ImClone Systems Incorporated
Industry: Company
DescriptionImClone Systems Incorporated was a biopharmaceutical company dedicated to developing biologic medicines in the area of oncology. It was founded in 1984 and had its corporate headquarters in Bridgewater, New Jersey and its research headquarters in New York City. Founder: Samuel D. Waksal Founded: 1984 Headquarters: New York City, NY Parent organization: Eli Lilly and Company Number of employees: 1,128 Subsidiaries: ImClone Systems Corp, EndoClone Inc
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ImClone Systems Incorporated Employees
Pfizer, Centers for Therapeutic Innovation August 2012 - Present
ImClone Systems Incorporated January 2003 - July 2012
Dr. Reddy's Laboratories April 1995 - May 2002
Skills
Monoclonal Antibodies -..., Oncology Therapeutics, Pharmacology., Pharmacodynamic..., Signal Transduction, Translational Biomarkers, Group Leadership, Assay Development, RNAi, Viral Vectors, RT-PCR, Luminex, MesoScale, Pharmacology, Biomarkers, In Vivo, Cell Culture, Monoclonal Antibodies, Oncology, Cell, Immunology, Flow Cytometry, In Vitro, Clinical Trials, Validation, Transfection, FDA, Small Molecules, Drug Discovery, Biochemistry, Western Blotting, Protein Chemistry, IND, Molecular Biology, Drug Development, Biomarker Discovery, Animal Models, Mass Spectrometry, Proteomics, Clinical Development, Antibodies, ELISA, Genomics, Cancer, Biopharmaceuticals, Biotechnology, Cell Biology, Laboratory, Lifesciences, PK/PD
Education
Sri Venkateswara University 1992 — 1994
Master of Science, Virology
Sri Venkateswara University 1989 — 1992
Bachelor of Science, Chemistry and Biology
Incyte January 2014 - Present
Alexion Pharmaceuticals July 2012 - January 2014
ImClone Systems March 2010 - July 2012
Imclone Systems Incorporated December 2006 - March 2010
Sanofi-Aventis March 2004 - December 2006
Sanofi-Aventis September 2001 - March 2004
Abbott Laboratories June 2000 - July 2001
Skills
Oncology, Hematology, Radiation Oncology, Reimbursement, Formulary, Hospital Sales, Biotechnology, Cancer, Cardiology, Hospitals, Managed Care, Pharmaceutical Sales, Radiation Therapy, Biologics, Buy, Neurology, Medicine, Pharmaceutical Industry, Product Launch
Education
Ashland University 1990 — 1994
MBA, Business
The University of Akron 1985 — 1990
Bachelors in Science, Business and Organizational Communications
Eli Lilly and Company April 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - November 2011
ImClone Systems, wholly-owned subsidiary of Eli Lilly & Co. 2000 - March 2011
ImClone Systems Incorporated January 2008 - December 2010
ImClone Systems Incorporated January 2005 - December 2007
ImClone Systems Incorporated June 2004 - December 2005
ImClone Systems Incorporated November 2000 - June 2004
Roche Molecular Systems 1997 - 2000
University of Pittsburgh Medical Center, Department of Pharmacology, Lazo Laboratory April 1996 - May 1997
Skills
Validation, Sop, Change Control, Calibration, Quality Assurance, GMP, FDA, 21 CFR Part 11, Clean Rooms, Biopharmaceuticals, Metrology, CAPA, Biotechnology, Software Documentation, Pharmaceutical Industry, Management, Aseptic Processing, GLP, Computer System..., LIMS, Trackwise, Electronics, GxP, V&V, Cleaning Validation, GAMP, SAP, cGMP practices, SOP development, Lean Six Sigma, DMAIC
Education
University of Pittsburgh 1993 — 1997
Bachlors of Science
Société Générale September 2014 - Present
TechPar Group August 2011 - August 2014
Bridgewater Associates February 2013 - June 2014
Centerlight Health System May 2012 - May 2012
Beth Abraham Family of Health Services August 2011 - November 2011
Kadmon Pharmaceuticals August 2010 - March 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2008 - August 2010
ImClone Systems Incorporated July 2006 - June 2008
ImClone Systems Incorporated January 2004 - June 2006
ImClone Systems Incorporated January 2002 - December 2003
Skills
Cloud Computing, Information Technology, Project Portfolio..., IT Operations, Active Directory, IT Management, PMO, Enterprise Software, Governance, Data Center, Security, Process Improvement, Windows 7, SaaS, Department Budgeting, Microsoft Excel, Visio, Windows Server, Corporate Websites, Storage Area Networks, Strategy, Business Process..., Team Leadership, Microsoft Word, PowerPoint, Healthcare, Troubleshooting, SharePoint, Outsourcing, IT Governance, Resource Management, Business Relationship..., Relationship Management, Business Process..., Operational Efficiency, IT Procurement, Team Mentoring, iOS, Android, Daptiv PPM, Adobe Acrobat, Photoshop, Office 365, Network Design, Wireless Networking, Biopharmaceuticals, Quality Assurance, SDLC, Disaster Recovery, Project Management
Education
City University of New York-Baruch College 1996 — 1998
MBA, Computer Information Systems
Darkei Noam Rabbinical College 1989 — 1993
Touro College 1988 — 1991
BS, Mathematics
Mesivta Torah Vodaath Rabbinical Seminary
Novartis June 2015 - Present
Novartis October 2013 - May 2015
Novartis December 2012 - October 2013
Novartis April 2011 - December 2012
Rutgers University January 2010 - April 2011
Novartis Pharmceuticals July 2009 - April 2011
Rutgers University July 2009 - April 2011
Imclone Systems Incorporated May 2005 - August 2005
Skills
Medical Writing, Clinical Trials, Oncology, Pharmaceutical Industry, Clinical Research, Medical Education, Cancer, Medicine, Publications, Cross-functional Team..., Clinical Study Design, Publication Planning, Scientific..., Clinical Development
Education
University of the Sciences in Philadelphia 2003 — 2009
Doctor of Pharmacy (Pharm.D.), Pharmacy
Rutgers University-New Brunswick
Rutgers University-New Brunswick
FlowMetric, Inc June 2015 - Present
Eli Lilly and Company 2013 - May 2015
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - 2013
ImClone Systems Incorporated 2004 - 2008
ImClone Systems Incorporated 2002 - 2004
ImClone Systems Incorporated 2000 - 2002
Centocor 1998 - 2000
University of Pennsylvania 1994 - 1998
University of Pennsylvania 1990 - 1994
Skills
Pharmaceutical Industry, FDA, Biotechnology, Clinical Trials, Clinical Development, GCP, Life Sciences, Drug Development, Oncology, Biopharmaceuticals, Bioanalysis, Immunology, Clinical Pharmacology, Biologics, Monoclonal Antibodies, Clinical Research, Translational Medicine, GLP, Drug Discovery, IND, SOP
Education
The University of Texas Health Science Center at Houston
Doctor of Philosophy (Ph.D.), Immunology
New York University
Master of Science (M.S.), Biochemistry and Molecular Biology
Stony Brook University
Bachelor of Science (B.S.), Biology
Aerotek March 2015 - Present
MeetingPoint, LLC March 2011 - Present
ArborSys Group 2012 - 2015
Lux Biosciences, Inc. November 2010 - January 2012
K&L Consulting Services, Inc. 2011 - 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - 2010
ImClone Systems Incorporated 2006 - 2008
Organon Pharmaceuticals 2001 - 2006
J Reyes Consulting LLC 1999 - 2001
PPD 1998 - 1999
Skills
Operations and..., Business Analysis and..., Strategic Planning and..., Technology Portfolio..., Department/Project..., Leadership Influence..., Stakeholder and..., Mentoring and Team..., Managing Teams and..., Problem Solving and..., Clinical Data Management, Business Process..., Process-Technology..., Clinical Development..., SOP/Work Instruction..., Audit..., Problem Solving, Clinical Development, Computer System..., Project Management, Budgets, IT Portfolio, Software Documentation, Clinical Trials, Business Process..., Business Analysis, EDC, Pharmaceutical Industry, Business Process, 21 CFR Part 11, GCP, Validation, FDA, CTMS, Quality Assurance, Sop, GxP, Clinical Research, Cross-functional Team..., Change Control, Clinical Operations, Program Management, CRO, Change Management, Biotechnology, Oracle Clinical, Medical Writing, Data Management, Pharmaceutics, Regulatory Affairs
Education
Fairleigh Dickinson University-Metropolitan Campus
MBA, Pharm-Chem Studies/Pharmaceutical Management
Rutgers, The State University of New Jersey-New Brunswick
BA, Biological Sciences
Super Enterprises-USA, Inc. May 2013 - Present
Anvil Knitwear January 2011 - December 2012
Anvil Knitwear August 2010 - January 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2008 - 2009
ImClone Systems Incorporated 2007 - 2008
ImClone Systems Incorporated 2002 - 2007
ADP 2001 - 2002
United Rentals 1999 - 2001
Mannesmann Corporation 1994 - 1999
Volvo Penta 1988 - 1994
Skills
Accounting, Sarbanes-Oxley Act, Internal Controls, Cost Accounting, Mergers, Due Diligence, Auditing, Internal Audit, SEC, Strategic Financial..., Risk Assessment, Acquisition Integration, Corporate Tax Planning, Cash Management, Financial Reporting, Financial Analysis, Compliance
Education
State University of New York College at Oswego 1974 — 1978
BS
Katten Muchin Rosenman LLP June 2014 - Present
Zukerman Gore Brandeis & Crossman LLP September 2009 - June 2014
Schulte Roth & Zabel LLP January 2006 - June 2009
O'Melveny & Myers LLP October 2004 - January 2006
O'Melveny & Myers LLP May 2003 - August 2003
IMCLONE SYSTEMS INCORPORATED May 2002 - April 2003
Skills
Mergers, Corporate Governance, Securities, Contract Negotiation, Private Equity, Joint Ventures, Corporate Finance, Licensing, Corporate Law, Mergers & Acquisitions, Securities Regulation, Litigation, Commercial Litigation, Restructuring, Strategy
Education
New York University School of Law 2001 — 2004
J.D
New York University College of Arts & Science 1997 — 2001
BA, magna cum laude
Hunter College High School 1991 — 1997
N/A
The Blackstone Group September 2013 - Present
Select Equity Group June 2012 - September 2013
PricewaterhouseCoopers January 2009 - June 2012
Immunomedics February 2007 - December 2009
ImClone Systems Incorporated February 2005 - January 2007
Skills
Financial Analysis, Budgeting, Financial Reporting, Internal Controls, Investments, Budgets, Investran, Form PF, Wall Street Systems, Private Equity, Valuation, Corporate Finance, Equities
Education
Seton Hall University 2007 — 2009
MBA, Business Administration, accounting, statistics, tax, and finance
West Virginia University 1999 — 2004
Bachelors, Mechanical Engineering
Glenmark Pharmaceuticals 2013 - Present
Rutgers Industry Advisory Board - Life Science 2009 - Present
Life Science Leader Magazine December 2014 - Present
Samyang Corporation 2009 - 2012
Caliper Life Sciences - Discovery Alliances & Services Division (formerly Xenogen Biosciences) 2007 - 2009
Biotechnology Council of NJ 2006 - 2007
Biotechnology Council of New Jersey 2005 - 2007
ImClone Systems Incorporated 2000 - 2002
Roche Molecular Systems, a division of Hoffman-LaRoche 1993 - 1995
Skills
Contract Negotiations, Problem Solving, Customer Service, Goal Oriented, Instrumentation, Licensing Agreements, Term Sheets, Drug Discovery, Drug Delivery, Drug Development, Pharmaceutical Industry, Biotechnology Industry, Technology Transfer, Contract Negotiation, R&D, Biotechnology, Clinical Development, Protein Chemistry, Infectious Diseases, Strategy, Biopharmaceuticals, Assay Development, Immunology, Commercialization, Leadership, Molecular Biology, Lifesciences, Licensing, PCR, Pharmaceutics, Sop, Oncology, Life Sciences, SOP
Education
Mount Sinai School of Medicine of New York University 1995 — 2000
PhD, Biomedical Sciences
Rutgers University-New Brunswick 1989 — 1993
BA, Biochemistry, minor English and Economics
Intersection Technology Solutions March 2015 - Present
Entia Ventures, LLC / Primal Innovation, LLC March 2012 - March 2015
Raytheon Technical Services Company February 2010 - February 2012
iStar Financial September 2007 - October 2009
ImClone Systems Incorporated April 2004 - August 2007
Skills
Leadership, IT Strategy, IT Management, Vendor Management, Department Budgeting, Enterprise Architecture, Documentation, Process Improvement, IT Operations, Business Intelligence, Management, VMware, ITIL, Program Management, Solution Architecture, Budgets, Active Directory, Servers, Integration, Windows Server, Storage Area Networks, Disaster Recovery, Cloud Computing, Operating Systems, SharePoint, Troubleshooting, Virtualization, Cisco Technologies, Firewalls, Software Documentation, Data Center, Networking, System Administration, Microsoft Exchange, VMware ESX, Project Management, Technical Support, vSphere, Security, VPN, Windows 7, Network Administration, SAN, Storage, Linux, Routers, WAN, Network Security, DNS, DHCP
Education
New York Institute of Technology 2005 — 2009
Masters, Information, Network and Computer Security
SUNY Albany 2000 — 2003
Information Science Bachelors, IT, Business, Computer Science
International Consortium of IT Professionals (ICTP) 2003 — 2003
Vocational, A+, CCNA, MCSE, LPIC
TRAC Intermodal November 2013 - Present
Savient Pharmaceuticals, Inc. July 2011 - November 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company June 2011 - July 2011
ImClone Systems January 2008 - May 2011
ImClone Systems Incorporated January 2005 - December 2007
ImClone Systems Incorporated July 2002 - December 2004
ImClone Systems Incorporated January 2001 - July 2002
ImClone Systems Incorporated January 1998 - December 2000
Skills
Active Directory, Vendor Management, Project Management, Windows 7, Cross-functional Team..., Disaster Recovery, System Administration, Integration, Cloud Computing, Change Management, IT Management, SharePoint, ITIL, VMware, Windows Server, Citrix, Cisco Technologies, IT Strategy, SaaS, Quality Assurance, Infrastructure, Information Technology, Blackberry Enterprise..., Cisco Call Manager, Storage Area Networks, Management, Change Control, Lotus Notes, Backup Exec, Data Center, Troubleshooting, Security, Virtualization, IT Operations, Servers, Software Documentation, VMware Infrastructure, Hardware, Help Desk Support, High Availability, Computer Hardware, Enterprise Software, Software Installation, Switches, Microsoft Exchange, Databases, VMware ESX, Enterprise Architecture, VPN, SAN
Education
University of Phoenix 2014 — 2016
Bachelor of Applied Science (BASc), Management, 3.9 GPA
LaGuardia Community College
Associate of Science, Telecommunications
CMC Biologics February 2015 - Present
Gilead Sciences July 2013 - August 2014
Shire HGT November 2013 - April 2014
Genzyme May 2013 - September 2013
Laureate Biopharmaceutical Services October 2011 - October 2012
Laureate Biopharmaceutical Services October 2011 - August 2012
Dendreon Corporation June 2010 - October 2011
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2000 - 2010
Imclone Systems Incorporated March 2002 - October 2005
Imclone Systems Incorporated January 2002 - April 2002
Skills
cGMP, Aseptic Processing, Process Improvement, GMP, Process Scheduler, Validation, Project Planning, Coaching, Sop, Biotechnology, Filtration, CAPA, LIMS, Change Control, Technology Transfer, Cleaning Validation, GLP, Pharmaceutical Industry, FDA, Biopharmaceuticals, Regulatory Affairs, Lifesciences, 21 CFR Part 11, Quality Assurance, Aseptic Technique, Cell, Cell Culture, Quality Control, Fermentation, Monoclonal Antibodies, Process Simulation, cGMP manufacturing, Life Sciences, SOP
Education
Claflin University 1985 — 1988
chemistry
Dwight Morrow High School
arivis AG July 2011 - Present
Mission3 August 2009 - June 2011
Celgene Corporation September 2008 - June 2009
ImClone Systems Incorporated August 2006 - September 2008
OrthoLogic Corp September 2005 - July 2006
ImClone Systems Incorporated January 2003 - August 2005
Skills
eCTD, IND, Life Sciences, Clinical Research, Oncology, Biologics, eTMF, Document Management, EDM, Lifesciences, Regulatory Submissions, Regulatory Affairs, Clinical Trials, Sop, Validation, FDA, NDA, EDC, Biotechnology, Change Control, Cross-functional Team..., GMP, Regulations, Medical Devices, Regulatory Requirements, Pharmaceutical Industry, 21 CFR Part 11, GCP, CRO, Computer System..., SOP, Clinical Development, Drug Development, Management, Biopharmaceuticals, CTMS, Technology Transfer
Education
Arizona State University 2009 — 2010
MS, Clinical Research Management
Rutgers University 2000 — 2002
Bachelor of Arts, Communications and English
North Hunterdon 1994 — 1997
Amicus Therapeutics November 2012 - Present
Amicus Therapeutics July 2012 - November 2012
Mitsubishi Tanabe Pharma Development America, Inc. January 2010 - July 2012
Amicus Therapeutics, Inc April 2008 - October 2009
PharmaNet, Inc May 2007 - April 2008
SkyePharma Inc March 2005 - May 2007
Idun Pharmaceuticals, Inc September 2003 - February 2005
ImClone Systems Incorporated March 2000 - May 2003
New Horizons Computer Learning Center January 1999 - March 2000
Huntington Learning Center May 1997 - October 1998
Skills
Clinical Trials, Regulatory Affairs, Regulatory Submissions, GCP, IND, FDA, CRO, NDA, Regulatory Requirements, Clinical Research, Clinical Operations, Protocol, Clinical Study Design, Pharmaceutical Industry, Software Documentation, eCTD, Sop
Education
Caldwell College 1989 — 1993
Bachelor of Arts, Elementary Education and English
Caldwell College 1989 — 1993
BA, Elementary Education and English; Extension
RRD International, LLC June 2010 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company July 2008 - June 2010
ImClone Systems Incorporated March 2008 - July 2008
Cephalon, Inc. July 2007 - 2008
Bristol-Myers Squibb Company April 2006 - July 2007
PharmaNet June 2004 - April 2006
PharmaNet May 2000 - May 2004
Adis International 1999 - 2000
Skills
Clinical Trials, Oncology, CRO, Clinical Research, Clinical Development, Clinical Trial..., Biotechnology, EDC, GCP, Drug Development, Biopharmaceuticals, Regulatory Affairs, Clinical Monitoring, Medical Writing, Protocol, GMP, Clinical Operations, Lifesciences, Cancer, Regulatory Submissions, CTMS, FDA, Pharmaceutical Industry, ICH-GCP, 21 CFR Part 11, Clinical Data Management, Pharmaceutics
Education
Penn State University 1982 — 1986
B.S., Nursing
ImClone Systems Incorporated August 2008 - Present
Information Architects November 2007 - March 2008
B2X Corp April 2007 - November 2007
Northwest Building Supply, Inc. July 2005 - April 2007
E*Trade Professional May 2004 - June 2005
Skills
Troubleshooting, Active Directory, VMware, Windows Server, Disaster Recovery, High Availability, Cloud Computing, Enterprise Architecture, Load Balancing, System Administration, Virtualization, Data Center, Servers, Microsoft Technologies, Windows, VMware Infrastructure, VMware ESX, Architecture, Sonicwall, Information Technology, Windows 7, ITIL, Integration, Citrix, SharePoint, IT Strategy, Computer System..., Networking, XP, Architectures, Windows XP, Microsoft Exchange, Security
Education
Fairleigh Dickinson University 2000 — 2004
B.S., Computer Science
Axovant Sciences Inc. June 2015 - Present
NPS Pharmaceuticals February 2012 - May 2015
NPS Pharmaceuticals March 2006 - February 2012
ImClone Systems Incorporated January 2002 - December 2005
Skills
Human Resources, Onboarding, Pharmaceutical Industry, HRIS, Biotechnology, Personnel Management, Performance Management, Employee Relations, Benefits Administration, Recruiting, Succession Planning, Lifesciences, Compensation, Executive Compensation..., Retention & Equity Plan..., Recognition Program..., Resources Planning and...
Education
Adelphi University 1994 — 1996
MA, Secondary Education
University at Albany, SUNY 1990 — 1994
BA, Sociology
Eli Lilly and Company September 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2007 - September 2011
ImClone Systems Incorporated January 2005 - January 2007
ImClone Systems Incorporated January 2000 - December 2004
Johnson & Johnson 1994 - 2000
Skills
GXP Training, Employee and Leadership..., Personel Qualification, Performance Management, Biotechnology, Sop, Biopharmaceuticals, GMP, Training, Pharmaceutical Industry, Employee Training, Change Management, Quality Assurance, Management, GxP, 21 CFR Part 11, Leadership, Organizational..., E-Learning, Lifesciences, Cross-functional Team..., Leadership Development, CAPA, FDA, Change Control, Program Management, Computer System..., GLP, Quality System, Project Management, Strategic Planning
Education
Cedar Crest College 1986 — 1990
BS, Genetic Engineering
ImClone Systems Incorporated January 2008 - Present
Schering-Plough 2001 - 2004
Siegfried USA, Inc 2000 - 2001
ValiCor Associates Inc. April 1997 - October 2000
ESI-Lederle 1985 - 1997
Skills
Quality Assurance, Validation, Biotechnology, Sop, FDA, GMP, Process Improvement, Pharmaceutical Industry, Change Control, GxP
Education
Temple University 1979 — 1984
Clontech April 2011 - Present
ImClone Systems Incorporated November 2002 - April 2011
Minds Matter August 2005 - June 2008
Harvard Institute of Medicine September 2001 - September 2002
Beth Israel Medical Center August 2000 - September 2001
Skills
qPCR, Cell Culture, Assay Development, Molecular Biology, ELISA, PCR, Biotechnology, Western Blotting, Genomics, Protein Purification, Biochemistry, Cell Biology, Protein Chemistry, Immunology, Flow Cytometry, Protein Expression, Lifesciences, Drug Discovery, Cell, Oncology
Education
Dartmouth College 1996 — 2000
A.B, Biochemistry
Horace Mann School 1990 — 1996
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company December 2006 - February 2011
ImClone Systems Incorporated June 2005 - November 2006
Johnson & Johnson June 2004 - August 2004
Merck January 2004 - January 2004
Skills
cGMP, Environmental Monitoring, GLP, GxP, SOP, Sop, CAPA, FDA, Validation, GMP, Microbiology, LIMS, Biotechnology
Education
Lafayette College 2001 — 2005
Bachelor of Applied Science (B.A.Sc.), Biochemistry, 2001-2005
Metuchen High School 1997 — 2001
Novo Nordisk A/S July 2012 - Present
Novo Nordisk A/S May 2011 - July 2012
Teva Pharmaceuticals 2008 - April 2011
Novo Nordisk 2007 - 2008
ImClone Systems Incorporated 2005 - 2007
Neose Technologies 2004 - 2005
Skills
FDA, Regulatory Submissions, Regulatory Affairs, eCTD, Sop, Validation, Pharmaceutical Industry, GMP, CAPA
Education
Temple University 2005 — 2006
Drug Development, QA/RA
Penn State University 1999 — 2003
Bachelor of Science (B.S.), Biology
Novira Therapeutics January 2015 - Present
Omthera Pharmaceuticals, Inc. December 2011 - December 2014
ImClone Systems Incorporated July 2007 - November 2011
Protalex, Inc. 2004 - 2007
University of Pennsylvania 1995 - 1999
Skills
IND, Regulatory Affairs, NDA, Pharmaceutical Industry, eCTD, Biopharmaceuticals, Clinical Operations, Oncology, Regulatory Submissions, Clinical Trials, CRO, Clinical Development, Cross-functional Team..., Drug Development, GMP, Technology Transfer, Protein Chemistry, GxP, Sop, FDA, Monoclonal Antibodies, Biotechnology, GCP, Biologics, Regulatory Requirements, Pharmacovigilance, Validation
Education
Massachusetts Institute of Technology 1999 — 2004
Doctor of Philosophy (PhD), Biochemistry
University of Pennsylvania 1995 — 1999
BA, Biochemistry, Religious Studies
GnP Design Group April 2007 - Present
Dr. Sungki Lee September 2002 - January 2007
ImClone Systems Incorporated January 2001 - September 2002
Education
Saraswati River Yoga 2007 — 2007
RYT200hr, Yoga, Meditation, Pranayama
Middlesex County Community College 2002 — 2004
Biology
Raritan Valley Community College 1999 — 2001
Environmental Science, Biology, Business
Lonza September 2010 - Present
ImClone Systems Incorporated 2005 - October 2010
Hoffmann-La Roche July 2003 - March 2005
Baxter 2002 - 2003
Merck 2000 - 2001
Skills
LIMS, Lifesciences, Change Control, Microbiology, GMP, Biopharmaceuticals, Trackwise, Biotechnology, 21 CFR Part 11, FDA, Aseptic Processing, Validation, GLP, GxP, SOP, V&V, Quality Control, CAPA, Aseptic Technique, Technology Transfer, Computer System..., Life Sciences, Quality System, Cleaning Validation
Education
University of Delaware 1996 — 2000
Bachelor of Arts (B.A.), Biological Sciences
Eli Lilly and Company December 2009 - Present
ImClone Systems Incorporated March 2004 - December 2009
Ventiv Health U.S. Sales March 2000 - February 2004
RennerBrown March 1999 - March 2000
Skills
Windows 7, Windows Server, VMware, System Administration, ITIL, Laptops, Computer Hardware, Windows, Servers, Troubleshooting, VPN, Technical Support, Operating Systems, Active Directory, Blackberry Enterprise..., Windows XP, XP, Software Documentation, Vendor Management, Document Management, Disaster Recovery, SharePoint, Cisco Technologies
Education
The Chubb Institute 1998 — 1998
Graduate, Networking and Data Center Support
Raritan Valley Community College 1991 — 1994
A.A., Arts
Bridgwater Raritan High School East 1987 — 1991
Graduate
Eli Lilly and Company 2009 - Present
Medarex March 2008 - December 2008
ImClone Systems Incorporated December 2005 - February 2008
Noninvasive Technologies 2002 - 2005
Braton Biotech 1995 - 2001
Skills
Antibodies, Cell, ELISA, Assay Development, Technology Transfer, HPLC, Biotechnology, Pharmacokinetics, Monoclonal Antibodies, Validation, Clinical Development, Immunoassays, Molecular Biology, Protein Purification, Cell Biology, Protein Expression, Cancer, Protein Chemistry, Transfection, Cell Culture, In Vitro, Biochemistry, Lifesciences, GLP, Drug Discovery, Immunology, Flow Cytometry, Purification, SDS-PAGE, Biopharmaceuticals, Pharmaceutical Industry
Education
Indian Institute of Technology, Delhi 1983 — 1990
Ph.D., Biochemistry
KPMG LLP - Pharmaceutical Advisory Services June 2005 - Present
KPMG LLP - Forensic Services June 2005 - Present
ImClone Systems, Incorporated February 2002 - February 2005
ICN Pharmaceuticals 1994 - 2001
Education
Touro College School of Law 1980 — 1983
Juris Doctor
Syracuse University 1976 — 1980
Celgene October 2012 - Present
Pfizer July 2009 - December 2011
ImClone Systems Incorporated April 2007 - January 2009
ImClone Systems Incorporated August 2005 - April 2007
ImClone Systems Incorporated June 2004 - August 2005
Aventis Pharmaceuticals July 2000 - May 2004
Migliara/kaplan 1996 - 2000
Glickman Research Associates 1996 - 1998
Education
Montclair State University
Bachelor of Arts
Imclone Systems Incorporated August 2007 - Present
Education
Postgraduate Institute of Medical Education and Research 1982 — 1984
BASF September 2011 - Present
Stryker Spine June 2008 - August 2011
Integra Life Sciences July 2006 - June 2008
ImClone Systems Incorporated September 2004 - July 2006
Immunomedics Incorporated October 2003 - August 2004
Stryker Howmedica Osteonics (Orthopedics) September 2002 - May 2003
Princeton Materials Institute June 2002 - August 2002
Skills
FDA, V&V, Design Control, Validation, Sop, Auditing, Training, Complaint Investigations, IQ, Quality System, Medical Devices, CAPA, GMP, ISO 13485, Root Cause Analysis, 21 CFR Part 11, Manufacturing, ISO, Process Engineering, Quality Management, SOP
Education
Seton Hall University School of Law 2010 — 2012
Master of Science in Jurisprudence (M.S.J), Health Law and Intellectual Property Law
Seton Hall University School of Law 2010 — 2010
Certification Program, Healthcare Compliance Certification
Rutgers University-New Brunswick 1999 — 2003
B.S., Biomedical Engineering
High School
The Medicines Company June 2013 - Present
The Medicines Company August 2011 - Present
The Medicines Company July 2007 - August 2011
The Medicines Company January 2007 - July 2007
ImClone Systems, Incorporated April 2003 - January 2007
Princeton Radiology Associates January 2002 - April 2003
St. Vincent's Sacred Heart Institute January 2000 - January 2001
St. Vincent's Hospital January 1998 - January 2000
Skills
CRO, Clinical Research, Pharmacovigilance, FDA, Sop, Quality Assurance, Healthcare, Data Management, Drug Safety, Clinical Development, Oncology, Pharmaceutical Industry, GCP, Clinical Trials, 21 CFR Part 11, Clinical Study Design, Protocol, EDC, Clinical Data Management, Cardiology
Education
University of Technology 2000 — 2001
Master of Nursing Management, Nursing Management Professional Studies
University of New South Wales 1998 — 1999
Master of International Social Development, International/Global Studies
University of Sydney 1995 — 1998
Bachelor of Nursing, Registered Nursing/Registered Nurse
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Arts (Art History), Art History, English and Communications
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company November 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2011 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2010 - Present
ImClone Systems Incorporated August 2001 - Present
Skills
SAP, GMP, Validation, Biotechnology, Computer System..., Pharmaceutical Industry, 21 CFR Part 11, Sop, FDA, ITIL, Oncology, Lifesciences, Change Control, Technology Transfer, Lotus Notes, LIMS
Education
University at Albany, SUNY 2002 — 2004
MBA, Information Systems
State University of New York College at Oneonta 1975 — 1976
BS, Geology
Medivation, Inc. May 2015 - Present
InterMune 2013 - March 2015
Cornerstone Therapeutics 2009 - 2013
ImClone Systems Incorporated 2008 - 2009
CollaGenex Pharmaceuticals 2004 - 2008
Baxter International 1989 - 2004
Gibson, Dunn & Crutcher LLP 1986 - 1989
Skills
Biotechnology, Patents, Licensing, Business Development, Business Strategy, Mergers, Mergers & Acquisitions, Risk Management, Strategy, Intellectual Property, Corporate Governance, Strategic Planning, Negotiation, Human Resources, Pharmaceutical Industry, Leadership, FDA, Regulatory Affairs, Start-ups, Corporate Law, Technology Transfer, Due Diligence, Patent Litigation, Securities Regulation, Biopharmaceuticals, Joint Ventures, Lifesciences, Patent Prosecution, Trade Secrets
Education
Stanford University Law School 1981 — 1985
J.D., Law
University of North Carolina at Chapel Hill 1976 — 1979
B.A., English
Winchester College 1971 — 1975
A Level, Art History, Economics, German
Carn Brea School
Common Entrance, Reading Writing Arithmetic
Eli Lilly and Company, Branchburg, NJ October 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2011 - September 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2010 - December 2010
ImClone Systems, a Wholly-Owned Subsidiary of Eli Lilly & Co July 2008 - December 2009
ImClone Systems Incorporated August 2007 - June 2008
Skills
Biochemistry, Protein Chemistry, Validation, NMR, GMP, Protein Purification, Spectroscopy, Biophysics, Sop, Monoclonal Antibodies, Purification, Chromatography, Biopharmaceuticals, Drug Discovery, Assay Development
Education
University of Pennsylvania School of Medicine 2000 — 2006
Senior Research Investigator; Research Associate; Postdoc in Dr. Walter Englander's lab, Biochemistry & Biophysics
University of Mississippi 1998 — 2000
Postdoctoral Research Associate in Dr. Maurice Eftink's Lab, Biochemistry & Biophysics
Tata Institute of Fundamental Research 1992 — 1998
Ph.D., Biochemistry & Biophysics
Counter Hack Challenges, LLC. September 2014 - Present
Phoenix Contact USA March 2014 - Present
Phoenix Contact USA September 2011 - Present
Delaware Air National Guard January 2008 - July 2015
CH2M HILL October 2008 - September 2011
Colorado Network Staffing 2011 - 2011
ImClone Systems Incorporated December 2004 - October 2008
U.S. Air Force /Air National Guard January 1992 - January 2008
DSM Nutritional Products (formerly Roche Vitamins) January 1999 - January 2005
Skills
SCADA, Wireless, Firewalls, Ethernet, Automation, Security, Troubleshooting, Integration, Programming, Engineering, CISSP, Security +, Critical Infrastructure..., Industrial Control, Network Security, Instrumentation, PLC, Systems Engineering, Process Automation, TCP/IP, Control Systems Design, Networking, Information Security..., CompTIA, Process Control, Computer Security, Wonderware, VPN, Switches, Routers, Project Management, Risk Assessment, Penetration Testing, Modbus, HMIs, Electricians, Electrical Engineering, Electronics, Security+
Education
Northampton Community College 2004 — 2008
AAS Computer Information Technology, Networking
Community College of the Air Force
AAS Aircraft Maintenance Technology, Aircraft Electrical/Environmental systems
Eli Lilly and Company December 2007 - Present
ImClone Systems Incorporated January 2003 - November 2007
ImClone Systems Incorporated December 2000 - December 2002
Centocor March 1999 - December 2000
Centocor August 1998 - February 1999
Centocor (Diagnostics division) March 1997 - August 1998
Skills
GMP, Sop, FDA, Pharmaceutical Industry, Biotechnology, Technology Transfer, Trackwise, Change Control, Biopharmaceuticals, 21 CFR Part 11, CAPA, SAP Implementation, Materials Management, Supply Chain Management
Education
Temple University
BS, Biology
EliLilly NJ-NY (former ImClone Systems subsidiary) November 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2010 - November 2014
ImClone Systems January 2008 - December 2009
ImClone Systems Incorporated January 2006 - December 2007
ImClone Systems Incorporated July 2005 - December 2005
ImClone Systems Incorporated January 2003 - July 2005
ImClone Systems Incorporated December 2001 - December 2002
Skills
SharePoint, GxP, Cisco Technologies, Windows Server, SAN, VMware ESX, VMware, IT Management, DHCP, Data Center, Enterprise Software, DNS, Servers, Storage Area Networks, Change Control, Microsoft Office, Cisco IOS, Active Directory, Disaster Recovery, Citrix, VPN, Help Desk Support, 21 CFR Part 11, Windows 7, System Administration, Information Technology, IT Operations, Troubleshooting, Visio, Network Administration, Infrastructure, System Deployment, XP, Technical Support, Software Documentation, VMware Infrastructure, Microsoft Exchange, Operating Systems, Firewalls, Network Security, Network Architecture, Windows XP, ITIL, TCP/IP, Virtualization, WAN
Education
Talmudical Institute of Upstate New York
Bachelor of Arts (B.A.)
Lycera April 2015 - Present
Dendreon April 2012 - April 2015
Savient Pharmaceuticals, Inc. April 2011 - March 2012
Allos Therapeutics October 2009 - April 2011
ImClone Systems January 2009 - October 2009
ImClone Systems Incorporated January 2008 - January 2009
ImClone Systems Incorporated October 2006 - January 2008
ImClone Systems Incoproated May 2005 - October 2006
sanofi-aventis July 2004 - May 2005
sanofi-aventis July 2002 - July 2004
Skills
Business Development, Market Research, Pharmaceutical Sales, Project Management, Pharmaceutical Industry, Strategy, Product Development, Marketing, Marketing Strategy, Biotechnology, Oncology, Cross-functional Team..., Product Launch, Sales
Education
Temple University 1991 — 1995
BBA, Finance; Risk Management
Elanco November 2014 - Present
ImClone Systems Incorporated December 2000 - October 2014
Wyeth 1994 - 2000
Skills
Validation, EHS, Environmental Compliance, Biotechnology, Pharmaceutical Industry, Environmental..., Hazardous Waste..., Ergonomics, CAPA, GMP, Root Cause Analysis, Biopharmaceuticals, Change Control
Education
Texas Tech University
Bachelor of Science (BS), Chemistry
University of Medicine and Dentistry of New Jersey -Robert Wood Johnson Medical School
Master of Public Health (MPH), Occupational Health and Industrial Hygiene
Merck 2010 - Present
Shire Pharmaceuticals 2006 - 2010
ImClone Systems Incorporated 2000 - 2006
Bristol-Myers Squibb 1996 - 2000
Roche Pharmaceuticals 1988 - 1995
Skills
Drug Development, Regulatory Strategy, Biologics, Oncology, FDA, Biotechnology, Strategy, Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, Biopharmaceuticals, Orphan Drugs
Education
Rutgers, The State University of New Jersey-New Brunswick 1983 — 1988
Ph.D., Chemical and Biochemical Engineering
Colorado State University 1981 — 1983
M.S, Chemical Engineering
Indian Institute of Technology, Bombay 1976 — 1981
B.Tech., Chemical Engineering
Columbia University January 2011 - Present
IMCLONE SYSTEMS INCORPORATED July 2007 - November 2008
Lowenstein Sandler June 2006 - July 2007
Budd Larner June 2002 - June 2006
ImClone, IP law firms, venture capital firms 1995 - 2002
ImClone Systems Incorporated April 1992 - July 1995
COOPER & DUNHAM August 1989 - April 1992
Skills
Patents, Patent Prosecution, Intellectual Property, Licensing, Biotechnology, Trademarks, Patentability, Patent Litigation, Technology Transfer, Commercialization, Legal Writing, Venture Capital, Due Diligence, Trade Secrets, Litigation
Education
TUFTS UNIVERSITY, Jackson College
B.S, Biology
University of London
Biology; English literature
Brooklyn Law School
J.D.
Allos Therapeutics October 2009 - January 2011
Imclone Systems Incorporated March 2007 - December 2009
Millennium Pharmaceuticals March 2003 - June 2007
Genomic Health Incorporated July 2006 - March 2007
IDEC Pharmaceuticals July 1997 - March 2003
Adria/Pharmacia Corporation June 1986 - July 1997
Education
Arizona State University 1976 — 1980
BS, Business/Communications
Progenitor Cell Therapy, A Neostem Company June 2014 - Present
Daus Consulting November 2013 - June 2014
Laureate Biopharma February 2011 - October 2013
Daus Consulting 2007 - 2011
ImClone Systems Incorporated 2000 - 2007
Smith-Kline Beecham Pharmaceuticals (SKB) 1997 - 2000
Johnson & Johnson (Ortho Diagnostic Systems, Inc.) 1990 - 1996
Skills
Pharmaceutical Industry, Project Management, Pharmaceutical Sales, Microsoft Office, Strategic Planning, Cross-functional Team..., Quality Assurance, Quality Systems, Quality Control, Analytical Method..., Biopharmaceuticals, Validation, Quality System, Regulatory Affairs, Biotechnology, GMP, Analysis, FDA, SOP, Medical Devices
Education
Rutgers, The State University of New Jersey-New Brunswick 1990 — 1996
Doctor of Philosophy (PhD), Microbiology & Molecular Genetics
Rutgers, The State University of New Jersey-New Brunswick 1987 — 1990
Master of Science (MS), Microbiology
Millersville University of Pennsylvania
Bachelor of Science (BS), Medical Technology, Summa cum laude
Taiho Oncology January 2015 - Present
Dendreon March 2013 - January 2015
Eli Lilly and Company March 2010 - March 2013
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company March 2008 - February 2010
ImClone Systems Incorporated March 2008 - February 2010
Bristol-Myers Squibb August 1983 - February 2008
Skills
Oncology, Biotechnology, Pharmaceutical Industry
Education
Arkansas State University 1971 — 1973
BS, Wildlife Management
Arkansas State University 1971 — 1973
Taiho Oncology, Inc. 2014 - Present
DAIICHI SANKYO, INC. 2012 - 2013
DAIICHI SANKYO, INC 2009 - 2012
IMCLONE SYSTEMS INCORPORATED 2006 - 2009
IMCLONE SYSTEMS INCORPORATED 2005 - 2006
AVENTIS PHARMACEUTICALS, INC. 2003 - 2005
AVENTIS PHARMACEUTICALS, INC. 2001 - 2003
Rhone-Poulenc Rorer 2000 - 2001
Rhone-Poulenc Rorer 1999 - 2000
Rhone-Poulenc Rorer 1998 - 1999
Skills
Biotechnology, Market Access, Cross-functional Team..., Leadership, Strategy, Product Launch, Oncology, Clinical Trials, Product Development, Pharmaceutical Industry, Marketing, Management, Urology, Team Leadership, V&V, Diabetes, Hospitals, Clinical Development, Cardiology, Drug Development, Managed Care, Pharmaceutical Sales, Sales Operations, Medical Devices, Sales Effectiveness, Hospital Sales, Pharmaceutics, Gastroenterology
Education
Creighton University
Bachelor of Science (B.S.) Biology
Saint Louis University
Master of Business Administration (MBA)
Currently unemployed - looking for a job Validation EngineerHerbalife International of America, IncJanuary 2014 - September 2014
Lancaster Laboratories August 2012 - May 2013
Alpha Consulting Corp October 2011 - June 2012
Sun Pharmaceutical Industries Inc March 2011 - October 2011
Technisource March 2010 - December 2010
ImClone Systems Incorporated 2008 - 2010
Centocor 2005 - 2007
Lancaster Laboratories 1999 - 2005
Johnson & Johnson/Merck 1999 - 2005
Skills
Cell Culture, PCR, ELISA, Biotechnology, Molecular Biology, Chromatography, GLP, Western Blotting, Biochemistry, Protein Chemistry, GMP, Microbiology, Validation, SOP, HPLC, Laboratory, FDA, 21 CFR Part 11, Analytical Chemistry, Quality Assurance, LIMS, Change Control, Pharmaceutical Industry
Education
Temple University 2001 — 2004
Master's degree, QA/RA
Alvernia College 1980 — 1983
B.S., Chemistry
SPEX CertiPrep Group, LLC August 2012 - April 2015
Precision Testing Labs December 2006 - August 2012
Imclone Systems Incorporated November 2004 - December 2006
DPT Incorporated September 2004 - November 2004
Church and Dwight Company, Inc March 2004 - September 2004
Environmental Evaluation Group September 2002 - June 2003
Skills
GC-MS, Organic Chemistry, Chemstation, Method Development, Chemistry, Gas Chromatography, Chromatography
Education
Stockton University
B.S, Marine Science
Stockton University
Bachelor of Science (B.S.), Marine Science