Histogenics Company

Industry: Company

Description

Headquarters: Waltham, MA Founded: 2000 Subsidiaries: ProChon Biotech Ltd., Histogenics Limited, Histogenics Securities Corporation

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Histogenics Employees

Employee
Years
Job
Industry
Aron Rosenberg Aron Rosenberg Greater Boston Area Details
Aron Rosenberg's Histogenics Experience February 2013 - Present
Job Program Director at Histogenics
Industry Medical Devices
Experience
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

Lawrence Aidoo Lawrence Aidoo Greater Boston Area Details
Lawrence Aidoo's Histogenics Experience June 2008 - December 2008
Job Sr. Research Associate at Allena Pharmaceuticals
Industry Biotechnology
Experience
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

Matthew Whitnell Matthew Whitnell Greater Boston Area Details
Matthew Whitnell's Histogenics Experience December 2014 - Present
Job QC Technician Microbiology at Histogenics
Industry Biotechnology
Experience
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

Gauravi Prabhu Gauravi Prabhu Boston, Massachusetts Details
Gauravi Prabhu's Histogenics Experience April 2012 - July 2014
Job QA/QI Specialist II at DFCI
Industry Biotechnology
Experience
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

Daniel Ritchie Daniel Ritchie Greater Boston Area Details
Daniel Ritchie's Histogenics Experience July 2013 - Present
Job QC Microbiology Analyst
Industry Pharmaceuticals
Experience
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

Chris Barnowski, MD Chris Barnowski, MD Greater Boston Area Details
Chris Barnowski, MD's Histogenics Experience November 2011 - April 2013
Job Associate Director, Global Medical Affairs at Biogen Idec
Industry Medical Devices
Experience
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

Nancy Duarte-Lonnroth, RAC (US) Nancy Duarte-Lonnroth, RAC (US) Greater Boston Area Details
Nancy Duarte-Lonnroth, RAC (US)'s Histogenics Experience April 2007 - October 2008
Job Senior Director, QA at AMAG Pharmaceuticals
Industry Pharmaceuticals
Experience
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

Binesh Prabhakar Binesh Prabhakar Greater Boston Area Details
Binesh Prabhakar's Histogenics Experience November 2012 - March 2013
Job Partner at Cambridge IT Compliance LLC.
Industry Pharmaceuticals
Experience
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

Wyatt Gilmore Wyatt Gilmore Greater Boston Area Details
Wyatt Gilmore's Histogenics Experience July 2011 - December 2012
Job Associate Technical Project Manager at Quintiles
Industry Higher Education
Experience
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

Alina Rokicki Alina Rokicki Greater Boston Area Details
Alina Rokicki's Histogenics Experience 2006 - 2007
Job Senior Director of QA at TESARO
Industry Biotechnology
Experience
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

Darlee Burns Darlee Burns Allentown, Pennsylvania Area Details
Darlee Burns's Histogenics Experience January 2010 - October 2010
Job Quality Assurance Manager at Whitford Corporation
Industry Medical Devices
Experience
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

Tedd Gosian Tedd Gosian Greater Boston Area Details
Tedd Gosian's Histogenics Experience 2007 - 2008
Job Knowledgeable health care professional with many years experience in various health care settings and industry.
Industry Medical Devices
Experience
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

Diana Toothaker Diana Toothaker Greater Boston Area Details
Diana Toothaker's Histogenics Experience December 2011 - April 2012
Job Retail buyer
Industry Retail
Experience
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

Karla Quick Karla Quick Raleigh-Durham, North Carolina Area Details
Karla Quick's Histogenics Experience January 2014 - February 2015
Job Clinical Field Specialist at Histogenics
Industry Research
Experience
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

Patrick Rose Patrick Rose United States Details
Patrick Rose's Histogenics Experience April 2012 - March 2015
Job Senior Clinical Supply Specialist at PAREXEL
Industry Logistics and Supply Chain
Experience
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

Juan Mauricio Perez Juan Mauricio Perez Greater Boston Area Details
Juan Mauricio Perez's Histogenics Experience May 2013 - November 2013
Job Lab Assistant Intern at Blueprint Medicines
Industry Biotechnology
Experience
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

Anusuya Hazarika Anusuya Hazarika Greater Boston Area Details
Anusuya Hazarika's Histogenics Experience February 2007 - March 2008
Job Senior QC Associate at Amgen
Industry Biotechnology
Experience
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

Theresa Wingrove Theresa Wingrove Greater Boston Area Details
Theresa Wingrove's Histogenics Experience November 2006 - January 2011
Job at
Industry Research
Experience
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

Adam Gridley Adam Gridley Greater Boston Area Details
Adam Gridley's Histogenics Experience May 2014 - Present
Job President & CEO at Histogenics
Industry Biotechnology
Experience
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

Sam Charron Sam Charron Greater Boston Area Details
Sam Charron's Histogenics Experience May 2013 - Present
Job Manufacturing Manager at Histogenics
Industry Biotechnology
Experience
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

Justin Chow Justin Chow Greater Boston Area Details
Justin Chow's Histogenics Experience July 2013 - Present
Job Director of Finance at Histogenics
Industry Accounting
Experience
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

Mark Morana Mark Morana Greater Boston Area Details
Mark Morana's Histogenics Experience 2013 - 2014
Job Consultant TMV at Enhanced Compliance Inc.
Industry Pharmaceuticals
Experience
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

Michele McKay Michele McKay Greater Boston Area Details
Michele McKay's Histogenics Experience February 2010 - September 2010
Job Senior Quality Engineer at Genzyme
Industry Biotechnology
Experience
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.)

Jeannine Pafume Jeannine Pafume Greater Boston Area Details
Jeannine Pafume's Histogenics Experience August 2012 - September 2013
Job Sr. Compliance Specialist F&E at Shire
Industry Biotechnology
Experience
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

Jan Stolarski Jan Stolarski Greater Boston Area Details
Jan Stolarski's Histogenics Experience May 2006 - July 2008
Job QA Compliance at RMB
Industry Biotechnology
Experience
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

William Irons William Irons Greater Philadelphia Area Details
William Irons's Histogenics Experience August 2008 - December 2008
Job Director, Client Business Development MD&D at Novella Clinical
Industry Medical Devices
Experience
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

Jotheeswaran Periannan Jotheeswaran Periannan Ossining, New York Details
Jotheeswaran Periannan's Histogenics Experience November 2007 - September 2011
Job Genetic Research Analyst at Histogenetics Lab, NY
Industry Research
Experience
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

Sonya Shortkroff Sonya Shortkroff Greater Boston Area Details
Sonya Shortkroff's Histogenics Experience 2006 - Present
Job Director of Research and Development at Histogenics
Industry Biotechnology
Experience
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

Frank Sukernick Frank Sukernick Greater Boston Area Details
Frank Sukernick's Histogenics Experience September 2007 - November 2008
Job Process Development Engineer IV at Takeda Pharmaceuticals Intl.
Industry Biotechnology
Experience
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

Ethel Christman Ethel Christman Greater Boston Area Details
Ethel Christman's Histogenics Experience 2008 - 2008
Job Quality Assurance and Regulatory Professional with Experience in Manufacture of Medical Devices and Biopharmaceuticals
Industry Medical Devices
Experience
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

Rich Vaillant Rich Vaillant Greater Boston Area Details
Rich Vaillant's Histogenics Experience January 2006 - Present
Job CFO at Histogenics
Industry Research
Experience
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

Christina Mastandrea Christina Mastandrea Greater Boston Area Details
Christina Mastandrea's Histogenics Experience January 2010 - September 2010
Job Manager, Clinical Affairs at Hologic
Industry Research
Experience
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

Sandra Nolte Sandra Nolte Greater Boston Area Details
Sandra Nolte's Histogenics Experience September 2013 - May 2014
Job Validation Consultant
Industry Biotechnology
Experience
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

Julie Lindsay Julie Lindsay Greater San Diego Area Details
Julie Lindsay's Histogenics Experience 2013 - 2014
Job Clinical Field Manager at Silk Road Medical, Inc.
Industry Medical Devices
Experience
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

Karrin Moore Karrin Moore Greater New York City Area Details
Karrin Moore's Histogenics Experience 2010 - 2010
Job Head Volleyball Coach at Pace University
Industry Sports
Experience
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

Tin Tin Lay Tin Tin Lay Cambridge, Massachusetts Details
Tin Tin Lay's Histogenics Experience June 2011 - 2012
Job Quality Assurance Associate at Biogen Idec
Industry Medical Devices
Experience
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

Stephanie Ruggiero Stephanie Ruggiero Haverhill, Massachusetts Details
Stephanie Ruggiero's Histogenics Experience October 2014 - Present
Job Clinical Study Manager at Histogenics
Industry Biotechnology
Experience
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

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