Nuron Biotech Inc
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Nuron Biotech Inc Employees
Pfizer January 2015 - Present
Nuron Biotech Inc February 2013 - December 2014
Pfizer 2009 - 2013
Formally Wyeth 2001 - 2009
Pfizer Animal Health 2000 - 2001
Pfizer Animal Health 1998 - 2000
Pfizer Animal Health 1997 - 1998
Pfizer Animal Health 1995 - 1997
Formally SmithKline Beecham 1987 - 1995
Skills
Customer Service, Vaccines, Microsoft Office, PowerPoint, Microsoft Word, Pharmaceutical Industry, Marketing Strategy, Cross-functional Team..., Microsoft Excel, Strategic Planning, Biotechnology, Infectious Diseases, Pharmaceutical Sales, Brand Management, Global Marketing, Marketing, Business Strategy, Forecasting, Leadership, Product Launch, Strategy
Education
Saint Joseph's University
Master of Business Administration (M.B.A.), Marketing
University of Maryland College Park 1981 — 1985
Bachelor's degree, Biology / Animal Sciences
University of Maryland College Park
Bachelor's degree, Business, Management, Marketing, and Related Support Services
Sanofi Pasteur 2015 - Present
Nuron Biotech Inc 2012 - 2014
West Pharmaceutical Services 2010 - 2012
GSK 2009 - 2010
Teva Pharmaceuticals 2004 - 2009
Merck 2002 - 2003
Merck 1997 - 2001
Merck 1993 - 1996
Merck 1990 - 1992
Merck 1985 - 1990
Skills
Validation, Vaccines, Medical Devices, Quality System, Aseptic Processing, Pharmaceutical Industry, Quality Assurance, Sterilization, Regulatory Submissions, Microbiology, Manufacturing, R&D, Biologics, Contract Manufacturing, Clinical Trials, Commissioning, Technical Transfers, Product Development, Fill/Finish, Sterile Manufacturing, FDA
Education
.University of Michigan
BS, Chemical Engineering with Bio Emphasis
Calvin College
BS, Engineering and Letters
Delta Point, Inc. 2014 - 2014
Nuron Biotech Inc May 2013 - September 2013
Skills
Biotechnology, PCR, Molecular Biology, Drug Development, Clinical Research, Clinical Monitoring, Clinical Trials, Medical Affairs, Clinical Affairs, Microsoft Office, Research, Infectious Diseases, Vaccines, Clinical Development, GCP, CRO, Medical Writing, CTMS, Regulatory Submissions, Therapeutic Areas, Biopharmaceuticals, IND
Education
West Chester University of Pennsylvania 2012 — 2014
Bachelor of Science (BSc), Pharmaceutics and Drug Design
Delaware County Community College 2010 — 2012
Associate of Science (A.S.), Sciences for Health Professions
Yale University May 2014 - Present
Husktech Computer Service January 2013 - May 2014
Robert R. Birge Laboratory January 2012 - May 2014
Brody Research Group May 2013 - August 2013
Nuron Biotech Inc June 2012 - August 2012
Wegmans Food Markets June 2010 - June 2012
Liberty Property Trust June 2009 - August 2009
Skills
Protein Purification, Chromotography, Membrane Filtration, Creating Media, PCR, Protein Mutagenesis, DNA Transfection, Confocal Microscopy, Fluorescence Microscopy, Time Lapse Microscopy, Image Processing, Flow Cyto, Immunostaining, Data Analysis and..., BLAST, Expert in Microsoft..., Microsoft Office, Protein Chemistry, Chromatography, SDS-PAGE, Gel Electrophoresis
Education
Yale University 2014 — 2020
Doctor of Philosophy (Ph.D.), Biochemistry, Biophysics, and Structural Biology
The University of Connecticut 2010 — 2014
Bachelor of Science (B.S.), Cell/Cellular and Molecular Biology
Great Valley High School 2006 — 2010
Merial, a Sanofi Company December 2013 - Present
Nuron Biotech Inc September 2012 - November 2013
Pfizer 2010 - 2012
Wyeth Vaccine, RTP, NC 2003 - 2010
Wyeth Vaccines, Pearl River, NY January 1999 - June 2003
Covance Laboratories December 1996 - December 1998
Skills
Vaccines, Analytical Assay..., Protein Chemistry, Formulation Development, ELISA, Polysaccharide..., cGMP, Technology Transfer, Reg Toxicology, HPLC, QC lab, Analytical Skills, Formulation, GMP, GLP, FDA, Assay Development, Process Simulation, Clinical Trials, Biotechnology, CMC, Validation, Biopharmaceuticals, Quality Control, 21 CFR Part 11, Characterization, V&V, Drug Development, Sop, Clinical Research, Toxicology, Immunology, CAPA, Clinical Development, R&D, Drug Discovery, Analytical Chemistry, LIMS, Cross-functional Team..., Chromatography, Pharmaceutical Industry, Purification, IND, Biochemistry, Pharmaceutics, Regulatory Affairs, LC-MS, Cell, Chemistry, GCP
Education
Duke University School of Medicine 1994 — 1996
Post-Doctoral Fellow in Clinical Chemistry
University of Nebraska-Lincoln 1992 — 1994
Ph.D., Analytical Chemistry
University of Nebraska-Lincoln 1989 — 1992
M.S., Analytical Chemistry
Minnesota State University, Mankato 1985 — 1989
B.S., Organic
SynCardia Systems, Inc. March 2015 - Present
CannaPharmaRx February 2015 - Present
II-VI Incorporated November 2006 - Present
Nuron Biotech Inc April 2012 - December 2014
The Campbell Companies February 2012 - May 2012
Quench USA, Inc. July 2010 - February 2012
Globus Medical December 2008 - October 2009
Kensey Nash Corporation (now DSM) April 1996 - November 2008
Deloitte & Touche September 1990 - April 1996
Skills
Board Leadership, Financial Management, Audit Committee, IPO, SEC reporting, Medical Devices, CRO, Executive Management, Executive Reporting, Personnel Leadership, M&A due diligence, M&A experience, ERP, Biotechnology, Human Capital Management, Succession Planning, Executive Compensation, Strategy, Managerial Finance, Leadership, SEC filings, Executive Pay, Due Diligence, Investor Relations, Management, Mergers, Mergers & Acquisitions, Finance, Process Improvement, Auditing, Personnel Management, Business Strategy, Acquisition Integration, Sarbanes-Oxley Act, Start-ups, Private Sector, Public Speaking, Public Sector, Cash Flow Forecasting, Board Governance, Success Driven, Great Plains Software, Proxy Contests, Internal Controls, Public Companies, Revenue Recognition, Financial Analysis, Financial Reporting
Education
Philadelphia University 1987 — 1989
Bachelor of Science (BS), Accounting
University of Maryland College Park 1986 — 1987
Interior Design
The Catholic University of America 1985 — 1986
Accounting
Theravance Biopharma, Inc. June 2014 - July 2015
Bavarian Nordic Inc April 2013 - June 2014
Nuron Biotech Inc May 2012 - July 2012
Nuron Biotech Inc March 2012 - May 2012
Human Genome Sciences November 2004 - January 2012
Amylin Pharmaceuticals - a wholly owned subsidiary of Bristol-Myers Squibb May 2003 - November 2004
Wyeth Consumer Healthcare November 2001 - April 2003
DuPont April 2000 - October 2001
TEMPLE UNIVERSITY SCHOOL OF MEDICINE July 1998 - March 2000
Skills
GMP, Pharmaceuticals, Clinical Trials, SAP, EDMS, QUMAS, Labeling, Pharmaceutical Industry, Document Management, Sop, Regulatory Affairs, Quality Assurance, Clinical Development, GCP, Biotechnology, Validation, CTMS, FDA, Clinical Study Design, Protocol, Oncology, Infectious Diseases, CAPA, Biopharmaceuticals, IND, 21 CFR Part 11, Drug Development, GLP, Immunology, CRO, Pharmacology, Clinical Monitoring, SOP, Supply Chain Management
Education
Villanova University
Clinical Research Coordinator Certification
University of Pittsburgh 1992 — 1996
Bachelor of Science, Biology
Conestoga High School
Regulatory Affairs Professionals Society
De Lage Landen November 2014 - Present
Nuron Biotech Inc October 2012 - Present
Quench USA, King of Prussia, PA August 2010 - September 2012
Northeastern University Bookstore September 2006 - May 2010
Microsoft Ireland Operations Limited February 2009 - July 2009
Akamai Technologies, Inc January 2008 - July 2008
Skills
Analysis, Account Management, Change Management, Competitive Analysis, Customer Satisfaction, Customer Service, Databases, Employee Training, Finance, Forecasting, Human Resources, Leadership, Management, Market Research, Marketing, Microsoft Office, Microsoft Word, Problem Solving, Process Improvement, Project Management, Quality Assurance, Sales, Software Documentation, Strategic Planning, Time Management
Education
Northeastern University 2005 — 2010
Bachelor of Science, International Business- Finance and Insurance, minor in International Affairs
Dublin City University 2008 — 2009
European Business Trans-Atlantic Studies
Independent Consultant July 2014 - Present
Nuron Biotech Inc July 2012 - July 2014
International Partnership for Microbicides September 2008 - September 2011
Wyeth Research 2006 - 2008
Wyeth 2002 - 2005
Wyeth 1997 - 2002
Wyeth 1988 - 1997
Skills
Sop, CTMS, Clinical Trials, Pharmaceutical Industry, Clinical Development, GCP, Biopharmaceuticals, Strategy, Project Management, FDA, Neurology, Leadership, Clinical Research, ICH-GCP, Management, Biotechnology, Lifesciences, SharePoint, 21 CFR Part 11, Drug Development, Vaccines, EDC, Clinical Monitoring, Protocol, Pharmacovigilance, Change Control, Technology Transfer, GMP
Education
Saint Joseph's University - Erivan K. Haub School of Business 1987 — 1993
MBA, International Business
Temple University & School of Pharmacy 1978 — 1983
BS Pharmacy, Pharmacy
Iroko Pharmaceuticals, LLC June 2015 - Present
RE/MAX Classic February 2015 - Present
Attolon June 2013 - June 2015
Nuron Biotech Inc November 2011 - June 2013
Robert Half Finance & Accounting November 2011 - February 2012
Iberdrola Renewables/Community Energy, Inc October 2006 - November 2010
Solomon Edwards Group January 2006 - October 2006
Sanofi-Synthelabo Research September 1997 - May 2002
Skills
Accounting, Financial Reporting, Cash Flow, Accounts Receivable, Accounts Payable, Accruals, Excel, Financial Analysis, Payroll, Quickbooks, Budgeting, Forecasting, Reconciliation, General Ledger, Microsoft Excel, Renewable Energy, Budgets, Account Reconciliation, Analysis, Finance, Financial Statements, Sarbanes-Oxley Act, Auditing, Fixed Assets, Cost Accounting, Management, Variance Analysis, Internal Controls, Revenue Recognition, GAAP, Financial Modeling, Process Improvement
Education
Villanova University 2013 — 2013
Certified Management Accountant, Part II
Cabrini College 1990 — 1994
Bachelor of Science, Business Administration; Finance and Economics
Cognizant Technology Solutions October 2014 - Present
Nuron Biotech Inc. April 2014 - September 2014
Consultant in Global Pharmacovigilance May 2007 - December 2013
Genaera Corporation October 2005 - April 2007
Chester Avenue Pharmacy and Healthcare April 2003 - September 2005
Aventis-Pasteur October 1996 - March 2003
Skills
Drug Safety, Pharmacovigilance, Risk Management, Signal detection and..., Pharmacovigilance plans, Risk Management Plans, Risk MaPPs, Clinical Research, Clinical Trials, Medical Writing,..., Periodic Risk Benefit..., Periodic Safety Update..., Clinical Study Reports..., Quarterly Study Reports..., Annual Study Reports..., US PADER reports, Published Author, Regulatory Affairs, Global Regulatory..., FDA, EU. EMEA,..., SOP evaluation and..., FDA Inspections, EU, MHRA Inspections, Inspection preparedness..., AE database selection,..., Data review, analysis..., Adhoc AE requests from..., PV training and..., Employee selection,..., Review and evaluation..., Persuasive Presentations, Budgeting and Resource..., Medical Writing, Regulatory Submissions, FDA, Sop, GCP, Validation, CRO
Education
Drexel University - College of Business and Administration
MBA, Management
Philadelphia College of Pharmacy and Science
BSc, Pharmacy
Nuron Biotech Inc. October 2010 - Present
AAPS 1988 - Present
Merck Research Laboratories April 2004 - September 2010
Merck 2004 - 2009
Wyeth Pharmaceuticals 2002 - 2004
sanofi-aventis 2000 - 2002
US Food & Drug Administration 1993 - 2000
Skills
Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Drug Development, Clinical Development, Technology Transfer, FDA, Clinical Trials, GMP, Biotechnology, Pharmaceutics, Sop, Drug Discovery, Validation, Biopharmaceuticals
Education
University of Louisiana at Monroe 1988 — 1993
Ph.D., Pharmaceutics
Nagpur University 1983 — 1985
M.Pharm, Pharmacokinetics
Kakatiya University 1978 — 1982
B. Pharm, Pharmaceutical Sciences
NextSource Biotechnology June 2014 - Present
RCDVaccine, LLC May 2010 - Present
Vaccine Logistic Solutions May 2010 - Present
NextSource Biotechnology February 2014 - May 2014
Nuron Biotech Inc May 2010 - April 2013
Pfizer 2009 - May 2010
Wyeth January 2000 - October 2009
Wyeth Pharmaceuticals May 1996 - December 1999
Wyeth November 1995 - May 1996
Wyeth May 1995 - November 1995
Skills
Project Planning, Pharmaceutical Industry, Biotechnology, Negotiation, Vaccines, is a serial entrepreneur, Leadership, Program Management, FDA, Oncology, Pharmaceutics, Healthcare, Product Management, Cross-functional Team..., Business Development, Clinical Development, Entrepreneurship, Product Launch, Start-ups, Marketing, Technology Transfer, Medical Devices, Clinical Trials, Biopharmaceuticals, Pharmaceutical Sales, Management, Strategic Planning, Sales Effectiveness, Managed Care, Commercialization, Cardiology, Strategy, Sales Operations, Life Sciences, Sales, Infectious Diseases, Neurology, Market Access, Regulatory Affairs, Sales Management, Marketing Strategy, Hospital Sales
Education
Harvard University 2008 — 2009
Business Negotiations
University of Pittsburgh 1974 — 1978
B.A / B.S, Chemistry, Biology, English
Zynitech Medical Inc January 2014 - Present
Nuron Biotech Inc 2010 - May 2014
Nuron Biotech Inc 2010 - May 2013
BaroFold 2007 - 2009
Pfizer 1997 - 2007
Skills
Biotechnology, Life Sciences, Vaccines, GMP, Protein Chemistry, Pharmaceutical Industry, R&D, Start-ups, Biologics
Education
University of Connecticut 1991 — 1997
PhD, Pharmaceutical Sciences
AstraZeneca July 2014 - Present
JZK Consulting, LLC 2014 - Present
Nuron Biotech Inc August 2013 - September 2014
Applied Clinical Intelligence March 2012 - August 2013
InSightec August 2004 - March 2012
i3 Statprobe June 2002 - August 2004
ICON Clinical Research October 1998 - June 2002
Skills
Clinical Trials, FDA, Clinical Research, Regulatory Submissions, Regulatory Affairs, Quality Assurance, CTMS, Medical Imaging, GCP, Sop, Validation, CRO, EDC, Data Management, Clinical Monitoring, Oncology, Protocol, Medical Devices, Clinical Development, Biotechnology, Infectious Diseases, Pharmaceutical Industry
Education
East Stroudsburg University of Pennsylvania 1995 — 1996
MS, Cardiac Rehabilitation and Exercise Science
Towson University 1992 — 1996
Bachelor of Science (BS), Kinesiology and Exercise Science
OJR
P L Owen Consulting October 2014 - Present
Nuron Biotech Inc July 2012 - Present
Nuron Biotech January 2011 - June 2012
Pfizer (Legacy Wyeth) November 2008 - October 2009
Wyeth Biotech May 2007 - November 2008
Wyeth Vaccines January 2004 - May 2007
Wyeth Vaccines April 2003 - January 2004
Wyeth-Lederle Vaccines and Pediatrics July 1999 - March 2003
Wyeth-Lederle Vaccines and Pediatrics 1997 - 1999
Wyeth-Lederle Vaccines and Pediatrics 1991 - 1995
Skills
Validation, Quality System, GMP, Quality Control, Quality Assurance, FDA, CAPA, Sop, Manufacturing, Vaccines, Reviews, Software Documentation, 21 CFR Part 11, Change Control, Fermentation, LIMS, Leadership, ISO, Cross-functional Team..., Purification, Pharmaceutical Industry, Quality Auditing, Management, Biotechnology, Auditing, Training
Education
North Carolina State University 1975 — 1979
BS in Wildlife Biology, Wildlife Biology
Lees-McRae College 1973 — 1975
Associate of Science, Biology
Datatrak International April 2014 - Present
Datatrak International February 2013 - April 2014
Nuron Biotech Inc March 2011 - February 2013
Pharm-Olam International November 2010 - April 2011
Pharm-Olam International September 2008 - November 2010
Pharm-Olam International November 2007 - September 2008
Datatrak International February 2006 - October 2007
ClickFind, Inc. August 2003 - February 2006
Skills
Clinical Data Management, EDC, 21 CFR Part 11, FDA, EVWEB, Computer System..., Budget Monitoring, Project Management, Software Project..., GCP, Vendor Management, Vendor Contracts, EDC Programming, Clinical Research, Clinical Trial Oversight, Clinical Trials, Clinical Development, Pharmaceutical Industry, Sop, Lifesciences, CRO, CTMS, Regulatory Submissions, Data Management, Regulatory Affairs, Oncology, Biotechnology, Validation, Therapeutic Areas, Medical Devices, Protocol, Regulatory Requirements, Quality Assurance, Pharmacovigilance, Vaccines, ICH-GCP, Infectious Diseases, Drug Development, Cardiology, Medical Writing, GMP, Neurology, Change Control, SOP
Education
Texas A&M University - Mays Business School 2001 — 2004
BA, Management
Spark Therapeutics, Inc. 2014 - Present
Nuron Biotech Inc 2011 - 2014
MedImmune 2010 - 2011
Tengion 2005 - 2010
ValSource, LLC 2002 - 2005
Aventis Behring 2000 - 2002
GlaxoSmithKline 1998 - 2000
Wyeth 1996 - 1998
Raytheon Engineers & Constructors 1992 - 1996
Centocor 1990 - 1992
Skills
Validation, Quality Assurance, Microbiology, GMP, CAPA, FDA, Sop, Biotechnology, Change Control, 21 CFR Part 11, Biopharmaceuticals, Technology Transfer, Computer System..., Regulatory Submissions, Clinical Development, Quality System, GxP, Aseptic Processing, Quality Auditing, EDC, Regulatory Affairs, IND, V&V, Vaccines, LIMS, GCP, Cleaning Validation, SOP
Education
Immaculata University 1987 — 1991
BA, Biology
PAREXEL May 2014 - Present
Nuron Biotech Inc April 2013 - April 2014
Merck August 2012 - March 2013
Merck Sharp & Dohme January 2011 - August 2012
Merck September 2007 - January 2011
Merck Sharp & Dohme December 2005 - September 2007
Merck Sharp & Dohme December 2004 - December 2005
Merck Sharp & Dohme April 2002 - December 2004
West Pharmaceutical Services 1998 - 2002
Skills
Computer System..., Pharmaceutical Industry, GMP, GxP, Change Control, Validation, FDA, Clinical Trials, Regulatory Submissions, 21 CFR Part 11, Clinical Development, Drug Development, Oncology, Infectious Diseases, Neuroscience, Leadership, Project Portfolio..., CRO, Cross-functional Team..., GCP
Education
University of Scranton 1991 — 1995
Bachelor's degree, Biology, General
Insmed Incorporated November 2013 - Present
Velcera 2013 - Present
Nuron Biotech Inc 2013 - 2013
Integra LifeSciences November 2008 - March 2012
Ascenta Therapeutics 2008 - 2008
VIASYS Healthcare March 2004 - May 2007
The Immune Response Corporation 2000 - 2004
The Liposome Company, Inc. 1997 - 2000
CertainTeed Corporation March 1994 - March 1997
Carter-Wallace Inc. 1989 - 1994
Skills
Forecasting, Process Improvement, Financial Analysis, Auditing, Budgets, Management, ERP, Sarbanes-Oxley Act, Manufacturing, Cost Accounting, Strategic Planning, Variance Analysis, Accounting, Finance, Internal Controls, Financial Accounting, Managerial Finance, Financial Reporting, Leadership, Analysis, Strategic Financial..., Lean Manufacturing, Mergers & Acquisitions, Project Management, GAAP, SEC filings, Cross-functional Team..., US GAAP, Business Planning, Financial Modeling, Internal Audit, Due Diligence, Acquisition Integration, Expense Management, General Ledger, Consolidation, Corporate Finance, Statutory Accounting, Revenue Recognition, Balance Sheet, Cash Flow, Medical Devices, Biotechnology
Education
University of Nebraska-Lincoln
Bachelor of Business Administration (BA), Accounting and Finance
Qualitest Pharmaceuticals April 2014 - Present
Shire Pharmaceuticals September 2013 - April 2014
Nuron Biotech Inc November 2011 - August 2013
WuXi AppTec January 2007 - July 2011
GlaxoSmithKline July 2006 - September 2006
GlaxoSmithKline March 2006 - April 2006
Xerimis June 2005 - December 2005
Skills
GMP, Quality Assurance, FDA, CMO management, GLP, CAPA, GxP, SOP, Microsoft Office, Quality Control, Change Control, Resume Writing, Validation, Lotus Notes, 21 CFR Part 11, Regulatory Requirements, Six Sigma, Creative Writing, Manufacturing, Software Documentation, 21 CFR Part 58, 21 CFR Part 211, MS Office Suite, SOPs, Pharmaceutical Industry, Biotechnology, Laboratory, Quality System, Biopharmaceuticals, Quality Management, SAP Implementation, SAP
Education
Temple University Graduate School 2014 — 2017
Master of Science (M.S.), Quality Assurance/Regulatory Affairs
Temple University, School of Pharmacy 2010 — 2014
Certificate of Drug Discovey
Morgan State University 2001 — 2005
B.S., Biology
Willingboro High school
Teva Pharmaceuticals November 2014 - Present
Nuron Biotech Inc March 2012 - October 2014
Adolor March 2007 - April 2012
TargetRx 2001 - 2007
Skills
Biotechnology, Analytics, Account Management, Vaccines, Segmentation, Sales Effectiveness, Product Launch, Pharmaceutical Sales, Pharmaceutical Industry, Oncology, Medical Devices, Market Analysis, Managed Care, Lifesciences, Global Marketing, Clinical Trials, CRO
Education
Saint Joseph's University - Erivan K. Haub School of Business 2005 — 2010
MBA, International Marketing, Pharmaceutical Marketing
Saint Joseph's University - Erivan K. Haub School of Business 1996 — 2000
B.S., Pharmaceutical Marketing
Novartis October 2013 - Present
Nuron Biotech Inc February 2013 - October 2013
SynteractHCR October 2012 - February 2013
Incyte March 2011 - April 2012
Celgene November 2009 - March 2011
sanofi-aventis 2003 - 2009
AstraZeneca Mexico 2000 - 2003
GlaxoWellcome 1996 - 2000
Centro Medico Nacional Siglo XXI, IMSS 1993 - 1996
Skills
Clinical Development, Clinical Research, Clinical Study Design, Oncology Clinical..., Respiratory Disease, CNS disorders, Immunologic Diseases, Asthma, Infectious Diseases, Cross-functional Team..., Team Leadership, Drug Safety, Drug Development, Multicultural, Bilingual, Medical Devices, Medical Affairs, Healthcare Industry, Medical Device R&D, Scientific..., Clinical Pharmacology, CTMS, Clinical Trials, Oncology, GCP, Hematology, Regulatory Affairs, Pharmaceutical Industry, Line Management, Project Management, Cardiology, Protocol, Diabetes, Rheumatology, Biotechnology, Medicine, Medical Writing, Pharmacovigilance, Regulatory Submissions, ICH-GCP, Neurology, EDC, Clinical Monitoring, Endocrinology, Immunology, Vaccines, Gastroenterology, Dermatology, Biopharmaceuticals, FDA
Education
Universidad Nacional Autónoma de México 1986 — 1992
MD, Doctor in Medicine
Nuron Biotech Inc December 2010 - Present
WORLDWIDE CLINICAL TRIALS 2008 - 2009
ICON Clinical Research 2003 - 2007
PHARMANET - (FORMERLY MEDEX CLINICAL TRIAL SERVICES, INC 1999 - 2003
MEDEX Clinical Trial Services 1999 - 2001
PHOENIX INTERNATIONAL LIFE SCIENCES 1997 - 1999
SANOFI WINTHROP PHARMACEUTICALS 1991 - 1997
Skills
Clinical Research, Clinical Trials, Endocrinology, Infectious Diseases, CNS, Cardiovascular, Women's Health, Urology, Depression, Traumatic Brain Injury, multiple sclerosis, Pediatrics, Central Nervous System, Sop, Pharmaceutical Industry, FDA, Medical Writing, CTMS, Clinical Monitoring, EDC, Therapeutic Areas, Clinical Development, GCP, SOP
Education
St. Joseph's University 2002 — 2003
West Virginia Wesleyan College
Wesleyan College
BACHELOR OF SCIENCE
Nuron Biotech Inc May 2014 - Present
Merck July 2012 - March 2014
Calhoun Jewelers November 2010 - 2012
sanofi-aventis December 1998 - June 2010
Skills
Clinical Research, Healthcare, Cancer, Drug Development, Clinical Data Management, Regulatory Submissions, Protocol, Sop, Medical Writing, Regulatory Affairs, FDA, Medical Affairs, Quality Assurance, Pharmacovigilance, Vaccines
Education
Ursinus College 2000 — 2004
BS, Psychology
Montgomery County Community College 1980 — 1983
AAS, Nursing, RN
SQA Services September 2013 - July 2015
Nuron Biotech Inc November 2012 - August 2013
Pfizer November 2011 - November 2012
Pfizer October 2009 - October 2011
Wyeth December 2001 - December 2009
cGMP Validation L.L.C January 2000 - January 2001
Aviron Inc January 1998 - January 2000
Goodwin Biotechnology, Inc January 1996 - January 1998
Centocor, Inc January 1993 - January 1996
Johnson and Johnson, Ortho Diagnostics January 1989 - January 1993
Skills
GMP, Sop, Pharmaceutical Industry, V&V, Aseptic Processing, GxP, FDA, CAPA, Validation, Technology Transfer, 21 CFR Part 11, Change Control, Vaccines, Quality System, Biopharmaceuticals, Quality Assurance, Biotechnology, Medical Devices, Regulatory Affairs, GLP, Computer System..., Quality Control, LIMS, Cleaning Validation, Regulatory Submissions, Regulatory Requirements, SOP, IND
Education
Fairleigh Dickinson University-Madison NJ 1972 — 1975
Graduate: M.S, Chemistry
City University of New York City College 1965 — 1969
BS, Chemistry
Incyte December 2013 - Present
Nuron Biotech Inc September 2012 - November 2013
AstraZeneca November 2011 - July 2012
Joule Clinical Staffing May 2010 - October 2010
Omnicare Clinical Research April 2009 - April 2010
Omnicare Clinical Research July 2007 - April 2009
Omnicare Clinical Research March 2007 - July 2007
Temple University Hospital March 2005 - March 2007
Temple University Hospital May 2002 - February 2005
Skills
GCP, Clinical Research, Clinical Trials, Neurology, Pulmonology, EDC, Rheumatoid Arthritis, DataTrak, Medidata, Leading Positive Change, Build Strong Teams, Strongly self-motivated, Technically Strong, Clinical Development, ICH-GCP, Quality Assurance, CTMS, Inform, Oncology, Therapeutic Areas, CRO, Clinical Operations, FDA, Pharmaceutical Industry, Infectious Diseases, Vaccines, Biotechnology, Oncology Clinical..., Data Management, Regulatory Affairs, Regulatory Submissions, Central Nervous System, Drug Development, Endocrinology, Rheumatology, Oracle Clinical, Clinical Data Management, Pharmacovigilance, Protocol, IND, Clinical Monitoring, Sop, Clinical Research..., CRF design, Immunology, Cardiology, Psychiatry, Diabetes, Hematology, Trial Management
Education
Shippensburg University of Pennsylvania 1999 — 2003
Bachelor of Science (BS), Biology
Independent February 2010 - Present
Nuron Biotech Inc August 2012 - June 2014
PharmaNet/i3 Strategic Resourcing April 2012 - August 2012
Kforce Clinical Research, Inc. January 2011 - April 2012
Cephalon August 1999 - January 2010
Skills
Central Nervous System, Neurology, EDC, CRO, Clinical Trials, Clinical Development, CTMS, Medical Writing, Clinical Monitoring, Clinical Research, Clinical Data Management, Lifesciences, GCP, Clinical Operations, Psychiatry, Protocol, FDA, Vaccines, Biotechnology, Therapeutic Areas, ICH-GCP, Oncology, Regulatory Submissions, IND, Drug Development, Pharmaceutical Industry, Medical Affairs, Regulatory Affairs, Infectious Diseases, Pharmacovigilance, Sop
Education
University of Pennsylvania 1970 — 1972
MSN, Nursing
Janssen, Pharmaceutical Companies of Johnson and Johnson May 2014 - Present
Nuron Biotech Inc July 2012 - May 2014
Merck February 2007 - December 2011
Merck November 2000 - February 2007
Merck 1998 - 2000
Skills
Biopharmaceutical..., Laboratory Operations..., Quality Control/Quality..., Regulatory Compliance, Quality Management..., Continuous Improvement, Lean Manufacturing/Six..., Warehouse..., Technical..., Raw Material (Receipt,..., Environmental Monitoring, Personnel..., Scheduling & Planning, Project Management, Data Analysis/Batch..., Process Scheduler, Laboratory, Project Planning, Testing, Quality System, GMP, Quality Assurance, Sop, GLP, Change Control, SOP, V&V, Quality Control
Education
Rutgers University 1981 — 1986
B.A, Biology
Paul VI High School, Haddonfield NJ 1977 — 1981
Diploma, College prepatory - life sciences
Owner - Owls Head Consulting July 2014 - Present
Nuron Biotech Inc 2011 - 2014
LabCorp - Tandem Labs (CRO) 2008 - 2011
Merck & Co., Inc. February 1996 - February 2008
Cornell University, Ithaca New York 1988 - 1991
University of Connecticut September 1983 - May 1988
Skills
Cell Culture, Vaccines, Biomarkers, Biotechnology, CRO, Animal Models, Biochemistry, Clinical Trials, Assay Development, Clinical Development, ELISA, Biologics, Biopharmaceuticals, IND, Translational Medicine, GLP
Education
University of Pennsylvania
The University of Connecticut
Mitchell College, New London Connecticut
Nuron Biotech Inc June 2011 - June 2013
Skills
Marketing, Marketing Strategy, Business Strategy, Market Research, Team Leadership
Education
Drexel University 2012 — 2016