Histogenics Corporation
Industry: Company
DescriptionHeadquarters: Waltham, MA Founded: 2000 Subsidiaries: ProChon Biotech Ltd., Histogenics Limited, Histogenics Securities Corporation
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Histogenics Corporation Employees
Histogenics Corporation July 2014 - Present
Genzyme November 2011 - July 2014
Genzyme October 2010 - November 2011
Genzyme April 2007 - October 2010
Genzyme June 2003 - April 2007
Genzyme June 2001 - June 2003
Eli Lilly and Company June 2000 - August 2000
Skills
CAPA, FDA, Quality Assurance, Change Control, Sop, Quality System, Process Engineering, Cross-functional Team..., Chromatography, Quality Control, Root Cause Analysis, Manufacturing
Education
University of Michigan 2000 — 2001
Master of Science (MS), Biomedical Engineering
University of Michigan 1996 — 2000
Bachelor of Science in Engineering (BSE), Chemical Engineering
Sucampo Pharmaceuticals, Inc. December 2014 - Present
Portola Pharmaceuticals March 2014 - Present
Histogenics Corporation November 2013 - Present
Biotechnology Industry Organization January 2013 - Present
Pharmaceutical Research and Manufacturers of America January 2013 - Present
Cempra July 2009 - Present
Cortendo AB March 2015 - Present
Dendreon Corporation January 2012 - August 2014
Tranzyme Pharma December 2010 - July 2013
New Jersey BIO January 2009 - January 2013
Education
University of Rochester - Simon Business School 1984 — 1986
East Stroudsburg University of Pennsylvania 1978 — 1981
Bachelor of Science (BS)
University of Pittsburgh 1976 — 1978
Histogenics Corporation August 2014 - Present
including SerenaGroup February 2013 - 2014
Shire Regenerative Medicine November 2008 - January 2013
Johnson & Johnson January 2006 - November 2008
OraPharma Inc. March 2001 - January 2006
Skills
Certified Clinical...
Education
Penn State University 1983 — 1987
BS, Business Logistics
Histogenics Corporation February 2015 - Present
Histogenics January 2014 - February 2015
Histogenics September 2012 - January 2014
Boston Medical Center September 2011 - September 2012
Northeastern University January 2011 - September 2011
Northeastern University September 2009 - December 2010
MassAHEC Health Workforce June 2010 - September 2010
Dana-Farber Cancer Institute March 2008 - August 2009
Dana-Farber Cancer Institute December 2007 - August 2009
Dana-Farber Cancer Institute December 2007 - March 2008
Skills
Public Health, Research, Grant Writing, Clinical Research, Literature Reviews, Healthcare, Data Collection, Policy Analysis, Program Evaluation, Qualitative Research, Data Analysis, Non-profits, Health Education, Program Development, Nonprofits, Fundraising, Public Speaking, Key Account Management, IRB
Education
Northeastern University 2009 — 2011
Master, Public Health
University of Nottingham, School of Politics 2006 — 2007
Master of Arts, International Relations
University of Massachusetts, Amherst 2003 — 2006
BA, Spanish and Italian
Stoneham High
American Surgical Company April 2014 - Present
RVJ Enterprises, LLC. of Bourne, MA July 2012 - Present
Histogenics Corporation, August 2012 - March 2014
DePuy Spine May 2001 - November 2011
Smith & Nephew, ENT February 1998 - April 2001
Ansell Perry, Inc. 1995 - 1998
Smith & Nephew, Perry 1993 - 1995
Skills
16 + years of Marketing..., Excellent Relations..., Strategic & Tactical..., Cross-functional Team..., Product Branding &..., Asset Management, Forecasting & Sales..., Financial Modeling, Strong Crisis Management, Profitability & Value..., Product Launch &..., Global Business..., External & Internal..., Product Management, Product Life Cycle..., Marketing Strategy, Marketing Operations, Medical Device Marketing, Healthcare Marketing, Upstream and Downstream..., Promo & P/L Budget..., Product Launch, Medical Devices, Strategic Planning, Cross-functional Team..., Marketing, Positioning, FDA, Surgery, Product Lifecycle..., Biologics, Marketing Management, Surgical Instruments, Spine, Surgeons, Operating Room, Commercialization, Orthopedic, Product Development, Disposables, Market Development, Global Marketing, Capital Equipment, Neurosurgery, Urology, Sales Operations, ISO 13485, Design Control, ENT, Sales Effectiveness
Education
University of Phoenix, Phoenix, AZ 2003 — 2005
MBA, Business Administration and Management, General
Nicholls State University 1980 — 1985
Bachelor of Science:, Marketing / Aeronautical Science
Vanguard Clinical Consulting January 2013 - Present
Isis Pharmaceuticals June 2012 - Present
Histogenics Corporation April 2014 - Present
Millennium Pharmaceuticals October 2011 - October 2013
Advanced BioHealing February 2009 - October 2011
Tissue Repair Company April 2008 - February 2009
Cardium Therapeutics April 2008 - February 2009
PPD, Inc. July 2007 - April 2008
Covance, Inc. December 2006 - June 2007
University of California, San Diego February 2006 - December 2006
Skills
Clinical Trials, Clinical Development, Biotechnology, Oncology, CTMS, CRO, GCP, Pharmaceutical Industry, Clinical Research, EDC, Sop, Clinical Monitoring, FDA, Medical Devices, Clinical Data Management, Protocol Design, Operations Management, Cross-functional Team..., ICH-GCP, Clinical Study Design, Clinical Operations, Diabetes, Regulatory Requirements, Data Management, Vendor Management, SOP
Education
University of California, San Diego 2000 — 2005
Bachelor of Science/Bachelor of Arts, Biology/English Literature
Histogenics Corporation July 2013 - Present
Genzyme Biosurgery January 2012 - July 2013
OPK Biotech, LLC October 2011 - January 2012
OPK Biotech, LLC February 2010 - October 2011
Sur La Table January 2007 - February 2010
Sur La Table October 2006 - December 2006
Skills
Biotechnology, HPLC, Protein Purification, Troubleshooting, Customer Service, Sales, Sop, Purification, Gel Electrophoresis, GMP, Chromatography, GLP, Validation, ELISA, CAPA, Aseptic Technique, SOP
Education
Boston University School of Medicine 2006 — 2007
Biomedical Laboratory Science, Biotechnology
Synta Pharmaceuticals April 2015 - Present
Histogenics Corporation February 2015 - March 2015
IntelligentMDx July 2013 - January 2015
Predictive BioSciences January 2012 - June 2013
Predictive BioSciences 2011 - 2012
BioSphere Medical May 2008 - December 2010
BioSphere Medical, Inc. 2004 - 2008
BioSphere Medical, Inc. 2000 - 2004
Feinstein Kean Healthcare June 1999 - November 2000
Prior Experience 1995 - 2000
Skills
Human Resources, Start-ups, Recruiting, Training, Employee Relations, HRIS, Strategy, Change Management, Sales Management, Team Building, Personnel Management, Strategic Partnerships, Management, Program Management, Process Improvement, Succession Planning, Medical Devices, Leadership, Operations Management, Mergers & Acquisitions, Coaching, Strategic Planning, Deferred Compensation, Hiring, Talent Acquisition, Negotiation, Marketing, Employee Benefits, Sales, Talent Management, HR Consulting, Project Planning, Organizational..., Executive Management, Onboarding, Performance Management, Consulting, Applicant Tracking..., Benefits Administration, Workforce Planning, Employee Engagement, Career Development, Biotechnology, Investor Relations
Education
University of Massachusetts Boston
BioStructures, LLC. January 2015 - June 2015
PMI San Diego Chapter July 2014 - December 2014
Advanced Biologics, LLC April 2010 - April 2014
Alphatec Spine December 2007 - April 2010
Histogenics Corporation April 2006 - November 2007
Skills
Biomaterials, Cell Culture, Testing, Registered patent agent, IP, Tissue Engineering, Medical Devices, Cell, R&D, Biomedical Engineering, Characterization, Minitab, Patents, Project Management, Spine, Registered Patent..., Design Control, Product Development, ISO 13485, Design of Experiments, FDA, Management
Education
University of California, San Diego 2008 — 2010
Certificate, Project Management
Columbia University in the City of New York 2004 — 2006
M.S., Biomedical Engineering
Clemson University 2002 — 2004
M.S., Bioengineering
University of Toronto 1998 — 2002
B.S., Materials Engineering
Histogenics Corporation July 2014 - Present
McGladrey December 2011 - July 2014
Grace-Hunt, LLC June 2006 - December 2011
ePartners August 1998 - May 2006
Vitale Caturano 1998 - 1998
KPMG 1995 - 1998
Donlan Financial Group 1985 - 1995
Skills
Microsoft Dynamics, Professional Services, ERP, Intacct, NetSuite, Business Process..., Crystal Reports, CRM, Business Intelligence, Microsoft CRM, Business Process, Software Implementation, Business Analysis, SharePoint, Consulting
Education
Bentley College - Elkin B. McCallum Graduate School of Business 1986 — 1989
MBA, Accounting
University of Massachusetts Dartmouth 1982 — 1985
BS, Finance
Massasoit Community College 1980 — 1982
Associates - Science, Science
Histogenics Corporation September 2015 - Present
Skills
Accounting, Financial Analysis, Financial Reporting, Sarbanes-Oxley Act, Auditing, SEC filings, Revenue Recognition, Internal Controls, Strategic Financial..., US GAAP, Valuation, Business Planning, Tax, ERP Selection, ERP Implementations, Mergers & Acquisitions, Cash Management, Vendor Management, Management, IPO, Due Diligence, Microsoft Excel, Corporate Finance, Finance, Budgets, ERP, Consolidation, Managerial Finance, Compliance, IPO Readiness, Treasury Management, Risk Management, Purchasing Processes, Financial Modeling, SEC Filings
Education
Bentley College - Elkin B. McCallum Graduate School of Business 1992 — 1996
MSF
University of Massachusetts Boston 1982 — 1986
BS
Xaverian
Histogenics Corporation 2014 - Present
Pernix Therapeutics March 2010 - Present
Neurocrine Biosciences 2002 - Present
Specialty Pharma Consulting Inc 2000 - Present
Orexigen Pharmaceuticals 2009 - 2010
Amgen Inc. 2005 - 2006
Skills
Pharmaceutical Industry, Drug Development, Clinical Trials, Biotechnology, Clinical Development, Oncology, Regulatory Submissions, CRO, Life Sciences, FDA, GCP, Biopharmaceuticals, Clinical Research, Regulatory Affairs, Infectious Diseases, Medical Devices, Drug Discovery, Pharmacovigilance, Medicine, Psychiatry, Lifesciences, CTMS, Neuroscience, Gastroenterology
Education
University of California, San Diego - School of Medicine 1980 — 1984
MD, Medicine
Vericel Corporation December 2014 - Present
Histogenics Corporation 2015 - 2015
Histogenics Corporation 2015 - 2015
Histogenics Corporation 2015 - 2015
Worcester Polytechnic Institute 2014 - 2014
Worcester Polytechnic Institute 2014 - 2014
Skills
Thin Films, Sputtering, Characterization, Physics, PVD, Depositions, CVD, Spectroscopy, Scanning Electron..., Materials Science, Raman, Electrochemistry, Materials
Education
Worcester Polytechnic Institute 2014 — 2014
certificate in biomanufaturing
Bunker Hill Community College
Bunker Hill Community College
Bunker Hill Community College
Bunker Hill Community College
University of Massachusetts Boston
Histogenics Corporation July 2015 - Present
Genzyme June 2014 - December 2014
Anika Therapeutics June 2014 - June 2014
Eisai March 2013 - November 2013
Repligen Corporation November 2010 - November 2012
Joule Biotechnologies September 2008 - October 2010
Avecia Biotechnologies June 2005 - June 2008
Skills
Quality Control, Analytical Chemistry, Biotechnology, Chromatography, Pharmaceutical Industry, HPLC, GLP, Validation, GMP, FDA, Life Sciences, UV/Vis, LIMS, 21 CFR Part 11, CAPA
Education
University of Massachusetts Lowell 1998 — 2000
Masters, Clinincal lab Sciences
Histogenics Corporation July 2014 - Present
Millennium Pharmaceuticals January 2012 - June 2014
Eli Lilly & Co August 2009 - February 2012
Skills
Drug Development, Biotechnology, Oncology, Medical Writing, Pharmaceutical Industry, CRO, Clinical Trials, GCP, Clinical Operations, Medicine, Clinical Development, Regulatory Submissions, Clinical Data Management, Hematology, Clinical Research, EDC, Cancer, CTMS, Therapeutic Areas, Immunology
Education
Boston College
Bachelor of Science (B.S.), Nursing Science
University of California, San Francisco
Master's degree
Histogenics Corporation August 2013 - Present
Covidien June 2011 - July 2013
Covidien June 2010 - June 2011
Covidien, Surgical Devices June 2009 - June 2010
Covidien August 2006 - June 2009
Confluent Surgical June 2001 - August 2006
Boston Scientific June 1999 - May 2001
Computer Motion Incorporated April 1998 - April 1999
Biotronik April 1997 - April 1998
Telectronics June 1996 - December 1996
Skills
FDA, Clinical Affairs, Medical Devices, Design Control, ISO 13485, Regulatory Affairs, Clinical Trials, CAPA, Clinical Development, Biomedical Engineering, PMA, Biotechnology, Regulatory Submissions, CTMS, Commercialization, Validation, Lifesciences, GCP, Operating Room, Clinical Research, Cardiology, CRO, Oncology, Pharmaceutical Industry, Global Drug Development, Drug Development, Life Sciences
Education
Cleveland State University
Bachelor's Degree, Biology
Histogenics Corporation September 2014 - Present
Ironwood Pharmaceuticals May 2012 - July 2013
AMAG Pharmaceuticals July 2013 - 2013
Genzyme Biosurgery October 2008 - May 2012
Genzyme Biosurgery October 2007 - October 2008
Alkermes August 2000 - August 2001
Skills
GMP, Validation, Change Control, Quality Assurance, Sop, GLP, 21 CFR Part 11, GCP, GxP, CAPA, Pharmaceutical Industry, Regulatory Requirements, Data Management, SOP
Education
Suffolk University 2001 — 2005
BS/BA, Business Management
Pine Manor College 1998 — 2000
Histogenics Corporation April 2013 - Present
Terumo Cardiovascular Systems Corporation October 2011 - April 2013
Dept of Defense June 2009 - November 2012
Pliant Corporation August 2008 - July 2009
CR Bard February 2005 - August 2008
SC Johnson January 2004 - June 2004
Boston Scientific January 2003 - August 2003
Skills
Consumer Products, Leadership, FDA, Lean Manufacturing, Logistics, Management, Manufacturing, Medical Devices, Packaging, Packaging Engineering, Product Development, Quality Assurance, R, Six Sigma, Validation, Cross-functional Team...
Education
Boston University 2011 — 2013
MS Administrative Studies, Innovation and Technology Concentration
University of Wisconsin-Stout 1999 — 2004
BS, Packaging
Seton Medical Center Hays July 2009 - Present
Histogenics Corporation January 2008 - January 2009
BioVex Inc. January 2006 - May 2006
Antigenics, Inc December 2004 - July 2005
Pfizer Pharmaceuticals February 2002 - December 2004
Biogen Idec May 1998 - February 2001
Skills
Regulatory Affairs, Medical Writing, Protocol, Oversight, Training, Clinical Trials, Clinical Development, CRO, Drug Development, Biotechnology, Oncology, FDA, Pharmaceutical Industry, CTMS, Lifesciences, Clinical Research, Regulatory Submissions, Medical Devices, Sop, Infectious Diseases
Education
University of Illinois at Chicago 1991 — 1994
PharmD, Clinical Pharmaceutics
University of Houston-Clear Lake 1977 — 1980
MSc, Health Services Administration
Histogenics Corporation August 2014 - Present
Siemens Healthcare February 2014 - August 2014
Organogenesis May 2007 - February 2014
Stonehill College September 2006 - June 2010
Organogenesis Inc. September 2004 - May 2007
Skills
Cell Culture, Lifesciences, ELISA, Cell, Biotechnology, Validation, Cell Biology, GMP, GLP, PCR, Western Blotting, Aseptic Technique, In Vitro, Molecular Biology, Assay Development, Life Sciences
Education
Stonehill College 2000 — 2004
BS, Biochemistry
Histogenics Corporation 2014 - Present
Restoration Robotics July 2012 - April 2014
Medtronic September 2008 - July 2012
St. Jude Medical July 2005 - December 2005
Skills
Image Guided Surgery, FDA, Medical Imaging, ISO 13485, Computer Science, Solidworks, PTC Pro/Engineer, COMSOL, Labview, Design Control, GD&T, Matlab, Visual Basic, Computer Assisted..., Robotics, Medical Devices, Biomedical Engineering, Hospitals, Neurosurgery, Capital Equipment, Minimally Invasive..., Operating Room, Spine, Product Launch, Market Development, Sales Operations, Cross-functional Team..., SolidWorks, Product Development, LabVIEW, Healthcare, Management
Education
California Polytechnic State University-San Luis Obispo 2006 — 2008
Master of Science (M.S.), Biomedical/Medical Engineering
California Polytechnic State University-San Luis Obispo 2002 — 2006
Bachelor of Science (B.S.), General Engineering
Histogenics Corporation March 2014 - Present
Genzyme Biosurgery May 2011 - February 2014
CVS January 2005 - January 2009
Skills
GMP, R&D, Cell Culture, Manufacturing, FDA, Sop, Cell, Biotechnology, Pharmaceutical Industry, ELISA, Aseptic Technique, HPLC, Chromatography, Purification, Microbiology, SOP, TrackWise, Quality Control
Education
University of Massachusetts Lowell 2006 — 2010
Bachelor of Biological Sciences, Biotechnology
Histogenics Corporation September 2015 - Present
Siemens Healthcare March 2014 - September 2015
bluebird bio June 2010 - March 2014
Medway Public Schools August 2008 - June 2010
Genzyme Science January 2008 - February 2008
Genzyme Drug and Biomaterial Discovery and Development May 2007 - August 2007
Genzyme Drug and Biomaterial Discovery and Development December 2006 - January 2007
University of Massachusetts 2007 - 2007
Genzyme Drug and Biomaterial Discovery and Development January 2006 - August 2006
Putnam Investments 2004 - 2004
Skills
Western Blotting, Cell, Assay Development, SDS-PAGE, In Vitro, Cell Culture, PCR, Molecular Biology, Lifesciences, HPLC, Biotechnology, Flow Cytometry, High Throughput..., Immunology, ELISA, Biopharmaceuticals, Purification, Drug Discovery, Enzyme Assays, Biochemistry, Cell Biology, Gel Electrophoresis, Validation, Life Sciences
Education
University of Massachusetts, Amherst 2003 — 2008
B.S., Biology
Foxboro High School
Regis College
Regis College
Histogenics Corporation February 2015 - Present
Endochoice Holdings Inc. (GI) August 2014 - Present
Cempra Inc. April 2012 - Present
INC February 2011 - August 2013
TransEnterix, Inc. March 2009 - February 2011
INC Research 2007 - 2010
NxStage Medical July 2005 - November 2006
CTI Molecular Imaging January 2002 - May 2005
Interland Inc. March 2000 - September 2001
Novoste Corporation July 1996 - February 2000
Skills
Mergers, Venture Capital, Cardiology, Orthopedic, Capital Equipment, Private Equity, Clinical Research, Urology, IPO, Strategic Planning, Start-ups, Financial Modeling, Financial Analysis, Financial Reporting, Medical Devices, Finance, Mergers & Acquisitions, Biotechnology, Acquisition Integration, Investor Relations, Restructuring, Pharmaceutical Industry, Business Development, Due Diligence
Education
Emory University - Goizueta Business School 1992 — 1993
MBA
Wake Forest University 1973 — 1977
BS, Accounting
Histogenics October 2014 - Present
Histogenics Corporation March 2014 - October 2014
Histgenics June 2012 - November 2012
Histogenics July 2007 - March 2009
MediSpectra December 2005 - July 2007
Thoratec August 2005 - November 2005
MediSpectra June 2004 - June 2005
NMT Medical March 2004 - June 2004
MediSpectra September 2000 - November 2003
Presentation of Mary Academy September 1998 - August 2000
Skills
Field Monitoring..., Educator Certification...
Education
University of New England 1994 — 1998
Bachelor of Science (B.S.), Medical Biology