Wellstat Management Company
Founded: 2007 Parent organization: Wellstat Group of Companies Subsidiaries: Wellstat Therapeutics Corporation, Wellstat Biologics Corporation, Wellstat Ophthalmics Corporation
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Wellstat Management Company Employees
Emergent BioSolutions June 2013 - Present
Wellstat Management Company October 2012 - July 2013
MedImmune November 2010 - December 2012
Independent 2010 - November 2010
MiddleBrook Pharmaceuticals, Inc. December 2000 - August 2010
Purdue Pharma, LP September 2000 - December 2000
MIMC/M2 Worldwide, Inc. March 2000 - October 2000
Otsuka June 1998 - August 1999
Otsuka America Pharmaceutical, Inc. December 1994 - June 1998
Merck & Co., Inc. June 1992 - December 1994
Skills
Clinical Research, Clinical Pharmacology, IND, Regulations, Regulatory Submissions, Regulatory Affairs, GCP, FDA, Oncology, Pharmaceutical Industry, Drug Development, GMP, Sop, Clinical Development, Management, Clinical Trials, Biotechnology, Infectious Diseases, CRO, Validation, Pharmacovigilance, Lifesciences
Education
Cabrini College 1988 — 1992
BS, Statistics; Business Administration
Wissahickon 1984 — 1988
ECT Consulting Inc 2014 - Present
Alcon Laboratories, Inc. June 2012 - December 2013
Wellstat Management Company January 2009 - June 2012
sanofi pasteur acambis campus January 2008 - January 2009
InVitro Technologies 2006 - 2007
Celsis In Vitro 2006 - 2007
GenVec November 2004 - December 2006
SAIC Frederick July 2002 - November 2004
SAIC July 2002 - November 2004
MedImmune 1999 - 2002
Skills
Regulatory Affairs, Quality System, Validation, Quality Auditing, Quality Control, Quality Management, Quality Assurance, GLP, FDA, GMP, Biotechnology, CAPA, Sop, Regulatory Submissions
Education
University of Puerto Rico 1981 — 1987
MS, Biology
Wellstat Management Company October 2014 - Present
Wellstat Management Company July 2013 - Present
Validant March 2013 - July 2013
Hill Dermaceuticals, Inc. April 2008 - July 2012
Hill Dermaceuticals, Inc. December 2001 - April 2008
Skills
SOP, Quality Assurance, Validation, Pharmaceutical Industry, GMP, Product Development, Healthcare, Regulatory Submissions, Microsoft Office, Program Management, Sop, Medical Devices, Root Cause Analysis, Coaching, Project Planning, Product Launch, Account Management, Strategic Planning, PowerPoint, Project Management
Education
University of Central Florida - College of Business Administration 2001 — 2003
Master of Business Administration (M.B.A.), Concentration in Health Services Management
University of Central Florida 1997 — 2000
Bachelor of Science (B.S.), Health Services Administration
Wellstat Management Company January 2008 - November 2009
Kadant Black Clawson June 2006 - October 2007
Roto Rooter August 1999 - June 2006
Schulte & Uhrig CPA's 1986 - 1993
Education
University of Cincinnati
Wellstat Management Company June 2007 - Present
The Arrow Project 2006 - 2007
Winchester Homes Inc. 2005 - 2006
Nutramax Laboratories, Inc. 2003 - 2005
Skills
Performance Management, Outlook, Employee Relations, Microsoft Excel, Benefits Administration, PowerPoint, Customer Service, Microsoft Office, Onboarding, Recruiting, Process Improvement, Human Resources, Training, Payroll, Organizational..., Interviews, Applicant Tracking..., PeopleSoft, Personnel Management, New Hire Orientations, Employee Benefits, Editing and publishing, Marketing and..., Workforce Planning
Education
College of Notre Dame of Maryland 1999 — 2003
Bachelor of Arts (BA), Business Administration and Management, General
Notre Dame of Maryland University 1999 — 2003
BA, Management
Wellstat Management Company 2014 - Present
Leidos Biomedical Research, Inc. 1984 - 2014
Skills
EHS, Environmental Permitting, Lifesciences, Biotechnology, DNA, Virology, Hazardous Waste..., Emergency Management, Hazardous Materials, Environmental Health, HAZWOPER, Molecular Biology, Life Sciences, Occupational Health, Environmental Compliance, Policy, Program Management, Risk Assessment, Environmental Awareness, Training
Education
The Johns Hopkins University
Master of Science (M.S.), Environmental Science & Policy
University of Maryland College Park
Bachelor of Science (B.S.), Zoology/Animal Biology
Aeras 2011 - Present
Wellstat Management Company August 2005 - July 2011
NBCOT August 2001 - June 2005
Skills
Biotechnology, Excel, Microsoft Office, Problem Solving, PowerPoint, Documentation, Editing, Writing, Access, Customer Relations, GMP, Customer Service, Outlook, Microsoft Excel, Software Documentation, Budgets, Change Control, GLP, FDA, Training, Quality Assurance, GxP, Sop, SOP
Education
Kaplan University-Hagerstown Campus 2014 — 2016
AAS, International Public Health/International Health
GHS
Lee & Morse, P.C. January 2014 - Present
Roberts Mlotkowski Safran & Cole, P.C. March 2012 - August 2013
Wellstat Management Company September 2009 - March 2012
Crowell & Moring LLP January 2008 - September 2009
Buchanan Igersoll & Rooney PC June 2005 - January 2008
Burns, Doane, Swecker, and Mathis LLP October 2003 - June 2005
IBM January 1999 - August 1999
Skills
Patents, Patent Prosecution, Registered Patent..., Patentability, Intellectual Property, Licensing
Education
University of North Carolina School of Law 2000 — 2003
JD
Case Western Reserve University 1995 — 2000
BSE, Chemical Engineering
Wellstat Management Company December 2001 - Present
Pathology Associates (PAI) now known as Charles River 1995 - 2001
Skills
GMP, Validation, FDA, Biotechnology, GLP, Pharmaceutical Industry, Quality Assurance, Clinical Development, Laboratory
Education
University of Maryland College Park 1974 — 1978
BS, Animal Science
CoStar Group April 2012 - Present
Wellstat Management Company March 2008 - April 2012
Forrester Construction Company January 2000 - March 2008
Skills
Timberline, Outlook, Excel, Word, PowerPoint, Accounts Payable, Payroll, General Ledger, JDE One World, Navision, ADP Payroll, Concur, Access, Microsoft Word, Deltek, Microsoft Excel, Accounting, Account Reconciliation, QuickBooks, Sage, Management, Microsoft Office, JD Edwards
Education
Southwestern Oklahoma State University 1995 — 1999
BBA, Accounting
Shamrock High School 1990 — 1995
High School Diploma
George Mason University April 2014 - Present
Wellstat Management Company October 2007 - April 2014
Nabi Biopharmaceuticals 2003 - 2007
Celera Genomics June 2001 - December 2003
PBDewberry October 2000 - June 2001
DMJM/HTB July 1996 - October 2000
Fairfax County Health Department 1990 - 1996
Education
The Johns Hopkins University 1994 — 1998
MPH, Enviromnmental Health Sciences
University of Virginia 1981 — 1985
BA, Biology
Food and Drug Administration December 2014 - Present
Emergent BioSolutions January 2014 - November 2014
Wellstat Management Company January 2004 - January 2014
Cambrex March 2001 - January 2004
Life Technologies April 1997 - March 2001
Fujisawa May 1986 - April 1997
Skills
GMP, Biotechnology, GLP, Validation, HPLC, FDA, Cell, Pharmaceutical Industry, Technology Transfer, Cleaning Validation, V&V, Quality Assurance, CAPA, Change Control, Aseptic Processing, 21 CFR Part 11, LIMS, Quality System, GAMP
Education
Erie Community College 1982 — 1986
Associate of Arts and Sciences (AAS), Chemical Technology/Technician, 3.8
University of Phoenix
QIAGEN March 2014 - Present
QIAGEN April 2011 - March 2014
Wellstat Management Company June 2006 - April 2011
Wellstat Biologics 2006 - 2011
Skills
Microsoft Office, HTML, cGMP, Customer Service, Excel, Word, PowerPoint, Editing, English, Writing, Documentation, Access, Public Speaking, Problem Solving, Document Management, Administration, Brazilian Portuguese, Microsoft Word, MasterControl(TM), FDA, Software Documentation, GMP, Technical Writing, Sop, Microsoft Excel, GLP, Assay Development, Biopharmaceuticals, Change Control
Education
Montgomery College
Associate of Science (AS), Life Sciences
Thermo Fisher May 2015 - Present
Wellstat Management Company April 2014 - January 2015
Alcon, a Novartis company August 2013 - March 2014
Hyde Engineering + Consulting April 2013 - July 2013
Genzyme January 2013 - March 2013
Alcon, a Novartis company June 2012 - December 2012
SNC-Lavalin November 2011 - June 2012
BD January 2010 - October 2011
Covidien September 2007 - January 2010
Human Genome Sciences/GSK May 2001 - September 2007
Skills
Cleaning Validation, Validation, V&V, CAPA, GMP, Sterilization, Continuous Improvement, cGMP manufacturing, FMEA, Biopharmaceuticals, GAMP, Change Control, Sop, 21 CFR Part 11, Trackwise, FDA, Aseptic Processing, LIMS, Laboratory, Protocol, Equipment Qualification, Biotechnology, Quality Assurance, Pharmaceutical Industry, Quality Control, Computer System..., Manufacturing
Education
The Johns Hopkins University 2005 — 2007
MS, Biotechnology
University of Maryland Baltimore County 1999 — 2001
BS, Biology
University of Pittsburgh 1997 — 1999
Biology
Wellstat Management Company February 2014 - Present
32 Beach Ave 2007 - 2012
Biosynexus Incorporated May 2009 - July 2011
Education
Saint Joseph's College
B.A.
University of Notre Dame Law School
J.D.
Wellstat Management Company 2001 - Present
Advanced Vision Therapies, Inc., now Wellstat Ophthalmics Corporation 2001 - Present
Wellstat Opthalmics Corporation 2001 - Present
Skills
Immunoassays, Animal Husbandry, Cell, ELISA, Monoclonal Antibodies, Vaccines, Assay Development, Purification, Sop, Biotechnology, In Vitro, Management, Western Blotting, SOP development, Dosing, Immunology, Transfection, Flow Cytometry, Cell Culture, Molecular Biology, Laboratory, SOP, Life Sciences
Education
Southern Illinois University, Carbondale 1977 — 1981
Bachelor's degree, Animal Sciences, 3.97
Danaher Corporation March 2014 - Present
Wellstat Management Company May 2011 - March 2014
Wellstat Management Company June 2007 - April 2011
BioVeris Corporation June 2005 - May 2007
Wilmer Hale September 2001 - May 2005
Skills
Biotechnology, Technology Transfer, Intellectual Property, Pharmaceutical Industry, Licensing, GMP, ELISA, Legal Writing, Commercial Litigation, Estate Planning, R&D, FCPA, Strategic Planning, Client Counseling, Legal Advice, Sarbanes-Oxley Act, Pharmacovigilance, Corporate Finance
Education
University of Maryland School of Law 1998 — 2001
Doctor of Law (J.D.)
The College of William and Mary 1990 — 1994
Bachelor of Arts (B.A.), International Relations and Affairs
Wellstat Management Company March 2008 - Present
Wellstat Therapeutics Corporation July 2000 - March 2008
Hoffmann-La Roche January 1999 - June 2000
Hoffmann-La Roche June 1996 - December 1998
Cooper & Dunham LLP August 1993 - May 1996
Cooper & Dunham LLP May 1992 - April 1993
McAulay Fisher Nissen Goldberg & Kiel May 1991 - December 1991
Skills
Intellectual Property, Patent Prosecution, Registered Patent..., Freedom to Operate, Office Action Responses, Licensing, Pharmaceutical Industry, Biotechnology Industry, Legal Advice, Technology Transfer, Biotechnology, Due Diligence, Life Sciences, Patent Litigation, Patents, Trade Secrets, Trademarks
Education
New York University School of Law 1990 — 1993
Juris Doctor
University of Pennsylvania 1986 — 1990
Master of Science (M.S.), Biological Chemistry
Yeshiva University 1982 — 1986
Bachelor of Arts (B.A.), Chemistry
Wellstat Management Company March 2013 - Present
BMO Nesbitt Burns 2002 - 2004
KRG Capital 2001 - 2002
JPMorgan Chase 1999 - 2001
Skills
Equities, Mutual Funds, Investments, Securities, Fixed Income, Bloomberg, Bonds, Financial Analysis, Finance, Due Diligence, Mergers, Valuation, Financial Modeling
Education
Northwestern University 1996 — 1999
BA in Political Science and Economics
Wellstat Management Company 2013 - 2013
Skills
Microsoft Office, Microsoft Word, Microsoft Excel, PowerPoint, Research, Teamwork
Education
Penn State University 2010 — 2014