Histogenics Company
Industry: Company
DescriptionHeadquarters: Waltham, MA Founded: 2000 Subsidiaries: ProChon Biotech Ltd., Histogenics Limited, Histogenics Securities Corporation
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Histogenics Employees
Histogenics February 2013 - Present
Etex Corporation July 2012 - February 2013
ETEX Corporation September 2001 - July 2012
Massachusetts Institute of Technology January 2000 - August 2001
W.L. Gore June 1996 - August 1996
The Childrens Hospital of Philadelphia 1993 - 1994
Skills
Design Control, Six Sigma, Lean Sigma, Product Development, Packaging, FDA, Biomedical Engineering, Tissue Engineering, R&D, Clinical Research, Product Launch, Biomaterials, GMP, Validation, Medical Devices, Orthopedic, Design of Experiments, Drug Delivery, Biotechnology, Technology Transfer, ISO 13485, CAPA, Lifesciences, V&V, Clinical Development, Regulatory Affairs, Commercialization, Quality System, Biologics, Pharmaceutical Industry, GLP, Biopharmaceuticals, 21 CFR Part 11, Sop, Life Sciences, SOP, Orthopedics
Education
Boston University - School of Management 2008 — 2011
MBA, Business Administration
Massachusetts Institute of Technology 1999 — 2001
MS, Materials Science and Engineering
Penn State University 1993 — 1997
BS, Engineering Science and Mechanics
Allena Pharmaceuticals September 2012 - Present
Acceleron Pharma February 2012 - September 2012
SRU Biosystems February 2009 - December 2011
Histogenics June 2008 - December 2008
BD Biosciences January 2008 - June 2008
Alkermes January 2008 - March 2008
Skills
Cell Based Assays, Biochemical Assays, Surface Chemistry, Biotechnology, ELISA, Cell Culture, Lifesciences, Protein Chemistry, GMP, Biochemistry, SDS-PAGE, Molecular Biology, Medical Devices, Aseptic Technique, Laboratory, Assay Development, Immunoassays, Quality Control, Flow Cytometry, Sop, Cell
Education
Walden University 2013 — 2015
Master of Business Administration (MBA), Corporate Finance
University of Massachusetts at Lowell 2004 — 2007
Bachelor of Science (BS), Biology
Community College of Rhode Island 2003 — 2004
AS, Biology
Histogenics December 2014 - Present
New England Aquarium September 2014 - November 2014
New England Aquarium July 2012 - August 2014
Coastal Marine Education Research Academy July 2013 - August 2013
Genzyme April 2007 - July 2011
genzyme November 2001 - 2007
AstraZeneca August 2001 - October 2001
Collagenesis 1998 - 1999
Skills
Technical Writing, Aseptic Technique, Data Analysis, Quality Control, Pharmaceutical Industry, Microbiology
Education
University of New Hampshire Durham 2012 — 2014
Zoology/Animal Biology
UMass Lowell 1992 — 1997
BA, Enviomental Science
Dana-Farber Cancer Institute August 2014 - Present
Histogenics April 2012 - July 2014
New England Biolabs August 2011 - March 2012
Millennium Pharmaceuticals May 2011 - August 2011
Genzyme January 2010 - June 2010
Millennium Pharmaceuticals Inc., January 2009 - June 2009
Wyeth BioPharma May 2007 - July 2007
Skills
GMP, Quality Control, Quality Assurance, CAPA, Change Control, cGMP practices, Deviations/Investigation..., Medical Devices, Pharmaceutical Industry, Trackwise, DNA, HPLC, GxP, Microbiology, GLP, Antibodies, FDA, Cell, Quality System, 21 CFR Part 11, Lifesciences, Protein Chemistry, Cell Culture, Clinical Trials, Biotechnology, Western Blotting, SDS-PAGE, Validation, Software Documentation, Aseptic Processing, Affinity Chromatography, ELISA, Drug Development, LIMS, ISO 13485, Sop
Education
Northeastern University 2007 — 2011
Bachelor of Science (B.S.), Biology, General
Chelmsford High School 2002 — 2006
Histogenics July 2013 - Present
Genzyme January 2013 - July 2013
Validation Technologies, Inc. November 2011 - December 2012
MassBiologics August 2011 - November 2011
Masy Systems, Inc. May 2011 - July 2011
Masy Systems, Inc. July 2008 - January 2011
Skills
cGMP, Validation, GMP, ISO, Excel, Aseptic Technique, Cell Culture, EMT, Microbiology, Aseptic Processing, Microsoft Excel, Quality Control, Laboratory, FDA
Education
Worcester Polytechnic Institute 2007 — 2011
B.S., Biotechnology
Fachhochschule Konstanz - Hochschule für Technik, Wirtschaft und Gestaltung 2009 — 2009
German Language and Literature
Biogen Idec May 2013 - Present
Histogenics November 2011 - April 2013
Johnson & Johnson June 2009 - March 2011
Johnson & Johnson March 2007 - May 2009
Johnson & Johnson August 2005 - March 2007
Science Oriented Solutions (contract for J&J) July 2002 - August 2005
Skills
Orthopedic, Pharmaceutical Industry, Medical Devices
Education
Brown University 2000 — 2001
Residency
Georgetown University 1996 — 2000
MD
Boston College 1992 — 1996
BS, Biology
Celestica February 2013 - 2015
Celestica April 2009 - February 2013
Acusphere, Inc. October 2008 - April 2009
Confidential June 2008 - October 2008
Histogenics April 2007 - October 2008
Stryker Biotech 2006 - 2007
Alkermes 2001 - 2006
Armstrong Pharmaceuticals 1997 - 2002
ATC Associates 1993 - 1997
Skills
Strong technical and..., Working knowledge of..., Advanced knowledge of..., FDA, GMP, Iso 9000, Management, Budgets, Conflict Management, Forging, GCPs, Validation, ISO 13485, Laboratory, Team Building, Regulations, Manufacturing, Quality System, Strategy, Quality Auditing, Process Improvement, CAPA, Biotechnology, Cross-functional Team..., Six Sigma, Medical Devices, Quality Assurance, Supplier Quality, Pharmaceutical Industry
Education
University of Massachusetts Lowell 2003 — 2005
MS, Chemistry
Franklin Pierce University 2002 — 2005
MBA, Leadership
University of Massachusetts Lowell 1989 — 1994
BA; BS, Modern Languages; Chemistry
Cambridge IT Compliance LLC. March 2013 - Present
Syner-G Pharma CMC Consulting LLC September 2012 - Present
Histogenics November 2012 - March 2013
Ziopharm Oncology November 2012 - January 2013
Vertex Pharmaceuticals October 2011 - September 2012
Vertex Pharmaceuticals September 2008 - October 2011
My Piece Of Chennai January 2010 - July 2010
Bunker Hill Community College August 2008 - April 2010
Cignus Solutions LLC 2005 - January 2009
Wyeth 2006 - 2008
Skills
Entrepreneurship, Change Management, Strategic Planning, Consent Decree, Quality Assurance, Quality System, Laboratory Automation, Regulatory Guidelines, FDA, FDA GMP, 21 CFR Part 11, 21 CFR, Computer System..., Infrastructure, network qualification, ITIL, GAMP, System Design, System Testing, Business Requirements, Trackwise, Documentum, Argus Safety, ARISg, SAP, Oracle Applications, Biotechnology, GxP, GMP, Validation, Lifesciences, Change Control, Drug Development, CAPA, LIMS, Regulatory Requirements, Quality Auditing, Medical Devices, Quality Control, Technology Transfer, Sop, Pharmaceutical Industry, SOP, TrackWise, Life Sciences
Education
Babson College - Franklin W. Olin Graduate School of Business 2010 — 2012
Fast Track MBA
Texas A&M University-Corpus Christi 2002 — 2004
Masters of Science, Environmental Science
University of Madras 1996 — 2000
Bachelors in Engineering Degree, Electronics and Communication
St Bede's Anglo Indian Higher Secondary School 1983 — 1993
Higher Secondary
Quintiles July 2014 - Present
PAREXEL January 2013 - July 2014
PAREXEL Academy January 2013 - March 2013
Histogenics July 2011 - December 2012
Histogenics February 2011 - October 2011
Tetragenetics Inc. May 2011 - August 2011
Emmanuel College September 2009 - May 2011
Massachusetts General Hospital- Department of Anesthesia, Critical Care, and Pain Medicine June 2010 - September 2010
Skills
Project Management, EDC Development, Client Management, SDLC, GCP Compliance, Patient Safety, Clinical Trials, Clinical Research, Clinical Site Monitoring, Statistics, Data Analysis, Leadership, Change Control, GCP, Quality Control, Biotechnology, FDA, Validation, EDC, Regulatory Affairs, Microsoft Word, CTMS, Customer Service
Education
Salem State University 2013 — 2013
Management Certification, Clinical Trial Management
Emmanuel College 2007 — 2011
Bachelors of Science, Biology
Northeastern University 2010 — 2010
Emergency Medical Technician Certification, EMT-B
Mansfield High School 2003 — 2007
High School Degree, Academics
TESARO 2013 - Present
Dyax Corp. 2007 - 2013
Histogenics 2006 - 2007
Genentech 2004 - 2006
Human Genome Sciences 2001 - 2004
Gene Logic, Inc. 1998 - 2001
KPL 1988 - 1994
Skills
Quality Assurance, GMP, Biotechnology, FDA, Quality System, Sop, CAPA, Compliance, Trackwise, Quality Systems, cGMP, PAI, Master Control, Biopharmaceuticals, GLP, Technology Transfer
Education
The Johns Hopkins University
MS, Biotechnology
Whitford Corporation October 2014 - Present
IntelligentMDx March 2013 - June 2014
Novartis February 2011 - March 2013
Histogenics January 2010 - October 2010
Insulet Corporation January 2009 - October 2009
Osmetech Molecular Diagnostics March 2008 - December 2008
Osmetech Molecular Diagnostics July 2005 - March 2008
Tepnel Lifecodes Corporation August 2003 - July 2005
Lifecodes Corporation July 2000 - August 2003
Education
Westfield State University
Bachelor of Science Degree, Biology
Harvard University
ALM, Extension Studies
CROMSOURCE Inc. June 2012 - August 2014
Pleiad Inc April 2010 - July 2012
Clinical Consulting July 2009 - April 2010
Medvance Clinical Research Limited July 2008 - July 2009
Histogenics 2007 - 2008
Thoratec 2005 - 2007
Smith & Nephew Inc. 1995 - 2005
Acufex 1992 - 1995
Genzyme 1990 - 1992
American Medical Systems, Division of Pfizer 1984 - 1990
Skills
Medical Devices, Clinical Research, Clinical Trials, FDA, Regulatory Affairs, Biotechnology, Orthopedic, CTMS, CRO, Pharmaceutical Industry, Urology, Clinical Study Design, Surgery, Therapeutic Areas, Healthcare
Education
Stony Brook University 1975 — 1977
BS, Physician Assistant Education
University of Rochester
Histogenics December 2011 - April 2012
Moda Kai 2009 - September 2011
The Wedding Ring Shop 2008 - 2009
Museum of Fine Arts, Boston 2006 - 2008
Talbots 2003 - 2006
Museum Enterprise Partners 2002 - 2003
Staples 1998 - 2001
Skills
Visual Merchandising, Marketing, Inventory Control, Negotiation, Product Development, Demand Planning, Multi-channel Retail, Jewelry, Merchandising, Inventory Management, Customer Service, Sales, Microsoft Office, Event Planning, Budgets, Fashion
Education
Endicott College 1994 — 1998
BS, Retailing
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
PAREXEL March 2015 - Present
Histogenics April 2012 - March 2015
Skills
White belt to..., Safety Committee, First Aid, HAZWOPER, FDA Audit runner, Bioreactor change over..., GMP, FDA GMP, Area trainer, Cell Culture, Employee Training, Laboratory Skills, FDA, Sop, GLP, Clinical Development, 21 CFR Part 11, CTMS, Regulatory Affairs, Biotechnology, Pharmaceutical Industry, CAPA, Life Sciences, Medical Devices, Quality System, Quality Assurance, Change Control, Biopharmaceuticals, Validation, Aseptic Processing, Leadership, Microsoft Excel, Microsoft Office, LIMS, Clinical Trials, Laboratory, Process Improvement, Training, Microsoft Word, SOP, Quality Control, Cross-functional Team...
Education
Greater Lowell Technical School 1994 — 1997
Blueprint Medicines April 2015 - Present
Biocell Center Corp. November 2009 - Present
Broad Institute May 2014 - December 2014
Histogenics May 2013 - November 2013
Biogen Idec September 2011 - March 2013
Bedford Stem Cell research Foundation October 2010 - May 2012
Minerva Biotechnologies May 2010 - September 2010
Lonza: A Global Leader In Life Sciences October 2009 - May 2010
Microbia July 2007 - October 2009
Middlesex Community College July 2008 - January 2009
Skills
Cell Culture, Microbiology, Mammalian Cell Culture, Bioreactor, Sop, Fermentation, 21 CFR Part 11, Embryonic Stem Cells, Quality Control, Technology Transfer, Assay Development, Laboratory Skills, Reagents, SAP ERP, ELISA, Biotechnology, Life Sciences, FDA Clinical..., IPs cell lines, Stem Cells, growth, split and..., Cryopreservation of..., Media and buffers..., Preparation and..., Sterilization and ..., calibration of..., Small and Large..., Maintenance of..., Knowledge of cGMPS,..., Daily log books,..., Biohazard Disposal and..., DOT, RCRA, IATA..., Aliquots preparation, Replica plate
Education
Harvard Extension School 2015 — 2017
Bachelor’s Degree, Biology, Currently taking classes
Duke University School of Medicine 2013 — 2013
certification, FDA clinical investigator
Middlesex Community College 2007 — 2009
Associate, Biotechnology
Harvard stem cell institute 2008 — 2008
Training, embryonic stem cell
National University of Colombia 1995 — 1999
Bachelor's Degree, Agricultural Engineering, not Graduated
Amgen February 2013 - Present
Lantheus Medical Imaging July 2008 - February 2013
Histogenics February 2007 - March 2008
Nutramax January 2006 - November 2006
Skills
cGMP practices, Microbiology, LAL, Bioburden, LIMS, CAPA, Change Control, Environmental Monitoring, Sterility, Clean Rooms, Quality Control, Validation, ISOtrain, Aseptic Processing
Education
UMass Lowell 2004 — 2004
Graduate Certification, Biotechnology and BioProcessing
Bangalore University 2000 — 2002
Master of Science (MSc), Microbiology
ImmunoGen, Inc. January 2011 - Present
Histogenics November 2006 - January 2011
MediSpectra 2000 - 2006
Pfizer Infusaid 1988 - 1999
Skills
Regulatory Affairs, Clinical Development, Clinical Research, Biotechnology, Clinical Trials, Regulatory Submissions, FDA, Lifesciences, Drug Development, Sop, CRO, Pharmaceutical Industry, Drug Discovery, GCP, Technology Transfer
Education
Brown University
BS, Biochemistry
University of Rochester
MS PhD, Biochemistry Toxicology
Histogenics May 2014 - Present
Merz North America October 2012 - May 2014
Merz Aesthetics September 2011 - October 2012
Merz Aesthetics August 2010 - September 2011
BioForm Medical, Inc. September 2008 - August 2010
BioForm Medical July 2005 - September 2008
BioForm Medical, Inc. May 2004 - July 2005
BioForm Medical, Inc. September 2003 - April 2004
Gliatech November 1996 - June 2003
Pintail Systems, Inc. September 1990 - October 1996
Skills
Business Development, Medical Devices, Product Development, Corporate Development, Investor Relations, Strategy, Product Launch, Market Development, FDA, Start-ups, Cross-functional Team..., Pharmaceutical Industry, Biotechnology, Strategic Planning, Manufacturing, Venture Capital, Regulatory Affairs, R&D, Global Marketing, IPO, Commercialization, Healthcare, Lifesciences, Business Strategy, Competitive Analysis, Corporate Finance, Quality Assurance, Acquisition Integration, PMA, NDA, Mergers & Acquisitions
Education
University of Denver - Daniels College of Business 1994 — 1996
MBA
University of Denver 1990 — 1994
BS, Accounting
Histogenics May 2013 - Present
Histogenics April 2011 - April 2013
Commissioning Agents, Inc November 2010 - April 2011
Histogenics December 2009 - September 2010
Shire HGT April 2005 - November 2009
Shire HGT June 2001 - April 2005
TKT 2001 - 2004
Skills
GMP, Validation, SOP, Biotechnology, Cell Culture, cGMP, Documentation, Manufacturing, Aseptic Processing, SAP, Change Control, CAPA, Sop, Software Documentation, LIMS, Technology Transfer, Quality System, GLP, Medical Devices, Aseptic Technique, Biopharmaceuticals, Pharmaceutical Industry, Trackwise, 21 CFR Part 11, FDA
Education
Babson College - Franklin W. Olin Graduate School of Business 2014 — 2019
Master of Business Administration (MBA)
University of Massachusetts Dartmouth 1997 — 2001
BS, Biology, General
Histogenics July 2013 - Present
Comverse Technology September 2011 - March 2013
The Mayo Group October 2009 - August 2011
Ovid Technologies January 2008 - September 2009
Dresser, Inc. March 2006 - June 2007
GSI Group July 2004 - March 2006
Textron July 2002 - July 2004
American Tower January 2001 - July 2002
Parent, McLaughlin & Nangle, CPAs March 1998 - January 2001
Skills
Accounting, Technical Accounting..., Financial Reporting, Auditing, Sarbanes-Oxley, Analysis, P&L Operations, Financial Risk, Operational Risk, Enterprise Risk..., Budget Forecasts, G/L Reconciliations, Project Management, Enterprise Systems..., Month End Close, Strategic Finance, Consolidation, Consultation Skills, Revenue Recognition, Mentoring, Compliance, Operations Management
Education
Bentley University 1988 — 1992
Bachelor of Science (BS), Accounting
Enhanced Compliance Inc. March 2014 - Present
Enhanced Compliance September 2011 - Present
Hologic, Inc. 2015 - 2015
Atrium Medical Corporation 2014 - 2015
Atrium Medical Corporation 2014 - 2015
Atrium Medical Corporation 2014 - 2015
Histogenics 2013 - 2014
Histogenics 2013 - 2014
Boston Scientific January 2012 - May 2013
Boston Scientific, Marlborough, MA 2007 - 2012
Skills
Validation, Validations, Medical Devices, Quality Assurance, Compliance, Pharmaceuticals, Computer System..., R&D, CAPA, FDA, V&V, Sop, Design of Experiments, Pharmaceutical Industry, Testing, ISO 13485, Quality System, GMP, Change Control, Software, 21 CFR Part 11
Education
Northeastern University 1981 — 1985
Bachelor of Science (B.S.), Mechanical Engineering
University of Massachusetts Boston 1979 — 1981
Genzyme June 2012 - Present
Genzyme October 2010 - June 2012
Histogenics February 2010 - September 2010
GTC Biotherapeutics October 2004 - November 2009
Stryker Biotech March 1999 - September 2004
Biogen March 1990 - March 1999
Skills
GMP, HPLC, FDA, CAPA, Validation, Biotechnology, Pharmaceutical Industry, Change Control, Biopharmaceuticals, V&V, GLP, Quality Assurance, Sop, Analytical Chemistry, Quality Control, Quality System, Trackwise, Laboratory, Quality Management, GxP, Aseptic Processing, Assay Development, 21 CFR Part 11, Software Documentation, Technology Transfer, SDS-PAGE, LIMS
Education
Worcester Polytechnic Institute 2007 — 2008
Graduate Certificate
Rochester Institute of Technology 1983 — 1987
Bachelor of Science (B.S.)
Shire March 2014 - Present
IMC Global Services September 2013 - January 2014
Histogenics August 2012 - September 2013
Genzyme February 2011 - August 2012
Genzyme June 2009 - February 2011
Hyaluron November 2007 - June 2009
Hyaluron Contract Manufacturing November 2007 - June 2009
BD Biosciences January 2007 - November 2007
Biogen April 2006 - January 2007
Antigenics June 2004 - December 2005
Skills
FDA, Quality Assurance, CAPA, Biotechnology, V&V, ISO 13485, Microsoft Excel, Quality Control, Manufacturing, Trackwise, Software Documentation, Training, Change Control, Root Cause Analysis, Quality Auditing, cGMP practices, Quality System, GxP, Deviations
Education
St. Joseph's College (ME) 1985 — 1989
Bachelor's of Arts, Biology, General
Billerica Memorial High School
Lonza April 2012 - September 2013
Shire HGT May 2011 - March 2012
Genzyme March 2010 - May 2011
Bio-Concept Laboratories, Inc. August 2008 - March 2009
Histogenics May 2006 - July 2008
Massachusetts Biologic Laboratories May 2004 - May 2006
Biogen Idec December 1983 - November 2003
Skills
FDA, Biotechnology, Validation, GMP, Technology Transfer, Biopharmaceuticals, CAPA, GAMP, Quality System, GxP, Cell Culture, V&V, Sop, 21 CFR Part 11, Aseptic Processing, Change Control, Manufacturing, LIMS, Computer System..., GLP, Pharmaceutical Industry, Trackwise, Quality Assurance, Purification, Cleaning Validation, Regulatory Affairs, Lifesciences, Contract Manufacturing, Vaccines, Chromatography, Quality Control, Sterilization, Process Simulation, ISO 13485, Filtration, Medical Devices, R&D, Drug Development, Regulatory Requirements, Regulatory Submissions, Quality Auditing, Monoclonal Antibodies, HPLC, Clinical Trials, SOP
Education
Cambridge College 2004 — 2006
Master, Management
SeraCare Life Sciences May 2011 - December 2014
LeMaitre Vascular January 2009 - March 2011
Histogenics August 2008 - December 2008
ETEX Corporation 2007 - 2008
MicroDose Technologies 2000 - 2007
FDA 1996 - 2000
Skills
Clinical Research, FDA Submissions, FDA GMP, GCPs, GLPs, Project Management, Budget Process, Risk Management, Financial Analysis, Statistical Modeling, Strategic Planning, Product Development, Decision Modeling, Medical Devices, Pharmaceutical Industry, Biotechnology Industry, Regulatory Affairs, FDA, Design Control, Validation, Orthopedic, Biotechnology, Lifesciences, Clinical Trials, Drug Development, Clinical Development, Sop, ISO 13485, Biopharmaceuticals, Life Sciences, CAPA, SOP, CRO, Orthopedics, Oncology
Education
Babson College - Franklin W. Olin Graduate School of Business 2009 — 2012
MBA
Drexel University 1993 — 1998
B.S., Biology
Histogenetics Lab, NY October 2011 - Present
Histogenics November 2007 - September 2011
Histogenetics India Pvt. Ltd 2007 - 2008
Skills
PCR, DNA extraction, ELISA, DNA sequencing, DNA, Bioinformatics, Genetics, SDS-PAGE, Biochemistry, Biotechnology, Molecular Biology, Western Blotting, Cell Culture
Education
Bharathidasan University 2005 — 2007
Master of Science, Biotechnology
Histogenics 2006 - Present
Brigham and Women's Hospital 1990 - 2006
Skills
Tissue Engineering, ELISA, RT-PCR, Cell, Stem Cells, Histology, Clinical Trials, Medical Devices, Orthopedic, R&D, Animal Models, Biotechnology, GLP, FDA, Biomaterials, In Vitro, Cell Biology, Biochemistry, Tissue Culture, Cell Culture, Biomedical Engineering, In Vivo, Lifesciences, Drug Development, Flow Cytometry, Drug Delivery, Validation, Protein Chemistry, Life Sciences, Orthopedics
Education
University of Bristol 1996 — 2000
PhD, Medicine-Rheumatology
Northeastern University
MS, Medicinal Chemistry
Takeda Pharmaceutical Company Ltd February 2009 - Present
Histogenics September 2007 - November 2008
EMD Serono 2008 - 2008
Biovest December 2005 - August 2007
Skills
Purification, Cell Culture, Cell, GMP, Protein Expression, Immunoassays, Mammalian Cell Culture, Vaccines, Process Simulation, Cancer
Education
Penn State University
Bachelors, Life Sciences, Chemistry, Physics
Quinsigamond Community College
Biotechnology Certification, Molecular Biology, Microbiology, Biotechnology
CVS Pharmacy January 2014 - July 2014
Nitto Denko 2010 - 2013
Cold Chain Technologies 2009 - 2010
Histogenics 2008 - 2008
Repligen Corporation 2007 - 2008
Matritech Inc 2004 - 2007
Skills
Quality Management, Quality Auditing, CAPAs, GMP, GxP, Validation, Deviation Management, ISO 9000, ISO 13485, Change Management, Change Control, Quality Measures, Regulatory Submissions, Design Master File (DMF), Lean Manufacturing, Kaizen, Kanban, Manufacturing, ISO 14001, SOP, External Audit, Internal Audit, Vendor Management, FDA, Medical Devices, SOP authoring, CAPA, Continuous Improvement, Six Sigma, Iso 9000, Sop
Education
Northeastern University
Norwich Univ/Yale NH Med Tech/Northeastern Reg. Affairs
B.S., Medical Technology
Histogenics January 2006 - Present
ACMI August 2001 - January 2006
Boston Scientific March 1987 - March 1999
Education
Merrimack College
BS Business Administration, Accounting
Suffolk University - Sawyer Business School
MSA, Accounting
Hologic November 2010 - Present
Histogenics January 2010 - September 2010
WorldCare Clinical, LLC March 2004 - July 2009
Codman & Shurtleff, Inc. January 2000 - March 2004
Skills
Clinical Development, Clinical Operations, Clinical Research, CTMS, Clinical Trials, FDA, IND, Medical Devices, Biotechnology, CRO, GCP, Oncology, Pharmaceutical Industry, Regulatory Affairs
Education
Suffolk University 1990 — 1994
BS, Science
Genzyme May 2014 - October 2014
Histogenics September 2013 - May 2014
Compli LLC January 2011 - December 2011
Shire (ICQ Consultants) February 2010 - June 2011
Biogen Idec October 2007 - December 2009
Bayer July 2006 - May 2007
Sanofi Pasteur February 2006 - May 2006
Massachusetts Public Health Biologic Laboratories April 2005 - January 2006
Biovest January 2005 - April 2005
Amgen December 2003 - October 2004
Skills
Validation, CAPA, V&V
Education
Boston University 2004 — 2005
Universidad de Los Andes 1988 — 2003
BA
University of Massachusetts Lowell
Biotechnology
Worcester Polytechnic Institute
MBA
Silk Road Medical, Inc. August 2015 - Present
Silk Road Medical, Inc. July 2014 - Present
Histogenics 2013 - 2014
Altura Medical April 2012 - August 2013
Vascutek Ltd, a TERUMO Company January 2009 - April 2012
Bard Peripheral Vascular 2008 - 2009
Edwards Lifesciences 2004 - 2008
Skills
Clinical Research, Medical Devices, Cardiology, FDA, Clinical Trials, Regulatory Affairs, GCP, Clinical Development, Product Development, Lifesciences, Regulatory Submissions, Healthcare, Sop, Interventional..., ISO 13485, Clinical Monitoring, EDC, Vascular, Clinical Study Design
Education
California State University-Long Beach
MPH, Health Sciences-Public Health
University of Iowa
BS, Health Science
Pace University May 2010 - Present
Harvard University September 2007 - May 2010
Bentley University August 2007 - May 2010
Histogenics 2010 - 2010
Skills
Higher Education, Public Speaking, Coaching, Social Media, Microsoft Excel, Microsoft Exchange, Practice Management, Game Management, Video Editing, Editing, Event Planning, College Recruiting, Fundraising, Student Affairs, Communication Skills, Social Networking, Sports Coaching
Education
Northeastern University 2001 — 2006
BA, Journalism
Mountain Pointe High School 1997 — 2001
Biogen Idec 2012 - Present
Histogenics June 2011 - 2012
Massachusetts Biologics Laboratories 2004 - 2011
Skills
Laboratory, Change Control, Sop, Quality Assurance, Quality Control, GMP, Microbiology, Quality System, 21 CFR, Microsoft Office, CAPA, Document Management, Aseptic Processing
Education
Boston University
Management Development Program
Bunker Hill Community College
Associate of Science (A.S.), Computer Technology/Computer Systems Technology
Cambridge Biomedical Careers Program
Biotechnology
Rangoon University, Burma
Bachelor of Science (B.S.), Biology, General
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