Skills
Public Health, Protein Purification, Lifesciences, Clinical Trials, Data Analysis, Cell Culture, Biochemistry, PCR, Molecular Biology, Biotechnology, Healthcare, FDA, Western Blotting, Clinical Research, Pharmaceutical Industry, Technology Transfer, Life Sciences
Education
University of Maryland School of Medicine 2010 — 2014
Doctor of Medicine (M.D.), Medicine
The Johns Hopkins University 2008 — 2010
Masters of Science, Biomedical Engineering
University of Maryland College Park 2001 — 2005
Bachelor of Science, Biological Resources Engineering
Human Genome Sciences June 2011 - Present
Fannie Mae October 2010 - June 2011
Unisys March 2010 - October 2010
Booz Allen Hamilton May 2009 - March 2010
Fannie Mae March 2001 - May 2009
Skills
Data Warehousing, Enterprise Architecture, Business Intelligence, ETL, Databases, PL/SQL, Oracle, Data Modeling, Data Warehouse..., Performance Tuning
Education
The George Washington University 1993 — 1995
Master, Applied Statistics
GSK August 2015 - Present
GSK January 2013 - August 2015
Human Genome Sciences September 2007 - December 2012
MRI Medical 2006 - 2007
Biogen Idec 2001 - 2006
EMC 1997 - 2001
Price Waterhouse Management Consultants 1996 - 1997
Skills
Biotechnology, Cross-functional Team..., Pharmaceutical Industry, Manufacturing, Supply Chain, FDA, MRP, Logistics, Supply Chain Management, Start-ups
Education
The Johns Hopkins University 1974 — 1978
BA, Political Economy
George Mason University August 2011 - Present
MedImmune November 2009 - September 2011
Human Genome Sciences July 2000 - November 2009
Skills
Biotechnology, Biochemistry, Cell Culture, Western Blotting, PCR, Molecular Biology, qPCR, Technology Transfer, Protein Purification, Statistics, ELISA, SDS-PAGE, Microbiology, Process Development, Infectious Diseases, Protein Expression, Fermentation, Virology, Cell, Protein Chemistry, Chromatography, Lifesciences, DNA, Cell Biology, Genomics, Immunology, Biopharmaceuticals, Life Sciences
Education
The Johns Hopkins University 2002 — 2005
MS, Biotechnology
Virginia Polytechnic Institute and State University 1997 — 2000
BS, Biochemistry and Chemistry
Airbus June 2010 - Present
International Monetary Fund June 2004 - June 2010
Human Genome Sciences January 2002 - June 2004
Meds Publishing January 2000 - December 2002
Celera Corporation 1999 - 2000
Manugistics 1998 - 1999
Skills
Technical Support, Hardware, Project Management, Program Management, Integration, Requirements Analysis, SharePoint, Visio, ITIL, Active Directory, Configuration Management, Testing, Process Improvement, Systems Engineering, System Administration
Education
Towson University
Bachelor's degree, Mass Communication/Media Studies
Otsuka August 2004 - Present
Human Genome Sciences December 2003 - July 2004
MedImmune January 2002 - December 2003
Mckesson Bioservices October 1998 - January 2002
Skills
Clinical Research, GMP, Protocol, Pharmaceutical Industry, Clinical Trials, CTMS, Oncology, Biotechnology, GCP, CRO, Clinical Development, Sop, EDC, Validation, 21 CFR Part 11, Regulatory Affairs, FDA, Pharmaceutics, Pharmacovigilance, Quality Assurance, Infectious Diseases, Regulatory Submissions, ICH-GCP, Therapeutic Areas, Drug Development, Clinical Pharmacology, IND, Clinical Monitoring
Education
The Ohio State University 1984 — 1989
BS Pharmacy, Pharmacy
KBI Biopharma January 2015 - Present
KBI Biopharma January 2014 - December 2014
KBI Biopharma May 2012 - December 2013
KBI Biopharma October 2010 - May 2012
Tensility International Corporation May 2009 - 2010
Irvine Pharmaceutical Services May 2008 - January 2009
CMC ICOS Biologics November 2005 - May 2008
Human Genome Sciences 1999 - 2005
Skills
GMP, Technology Transfer, Biotechnology, Chromatography, GLP, Purification, Pharmaceutical Industry, SOP, Protein Chemistry, FDA, R&D
Education
Virginia Polytechnic Institute and State University 1993 — 1998
B.S., Biochemistry
The Johns Hopkins University
Biotechnology
BioReliance by Sigma-Aldrich February 2013 - Present
Human Genome Sciences July 2005 - January 2013
Kamerow, Weintraub & Swain LLP (now Goodman and Company LLP) February 2005 - July 2005
Education
University of Baltimore
Bachelor, Accounting
Otsuka Pharmaceutical Companies (U.S.) March 2013 - Present
Human Genome Sciences May 2011 - January 2013
Human Genome Sciences November 2007 - May 2011
University of Maryland 2006 - June 2007
Integrium November 2004 - July 2005
Edwards Lifesciences June 2000 - November 2004
Center for Community Health, UCLA November 1998 - June 2000
Skills
SAS, Statistical Analysis, Phase I-IV clinical..., Project Management
Education
UCLA 1996 — 1998
Master of Science (MS), Biostatistics
Tamkang University 1990 — 1994
Bachelor of Science (BS), Mathematical Statistics
Veridex, LLC (a J&J Company) 2003 - January 2010
Roche Molecular Systems March 2003 - October 2003
Human Genome Sciences February 2002 - March 2003
Roswell Park Cancer Institute January 1999 - February 2002
Education
University at Buffalo 1999 — 2001
MS, Natural Sciences: Oncology
Syracuse University 1994 — 1998
BS, Biochemistry
Osiris Therapeutics July 2008 - April 2009
Human Genome Sciences May 2008 - July 2008
Chesapeake Biological Labs January 2002 - April 2006
Universal Health Care June 1999 - December 2001
Education
Towson University 1999 — 2000
BSc, Biology
Questcor Pharmaceuticals 2012 - Present
Human Genome Sciences October 2010 - October 2012
Cumberland Hall Hospital May 2008 - February 2010
Centocor January 2004 - February 2007
Centocor January 2002 - January 2004
Centocor July 1999 - February 2001
RHONE POULENC RORER PHARMACEUTICALS November 1994 - July 1999
WALLACE LABORATORIES June 1993 - October 1994
Skills
Sales and Sales..., Strategic Planning, Customer Focused...
Education
Troy State University
Masters, Business Administration
University of Alabama
Bachelor of Science, Marketing
UCB April 2014 - Present
Genzyme September 2012 - March 2014
Human Genome Sciences October 2010 - September 2012
EMD Serono September 2004 - October 2010
Agouron Pharmaceuticals Inc March 1999 - August 2004
Sequus Pharmaceuticals May 1996 - February 1999
Roxane Laboratories: a division of Boehringer Ingelheim Inc. February 1993 - April 1996
Roxane Laboratories January 1987 - January 1993
Skills
Immunology, Oncology, Buy and Bill, Rheumatology, Infused Biologics, Sales Effectiveness, Product Launch, Hospital Sales, Dermatology, Buy & Bill, Infectious Diseases, Neurology, Biotechnology, Endocrinology, Hospitals, Market Planning, Sales Operations, Clinical Research, Pharmaceutical Industry, Pharmaceutical Sales, Medical Devices, Managed Care, Cardiology
Education
University of California, San Diego
BA, Psychology
Attimo Research and Development July 2014 - January 2015
Intrexon Corporation March 2011 - January 2013
J. Craig Venter Institute 2004 - February 2011
Human Genome Sciences 1998 - 2004
Skills
Biotechnology, Molecular Biology, Lifesciences, Genomics, PCR, Assay Development, Protein Purification, Microbiology, DNA, DNA sequencing
Education
The Johns Hopkins University 2000 — 2003
Masters, Biotechnology
Virginia Polytechnic Institute and State University 1994 — 1998
B.S., Biology
Navigant 2013 - Present
Human Genome Sciences 2011 - 2013
Shire Pharmaceuticals 2010 - 2011
AstraZeneca 2008 - 2010
Comcast 2006 - 2008
Skills
SDLC, Integration, Databases, Project Management, Litigation Support, Management, Testing, Computer Forensics, Data Warehousing, Information Technology, Software Documentation, Document Review, Vendor Management, Document Management, Process Improvement, Warehousing, Consulting
Education
University of Dayton 2002 — 2006
Bachelor's in Business Administration, Management Information Systems
Montgomery County Public Schools 2000 - 2007
The Jefferson School 1999 - 2000
Gene Logic 1996 - 1999
Human Genome Sciences 1995 - 1996
Education
The George Washington University 2000 — 2002
M.Ed, Secondary Education - Physics
The Johns Hopkins University 1991 — 1995
BS, Chemical Engineering
Zalgen Labs August 2013 - Present
Autoimmune Technologies, LLC September 2008 - Present
BioFactura, Inc. April 2005 - August 2008
Human Genome Sciences April 2001 - April 2005
MedImmune April 1996 - April 2001
Skills
Biotechnology, Immunodiagnostics, Immunotherapeutics, vaccines, Assay Development, International Logistics, Molecular Biology, Cell Culture, ELISA, Pharmaceutical Industry, Lifesciences, Biochemistry, Science, Vaccines, Monoclonal Antibodies, In Vivo, Animal Models, Infectious Diseases, Antibodies, Immunology, Life Sciences
Education
Tulane University School of Medicine 2008 — 2010
Doctor of Philosophy (Ph.D.), Biomedical Sciences, Virology
UMASS Amherst 1987 — 1991
Bachelor of Science (B.S.), Microbiology
Baxalta April 2015 - Present
Baxter International Inc. February 2012 - April 2015
Human Genome Sciences March 2010 - October 2011
Emerson Process Management July 2007 - January 2010
Bausch and Lomb Corp June 2005 - May 2006
Mcgean March 2003 - February 2005
Skills
Automation, Process Control, Instrumentation, Validation, Engineering, Process Engineering, PLC, Process Automation, Manufacturing, Project Engineering, Six Sigma
Education
The University of Akron 2000 — 2003
Bachelor’s Degree, Chemical Engineering
Novartis August 2013 - Present
Sanofi/Genzyme August 2012 - August 2013
Human Genome Sciences August 2008 - August 2012
Ortho Biotech January 2007 - August 2008
Physicians' Education Resource 2006 - 2007
Skills
Immunology, Oncology, Infectious Diseases, Rheumatology, Nephrology, Allergy, Asthma, Gastroenterology, Hematology, Medical Affairs, Orthopedic, Medical Writing, Pain Management, Biotechnology, Clinical Development, Cell, Clinical Trials
Education
Texas Tech University Health Sciences Center 1996 — 2002
Ph.D., Medical Microbiology
Quark Pharmaceuticals March 2014 - Present
Human Genome Sciences June 1998 - January 2013
Boehringer Mannheim Pharmaceuticals January 1989 - December 1997
Warner Lambert/Parke Davis June 1984 - May 1989
Skills
Biostatistics, Biotechnology, Biopharmaceuticals, Clinical Development, Pharmaceutical Industry, Immunology, Drug Development, Oncology, Clinical Trials, FDA, IND, Regulatory Submissions, Clinical Research, Translational Medicine, GCP, Pharmacovigilance, Infectious Diseases, Vaccines, CRO
Education
University of Michigan
PhD, Epidemiology
University of Michigan
MS, Biostatistics
University of California, Berkeley
MS, Epidemiology
University of California, Berkeley
BS, Genetics
Questcor Pharmaceuticals November 2012 - Present
Human Genome Sciences October 2010 - Present
Human Genome Sciences October 2010 - October 2012
Biogen Idec 2006 - 2010
Elan Pharmaceuticals 1997 - 2004
Skills
Buy & Bill, Rheumatology, Gastroenterology, Neurology, Hospital Sales, Pharmaceutical Sales, Managed Care, Oncology, Pharmaceutical Industry, Infectious Diseases, Biopharmaceuticals, Nephrology, Product Launch, Immunology, Biotechnology, Sales Effectiveness, Market Access, Diabetes
Education
University of Central Oklahoma 1986 — 1990
BS, Business
Human Genome Sciences August 1997 - Present
Skills
EDC, Biotechnology, Clinical Data Management, Clinical Trials, Microsoft Office, Oracle Clinical, CRO, Oncology, Drug Development, Infectious Diseases, Clinical Development, GCP, Pharmaceutical Industry, Lifesciences, IND
Education
University of California, Davis
Bachelor of Science (BS), Animal Sciences, 3.8
University Complutense, Madrid, Spain
Veterinary Medicine
MedImmune QA AdvisorAstraZenecaMarch 2008 - Present
United Therapeutics 2004 - 2008
Human Genome Sciences 1998 - 2004
Peptide Technologies May 1990 - 1998
Skills
Validation, FDA, Quality Systems, GMP, LIMS, Quality Auditing, Inspection, GCP, Biotechnology, cGMP, GLP, Auditing, CAPA, Manufacturing, Quality Assurance, Clinical, Testing, 21 CFR Part 11, Six Sigma, Validations, Compliance, QC, ISO, SOP, Regulatory Affairs, Computer System..., Clinical Development, Continuous Improvement, Chromatography, Product Development, CRO, Technical Writing, Statistics, Calibration, Documentation, Lean Manufacturing, Molecular Biology, Characterization, Pharmaceuticals, Research, Document Management, Analysis, USP, Medical Devices, HPLC, Regulatory Submissions, Biopharmaceuticals, Technology Transfer, Change Control, IND
Education
John Hopkins University
Masters, Masters of Science in Biotechnology, concentration on Regulatory Affairs
Trinity University-Washington
Bachelor of Science (B.S.), Major in Biochemistry, Minor in Biology and Math
American University March 2013 - Present
Strategic communications that support business priorities. November 2012 - Present
Human Genome Sciences June 2010 - October 2012
Human Genome Sciences July 2007 - June 2010
Human Genome Sciences January 2003 - July 2007
Manugistics October 1999 - January 2003
Skills
Internal Communications, Marketing, Project Management, Event Management, Intranet, HTML + CSS, Photoshop, Flash, InDesign, Newsletters, Meeting Planning, Graphic Design, Event Planning
Education
University of Arizona
B.S. Business Administration, Marketing
Human Genome Sciences October 2010 - Present
Biogen Idec January 2006 - October 2010
Solstice Neurosciences January 2005 - January 2006
Elan Pharmaceuticals July 1997 - December 2004
Education
University of Central Oklahoma 1985 — 1990
BS, Business
Quintiles January 2015 - Present
PAREXEL March 2008 - December 2014
Quality Associates Incorporated April 2005 - February 2008
Nabi Biopharmaceuticals December 2002 - April 2005
Human Genome Sciences January 2001 - December 2002
United States Department of Agriculture February 1995 - December 2000
Skills
Quality Auditing, Process Auditing, Supplier Auditing, Technical Writing, GCP, GLP, Bioanalysis, Quality Assurance, Clinical Research, Lifesciences, GMP, Sop, Biotechnology, Clinical Trials, Validation, Auditing, Biopharmaceuticals, FDA, 21 CFR Part 11, CRO, ICH-GCP, Life Sciences, SOP
Education
University of Maryland College Park 1994 — 1997
BS, Cell Molecular Biology and Genetics
Towson University 1993 — 1994
Music Education
GlaxoSmithKline December 2012 - Present
Human Genome Sciences February 2003 - December 2012
Celera Corporation May 2001 - February 2003
Skills
HPLC, Mass Spectrometry, Chemistry, Capillary..., GLP, LIMS, Biotechnology, Chromatography, GMP, Validation, Sop, LC-MS, Protein Chemistry, Technology Transfer, Biopharmaceuticals, Quality Control, Method Development, SOP
Education
Texas A&M University-Corpus Christi
BS, Chemistry
AVANZA Laboratories March 2012 - Present
Human Genome Sciences August 1996 - January 2012
Skills
Cell Culture, Mammalian cell culture, Molecular Biology, Cell Based Assays, Biotechnology, ELISA, Western Blotting, Chromatography, Immunology, SDS-PAGE, PCR, Biochemistry, Gel Electrophoresis, Cell Biology, DNA, GLP, Cell, Monoclonal Antibodies, In Vitro, Transfection, Fluorescence, SOP, Genomics, Validation, Assay Development
Education
Calcutta University 1980 — 1983
Master of Science (MSc), Biochemistry
BioSurface Engineering Technologies June 2004 - Present
Human Genome Sciences 2001 - 2004
Life Technologies Inc. 1999 - 2001
Skills
Experienced Peptide..., Chromatography, HPLC, Peptides, Biochemistry, Protein Chemistry, Purification, LC-MS, Drug Discovery
Education
東京工業大学 / Tokyo Institute of Technology
Doctor of Philosophy (Ph.D.), Organic Chemistry
GlaxoSmithKline December 2012 - Present
Human Genome Sciences May 2010 - December 2012
Lonza February 2007 - May 2010
Skills
GMP, Change Control, LIMS, Sop, CAPA, FDA, Biotechnology, Aseptic Technique, Validation, Biopharmaceuticals, Cleaning Validation, Microbiology, GLP, SOP, Quality Control
Education
Towson University 2003 — 2006
BS, Biology
GlaxoSmithKline April 2011 - Present
Human Genome Sciences August 2008 - March 2011
Skills
cGMP, Biotechnology, Quality Systems, Microbiology, CAPA, Validation, GMP, Cell Culture, Molecular Biology, QC, Biopharmaceuticals, LIMS, Change Control, Cell Based Assays, Continuous Improvement, SOP, Sop, Quality Control, GLP, FDA, Quality System
Education
Swami Ramanand Teerth Marathwada University 1998 — 2000
MSc, Microbiology
FORUM Pharmaceuticals (formerly Envivo Pharmaceuticals) February 2014 - Present
GlaxoSmithKline September 2012 - February 2014
Human Genome Sciences January 2011 - January 2013
Biogen Idec September 2007 - October 2010
Novartis Pharmaceuticals 2003 - 2007
Skills
Medical Affairs, Neuroscience, Neurology, Rheumatology, Immunology, Clinical Trials, Pharmaceutical Industry, Biotechnology, Molecular Biology, Autoimmune Diseases, Clinical Development, Alzheimer's disease
Education
Tulane University
PhD, Neuroscience
The University of Texas at Austin
BA, Biology
GlaxoSmithKline; HGS 2011 - Present
Fina Biosolutions 2011 - 2011
QIAGEN 2008 - 2010
QIAGEN 2006 - 2008
MetaMorphix,. Inc 2004 - 2006
Human Genome Sciences 2002 - 2004
Human Genome Sciences, Inc. 2000 - 2002
Bioqual 1997 - 2000
Romer Labs Inc 1996 - 1997
University of California-Davis 1992 - 1995
Skills
Statistics, Vector NTI, Chromatography, ELISA, Protein Purification, Analytical Chemistry, Bioassay, Cell Culture, Purification, Biotechnology, SDS-PAGE, Protein Chemistry, Molecular Biology, Western Blotting, Antibodies, DNA, GMP, Sop, Cell
Education
The Johns Hopkins University 1997 — 2000
M.S, Biotechnology, Bioinformatics focus.
University of California, Davis
M.S, Agricultural and Environmental Chemistry
Meso Scale Discovery April 2012 - Present
Human Genome Sciences March 2008 - January 2012
National Institutes of Health April 2004 - March 2008
The Institute for Genomic Research August 2001 - March 2004
Skills
Molecular Biology, Antibodies
Education
The University of Texas Health Science Center at Houston 1994 — 2001
PhD, Molecular biology, oncology
The University of Hong Kong 1986 — 1989
B. Sc., Chemistry, Biology
Vaccine Research Center, NIAID, NIH June 2014 - Present
GlaxoSmithKline June 2013 - June 2014
University of Maryland September 2012 - June 2013
Human Genome Sciences May 2003 - August 2005
Emergent BioSolutions July 2000 - April 2003
Skills
Protein Purification, Biotechnology, SDS-PAGE, ELISA, Cell Culture, Biochemistry, Purification, Assay Development, Western Blotting, PCR, Molecular Biology, Protein Chemistry, Gel Electrophoresis, Immunology, Lifesciences
Education
University of Maryland College Park 2006 — 2012
Doctor of Philosophy (Ph.D.), Biochemistry
The Johns Hopkins University 2000 — 2003
Master of Science (M.S.), Biotechnology
The College of William and Mary 1996 — 2000
Bachelor of Science (B.S.), Biology
UCB November 2012 - Present
Human Genome Sciences January 2010 - October 2012
Centocor December 1999 - January 2010
Ethicon Endo-Surgery April 1996 - December 1999
Skills
Pharmaceutical Industry, Pharmaceutical Sales, Quality Assurance, Endocrinology, Program Management, Supply Chain, Protocol, Competitive Intelligence, Operations Management
Education
The University of Akron 1978 — 1982
Bachelor of Arts (B.A.), Mass Media Communications
PharmAthene April 2012 - March 2013
Human Genome Sciences 2003 - 2012
EntreMed 2000 - 2002
Skills
Biotechnology
Education
The Johns Hopkins University 2002 — 2005
MS, Biotechnology
Tuskegee University
BS, Biology
Intrexon Corporation August 2014 - Present
Human Genome Sciences April 1998 - January 2013
Pro-Neuron, Inc. (now Wellstat Therapeutics) January 1992 - April 1998
University of Florida August 1988 - August 1991
Skills
Animal Models, In Vivo, In Vitro, Preclinical Studies, Mammalian Cell Culture, Cell-based Assays, Oncology Research, Assay Development, Hepatocytes, ELISA, Western Blotting, Tissue Culture, Biomarkers, Cytotoxicity, Preclinical Pharmacology, Neuropharmacology, Rodent Surgery, Pharmacokinetics, GraphPad Prism, SoftMax Pro, Affinity Chromatography, Biotechnology, Monoclonal Antibodies, Primary Cell Isolation, Molecular Biology, HPLC, GLP, Drug Discovery, Aseptic Technique, Drug Development, Antibodies, Immunoassays, Pharmaceutical Industry, Immunoprecipitation, Small Animal Models, IACUC, Mouse Handling, PBMC isolation, BCA Protein Assay, Luciferase Assay, Behavioral Neuroscience, Microscopy, SDS-PAGE, CNS disorders, SigmaStat, Oncology, Pharmacology, Biomarker Discovery, Clinical Development, Transfection
Education
The Johns Hopkins University 1999 — 2004
Master of Science (MSc), Biotechnology, GPA 4.0/ 4.0
University of Florida 1985 — 1991
Bachelor of Science (BSc), Neurobiology and Neurosciences, GPA 3.72/ 4.0
MacroGenics, Inc. June 2013 - Present
Human Genome Sciences June 2012 - March 2013
Human Genome Sciences December 2006 - June 2012
Human Genome Sciences July 2004 - December 2006
Human Genome Sciences August 2002 - July 2004
Human Genome Sciences October 1998 - August 2002
Skills
Biopharmaceuticals, Clinical Development, Drug Development, Biotechnology, GLP, Monoclonal Antibodies, IND, Antibodies, Assay Development, CRO, CTMS, Clinical Data Management, Clinical Trials, EDC, FDA, GCP, ICH-GCP, Immunology, Life Sciences, Oncology, Lifesciences, Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, SOP, Sop, Technology Transfer, Vaccines, Validation
Education
The Johns Hopkins University 1999 — 2002
Master of Science (M.S.), Biotechnology
Virginia Polytechnic Institute and State University 1994 — 1998
Bachelor of Science (B.S.), Biochemistry
Human Genome Sciences October 2010 - October 2012
Biogen Idec January 2006 - October 2010
Centocor November 2003 - January 2006
Schering-Plough Research Institute July 1996 - November 2003
Skills
Rheumatology, Pharmaceutical Sales, Managed Care, Oncology, Pharmaceutical Industry, Biotechnology, IV Sales, Monoclonal Antibodies, Interferons
Education
Texas Tech University 1991 — 1993
Master's degree, Hospitality Administration/Management
Texas Tech University 1987 — 1991
Bachelor's degree, Hospitality Administration/Management
National Cancer Institute (NCI) November 2014 - Present
Johns Hopkins University August 2010 - October 2014
Human Genome Sciences September 2006 - August 2010
Skills
Biotechnology
Education
Johns Hopkins School of Medicine 2010 — 2014
PhD, Biomedical Engineering
The Johns Hopkins University 2007 — 2010
MS, Biotechnology
University of Maryland College Park 2002 — 2006
BS, Chemical Engineering
Human Genome Sciences August 2007 - Present
Advanced Bioscience Labs April 2006 - August 2007
Merck December 2002 - April 2006
Skills
Corporate Biological..., Corporate Radiation..., Corporate Chemical..., Laboratory Manager, OSHA trainer, protocol and manual...
Education
The Ohio State University 1983 — 1985
Masters of Science, Animal Physiology
University of Maryland College Park 1977 — 1980
Bachelors of Science, Animal Science/Pre-Vet
Teva Pharmaceuticals February 2008 - Present
CoGenesys June 2005 - February 2008
Human Genome Sciences October 1998 - June 2005
The Phillips Collection November 1992 - November 2001
Childrens National Medical Center June 1996 - June 1998
Skills
Validation, Technology Transfer, Biotechnology, GMP, GLP, Sop, Assay Development, Biopharmaceuticals, Life Sciences, In Vitro, Cell, Pharmaceutical Industry
Education
University of Maryland College Park 1993 — 1996
Bachelor of Science (B.S.), Biology, General, GPA of 3.3 out of 4.0
The Catholic University of America 1988 — 1992
Bachelor of Arts, Music Performance (Piano), Magna cum laude
Human Genome Sciences December 2004 - August 2012
Abbott December 1985 - August 2004
McKinsey & Company March 1979 - December 1985
Arthur Andersen Business Consulting September 1974 - July 1977
Education
The University of Chicago - Booth School of Business 1977 — 1979
Master of Business Administration (MBA), Finance, General, Marketing
The College of William and Mary 1970 — 1974
Bachelor of Business Administration (BBA), Accounting