EMD Pharmaceuticals
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EMD Pharmaceuticals Employees
Employee
Years
Job
Industry
Amy Warren Amy Warren's EMD Pharmaceuticals Experience 2000 - 2002
Job Physician Liaison at WhiteCoat Designs
Industry Pharmaceuticals
Experience
WhiteCoat Designs February 2014 - Present
OnCall LLC January 2013 - February 2014
Pfizer March 2011 - September 2011
King Pharmaceuticals 2006 - February 2011
Hawthorn Pharmaceuticals 2004 - 2006
Biovation Limited 2002 - 2004
EMD Pharmaceuticals 2000 - 2002
Skills
Pain Management, Pharmaceutical Sales, Rheumatology, Endocrinology, Neurology, Cardiology, Gastroenterology, Urology, Managed Care, Pharmaceutical Industry, Pulmonology, Dermatology, Diabetes, Sales Effectiveness, Allergy
Education
East Carolina University 1992 — 1996
BS, Criminal Justice
WhiteCoat Designs February 2014 - Present
OnCall LLC January 2013 - February 2014
Pfizer March 2011 - September 2011
King Pharmaceuticals 2006 - February 2011
Hawthorn Pharmaceuticals 2004 - 2006
Biovation Limited 2002 - 2004
EMD Pharmaceuticals 2000 - 2002
Skills
Pain Management, Pharmaceutical Sales, Rheumatology, Endocrinology, Neurology, Cardiology, Gastroenterology, Urology, Managed Care, Pharmaceutical Industry, Pulmonology, Dermatology, Diabetes, Sales Effectiveness, Allergy
Education
East Carolina University 1992 — 1996
BS, Criminal Justice
David Fitts David Fitts's EMD Pharmaceuticals Experience 2000 - 2006
Job Independent Biostatistician
Industry Pharmaceuticals
Experience
Minimal Sufficiency September 2014 - Present
Shire Pharmaceuticals January 2014 - August 2014
ViroPharma, Inc March 2008 - January 2014
Premier Research Group June 2007 - March 2008
Anlyan Consulting, LLC 2006 - 2008
EMD Pharmaceuticals 2000 - 2006
Merck KGaA 2000 - 2006
SmithKline Beecham 1996 - 2000
Skills
Clinical Trials, Clinical Development, Biostatistics, Clinical Data Management, Oncology, Drug Development, Pharmaceutical Industry, Data Management, Clinical Research, CDISC, Statistical Programming, Epidemiology, Infectious Diseases, Biotechnology, Pharmaceutics, CRO, Clinical Operations, GCP, Regulatory Submissions, Statistics
Education
Tulane University 1980 — 1988
PhD, MPH, Epidemiology
Minimal Sufficiency September 2014 - Present
Shire Pharmaceuticals January 2014 - August 2014
ViroPharma, Inc March 2008 - January 2014
Premier Research Group June 2007 - March 2008
Anlyan Consulting, LLC 2006 - 2008
EMD Pharmaceuticals 2000 - 2006
Merck KGaA 2000 - 2006
SmithKline Beecham 1996 - 2000
Skills
Clinical Trials, Clinical Development, Biostatistics, Clinical Data Management, Oncology, Drug Development, Pharmaceutical Industry, Data Management, Clinical Research, CDISC, Statistical Programming, Epidemiology, Infectious Diseases, Biotechnology, Pharmaceutics, CRO, Clinical Operations, GCP, Regulatory Submissions, Statistics
Education
Tulane University 1980 — 1988
PhD, MPH, Epidemiology
James Nolan James Nolan's EMD Pharmaceuticals Experience May 2004 - December 2007
Job Head of Process Development at BIND Therapeutics
Industry Biotechnology
Experience
BIND Therapeutics June 2013 - Present
Genzyme September 2012 - June 2013
EMD Serono, Inc. October 2009 - April 2012
Merck Serono April 2009 - October 2009
EMD Serono, Inc. December 2007 - March 2009
EMD Pharmaceuticals May 2004 - December 2007
EMD Pharmaceuticals June 2002 - May 2004
Skills
Analytical Chemistry, Biotechnology, Business Strategy, Business Process..., Business Analysis, Characterization, Technology Transfer, HPLC, Protein Chemistry, Protein Purification, ELISA, Lifesciences, Drug Development, Pharmaceutical Industry, Chemistry, Purification, Oncology, Chromatography, Team Building, International Project..., Intercultural..., Organizational..., Organizational Behavior, Project Management, Six Sigma, Lean Manufacturing, Lean Startup, GMP, Sop, Cell Culture, Validation
Education
Worcester Polytechnic Institute 2009 — 2012
Master of Business Administration (MBA)
Syracuse University - Shanghai, China 2012 — 2012
The Ascent of the Chinese Economy, Chinese Economics and International Finance
University of Massachusetts Lowell 2004 — 2007
MS, Biological Sciences
Worcester Polytechnic Institute 1997 — 2001
BS, Biology and Biotechnology (Conc: Cellular, Molecular & Genetics)
BIND Therapeutics June 2013 - Present
Genzyme September 2012 - June 2013
EMD Serono, Inc. October 2009 - April 2012
Merck Serono April 2009 - October 2009
EMD Serono, Inc. December 2007 - March 2009
EMD Pharmaceuticals May 2004 - December 2007
EMD Pharmaceuticals June 2002 - May 2004
Skills
Analytical Chemistry, Biotechnology, Business Strategy, Business Process..., Business Analysis, Characterization, Technology Transfer, HPLC, Protein Chemistry, Protein Purification, ELISA, Lifesciences, Drug Development, Pharmaceutical Industry, Chemistry, Purification, Oncology, Chromatography, Team Building, International Project..., Intercultural..., Organizational..., Organizational Behavior, Project Management, Six Sigma, Lean Manufacturing, Lean Startup, GMP, Sop, Cell Culture, Validation
Education
Worcester Polytechnic Institute 2009 — 2012
Master of Business Administration (MBA)
Syracuse University - Shanghai, China 2012 — 2012
The Ascent of the Chinese Economy, Chinese Economics and International Finance
University of Massachusetts Lowell 2004 — 2007
MS, Biological Sciences
Worcester Polytechnic Institute 1997 — 2001
BS, Biology and Biotechnology (Conc: Cellular, Molecular & Genetics)
Amara Brown's EMD Pharmaceuticals Experience July 2005 - December 2005
Job at
Industry Education Management
Experience
Sponsors for Educational Opportunity August 2013 - Present
Teach For America June 2012 - August 2013
Teach For America April 2012 - July 2012
Charlotte-Mecklenburg Schools August 2008 - June 2012
Charlotte-Mecklenburg Schools August 2009 - July 2011
Charlotte-Mecklenburg Schools June 2010 - June 2011
Teach For America June 2008 - June 2010
EMC Corporation July 2007 - December 2007
E Ink July 2006 - December 2006
EMD Pharmaceuticals July 2005 - December 2005
Skills
Nonprofits, Research, Leadership, Teaching, Community Outreach, Staff Development, Data Analysis, Microsoft Office, Leadership Development, Classroom, Curriculum Design, Event Management, Tutoring
Education
University of North Carolina at Charlotte 2008 — 2011
Teaching Certification
Northeastern University 2003 — 2008
BS, Chemical Engineering
Sponsors for Educational Opportunity August 2013 - Present
Teach For America June 2012 - August 2013
Teach For America April 2012 - July 2012
Charlotte-Mecklenburg Schools August 2008 - June 2012
Charlotte-Mecklenburg Schools August 2009 - July 2011
Charlotte-Mecklenburg Schools June 2010 - June 2011
Teach For America June 2008 - June 2010
EMC Corporation July 2007 - December 2007
E Ink July 2006 - December 2006
EMD Pharmaceuticals July 2005 - December 2005
Skills
Nonprofits, Research, Leadership, Teaching, Community Outreach, Staff Development, Data Analysis, Microsoft Office, Leadership Development, Classroom, Curriculum Design, Event Management, Tutoring
Education
University of North Carolina at Charlotte 2008 — 2011
Teaching Certification
Northeastern University 2003 — 2008
BS, Chemical Engineering
Casi DeYoung Casi DeYoung's EMD Pharmaceuticals Experience April 2000 - October 2005
Job Chief Business Officer at Mirna Therapeutics, Inc.
Industry Pharmaceuticals
Experience
Mirna Therapeutics, Inc. March 2014 - Present
Reata Pharmaceuticals May 2008 - December 2013
ODC Therapy November 2005 - March 2008
EMD Pharmaceuticals April 2000 - October 2005
Merck KGaA 2000 - 2005
Accenture December 1994 - March 2000
Education
The University of Texas at Austin - The Red McCombs School of Business 1992 — 1994
MBA
Southwestern University 1988 — 1991
BS, Chemistry, Mathematics
Mirna Therapeutics, Inc. March 2014 - Present
Reata Pharmaceuticals May 2008 - December 2013
ODC Therapy November 2005 - March 2008
EMD Pharmaceuticals April 2000 - October 2005
Merck KGaA 2000 - 2005
Accenture December 1994 - March 2000
Education
The University of Texas at Austin - The Red McCombs School of Business 1992 — 1994
MBA
Southwestern University 1988 — 1991
BS, Chemistry, Mathematics
Jean Chitwood Jean Chitwood's EMD Pharmaceuticals Experience 2000 - 2005
Job Corporate Development | Marketing | Business Startup | New Product Development | Business Planning
Industry Pharmaceuticals
Experience
INC Research, LLC 2006 - Present
Erimos Phamaceuticals 2005 - 2006
EMD Pharmaceuticals 2000 - 2005
Quintiles 1998 - 2000
Quintiles 1996 - 1998
Glaxo Wellcome 1988 - 1995
University of Virginia 1980 - 1986
Skills
Start-up Environments, Program Management, Business Planning, Strategic Planning, Clinical Trials, Product Development, Mergers, Fundraising, Integration, Web Marketing, Board of Director..., Patient Advocacy, Healthcare, Team Building, Leadership, Start-ups, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Business Development, Business Strategy, Oncology, Clinical Research, Mergers & Acquisitions, CRO, Start-up Environment, Product Launch, Clinical Development
Education
UNC Kenan-Flagler Business School 1986 — 1988
Masters, Business Administration
Radford University 1976 — 1980
Bachelor of Science, Medical Technology
INC Research, LLC 2006 - Present
Erimos Phamaceuticals 2005 - 2006
EMD Pharmaceuticals 2000 - 2005
Quintiles 1998 - 2000
Quintiles 1996 - 1998
Glaxo Wellcome 1988 - 1995
University of Virginia 1980 - 1986
Skills
Start-up Environments, Program Management, Business Planning, Strategic Planning, Clinical Trials, Product Development, Mergers, Fundraising, Integration, Web Marketing, Board of Director..., Patient Advocacy, Healthcare, Team Building, Leadership, Start-ups, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Business Development, Business Strategy, Oncology, Clinical Research, Mergers & Acquisitions, CRO, Start-up Environment, Product Launch, Clinical Development
Education
UNC Kenan-Flagler Business School 1986 — 1988
Masters, Business Administration
Radford University 1976 — 1980
Bachelor of Science, Medical Technology
Michael Glacken Michael Glacken's EMD Pharmaceuticals Experience December 2002 - June 2003
Job Senior Consultant at BioProcess Technology Consultants, Inc.
Industry Biotechnology
Experience
BioProcess Technology Consultants, Inc. August 2014 - Present
National Center for Therapeutics Manufacturing June 2014 - Present
Joule Unlimited Technologies, Inc October 2013 - August 2014
Joule Unlimited Technologies, Inc. July 2010 - October 2013
Millennium Pharmaceuticals July 2009 - July 2010
Millennium Pharmaceuticals July 2006 - July 2009
Millennium Pharmaceuticals April 2005 - July 2006
Millennium Pharmaceuticals September 2004 - April 2005
Xcellerex July 2003 - August 2004
EMD Pharmaceuticals December 2002 - June 2003
Skills
Biopharmaceutical CMC, High Throughout..., Bioprocess, CMC, Cell Culture, Bioreactor, Biochemical Engineering, Fermentation Technology, Biotechnology Industry, Processes Development, Tissue Culture, Fermentation Process..., Process Engineering, Biotechnology, Biopharmaceuticals, GMP, Technology Transfer, Purification
Education
Massachusetts Institute of Technology 1981 — 1987
Doctor of Philosophy (Ph.D.), Biochemical Engineering
University of Maryland College Park 1976 — 1980
Bachelor of Science (B.S.), Chemical Engineering
BioProcess Technology Consultants, Inc. August 2014 - Present
National Center for Therapeutics Manufacturing June 2014 - Present
Joule Unlimited Technologies, Inc October 2013 - August 2014
Joule Unlimited Technologies, Inc. July 2010 - October 2013
Millennium Pharmaceuticals July 2009 - July 2010
Millennium Pharmaceuticals July 2006 - July 2009
Millennium Pharmaceuticals April 2005 - July 2006
Millennium Pharmaceuticals September 2004 - April 2005
Xcellerex July 2003 - August 2004
EMD Pharmaceuticals December 2002 - June 2003
Skills
Biopharmaceutical CMC, High Throughout..., Bioprocess, CMC, Cell Culture, Bioreactor, Biochemical Engineering, Fermentation Technology, Biotechnology Industry, Processes Development, Tissue Culture, Fermentation Process..., Process Engineering, Biotechnology, Biopharmaceuticals, GMP, Technology Transfer, Purification
Education
Massachusetts Institute of Technology 1981 — 1987
Doctor of Philosophy (Ph.D.), Biochemical Engineering
University of Maryland College Park 1976 — 1980
Bachelor of Science (B.S.), Chemical Engineering
Patrick Roberts Patrick Roberts's EMD Pharmaceuticals Experience 2005 - 2007
Job Director of Translational Medicine at G1 Therapeutics
Industry Biotechnology
Experience
G1 Therapeutics April 2014 - Present
G1 Therapeutics July 2012 - April 2014
G1 Therapeutics April 2009 - July 2012
EMD Pharmaceuticals 2005 - 2007
Skills
Oncology, Clinical Development, Drug Development, Clinical Trials, Lifesciences, Translational Research, Infectious Diseases, Clinical Research, Drug Discovery, In Vivo, Biomarker Discovery, Pharmaceutical Industry, Biotechnology, Animal Models, Life Sciences, Translational Medicine
Education
University of North Carolina at Chapel Hill 2007 — 2012
Post Docotoral Research Associate
University of North Carolina at Chapel Hill 2002 — 2007
PhD, Pharmaceutical Sciences
University of Kentucky College of Pharmacy 1998 — 2002
PharmD, Pharmacy
G1 Therapeutics April 2014 - Present
G1 Therapeutics July 2012 - April 2014
G1 Therapeutics April 2009 - July 2012
EMD Pharmaceuticals 2005 - 2007
Skills
Oncology, Clinical Development, Drug Development, Clinical Trials, Lifesciences, Translational Research, Infectious Diseases, Clinical Research, Drug Discovery, In Vivo, Biomarker Discovery, Pharmaceutical Industry, Biotechnology, Animal Models, Life Sciences, Translational Medicine
Education
University of North Carolina at Chapel Hill 2007 — 2012
Post Docotoral Research Associate
University of North Carolina at Chapel Hill 2002 — 2007
PhD, Pharmaceutical Sciences
University of Kentucky College of Pharmacy 1998 — 2002
PharmD, Pharmacy
Jeff New's EMD Pharmaceuticals Experience 2006 - 2006
Job Director, Medical Affairs
Industry Pharmaceuticals
Experience
Lundbeck June 2014 - Present
Chelsea Therapeutics March 2014 - June 2014
Impax Laboratories September 2012 - March 2014
Chelsea Therapeutics July 2011 - July 2012
Pharmaceutical Strategic Initiatives, LLC January 2009 - May 2011
Dey Pharma L.P 2006 - 2008
EMD Pharmaceuticals 2006 - 2006
Mylan Bertek Pharmaceuticals 2004 - 2006
Takeda Pharmaceuticals April 2000 - 2004
PPD December 1997 - April 2000
Skills
Medical Affairs, KOL development, KOL Identification, Slide Preparation, Medical Education, MSL Management, Medical Information, Strategic Communications, Medical Communications, Pharmaceutical Industry, Clinical Trials, Clinical Research, Compliance, Advisory Boards, Drug Product, Health Advocacy, Patient Outcomes, Patient Education, Patient Reported..., Clinical Outcomes, PowerPoint, Grants, Field Operations, Strategic Planning, GCP, Product Lifecycle..., Business Coaching, Regulatory Requirements, Development Of..., Content Development, Publication Planning, Publication Strategy, Booth Staff Training, Speaker Support, Management, Recommended, Diligent, High Performer, Parkinson's, Type 2 Diabetes, Respiratory Products, Hypertension, CNS disorders, Anaphylaxis, Orphan Drugs, Technical Information, Infectious Diseases, Endocrinology, Drug Development, Medical Writing
Education
University of North Carolina at Chapel Hill 1998 — 2002
Doctor of Pharmacy (PharmD), Pharmacy
University of North Carolina at Chapel Hill 1986 — 1991
Bachelor of Science (BS), Pharmacy
Lundbeck June 2014 - Present
Chelsea Therapeutics March 2014 - June 2014
Impax Laboratories September 2012 - March 2014
Chelsea Therapeutics July 2011 - July 2012
Pharmaceutical Strategic Initiatives, LLC January 2009 - May 2011
Dey Pharma L.P 2006 - 2008
EMD Pharmaceuticals 2006 - 2006
Mylan Bertek Pharmaceuticals 2004 - 2006
Takeda Pharmaceuticals April 2000 - 2004
PPD December 1997 - April 2000
Skills
Medical Affairs, KOL development, KOL Identification, Slide Preparation, Medical Education, MSL Management, Medical Information, Strategic Communications, Medical Communications, Pharmaceutical Industry, Clinical Trials, Clinical Research, Compliance, Advisory Boards, Drug Product, Health Advocacy, Patient Outcomes, Patient Education, Patient Reported..., Clinical Outcomes, PowerPoint, Grants, Field Operations, Strategic Planning, GCP, Product Lifecycle..., Business Coaching, Regulatory Requirements, Development Of..., Content Development, Publication Planning, Publication Strategy, Booth Staff Training, Speaker Support, Management, Recommended, Diligent, High Performer, Parkinson's, Type 2 Diabetes, Respiratory Products, Hypertension, CNS disorders, Anaphylaxis, Orphan Drugs, Technical Information, Infectious Diseases, Endocrinology, Drug Development, Medical Writing
Education
University of North Carolina at Chapel Hill 1998 — 2002
Doctor of Pharmacy (PharmD), Pharmacy
University of North Carolina at Chapel Hill 1986 — 1991
Bachelor of Science (BS), Pharmacy
Ioannis Papayannopoulos Ioannis Papayannopoulos's EMD Pharmaceuticals Experience 2001 - 2002
Job Mass spectrometry, proteomics, analytical protein chemistrty
Industry Research
Experience
Celldex Therapeutics June 2015 - Present
Targanox Inc. July 2013 - June 2015
MIT July 2006 - February 2013
Altus Pharmaceuticals 2005 - 2006
CuraGen Corporation 2005 - 2005
Applied Biosystems 2002 - 2004
EMD Pharmaceuticals 2001 - 2002
AstraZeneca R&D 1998 - 2000
Covance Biotechnology Services 1996 - 1998
Biogen 1993 - 1996
Skills
Mass Spectrometry, Protein Chemistry, Pharmaceuticals, Biomarker Discovery, Proteomics, LC-MS, HPLC, Chemistry, Characterization, Analytical Chemistry, Pharmaceutical Industry, NMR spectroscopy, Biotechnology, Gas Chromatography, Chromatography, Immunoassays, R&D, Biomarkers, Laboratory, Drug Development, Formulation, Purification, NMR, Drug Discovery, UV/Vis, Assay Development, Science, Lifesciences, GC-MS, Biochemistry, Organic Chemistry, Spectroscopy, Protein Purification, Cell
Education
Massachusetts Institute of Technology 1981 — 1987
Ph.D., Organic Chemistry - Mass Spectrometry
Bowdoin College 1977 — 1981
A.B., Chemistry
Celldex Therapeutics June 2015 - Present
Targanox Inc. July 2013 - June 2015
MIT July 2006 - February 2013
Altus Pharmaceuticals 2005 - 2006
CuraGen Corporation 2005 - 2005
Applied Biosystems 2002 - 2004
EMD Pharmaceuticals 2001 - 2002
AstraZeneca R&D 1998 - 2000
Covance Biotechnology Services 1996 - 1998
Biogen 1993 - 1996
Skills
Mass Spectrometry, Protein Chemistry, Pharmaceuticals, Biomarker Discovery, Proteomics, LC-MS, HPLC, Chemistry, Characterization, Analytical Chemistry, Pharmaceutical Industry, NMR spectroscopy, Biotechnology, Gas Chromatography, Chromatography, Immunoassays, R&D, Biomarkers, Laboratory, Drug Development, Formulation, Purification, NMR, Drug Discovery, UV/Vis, Assay Development, Science, Lifesciences, GC-MS, Biochemistry, Organic Chemistry, Spectroscopy, Protein Purification, Cell
Education
Massachusetts Institute of Technology 1981 — 1987
Ph.D., Organic Chemistry - Mass Spectrometry
Bowdoin College 1977 — 1981
A.B., Chemistry
Kathy Elks Kathy Elks's EMD Pharmaceuticals Experience 2002 - 2007
Job Associate Director at Impact Pharmaceutical Services, Inc.
Industry Pharmaceuticals
Experience
Impact Pharmaceutical Services, Inc. June 2013 - Present
Chimerix, Inc. June 2010 - May 2013
BioCryst Pharmaceuticals, Inc. May 2009 - May 2010
SRA International September 2007 - May 2009
EMD Pharmaceuticals 2002 - 2007
Triangle Pharmaceuticals March 2000 - October 2002
Burroughs Wellcome Company October 1979 - November 1993
Skills
Regulatory Submissions, Pharmaceutical Industry, Regulatory Affairs, Drug Development, FDA, Analytical Chemistry, Sop, Infectious Diseases, Technology Transfer, ICH-GCP, IND, Protocol, GCP, CTMS, CAPA, Pharmacovigilance, Biotechnology, 21 CFR Part 11, Drug Discovery, EDC, Lifesciences, Clinical Development, GLP, Validation, GMP, CRO, Clinical Trials, Medical Writing, Clinical Research, Therapeutic Areas, Computer System..., Oncology, Biopharmaceuticals, Change Control, GxP, LIMS, Pharmaceutics, Regulatory Requirements, SOP development, Life Sciences, SOP
Education
North Carolina Wesleyan College 2000 — 2002
BS, Business
Impact Pharmaceutical Services, Inc. June 2013 - Present
Chimerix, Inc. June 2010 - May 2013
BioCryst Pharmaceuticals, Inc. May 2009 - May 2010
SRA International September 2007 - May 2009
EMD Pharmaceuticals 2002 - 2007
Triangle Pharmaceuticals March 2000 - October 2002
Burroughs Wellcome Company October 1979 - November 1993
Skills
Regulatory Submissions, Pharmaceutical Industry, Regulatory Affairs, Drug Development, FDA, Analytical Chemistry, Sop, Infectious Diseases, Technology Transfer, ICH-GCP, IND, Protocol, GCP, CTMS, CAPA, Pharmacovigilance, Biotechnology, 21 CFR Part 11, Drug Discovery, EDC, Lifesciences, Clinical Development, GLP, Validation, GMP, CRO, Clinical Trials, Medical Writing, Clinical Research, Therapeutic Areas, Computer System..., Oncology, Biopharmaceuticals, Change Control, GxP, LIMS, Pharmaceutics, Regulatory Requirements, SOP development, Life Sciences, SOP
Education
North Carolina Wesleyan College 2000 — 2002
BS, Business
Christine Gebski Christine Gebski's EMD Pharmaceuticals Experience November 2001 - October 2004
Job Vice President, Product Management and Field Applications at Repligen Corporation
Industry Biotechnology
Experience
Repligen Corporation June 2015 - Present
Consultant - Biotechnology Professional November 2014 - May 2015
Thermo Fisher Scientific (Life Technologies) October 2011 - November 2014
Applied Biosystems/LIFE Technologies October 2004 - July 2012
EMD Pharmaceuticals November 2001 - October 2004
Shire HGT October 1999 - October 2001
Genzyme June 1989 - October 1999
Skills
Downstream Processing, Chromatography, Purification, Biotechnology, Biopharmaceuticals, Technology Transfer, Process Development, Protein Chemistry, BioChromatography, Troubleshooting, Assay Development, HPLC, GMP, Validation, Biochemistry, Protein Purification, Lifesciences, Cell Culture, ELISA, Product Development, Introducing New Products, Business Planning, P&L Management, Forecasting, Strategic Planning, Technical Writing, Technical Training, Cross-functional Team..., Life Sciences, Genomics, Process Simulation, Chemistry, LIMS, Mass Spectrometry, Characterization, R&D
Education
University of Massachusetts Lowell 1991 — 1994
Masters, Biotechnology
University of Vermont 1985 — 1989
BS, Biology
Repligen Corporation June 2015 - Present
Consultant - Biotechnology Professional November 2014 - May 2015
Thermo Fisher Scientific (Life Technologies) October 2011 - November 2014
Applied Biosystems/LIFE Technologies October 2004 - July 2012
EMD Pharmaceuticals November 2001 - October 2004
Shire HGT October 1999 - October 2001
Genzyme June 1989 - October 1999
Skills
Downstream Processing, Chromatography, Purification, Biotechnology, Biopharmaceuticals, Technology Transfer, Process Development, Protein Chemistry, BioChromatography, Troubleshooting, Assay Development, HPLC, GMP, Validation, Biochemistry, Protein Purification, Lifesciences, Cell Culture, ELISA, Product Development, Introducing New Products, Business Planning, P&L Management, Forecasting, Strategic Planning, Technical Writing, Technical Training, Cross-functional Team..., Life Sciences, Genomics, Process Simulation, Chemistry, LIMS, Mass Spectrometry, Characterization, R&D
Education
University of Massachusetts Lowell 1991 — 1994
Masters, Biotechnology
University of Vermont 1985 — 1989
BS, Biology
Elliott Berger Elliott Berger's EMD Pharmaceuticals Experience 1999 - 2007
Job Sr. Vice President Regulatory Affairs at BioCryst Pharmaceuticals
Industry Pharmaceuticals
Experience
BioCryst Pharmaceuticals 2007 - Present
EMD Pharmaceuticals 1999 - 2007
Merck KGaA/Merck Santé 1999 - 2007
Astra Pharmaceuticals 1998 - 1999
Astra Merck 1992 - 1998
Merck Research Labs 1981 - 1992
Merck Research Labs 1975 - 1981
Skills
Regulatory Submissions, Clinical Development, Regulatory Affairs, Pharmaceutical Industry, Clinical Trials, Drug Development, Biotechnology, FDA, IND, Pharmacovigilance, eCTD, GCP, Clinical Research, NDA, Lifesciences, CMC, GMP, Regulations, Quality Assurance, Regulatory Requirements, Pharmaceutics, Biopharmaceuticals, 21 CFR Part 11, Therapeutic Areas, Sop, Infectious Diseases, Drug Discovery, Technology Transfer, V&V, GLP, Clinical Data Management, Life Sciences
Education
Temple University School of Medicine 1973 — 1981
MS, PH.D, Biometrics
Temple University 1969 — 1973
BA, Mathematics
Central High School of Philadelphia 1965 — 1969
BA (HON)
BioCryst Pharmaceuticals 2007 - Present
EMD Pharmaceuticals 1999 - 2007
Merck KGaA/Merck Santé 1999 - 2007
Astra Pharmaceuticals 1998 - 1999
Astra Merck 1992 - 1998
Merck Research Labs 1981 - 1992
Merck Research Labs 1975 - 1981
Skills
Regulatory Submissions, Clinical Development, Regulatory Affairs, Pharmaceutical Industry, Clinical Trials, Drug Development, Biotechnology, FDA, IND, Pharmacovigilance, eCTD, GCP, Clinical Research, NDA, Lifesciences, CMC, GMP, Regulations, Quality Assurance, Regulatory Requirements, Pharmaceutics, Biopharmaceuticals, 21 CFR Part 11, Therapeutic Areas, Sop, Infectious Diseases, Drug Discovery, Technology Transfer, V&V, GLP, Clinical Data Management, Life Sciences
Education
Temple University School of Medicine 1973 — 1981
MS, PH.D, Biometrics
Temple University 1969 — 1973
BA, Mathematics
Central High School of Philadelphia 1965 — 1969
BA (HON)
Michael Bellero Michael Bellero's EMD Pharmaceuticals Experience April 2003 - June 2004
Job Director, Regulatory Technology at Otsuka Pharmaceutical Companies (U.S.)
Industry Pharmaceuticals
Experience
Otsuka Pharmaceutical Companies (U.S.) May 2015 - Present
Otsuka July 2011 - Present
GE Healthcare April 2010 - July 2011
GE Healthcare October 2005 - April 2010
Sandoz June 2004 - October 2005
EMD Pharmaceuticals April 2003 - June 2004
Merck KGaA April 2003 - June 2004
Novartis December 2001 - April 2003
Hoffmann-La Roche October 1999 - December 2001
Schering Plough October 1997 - October 1999
Skills
Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, GCP, 21 CFR Part 11, Validation, IND, Clinical Trials, Clinical Development, eCTD, Software Documentation, Quality Assurance, Sop, Change Control, Document Management, GxP, Computer System..., Documentum
Education
Montclair State University 1987 — 1994
Otsuka Pharmaceutical Companies (U.S.) May 2015 - Present
Otsuka July 2011 - Present
GE Healthcare April 2010 - July 2011
GE Healthcare October 2005 - April 2010
Sandoz June 2004 - October 2005
EMD Pharmaceuticals April 2003 - June 2004
Merck KGaA April 2003 - June 2004
Novartis December 2001 - April 2003
Hoffmann-La Roche October 1999 - December 2001
Schering Plough October 1997 - October 1999
Skills
Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, GCP, 21 CFR Part 11, Validation, IND, Clinical Trials, Clinical Development, eCTD, Software Documentation, Quality Assurance, Sop, Change Control, Document Management, GxP, Computer System..., Documentum
Education
Montclair State University 1987 — 1994
Ted Stover Ted Stover's EMD Pharmaceuticals Experience 2000 - 2004
Job Vice President of Manufacturing at Sancilio & company
Industry Pharmaceuticals
Experience
Sancilio & company April 2014 - Present
Sancilio & company August 2012 - April 2014
Prioria Robotics November 2010 - July 2012
Prioria Robotics November 2010 - February 2012
Natural Elements Painting July 2008 - June 2010
Gainesville Area Chamber of Commerce 2008 - June 2010
OxThera 2004 - 2008
EMD Pharmaceuticals 2000 - 2004
Primedica 1998 - 2000
MGH 1997 - 1998
Skills
Project Management, Strategic Planning, Microsoft Office, Research, Customer Service, Team Building, PowerPoint, Microsoft Excel, Program Management, Operations Management, Biotechnology, Analytical Methods..., Analytical Method..., Management, New Business Development, IND, NDA, ANDA, Business Development, Technology Transfer, GMP, Formulation, Validation, Pharmaceutical Industry, HPLC, Sop, GLP, FDA, Chemistry, Medical Devices, R&D, Manufacturing, Biochemistry, Clinical Trials, Quality Control, Clinical Development, Laboratory, Pharmaceutics, LC-MS, Oncology, Lifesciences, CAPA, Assay Development, Analytical Chemistry, Chromatography, Drug Development, Commercialization, Quality System, Biopharmaceuticals, Cross-functional Team...
Education
University of Florida 2012 — 2014
MBA
Northeastern University 2001 — 2003
Bucknell University 1993 — 1997
BS, Biochemistry
Sancilio & company April 2014 - Present
Sancilio & company August 2012 - April 2014
Prioria Robotics November 2010 - July 2012
Prioria Robotics November 2010 - February 2012
Natural Elements Painting July 2008 - June 2010
Gainesville Area Chamber of Commerce 2008 - June 2010
OxThera 2004 - 2008
EMD Pharmaceuticals 2000 - 2004
Primedica 1998 - 2000
MGH 1997 - 1998
Skills
Project Management, Strategic Planning, Microsoft Office, Research, Customer Service, Team Building, PowerPoint, Microsoft Excel, Program Management, Operations Management, Biotechnology, Analytical Methods..., Analytical Method..., Management, New Business Development, IND, NDA, ANDA, Business Development, Technology Transfer, GMP, Formulation, Validation, Pharmaceutical Industry, HPLC, Sop, GLP, FDA, Chemistry, Medical Devices, R&D, Manufacturing, Biochemistry, Clinical Trials, Quality Control, Clinical Development, Laboratory, Pharmaceutics, LC-MS, Oncology, Lifesciences, CAPA, Assay Development, Analytical Chemistry, Chromatography, Drug Development, Commercialization, Quality System, Biopharmaceuticals, Cross-functional Team...
Education
University of Florida 2012 — 2014
MBA
Northeastern University 2001 — 2003
Bucknell University 1993 — 1997
BS, Biochemistry
Kristine C. Federico Kristine C. Federico's EMD Pharmaceuticals Experience January 2001 - June 2007
Job Director, Clinical Operations at VitalTherapies
Industry Biotechnology
Experience
VitalTherapies August 2014 - Present
Hologic Gen-Probe February 2013 - October 2013
Nereus Pharmaceuticals June 2007 - November 2012
EMD Pharmaceuticals January 2001 - June 2007
Quintiles January 1998 - April 2001
Millard Fillmore Clinical Research Center January 1989 - June 1998
Hospice of Buffalo May 1991 - June 1995
Women and Children's Hospital of Buffalo January 1988 - December 1989
Skills
Clinical Development, Pharmaceutical Industry, CTMS, Clinical Trials, Clinical Research, Sop, Protocol, Drug Development, Regulatory Affairs, Biotechnology, GCP, Regulatory Submissions, eCTD, Oncology, IND, Clinical Operations, Clinical Monitoring, EDC, CRO
Education
State University of New York at Buffalo
BS - Magna Cum Laude, Nursing
VitalTherapies August 2014 - Present
Hologic Gen-Probe February 2013 - October 2013
Nereus Pharmaceuticals June 2007 - November 2012
EMD Pharmaceuticals January 2001 - June 2007
Quintiles January 1998 - April 2001
Millard Fillmore Clinical Research Center January 1989 - June 1998
Hospice of Buffalo May 1991 - June 1995
Women and Children's Hospital of Buffalo January 1988 - December 1989
Skills
Clinical Development, Pharmaceutical Industry, CTMS, Clinical Trials, Clinical Research, Sop, Protocol, Drug Development, Regulatory Affairs, Biotechnology, GCP, Regulatory Submissions, eCTD, Oncology, IND, Clinical Operations, Clinical Monitoring, EDC, CRO
Education
State University of New York at Buffalo
BS - Magna Cum Laude, Nursing
Kate Worthington PhD MBA's EMD Pharmaceuticals Experience June 2001 - December 2003
Job Senior Director Medical Affairs at Celldex Therapeutics
Industry Pharmaceuticals
Experience
Celldex Therapeutics September 2014 - Present
Sanofi January 2014 - May 2014
Sanofi April 2013 - May 2014
The Ben and Catherine Ivy Foundation September 2011 - May 2014
Merck November 2009 - August 2010
Schering-Plough May 2005 - April 2010
EMD Pharmaceuticals June 2001 - December 2003
Research Corporation Technologies September 1998 - May 2001
Education
Syracuse University - Martin J. Whitman School of Management 1996 — 1998
MBA, Organizational Behavior
Northwestern University 1988 — 1994
PhD, Tumor Cell Biology
Northwestern University - The Feinberg School of Medicine 1988 — 1994
PhD, Tumor Cell Biology
Syracuse University 1986 — 1988
BS, Biology
Cornell University 1983 — 1984
Mechanical Engineering
Kent School 1980 — 1983
High School
The Fay School 1978 — 1980
Middle School
Celldex Therapeutics September 2014 - Present
Sanofi January 2014 - May 2014
Sanofi April 2013 - May 2014
The Ben and Catherine Ivy Foundation September 2011 - May 2014
Merck November 2009 - August 2010
Schering-Plough May 2005 - April 2010
EMD Pharmaceuticals June 2001 - December 2003
Research Corporation Technologies September 1998 - May 2001
Education
Syracuse University - Martin J. Whitman School of Management 1996 — 1998
MBA, Organizational Behavior
Northwestern University 1988 — 1994
PhD, Tumor Cell Biology
Northwestern University - The Feinberg School of Medicine 1988 — 1994
PhD, Tumor Cell Biology
Syracuse University 1986 — 1988
BS, Biology
Cornell University 1983 — 1984
Mechanical Engineering
Kent School 1980 — 1983
High School
The Fay School 1978 — 1980
Middle School
Jason Hayes Jason Hayes's EMD Pharmaceuticals Experience December 2000 - March 2002
Job SVP, Business Development
Industry Marketing and Advertising
Experience
Conisus LLC August 2007 - Present
P4 Healthcare August 2006 - August 2007
Biomira Inc. March 2002 - August 2007
EMD Pharmaceuticals December 2000 - March 2002
Ligand Pharmaceuticals September 1998 - December 2000
Rhone-Poulenc Rorer January 1996 - September 1998
Bristol-Myers Squibb June 1990 - December 1995
General Electric (GE) 1989 - 1990
Skills
Oncology, Biotechnology, Pharmaceutical Industry, Commercialization, Managed Care, Pharmaceutical Sales, Healthcare, Hematology, Strategic Planning, Business Development, Clinical Development, Competitive Intelligence, Product Launch, Sales, Cross-functional Team..., Global Marketing
Education
Duke University 1986 — 1989
BA, History
duke university 1986 — 1989
Bachelor's degree
Conisus LLC August 2007 - Present
P4 Healthcare August 2006 - August 2007
Biomira Inc. March 2002 - August 2007
EMD Pharmaceuticals December 2000 - March 2002
Ligand Pharmaceuticals September 1998 - December 2000
Rhone-Poulenc Rorer January 1996 - September 1998
Bristol-Myers Squibb June 1990 - December 1995
General Electric (GE) 1989 - 1990
Skills
Oncology, Biotechnology, Pharmaceutical Industry, Commercialization, Managed Care, Pharmaceutical Sales, Healthcare, Hematology, Strategic Planning, Business Development, Clinical Development, Competitive Intelligence, Product Launch, Sales, Cross-functional Team..., Global Marketing
Education
Duke University 1986 — 1989
BA, History
duke university 1986 — 1989
Bachelor's degree
Cemal Unal's EMD Pharmaceuticals Experience May 2001 - June 2006
Job Owner at Biometrical Solutions LLC, A Statistical Consulting and Statistical Programming Company
Industry Pharmaceuticals
Experience
Biometrical Solutions LLC June 2010 - Present
bdsi 2010 - 2015
pozen June 2006 - June 2010
EMD Pharmaceuticals May 2001 - June 2006
Merck KGaA 2001 - 2006
EMD Pharmceuticals (Subsidiary of Merck KGaA) 2001 - 2006
PPD September 1994 - May 2001
GlaxoWellcome September 1993 - September 1994
Skills
Clinical Trials, Oncology, Clinical Development, Six Sigma, Pharmaceutical Industry, Biostatistics, CRO, NDA, Clinical Study Design, Drug Development, FDA, Statistical Programming, Statistics, Data Management, Data Analysis, Biotechnology, SAS, Clinical Research, Protocol, Therapeutic Areas, Sop
Education
North Carolina State University 1990 — 1995
Doctor of Philosophy (PhD), Statistics
Middle East Technical University (METU), Ankara-Turkey 1987 — 1990
Masters, Statistics
Biometrical Solutions LLC June 2010 - Present
bdsi 2010 - 2015
pozen June 2006 - June 2010
EMD Pharmaceuticals May 2001 - June 2006
Merck KGaA 2001 - 2006
EMD Pharmceuticals (Subsidiary of Merck KGaA) 2001 - 2006
PPD September 1994 - May 2001
GlaxoWellcome September 1993 - September 1994
Skills
Clinical Trials, Oncology, Clinical Development, Six Sigma, Pharmaceutical Industry, Biostatistics, CRO, NDA, Clinical Study Design, Drug Development, FDA, Statistical Programming, Statistics, Data Management, Data Analysis, Biotechnology, SAS, Clinical Research, Protocol, Therapeutic Areas, Sop
Education
North Carolina State University 1990 — 1995
Doctor of Philosophy (PhD), Statistics
Middle East Technical University (METU), Ankara-Turkey 1987 — 1990
Masters, Statistics
Sandra Moreira Sandra Moreira's EMD Pharmaceuticals Experience 2005 - 2006
Job Director, Quality Assurance Operations at Genzyme
Industry Biotechnology
Experience
Genzyme April 2014 - Present
Genzyme 2012 - 2014
Genzyme 2011 - 2011
EMD Serono 2009 - 2011
EMD Serono 2006 - 2009
EMD Serono, Inc. 2006 - 2006
EMD Pharmaceuticals 2005 - 2006
Merck KGaA 2000 - 2005
Merck KGaA 1998 - 1999
Merck KGaA 1996 - 1998
Skills
GMP, CAPA, FDA, GLP, Technology Transfer, Quality Control, Biotechnology, Change Control, Sop, Pharmaceutical Industry, HPLC, Quality Assurance, Quality System, EU GMP, US GMP, Microbiology
Education
University of New Hampshire -- Peter T. Paul College of Business and Economics
MBA
Johannes Gutenberg University Mainz
Molecularbiologie
Industry & Handelskammer (IHK)
Biology
Industry & Handelskammer (IHK)
Biology
Genzyme April 2014 - Present
Genzyme 2012 - 2014
Genzyme 2011 - 2011
EMD Serono 2009 - 2011
EMD Serono 2006 - 2009
EMD Serono, Inc. 2006 - 2006
EMD Pharmaceuticals 2005 - 2006
Merck KGaA 2000 - 2005
Merck KGaA 1998 - 1999
Merck KGaA 1996 - 1998
Skills
GMP, CAPA, FDA, GLP, Technology Transfer, Quality Control, Biotechnology, Change Control, Sop, Pharmaceutical Industry, HPLC, Quality Assurance, Quality System, EU GMP, US GMP, Microbiology
Education
University of New Hampshire -- Peter T. Paul College of Business and Economics
MBA
Johannes Gutenberg University Mainz
Molecularbiologie
Industry & Handelskammer (IHK)
Biology
Industry & Handelskammer (IHK)
Biology
Jacob Bonenberger's EMD Pharmaceuticals Experience December 2004 - May 2005
Job Consultant
Industry Research
Experience
Independent Consultant June 2014 - Present
Ipsos April 2008 - June 2014
Bristol-Myers Squibb March 2006 - April 2008
Novan, Inc. October 2005 - March 2006
Bristol-Myers Squibb June 2005 - August 2005
Becton Dickinson March 2005 - May 2005
EMD Pharmaceuticals December 2004 - May 2005
Johnston, Zabor, McManus, Inc. (now Phoenix Healthcare) 2001 - 2004
Harris Interactive 2000 - 2001
Skills
Market Research, Pharmaceutical Industry, Strategy, Forecasting, Competitive Intelligence, Segmentation, Biotechnology, Analytics, Pricing, Business Development, Business Strategy, Marketing Strategy, Problem Solving, Product Launch, Customer Insight, Pharmaceuticals, Commercial Strategies, Monte Carlo Simulation, Neuroscience, Valuation, Emerging Markets, Secondary Research, Market Opportunity..., Commercial Planning, Key Opinion Leader..., DTC, Putting Out Fires, Grit, Teamwork, Pragmatic, Intellectually Curious, Tenacious Work Ethic, Entrepreneurship, Mergers & Acquisitions, Team Leadership
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2004 — 2006
MBA
Appalachian State University 1997 — 2000
MA
University of North Carolina at Chapel Hill 1992 — 1996
BS
Independent Consultant June 2014 - Present
Ipsos April 2008 - June 2014
Bristol-Myers Squibb March 2006 - April 2008
Novan, Inc. October 2005 - March 2006
Bristol-Myers Squibb June 2005 - August 2005
Becton Dickinson March 2005 - May 2005
EMD Pharmaceuticals December 2004 - May 2005
Johnston, Zabor, McManus, Inc. (now Phoenix Healthcare) 2001 - 2004
Harris Interactive 2000 - 2001
Skills
Market Research, Pharmaceutical Industry, Strategy, Forecasting, Competitive Intelligence, Segmentation, Biotechnology, Analytics, Pricing, Business Development, Business Strategy, Marketing Strategy, Problem Solving, Product Launch, Customer Insight, Pharmaceuticals, Commercial Strategies, Monte Carlo Simulation, Neuroscience, Valuation, Emerging Markets, Secondary Research, Market Opportunity..., Commercial Planning, Key Opinion Leader..., DTC, Putting Out Fires, Grit, Teamwork, Pragmatic, Intellectually Curious, Tenacious Work Ethic, Entrepreneurship, Mergers & Acquisitions, Team Leadership
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2004 — 2006
MBA
Appalachian State University 1997 — 2000
MA
University of North Carolina at Chapel Hill 1992 — 1996
BS
Tina Scalzo's EMD Pharmaceuticals Experience 2002 - 2004
Job Scientist II at Novartis Vaccines
Industry Biotechnology
Experience
Novartis Vaccines 2009 - Present
Acceleron Pharma 2006 - 2009
Millennium Pharmaceuticals 2004 - 2006
EMD Pharmaceuticals 2002 - 2004
Progenics Pharmaceuticals 1997 - 2002
Danbury Internal Medicine Associates 1993 - 1997
Skills
Assay Development, Immunology, PBMC isolation, Mammalian Cell Culture, ELISPOT, Multi-color Flow..., Cytokines, Multiplexing, Luminex, Hybridoma, Monoclonal Antibodies, Biosensors, Cell Based Assays, Bioassay, Immunoassays, ELISA, Immunization, Serology, Virus Culture, Plaque Assay, Immunoprecipitation, Western Blotting, SDS-PAGE, Gel Electrophoresis, Protein Conjugation, Affinity Chromatography, Column Chromatography, Chromatography, Isoelectric Focusing, UV/Vis, Spectroscopy, Biotechnology, Biochemistry, Protein Chemistry, Oncology, Biologics, Vaccines, Biopharmaceuticals, Technology Transfer, Analytical Methods..., SOP authoring, Technical Documentation, GLP, GMP, GraphPad Prism, FlowJo, Spotfire
Education
New York Medical College 1997 — 2002
MS, Microbiology & Immunology
University of Connecticut 1990 — 1995
BS, Physiology & Neurobiology
Novartis Vaccines 2009 - Present
Acceleron Pharma 2006 - 2009
Millennium Pharmaceuticals 2004 - 2006
EMD Pharmaceuticals 2002 - 2004
Progenics Pharmaceuticals 1997 - 2002
Danbury Internal Medicine Associates 1993 - 1997
Skills
Assay Development, Immunology, PBMC isolation, Mammalian Cell Culture, ELISPOT, Multi-color Flow..., Cytokines, Multiplexing, Luminex, Hybridoma, Monoclonal Antibodies, Biosensors, Cell Based Assays, Bioassay, Immunoassays, ELISA, Immunization, Serology, Virus Culture, Plaque Assay, Immunoprecipitation, Western Blotting, SDS-PAGE, Gel Electrophoresis, Protein Conjugation, Affinity Chromatography, Column Chromatography, Chromatography, Isoelectric Focusing, UV/Vis, Spectroscopy, Biotechnology, Biochemistry, Protein Chemistry, Oncology, Biologics, Vaccines, Biopharmaceuticals, Technology Transfer, Analytical Methods..., SOP authoring, Technical Documentation, GLP, GMP, GraphPad Prism, FlowJo, Spotfire
Education
New York Medical College 1997 — 2002
MS, Microbiology & Immunology
University of Connecticut 1990 — 1995
BS, Physiology & Neurobiology
Anne Kowal's EMD Pharmaceuticals Experience 2000 - 2004
Job Director, Head of Analytical Development Biologics at Takeda Pharmaceuticals
Industry Biotechnology
Experience
Takeda Pharmaceuticals May 2004 - Present
Millennium Pharmaceuticals May 2004 - Present
Millennium Pharmaceuticals May 2004 - Present
EMD Pharmaceuticals 2000 - 2004
Skills
Drug Development, CMC, Biopharmaceuticals, Assay Development, Technology Transfer, Validation, Protein Chemistry, Chromatography, Bioassay, Project Management, GMP, GLP, Drug Discovery, Biotechnology, IND, Clinical Development, Formulation, Analytical Chemistry
Education
Brown University
Doctor of Philosophy (Ph.D.)
Massachusetts Institute of Technology
Post-doctoral scientist
Tufts University
Bachelor of Science (BS)
Takeda Pharmaceuticals May 2004 - Present
Millennium Pharmaceuticals May 2004 - Present
Millennium Pharmaceuticals May 2004 - Present
EMD Pharmaceuticals 2000 - 2004
Skills
Drug Development, CMC, Biopharmaceuticals, Assay Development, Technology Transfer, Validation, Protein Chemistry, Chromatography, Bioassay, Project Management, GMP, GLP, Drug Discovery, Biotechnology, IND, Clinical Development, Formulation, Analytical Chemistry
Education
Brown University
Doctor of Philosophy (Ph.D.)
Massachusetts Institute of Technology
Post-doctoral scientist
Tufts University
Bachelor of Science (BS)
Donna Babiar's EMD Pharmaceuticals Experience 2005 - 2007
Job Clinical and Quality Consultant at Chimerix, Inc.
Industry Pharmaceuticals
Experience
DJB Clinical Consulting, Inc. February 2012 - Present
Grifols 2015 - 2015
DJB Clinical Consulting, Inc. (Owner) July 2007 - February 2012
BioCryst Pharmaceuticals July 2007 - January 2012
EMD Pharmaceuticals 2005 - 2007
XTL Bio February 2004 - June 2005
Schering-Plough Research Institute September 1999 - February 2004
GlaxoSmithKline June 1997 - September 1999
Quintiles July 1993 - June 1997
Skills
Pharmaceutical Industry, Clinical Research, Clinical Trials, GCP, CRO, Clinical Development, CTMS, Teamwork, Regulatory Submissions, ICH-GCP, Contractors, Clinical Study Design, Sop, Oncology, Team Leadership, Regulatory Affairs, FDA, Clinical Data Management, Pharmacovigilance, 21 CFR Part 11, Infectious Diseases, Biotechnology, Medical Writing, Biopharmaceuticals, Protocol, Clinical Monitoring, Regulatory Requirements, Clinical Operations, SOP
Education
State University of New York - System 1987 — 1991
Bachelor of Applied Science (B.A.Sc.)
DJB Clinical Consulting, Inc. February 2012 - Present
Grifols 2015 - 2015
DJB Clinical Consulting, Inc. (Owner) July 2007 - February 2012
BioCryst Pharmaceuticals July 2007 - January 2012
EMD Pharmaceuticals 2005 - 2007
XTL Bio February 2004 - June 2005
Schering-Plough Research Institute September 1999 - February 2004
GlaxoSmithKline June 1997 - September 1999
Quintiles July 1993 - June 1997
Skills
Pharmaceutical Industry, Clinical Research, Clinical Trials, GCP, CRO, Clinical Development, CTMS, Teamwork, Regulatory Submissions, ICH-GCP, Contractors, Clinical Study Design, Sop, Oncology, Team Leadership, Regulatory Affairs, FDA, Clinical Data Management, Pharmacovigilance, 21 CFR Part 11, Infectious Diseases, Biotechnology, Medical Writing, Biopharmaceuticals, Protocol, Clinical Monitoring, Regulatory Requirements, Clinical Operations, SOP
Education
State University of New York - System 1987 — 1991
Bachelor of Applied Science (B.A.Sc.)
David Vance's EMD Pharmaceuticals Experience 2002 - 2004
Job Sr. Dir. Business Conduct at Biopharma
Industry Pharmaceuticals
Experience
Noven Pharmaceuticals, Inc. February 2008 - Present
Gilead Sciences 2004 - 2007
EMD Pharmaceuticals 2002 - 2004
GlaxoSmithKline 2001 - 2002
GlaxoWellcome 1995 - 2000
Glaxo Wellcome 1995 - 2000
Burroughs Wellcome 1985 - 1995
Baker & McKenzie 1980 - 1985
U.S. District Court, District of Columbia 1979 - 1980
U.S Army 1972 - 1976
Skills
Clinical Trials, Sales Effectiveness, Managed Care, Pharmaceutical Industry, Due Diligence, Product Launch, Process Improvement, Regulatory Affairs, Program Management, Biotechnology, Regulatory Submissions, Contract Negotiation, Strategy, Strategic Planning, Pharmaceutical Sales, Cardiology, Cross-functional Team..., FDA, Corporate Governance, Commercialization, Healthcare, Regulatory Requirements, Technology Transfer
Education
Georgetown University Law Center
JD
University of Arizona
BA, German, Government
University of Cologne
Fulbright Scholar, East European History
University of Southern California
MA, International Relations
Noven Pharmaceuticals, Inc. February 2008 - Present
Gilead Sciences 2004 - 2007
EMD Pharmaceuticals 2002 - 2004
GlaxoSmithKline 2001 - 2002
GlaxoWellcome 1995 - 2000
Glaxo Wellcome 1995 - 2000
Burroughs Wellcome 1985 - 1995
Baker & McKenzie 1980 - 1985
U.S. District Court, District of Columbia 1979 - 1980
U.S Army 1972 - 1976
Skills
Clinical Trials, Sales Effectiveness, Managed Care, Pharmaceutical Industry, Due Diligence, Product Launch, Process Improvement, Regulatory Affairs, Program Management, Biotechnology, Regulatory Submissions, Contract Negotiation, Strategy, Strategic Planning, Pharmaceutical Sales, Cardiology, Cross-functional Team..., FDA, Corporate Governance, Commercialization, Healthcare, Regulatory Requirements, Technology Transfer
Education
Georgetown University Law Center
JD
University of Arizona
BA, German, Government
University of Cologne
Fulbright Scholar, East European History
University of Southern California
MA, International Relations
Richard Schoenfeld's EMD Pharmaceuticals Experience 2000 - 2004
Job Principal at BioWorks Consulting, LLC
Industry Biotechnology
Experience
BioWorks Consulting, LLC 2007 - Present
EMD Pharmaceuticals 2000 - 2004
Genzyme 1989 - 2000
Skills
Lifesciences, FDA, Biotechnology, Technology Transfer, Oncology, Biopharmaceuticals, Due Diligence, Validation, V&V, Protein Chemistry, Process Simulation, Commercialization, Cell Culture, Mammalian Cell Culture, R&D, GMP, Pharmaceutical Industry, Regulatory Affairs, Clinical Development, Contract Manufacturing, Biologics, Manufacturing, Sop, Life Sciences, SOP
Education
Bentley College 1996 — 1997
Advanced Graduate Certificate, Business Ethics
John Cook School of Business at Saint Louis University 1977 — 1980
Master of Business Administration (MBA)
Polytechnic Institute of Brooklyn 1971 — 1975
Ph.D. and M.S., BioEngineering
Northeastern University 1966 — 1971
Bachelor of Science (B.S.), Chemical Engineering
BioWorks Consulting, LLC 2007 - Present
EMD Pharmaceuticals 2000 - 2004
Genzyme 1989 - 2000
Skills
Lifesciences, FDA, Biotechnology, Technology Transfer, Oncology, Biopharmaceuticals, Due Diligence, Validation, V&V, Protein Chemistry, Process Simulation, Commercialization, Cell Culture, Mammalian Cell Culture, R&D, GMP, Pharmaceutical Industry, Regulatory Affairs, Clinical Development, Contract Manufacturing, Biologics, Manufacturing, Sop, Life Sciences, SOP
Education
Bentley College 1996 — 1997
Advanced Graduate Certificate, Business Ethics
John Cook School of Business at Saint Louis University 1977 — 1980
Master of Business Administration (MBA)
Polytechnic Institute of Brooklyn 1971 — 1975
Ph.D. and M.S., BioEngineering
Northeastern University 1966 — 1971
Bachelor of Science (B.S.), Chemical Engineering
Molly Gavigan RN JD's EMD Pharmaceuticals Experience 2001 - 2004
Job Palliative Care Research Cooperative Group
Industry Hospital & Health Care
Experience
Duke University 2005 - Present
Quintiles 2004 - 2005
EMD Pharmaceuticals 2001 - 2004
Quintiles 1999 - 2001
PPD 1994 - 1999
University of North Carolina, Lineberger Cancer Center 1986 - 1994
Roswell Park Cancer Institute 1976 - 1986
Education
Niagara University School of Nursing
RN BSN
North Carolina Central University School of Law
JD
Duke University 2005 - Present
Quintiles 2004 - 2005
EMD Pharmaceuticals 2001 - 2004
Quintiles 1999 - 2001
PPD 1994 - 1999
University of North Carolina, Lineberger Cancer Center 1986 - 1994
Roswell Park Cancer Institute 1976 - 1986
Education
Niagara University School of Nursing
RN BSN
North Carolina Central University School of Law
JD
Pat Wing's EMD Pharmaceuticals Experience 2001 - 2005
Job Director Oncology at Novartis
Industry Pharmaceuticals
Experience
Novartis April 2007 - Present
EMD Pharmaceuticals 2001 - 2005
Quintiles 1998 - 2001
Skills
CTMS, CRO, GCP, Clinical Research, Drug Development, Biotechnology, Oncology Clinical..., Clinical Operations, Diabetes, Regulatory Submissions, Oncology, Pharmacovigilance, 21 CFR Part 11, Neurology, Drug Discovery, Cardiology, EDC, Cancer, Pharmaceutical Industry, Clinical Monitoring, IND, Endocrinology, ICH-GCP, Rheumatology, Clinical Development, Clinical Data Management, Sop, Therapeutic Areas, Clinical Trials, Translational Medicine, Clinical Study Design, Protocol, Infectious Diseases, Breast Cancer, Dermatology, Biopharmaceuticals, Oracle Clinical, Pharmacology, Regulatory Affairs, Immunology, Vaccines, CRF design, FDA, Patient Recruitment, Clinical Pharmacology, Lifesciences, Medical Devices, SOP development, Life Sciences, SOP
Education
State University of New York College at Buffalo
nursing
Novartis April 2007 - Present
EMD Pharmaceuticals 2001 - 2005
Quintiles 1998 - 2001
Skills
CTMS, CRO, GCP, Clinical Research, Drug Development, Biotechnology, Oncology Clinical..., Clinical Operations, Diabetes, Regulatory Submissions, Oncology, Pharmacovigilance, 21 CFR Part 11, Neurology, Drug Discovery, Cardiology, EDC, Cancer, Pharmaceutical Industry, Clinical Monitoring, IND, Endocrinology, ICH-GCP, Rheumatology, Clinical Development, Clinical Data Management, Sop, Therapeutic Areas, Clinical Trials, Translational Medicine, Clinical Study Design, Protocol, Infectious Diseases, Breast Cancer, Dermatology, Biopharmaceuticals, Oracle Clinical, Pharmacology, Regulatory Affairs, Immunology, Vaccines, CRF design, FDA, Patient Recruitment, Clinical Pharmacology, Lifesciences, Medical Devices, SOP development, Life Sciences, SOP
Education
State University of New York College at Buffalo
nursing
Rae Hope's EMD Pharmaceuticals Experience August 2002 - April 2004
Job Experienced Clinical Data Analyst
Industry Pharmaceuticals
Experience
Chiltern International November 2012 - May 2013
RTI International July 2011 - March 2012
INC Research April 2010 - June 2011
PAREXEL July 2008 - January 2009
etrials Worldwide February 2007 - May 2008
GlaxoSmithKline July 2006 - February 2007
PPD September 2004 - July 2006
EMD Pharmaceuticals August 2002 - April 2004
emd 2000 - 2004
Skills
Clinical Data Management, EDC, Data Management, Oracle Clinical, Inform, Software Documentation, Clinical Research, Protocol, ICH-GCP, Clinical Trials
Education
Troy University Dothan 1991 — 1995
BSBA, Business Management
Borough of Manhattan Community College 1987 — 1988
Business Management/Marketing
Chiltern International November 2012 - May 2013
RTI International July 2011 - March 2012
INC Research April 2010 - June 2011
PAREXEL July 2008 - January 2009
etrials Worldwide February 2007 - May 2008
GlaxoSmithKline July 2006 - February 2007
PPD September 2004 - July 2006
EMD Pharmaceuticals August 2002 - April 2004
emd 2000 - 2004
Skills
Clinical Data Management, EDC, Data Management, Oracle Clinical, Inform, Software Documentation, Clinical Research, Protocol, ICH-GCP, Clinical Trials
Education
Troy University Dothan 1991 — 1995
BSBA, Business Management
Borough of Manhattan Community College 1987 — 1988
Business Management/Marketing
Jeffrey Spears's EMD Pharmaceuticals Experience October 2005 - October 2006
Job Medical Affairs Director, Hematology at Grifols Inc
Industry Biotechnology
Experience
Drug Information Association 2002 - 2014
Talecris November 2006 - July 2011
IISRA 2009 - 2011
EMD Pharmaceuticals October 2005 - October 2006
Mylan Bertek Pharmaceuticals March 2003 - October 2005
Mylan Laboratories 2003 - 2005
Pharmacia 2000 - 2003
Searle 1996 - 2000
Skills
Pharmaceutical Industry, Managed Care, Healthcare, Biotechnology, Medical Writing, Oncology, Clinical Development, Medical Affairs, Strategy, Medical Education, Clinical Trials, Hematology, Clinical Research, Sop, Lifesciences, Pharmaceutical Sales, Regulatory Affairs, Infectious Diseases, FDA, Drug Development, GCP, Neurology, CRO, Biopharmaceuticals, Regulatory Submissions, Pharmaceutics, Pharmacology, Health Economics, Immunology, Life Sciences
Education
University of Cincinnati 1970 — 1977
Drug Information Association 2002 - 2014
Talecris November 2006 - July 2011
IISRA 2009 - 2011
EMD Pharmaceuticals October 2005 - October 2006
Mylan Bertek Pharmaceuticals March 2003 - October 2005
Mylan Laboratories 2003 - 2005
Pharmacia 2000 - 2003
Searle 1996 - 2000
Skills
Pharmaceutical Industry, Managed Care, Healthcare, Biotechnology, Medical Writing, Oncology, Clinical Development, Medical Affairs, Strategy, Medical Education, Clinical Trials, Hematology, Clinical Research, Sop, Lifesciences, Pharmaceutical Sales, Regulatory Affairs, Infectious Diseases, FDA, Drug Development, GCP, Neurology, CRO, Biopharmaceuticals, Regulatory Submissions, Pharmaceutics, Pharmacology, Health Economics, Immunology, Life Sciences
Education
University of Cincinnati 1970 — 1977
Patty Wilmoth's EMD Pharmaceuticals Experience January 2006 - March 2007
Job Senior Manager QA Clinical Compliance at Salix Pharmaceuticals
Industry Pharmaceuticals
Experience
Salix Pharmaceuticals April 2007 - Present
EMD Pharmaceuticals January 2006 - March 2007
Inspire Pharmaceuticals March 2001 - September 2005
Magellan Laboratories 1993 - 2001
Magellan Labs/Cardinal Health 1993 - 2001
Skills
GMP, GCP, QA, QC, GMP, Pharmaceutical Industry, Quality Assurance, CAPA, FDA, Clinical Trials, Quality Auditing, 21 CFR Part 11, Clinical Research, GCP, Sop, Regulatory Affairs, Clinical Development, SOP, CRO, Validation
Education
Appalachian State University
Salix Pharmaceuticals April 2007 - Present
EMD Pharmaceuticals January 2006 - March 2007
Inspire Pharmaceuticals March 2001 - September 2005
Magellan Laboratories 1993 - 2001
Magellan Labs/Cardinal Health 1993 - 2001
Skills
GMP, GCP, QA, QC, GMP, Pharmaceutical Industry, Quality Assurance, CAPA, FDA, Clinical Trials, Quality Auditing, 21 CFR Part 11, Clinical Research, GCP, Sop, Regulatory Affairs, Clinical Development, SOP, CRO, Validation
Education
Appalachian State University
Philip Breitfeld's EMD Pharmaceuticals Experience August 2005 - March 2007
Job VP, Global Head, Therapeutic Centers of Excellence at Quintiles
Industry Pharmaceuticals
Experience
Quintiles April 2014 - Present
Quintiles April 2014 - Present
Quintiles October 2011 - April 2014
EMD Serono March 2009 - October 2011
EMD Serono, Inc March 2009 - October 2011
BioCryst Pharmaceuticals 2007 - 2009
EMD Pharmaceuticals August 2005 - March 2007
Skills
Clinical Development, Drug Development, Pharmaceutical Industry, Clinical Trials, Oncology, Biotechnology, CTMS, GCP, Medicine, Biopharmaceuticals, Infectious Diseases, Therapeutic Areas, CRO, Genomics, Lifesciences, Biomarkers, Immunology, IND, Clinical Research, Life Sciences
Education
University of Rochester School of Medicine and Dentistry 1975 — 1979
MD, Medicine
Princeton University 1971 — 1975
A.B., Chemistry
Quintiles April 2014 - Present
Quintiles April 2014 - Present
Quintiles October 2011 - April 2014
EMD Serono March 2009 - October 2011
EMD Serono, Inc March 2009 - October 2011
BioCryst Pharmaceuticals 2007 - 2009
EMD Pharmaceuticals August 2005 - March 2007
Skills
Clinical Development, Drug Development, Pharmaceutical Industry, Clinical Trials, Oncology, Biotechnology, CTMS, GCP, Medicine, Biopharmaceuticals, Infectious Diseases, Therapeutic Areas, CRO, Genomics, Lifesciences, Biomarkers, Immunology, IND, Clinical Research, Life Sciences
Education
University of Rochester School of Medicine and Dentistry 1975 — 1979
MD, Medicine
Princeton University 1971 — 1975
A.B., Chemistry
Caitlin Conklin's EMD Pharmaceuticals Experience January 2007 - June 2007
Job Process Engineer at Motiva Enterprises LLC
Industry Oil & Energy
Experience
Motiva Enterprises LLC September 2014 - Present
Motiva Enterprises LLC September 2012 - September 2014
Motiva Enterprises LLC July 2009 - September 2012
Motiva Enterprises LLC July 2008 - July 2009
EMD Pharmaceuticals January 2007 - June 2007
EMD Lexigen Research Center January 2006 - June 2006
Skills
Process Simulation, Chemical Engineering, Process Engineering, Engineering, Project Engineering, Root Cause Analysis, Energy, Refinery, Lean Manufacturing, Refining, Manufacturing
Education
Tulane University - A.B. Freeman School of Business 2011 — 2014
Master of Business Administration (MBA), Energy Specialization
Northeastern University 2003 — 2008
BS, Chemical Engineering
Motiva Enterprises LLC September 2014 - Present
Motiva Enterprises LLC September 2012 - September 2014
Motiva Enterprises LLC July 2009 - September 2012
Motiva Enterprises LLC July 2008 - July 2009
EMD Pharmaceuticals January 2007 - June 2007
EMD Lexigen Research Center January 2006 - June 2006
Skills
Process Simulation, Chemical Engineering, Process Engineering, Engineering, Project Engineering, Root Cause Analysis, Energy, Refinery, Lean Manufacturing, Refining, Manufacturing
Education
Tulane University - A.B. Freeman School of Business 2011 — 2014
Master of Business Administration (MBA), Energy Specialization
Northeastern University 2003 — 2008
BS, Chemical Engineering
Jon Stonehouse's EMD Pharmaceuticals Experience 2000 - 2002
Job CEO at BioCryst Pharmaceuticals
Industry Biotechnology
Experience
BioCryst Pharmaceuticals 2007 - Present
Merck KGaA 2002 - 2006
EMD Pharmaceuticals 2000 - 2002
AstraZeneca 1998 - 1999
Astra Merck 1992 - 1997
Merck 1987 - 1992
Education
University of Minnesota-Twin Cities
.Bachelor of Science, Microbiology
BioCryst Pharmaceuticals 2007 - Present
Merck KGaA 2002 - 2006
EMD Pharmaceuticals 2000 - 2002
AstraZeneca 1998 - 1999
Astra Merck 1992 - 1997
Merck 1987 - 1992
Education
University of Minnesota-Twin Cities
.Bachelor of Science, Microbiology
Gilda Thomas's EMD Pharmaceuticals Experience 2001 - 2007
Job SVP & General Counsel at Pozen Inc.
Industry Pharmaceuticals
Experience
Pozen Inc. January 2007 - Present
EMD Pharmaceuticals 2001 - 2007
GlaxoWellcome 1995 - 2000
Burroughs Wellcome 1986 - 1995
Skills
Mergers, Intellectual Property, Pharmaceutical Industry, Due Diligence, Contract Negotiation, Litigation, Biotechnology, Commercial Litigation, Technology Transfer, Regulatory Affairs, Patents
Education
Harvard 1979 — 1982
J.D., Law
Wellesley College 1972 — 1976
B.A., History
Pozen Inc. January 2007 - Present
EMD Pharmaceuticals 2001 - 2007
GlaxoWellcome 1995 - 2000
Burroughs Wellcome 1986 - 1995
Skills
Mergers, Intellectual Property, Pharmaceutical Industry, Due Diligence, Contract Negotiation, Litigation, Biotechnology, Commercial Litigation, Technology Transfer, Regulatory Affairs, Patents
Education
Harvard 1979 — 1982
J.D., Law
Wellesley College 1972 — 1976
B.A., History
Eric Tomhave's EMD Pharmaceuticals Experience February 2006 - July 2007
Job Global Project Manager at ReSearch Pharmaceutical Services
Industry Pharmaceuticals
Experience
ReSearch Pharmaceutical Services January 2010 - Present
Premier Research Group September 2007 - October 2009
EMD Pharmaceuticals February 2006 - July 2007
EMD pharmaceuticals/ Merck KGaA 2005 - 2007
Parkwood Volunteer Fire Department 1996 - 2006
PAREXEL 1998 - 2005
Duke University Medical Center 1989 - 1998
Scripps Clinic and Research Foundation 1985 - 1989
Skills
Clinical Trials, Oncology, Clinical Research, CRO, Clinical Development, CTMS, EDC, Protocol, Pharmaceutical Industry, GCP, Sop, Regulatory Affairs
Education
San Diego State University-California State University 1978 — 1986
Bachelor of Science (BS), Biology/molecular
ReSearch Pharmaceutical Services January 2010 - Present
Premier Research Group September 2007 - October 2009
EMD Pharmaceuticals February 2006 - July 2007
EMD pharmaceuticals/ Merck KGaA 2005 - 2007
Parkwood Volunteer Fire Department 1996 - 2006
PAREXEL 1998 - 2005
Duke University Medical Center 1989 - 1998
Scripps Clinic and Research Foundation 1985 - 1989
Skills
Clinical Trials, Oncology, Clinical Research, CRO, Clinical Development, CTMS, EDC, Protocol, Pharmaceutical Industry, GCP, Sop, Regulatory Affairs
Education
San Diego State University-California State University 1978 — 1986
Bachelor of Science (BS), Biology/molecular
Bob Stoner's EMD Pharmaceuticals Experience 2000 - 2007
Job Vice President Human Resources at BioCryst Pharmaceuticals
Industry Biotechnology
Experience
BioCryst Pharmaceuticals January 2008 - Present
EMD Pharmceuticals (Subsidiary of Merck KGaA) 2000 - 2007
EMD Pharmaceuticals 2000 - 2007
AstraZeneca 1995 - 2000
Bell & Howell 1990 - 1995
Skills
Biotechnology, Pharmaceutical Industry, Strategic Planning, Clinical Research, Employee Relations, Talent Management, Strategy, Deferred Compensation, Leadership, Cross-functional Team..., Performance Management, Executive Coaching, Mergers & Acquisitions, Human Resources, Process Improvement, Workforce Planning, Leadership Development, Succession Planning, Lifesciences, Organizational Design, Start-ups, Onboarding, Employee Engagement, Organizational..., HR Transformation, Organizational..., Personnel Management
Education
Southern Illinois University, Carbondale 1972 — 1977
Bachelor of Science (BS), Business Administration and Management, General
BioCryst Pharmaceuticals January 2008 - Present
EMD Pharmceuticals (Subsidiary of Merck KGaA) 2000 - 2007
EMD Pharmaceuticals 2000 - 2007
AstraZeneca 1995 - 2000
Bell & Howell 1990 - 1995
Skills
Biotechnology, Pharmaceutical Industry, Strategic Planning, Clinical Research, Employee Relations, Talent Management, Strategy, Deferred Compensation, Leadership, Cross-functional Team..., Performance Management, Executive Coaching, Mergers & Acquisitions, Human Resources, Process Improvement, Workforce Planning, Leadership Development, Succession Planning, Lifesciences, Organizational Design, Start-ups, Onboarding, Employee Engagement, Organizational..., HR Transformation, Organizational..., Personnel Management
Education
Southern Illinois University, Carbondale 1972 — 1977
Bachelor of Science (BS), Business Administration and Management, General
Walter Tatarowicz's EMD Pharmaceuticals Experience 2002 - 2004
Job Medical Science Liaison at BTG
Industry Pharmaceuticals
Experience
BTG July 2014 - Present
Pinnacle Biologics, Inc. April 2013 - June 2014
Affymax March 2012 - March 2013
ViroPharma Incorporated August 2005 - November 2011
EMD Pharmaceuticals 2002 - 2004
Skills
Medical Affairs, Clinical Development, Biotechnology, Clinical Trials, Oncology, Infectious Diseases, FDA, Medical Education, Regulatory Affairs, Pharmaceutical Industry, Nephrology, Clinical Research, End Stage Renal Disease, Medical Writing
Education
Loyola University of Chicago 1987 — 1992
Doctor of Philosophy (Ph.D.), Microbiology/Immunology
Loyola University of Chicago 1975 — 1979
B.S., Biology, General
BTG July 2014 - Present
Pinnacle Biologics, Inc. April 2013 - June 2014
Affymax March 2012 - March 2013
ViroPharma Incorporated August 2005 - November 2011
EMD Pharmaceuticals 2002 - 2004
Skills
Medical Affairs, Clinical Development, Biotechnology, Clinical Trials, Oncology, Infectious Diseases, FDA, Medical Education, Regulatory Affairs, Pharmaceutical Industry, Nephrology, Clinical Research, End Stage Renal Disease, Medical Writing
Education
Loyola University of Chicago 1987 — 1992
Doctor of Philosophy (Ph.D.), Microbiology/Immunology
Loyola University of Chicago 1975 — 1979
B.S., Biology, General
Margaret (Xiaoguang) Liu's EMD Pharmaceuticals Experience 2005 - 2006
Job Assistant Professor
Industry Biotechnology
Experience
Universoty of Alabama January 2012 - Present
Life Technologies Inc July 2007 - July 2011
Lonza June 2006 - July 2007
EMD Pharmaceuticals 2005 - 2006
The Ohio State University 2001 - 2005
The Ohio State University 2001 - 2005
Skills
Protein Chemistry, Cell Culture, Biopharmaceuticals, HPLC, Proteomics, Biofuels, Mammalian Cell Culture, Cell, Biotechnology, Fermentation, Protein Purification, Research, Purification
Education
The Ohio State University 2001 — 2005
Tianjin University
Universoty of Alabama January 2012 - Present
Life Technologies Inc July 2007 - July 2011
Lonza June 2006 - July 2007
EMD Pharmaceuticals 2005 - 2006
The Ohio State University 2001 - 2005
The Ohio State University 2001 - 2005
Skills
Protein Chemistry, Cell Culture, Biopharmaceuticals, HPLC, Proteomics, Biofuels, Mammalian Cell Culture, Cell, Biotechnology, Fermentation, Protein Purification, Research, Purification
Education
The Ohio State University 2001 — 2005
Tianjin University
Betty Rowbotham's EMD Pharmaceuticals Experience February 2001 - March 2002
Job Director, Clinical Innovation
Industry Pharmaceuticals
Experience
Novartis November 2009 - Present
US Oncology March 2006 - May 2009
ECR Associates March 2002 - March 2006
EMD Pharmaceuticals February 2001 - March 2002
GlaxoSmithKline March 1983 - January 2001
GlaxoWellcome 1995 - 2001
Burroughs Wellcome 1981 - 1995
Skills
Oncology, Cross-functional Team..., Clinical Research, Product Development, CRM, Healthcare, Marketing, Pharmaceutical Industry, Managed Care, Neurology
Education
Saint Joseph's College
BS
Vassar School of Nursing
RN, nursing
Novartis November 2009 - Present
US Oncology March 2006 - May 2009
ECR Associates March 2002 - March 2006
EMD Pharmaceuticals February 2001 - March 2002
GlaxoSmithKline March 1983 - January 2001
GlaxoWellcome 1995 - 2001
Burroughs Wellcome 1981 - 1995
Skills
Oncology, Cross-functional Team..., Clinical Research, Product Development, CRM, Healthcare, Marketing, Pharmaceutical Industry, Managed Care, Neurology
Education
Saint Joseph's College
BS
Vassar School of Nursing
RN, nursing
Christopher Shanne's EMD Pharmaceuticals Experience March 2005 - September 2006
Job Sr. Consultant at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL December 2013 - Present
Chimerix, Inc. December 2010 - November 2013
Valeant Pharmaceuticals August 2010 - December 2010
Biogen Idec October 2008 - April 2010
Biogen Idec September 2006 - October 2008
EMD Pharmaceuticals March 2005 - September 2006
PPD April 2004 - March 2005
PPD August 2002 - April 2004
PPD September 2001 - August 2002
PPD February 2000 - September 2001
Skills
CMC, eCTD, Regulatory Submissions, Clinical Development, Regulatory Affairs, Pharmaceutical Industry, Infectious Diseases, FDA, IND, Clinical Trials, Drug Development, Biotechnology, Clinical Research, CRO, Pharmacovigilance, Sop, CTMS, GCP, Biopharmaceuticals, Regulations, Medical Writing, 21 CFR Part 11, NDA, GLP, Therapeutic Areas, Vaccines, Oncology, GMP, Regulatory Requirements, Protocol, Technology Transfer, Validation, ICH-GCP, CAPA, EDC, Biologics
Education
State University of New York College at Fredonia 1994 — 1996
BA, Literature, Philosophy
PAREXEL December 2013 - Present
Chimerix, Inc. December 2010 - November 2013
Valeant Pharmaceuticals August 2010 - December 2010
Biogen Idec October 2008 - April 2010
Biogen Idec September 2006 - October 2008
EMD Pharmaceuticals March 2005 - September 2006
PPD April 2004 - March 2005
PPD August 2002 - April 2004
PPD September 2001 - August 2002
PPD February 2000 - September 2001
Skills
CMC, eCTD, Regulatory Submissions, Clinical Development, Regulatory Affairs, Pharmaceutical Industry, Infectious Diseases, FDA, IND, Clinical Trials, Drug Development, Biotechnology, Clinical Research, CRO, Pharmacovigilance, Sop, CTMS, GCP, Biopharmaceuticals, Regulations, Medical Writing, 21 CFR Part 11, NDA, GLP, Therapeutic Areas, Vaccines, Oncology, GMP, Regulatory Requirements, Protocol, Technology Transfer, Validation, ICH-GCP, CAPA, EDC, Biologics
Education
State University of New York College at Fredonia 1994 — 1996
BA, Literature, Philosophy
Daniel (DJ) Harkins's EMD Pharmaceuticals Experience December 2004 - August 2006
Job Downstream Supervisor at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec November 2014 - Present
Biogen Idec April 2012 - November 2014
Biogen Idec September 2011 - April 2012
Biogen Idec October 2010 - April 2012
Biogen Idec August 2010 - April 2012
Biogen Idec March 2008 - October 2010
Biogen Idec January 2007 - March 2008
EMD Pharmaceuticals Inc December 2004 - September 2006
EMD Pharmaceuticals December 2004 - August 2006
Skills
Biotechnology, Cell Culture, Validation, cGMP, GMP, Protein Purification, Problem Solving, Process Validation, Sop, Cell, Filtration, Purification, V&V, Biopharmaceuticals, Aseptic Technique, Protein Chemistry, Quality Assurance, FDA, Technology Transfer, SOP
Education
Boston University 2008 — 2014
BS; Certification, Biomedical Laboratories and Clinical Sciences; Management, Cum Laude
Middlesex Community College 2004 — 2008
Associates, Biotechnology
Middlesex Community College 2004 — 2006
Certificate and Associates, Biotechnology
Minuteman Tech 1998 — 2000
High School Diploma; H. S, High School/Secondary Diplomas and Certificates
Biogen Idec November 2014 - Present
Biogen Idec April 2012 - November 2014
Biogen Idec September 2011 - April 2012
Biogen Idec October 2010 - April 2012
Biogen Idec August 2010 - April 2012
Biogen Idec March 2008 - October 2010
Biogen Idec January 2007 - March 2008
EMD Pharmaceuticals Inc December 2004 - September 2006
EMD Pharmaceuticals December 2004 - August 2006
Skills
Biotechnology, Cell Culture, Validation, cGMP, GMP, Protein Purification, Problem Solving, Process Validation, Sop, Cell, Filtration, Purification, V&V, Biopharmaceuticals, Aseptic Technique, Protein Chemistry, Quality Assurance, FDA, Technology Transfer, SOP
Education
Boston University 2008 — 2014
BS; Certification, Biomedical Laboratories and Clinical Sciences; Management, Cum Laude
Middlesex Community College 2004 — 2008
Associates, Biotechnology
Middlesex Community College 2004 — 2006
Certificate and Associates, Biotechnology
Minuteman Tech 1998 — 2000
High School Diploma; H. S, High School/Secondary Diplomas and Certificates
Drusilla Scott's EMD Pharmaceuticals Experience 2005 - 2007
Job VP, Regulatory Affairs at Cempra Pharmaceuticals
Industry Pharmaceuticals
Experience
Cempra Pharmaceuticals November 2007 - Present
EMD Pharmaceuticals 2005 - 2007
Isis Pharmaceuticals 2003 - 2005
Parke-Davis 1989 - 2002
Skills
Regulatory Affairs, IND, Pharmaceuticals, Policy
Education
University of North Carolina at Chapel Hill
PhD, Pharmacology
Western Carolina University
BS, Chemistry
Cempra Pharmaceuticals November 2007 - Present
EMD Pharmaceuticals 2005 - 2007
Isis Pharmaceuticals 2003 - 2005
Parke-Davis 1989 - 2002
Skills
Regulatory Affairs, IND, Pharmaceuticals, Policy
Education
University of North Carolina at Chapel Hill
PhD, Pharmacology
Western Carolina University
BS, Chemistry
Nikki (Wooten-Purnell) Purnell's EMD Pharmaceuticals Experience April 2003 - April 2004
Job Business Information Associate at inVentiv Health
Industry Pharmaceuticals
Experience
inVentiv Health Clinical January 2015 - Present
inVentiv Health Clinical March 2012 - January 2015
inVentiv Health Clinical July 2007 - March 2012
PPD July 2004 - July 2007
EMD Pharmaceuticals April 2003 - April 2004
Federal Signal Corporation December 1998 - October 2002
LibertyHealth Jersey City Medical Center 1995 - 1997
Skills
Salesforce.com, Research, Data Analysis, Interpersonal..., SharePoint, Pharmaceutical Industry, Budgets, Clinical Development, Business Development, Organizational Skills, Social Media, Social Media Marketing, Process Improvement, Microsoft Office, Time Management, Project Management, Program Management, Event Planning, Microsoft Word, PowerPoint, Microsoft Excel, Heavy Calendaring, Executive Level..., Virtual Administrative..., High Level Of..., Clinical Research, Data Integrity, Ad Hoc Reporting, SFDC, Meeting Planning, WebEx, Web Conferences, Sales, Advanced Internet &..., Problem Solving Skills, Interpersonal..., Researching Skills, Sales Reporting Skills, Meeting Organization..., Teleconference..., Telecommuting, Training, CRO, Onboarding, CRM, Healthcare, Office Administration, Travel Arrangements, Reporting & Analysis, Financial Reporting
Education
University of North Carolina at Chapel Hill 2005 — 2007
Central Texas College
inVentiv Health Clinical January 2015 - Present
inVentiv Health Clinical March 2012 - January 2015
inVentiv Health Clinical July 2007 - March 2012
PPD July 2004 - July 2007
EMD Pharmaceuticals April 2003 - April 2004
Federal Signal Corporation December 1998 - October 2002
LibertyHealth Jersey City Medical Center 1995 - 1997
Skills
Salesforce.com, Research, Data Analysis, Interpersonal..., SharePoint, Pharmaceutical Industry, Budgets, Clinical Development, Business Development, Organizational Skills, Social Media, Social Media Marketing, Process Improvement, Microsoft Office, Time Management, Project Management, Program Management, Event Planning, Microsoft Word, PowerPoint, Microsoft Excel, Heavy Calendaring, Executive Level..., Virtual Administrative..., High Level Of..., Clinical Research, Data Integrity, Ad Hoc Reporting, SFDC, Meeting Planning, WebEx, Web Conferences, Sales, Advanced Internet &..., Problem Solving Skills, Interpersonal..., Researching Skills, Sales Reporting Skills, Meeting Organization..., Teleconference..., Telecommuting, Training, CRO, Onboarding, CRM, Healthcare, Office Administration, Travel Arrangements, Reporting & Analysis, Financial Reporting
Education
University of North Carolina at Chapel Hill 2005 — 2007
Central Texas College
Judy Bryson's EMD Pharmaceuticals Experience 2001 - 2006
Job Pharmaceutical Clinical Development, Retired
Industry Pharmaceuticals
Experience
UCB Biosciences, INC August 2013 - Present
UCB Biosciences, Inc. May 2011 - Present
ICON Clinical Research January 2010 - May 2011
Bryson Drug Development 2008 - January 2010
Serenex 2007 - 2008
Pozen 2006 - 2007
EMD Pharmaceuticals 2001 - 2006
EMD Merck KGaA Pharmaceuticals 2001 - 2006
GlaxoWellcome 1996 - 2001
GlaxoSmithKline 1986 - 2001
Skills
Oncology, Immunology, Clinical Research, Clinical Development, Pharmaceutical Industry, Drug Development, Medical Affairs, Clinical Operations, Clinical Trials, GCP, Infectious Diseases, Biotechnology, Lifesciences, Managed Care, CTMS
Education
University of North Carolina at Chapel Hill 1982 — 1986
PharmD, Clinical Pharmacy
Sewanee-The University of the South 1973 — 1976
BA, Biology
UCB Biosciences, INC August 2013 - Present
UCB Biosciences, Inc. May 2011 - Present
ICON Clinical Research January 2010 - May 2011
Bryson Drug Development 2008 - January 2010
Serenex 2007 - 2008
Pozen 2006 - 2007
EMD Pharmaceuticals 2001 - 2006
EMD Merck KGaA Pharmaceuticals 2001 - 2006
GlaxoWellcome 1996 - 2001
GlaxoSmithKline 1986 - 2001
Skills
Oncology, Immunology, Clinical Research, Clinical Development, Pharmaceutical Industry, Drug Development, Medical Affairs, Clinical Operations, Clinical Trials, GCP, Infectious Diseases, Biotechnology, Lifesciences, Managed Care, CTMS
Education
University of North Carolina at Chapel Hill 1982 — 1986
PharmD, Clinical Pharmacy
Sewanee-The University of the South 1973 — 1976
BA, Biology
Izzy Pike's EMD Pharmaceuticals Experience 2001 - 2001
Job President at Izzy Pike, MD, Consulting, LLC
Industry Pharmaceuticals
Experience
Izzy Pike, MD, Consulting, LLC August 2003 - Present
Merix Bioscience, Inc. September 2001 - August 2003
EMD Pharmaceuticals 2001 - 2001
Bristol-Myers Squibb July 1988 - March 1998
WNC Hematology Oncology, PA 1975 - 1988
Skills
Oncology, Clinical Development, Drug Development, Immunology, Clinical Research, Pharmaceutical Industry, Vaccines, FDA, Regulatory Submissions, Lifesciences, Cancer, Medicine, Cell, Infectious Diseases, Hematology, Clinical Trials, GCP, Biotechnology, CTMS, Biopharmaceuticals, Drug Discovery, Medical Writing, Regulatory Affairs, Sop, CRO, Technology Transfer, Commercialization, Pharmacology, GLP, IND, Validation, 21 CFR Part 11, GMP, SOP, Life Sciences
Education
Emory University School of Medicine 1963 — 1967
MD
Izzy Pike, MD, Consulting, LLC August 2003 - Present
Merix Bioscience, Inc. September 2001 - August 2003
EMD Pharmaceuticals 2001 - 2001
Bristol-Myers Squibb July 1988 - March 1998
WNC Hematology Oncology, PA 1975 - 1988
Skills
Oncology, Clinical Development, Drug Development, Immunology, Clinical Research, Pharmaceutical Industry, Vaccines, FDA, Regulatory Submissions, Lifesciences, Cancer, Medicine, Cell, Infectious Diseases, Hematology, Clinical Trials, GCP, Biotechnology, CTMS, Biopharmaceuticals, Drug Discovery, Medical Writing, Regulatory Affairs, Sop, CRO, Technology Transfer, Commercialization, Pharmacology, GLP, IND, Validation, 21 CFR Part 11, GMP, SOP, Life Sciences
Education
Emory University School of Medicine 1963 — 1967
MD
Mary Ann Watson's EMD Pharmaceuticals Experience May 2002 - May 2004
Job Director, Global Scientific Communications and Training at Onyx Pharmaceuticals
Industry Pharmaceuticals
Experience
Onyx Pharmaceuticals October 2014 - Present
Onyx Pharmaceuticals October 2010 - October 2014
Onyx Pharmaceuticals August 2004 - October 2010
EMD Pharmaceuticals May 2002 - May 2004
Genentech July 2000 - May 2002
The Regence Group February 1999 - July 2000
SmithKline Beecham May 1996 - January 1999
Legacy Health September 1991 - May 1996
Skills
Clinical Development, Hematology, Medical Affairs, Infectious Diseases, Oncology, Medical Communications, Medicine, Clinical Trials, Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Clinical Research, Lifesciences, Immunology, Therapeutic Areas, Drug Development, Medical Writing, Pharmaceutical Sales, IND, Urology, Pharmacology, Pharmacovigilance, Neurology, Diabetes, Regulatory Submissions, GCP, Vaccines, Gastroenterology, Neuroscience, CRO, Dermatology, Endocrinology, Rheumatology, Regulatory Affairs, Cardiology, CTMS, Cancer
Education
The University of Texas Health Science Center at San Antonio 1990 — 1991
Heme/Onc Residency
The University of Texas Health Science Center at San Antonio 1988 — 1990
PharmD
Oregon State University 1981 — 1986
BS, Pharmacy
Onyx Pharmaceuticals October 2014 - Present
Onyx Pharmaceuticals October 2010 - October 2014
Onyx Pharmaceuticals August 2004 - October 2010
EMD Pharmaceuticals May 2002 - May 2004
Genentech July 2000 - May 2002
The Regence Group February 1999 - July 2000
SmithKline Beecham May 1996 - January 1999
Legacy Health September 1991 - May 1996
Skills
Clinical Development, Hematology, Medical Affairs, Infectious Diseases, Oncology, Medical Communications, Medicine, Clinical Trials, Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Clinical Research, Lifesciences, Immunology, Therapeutic Areas, Drug Development, Medical Writing, Pharmaceutical Sales, IND, Urology, Pharmacology, Pharmacovigilance, Neurology, Diabetes, Regulatory Submissions, GCP, Vaccines, Gastroenterology, Neuroscience, CRO, Dermatology, Endocrinology, Rheumatology, Regulatory Affairs, Cardiology, CTMS, Cancer
Education
The University of Texas Health Science Center at San Antonio 1990 — 1991
Heme/Onc Residency
The University of Texas Health Science Center at San Antonio 1988 — 1990
PharmD
Oregon State University 1981 — 1986
BS, Pharmacy
Rhonda Sessoms's EMD Pharmaceuticals Experience 2001 - 2007
Job Human Resources at Wood Real Estate Investors, LLC
Industry Construction
Experience
Wood Real Estate Investors, LLC May 2008 - Present
Talecris Biotherapeutics 2007 - 2008
EMD Pharmaceuticals 2001 - 2007
Skills
HRIS, Employee Relations, Onboarding, Human Resources, Deferred Compensation, Recruiting, ADP Payroll, Pharmaceutical Industry, Employee Benefits, Workforce Planning, Performance Management, Succession Planning, HR Policies, Personnel Management, Talent Management, Applicant Tracking..., College Recruiting, Employee Engagement
Education
University of North Carolina at Greensboro 1977 — 1981
BS, Business Administration: Personnel
Wood Real Estate Investors, LLC May 2008 - Present
Talecris Biotherapeutics 2007 - 2008
EMD Pharmaceuticals 2001 - 2007
Skills
HRIS, Employee Relations, Onboarding, Human Resources, Deferred Compensation, Recruiting, ADP Payroll, Pharmaceutical Industry, Employee Benefits, Workforce Planning, Performance Management, Succession Planning, HR Policies, Personnel Management, Talent Management, Applicant Tracking..., College Recruiting, Employee Engagement
Education
University of North Carolina at Greensboro 1977 — 1981
BS, Business Administration: Personnel
Cassandra Mitchell's EMD Pharmaceuticals Experience September 2002 - July 2006
Job Executive Assistant, President North America Operations at Patheon Pharmaceuticals
Industry Pharmaceuticals
Experience
Patheon Pharmaceuticals March 2010 - Present
Sony Ericsson January 2007 - June 2010
EMD Pharmaceuticals September 2002 - July 2006
Parata Systems 2006 - 2006
Skills
Forecasting, Marketing, Team Leadership, Sales, Process Improvement, Leadership, Training, Management, Sales Operations, Cross-functional Team..., Customer Service, Microsoft Office, Team Building, Strategic Planning, Program Management
Education
University of North Carolina at Chapel Hill
BA, Communications
Patheon Pharmaceuticals March 2010 - Present
Sony Ericsson January 2007 - June 2010
EMD Pharmaceuticals September 2002 - July 2006
Parata Systems 2006 - 2006
Skills
Forecasting, Marketing, Team Leadership, Sales, Process Improvement, Leadership, Training, Management, Sales Operations, Cross-functional Team..., Customer Service, Microsoft Office, Team Building, Strategic Planning, Program Management
Education
University of North Carolina at Chapel Hill
BA, Communications
Jackie Imm's EMD Pharmaceuticals Experience September 2001 - June 2004
Job Associate Director, Clinical Trial Services at United Therapeutics
Industry Pharmaceuticals
Experience
United Therapeutics Corporation November 2013 - Present
United Therapeutics Corporation June 2010 - November 2013
Array BioPharma September 2008 - May 2010
INC Research September 2007 - August 2008
SCHWARZ BIOSCIENCES, Inc August 2006 - September 2007
SCHWARZ BIOSCIENCES, Inc June 2004 - August 2006
EMD Pharmaceuticals September 2001 - June 2004
Resource Solutions November 2000 - September 2001
JoAnn Stores, Inc March 1999 - November 2000
Barnes and Noble March 1997 - March 1999
Skills
Training, ICH-GCP, CTMS, CRO, Pharmaceutical Industry, Clinical Trials, Protocol, Sop, Clinical Research, Clinical Monitoring, Clinical Development, Data Management, EDC, GCP, Drug Development, SOP, Biotechnology
Education
University of Iowa 1985 — 1989
BA, Communication Studies
United Therapeutics Corporation November 2013 - Present
United Therapeutics Corporation June 2010 - November 2013
Array BioPharma September 2008 - May 2010
INC Research September 2007 - August 2008
SCHWARZ BIOSCIENCES, Inc August 2006 - September 2007
SCHWARZ BIOSCIENCES, Inc June 2004 - August 2006
EMD Pharmaceuticals September 2001 - June 2004
Resource Solutions November 2000 - September 2001
JoAnn Stores, Inc March 1999 - November 2000
Barnes and Noble March 1997 - March 1999
Skills
Training, ICH-GCP, CTMS, CRO, Pharmaceutical Industry, Clinical Trials, Protocol, Sop, Clinical Research, Clinical Monitoring, Clinical Development, Data Management, EDC, GCP, Drug Development, SOP, Biotechnology
Education
University of Iowa 1985 — 1989
BA, Communication Studies
Timothy Kellogg's EMD Pharmaceuticals Experience 2002 - 2004
Job Senior Scientist at Amgen Woburn
Industry Biotechnology
Experience
Amgen October 2010 - Present
BioVex October 2010 - March 2011
Millennium Pharmaceuticals January 2008 - October 2010
Tanox, Inc. June 2004 - December 2007
EMD Pharmaceuticals 2002 - 2004
Skills
Chromatography, Biotechnology, Biopharmaceuticals, GMP, Purification, Technology Transfer
Education
University of Massachusetts Lowell 2000 — 2004
MS, Biology
University of Rochester 1989 — 1994
BA, Chemistry
Amgen October 2010 - Present
BioVex October 2010 - March 2011
Millennium Pharmaceuticals January 2008 - October 2010
Tanox, Inc. June 2004 - December 2007
EMD Pharmaceuticals 2002 - 2004
Skills
Chromatography, Biotechnology, Biopharmaceuticals, GMP, Purification, Technology Transfer
Education
University of Massachusetts Lowell 2000 — 2004
MS, Biology
University of Rochester 1989 — 1994
BA, Chemistry
Michael Faletto's EMD Pharmaceuticals Experience 2000 - 2004
Job Executive Director, Regulatory Policy, Global Regulatory Affairs HematologyOncology
Industry Pharmaceuticals
Experience
Celgene January 2013 - Present
Celgene November 2011 - January 2013
Celgene May 2007 - November 2011
Roche Pharmaceuticals 2004 - 2007
EMD Pharmaceuticals 2000 - 2004
Pfizer 1999 - 2000
Skills
Regulatory Affairs, IND, Clinical Development, Regulatory Submissions, Oncology, Pharmaceutical Industry, Drug Development, eCTD, Clinical Trials, Biotechnology, FDA, GCP, Biopharmaceuticals, NDA, CRO, Regulatory Requirements, Pharmacovigilance, Lifesciences, Therapeutic Areas, Sop, Technology Transfer, Regulations, Vaccines, ICH-GCP, Life Sciences, SOP
Education
University at Buffalo 1980 — 1987
PhD, Pharmacology
University of Scranton 1976 — 1980
BS, Biochemistry
University of Scranton 1976 — 1980
BS, Biochemistry
Celgene January 2013 - Present
Celgene November 2011 - January 2013
Celgene May 2007 - November 2011
Roche Pharmaceuticals 2004 - 2007
EMD Pharmaceuticals 2000 - 2004
Pfizer 1999 - 2000
Skills
Regulatory Affairs, IND, Clinical Development, Regulatory Submissions, Oncology, Pharmaceutical Industry, Drug Development, eCTD, Clinical Trials, Biotechnology, FDA, GCP, Biopharmaceuticals, NDA, CRO, Regulatory Requirements, Pharmacovigilance, Lifesciences, Therapeutic Areas, Sop, Technology Transfer, Regulations, Vaccines, ICH-GCP, Life Sciences, SOP
Education
University at Buffalo 1980 — 1987
PhD, Pharmacology
University of Scranton 1976 — 1980
BS, Biochemistry
University of Scranton 1976 — 1980
BS, Biochemistry
Stephen DiBona's EMD Pharmaceuticals Experience May 2007 - May 2010
Job Quality Control at Genzyme
Industry Biotechnology
Experience
Genzyme May 2010 - Present
EMD Serono May 2007 - May 2010
EMD Pharmaceuticals May 2007 - May 2010
Johnson Matthey Pharma Services April 2004 - May 2007
Unilever May 2003 - March 2004
MedImmune May 2002 - August 2002
Skills
Quality Control, HPLC, Validation, GMP, FDA, Biotechnology, Technology Transfer
Education
Seton Hall University 1999 — 2003
BS, Chemistry
Genzyme May 2010 - Present
EMD Serono May 2007 - May 2010
EMD Pharmaceuticals May 2007 - May 2010
Johnson Matthey Pharma Services April 2004 - May 2007
Unilever May 2003 - March 2004
MedImmune May 2002 - August 2002
Skills
Quality Control, HPLC, Validation, GMP, FDA, Biotechnology, Technology Transfer
Education
Seton Hall University 1999 — 2003
BS, Chemistry
Mark Zemler's EMD Pharmaceuticals Experience March 2002 - May 2004
Job Associate Director Quality Control at Merck
Industry Pharmaceuticals
Experience
Merck January 2015 - Present
Fujifilm Diosynth Biotechnologies May 2008 - November 2014
Diosynth Biotechnology- a part of Schering Plough 2007 - 2008
Diosynth Biotechnology May 2004 - 2007
EMD Pharmaceuticals March 2002 - May 2004
Bayer January 2000 - March 2002
Bayer Animal Helath 1994 - 2000
Bayer 1979 - 1994
Skills
Clinical GMP, Environmental Monitoring, Quality Systems, Pharmaceutical..., Clean Room Management, Facility Validation, Method Development and..., Quality System, Quality Assurance, V&V, GMP, Microbiology, Aseptic Processing, Biotechnology, Quality Control, Aseptic Technique, Pharmaceutical Industry, BPF, Biopharmaceuticals, Technology Transfer, FDA, 21 CFR Part 11, SOP, Validation
Education
Friends University 1995 — 1996
MS, Total Quality Management
Washinton State University
Bachelor's Degree, Bacteriology and Public Health
Merck January 2015 - Present
Fujifilm Diosynth Biotechnologies May 2008 - November 2014
Diosynth Biotechnology- a part of Schering Plough 2007 - 2008
Diosynth Biotechnology May 2004 - 2007
EMD Pharmaceuticals March 2002 - May 2004
Bayer January 2000 - March 2002
Bayer Animal Helath 1994 - 2000
Bayer 1979 - 1994
Skills
Clinical GMP, Environmental Monitoring, Quality Systems, Pharmaceutical..., Clean Room Management, Facility Validation, Method Development and..., Quality System, Quality Assurance, V&V, GMP, Microbiology, Aseptic Processing, Biotechnology, Quality Control, Aseptic Technique, Pharmaceutical Industry, BPF, Biopharmaceuticals, Technology Transfer, FDA, 21 CFR Part 11, SOP, Validation
Education
Friends University 1995 — 1996
MS, Total Quality Management
Washinton State University
Bachelor's Degree, Bacteriology and Public Health
James Malavich's EMD Pharmaceuticals Experience January 2003 - April 2005
Job QC Microbiology Scientist
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb June 2011 - Present
Bristol-Myers Squibb June 2010 - June 2011
Bristol-Myers Squibb November 2007 - June 2010
Wyeth Biotech April 2005 - November 2007
EMD Pharmaceuticals January 2003 - April 2005
EMD Pharmaceuticals October 2001 - January 2003
Alkermes April 2001 - October 2001
Transkaryotic Therapies Inc. September 1999 - April 2001
Skills
GMP, Biotechnology, Pharmaceutical Industry, Quality Control, SOP, FDA, Validation, 21 CFR Part 11, CAPA, Change Control
Education
University of Massachusetts at Lowell 1999 — 2001
Graduate Certificate, Bioprocessing/Engineering
Salem State College 1995 — 1999
Bachelors, Biology
Bristol-Myers Squibb June 2011 - Present
Bristol-Myers Squibb June 2010 - June 2011
Bristol-Myers Squibb November 2007 - June 2010
Wyeth Biotech April 2005 - November 2007
EMD Pharmaceuticals January 2003 - April 2005
EMD Pharmaceuticals October 2001 - January 2003
Alkermes April 2001 - October 2001
Transkaryotic Therapies Inc. September 1999 - April 2001
Skills
GMP, Biotechnology, Pharmaceutical Industry, Quality Control, SOP, FDA, Validation, 21 CFR Part 11, CAPA, Change Control
Education
University of Massachusetts at Lowell 1999 — 2001
Graduate Certificate, Bioprocessing/Engineering
Salem State College 1995 — 1999
Bachelors, Biology
Jim Jin's EMD Pharmaceuticals Experience 2001 - 2005
Job Associate Director at Eisai Pharmaceuticals
Industry Pharmaceuticals
Experience
Eisai Pharmaceuticals July 2010 - Present
AAI Pharma 2008 - 2010
Amgen 2006 - 2008
EMD Pharmaceuticals 2001 - 2005
Education
Penn State University 1997 — 1999
MS, Statistics
Beijng University
BS, Genetics
Eisai Pharmaceuticals July 2010 - Present
AAI Pharma 2008 - 2010
Amgen 2006 - 2008
EMD Pharmaceuticals 2001 - 2005
Education
Penn State University 1997 — 1999
MS, Statistics
Beijng University
BS, Genetics
Raj Kishore's EMD Pharmaceuticals Experience September 2004 - August 2007
Job Senior Director, Global Regulatory Strategy at Quintiles
Industry Pharmaceuticals
Experience
Quintiles September 2007 - December 2011
EMD Pharmaceuticals September 2004 - August 2007
Shire Pharmaceuticals 2000 - 2004
OGD/CDER/FDA 1990 - 1996
OGD/CDER/FDA August 1986 - January 1990
BARC 1963 - 1966
BARC 1963 - 1966
BARC 1963 - 1966
BARC 1963 - 1966
Skills
Clinical Trials, Oncology, Clinical Development, CTMS, GCP, EDC, Pharmaceutical Sales, Therapeutic Areas, ICH-GCP, Biotechnology, Clinical Monitoring, Cardiology, Clinical Research, Diabetes, Clinical Data Management, Pharmacovigilance
Education
Clark University
Doctor of Philosophy (Ph.D.), Chemistry
Quintiles September 2007 - December 2011
EMD Pharmaceuticals September 2004 - August 2007
Shire Pharmaceuticals 2000 - 2004
OGD/CDER/FDA 1990 - 1996
OGD/CDER/FDA August 1986 - January 1990
BARC 1963 - 1966
BARC 1963 - 1966
BARC 1963 - 1966
BARC 1963 - 1966
Skills
Clinical Trials, Oncology, Clinical Development, CTMS, GCP, EDC, Pharmaceutical Sales, Therapeutic Areas, ICH-GCP, Biotechnology, Clinical Monitoring, Cardiology, Clinical Research, Diabetes, Clinical Data Management, Pharmacovigilance
Education
Clark University
Doctor of Philosophy (Ph.D.), Chemistry
Brett Mendenhall's EMD Pharmaceuticals Experience May 2003 - January 2007
Job Continuous Improvement Sr. Analyst at Genzyme
Industry Biotechnology
Experience
Genzyme April 2011 - Present
EMD Serono January 2007 - January 2011
EMD Pharmaceuticals May 2003 - January 2007
Genzyme April 2001 - May 2003
Genzyme October 1995 - April 2001
Education
University of Massachusetts Lowell
BS, Mechanical Engineering Technology
Genzyme April 2011 - Present
EMD Serono January 2007 - January 2011
EMD Pharmaceuticals May 2003 - January 2007
Genzyme April 2001 - May 2003
Genzyme October 1995 - April 2001
Education
University of Massachusetts Lowell
BS, Mechanical Engineering Technology