Unigene Laboratories, Inc.
Industry: Company
DescriptionUnigene Laboratories was a biopharmaceutical company, engaged in the research and development of peptides for medical purposes. The company was founded in 1980 and is located in New Jersey. The company's primary focus is on the development of calcitonin and related peptides for the treatment of osteoporosis. Headquarters: Boonton, NJ Founded: 1980
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Unigene Laboratories, Inc. Employees
Enteris BioPharma, Inc. July 2013 - Present
Unigene Laboratories, Inc. April 2012 - June 2013
Duff & Phelps June 2011 - April 2012
Enzon Pharmaceuticals November 2005 - April 2011
Reliant Pharmaceuticals, Inc. May 2001 - October 2005
Deloitte June 1994 - April 2001
Skills
Consolidated Financial..., Financial Systems, M&A experience, Sarbanes-Oxley Act, SEC filings, GAAP, Internal Controls, Financial Reporting, Auditing, Revenue Recognition, Mergers & Acquisitions, Management, Accounting, Accounts Receivable, Cash Flow, Leadership, Budgets, Finance, Analysis, Financial Statements, Strategy, Restructuring, CPA, Tax, ERP, US GAAP, Due Diligence, Divestitures, Forecasting, Valuation, Consolidation
Education
Rhodes University 1982 — 1989
Genpact Pharmalink June 2013 - December 2014
Unigene Laboratories, Inc. January 2012 - June 2013
Unigene Laboratories, Inc. June 2011 - June 2013
Unigene Laboratories Inc March 2008 - June 2011
International Trading Pharmaceutical Laboratories December 2005 - December 2007
Skills
FDA Regulations, ICH Guidelines, cGMP Compliance, HPLC Assays, Dissolution Method..., MS Office Suite, ANOVA, GMP, FDA, Wet Chemistry, HPLC, Assay Development, Dissolution, Validation, Pharmaceutical Industry, ICH guidelines, Biopharmaceuticals, GLP, Sop, Microsoft Office, Regulatory Affairs, Analytical Chemistry, Quality Control, Pharmaceutics, UV/Vis, Quality Assurance, Quality System, SOP
Education
Northeastern University 2010 — 2011
Masters, Drugs, Biologics, and Medical Device Regulatory Affairs
Rutgers University-New Brunswick 2000 — 2005
Bachelors, Cell Biology and Neuroscience
Enteris BioPharma, Inc. June 2013 - Present
Unigene Laboratories, Inc. September 2012 - June 2013
Novartis Pharmaceuticals Corporation December 2008 - September 2012
Human Genome Sciences, Inc. December 2003 - January 2008
National Institute of Standards and Technology September 2002 - December 2003
Yale University October 2001 - July 2002
Skills
Formulation, Drug Delivery, Protein Chemistry, UV/Vis, Assay Development, Drug Development, Analytical Chemistry, Project Management, Pharmaceutical Industry, Chemistry, Biochemistry, Peptides, GMP, Spectroscopy, Clinical Development, Fluorescence, Biopharmaceuticals, Bioanalysis, GLP, Pharmaceutical..., CMC, Team Building, Pharmacokinetics, Solid Oral Dosage Forms, Granulation, Inorganic Chemistry, Lyophilization, Management, Biophysical Chemistry, Drug Product, Capsules, Tablets, Tablet Compression, Bioavailability, Bioinorganic Chemistry, Cross-functional Team...
Education
Yale University 1996 — 2001
Ph.D., Chemistry
Haverford College 1992 — 1996
B.A., Chemistry
Union High School 1989 — 1992
Immunostics, Inc May 2013 - Present
Brookdale Community College September 2011 - May 2013
Henry Hudson Regional School September 2008 - June 2011
Poricy Park Conservancy September 2007 - June 2008
PharmaGenics, Inc. December 1991 - June 1997
Unigene Laboratories, Inc. September 1985 - November 1991
Skills
Molecular Biology, Cell Biology, Microscopy, DNA sequencing, Western Blotting, Northern Blotting, PCR, Mammalian Cell Culture, Bacterial Transformation, Laboratory, Data Analysis, Lesson Planning, teaching, Education, Curriculum Development, Problem Solving, Microsoft Office, Strong organizational..., Highly detail oriented, Access, HPLC, Biomarkers, Aseptic Technique, Drug Discovery, Community Outreach, Biology, Career Development, Staff Development, R&D, Experimental Design, Regulatory Affairs, Assay Development, RNA isolation, Protein Chemistry, Lifesciences, Training, Leadership Development, Clinical Research, DNA, FPLC, SDS-PAGE, Biochemistry, Biotechnology, Molecular Cloning, Protein Purification, Protein Expression, GLP, Organizational..., Nonprofits, Sequence Analysis
Education
Illinois State University 1982 — 1985
Master of Science (MS), Biology, General, GPA 3.5
The University of Connecticut 1978 — 1982
Bachelor of Science (BS), Biology, General
Mercer County Community College 2012 — 2013
Clinical Development and Regulatory Affairs
Hackensack University Medical Center August 2012 - Present
Hackensack University Medical Center 2007 - Present
Unigene Laboratories, Inc. 2001 - 2007
Skills
Oncology, Healthcare Management, Patient Advocacy, Clinical Research
Education
UMDNJ 2009 — 2011
Master's degree, Adult Health Nurse/Nursing
Fairleigh Dickinson University 2005 — 2007
Bachelor's degree, Registered Nursing/Registered Nurse
Rutgers, The State University of New Jersey-New Brunswick 1996 — 2000
Bachelor's degree, Biology/Biological Sciences, General
CorePharma LLC November 2013 - Present
Unigene Laboratories, Inc. June 2011 - April 2013
Skills
HPLC, UV/Vis, GLP, Validation, GMP, Laboratory, Chemistry, Analytical Chemistry, IR, LIMS, Pharmaceutical Industry, Chromatography, Biopharmaceuticals, Gas Chromatography, SOP, Organic Chemistry, Technology Transfer, Biotechnology, Drug Discovery, FDA, CAPA, Regulatory Affairs
Education
New Jersey Institute of Technology 2011 — 2014
Master of Business Administration (MBA), Business Administration and Management, General
Rutgers, The State University of New Jersey-Newark
Rutgers, The State University of New Jersey - Rutgers Business School
Bachelor's degree, Chemistry
New Jersey Institute of Technology
Master of Business Administration (MBA), Finance, General
Shire February 2015 - Present
Shire September 2013 - February 2015
GlaxoSmithKline October 2012 - March 2013
GlaxoSmithKline March 2011 - September 2012
Consumer Product Testing Company November 2010 - January 2011
Consumer Product Testing Company April 2010 - November 2010
Schering-Plough Research Institute September 2008 - March 2010
Charles River Associates March 2008 - September 2008
Unigene Laboratories, Inc. October 2007 - March 2008
Skills
Auditing, Internal Audit, Compliance, Technical Writing, Manufacturing, Project Planning, Project Management, Quality Assurance, Regulatory Affairs, Toxicology, Animal Science, Study Coordination, Study Reports, Quality Control, Quality Auditing, Stability Studies, Analytical Chemistry, Biopharmaceuticals, HPLC, Pharmaceutical..., Medical Compliance, Statutory Compliances, Safety Compliance, Deviation Management, Deviations, Corrective Actions, Microsoft Office, Microsoft Excel, Microsoft Word, Change Management, Osmolality, Complaint Investigations, SAP R/3, Adobe Acrobat, Visio, SCADA, PowerPoint, SOP, FDA, GMP, Validation, Pharmaceutical Industry, GLP, Quality System, CAPA, Biotechnology, Laboratory, 21 CFR Part 11, Change Control
Education
Rutgers, The State University of New Jersey-New Brunswick 2003 — 2006
BS, Biology, General
West Virginia University 1999 — 2001
n/a, Pre-Medicine/Pre-Medical Studies
Public Health Research Institute Center at Rutgers, The State University of New Jersey July 2014 - Present
Enteris BioPharma, Inc. June 2013 - April 2014
Unigene Laboratories, Inc. June 2009 - June 2013
Skills
Biotechnology, Molecular Biology, GLP, ELISA, Chromatography, Analytical Chemistry, Immunoassays, UV/Vis, Biopharmaceuticals, Lifesciences, Aseptic Technique, cGMP practices, Analytical Methods..., SOP development, Animal Surgery, Peptides, Formulation, Solid Phase Extraction, Mass Spectrometry, Pharmacokinetics, Method Development, Pharmaceutical Industry, Drug Discovery, Assay Development, Laboratory, SOP, Pharmacodynamics, Research, In Vitro, In Vivo, HPLC, Fluorescence, Drug Development
Education
Montclair State University 2003 — 2008
Bachelors, Biology
Vertex Pharmaceuticals July 2015 - Present
Agilux Laboratories June 2014 - July 2015
Agilux Laboratories October 2012 - June 2014
Agilux Laboratories September 2011 - October 2012
Agilux Laboratories February 2011 - September 2011
Unigene Laboratories, Inc. June 2009 - August 2009
Skills
HPLC-MS, Microsoft Excel, Bioanalysis, Sample Preparation, Chromatography, Troubleshooting, Analysis, Time Management, Microsoft Office, Microsoft Word, Analytical Chemistry, Assay Development, Drug Discovery
Education
Clark University 2010 — 2013
Master of Arts (MA), Biology, General
Clark University 2006 — 2010
Bachelor of Arts (BA), Biology, General
Self-employed September 2013 - Present
Unigene Laboratories, Inc. January 1980 - June 2010
Skills
Management, Research, Peptides, Drug Delivery, Pharmaceutical..., Patents, Licensing, Contract Negotiation, Board of Directors, Investor Relations, Drug Development, FDA GMP, Compensation & Benefit, Scientific collaboration, Fund raising, GLP
Education
Northwestern University 1974 — 1979
Doctor of Philosophy (PhD), Biochemistry and Molecular Biology
Massachusetts Institute of Technology 1970 — 1974
Bachelor of Science (BS), Chemistry
Jenene Thomas Communications LLC. April 2014 - Present
Enteris BioPharma, Inc. June 2013 - April 2014
Unigene Laboratories, Inc. September 2012 - June 2013
Unigene Laboratories, Inc. May 2011 - September 2012
TD Bank November 2007 - May 2011
Skills
Pharmaceutical Industry, Biotechnology, Lifesciences, Cross-functional Team..., Business Development, Business Strategy, Strategic Planning, Business Planning, Project Management, Mergers & Acquisitions, Marketing Strategy, Financial Analysis, Microsoft Excel, Market Analysis, Financial Modeling
Education
Rider University
BA, Finance
Raritan Valley Community College
Pre-Pharmacy, Associate of Science
Bristol-Myers Squibb June 2013 - Present
Unigene Laboratories, Inc. January 2013 - April 2013
Unigene Laboratories December 2008 - January 2013
Wyeth Pharmaceuticals June 1996 - December 2008
Wyeth Research 1996 - 2008
Rutgers University 2004 - 2007
Skills
Industrial Microbiology, Biotechnology, Microbial Identification, Fermentation, Molecular Biology, Microbiology, HPLC, Drug Discovery, Biopharmaceuticals, Natural Products, Purification, Chemistry, Lifesciences, R&D, Biochemistry, Technology Transfer, GLP, Assay Development, Protein Chemistry, Chromatography, Drug Development, Laboratory, Mammalian Cell Culture
Education
Rutgers, The State University of New Jersey-New Brunswick 2004 — 2007
Ph.D., Microbiology and Molecular Genetics
Nutley High School
G&W Laboratories February 2014 - August 2014
Teva Pharmaceuticals April 2013 - February 2014
Unigene Laboratories, Inc. August 2012 - April 2013
Unigene Laboratories, Inc. August 2011 - August 2012
Long Island University, Department of Pharmaceutics May 2009 - May 2011
Treffer Pharmaceuticals August 2007 - April 2008
Skills
Titration, Dissolution, UV/Vis, HPLC, TLC, Wet Chemistry, Gas Chromatography, pH meter, Laboratory Equipment, WinNonlin, Viscometry, Microsoft Excel, GLP, Formulation, Biopharmaceuticals, GMP, Assay Development, Chromatography
Education
Long Island University 2009 — 2011
Master's Degree, Pharmaceutical Sciences (Industrial Pharmacy), 3.51
Rajiv Gandhi University of Health and Sciences 2003 — 2007
Bachelor's Degree, Pharmacy, 3.9
Morra and Associates March 2001 - Present
DISCOVERY TECHNOLOGY INTERNATIONAL, INC. 2012 - Present
SoluBest Ltd. June 2010 - Present
AdhereRx Corp. (FKA InforMedix Holdings, Inc.) December 2005 - Present
Unigene Laboratories, Inc. May 2001 - September 2010
SCOLR Pharma, Inc. August 2007 - June 2010
SCOLR Pharma, Inc. January 2009 - August 2009
BioPharm Solutions, Inc. July 2006 - January 2009
Medisys Technologies, Inc. March 2001 - December 2006
West Pharmaceutical Services, Inc. April 2003 - January 2005
Skills
Biotechnology, Medical Devices, R&D, Pharmaceuticals, Strategic Planning, Start-ups, Business Strategy, Business Planning, Contract Negotiation, Product Development, New Business Development, Strategy Development, Research, Venture Capital, Strategy, International Business, Pharmaceutical Industry, Drug Delivery, Mergers & Acquisitions, FDA, Product Management, Commercialization, Technology Transfer, Formulation, Clinical Development
Education
University of Massachusetts, Amherst, MA 1976 — 1980
Ph.D., Polymer Science & Engingeering
University of Massachusetts, Amherst, MA
M.B.A.
Princeton University
B.S.E., Chemical Engineering
Atrium Staffing September 2013 - Present
Unigene Laboratories, Inc. January 2012 - April 2013
UBS Financial Services May 2010 - July 2010
Worldwide Eucharistic Adoration Project March 2000 - 2010
Mass Kits for Africa February 2000 - 2010
Church & Sport June 2009 - July 2009
Calvin Klein May 2008 - July 2008
Skills
Excellent Organizer, Goal Oriented, Interpersonal Skills, Adapts Well To New..., Strong Communicator, Works Well Independently, Works Well In Group..., Budget Management, Excellent Multi-tasker, Detail Orientation, Business Development, Fundraising, Sales, Social Skills, Social Networking, Research, Budgets, Leadership, Corporate Communications, Time Management, Project Planning
Education
Muhlenberg College 2007 — 2011
Bachelor of Arts, Media and Communication
Phibro Animal Health March 2014 - Present
Pfizer September 2013 - Present
Pfizer (formerly Wyeth) January 2011 - August 2013
Wyeth Pharmaceuticals January 2008 - January 2011
Wyeth Pharmaceuticals November 2006 - January 2008
Unigene Laboratories, Inc. 2006 - 2006
Skills
Quality Assurance, LIMS, Biotechnology, GMP, CAPA, 21 CFR Part 11, Quality Control, FDA, SOP, GLP, Vaccines, Quality Auditing, Microbiology, Cell Culture, cGMP, Pharmaceuticals, Quality Systems, Western Blotting, PCR, Continuous Improvement, Process Improvement, Aseptic Technique, QC, SDS-PAGE, Compliance, Word, Documentation, Environmental Monitoring, Auditing, Biopharmaceuticals, Technical Writing, Quality Improvement, Team Leadership, Problem Solving, Data Analysis, Time Management, Presentations, Investigation, Molecular Biology, Testing, Microsoft Office, Excel, SAP, Medical Devices, Lifesciences, Lean Manufacturing, Cost Saving Initiatives, Regulations, Change Control
Education
Rutgers Business School 2015 — 2017
Master of Business Administration (MBA), Business Administration and Management, General
Iona College 2012 — 2013
Master of Business Administration (MBA), Business Administration and Management, General
Temple University 2010 — 2012
Drug Development Certificate, Quality Assurance/Regulatory Affairs
William Paterson University of New Jersey 2009 — 2011
Masters of Science, Biology
Montclair State University 2001 — 2006
Bachelors of Science, Biology
Mount Snow May 2015 - Present
Mount Snow October 2014 - April 2015
Mount Snow Chamber of Commerce July 2014 - October 2014
New Leaf Hyperbarics March 2013 - July 2014
Larson Automotive Group December 2012 - April 2013
CarpeVITA Inc. February 2012 - September 2012
Unigene Laboratories, Inc. August 2011 - March 2012
Ruby Tuesday January 2010 - August 2010
Bertucci's September 2008 - December 2009
Mount Ida College September 2007 - May 2009
Skills
Event Planning, Outlook, Microsoft Office, Public Speaking, PowerPoint, Nonprofits, Facebook, Social Media, Customer Service, Sales, Hospitality, Microsoft Word, Microsoft Excel, Leadership, Social Networking
Education
Mount Ida College 2005 — 2009
Bachelors, Business Administration
AccuTech Environmental Services, Inc March 2015 - Present
JM Sorge, Inc. Environmental Consultants July 2011 - February 2015
Oxford Diabetic Supply, Inc December 2010 - July 2011
Unigene Laboratories, Inc. February 2009 - December 2009
B2A/ Survsat June 2005 - August 2005
JTSurveying May 2005 - August 2005
Hillsboro Pharmacy August 2000 - August 2004
Skills
Sop, Environmental Awareness, Environmental Compliance, Laboratory, Environmental Consulting, Remediation, Data Analysis, Strategy, GMP, Renewable Energy, Time Management, Process Engineering
Education
Rutgers, The State University of New Jersey-New Brunswick 2004 — 2009
Bachelor of Science in Engineering, Industrial Engineering
Advaxis, Inc. October 2013 - Present
Dendreon January 2013 - October 2013
Unigene Laboratories, Inc. September 2010 - December 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2005 - October 2010
Hiway Theatre 2005 - 2007
AstraZeneca January 2001 - January 2005
Morgan, Lewis & Bockius LLP January 1998 - January 2001
Klehr Harrison Harvey Branzburg & Ellers September 1995 - January 1998
Skills
Legal Writing, V&V, Business Planning, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Licensing, FDA, Lifesciences, Technology Transfer, Intellectual Property, Oncology, Clinical Development, Medical Devices, Patents, Clinical Trials, Commercialization, Mergers, Due Diligence, Biopharmaceuticals, Joint Ventures, Corporate Governance, Regulatory Requirements, Out-licensing, R&D agreements, Development Agreements, Marketing Agreements, Management Of Outside..., Corporate Transactional, Pharmaceutics
Education
Temple University - James E. Beasley School of Law 1992 — 1995
J.D. magna cum laude
Syracuse University 1987 — 1991
B.S. Cum Laude
Pfizer November 2010 - Present
Pfizer November 2009 - November 2010
Unigene Laboratories, Inc. January 2009 - October 2009
Skills
GLP, Vaccines, ELISA, Monoclonal Antibodies, Drug Discovery, Assay Development, In Vitro, Pharmaceutical Industry, Immunoassays, Bioanalysis, Bacterial Cell Culture, Project Management, Project Planning, Leadership, Cross-functional..., Cross-functional..., Planning & Scheduling, Handle Multiple..., GMP, Problem Solving, Teamwork
Education
Ramapo College of New Jersey 2005 — 2009
Bachelor of Science (BS), Biology, General
Vela Diagnostics May 2012 - Present
BioReference Laboratories July 2007 - May 2012
Unigene Laboratories, Inc. July 2004 - July 2007
Skills
Medical Devices, Hardware Diagnostics, Biotechnology, Lifesciences, FDA, Validation, Genomics, Molecular Biology, ISO 13485, DNA sequencing, Laboratory Automation, Assay Development, PCR, R&D, DNA, GMP, Commercialization, Technology Transfer, Microbiology, Sequencing, Life Sciences, Laboratory
Education
William Paterson University of New Jersey 2005 — 2008
Master's degree, Biotechnology
Juniata College 2000 — 2004
Bachelor of Applied Science (B.A.Sc.), Biology, General
Defined Health October 2013 - Present
Defined Health August 2011 - September 2013
Unigene Laboratories, Inc. June 2007 - August 2011
Unigene Laboratories, Inc. May 2006 - August 2006
Skills
Clinical Development, Biotechnology, Infectious Diseases, Opportunity Assessment, Pharmaceutical Industry, Commercial Assessment, Forecasting, Assay Development, GMP, GLP, Drug Discovery, Biopharmaceuticals, Validation, Lifesciences, Drug Development, Competitive Intelligence, Life Sciences, Clinical Trials
Education
Rutgers, The State University of New Jersey-Newark 2010 — 2013
MBA, Pharmaceutical Management & Marketing
Rutgers University-New Brunswick 2007 — 2010
Master of Science, Cell & Developmental Biology
The College of New Jersey 2003 — 2007
Bachelor of Science, Biology
Celimmune December 2014 - Present
Creative BioVentures Corp 2002 - Present
Tolera Therapeutics December 2013 - Present
Tarsa Therapeutics June 2010 - Present
Unigene Laboratories, Inc. June 2010 - June 2013
INO Therapeutics, Inc. 1997 - December 2001
Ohmeda Pharmaceuticals, Inc. 1992 - 1997
Seton Healthcare Group 1990 - 1992
Seton Healthcare Group 1988 - 1990
Reckitt & Colman 1987 - 1988
Skills
Biotechnology, Biopharmaceuticals, Lifesciences, Pharmaceutical Industry, Drug Development, Technology Transfer, Commercialization, Clinical Development, Strategic Planning, Oncology, Strategy, Clinical Trials, Capital Raising, Start-up Ventures, FDA, Start-ups, R&D, Pharmaceutics, Business Development, Drug Delivery, Life Sciences, Turn Around Management, Crisis Management, Medical Devices, Mergers & Acquisitions, GMP, CRO, Drug Discovery, Regulatory Submissions, Licensing, Organizational..., DNA, Business Planning, GLP, Regulatory Affairs, Vaccines, Formulation, Validation
Education
The University of Manchester 1981 — 1984
BSc (Hons), Biochemistry & Applied Molecular Biology
University of Bradford 1987 — 1990
MBA, Corporate Strategy and Entrepreneurism; M&A transactions; and Corporate Development
Regeneron Pharmaceuticals January 2013 - Present
Unigene Laboratories, Inc. December 2008 - August 2012
Scimedx Corporation October 2008 - December 2008
AIDS Project New Haven February 2007 - March 2008
Quinnipiac University January 2007 - December 2007
Quinnipiac University September 2006 - December 2006
Rutgers University September 2003 - June 2004
Skills
Formulation Chemistry, Formulation Development, Solid Oral Dosage Forms, Capsules, HPLC, Small Animal Models, Animal Surgery, Microsurgery, Drug Delivery, ELISA, Enzyme Assays, Wet Chemistry, Pharmacology, Molecular Biology, PCR, Restriction Digestion, Molecular Genetics, Cryotomy, GLP, High Pressure Situations, Team-oriented, Project Coordination, Fundraising, HIPAA, Formulation, Drug Discovery, DNA
Education
University of Medicine and Dentistry of New Jersey 2010 — 2012
Master of Biomedical Sciences, Pharmacological Sciences concentration, 4.0
Quinnipiac University
Bachelor of Science, Microbiology / Molecular Biology major; Chemistry minor, 3.6
Montville Township High School
Symrise December 2014 - Present
BASF November 2012 - December 2014
Batpharma May 2011 - August 2011
Unigene Laboratories, Inc. April 2007 - May 2011
Skills
cGMP, GLP, GMP, HPLC, QC, SOP, Pharmaceuticals, Pharmaceutical Industry, Quality Control, 21 CFR Part 11, Sop, Pharmaceutics, V&V, Validation, Regulatory Affairs, Chromatography, LIMS
Education
New Jersey Institute of Technology 2009 — 2012
Master of Science (M.S.), Pharmaceutical Engineering
Hunter College 2000 — 2007
Bachelor's degree, Biochemistry
The Laurel March 2014 - October 2014
CVS Caremark Corporation June 2011 - July 2012
Saint Barnabas Health Care System February 2011 - July 2011
Unigene Laboratories, Inc. April 2008 - December 2009
Cosmetic Essence, Inc. February 2008 - April 2008
Starbucks Coffee Company June 2007 - January 2008
CFC-Youth, Inc December 2004 - June 2007
Tom Thumb Pharmacy June 2003 - December 2004
Skills
Pharmaceutical Industry, Sop, Musical Background, Piano, Experience Working with..., Children's Parties, Musical Instruments, Non-profit Leadership, Non-profit Volunteer, Microsoft Office, Microsoft Excel, PowerPoint, Microsoft Word, Data Analysis, Biotechnology, Public Speaking, HPLC, Healthcare, GMP, Validation, Social Media, Restaurants
Education
Texas Woman's University 1999 — 2003
B.S., Chemistry, Psychology
AstraZeneca (formerly Medimmune) March 2012 - Present
ConvaTec October 2010 - March 2012
ConvaTec August 2008 - October 2010
Bristol-Myers Squibb January 2006 - March 2008
Unigene Laboratories, Inc. January 2000 - December 2005
Skills
GMP, FDA, Biotechnology, Medical Devices, Validation, Quality System, Pharmaceutical Industry, Quality Assurance, ISO 13485, Biopharmaceuticals, Trackwise, Process Improvement, Contract Manufacturing, Aseptic Processing, Quality Auditing, Sop, Change Control, Regulatory Requirements, Continuous Improvement, GxP, V&V, Six Sigma, Lifesciences, CAPA, Quality Control, GAMP, GCP, Root Cause Analysis, Technology Transfer, HPLC, Clinical Trials, CRO, R&D, Computer System..., 21 CFR Part 11, GLP, Regulatory Affairs, Drug Development, Commercialization, Process Simulation, Oncology, IND, LIMS, Pharmaceutics, Clinical Development, Design Control, Manufacturing, Quality Management
Education
Stevens Institute of Technology 2002 — 2007
Master of Science, Pharmaceutical Engineering
St. Lawrence University 1995 — 1999
B.S., Biology
Seton Hall Prep 1991 — 1995
Gilead Sciences 2015 - Present
Gilead Sciences January 2015 - July 2015
Gilead Sciences 2008 - 2014
Nektar Therapeutics 2004 - 2008
Mustang Engineering 2002 - 2003
Burns and Roe 2001 - 2002
Washington Group International (Formerly Morrison Knudsen Corporation) 2000 - 2001
Unigene Laboratories, Inc. 1999 - 1999
Skills
Cross-functional Team..., Project Management, Project Planning, Engineering, Contract Negotiation, GMP, Facilities Management, Procurement, Management, Process Engineering, Risk Management, Capital Budgeting, Constructability, Large Capital Projects, Conflict Resolution, Schedule Control, Staff Mentoring, Diplomacy, Design Review, Scope Management
Education
Rutgers, The State University of New Jersey-New Brunswick 1993 — 1999
BS, Chemical Engineering with Biochemical Engineering Option
St Peter's Prep School 1989 — 1993
ForteBio - A Division of Pall Life Sciences January 2012 - Present
Molecular Devices March 2001 - January 2012
Mettler-Toledo International, Inc October 2000 - March 2001
Beckman Coulter 1998 - 2000
Delta F Corporation- Semiconductors February 1997 - December 1997
Pall Corporation June 1994 - February 1997
Waters Corporation January 1993 - February 1994
Unigene Laboratories, Inc. January 1992 - October 1993
Northeastern University September 1989 - December 1991
Arthur D. Little June 1989 - September 1989
Skills
Genomics, Immunology, Product Development, Laboratory, Management, Miller-Heiman Strategic..., Miller Heiman..., Sales Management, New Business Development
Education
Harvard Extension School
Marketing Management
Northeastern University
MS, Analytical Chemistry
University of Massachusetts, Amherst
Bachelor’s Degree, Chemistry
Unigene Laboratories, Inc. January 2011 - Present
Unigene Laboratories, Inc. September 2008 - December 2010
Unigene Laboratories, Inc. September 2006 - September 2008
Skills
Validation, GMP, Quality Assurance, Quality System, FDA, CAPA, Biotechnology, Sop, Pharmaceutical Industry, GLP, Change Control, Medical Devices, 21 CFR Part 11, Lifesciences, Microbiology, Regulatory Affairs, V&V, ISO 13485, Quality Management, Quality Auditing, Technology Transfer
Education
Eastern Michigan University 1991 — 1993
Master of Science (MS), Physiology, General
Formosa Plastics Corporation, USA October 2013 - Present
Slip Doctors of New Jersey LLC October 2010 - Present
Unigene Laboratories, Inc. April 2004 - May 2013
Skills
GMP, Financial Statements, Pharmaceutical Industry, Biotechnology, Cost Accounting, FDA, Cross-functional Team..., Sop, Process Improvement, Biopharmaceuticals, Technology Transfer, GLP, Sarbanes-Oxley Act, Validation, Regulatory Affairs
Education
New Jersey City University
BA, Business Management
Daiichi Sankyo, Inc. May 2014 - Present
Daiichi-Sankyo March 2013 - May 2014
Daiichi-Sankyo, Inc. June 2012 - March 2013
Marken LLP August 2011 - April 2012
Merck (formerly Schering-Plough) September 2006 - July 2011
Pfizer October 2004 - September 2006
Pfizer October 2001 - October 2004
Pfizer March 2000 - October 2001
Scientific Staffing January 1999 - March 2000
Unigene Laboratories, Inc. January 1997 - January 1999
Skills
Project Management, Manufacturing, Pharmaceutics, Lifesciences, Supply Chain, Change Control, CTMS, Supply Chain Management, CAPA, Demand Planning, Document Management, Clinical Development, Cross-functional Team..., Drug Development, Process Improvement, Software Documentation, Vendor Management, Validation
Education
The University of Connecticut School of Business 2002 — 2004
MBA, Management
State University of New York at Geneseo 1994 — 1996
BS, Biology
United States Coast Guard Academy 1992 — 1994
N/A, Marine Science
DRG International, Inc. September 2013 - Present
Child Care Resources October 2012 - August 2013
Child Care Resources of Monmouth County January 2012 - October 2012
Unigene Laboratories, Inc. August 2011 - December 2011
CytoSorbents March 2011 - April 2011
ZEUS Scientific, Inc. May 2008 - March 2010
Futures Community College September 2007 - January 2008
Family June 1999 - August 2007
Freehold Regional High School May 2007 - June 2007
Rumson Fair Haven Regional High School January 2007 - May 2007
Skills
Western Blotting, ELISA, Troubleshooting, Lotus Notes, Research, Microsoft Office, Machinery, Luminex, Clinicals, Molecular Biology, Microbiology, PowerPoint, Immunology, Biochemistry, Laboratory, Immunoassays, FDA, Science, GLP, Antibodies, GMP, Data Analysis, Validation, R, Biopharmaceuticals, Microsoft Excel, Biology, Microsoft Word, SDS-PAGE, Laboratory Skills, Gel Electrophoresis, Training, DNA extraction, Protein Purification, Product Development, Cell, Flow Cytometry, Lifesciences, Clinical Research
Education
Monmouth University 2005 — 2007
MAT, Secondary Education
Providence College 2001 — 2005
2005B.S, Biology
Enteris BioPharma, Inc. July 2013 - Present
Unigene Laboratories, Inc. September 2011 - July 2013
Unigene Laboratories, Inc. June 2005 - September 2011
Unigene Laboratories, Inc. May 2001 - June 2005
Unigene Laboratories, Inc. September 2000 - May 2001
Skills
GLP, GMP, FDA, Sop, Pharmaceutical Industry, Technology Transfer, HPLC, Assay Development, Validation, Batch Records, Tablet Compression, Tablet Coating, Encapsulation, Capsule Coating, Tablet Press, Pan Coater, Blend & Compression, Biopharmaceuticals, Granulation, Formulation, Drug Delivery, Biotechnology, 21 CFR Part 11, Chromatography, Change Control, Tablets, Regulatory Submissions, Analytical Chemistry, Drug Development
Education
Rutgers University-New Brunswick 1995 — 2000
BS, Biological Sciences
Sanofi Pasteur 2007 - Present
Unigene Laboratories, Inc. April 1999 - August 2007
Skills
21 CFR Part 11, Aseptic Processing, Biopharmaceuticals, Vaccines, Validation, Technology Transfer, Sop, SOP, Pharmaceutical Industry, GxP, GMP, GLP, FDA, Change Control, CAPA, Biotechnology
Education
Rutgers University-New Brunswick 1991 — 1996
B.S., Biological Sciences
Enteris BioPharma, Inc. July 2013 - Present
Unigene Laboratories, Inc. May 2011 - June 2013
Unigene Laboratories July 2004 - June 2011
Roche Molecular Systems August 2003 - July 2004
Skills
Biotechnology, Pharmaceutical Industry, GMP, Technology Transfer, Validation, Sop, Assay Development, HPLC, Chromatography, Change Control, Analytical Chemistry, Regulatory Submissions, Lifesciences, Biopharmaceuticals, Method Development, Drug Delivery, Clinical Development, Drug Development
Education
Rutgers, The State University of New Jersey-Newark 2014 — 2016
Master of Business Administration (M.B.A.)
Montclair State University 2000 — 2003
B.S., Molecular Biology
Regeneron Pharmaceuticals, Inc. August 2014 - Present
Roche 2004 - 2013
Unigene Laboratories, Inc. 2002 - 2004
Skills
Drug Development, Drug Discovery, Pharmaceutical Industry, GLP, Biotechnology, LC-MS, GMP, HPLC, GC-MS, GC, Gas Chromatography, Organic Chemistry, Analytical Chemistry, Mass Spectrometry, Purification, Assay Development, Protein Chemistry, Chemistry
Education
New Jersey Institute of Technology 2003 — 2006
M.Sc, Pharmaceutical Engineering
Montclair State University
B.Sc, Biochemistry
Bristol-Myers Squibb January 2014 - Present
Enteris BioPharma, Inc. June 2013 - December 2013
Unigene Laboratories, Inc. October 2012 - May 2013
Unigene Laboratories, Inc. January 2012 - October 2012
Unigene Laboratories, Inc. August 2009 - January 2012
Baxter Healthcare July 2003 - August 2005
Baxter Healthcare April 2001 - July 2003
Baxter Healthcare June 1999 - April 2001
Skills
Drug Delivery, Validation, Regulatory Submissions, Formulation, Pharmaceutics, HPLC, Drug Discovery, Drug Development, Biopharmaceuticals, Pharmacokinetics, Peptides, Biotechnology, Pharmaceutical Industry, GMP, ELISA, Clinical Development, GLP, Analytical Chemistry, Biochemistry, LIMS, Toxicology, Chromatography, ADME, Protein Chemistry, Assay Development, In Vitro, UV/Vis, Purification, Laboratory, Technology Transfer, LC-MS, In Vivo, Drug Metabolism, Dissolution, Bioanalysis, IND, Pharmaceutical Research, Small Molecules, CRO, Quality by Design
Education
Purdue University 2006 — 2009
Ph.D.
Rutgers University-New Brunswick 2004 — 2005
Ph.D.
Tarsa Therapeutics October 2009 - Present
Unigene Laboratories, Inc. September 1981 - March 2011
Skills
Biotechnology, Pharmaceutical Industry, Lifesciences, Technology Transfer, Clinical Development, Molecular Biology, Drug Discovery, Biopharmaceuticals, Drug Development, GMP, Drug Delivery, Clinical Trials, Oncology, FDA, Regulatory Affairs, CRO, Life Sciences, GLP, Commercialization
Education
Bates College 1970 — 1974
BS, Biology
The University of Connecticut 1974 — 1979
Ph.D., Pharmacology
Roche Institute of Molecular Biology 1979 — 1981
Post Doctoral Reserch, Cardiovascular Pharmacology
Seton Hall University 1999 — 2001
MSIB, International Business
Eli Lilly and Company September 2006 - Present
Unigene Laboratories, Inc. June 2004 - August 2005
Skills
Biotechnology, GMP, GLP, LIMS, Sop, Analytical Chemistry, CAPA, Protein Chemistry, Pharmaceutical Industry, HPLC, Oncology, GxP, Chromatography, Cell Culture, FDA, Validation
Education
Fairleigh Dickinson University-Florham Campus 2008 — 2010
MS, Biology
College of Saint Elizabeth 2000 — 2004
BS, Biology
LTS - Lohmann Therapy Systems July 2013 - Present
Sanofi Pasteur December 2008 - July 2013
Unigene Laboratories, Inc. March 1999 - December 2008
Merck November 1996 - March 1999
Skills
Pharmaceutical Industry, Validation, 21 CFR Part 11, Computer System..., Change Control, GMP, Vaccines, Sop, GxP, Clinical Trials, FDA, EDC, GCP, Biotechnology, LIMS, Technology Transfer, GAMP, Project Management, HPLC, Biopharmaceuticals, Process Simulation, Chromatography, V&V, Fermentation, Design of Experiments, CAPA, GLP, Quality System, SOP
Education
University of Scranton 2011 — 2016
Master of Business Administration (MBA), Master of Business Administration
Rutgers University 1991 — 1996
BS, Chemical Engineering
Unigene Laboratories, Inc. July 2011 - Present
Freelance March 2008 - May 2011
Roche Molecular Diagnostics, Inc., Branchburg NJ 2003 - 2007
Education
NJIT 2004 — 2006
MS, Chemistry
Rutgers, The State University of New Jersey-Newark 2000 — 2002
BA, Chemistry
Musculoskeletal Transplant Foundation October 2013 - Present
Unigene Laboratories, Inc. 2011 - 2013
Unigene Laboratories, Inc. 2009 - 2011
Unigene Laboratories, Inc. 2006 - 2009
Unigene Laboratories, Inc. 2003 - 2006
Unigene Laboratories, Inc. 2000 - 2003
Skills
Technology Transfer, GMP, Biopharmaceuticals, FDA, Validation, Pharmaceutical Industry, Sop, Biotechnology, 21 CFR Part 11, GAMP, Change Control, GxP, Computer System..., Clinical Trials, Cleaning Validation, GCP, CAPA, V&V, SOP
Education
New Jersey Institute of Technology 1995 — 2000
BS, Chemical Engineering
InVitae August 2012 - Present
Genomic Health 2009 - August 2012
Genomic Health 2000 - 2009
Incyte Pharmaceuticals 1991 - 2000
Invitron 1985 - 1991
Unigene Laboratories, Inc. 1983 - 1985
Skills
Biotechnology, Genomics, Lifesciences, Molecular Biology, Drug Discovery, Biopharmaceuticals, Commercialization, Oncology, Technology Transfer, Pharmaceutical Industry, Bioinformatics, Personalized Medicine
Education
University of Kansas 1979 — 1983
Ph.D., Biochemistry
Emporia State University 1975 — 1979
B.S., Chemistry
Unigene Laboratories, Inc. January 2007 - April 2013
Unigene Laboratories, Inc. May 2005 - December 2006
Unigene Laboratories, Inc. May 2004 - April 2005
Unigene Laboratories, Inc. September 2001 - April 2004
Skills
GMP, FDA, Biopharmaceuticals, Sop, GLP, CAPA, Change Control, Aseptic Processing, Validation, GxP, HPLC, Technology Transfer
Education
Rutgers, The State University of New Jersey-New Brunswick 1997 — 2001
BS, Biology
Managed Health Care Associates, Inc. November 2010 - Present
Unigene Laboratories, Inc. September 2005 - December 2009
M. Eagles Tool Warehouse, Inc. 1995 - 2004
Skills
Financial Statements, Microsoft Dynamics SL, Great Plains Software, Bank Reconciliation, Accruals, Accounts Payable, Job Costing, Financial Reporting, Cost Accounting, Auditing, Cash Management, Year-end Close, Fixed Assets, Finance, Budgets, Sarbanes-Oxley, Invoicing, Accounts Receivable, Spreadsheets, Monthly Close, Journal Entries, Accounting, Balance, Financial Analysis, Expenses, Peachtree, Variance Analysis, Sarbanes-Oxley Act, General Ledger, GAAP, Forecasting, Revenue Recognition, Payroll Taxes, Internal Controls, Cash Receipts, Accpac, Mas 90, Account Reconciliation, QuickBooks, Access, Sales Tax
Education
Thomas Edison State College 2004 — 2005
Accounting
Merck July 2014 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson July 2012 - July 2014
Unigene Laboratories, Inc. 2004 - 2009
Skills
Biotechnology, GMP, GLP, Trackwise, CAPA, Cell Culture, JavaScript, GxP, Quality Control, Quality Assurance, Validation, Research, 21 CFR Part 11, Deviation Management, HTML, Complaint Investigations, FDA, Pharmaceutical Industry, cGMP, LIMS, SAP, Spotfire, PI Processbook, Cell Based Assays, CSS Javascript, Yellow Belt, Kepner-Tregoe, Ruby on Rails, jQuery, iOS development, PHP, Delta V, SAP ERP, Emerson DeltaV, SOP, Purification, Biopharmaceuticals, Life Sciences
Education
Rutgers, The State University of New Jersey-Newark 2004 — 2006
Master of Science (MS), Biological and Biomedical Sciences
Redpoint Bio Corporation September 2007 - Present
Unigene Laboratories, Inc. May 1998 - November 2011
Cytogen Corporation June 2003 - May 2008
Dechert LLP July 1994 - December 2003
The Liposome Company, Inc. 1985 - 1994
Skills
Venture Capital, Joint Ventures, Corporate Governance, Medical Devices, Technology Transfer
Education
New York Law School 1977 — 1980
J.D. (cum laude), law
Cornell University 1969 — 1972
Postdoctoral research, Biological organo-metallic compounds
Iowa State University 1965 — 1971
Ph.D., Organic Chemistry
City University of New York-Brooklyn College 1961 — 1965
B.S., Chemistry
SK Life Science October 2012 - Present
Unigene Laboratories, Inc. August 2011 - October 2012
Unigene Laboratories, Inc. April 2011 - October 2012
Unigene Laboratories July 2007 - August 2011
Laboratory for Cancer Ontogeny and Therapeutics, University of Delaware September 2005 - May 2007
Skills
Biotechnology, GLP, HPLC, Pharmaceutical Industry, GMP, Clinical Development, GCP, Clinical Trials, Sop, FDA, Regulatory Affairs, Biopharmaceuticals, Lifesciences, Drug Development, Oncology
Education
University of Medicine and Dentistry of New Jersey 2010 — 2012
MS, Clinical Trial Sciences with a Specialization in Regulatory Affairs, 4.0
University of Delaware 2004 — 2007
BS, Biological Sciences with a Concentration in Biotechnology
Alcon, a Novartis company 2014 - Present
Novartis Consumer Health 2013 - 2014
Unigene Laboratories, Inc. 2012 - 2013
Novartis 2009 - 2012
Novartis 2004 - 2012
Skills
Pharmaceutical Industry, Clinical Development, Biotechnology, Drug Development, Technology Transfer, Oncology, Drug Discovery, HPLC, Biopharmaceuticals, CRO, Lifesciences, Monoclonal Antibodies, Pharmaceutics, GMP, Regulatory Affairs, Infectious Diseases, Biomarkers
Education
Rutgers Business School
Master of Business Administration (MBA)
Tufts University
Doctor of Philosophy (PhD)
NE-Tech-Docs LLC January 2013 - Present
GE Healthcare Life Sciences June 2005 - November 2012
Protein Sciences Corporation May 2005 - October 2005
CUNO Inc. June 1996 - May 2004
Unigene Laboratories, Inc. June 1994 - May 1996
The Pennsylvania State University September 1993 - May 1994
Pfizer, Inc. June 1978 - November 1986
Skills
GMP, FDA, Biopharmaceuticals, Manufacturing, Upstream, Primary Recovery, Downstream, Medical Devices, Technical Communications, Document Management, Validation, SOP, Extractables/Leachables, Documentation Systems, Quality Auditing, Product Development
Education
Lehigh University 1987 — 1993
Doctor of Philosophy (Ph.D.), Chemical Engineering
MIT 1973 — 1978
Bachelor of Science (2 - SB), Chemical Engineering, Applied Biology
BD December 2014 - Present
Shionogi Inc June 2011 - November 2014
Daiichi Sankyo June 2006 - June 2011
Berlex Inc. December 2002 - May 2006
Unigene Laboratories, Inc. April 1996 - December 2002
Skills
GMP, Sop, FDA, Validation, CAPA, 21 CFR Part 11, Pharmaceutical Industry, Change Control, Computer System..., GxP, Quality System, Aseptic Processing, Regulatory Affairs, Biotechnology, Quality Assurance
Education
Montclair State University
Master of Science (MS), Environmental Science
University of Delaware
Bachelor of Arts (BA), Biology/Biological Sciences, General
Ortho Clinical Diagnostics April 2002 - Present
Ortho Clinical Diagnostics June 1995 - April 2002
Ortho Clinical Diagnostics January 1987 - June 1995
Unigene Laboratories, Inc. March 1986 - January 1987
Morristown Memorial Hospital August 1984 - March 1986
LabCorp June 1980 - August 1984
LabCorp June 1980 - August 1984
Skills
ASQ CQA 2007, PEX Greenbelt, MLT ASCP, Quality Assurance, Quality System, Change Control, 21 CFR Part 11, ISO, Sop, Quality Auditing, GLP, CAPA, Laboratory, SOP, FDA, GMP, Validation, Medical Devices, ISO 13485, Biotechnology, V&V, Design Control, Pharmaceutical Industry, R&D
Education
Fairleigh Dickinson University 1984 — 1989
Master of Science (M.S.), Biology with Business Concentration
East Stroudsburg University of Pennsylvania 1978 — 1980
Bachelor of Science (BS), Biology/Biological Sciences, General
County College of Morris 1976 — 1978
Associate of Arts and Sciences (AAS), Medical Laboratory Technology
University of Virginia Health System July 2015 - Present
Henrico Doctors' Hospital June 2014 - June 2015
Virginia Commonwealth University August 2010 - May 2014
Consumer Product Testing Company Inc. September 2009 - January 2013
Unigene Laboratories, Inc. June 2011 - August 2011
Solix Inc. June 2006 - August 2009
Skills
Public Speaking, Medication Therapy...
Education
Virginia Commonwealth University 2010 — 2014
Doctor of Pharmacy (Pharm.D.)
Rutgers, The State University of New Jersey-New Brunswick 2009 — 2010
Biology/Biological Sciences, General
County College of Morris
Associate of Science (A.S.), Biology, General
Tyco Integrated Security March 2014 - Present
Unette Corporation November 2013 - March 2014
Optimus Construction, Inc. July 2013 - October 2013
Unigene Laboratories, Inc. December 2011 - May 2013
Unigene Laboratories, Inc. March 2011 - January 2012
Unigene Laboratories, Inc. January 2008 - March 2011
Skills
Microsoft Office, Microsoft Dynamics GP, ProWatch, Genetec, Microsoft Excel, Purchasing, Management, Microsoft Word, Research, PowerPoint, Leadership, Training, Rapid Eye, Logistics, Customer Service, Data Entry, Warehousing, Customer Satisfaction
Education
William Paterson University of New Jersey
Bachelor's degree, Business Administration and Management, General
Passaic County Community College
Rutgers New Jersey Medical School September 2009 - Present
UMDNJ/Rutgers university May 2012 - August 2012
William Paterson University January 2008 - May 2008
Unigene Laboratories, Inc. July 2007 - December 2007
Houston Baptist University November 2004 - July 2006
Glaxo Smith Kline Ltd., India May 2000 - June 2000
Skills
PBMC isolation,..., DNA, HPLC, Immunology, Laboratory, Microbiology, Molecular Biology, Virology, Research, Cell Biology, Cell Culture, Data Analysis, PCR, Genetics, Western Blotting, RT-PCR, Biochemistry
Education
Rutgers University-Newark 2009 — 2015
Doctor of Philosophy (Ph.D.), Immunology
William Paterson University of New Jersey 2007 — 2009
Master’s Degree, Biotechnology
University of Pune 1999 — 2002
Bachelor’s Degree, Microbiology, General