Elusys Therapeutics, Inc.
Industry: Company
DescriptionElusys Therapeutics is a biopharmaceutical company founded in Pine Brook, New Jersey in 1998. The company specializes in the development of antibodies for the treatment infectious diseases. Headquarters: New Jersey Founded: 1998 Key person: Elizabeth G. Posillico Type of business: Privately held company
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Elusys Therapeutics, Inc. Employees
Employee
Years
Job
Industry
Mary Lou Zett, MBA, PhD. Mary Lou Zett, MBA, PhD.'s Elusys Therapeutics, Inc. Experience May 2009 - November 2010
Job Realtor®, Information Specialist at Coldwell Banker Residential
Industry Real Estate
Experience
Coldwell Banker Residential April 2014 - Present
Regulatory Consultant to Merck/Schering-Plough Pharmaceuticals in Summit, NJ May 2011 - September 2013
Nanotherapeutics Inc June 2008 - May 2012
Elusys Therapeutics, Inc. May 2009 - November 2010
Nanotherapeutics 2008 - 2010
Progenics Pharmaceuticals June 2008 - May 2009
To The Point, LLC November 2007 - January 2009
Pfizer, Inc. May 2007 - May 2008
NovaDel Pharma Inc. January 2004 - April 2007
EXIMIAS Pharmaceutical Corporation 2003 - 2004
Skills
Clinical Trials, FDA, Biotechnology, Sop, Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, GLP, Validation, IND, GMP, Manufacturing, Drug Development, Quality System, Medical Devices, GCP, Technology Transfer, 21 CFR Part 11
Education
Fairleigh Dickinson University
MS
Fairleigh Dickinson University
MBA
Fielding Graduate University
PhD
Marywood University
BS
Rutgers, The State University of New Jersey-Newark
ABD
St Mary's High School
Coldwell Banker Residential April 2014 - Present
Regulatory Consultant to Merck/Schering-Plough Pharmaceuticals in Summit, NJ May 2011 - September 2013
Nanotherapeutics Inc June 2008 - May 2012
Elusys Therapeutics, Inc. May 2009 - November 2010
Nanotherapeutics 2008 - 2010
Progenics Pharmaceuticals June 2008 - May 2009
To The Point, LLC November 2007 - January 2009
Pfizer, Inc. May 2007 - May 2008
NovaDel Pharma Inc. January 2004 - April 2007
EXIMIAS Pharmaceutical Corporation 2003 - 2004
Skills
Clinical Trials, FDA, Biotechnology, Sop, Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, GLP, Validation, IND, GMP, Manufacturing, Drug Development, Quality System, Medical Devices, GCP, Technology Transfer, 21 CFR Part 11
Education
Fairleigh Dickinson University
MS
Fairleigh Dickinson University
MBA
Fielding Graduate University
PhD
Marywood University
BS
Rutgers, The State University of New Jersey-Newark
ABD
St Mary's High School
Erika Vaughn Erika Vaughn's Elusys Therapeutics, Inc. Experience June 2012 - September 2013
Job Vice President of Service atIota Xi Chapter of Phi Theta Kappa Honor Society
Industry Civic & Social Organization
Experience
Delicious Heights April 2015 - Present
Working Together - Navigating Past Bullying July 2013 - Present
Union County College History Club September 2013 - January 2014
Iota Xi Chapter of Phi Theta Kappa Honor Society September 2013 - January 2014
Elusys Therapeutics, Inc. June 2012 - September 2013
Summit Area YMCA September 2012 - May 2013
Berkeley Heights Playground Camp (Recreation Dept) June 2005 - August 2012
Skills
Microsoft Word, PowerPoint, Tutoring, Microsoft Excel, Time Management, Child Development, Microsoft Office, Leadership, Childcare, Drawing, Painting, Fitness, Teaching, Early Childhood..., Food, Technology, Nonprofits, Mathematics
Education
Fairleigh Dickinson University-College at Florham 2014 — 2017
Bachelor of Arts (B.A.) and Master in Education, Psychology, Education
Union County College 2012 — 2014
Associate of Arts (AA), Early Childhood Education and Teaching, 3.6 GPA
University of Delaware 2010 — 2011
Governor Livingston High School 2006 — 2010
3.38 GPA
Delicious Heights April 2015 - Present
Working Together - Navigating Past Bullying July 2013 - Present
Union County College History Club September 2013 - January 2014
Iota Xi Chapter of Phi Theta Kappa Honor Society September 2013 - January 2014
Elusys Therapeutics, Inc. June 2012 - September 2013
Summit Area YMCA September 2012 - May 2013
Berkeley Heights Playground Camp (Recreation Dept) June 2005 - August 2012
Skills
Microsoft Word, PowerPoint, Tutoring, Microsoft Excel, Time Management, Child Development, Microsoft Office, Leadership, Childcare, Drawing, Painting, Fitness, Teaching, Early Childhood..., Food, Technology, Nonprofits, Mathematics
Education
Fairleigh Dickinson University-College at Florham 2014 — 2017
Bachelor of Arts (B.A.) and Master in Education, Psychology, Education
Union County College 2012 — 2014
Associate of Arts (AA), Early Childhood Education and Teaching, 3.6 GPA
University of Delaware 2010 — 2011
Governor Livingston High School 2006 — 2010
3.38 GPA
George Spitalny, PhD George Spitalny, PhD's Elusys Therapeutics, Inc. Experience March 2001 - January 2005
Job Chief Scientific Officer at ERAD Therapeutics, Inc.
Industry Biotechnology
Experience
ERAD Therapeutics, Inc. December 2014 - Present
PARS Pharmaceutical Consulting April 2013 - 2014
G Spitalny Biopharma Consulting January 2012 - 2014
Kyowa Hakko Kirin Pharma, Inc. July 2010 - February 2012
Kyowa Kakko Kirin Pharma, Inc. January 2009 - July 2010
BioWa, Inc. (subsidiary of Kyowa Hakko) January 2005 - December 2008
Elusys Therapeutics, Inc. March 2001 - January 2005
Select Therapeutics, Inc. January 1997 - March 2001
Zotic Ltd. January 1995 - December 1997
TargeTech, Inc. January 1990 - December 1995
Skills
Biotechnology, Clinical Trials, Oncology, Clinical Development, Infectious Diseases, Immunology, Clinical Research, Strategic Planning, Drug Discovery, R&D, Cross-functional Team..., Business Strategy, IND, Parasitology, Malaria, Biodefense, Animal Models, Gene Therapy, Monoclonal Antibodies, Metabolic Diseases, Antibodies, Clinical Trial..., Protocol Development, Allergy, Medical Writing, Technical Presentations, Investor Presentations, Lifesciences, GLP, Regulatory Affairs, FDA, Technology Transfer, Drug Development, CTMS, Life Sciences, Metabolism, Protocol
Education
New York University School of Medicine
Ph.D., Parasitology/Immunology
The Pennsylvania State University
B.S., Biology
ERAD Therapeutics, Inc. December 2014 - Present
PARS Pharmaceutical Consulting April 2013 - 2014
G Spitalny Biopharma Consulting January 2012 - 2014
Kyowa Hakko Kirin Pharma, Inc. July 2010 - February 2012
Kyowa Kakko Kirin Pharma, Inc. January 2009 - July 2010
BioWa, Inc. (subsidiary of Kyowa Hakko) January 2005 - December 2008
Elusys Therapeutics, Inc. March 2001 - January 2005
Select Therapeutics, Inc. January 1997 - March 2001
Zotic Ltd. January 1995 - December 1997
TargeTech, Inc. January 1990 - December 1995
Skills
Biotechnology, Clinical Trials, Oncology, Clinical Development, Infectious Diseases, Immunology, Clinical Research, Strategic Planning, Drug Discovery, R&D, Cross-functional Team..., Business Strategy, IND, Parasitology, Malaria, Biodefense, Animal Models, Gene Therapy, Monoclonal Antibodies, Metabolic Diseases, Antibodies, Clinical Trial..., Protocol Development, Allergy, Medical Writing, Technical Presentations, Investor Presentations, Lifesciences, GLP, Regulatory Affairs, FDA, Technology Transfer, Drug Development, CTMS, Life Sciences, Metabolism, Protocol
Education
New York University School of Medicine
Ph.D., Parasitology/Immunology
The Pennsylvania State University
B.S., Biology
Lawrence Gyenes Lawrence Gyenes's Elusys Therapeutics, Inc. Experience October 2013 - Present
Job CFO at Elusys Therapeutics, Inc.
Industry Pharmaceuticals
Experience
Elusys Therapeutics, Inc. October 2013 - Present
Value Created & Realized LLC June 2013 - September 2013
Columbia Laboratories July 2009 - January 2013
Acusphere October 2007 - April 2009
Zila, Inc. March 2007 - July 2007
Savient Pharmaceuticals, Inc. August 2004 - October 2005
Reliant Pharmaceuticals, Inc. July 2001 - July 2004
DuPont Pharmaceuticals Company January 2001 - June 2001
Rand McNally & Co. February 1998 - September 2000
CompuServe Corporation April 1996 - January 1998
Skills
Investor Relations, Mergers, IPO, Joint Ventures, Fundraising, IT Management, Corporate Communications, Strategic Alliances, Management, Pharmaceutical Industry, Leadership, Mentoring, Mergers & Acquisitions, Strategy, Business Development, Due Diligence, Business Intelligence, Strategic Partnerships, Cross-functional Team..., Business Strategy, Marketing, Start-ups, Executive Management, Financial Modeling, Budgets, Strategic Planning, Financial Reporting, Managerial Finance, Sarbanes-Oxley Act, Accounting, Analysis, Forecasting, Business Planning, Auditing, Acquisition Integration, Competitive Analysis, Private Equity, Product Development, SEC filings, US GAAP, Internal Controls, Marketing Strategy, Sarbanes-Oxley, Valuation, Financial Analysis, Restructuring, Corporate Development
Education
The University of Chicago Booth School of Business 1981 — 1983
MBA, Executive Program
University of Illinois at Urbana-Champaign - College of Business 1968 — 1972
B.S., Accounting
Elusys Therapeutics, Inc. October 2013 - Present
Value Created & Realized LLC June 2013 - September 2013
Columbia Laboratories July 2009 - January 2013
Acusphere October 2007 - April 2009
Zila, Inc. March 2007 - July 2007
Savient Pharmaceuticals, Inc. August 2004 - October 2005
Reliant Pharmaceuticals, Inc. July 2001 - July 2004
DuPont Pharmaceuticals Company January 2001 - June 2001
Rand McNally & Co. February 1998 - September 2000
CompuServe Corporation April 1996 - January 1998
Skills
Investor Relations, Mergers, IPO, Joint Ventures, Fundraising, IT Management, Corporate Communications, Strategic Alliances, Management, Pharmaceutical Industry, Leadership, Mentoring, Mergers & Acquisitions, Strategy, Business Development, Due Diligence, Business Intelligence, Strategic Partnerships, Cross-functional Team..., Business Strategy, Marketing, Start-ups, Executive Management, Financial Modeling, Budgets, Strategic Planning, Financial Reporting, Managerial Finance, Sarbanes-Oxley Act, Accounting, Analysis, Forecasting, Business Planning, Auditing, Acquisition Integration, Competitive Analysis, Private Equity, Product Development, SEC filings, US GAAP, Internal Controls, Marketing Strategy, Sarbanes-Oxley, Valuation, Financial Analysis, Restructuring, Corporate Development
Education
The University of Chicago Booth School of Business 1981 — 1983
MBA, Executive Program
University of Illinois at Urbana-Champaign - College of Business 1968 — 1972
B.S., Accounting
Antonio Irizarry, MBA, PMP Antonio Irizarry, MBA, PMP's Elusys Therapeutics, Inc. Experience December 2014 - April 2015
Job Project Manager, Vecamyl at Turing Pharmaceuticals AG
Industry Pharmaceuticals
Experience
Turing Pharmaceuticals AG July 2015 - Present
Celldex Therapeutics April 2015 - June 2015
Elusys Therapeutics, Inc. December 2014 - April 2015
Elusys Therapeutics, Inc. January 2012 - December 2014
Merck via Research Pharmaceutical Services (RPS) December 2010 - January 2012
Merck via Technisource November 2009 - December 2010
Rutgers Business School March 2009 - November 2009
Novartis March 2008 - March 2009
Novartis August 2006 - February 2008
Roche Diagnostics via Adecco October 2004 - August 2006
Skills
Drug Development, FDA, Cross-functional Team..., Clinical Trials, Validation, GMP, R&D, Pharmaceutical Industry, CRO, Technology Transfer, 21 CFR Part 11, GLP, Sop, Biopharmaceuticals, Biotechnology, Chemistry, Forecasting, Chromatography, SAP, JD Edwards, Cognos, Supply Chain Management
Education
Rutgers, The State University of New Jersey-Newark 2006 — 2009
MBA, Marketing and Finance
Rutgers University-New Brunswick 2000 — 2002
BA, Chemistry
Turing Pharmaceuticals AG July 2015 - Present
Celldex Therapeutics April 2015 - June 2015
Elusys Therapeutics, Inc. December 2014 - April 2015
Elusys Therapeutics, Inc. January 2012 - December 2014
Merck via Research Pharmaceutical Services (RPS) December 2010 - January 2012
Merck via Technisource November 2009 - December 2010
Rutgers Business School March 2009 - November 2009
Novartis March 2008 - March 2009
Novartis August 2006 - February 2008
Roche Diagnostics via Adecco October 2004 - August 2006
Skills
Drug Development, FDA, Cross-functional Team..., Clinical Trials, Validation, GMP, R&D, Pharmaceutical Industry, CRO, Technology Transfer, 21 CFR Part 11, GLP, Sop, Biopharmaceuticals, Biotechnology, Chemistry, Forecasting, Chromatography, SAP, JD Edwards, Cognos, Supply Chain Management
Education
Rutgers, The State University of New Jersey-Newark 2006 — 2009
MBA, Marketing and Finance
Rutgers University-New Brunswick 2000 — 2002
BA, Chemistry
Robin Conrad Robin Conrad's Elusys Therapeutics, Inc. Experience April 2013 - Present
Job Vice President, Regulatory Affairs at Elusys Therapeutics, Inc.
Industry Pharmaceuticals
Experience
Elusys Therapeutics, Inc. April 2013 - Present
Elusys Therapeutics, Inc. November 2011 - Present
Hoffmann-La Roche, Inc January 2005 - November 2011
Hoffmann- La Roche, Inc January 2001 - January 2005
Hoffmann-La Roche, Inc January 1997 - January 2001
Hoffmann-La Roche Inc. June 1995 - January 1997
Enzon Inc February 1988 - June 1995
Skills
Document Management, Orphan Drugs, Regulatory Affairs, Regulatory Submissions, Clinical Development, IND, FDA, Biopharmaceuticals, GCP, Sop, Oncology, Pharmaceutical Industry, Clinical Trials, NDA, Drug Development, Immunology, Clinical Research, Lifesciences, Virology, Pharmacovigilance, Pharmaceutics, Commercialization, Compliance, Biologics, eCTD, GLP, CRO, Medical Writing, CTMS, Regulatory Requirements, Biotechnology, 21 CFR Part 11, Infectious Diseases, CAPA, Drug Discovery, CMC, Technology Transfer, Life Sciences, SOP
Education
Susquehanna University
BS, Biology
Temple University
M.S., Regulatory Affairs/Quality Assurance
Elusys Therapeutics, Inc. April 2013 - Present
Elusys Therapeutics, Inc. November 2011 - Present
Hoffmann-La Roche, Inc January 2005 - November 2011
Hoffmann- La Roche, Inc January 2001 - January 2005
Hoffmann-La Roche, Inc January 1997 - January 2001
Hoffmann-La Roche Inc. June 1995 - January 1997
Enzon Inc February 1988 - June 1995
Skills
Document Management, Orphan Drugs, Regulatory Affairs, Regulatory Submissions, Clinical Development, IND, FDA, Biopharmaceuticals, GCP, Sop, Oncology, Pharmaceutical Industry, Clinical Trials, NDA, Drug Development, Immunology, Clinical Research, Lifesciences, Virology, Pharmacovigilance, Pharmaceutics, Commercialization, Compliance, Biologics, eCTD, GLP, CRO, Medical Writing, CTMS, Regulatory Requirements, Biotechnology, 21 CFR Part 11, Infectious Diseases, CAPA, Drug Discovery, CMC, Technology Transfer, Life Sciences, SOP
Education
Susquehanna University
BS, Biology
Temple University
M.S., Regulatory Affairs/Quality Assurance
Doreen Ciolek Doreen Ciolek's Elusys Therapeutics, Inc. Experience January 2013 - Present
Job Senior CMC Analytical Scientist at Elusys Therapeutics, Inc.
Industry Biotechnology
Experience
Elusys Therapeutics, Inc. January 2013 - Present
Elusys Therapeutics October 2010 - December 2012
ENZON PHARMACEUTICALS, INC September 2009 - September 2010
PD REGULATORY SERVICES, INC January 2006 - June 2008
Roche Pharmaceuticals September 1990 - October 2005
Skills
Drug Metabolism, Biotechnology, Protein Purification, Protein Chemistry, HPLC, Assay Development, Validation, Chromatography, FDA, SDS-PAGE, LIMS, Gel Electrophoresis, V&V, Formulation, Pharmaceutical Industry, Drug Discovery, Method Development, GLP, Monoclonal Antibodies, Biopharmaceuticals, Purification, ELISA, Drug Development, Immunoassays, Lifesciences, Peptides, Cell Culture, Bioanalysis, In Vitro, CMC, GMP, Technology Transfer, Cell, Immunology, Biochemistry, Biomarkers, Clinical Development, Vaccines, Life Sciences
Education
William Paterson University of New Jersey 1995 — 1999
MS, Biotechnology
Rutgers University-New Brunswick 1985 — 1989
BS, Biology
Elusys Therapeutics, Inc. January 2013 - Present
Elusys Therapeutics October 2010 - December 2012
ENZON PHARMACEUTICALS, INC September 2009 - September 2010
PD REGULATORY SERVICES, INC January 2006 - June 2008
Roche Pharmaceuticals September 1990 - October 2005
Skills
Drug Metabolism, Biotechnology, Protein Purification, Protein Chemistry, HPLC, Assay Development, Validation, Chromatography, FDA, SDS-PAGE, LIMS, Gel Electrophoresis, V&V, Formulation, Pharmaceutical Industry, Drug Discovery, Method Development, GLP, Monoclonal Antibodies, Biopharmaceuticals, Purification, ELISA, Drug Development, Immunoassays, Lifesciences, Peptides, Cell Culture, Bioanalysis, In Vitro, CMC, GMP, Technology Transfer, Cell, Immunology, Biochemistry, Biomarkers, Clinical Development, Vaccines, Life Sciences
Education
William Paterson University of New Jersey 1995 — 1999
MS, Biotechnology
Rutgers University-New Brunswick 1985 — 1989
BS, Biology
Jessica Dunne Jessica Dunne's Elusys Therapeutics, Inc. Experience May 2005 - May 2008
Job Director, Discovery Research at JDRF
Industry Research
Experience
JDRF September 2014 - Present
Juvenile Diabetes Research Foundation October 2011 - Present
Juvenile Diabetes Research Foundation September 2008 - October 2011
Elusys Therapeutics, Inc. May 2005 - May 2008
Johnson & Johnson Pharmaceutical Research & Development August 2003 - May 2005
Skills
Autoimmune Diseases, In Vitro, Tissue Culture, Neuroscience, Flow Cytometry, In Vivo, Cell Culture, Inflammation, Molecular Biology, ELISA, Lifesciences, Biotechnology, Assay Development, Research, Pharmacokinetics, Clinical Development, Infectious Diseases, Biomaterials, Clinical Research, Drug Discovery, Translational Medicine, Immunology, Animal Models, Biology, Protein Chemistry, Biochemistry, Oncology, Cell Biology, Cell, Diabetes, Microbiology, Life Sciences
Education
University of Virginia 1998 — 2003
The Johns Hopkins University 1994 — 1998
B.S., Biomedical Engineering
The Ursuline School 1990 — 1994
JDRF September 2014 - Present
Juvenile Diabetes Research Foundation October 2011 - Present
Juvenile Diabetes Research Foundation September 2008 - October 2011
Elusys Therapeutics, Inc. May 2005 - May 2008
Johnson & Johnson Pharmaceutical Research & Development August 2003 - May 2005
Skills
Autoimmune Diseases, In Vitro, Tissue Culture, Neuroscience, Flow Cytometry, In Vivo, Cell Culture, Inflammation, Molecular Biology, ELISA, Lifesciences, Biotechnology, Assay Development, Research, Pharmacokinetics, Clinical Development, Infectious Diseases, Biomaterials, Clinical Research, Drug Discovery, Translational Medicine, Immunology, Animal Models, Biology, Protein Chemistry, Biochemistry, Oncology, Cell Biology, Cell, Diabetes, Microbiology, Life Sciences
Education
University of Virginia 1998 — 2003
The Johns Hopkins University 1994 — 1998
B.S., Biomedical Engineering
The Ursuline School 1990 — 1994
Muyeve Meroro Muyeve Meroro's Elusys Therapeutics, Inc. Experience February 2006 - January 2009
Job Senior Scientist at Merck & Co
Industry Biotechnology
Experience
Merck & Co January 2009 - Present
Elusys Therapeutics, Inc. February 2006 - January 2009
Regeneron Pharmaceuticals May 1996 - October 2005
United Nations March 1989 - February 1990
Skills
ELISA, Purification, HPLC, Protein Chemistry, Cell Culture, Technology Transfer, Project Planning, Project Portfolio..., Immunology, Pharmaceutical Industry, GCP, Vaccines, Drug Development, Cell, GLP, GMP, Lifesciences, Microbiology, Assay Development, Drug Discovery, Protein Purification, Regulatory Affairs, IND, Molecular Biology, Biotechnology, Gel Electrophoresis, Validation, Monoclonal Antibodies, Sop, PCR, Biopharmaceuticals, Clinical Development
Education
DeSales University 2009 — 2012
MBA, Project Management
Upsala College 1991 — 1995
BS, Biological Sciences
Augustineum Secondary School
Merck & Co January 2009 - Present
Elusys Therapeutics, Inc. February 2006 - January 2009
Regeneron Pharmaceuticals May 1996 - October 2005
United Nations March 1989 - February 1990
Skills
ELISA, Purification, HPLC, Protein Chemistry, Cell Culture, Technology Transfer, Project Planning, Project Portfolio..., Immunology, Pharmaceutical Industry, GCP, Vaccines, Drug Development, Cell, GLP, GMP, Lifesciences, Microbiology, Assay Development, Drug Discovery, Protein Purification, Regulatory Affairs, IND, Molecular Biology, Biotechnology, Gel Electrophoresis, Validation, Monoclonal Antibodies, Sop, PCR, Biopharmaceuticals, Clinical Development
Education
DeSales University 2009 — 2012
MBA, Project Management
Upsala College 1991 — 1995
BS, Biological Sciences
Augustineum Secondary School
David Zammit's Elusys Therapeutics, Inc. Experience June 2006 - August 2008
Job Director, Clinical Development Oncology
Industry Biotechnology
Experience
Asana BioSciences, LLC September 2015 - Present
Daiichi Sankyo, Inc. February 2015 - Present
Kyowa Hakko Kirin Pharma, Inc. January 2014 - January 2015
Kyowa Hakko Kirin Pharma, Inc. January 2011 - January 2015
Kyowa Hakko Kirin Pharma, Inc. June 2012 - December 2013
Kyowa Hakko Kirin Pharma, Inc. September 2010 - June 2012
Huntingdon Life Sciences January 2009 - September 2010
Elusys Therapeutics, Inc. June 2006 - August 2008
UCHC 2003 - 2006
Skills
Strategic Planning, Financial Analysis, Corporate Finance, Business Valuation, Equity Valuation, Cross-functional Team..., Program Management, Biotechnology, Pharmaceuticals, Drug Development, Clinical Research, Clinical Trials, Drug Discovery, R&D, Oncology, Autoimmune Diseases, Infectious Diseases, Immunology, Excel, MS Project, Word, Data Analysis, PowerPoint, Root Cause Analysis, Cell Based Assays, Enzyme Assays, Microsoft Excel, Pharmaceutical Industry, Cell, Global Management, IND, Biomarkers, FDA, Vaccines, GLP, Regulatory Submissions, CRO, Monoclonal Antibodies, Biopharmaceuticals, Lifesciences, Immunoassays, Animal Models, Regulatory Affairs, Life Sciences
Education
New York University - Leonard N. Stern School of Business 2009 — 2012
MBA, Corporate Finance, Strategy
Monash University 1993 — 2003
Bachelor of Science (BS), PhD, Immunology
Asana BioSciences, LLC September 2015 - Present
Daiichi Sankyo, Inc. February 2015 - Present
Kyowa Hakko Kirin Pharma, Inc. January 2014 - January 2015
Kyowa Hakko Kirin Pharma, Inc. January 2011 - January 2015
Kyowa Hakko Kirin Pharma, Inc. June 2012 - December 2013
Kyowa Hakko Kirin Pharma, Inc. September 2010 - June 2012
Huntingdon Life Sciences January 2009 - September 2010
Elusys Therapeutics, Inc. June 2006 - August 2008
UCHC 2003 - 2006
Skills
Strategic Planning, Financial Analysis, Corporate Finance, Business Valuation, Equity Valuation, Cross-functional Team..., Program Management, Biotechnology, Pharmaceuticals, Drug Development, Clinical Research, Clinical Trials, Drug Discovery, R&D, Oncology, Autoimmune Diseases, Infectious Diseases, Immunology, Excel, MS Project, Word, Data Analysis, PowerPoint, Root Cause Analysis, Cell Based Assays, Enzyme Assays, Microsoft Excel, Pharmaceutical Industry, Cell, Global Management, IND, Biomarkers, FDA, Vaccines, GLP, Regulatory Submissions, CRO, Monoclonal Antibodies, Biopharmaceuticals, Lifesciences, Immunoassays, Animal Models, Regulatory Affairs, Life Sciences
Education
New York University - Leonard N. Stern School of Business 2009 — 2012
MBA, Corporate Finance, Strategy
Monash University 1993 — 2003
Bachelor of Science (BS), PhD, Immunology
Elena Luganovski's Elusys Therapeutics, Inc. Experience 2009 - 2011
Job Associate Director, CMC Management at Daiichi Sankyo
Industry Biotechnology
Experience
Daiichi Sankyo, Inc. September 2014 - Present
Daiichi Sankyo January 2011 - September 2014
Elusys Therapeutics, Inc. 2009 - 2011
Elusys Therapeutics, Inc. 2006 - 2008
Elusys Therapeutics, Inc. 2005 - 2006
Roche Molecular Systems 2002 - 2003
Skills
Biotechnology, Monoclonal Antibodies, Lifesciences, Drug Discovery, ELISA, Clinical Development, Cell Culture, Pharmaceutical Industry, Biopharmaceuticals, Protein Chemistry, Technology Transfer, Drug Development, HPLC, Immunology, GLP
Education
Columbia University in the City of New York 2002 — 2005
MS, Biology
New York University 2010 — 2011
Certification, Project Management
Daiichi Sankyo, Inc. September 2014 - Present
Daiichi Sankyo January 2011 - September 2014
Elusys Therapeutics, Inc. 2009 - 2011
Elusys Therapeutics, Inc. 2006 - 2008
Elusys Therapeutics, Inc. 2005 - 2006
Roche Molecular Systems 2002 - 2003
Skills
Biotechnology, Monoclonal Antibodies, Lifesciences, Drug Discovery, ELISA, Clinical Development, Cell Culture, Pharmaceutical Industry, Biopharmaceuticals, Protein Chemistry, Technology Transfer, Drug Development, HPLC, Immunology, GLP
Education
Columbia University in the City of New York 2002 — 2005
MS, Biology
New York University 2010 — 2011
Certification, Project Management
Gregory Torre, PhD, Esq Gregory Torre, PhD, Esq's Elusys Therapeutics, Inc. Experience December 2010 - October 2011
Job Chief Regulatory Officer and Vice President, Operations at Sellas Life Sciences
Industry Pharmaceuticals
Experience
Sellas Life Sciences July 2015 - Present
Pfizer October 2011 - June 2015
Sellas Life Sciences 2015 - 2015
Sellas Life Sciences 2015 - 2015
Elusys Therapeutics, Inc. December 2010 - October 2011
Axiom Law/ The Torre Group LLC June 2010 - December 2010
The Alvogen Group September 2008 - July 2010
NPS Pharmaceuticals January 2006 - August 2007
Watson Pharmaceuticals April 2001 - July 2005
MannKind 2004 - 2005
Skills
Regulatory Affairs, Drug Development, Biotechnology, Clinical Development, Clinical Trials, FDA, Regulatory Submissions, Oncology, SOP, Intellectual Property, Pharmaceutical Industry, Generic Programming, GMP, Life Sciences, IND, Strategy, Biopharmaceuticals, CRO, Medical Devices, Sop, GCP, Cancer, Pharmacovigilance
Education
Brooklyn Law School 1984 — 1988
JD, Food and Drug Law
Saint John's University 1978 — 1981
PhD, Pharmacology/Toxicology
Saint John's University 1976 — 1978
MS, Pharmacology/Toxicology
Saint John's University 1971 — 1976
BS, Pharmacy
Sellas Life Sciences July 2015 - Present
Pfizer October 2011 - June 2015
Sellas Life Sciences 2015 - 2015
Sellas Life Sciences 2015 - 2015
Elusys Therapeutics, Inc. December 2010 - October 2011
Axiom Law/ The Torre Group LLC June 2010 - December 2010
The Alvogen Group September 2008 - July 2010
NPS Pharmaceuticals January 2006 - August 2007
Watson Pharmaceuticals April 2001 - July 2005
MannKind 2004 - 2005
Skills
Regulatory Affairs, Drug Development, Biotechnology, Clinical Development, Clinical Trials, FDA, Regulatory Submissions, Oncology, SOP, Intellectual Property, Pharmaceutical Industry, Generic Programming, GMP, Life Sciences, IND, Strategy, Biopharmaceuticals, CRO, Medical Devices, Sop, GCP, Cancer, Pharmacovigilance
Education
Brooklyn Law School 1984 — 1988
JD, Food and Drug Law
Saint John's University 1978 — 1981
PhD, Pharmacology/Toxicology
Saint John's University 1976 — 1978
MS, Pharmacology/Toxicology
Saint John's University 1971 — 1976
BS, Pharmacy
Jeffrey Hulmes Jeffrey Hulmes's Elusys Therapeutics, Inc. Experience June 2007 - April 2011
Job Scientist / Assistant Manager, Biopharmaceutical Testing at SGS
Industry Biotechnology
Experience
Elusys Therapeutics, Inc. June 2007 - April 2011
Bristol-Myers Squibb 2001 - 2007
ImClone Systems 1998 - 2000
W. Alton Jones Cell Science Center 1995 - 1998
American Cyanamid (Lederle) 1990 - 1995
Hoffmann-La Roche 1984 - 1990
Skills
Ligand Binding Assay..., Cell Culture,..., Electrospray mass..., High performance liquid..., Transcriptional..., 2D gel electrophoresis..., Protein microsequencing..., Amino acid analysis -..., Peptide synthesis with..., Peptide mapping -..., Characterization of..., Training in all of the..., ELISA, Cell Culture, Assay Development, Amino Acids, Protein Chemistry, Chemistry, GMP, Drug Discovery, GLP, Lifesciences, Biochemistry, HPLC, Biotechnology, Bioanalysis, Biomarkers, Cell, Drug Development, In Vitro, Monoclonal Antibodies, Mass Spectrometry, Proteomics, Molecular Biology, Validation, Peptides, Clinical Development, Biomarker Discovery, CRO, Laboratory, Life Sciences
Education
Rutgers, The State University of New Jersey-Newark 1984 — 1988
M.S., Zoology/Biochemistry
Rutgers University-New Brunswick 1979 — 1983
B.A., Biochemistry
New York Medical College 1991 — 1993
County College of Morris 2012 — 2013
High School +
Elusys Therapeutics, Inc. June 2007 - April 2011
Bristol-Myers Squibb 2001 - 2007
ImClone Systems 1998 - 2000
W. Alton Jones Cell Science Center 1995 - 1998
American Cyanamid (Lederle) 1990 - 1995
Hoffmann-La Roche 1984 - 1990
Skills
Ligand Binding Assay..., Cell Culture,..., Electrospray mass..., High performance liquid..., Transcriptional..., 2D gel electrophoresis..., Protein microsequencing..., Amino acid analysis -..., Peptide synthesis with..., Peptide mapping -..., Characterization of..., Training in all of the..., ELISA, Cell Culture, Assay Development, Amino Acids, Protein Chemistry, Chemistry, GMP, Drug Discovery, GLP, Lifesciences, Biochemistry, HPLC, Biotechnology, Bioanalysis, Biomarkers, Cell, Drug Development, In Vitro, Monoclonal Antibodies, Mass Spectrometry, Proteomics, Molecular Biology, Validation, Peptides, Clinical Development, Biomarker Discovery, CRO, Laboratory, Life Sciences
Education
Rutgers, The State University of New Jersey-Newark 1984 — 1988
M.S., Zoology/Biochemistry
Rutgers University-New Brunswick 1979 — 1983
B.A., Biochemistry
New York Medical College 1991 — 1993
County College of Morris 2012 — 2013
High School +
Jeff Wolf's Elusys Therapeutics, Inc. Experience March 1997 - July 2000
Job Founder and CEO at Heat Biologics
Industry Biotechnology
Experience
Heat Biologics May 2011 - Present
Seed-One Ventures 1996 - March 2011
GenerationOne February 2007 - February 2011
TyRx Pharma, Inc August 1998 - October 2006
Elusys Therapeutics, Inc. March 1997 - July 2000
Avigen April 1994 - May 1996
The Castle Group, LTD August 1990 - September 1995
Skills
Start-ups, Venture Capital, Corporate Development, Entrepreneurship, Strategy, Strategic Partnerships, Business Strategy, Biotechnology, Mergers & Acquisitions, Angel Investing, Business Development, Due Diligence, Commercialization, Licensing, Private Equity, M&A experience, Strategic Planning, Lifesciences, Technology Transfer, New Business Development
Education
Stanford University Graduate School of Business 1988 — 1990
MBA
New York University School of Law 1985 — 1988
J.D., Law
The University of Chicago 1981 — 1985
B.A., Economics
Heat Biologics May 2011 - Present
Seed-One Ventures 1996 - March 2011
GenerationOne February 2007 - February 2011
TyRx Pharma, Inc August 1998 - October 2006
Elusys Therapeutics, Inc. March 1997 - July 2000
Avigen April 1994 - May 1996
The Castle Group, LTD August 1990 - September 1995
Skills
Start-ups, Venture Capital, Corporate Development, Entrepreneurship, Strategy, Strategic Partnerships, Business Strategy, Biotechnology, Mergers & Acquisitions, Angel Investing, Business Development, Due Diligence, Commercialization, Licensing, Private Equity, M&A experience, Strategic Planning, Lifesciences, Technology Transfer, New Business Development
Education
Stanford University Graduate School of Business 1988 — 1990
MBA
New York University School of Law 1985 — 1988
J.D., Law
The University of Chicago 1981 — 1985
B.A., Economics
Anthony Samawova MBA Anthony Samawova MBA's Elusys Therapeutics, Inc. Experience June 2012 - Present
Job Senior Manager, Fill / Finish (Drug Product Manufacturing) at Elusys Therapeutics, Inc.
Industry Biotechnology
Experience
Elusys Therapeutics, Inc. June 2012 - Present
Laureate Biopharmaceutical Services October 2011 - June 2012
Dendreon Corporation April 2010 - October 2011
Pfizer Inc. March 2009 - April 2010
Wyeth Pharmaceuticals August 2006 - March 2009
Wyeth Pharmaceuticals May 2002 - August 2006
Skills
GMP, Validation, FDA, Aseptic Technique, CAPA, Sop, Aseptic Processing, Biotechnology, Pharmaceutical Industry, Clean Rooms, GLP, Formulation, Pharmaceutics, Deviations, Quality System, Lean Manufacturing, Cleaning Validation, Vaccines, Process Improvement, Biopharmaceuticals, Six Sigma, LIMS, Assay Development, Kaizen, Technology Transfer, Auditing, 21 CFR Part 11, cGMP manufacturing, V&V, Continuous Improvement, Regulatory Affairs, Manufacturing, Regulatory Submissions, Lifesciences, Operations Management, Strategic Planning, cGMP, Contract Manufacturing, Sterilization, Software Documentation, Process Simulation, Protein Chemistry, Regulatory Requirements, Pharmaceuticals, Protocol Writing, Quality Systems, Audit, CMC, Root Cause Analysis, Project Management
Education
State University of New York Empire State College 2011 — 2013
Master of Business Administration (MBA), Management
State University of New York Empire State College 2008 — 2010
Bachelor of Science, Biological Sciences
Cayuga County Community College 1998 — 2001
Associate of Arts and Sciences (AAS)
Mathematics, Science Research & Technology Magnet High School 1994 — 1998
Diploma, Mathematics and Science
Elusys Therapeutics, Inc. June 2012 - Present
Laureate Biopharmaceutical Services October 2011 - June 2012
Dendreon Corporation April 2010 - October 2011
Pfizer Inc. March 2009 - April 2010
Wyeth Pharmaceuticals August 2006 - March 2009
Wyeth Pharmaceuticals May 2002 - August 2006
Skills
GMP, Validation, FDA, Aseptic Technique, CAPA, Sop, Aseptic Processing, Biotechnology, Pharmaceutical Industry, Clean Rooms, GLP, Formulation, Pharmaceutics, Deviations, Quality System, Lean Manufacturing, Cleaning Validation, Vaccines, Process Improvement, Biopharmaceuticals, Six Sigma, LIMS, Assay Development, Kaizen, Technology Transfer, Auditing, 21 CFR Part 11, cGMP manufacturing, V&V, Continuous Improvement, Regulatory Affairs, Manufacturing, Regulatory Submissions, Lifesciences, Operations Management, Strategic Planning, cGMP, Contract Manufacturing, Sterilization, Software Documentation, Process Simulation, Protein Chemistry, Regulatory Requirements, Pharmaceuticals, Protocol Writing, Quality Systems, Audit, CMC, Root Cause Analysis, Project Management
Education
State University of New York Empire State College 2011 — 2013
Master of Business Administration (MBA), Management
State University of New York Empire State College 2008 — 2010
Bachelor of Science, Biological Sciences
Cayuga County Community College 1998 — 2001
Associate of Arts and Sciences (AAS)
Mathematics, Science Research & Technology Magnet High School 1994 — 1998
Diploma, Mathematics and Science
Anthony Pennello Anthony Pennello's Elusys Therapeutics, Inc. Experience December 2006 - August 2008
Job Principal Research Associate at ImClone Systems, a whollyowned subsidiary of Eli Lilly and Company
Industry Biotechnology
Experience
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2008 - Present
Elusys Therapeutics, Inc. December 2006 - August 2008
Bracco March 2005 - December 2006
Pharmacopeia June 2004 - March 2005
Rider University May 2002 - June 2004
Skills
Assay Development, Drug Discovery, Biotechnology, ELISA, Cell Culture, Immunology, Antibodies, In Vivo, Flow Cytometry, High Throughput..., Immunohistochemistry, Pharmacology, Cancer Research, Life Sciences, In Vitro
Education
Rider University 2000 — 2004
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2008 - Present
Elusys Therapeutics, Inc. December 2006 - August 2008
Bracco March 2005 - December 2006
Pharmacopeia June 2004 - March 2005
Rider University May 2002 - June 2004
Skills
Assay Development, Drug Discovery, Biotechnology, ELISA, Cell Culture, Immunology, Antibodies, In Vivo, Flow Cytometry, High Throughput..., Immunohistochemistry, Pharmacology, Cancer Research, Life Sciences, In Vitro
Education
Rider University 2000 — 2004
Vincent Pernice's Elusys Therapeutics, Inc. Experience 2004 — 2005
Job Associate Director, Lab Operations at PPD
Industry Pharmaceuticals
Experience
PPD August 2012 — Present
Johnson & Johnson April 2005 — August 2012
Kean University 2002 — 2008
Elusys Therapeutics, Inc. 2004 — 2005
Genta July 2002 — August 2004
Hoffmann-La Roche October 1996 — July 2002
Interferon Sciences October 1991 — October 1996
Skills
Management, Immunology, Genetics, Clinical Trials, Laboratory, Microsoft Office, Drug Development, ELISA, Regulatory Affairs, Project Management, Drug Discovery, Pharmaceutics, Quality Control, Chromatography, CAPA, Assay Development, Biochemistry, Protein Chemistry, Research, Cell, LIMS, Microbiology, Purification, Cell Culture, 21 CFR Part 11, CRO, GCP, V&V, LC-MS, Protein Purification, Change Control, Chemistry, Formulation, Regulatory Submissions, Oncology, Molecular Biology, CTMS, PCR, Regulatory Requirements, GxP, In Vitro, Immunoassays, Medical Devices, Monoclonal Antibodies, Quality System, Cell Biology, Biomarkers
Education
Kean University ... — 2002
Master of Science (MS), Biotechnology
PPD August 2012 — Present
Johnson & Johnson April 2005 — August 2012
Kean University 2002 — 2008
Elusys Therapeutics, Inc. 2004 — 2005
Genta July 2002 — August 2004
Hoffmann-La Roche October 1996 — July 2002
Interferon Sciences October 1991 — October 1996
Skills
Management, Immunology, Genetics, Clinical Trials, Laboratory, Microsoft Office, Drug Development, ELISA, Regulatory Affairs, Project Management, Drug Discovery, Pharmaceutics, Quality Control, Chromatography, CAPA, Assay Development, Biochemistry, Protein Chemistry, Research, Cell, LIMS, Microbiology, Purification, Cell Culture, 21 CFR Part 11, CRO, GCP, V&V, LC-MS, Protein Purification, Change Control, Chemistry, Formulation, Regulatory Submissions, Oncology, Molecular Biology, CTMS, PCR, Regulatory Requirements, GxP, In Vitro, Immunoassays, Medical Devices, Monoclonal Antibodies, Quality System, Cell Biology, Biomarkers
Education
Kean University ... — 2002
Master of Science (MS), Biotechnology
Marlena L. Maier BS, MBA's Elusys Therapeutics, Inc. Experience September 2012 - July 2014
Job Quality Manager, GLP Quality Assurance at Vertex Pharmaceuticals
Industry Pharmaceuticals
Experience
Vertex Pharmaceuticals March 2015 - Present
Elusys Therapeutics, Inc. September 2012 - July 2014
Merck January 2011 - December 2011
Merck (formerly Schering-Plough) January 2007 - January 2011
Schering-Plough Research Institute January 2002 - January 2007
Schering-Plough Research Institute January 2001 - January 2002
Tranquility Veterinary Clinic August 1996 - January 2001
Skills
GLP, Bioanalytical, Non-clinical, Clinical Pathology, Microsoft Office, Animal Models, Auditing, External Audit, OECD, 21 CFR Part 11, Dose Formulations, Training, Quality Assurance, Bioanalysis, Regulatory Affairs, GCP, Laboratory, Toxicology, CRO, Clinical Development, Sop, FDA, Computer System..., GxP, Biopharmaceuticals, V&V, Biotechnology, Pharmaceutical Industry, Drug Development, Lifesciences, LIMS, Vaccines, Quality System, Validation, Change Control, GMP, CAPA, Protocol, Pharmaceutics, Regulatory Requirements, Clinical Trials, SOP development, Software Documentation, HPLC, Technology Transfer, IND, SOP, Life Sciences, Drug Discovery, Project Management
Education
Centenary College
MBA, Business
Delaware Valley University
BS, Animal Science
Hackettstown High School
Vertex Pharmaceuticals March 2015 - Present
Elusys Therapeutics, Inc. September 2012 - July 2014
Merck January 2011 - December 2011
Merck (formerly Schering-Plough) January 2007 - January 2011
Schering-Plough Research Institute January 2002 - January 2007
Schering-Plough Research Institute January 2001 - January 2002
Tranquility Veterinary Clinic August 1996 - January 2001
Skills
GLP, Bioanalytical, Non-clinical, Clinical Pathology, Microsoft Office, Animal Models, Auditing, External Audit, OECD, 21 CFR Part 11, Dose Formulations, Training, Quality Assurance, Bioanalysis, Regulatory Affairs, GCP, Laboratory, Toxicology, CRO, Clinical Development, Sop, FDA, Computer System..., GxP, Biopharmaceuticals, V&V, Biotechnology, Pharmaceutical Industry, Drug Development, Lifesciences, LIMS, Vaccines, Quality System, Validation, Change Control, GMP, CAPA, Protocol, Pharmaceutics, Regulatory Requirements, Clinical Trials, SOP development, Software Documentation, HPLC, Technology Transfer, IND, SOP, Life Sciences, Drug Discovery, Project Management
Education
Centenary College
MBA, Business
Delaware Valley University
BS, Animal Science
Hackettstown High School
Ani Bhattacharya's Elusys Therapeutics, Inc. Experience June 2003 - December 2004
Job Associate Director, Commercial Business Analytics at Otsuka Pharmaceutical Companies (U.S.)
Industry Pharmaceuticals
Experience
Otsuka Pharmaceutical Companies (U.S.) October 2013 - Present
Merck April 2010 - August 2013
Merck May 2007 - April 2010
KOS Pharmaceuticals (acquired by Abbott) September 2005 - April 2007
Organon International (now Merck) January 2005 - September 2005
Elusys Therapeutics, Inc. June 2003 - December 2004
Skills
Sales Effectiveness, Strategy, Forecasting, Pharmaceutical Industry, Product Development, Market Research, Financial Modeling, Portfolio Management, Lifesciences, Product Launch, Biotechnology, Market Analysis, Technology Transfer, Cross-functional Team..., Competitive Analysis, Leadership, Commercialization, Pharmaceutical Sales, Pharmaceutics, Business Development, Diabetes, Therapeutic Areas, Competitive Intelligence, Drug Discovery, Market Access, Drug Development
Education
Rutgers, The State University of New Jersey-Newark 2001 — 2003
MBA, Marketing, Supply Chain Management
Indian Institute of Science 1991 — 1998
PhD, Molecular Biology
Otsuka Pharmaceutical Companies (U.S.) October 2013 - Present
Merck April 2010 - August 2013
Merck May 2007 - April 2010
KOS Pharmaceuticals (acquired by Abbott) September 2005 - April 2007
Organon International (now Merck) January 2005 - September 2005
Elusys Therapeutics, Inc. June 2003 - December 2004
Skills
Sales Effectiveness, Strategy, Forecasting, Pharmaceutical Industry, Product Development, Market Research, Financial Modeling, Portfolio Management, Lifesciences, Product Launch, Biotechnology, Market Analysis, Technology Transfer, Cross-functional Team..., Competitive Analysis, Leadership, Commercialization, Pharmaceutical Sales, Pharmaceutics, Business Development, Diabetes, Therapeutic Areas, Competitive Intelligence, Drug Discovery, Market Access, Drug Development
Education
Rutgers, The State University of New Jersey-Newark 2001 — 2003
MBA, Marketing, Supply Chain Management
Indian Institute of Science 1991 — 1998
PhD, Molecular Biology
Bob Gundel's Elusys Therapeutics, Inc. Experience February 2008 - December 2008
Job
Industry Biotechnology
Experience
Amorfix Life Sciences Ltd. January 2010 - July 2015
Heat Biologics October 2008 - January 2010
Elusys Therapeutics, Inc. February 2008 - December 2008
XOMA US LLC June 2002 - February 2007
Arius Research 2007 - 2007
Chiron Corporation June 2000 - June 2002
Bayer Corporation August 1992 - June 2000
Skills
Pharmacology, Clinical Development, Drug Development, Biopharmaceuticals, Drug Delivery, Clinical Research, Vaccines, Medical Writing, Cell, Pharmaceutical Industry, Venture Capital, Cancer, Infectious Diseases, Licensing, Drug Discovery, Start-ups, Oncology, Lifesciences, Strategic Planning, GMP, Biotechnology, Research, Biologics, Regulatory Affairs, Project Management, GLP, Clinical Trials, CRO, Medical Devices, Biochemistry, Technology Transfer, Immunoassays, Commercialization, FDA, Antibodies, Hardware Diagnostics, Assay Development, Immunology, Molecular Biology, Protein Chemistry, Biomarker Discovery, Genomics, Life Sciences
Education
Saint Mary's College of California 2005 — 2006
MBA, Business Administration
New York Medical College 1984 — 1988
PhD, Physiology
New York Medical College 1982 — 1984
MS, Physiology
Purchase College, SUNY 1976 — 1978
BA, Biology
Amorfix Life Sciences Ltd. January 2010 - July 2015
Heat Biologics October 2008 - January 2010
Elusys Therapeutics, Inc. February 2008 - December 2008
XOMA US LLC June 2002 - February 2007
Arius Research 2007 - 2007
Chiron Corporation June 2000 - June 2002
Bayer Corporation August 1992 - June 2000
Skills
Pharmacology, Clinical Development, Drug Development, Biopharmaceuticals, Drug Delivery, Clinical Research, Vaccines, Medical Writing, Cell, Pharmaceutical Industry, Venture Capital, Cancer, Infectious Diseases, Licensing, Drug Discovery, Start-ups, Oncology, Lifesciences, Strategic Planning, GMP, Biotechnology, Research, Biologics, Regulatory Affairs, Project Management, GLP, Clinical Trials, CRO, Medical Devices, Biochemistry, Technology Transfer, Immunoassays, Commercialization, FDA, Antibodies, Hardware Diagnostics, Assay Development, Immunology, Molecular Biology, Protein Chemistry, Biomarker Discovery, Genomics, Life Sciences
Education
Saint Mary's College of California 2005 — 2006
MBA, Business Administration
New York Medical College 1984 — 1988
PhD, Physiology
New York Medical College 1982 — 1984
MS, Physiology
Purchase College, SUNY 1976 — 1978
BA, Biology
Ben Sudovar's Elusys Therapeutics, Inc. Experience November 2002 - June 2008
Job Sr. Manager, R&D Finance at Forest Laboratories
Industry Pharmaceuticals
Experience
Forest Laboratories January 2012 - Present
Forest Laboratories December 2010 - January 2012
Forest Laboratories January 2009 - December 2010
Forest Laboratories June 2008 - December 2008
Elusys Therapeutics, Inc. November 2002 - June 2008
Skills
Cross-functional Team..., Strategy, Biotechnology, Budgets, Pharmaceutical Industry, Drug Development, Management, Clinical Development, FDA, Clinical Trials, Analysis, Forecasting, Lifesciences, CRO, R&D, Analytics, Clinical Research, Proposal Writing, GCP, Oncology, Regulatory Affairs, Cardiology, Finance, Business Development, Strategic Partnerships, Relationship Management
Education
Saint Peter's University 1997 — 2001
Bachelor's of Science Degree, Marketing
Montclair State University
MBA
Forest Laboratories January 2012 - Present
Forest Laboratories December 2010 - January 2012
Forest Laboratories January 2009 - December 2010
Forest Laboratories June 2008 - December 2008
Elusys Therapeutics, Inc. November 2002 - June 2008
Skills
Cross-functional Team..., Strategy, Biotechnology, Budgets, Pharmaceutical Industry, Drug Development, Management, Clinical Development, FDA, Clinical Trials, Analysis, Forecasting, Lifesciences, CRO, R&D, Analytics, Clinical Research, Proposal Writing, GCP, Oncology, Regulatory Affairs, Cardiology, Finance, Business Development, Strategic Partnerships, Relationship Management
Education
Saint Peter's University 1997 — 2001
Bachelor's of Science Degree, Marketing
Montclair State University
MBA
Steven Pincus's Elusys Therapeutics, Inc. Experience January 2001 - July 2007
Job AVP Virology and Analytical Methods Development
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies Texas, LLC June 2014 - Present
Pincus Consulting March 2012 - Present
Novavax October 2010 - March 2012
Novavax 2007 - 2010
Elusys Therapeutics, Inc. January 2001 - July 2007
Virogenetics 1987 - 2000
Skills
Vaccines, Monoclonal Antibodies, budgets, timelines,..., Discovery and Early..., Assay Transfer, Infectious Disease, Animal Models, Infectious Diseases, Project Planning, CRO, Budgets
Education
University at Buffalo 1978 — 1983
PhD, Biochemistry
University at Buffalo 1974 — 1978
BS, Biochemistry
Fujifilm Diosynth Biotechnologies Texas, LLC June 2014 - Present
Pincus Consulting March 2012 - Present
Novavax October 2010 - March 2012
Novavax 2007 - 2010
Elusys Therapeutics, Inc. January 2001 - July 2007
Virogenetics 1987 - 2000
Skills
Vaccines, Monoclonal Antibodies, budgets, timelines,..., Discovery and Early..., Assay Transfer, Infectious Disease, Animal Models, Infectious Diseases, Project Planning, CRO, Budgets
Education
University at Buffalo 1978 — 1983
PhD, Biochemistry
University at Buffalo 1974 — 1978
BS, Biochemistry
Annette Shadiack's Elusys Therapeutics, Inc. Experience March 2011 - July 2014
Job Vice President, Early Stage Development at TherapeuticsMD
Industry Pharmaceuticals
Experience
TherapeuticsMD October 2014 - Present
TherapeuticsMD July 2014 - October 2014
Elusys Therapeutics, Inc. March 2011 - July 2014
Global Alliance for TB Drug Development March 2009 - March 2011
Locus Pharmaceuticals October 2007 - December 2008
Palatin Technologies April 1998 - September 2007
Johnson and Johnson September 1996 - April 1998
Case Western Reserve University September 1992 - August 1996
Rutgers University 1986 - 1992
Skills
Drug Discovery, Monoclonal Antibodies, Biotechnology, Drug Development, Infectious Diseases, Pharmaceutical Industry, Nonclinical Development, Animal Models, Preclinical Safety, Team Leadership, Small Molecules, Peptides, Small Biopharmaceutical, Biopharmaceuticals, CRO, R&D, Cell, FDA, Regulatory Submissions, GLP, Clinical Research, Pharmacology, Immunology, Toxicology, Laboratory, Neuroscience, In Vivo, Assay Development, In Vitro, Project Management
Education
Rutgers, The State University of New Jersey-Newark 1986 — 1992
PhD, Neuroscience
Rutgers, The State University of New Jersey-Newark 1982 — 1986
BA, Zoology
TherapeuticsMD October 2014 - Present
TherapeuticsMD July 2014 - October 2014
Elusys Therapeutics, Inc. March 2011 - July 2014
Global Alliance for TB Drug Development March 2009 - March 2011
Locus Pharmaceuticals October 2007 - December 2008
Palatin Technologies April 1998 - September 2007
Johnson and Johnson September 1996 - April 1998
Case Western Reserve University September 1992 - August 1996
Rutgers University 1986 - 1992
Skills
Drug Discovery, Monoclonal Antibodies, Biotechnology, Drug Development, Infectious Diseases, Pharmaceutical Industry, Nonclinical Development, Animal Models, Preclinical Safety, Team Leadership, Small Molecules, Peptides, Small Biopharmaceutical, Biopharmaceuticals, CRO, R&D, Cell, FDA, Regulatory Submissions, GLP, Clinical Research, Pharmacology, Immunology, Toxicology, Laboratory, Neuroscience, In Vivo, Assay Development, In Vitro, Project Management
Education
Rutgers, The State University of New Jersey-Newark 1986 — 1992
PhD, Neuroscience
Rutgers, The State University of New Jersey-Newark 1982 — 1986
BA, Zoology
Heather Tang's Elusys Therapeutics, Inc. Experience August 2011 - July 2014
Job Project Manager for Global Launch at CMK Select
Industry Biotechnology
Experience
CMK Select September 2014 - Present
Elusys Therapeutics, Inc. August 2011 - July 2014
Schering Plough March 2008 - September 2011
Merck (legacy Schering-Plough) 2008 - 2011
Locus Technologies January 2008 - March 2008
Palatin Technologies April 2007 - September 2007
Emiphere Technology August 2001 - April 2007
Skills
Clinical Development, FDA, Pharmaceutical Industry, Drug Development, GLP, CRO, CTMS, Drug Discovery, GCP, Biopharmaceuticals, Lifesciences, Clinical Trials, Infectious Diseases, Regulatory Submissions, R&D, Sop
Education
University of Phoenix 2005 — 2007
Chinese Acedemy of Medicine 1991 — 1994
Master in Science, Microbiology/Immunology
Nanjing Medical University 1984 — 1989
Bachelor of Medicine, Public Health
CMK Select September 2014 - Present
Elusys Therapeutics, Inc. August 2011 - July 2014
Schering Plough March 2008 - September 2011
Merck (legacy Schering-Plough) 2008 - 2011
Locus Technologies January 2008 - March 2008
Palatin Technologies April 2007 - September 2007
Emiphere Technology August 2001 - April 2007
Skills
Clinical Development, FDA, Pharmaceutical Industry, Drug Development, GLP, CRO, CTMS, Drug Discovery, GCP, Biopharmaceuticals, Lifesciences, Clinical Trials, Infectious Diseases, Regulatory Submissions, R&D, Sop
Education
University of Phoenix 2005 — 2007
Chinese Acedemy of Medicine 1991 — 1994
Master in Science, Microbiology/Immunology
Nanjing Medical University 1984 — 1989
Bachelor of Medicine, Public Health
Cynthia Dillon's Elusys Therapeutics, Inc. Experience August 2012 - Present
Job Director, Regulatory Affairs at Elusys Therapeutics, Inc.
Industry Research
Experience
Elusys Therapeutics, Inc. August 2012 - Present
Hoffmann-La Roche November 2009 - August 2012
Hoffmann-La Roche April 1995 - November 2009
Education
Montclair State University 1980 — 1985
BS, Chemistry
Elusys Therapeutics, Inc. August 2012 - Present
Hoffmann-La Roche November 2009 - August 2012
Hoffmann-La Roche April 1995 - November 2009
Education
Montclair State University 1980 — 1985
BS, Chemistry
Marion McGlynn's Elusys Therapeutics, Inc. Experience June 2012 - Present
Job Executive Director, Project Management at Elusys Therapeutics
Industry Biotechnology
Experience
Elusys Therapeutics, Inc. June 2012 - Present
Sanofi January 2010 - June 2012
sanofi-aventis January 2008 - April 2011
sanofi-aventis May 2000 - December 2007
Regeneron Pharmaceuticals 1996 - 2000
Regeneron 1994 - 1996
Lederle Laboratories 1990 - 1994
Skills
Pharmaceutical Industry, Drug Development, Biotechnology, Regulatory Submissions, Clinical Development, Clinical Trials, Oncology, Drug Discovery, CRO, CTMS, GCP, Biopharmaceuticals, Regulatory Affairs, Life Sciences, IND, SOP, FDA
Education
Fairleigh Dickinson University-Metropolitan Campus 1992 — 1996
MBA, Pharmaceutical studies
New York University 1987 — 1990
MS, Molecular biology / biochemistry
Dublin City University 1981 — 1985
B Sc, Analytical Science
Elusys Therapeutics, Inc. June 2012 - Present
Sanofi January 2010 - June 2012
sanofi-aventis January 2008 - April 2011
sanofi-aventis May 2000 - December 2007
Regeneron Pharmaceuticals 1996 - 2000
Regeneron 1994 - 1996
Lederle Laboratories 1990 - 1994
Skills
Pharmaceutical Industry, Drug Development, Biotechnology, Regulatory Submissions, Clinical Development, Clinical Trials, Oncology, Drug Discovery, CRO, CTMS, GCP, Biopharmaceuticals, Regulatory Affairs, Life Sciences, IND, SOP, FDA
Education
Fairleigh Dickinson University-Metropolitan Campus 1992 — 1996
MBA, Pharmaceutical studies
New York University 1987 — 1990
MS, Molecular biology / biochemistry
Dublin City University 1981 — 1985
B Sc, Analytical Science
Lisa Raenae Hoverman, PhD, CPHIMS's Elusys Therapeutics, Inc. Experience July 2012 - Present
Job Scientific, Medical, & Health IT Communications Consultant | Writer | Editor | Proposal & Grant Manager | Professor
Industry Writing and Editing
Experience
XPRT, LLC September 2014 - Present
State of Indiana - Office of the Lieutenant Governor, Office of Small Business and Entrepreneurship November 2014 - Present
INCOSE January 2014 - Present
Hoverman Scientific and Medical Communications, Inc. 2008 - Present
Elusys Therapeutics, Inc. July 2012 - Present
Kelly, Anderson & Associates, Inc. July 2010 - Present
The Beerring Limited November 2007 - Present
Caradigm June 2012 - February 2013
Microsoft February 2009 - February 2013
Front Range Community College January 2012 - May 2012
Skills
Public Speaking, Technical Writing, Proposal Writing, Lecturing, Classroom Instruction, Laboratory Research, Capture Management, Medical Writing, Grant Writing, Classroom, Science, Editing, Biotechnology, Leadership, Project Management, Teaching, Molecular Biology, Lifesciences, Data Analysis, Biochemistry, Cell Biology, Scientific Writing, Management, Higher Education, Healthcare, Genomics, Process Improvement, Strategic Planning, Federal Grant Management, Federal Procurement, Federal Proposals, Federal Agencies, Project Management Tools, Education, Continuing Medical..., Grantsmanship, Grants, RFP Design, RFP Generation, RFP Experience, RFA Experience, Medical Communications, Scientific Presentation, Scientific Review, Scientific..., Scientific Liaison, Outstanding..., mHealth Writer, HIT Writer, HIT
Education
University of Pittsburgh 2001 — 2006
PhD, MCDB
Carlow Universtiy 1997 — 2001
Bachelor, Biology
XPRT, LLC September 2014 - Present
State of Indiana - Office of the Lieutenant Governor, Office of Small Business and Entrepreneurship November 2014 - Present
INCOSE January 2014 - Present
Hoverman Scientific and Medical Communications, Inc. 2008 - Present
Elusys Therapeutics, Inc. July 2012 - Present
Kelly, Anderson & Associates, Inc. July 2010 - Present
The Beerring Limited November 2007 - Present
Caradigm June 2012 - February 2013
Microsoft February 2009 - February 2013
Front Range Community College January 2012 - May 2012
Skills
Public Speaking, Technical Writing, Proposal Writing, Lecturing, Classroom Instruction, Laboratory Research, Capture Management, Medical Writing, Grant Writing, Classroom, Science, Editing, Biotechnology, Leadership, Project Management, Teaching, Molecular Biology, Lifesciences, Data Analysis, Biochemistry, Cell Biology, Scientific Writing, Management, Higher Education, Healthcare, Genomics, Process Improvement, Strategic Planning, Federal Grant Management, Federal Procurement, Federal Proposals, Federal Agencies, Project Management Tools, Education, Continuing Medical..., Grantsmanship, Grants, RFP Design, RFP Generation, RFP Experience, RFA Experience, Medical Communications, Scientific Presentation, Scientific Review, Scientific..., Scientific Liaison, Outstanding..., mHealth Writer, HIT Writer, HIT
Education
University of Pittsburgh 2001 — 2006
PhD, MCDB
Carlow Universtiy 1997 — 2001
Bachelor, Biology
Hui Xie's Elusys Therapeutics, Inc. Experience 2007 - 2008
Job Senior Support Scientist at GE Healthcare
Industry Biotechnology
Experience
GE Healthcare April 2013 - Present
GE Healthcare 2008 - 2013
Elusys Therapeutics, Inc. 2007 - 2008
Columbia University 2006 - 2007
Skills
Biochemistry, Lifesciences, Biotechnology, Cell Culture, Pharmaceutical Industry, Drug Discovery, Molecular Biology, ELISA, Genomics, Protein Chemistry, Cell Biology, Protein Purification, Chromatography, Life Sciences
Education
Columbia University College of Physicians and Surgeons 1999 — 2006
Ph.D., Pharmacology
Columbia University in the City of New York 1999 — 2006
Doctor of Philosophy (PhD), Pharmacology
Peking University 1994 — 1998
Bachelor of Science (BS), Biochemistry and Molecular Biology
GE Healthcare April 2013 - Present
GE Healthcare 2008 - 2013
Elusys Therapeutics, Inc. 2007 - 2008
Columbia University 2006 - 2007
Skills
Biochemistry, Lifesciences, Biotechnology, Cell Culture, Pharmaceutical Industry, Drug Discovery, Molecular Biology, ELISA, Genomics, Protein Chemistry, Cell Biology, Protein Purification, Chromatography, Life Sciences
Education
Columbia University College of Physicians and Surgeons 1999 — 2006
Ph.D., Pharmacology
Columbia University in the City of New York 1999 — 2006
Doctor of Philosophy (PhD), Pharmacology
Peking University 1994 — 1998
Bachelor of Science (BS), Biochemistry and Molecular Biology
Yongdong Liu's Elusys Therapeutics, Inc. Experience October 2006 - May 2008
Job Research Scientist I at Wyeth
Industry Pharmaceuticals
Experience
Wyeth September 2008 - Present
Elusys Therapeutics, Inc. October 2006 - May 2008
Channing Laboratory at Harvard Medical School August 2004 - October 2006
Education
State University of New York College at Buffalo 2002 — 2004
MS, Biotechnology
Medical College of Tongji University 1992 — 1997
MD, Clinical Medicine
Wyeth September 2008 - Present
Elusys Therapeutics, Inc. October 2006 - May 2008
Channing Laboratory at Harvard Medical School August 2004 - October 2006
Education
State University of New York College at Buffalo 2002 — 2004
MS, Biotechnology
Medical College of Tongji University 1992 — 1997
MD, Clinical Medicine
Parul Rangwalla's Elusys Therapeutics, Inc. Experience December 2002 - April 2003
Job Former Research Scientist at Pfizer
Industry Biotechnology
Experience
Pfizer November 2003 - March 2010
Elusys Therapeutics, Inc. December 2002 - April 2003
Hoffman-La Roche (Adecco) March 2001 - May 2002
Johnson & Johnson (Kelly Scientific Resources) June 2000 - December 2000
Skills
Bioanalysis, GLP, Clinical Development, Drug Metabolism, Drug Discovery, Pharmacokinetics, DMPK, Immunoassays, Validation, Sop, Protein Chemistry
Education
Montclair State University 2001 — 2003
MS, Biology
Rutgers University-New Brunswick 1996 — 2000
BS, Biology
Sollers
Sollers
Pfizer November 2003 - March 2010
Elusys Therapeutics, Inc. December 2002 - April 2003
Hoffman-La Roche (Adecco) March 2001 - May 2002
Johnson & Johnson (Kelly Scientific Resources) June 2000 - December 2000
Skills
Bioanalysis, GLP, Clinical Development, Drug Metabolism, Drug Discovery, Pharmacokinetics, DMPK, Immunoassays, Validation, Sop, Protein Chemistry
Education
Montclair State University 2001 — 2003
MS, Biology
Rutgers University-New Brunswick 1996 — 2000
BS, Biology
Sollers
Sollers
Alicia Lambe's Elusys Therapeutics, Inc. Experience May 2007 - April 2008
Job Research Associate
Industry Biotechnology
Experience
Regeneron Pharmaceuticals May 2010 - October 2011
Tandem Labs April 2008 - May 2010
Elusys Therapeutics, Inc. May 2007 - April 2008
Roche Molecular Systems November 2004 - April 2007
Skills
ELISA, Monoclonal Antibodies, Immunoassays, GLP, Antibodies, Assay Development, Molecular Biology, Protein Chemistry, Biotechnology, Life Sciences, Cell Culture, Pharmaceutical Industry, Drug Discovery, HPLC
Education
Montclair State University 2009 — 2013
Master, Molecular Biology
Montclair State University 1999 — 2004
BS, Biology
Regeneron Pharmaceuticals May 2010 - October 2011
Tandem Labs April 2008 - May 2010
Elusys Therapeutics, Inc. May 2007 - April 2008
Roche Molecular Systems November 2004 - April 2007
Skills
ELISA, Monoclonal Antibodies, Immunoassays, GLP, Antibodies, Assay Development, Molecular Biology, Protein Chemistry, Biotechnology, Life Sciences, Cell Culture, Pharmaceutical Industry, Drug Discovery, HPLC
Education
Montclair State University 2009 — 2013
Master, Molecular Biology
Montclair State University 1999 — 2004
BS, Biology
Edward Kowalik's Elusys Therapeutics, Inc. Experience September 2006 - August 2008
Job Scientist at BioAegis Therapeutics
Industry Pharmaceuticals
Experience
BioAegis Therapeutics October 2014 - Present
Merck & Co., Inc. August 2009 - November 2013
Elusys Therapeutics, Inc. September 2006 - August 2008
Rockefeller University March 2004 - September 2006
Roche Molecular Systems April 2003 - February 2004
Columbia University Medical Center July 2001 - January 2003
Skills
Assay Development, Drug Discovery, Cell Culture, Cell Biology, Pharmaceutical Industry, In Vitro, Biotechnology, Cell, In Vivo, GLP, Pharmacology, Molecular Biology, recombinant DNA..., ELISA, Protein Chemistry
Education
Drew University 1997 — 2000
BA, Biology
BioAegis Therapeutics October 2014 - Present
Merck & Co., Inc. August 2009 - November 2013
Elusys Therapeutics, Inc. September 2006 - August 2008
Rockefeller University March 2004 - September 2006
Roche Molecular Systems April 2003 - February 2004
Columbia University Medical Center July 2001 - January 2003
Skills
Assay Development, Drug Discovery, Cell Culture, Cell Biology, Pharmaceutical Industry, In Vitro, Biotechnology, Cell, In Vivo, GLP, Pharmacology, Molecular Biology, recombinant DNA..., ELISA, Protein Chemistry
Education
Drew University 1997 — 2000
BA, Biology
Mirna DiPano's Elusys Therapeutics, Inc. Experience 2004 - 2006
Job Global Program Dignostic Director, Regulatory Affairs at Novartis
Industry Medical Devices
Experience
Novartis Companion Diagnostics September 2012 - Present
Omron Healthcare, Inc. May 2010 - August 2012
Abbott Molecular Inc. March 2008 - May 2010
OraSure Technologies 2006 - 2008
Elusys Therapeutics, Inc. 2004 - 2006
Ortho Clinical Diagnostics 1989 - 2004
Johnson & Johnson 1989 - 2004
Skills
Quality System, FDA, Document Management, Quality Assurance, 21 CFR Part 11, CAPA, ISO 13485, Regulatory Affairs, Biotechnology, Medical Devices, GMP, Validation, V&V, GLP, ISO, Manufacturing, Quality Management, Cross-functional Team..., Regulatory Submissions, Design Control, Pharmaceutical Industry, Lifesciences, Quality Auditing, Sop, Change Control, Software Documentation
Education
Villanova University 2006 — 2007
Six Sigma Black Belt, Process Excellence
Regis University 2003 — 2005
MBA
Kean University 1980 — 1985
Bachelors of Science, Medical Technology
Novartis Companion Diagnostics September 2012 - Present
Omron Healthcare, Inc. May 2010 - August 2012
Abbott Molecular Inc. March 2008 - May 2010
OraSure Technologies 2006 - 2008
Elusys Therapeutics, Inc. 2004 - 2006
Ortho Clinical Diagnostics 1989 - 2004
Johnson & Johnson 1989 - 2004
Skills
Quality System, FDA, Document Management, Quality Assurance, 21 CFR Part 11, CAPA, ISO 13485, Regulatory Affairs, Biotechnology, Medical Devices, GMP, Validation, V&V, GLP, ISO, Manufacturing, Quality Management, Cross-functional Team..., Regulatory Submissions, Design Control, Pharmaceutical Industry, Lifesciences, Quality Auditing, Sop, Change Control, Software Documentation
Education
Villanova University 2006 — 2007
Six Sigma Black Belt, Process Excellence
Regis University 2003 — 2005
MBA
Kean University 1980 — 1985
Bachelors of Science, Medical Technology
elizabeth posillico, PhD's Elusys Therapeutics, Inc. Experience 2005 - Present
Job President & CEO at Elusys Therapeutics, Inc.
Industry Biotechnology
Experience
Elusys Therapeutics, Inc. 2005 - Present
Elusys Therapeutics, Inc. 2002 - 2005
Physiome Sciences 1999 - 2002
apoptogen 1996 - 1999
Genzyme 1986 - 1994
Skills
Immunology, Business Development, Lifesciences, Drug Development, Biotechnology, Biopharmaceuticals, Clinical Development, Pharmaceutical Industry, Technology Transfer, Drug Discovery, Oncology, Cell
Education
Duke University 1976 — 1981
PhD, Cell Biology
SUNY Potsdam 1974 — 1976
BA, Biology
Elusys Therapeutics, Inc. 2005 - Present
Elusys Therapeutics, Inc. 2002 - 2005
Physiome Sciences 1999 - 2002
apoptogen 1996 - 1999
Genzyme 1986 - 1994
Skills
Immunology, Business Development, Lifesciences, Drug Development, Biotechnology, Biopharmaceuticals, Clinical Development, Pharmaceutical Industry, Technology Transfer, Drug Discovery, Oncology, Cell
Education
Duke University 1976 — 1981
PhD, Cell Biology
SUNY Potsdam 1974 — 1976
BA, Biology
Estee Orani's Elusys Therapeutics, Inc. Experience May 2011 - August 2011
Job Quality Assurance Manager at BioArray Solutions
Industry Medical Devices
Experience
BioArray Solutions August 2013 - Present
BioArray Solutions August 2011 - August 2013
Elusys Therapeutics, Inc. May 2011 - August 2011
Elusys Therapeutics, Inc. November 2009 - May 2011
Perri Hecht Speech & Auditory Services September 2006 - October 2009
Rutgers University August 2008 - May 2009
Clara Maas Medical Center July 2007 - August 2007
Bioinformatics Lab at Brooklyn College August 2005 - January 2006
Reut Medical Center, Tel Aviv June 2003 - August 2005
American Health Aid July 2004 - August 2004
Skills
Matlab, Mathematica, Maple, Instron, Centrifugation, Pipetting, VRML, Testing, Validation, Biotechnology, FDA, Lifesciences, Quality System, Pharmaceutical Industry, GMP, Quality Assurance, Medical Devices, CAPA
Education
Rutgers University-New Brunswick 2006 — 2009
BS, Biomedical Engineering
City University of New York-Brooklyn College 2005 — 2005
Engineering
BioArray Solutions August 2013 - Present
BioArray Solutions August 2011 - August 2013
Elusys Therapeutics, Inc. May 2011 - August 2011
Elusys Therapeutics, Inc. November 2009 - May 2011
Perri Hecht Speech & Auditory Services September 2006 - October 2009
Rutgers University August 2008 - May 2009
Clara Maas Medical Center July 2007 - August 2007
Bioinformatics Lab at Brooklyn College August 2005 - January 2006
Reut Medical Center, Tel Aviv June 2003 - August 2005
American Health Aid July 2004 - August 2004
Skills
Matlab, Mathematica, Maple, Instron, Centrifugation, Pipetting, VRML, Testing, Validation, Biotechnology, FDA, Lifesciences, Quality System, Pharmaceutical Industry, GMP, Quality Assurance, Medical Devices, CAPA
Education
Rutgers University-New Brunswick 2006 — 2009
BS, Biomedical Engineering
City University of New York-Brooklyn College 2005 — 2005
Engineering
Cristen Taft-Bourgo's Elusys Therapeutics, Inc. Experience November 2012 - October 2014
Job Development and Manufacturing Specialist at Elusys Therapeutics
Industry Pharmaceuticals
Experience
Elusys Therapeutics October 2014 - Present
Elusys Therapeutics, Inc. November 2012 - October 2014
Dendreon July 2011 - October 2012
Dendreon November 2009 - August 2012
Roche Molecular Systems June 2005 - May 2009
starbucks 2000 - 2005
Skills
Chemistry, HPLC, ELISA, Gas Chromatography, V&V, Quality Control, Microbiology, Biotechnology, Lifesciences, CAPA, Change Control, LIMS, Assay Development, GMP, Pharmaceutical Industry, FDA, GLP, Validation, Cleaning Validation, Quality Assurance, Sop, Quality System, Manufacturing, Analytical Chemistry, 21 CFR Part 11, Biopharmaceuticals, Aseptic Technique, Regulatory Affairs, UV/Vis, Chromatography, GxP
Education
Ramapo College of New Jersey 2000 — 2005
BS, Biochemistry
Elusys Therapeutics October 2014 - Present
Elusys Therapeutics, Inc. November 2012 - October 2014
Dendreon July 2011 - October 2012
Dendreon November 2009 - August 2012
Roche Molecular Systems June 2005 - May 2009
starbucks 2000 - 2005
Skills
Chemistry, HPLC, ELISA, Gas Chromatography, V&V, Quality Control, Microbiology, Biotechnology, Lifesciences, CAPA, Change Control, LIMS, Assay Development, GMP, Pharmaceutical Industry, FDA, GLP, Validation, Cleaning Validation, Quality Assurance, Sop, Quality System, Manufacturing, Analytical Chemistry, 21 CFR Part 11, Biopharmaceuticals, Aseptic Technique, Regulatory Affairs, UV/Vis, Chromatography, GxP
Education
Ramapo College of New Jersey 2000 — 2005
BS, Biochemistry
Nestor Gonzales's Elusys Therapeutics, Inc. Experience November 2011 - June 2015
Job Director, GCP Quality Assurance at The Medicines Company
Industry Pharmaceuticals
Experience
The Medicines Company July 2015 - Present
Elusys Therapeutics, Inc. November 2011 - June 2015
Merck & Co., Inc. July 2011 - November 2011
Merck formerly Schering-Plough July 2009 - July 2011
Schering-Plough Research Institute December 2003 - June 2009
Schering-Plough Research Institute February 2000 - December 2003
Saint Clare's Health System January 1993 - October 2000
Skills
Pharmaceutical Industry, Regulatory Submissions, 21 CFR Part 11, Sop, Bioanalysis, Validation, GLP, Quality Assurance, FDA, Drug Discovery, Toxicology, CRO, LIMS, GMP, CAPA, Cross-functional Team..., Quality System, Lifesciences, GxP, Drug Development, GCP, Computer System..., Biotechnology, Regulatory Requirements, Analytical Chemistry, ELISA, Monoclonal Antibodies, IND, Clinical Development, Regulatory Affairs, Clinical Trials, Protocol, Microbiology, Life Sciences, SOP
Education
Centenary College 2004 — 2005
Master of Business Administration (MBA), Business Administration and Management, General
William Paterson University of New Jersey 1995 — 1999
Bachelor's degree, Biology/Biological Sciences, General
The Medicines Company July 2015 - Present
Elusys Therapeutics, Inc. November 2011 - June 2015
Merck & Co., Inc. July 2011 - November 2011
Merck formerly Schering-Plough July 2009 - July 2011
Schering-Plough Research Institute December 2003 - June 2009
Schering-Plough Research Institute February 2000 - December 2003
Saint Clare's Health System January 1993 - October 2000
Skills
Pharmaceutical Industry, Regulatory Submissions, 21 CFR Part 11, Sop, Bioanalysis, Validation, GLP, Quality Assurance, FDA, Drug Discovery, Toxicology, CRO, LIMS, GMP, CAPA, Cross-functional Team..., Quality System, Lifesciences, GxP, Drug Development, GCP, Computer System..., Biotechnology, Regulatory Requirements, Analytical Chemistry, ELISA, Monoclonal Antibodies, IND, Clinical Development, Regulatory Affairs, Clinical Trials, Protocol, Microbiology, Life Sciences, SOP
Education
Centenary College 2004 — 2005
Master of Business Administration (MBA), Business Administration and Management, General
William Paterson University of New Jersey 1995 — 1999
Bachelor's degree, Biology/Biological Sciences, General
Yolanda C. Castillo, RN, BSN's Elusys Therapeutics, Inc. Experience 2004 - 2006
Job Sr. Clinical Research Consultant
Industry Pharmaceuticals
Experience
Clinical Research Consulting November 1995 - Present
Daiichi Sankyo February 2009 - December 2009
Johnson & Johnson (Raritan) 2008 - 2009
Schering-Plough Research Institute 2006 - 2007
Elusys Therapeutics, Inc. 2004 - 2006
Novartis 2003 - 2004
Sanofi-Synthelabo 2002 - 2003
Teva Pharmaceuticals 1999 - 2000
Pfizer Pharmaceuticals 1998 - 1998
Roberts Pharmaceuticals (Shire) 1996 - 1997
Skills
CRO, CTMS, Clinical Development, Clinical Trials, Medical Writing, Pharmaceutical Industry, Oncology, Regulatory Submissions, Biotechnology, Clinical Research, Regulatory Affairs, Clinical Monitoring, EDC, GCP, Infectious Diseases, Lifesciences, Data Management, ICH-GCP, Therapeutic Areas, Medical Devices, Clinical Data Management, Protocol, Sop, Quality Assurance, Pharmacovigilance
Education
Manila Central University
Bachelor of Science in Nursing
Thomas Jefferson University
Diagnostic Medical Sonography/Sonographer and Ultrasound Technician
Thomas Jefferson University and Manila Central University
Bachelor's degree, Nursing Research and Clinical Nursing, CT Scan
Clinical Research Consulting November 1995 - Present
Daiichi Sankyo February 2009 - December 2009
Johnson & Johnson (Raritan) 2008 - 2009
Schering-Plough Research Institute 2006 - 2007
Elusys Therapeutics, Inc. 2004 - 2006
Novartis 2003 - 2004
Sanofi-Synthelabo 2002 - 2003
Teva Pharmaceuticals 1999 - 2000
Pfizer Pharmaceuticals 1998 - 1998
Roberts Pharmaceuticals (Shire) 1996 - 1997
Skills
CRO, CTMS, Clinical Development, Clinical Trials, Medical Writing, Pharmaceutical Industry, Oncology, Regulatory Submissions, Biotechnology, Clinical Research, Regulatory Affairs, Clinical Monitoring, EDC, GCP, Infectious Diseases, Lifesciences, Data Management, ICH-GCP, Therapeutic Areas, Medical Devices, Clinical Data Management, Protocol, Sop, Quality Assurance, Pharmacovigilance
Education
Manila Central University
Bachelor of Science in Nursing
Thomas Jefferson University
Diagnostic Medical Sonography/Sonographer and Ultrasound Technician
Thomas Jefferson University and Manila Central University
Bachelor's degree, Nursing Research and Clinical Nursing, CT Scan
Irena Kirman's Elusys Therapeutics, Inc. Experience 2006 - 2010
Job consultant
Industry Biotechnology
Experience
Beardsworth Consulting Group January 2011 - April 2011
Elusys Therapeutics, Inc. 2006 - 2010
Columbia University 1998 - 2005
Education
Rigas Stradina Universitate 1974 — 1990
MD, PhD, Medicine, Immunology
Beardsworth Consulting Group January 2011 - April 2011
Elusys Therapeutics, Inc. 2006 - 2010
Columbia University 1998 - 2005
Education
Rigas Stradina Universitate 1974 — 1990
MD, PhD, Medicine, Immunology
Natalya Serbina's Elusys Therapeutics, Inc. Experience October 2011 - Present
Job Senior Scientist, Nonclinical Development at Elusys Therapeutics, Inc.
Industry Pharmaceuticals
Experience
Elusys Therapeutics, Inc. October 2011 - Present
Memorial Sloan-Kettering Cancer Center 2007 - 2010
Memorial Sloan-Kettering Cancer Center 2005 - 2007
Memorial Sloan-Kettering Cancer Center 2001 - 2005
Skills
Drug Discovery, Biotechnology, Molecular Biology, Immunology, Infectious Diseases, Animal Models, Flow Cytometry, Clinical Trials, Drug Development, ELISA, Lifesciences, Cell, Cell Biology, Cell Culture
Education
University of Pittsburgh School of Medicine 1994 — 2000
Ph.D., Immunology
University of Pittsburgh 1992 — 1993
B.S., Biochemistry
Novosibirsk State University (NSU) 1987 — 1991
Biology
Elusys Therapeutics, Inc. October 2011 - Present
Memorial Sloan-Kettering Cancer Center 2007 - 2010
Memorial Sloan-Kettering Cancer Center 2005 - 2007
Memorial Sloan-Kettering Cancer Center 2001 - 2005
Skills
Drug Discovery, Biotechnology, Molecular Biology, Immunology, Infectious Diseases, Animal Models, Flow Cytometry, Clinical Trials, Drug Development, ELISA, Lifesciences, Cell, Cell Biology, Cell Culture
Education
University of Pittsburgh School of Medicine 1994 — 2000
Ph.D., Immunology
University of Pittsburgh 1992 — 1993
B.S., Biochemistry
Novosibirsk State University (NSU) 1987 — 1991
Biology
ketal shah's Elusys Therapeutics, Inc. Experience 2007 - 2008
Job Sr. Scientist at Eurofins Labs, working at Merck Inc.
Industry Pharmaceuticals
Experience
Merck June 2015 - Present
Eurofins Labs working at Merck July 2014 - June 2015
Tandem Labs July 2008 - July 2014
Elusys Therapeutics, Inc. 2007 - 2008
Ortho Clinical Diagnostics September 2004 - May 2005
Elusys Therapeutics March 2002 - September 2004
Roche February 2001 - March 2002
Skills
GLP, ELISA, Drug Discovery, Bioanalysis, Immunoassays, Chromatography, Protein Chemistry, HPLC, LIMS, Pharmaceutical Industry, Lifesciences, Cell Culture, Cell, CRO, Biotechnology, GMP, Biochemistry, Validation, Clinical Development, Drug Development, Immunology, PCR, Chemistry, Molecular Biology, Microbiology
Education
Rutgers, The State University of New Jersey-New Brunswick 1999 — 2001
BA, Biochemistry
Merck June 2015 - Present
Eurofins Labs working at Merck July 2014 - June 2015
Tandem Labs July 2008 - July 2014
Elusys Therapeutics, Inc. 2007 - 2008
Ortho Clinical Diagnostics September 2004 - May 2005
Elusys Therapeutics March 2002 - September 2004
Roche February 2001 - March 2002
Skills
GLP, ELISA, Drug Discovery, Bioanalysis, Immunoassays, Chromatography, Protein Chemistry, HPLC, LIMS, Pharmaceutical Industry, Lifesciences, Cell Culture, Cell, CRO, Biotechnology, GMP, Biochemistry, Validation, Clinical Development, Drug Development, Immunology, PCR, Chemistry, Molecular Biology, Microbiology
Education
Rutgers, The State University of New Jersey-New Brunswick 1999 — 2001
BA, Biochemistry
Edward Messick's Elusys Therapeutics, Inc. Experience 2010 - 2014
Job Bioinformatics, Software Development, Pharmaceuticals
Industry Pharmaceuticals
Experience
Quintiles May 2014 - October 2014
Elusys Therapeutics, Inc. 2010 - 2014
Rutgers University September 2013 - December 2013
St. Joseph Medical Center May 2008 - October 2012
Pathmark Stores, Inc. May 2011 - June 2011
Skills
Pharmaceutical Industry, Biotechnology, Microsoft Office, Data Analysis, PowerPoint, Microsoft Excel, Analysis, Microsoft Word, HTML, Healthcare, Research, C, Databases, Project Management, Software Project..., Marketing Strategy, Team Leadership, Pharmacology, JAVA, Python
Education
New Jersey Institute of Technology 2015 — 2016
Master's Degree, Bioinformatics, Computer Science, 4.0
Rutgers, The State University of New Jersey-New Brunswick 2006 — 2014
Bachelor of Science, Cell Biology and Neuroscience, Pharmaceutical Industry, Biotechnology, Computer Science, Biology, Business
Montville Township High School 2004 — 2008
Quintiles May 2014 - October 2014
Elusys Therapeutics, Inc. 2010 - 2014
Rutgers University September 2013 - December 2013
St. Joseph Medical Center May 2008 - October 2012
Pathmark Stores, Inc. May 2011 - June 2011
Skills
Pharmaceutical Industry, Biotechnology, Microsoft Office, Data Analysis, PowerPoint, Microsoft Excel, Analysis, Microsoft Word, HTML, Healthcare, Research, C, Databases, Project Management, Software Project..., Marketing Strategy, Team Leadership, Pharmacology, JAVA, Python
Education
New Jersey Institute of Technology 2015 — 2016
Master's Degree, Bioinformatics, Computer Science, 4.0
Rutgers, The State University of New Jersey-New Brunswick 2006 — 2014
Bachelor of Science, Cell Biology and Neuroscience, Pharmaceutical Industry, Biotechnology, Computer Science, Biology, Business
Montville Township High School 2004 — 2008
Camille Gentle's Elusys Therapeutics, Inc. Experience April 2011 - September 2011
Job Scientist (Cell Culture) at Pfizer
Industry Research
HAILIN WANG's Elusys Therapeutics, Inc. Experience November 2006 - October 2007
Job Clinical Date Associate at CRAA
Industry Research
Experience
CRAA August 2014 - Present
International Flavors and Fragrances, Inc. November 2007 - July 2014
Elusys Therapeutics, Inc. November 2006 - October 2007
UMDNJ September 2002 - October 2006
BioNike Laboratories, Inc. July 2000 - August 2002
Johns Hopkins School of Medicine September 1997 - July 2000
Skills
Molecular Biology, Molecular & Cellular..., Immunology, HTS with Flipr-Tetra..., Assay Development, Cell, ELISA, Protein Chemistry, Cell Culture, High Throughput..., Protein Expression, Purification, Cell Biology, RT-PCR, Antibodies, DNA, Recombinant DNA, Monoclonal Antibodies, Laboratory, Infectious Diseases, Yeast, Biochemistry, Microbiology, Western Blotting
Education
Lanzhou Institute of Bioproducts, Health Ministry in China 1990 — 1993
Master's degree, Microbiology and Immunology
Lanzhou University 1983 — 1987
Bachelor's degree, Cell biology and Anatomy, 3.7
CRAA August 2014 - Present
International Flavors and Fragrances, Inc. November 2007 - July 2014
Elusys Therapeutics, Inc. November 2006 - October 2007
UMDNJ September 2002 - October 2006
BioNike Laboratories, Inc. July 2000 - August 2002
Johns Hopkins School of Medicine September 1997 - July 2000
Skills
Molecular Biology, Molecular & Cellular..., Immunology, HTS with Flipr-Tetra..., Assay Development, Cell, ELISA, Protein Chemistry, Cell Culture, High Throughput..., Protein Expression, Purification, Cell Biology, RT-PCR, Antibodies, DNA, Recombinant DNA, Monoclonal Antibodies, Laboratory, Infectious Diseases, Yeast, Biochemistry, Microbiology, Western Blotting
Education
Lanzhou Institute of Bioproducts, Health Ministry in China 1990 — 1993
Master's degree, Microbiology and Immunology
Lanzhou University 1983 — 1987
Bachelor's degree, Cell biology and Anatomy, 3.7
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY