Isogen, LLC
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Isogen, LLC Employees
Employee
Years
Job
Industry
Robert Roy, P.E. Robert Roy, P.E.'s Isogen, LLC Experience 2008 - 2009
Job Director Aseptic Technology
Industry Mechanical or Industrial Engineering
Experience
Integrated Project Services (IPS) 2010 - Present
LBRK Engineering, LLC 2009 - 2010
Isogen LLC 2008 - 2009
BMS 1997 - 2007
Advanced Barrier Process 1997 - 1998
Marsam Pharmaceuticals 1993 - 1997
Skills
Validation, CAPA, FDA, Change Control, 21 CFR Part 11, Technology Transfer, V&V, Quality System, Aseptic Processing, Process Engineering, Medical Devices, Manufacturing, Biotechnology, GxP, Biopharmaceuticals, Quality Assurance, GLP, Process Simulation, GAMP, LIMS
Education
Rutgers University-New Brunswick 1980 — 1983
B.S.ChE, Chemical Engineering, Biochemical Engineering
Stevens Institute of Technology
MS, Business Administration and Management, General
Integrated Project Services (IPS) 2010 - Present
LBRK Engineering, LLC 2009 - 2010
Isogen LLC 2008 - 2009
BMS 1997 - 2007
Advanced Barrier Process 1997 - 1998
Marsam Pharmaceuticals 1993 - 1997
Skills
Validation, CAPA, FDA, Change Control, 21 CFR Part 11, Technology Transfer, V&V, Quality System, Aseptic Processing, Process Engineering, Medical Devices, Manufacturing, Biotechnology, GxP, Biopharmaceuticals, Quality Assurance, GLP, Process Simulation, GAMP, LIMS
Education
Rutgers University-New Brunswick 1980 — 1983
B.S.ChE, Chemical Engineering, Biochemical Engineering
Stevens Institute of Technology
MS, Business Administration and Management, General
Robin Uhl Robin Uhl's Isogen, LLC Experience February 2009 - November 2009
Job Marketing Director at Wipro Technologies
Industry Information Technology and Services
Experience
Wipro Technologies July 2010 - Present
Marketing and Communications January 2010 - Present
Isogen LLC February 2009 - November 2009
Chief Executive magazine January 2003 - December 2008
Butler International May 1996 - December 2008
Arthur Andersen June 1992 - May 1996
Dun & Bradstreet October 1987 - May 1992
Education
Rutgers University-New Brunswick 1981 — 1985
BA, English, Psychology
Wipro Technologies July 2010 - Present
Marketing and Communications January 2010 - Present
Isogen LLC February 2009 - November 2009
Chief Executive magazine January 2003 - December 2008
Butler International May 1996 - December 2008
Arthur Andersen June 1992 - May 1996
Dun & Bradstreet October 1987 - May 1992
Education
Rutgers University-New Brunswick 1981 — 1985
BA, English, Psychology
Robert Serra Robert Serra's Isogen, LLC Experience January 2008 - September 2009
Job CoFounder, Principal Consultant at QbD Auditing Inc.
Industry Pharmaceuticals
Experience
QbD Auditing Inc June 2009 - Present
BioPharma Consulting Inc. 2005 - Present
Isogen LLC January 2008 - September 2009
Novartis Consumer Health 2006 - 2007
Schering-Plough 2003 - 2004
Johnson & Johnson 1991 - 2003
Ethicon 1974 - 1989
Skills
Validation, Quality System, Six Sigma, Process Improvement, Biotechnology, Quality Auditing, Software Documentation, Start-ups, ISO 13485, GMP, Sop, FDA, Technology Transfer, Product Development, Pharmaceutical Industry, Medical Devices, CAPA, Regulatory Affairs, Quality Assurance, Design Control, Pharmaceutics
Education
Fairleigh Dickinson University 1966 — 1972
Bachelor's Degree, Chemistry
County College of Morris 2000 — 2007
AAS, Mechanical Engineering Technology
QbD Auditing Inc June 2009 - Present
BioPharma Consulting Inc. 2005 - Present
Isogen LLC January 2008 - September 2009
Novartis Consumer Health 2006 - 2007
Schering-Plough 2003 - 2004
Johnson & Johnson 1991 - 2003
Ethicon 1974 - 1989
Skills
Validation, Quality System, Six Sigma, Process Improvement, Biotechnology, Quality Auditing, Software Documentation, Start-ups, ISO 13485, GMP, Sop, FDA, Technology Transfer, Product Development, Pharmaceutical Industry, Medical Devices, CAPA, Regulatory Affairs, Quality Assurance, Design Control, Pharmaceutics
Education
Fairleigh Dickinson University 1966 — 1972
Bachelor's Degree, Chemistry
County College of Morris 2000 — 2007
AAS, Mechanical Engineering Technology
Kim Behler Kim Behler's Isogen, LLC Experience March 2009 - January 2011
Job
Industry Pharmaceuticals
Experience
Terumo June 2011 - Present
Isogen, LLC March 2009 - January 2011
Bristol-Myers Squibb Company June 2006 - March 2009
Bristol-Myers Squibb Company May 2001 - June 2006
Skills
GMP, Sop, FDA, Pharmaceutical Industry, Six Sigma, Validation, Medical Devices, Biotechnology, Manufacturing, Continuous Improvement, Lean Manufacturing, CAPA
Education
Rutgers University-New Brunswick 1999 — 2003
Bachelors of Science
Terumo June 2011 - Present
Isogen, LLC March 2009 - January 2011
Bristol-Myers Squibb Company June 2006 - March 2009
Bristol-Myers Squibb Company May 2001 - June 2006
Skills
GMP, Sop, FDA, Pharmaceutical Industry, Six Sigma, Validation, Medical Devices, Biotechnology, Manufacturing, Continuous Improvement, Lean Manufacturing, CAPA
Education
Rutgers University-New Brunswick 1999 — 2003
Bachelors of Science
Les Edwards Les Edwards's Isogen, LLC Experience January 2008 - December 2009
Job Director, Eastern Region at Skan US, Inc.
Industry Pharmaceuticals
Experience
Skan US, Inc. February 2011 - Present
Hanscome Validation and Consulting, LLC January 2010 - February 2011
Isogen, LLC January 2008 - December 2009
Advanced Barrier Process, LLC 2005 - 2008
Advanced Barrier Concepts, Inc. 1995 - 2004
Merck & Co., Inc. 1994 - 1995
Penn Medicine (University of Pennsylvania Health System) 1986 - 1990
Penn Medicine (University of Pennsylvania Health System) 1986 - 1990
Penn Medicine (University of Pennsylvania Health System) 1986 - 1990
Penn Medicine (University of Pennsylvania Health System) 1986 - 1990
Skills
GMP, Validation, Pharmaceutical Industry, CAPA, FDA, Sop, Biotechnology, Biopharmaceuticals, Quality Assurance, Manufacturing, Technology Transfer, Aseptic Processing, Environmental Monitoring, Bioburden, Contract Manufacturing, Pharmaceutics, Medical Devices, Process Simulation, Sterilization, 21 CFR Part 11, V&V
Education
University of Pennsylvania 1988 — 1990
MSE, Business, Bioengineering, Technology Mgmt
University of Pennsylvania 1982 — 1986
BSE, Bioengineering and Biomedical Engineering
Skan US, Inc. February 2011 - Present
Hanscome Validation and Consulting, LLC January 2010 - February 2011
Isogen, LLC January 2008 - December 2009
Advanced Barrier Process, LLC 2005 - 2008
Advanced Barrier Concepts, Inc. 1995 - 2004
Merck & Co., Inc. 1994 - 1995
Penn Medicine (University of Pennsylvania Health System) 1986 - 1990
Penn Medicine (University of Pennsylvania Health System) 1986 - 1990
Penn Medicine (University of Pennsylvania Health System) 1986 - 1990
Penn Medicine (University of Pennsylvania Health System) 1986 - 1990
Skills
GMP, Validation, Pharmaceutical Industry, CAPA, FDA, Sop, Biotechnology, Biopharmaceuticals, Quality Assurance, Manufacturing, Technology Transfer, Aseptic Processing, Environmental Monitoring, Bioburden, Contract Manufacturing, Pharmaceutics, Medical Devices, Process Simulation, Sterilization, 21 CFR Part 11, V&V
Education
University of Pennsylvania 1988 — 1990
MSE, Business, Bioengineering, Technology Mgmt
University of Pennsylvania 1982 — 1986
BSE, Bioengineering and Biomedical Engineering
Malcolm Montgomery Malcolm Montgomery's Isogen, LLC Experience April 2009 - November 2009
Job Director, Quality Control at Auxilium Pharmaceutical Inc.
Industry Pharmaceuticals
Experience
Auxilium Pharmaceutical Inc. September 2010 - Present
Isogen LLC April 2009 - November 2009
Microbac Laboratories, Inc. Southern Testing and Research Division (Wilson, NC) November 2006 - March 2009
Centocor Research and Development (Spring House, PA) of Johnson & Johnson Co. June 2003 - October 2006
Merck Manufacturing Division, Merck & Co. (West Point, PA) August 1998 - June 2003
Apollon, Inc., (Company ceased operations in 1998), (Malvern, PA) April 1995 - August 1998
Wyeth-Ayerst Laboratories (Radnor, PA) October 1993 - April 1995
Burroughs Wellcome Co. (Greenville, NC) January 1987 - August 1989
Skills
Vaccines
Education
University of Delaware 1989 — 1993
Ph.D., Analytical Chemistry
University of North Carolina at Chapel Hill 1976 — 1982
BS, Chemistry
Auxilium Pharmaceutical Inc. September 2010 - Present
Isogen LLC April 2009 - November 2009
Microbac Laboratories, Inc. Southern Testing and Research Division (Wilson, NC) November 2006 - March 2009
Centocor Research and Development (Spring House, PA) of Johnson & Johnson Co. June 2003 - October 2006
Merck Manufacturing Division, Merck & Co. (West Point, PA) August 1998 - June 2003
Apollon, Inc., (Company ceased operations in 1998), (Malvern, PA) April 1995 - August 1998
Wyeth-Ayerst Laboratories (Radnor, PA) October 1993 - April 1995
Burroughs Wellcome Co. (Greenville, NC) January 1987 - August 1989
Skills
Vaccines
Education
University of Delaware 1989 — 1993
Ph.D., Analytical Chemistry
University of North Carolina at Chapel Hill 1976 — 1982
BS, Chemistry
Lance Safford's Isogen, LLC Experience 1998 - 1999
Job Information Technology and Services Consultant and Professional
Industry Information Technology and Services
Experience
BrightStar Healthcare 2008 - Present
BrightStar Franchising, LLC 2008 - Present
Content Creations April 2007 - August 2008
Accenture 2006 - 2007
Accenture January 2004 - 2006
Accenture 2001 - 2004
IsoGen LLC 1998 - 1999
Skills
SDLC, Business Analysis, Integration, Process Improvement, Change Management, Project Management, Vendor Management, SQL, Quality Assurance, Program Management, Leadership, SharePoint, Analysis, Management, Strategic Planning, Software Project..., Requirements Analysis, Software Documentation, Project Portfolio..., Start-ups, Product Management, Management Consulting, Business Intelligence, Business Process, Enterprise Architecture, XML, Requirements Gathering, Microsoft SQL Server, ASP.NET, Testing, Cross-functional Team..., Data Analysis, Windows, Disaster Recovery, Team Leadership, IT Strategy, Agile Methodologies, C#, Team Building, Healthcare, Data Warehousing, Operations Management, ITIL, Business Development, Strategy, Agile Project Management, IT Management, Product Development, PMO, SOA
Education
Purdue University 1986 — 1991
Ph.D., Analytical Chemistry
Augustana College 1982 — 1986
B.A., Chemistry/Mathematics
BrightStar Healthcare 2008 - Present
BrightStar Franchising, LLC 2008 - Present
Content Creations April 2007 - August 2008
Accenture 2006 - 2007
Accenture January 2004 - 2006
Accenture 2001 - 2004
IsoGen LLC 1998 - 1999
Skills
SDLC, Business Analysis, Integration, Process Improvement, Change Management, Project Management, Vendor Management, SQL, Quality Assurance, Program Management, Leadership, SharePoint, Analysis, Management, Strategic Planning, Software Project..., Requirements Analysis, Software Documentation, Project Portfolio..., Start-ups, Product Management, Management Consulting, Business Intelligence, Business Process, Enterprise Architecture, XML, Requirements Gathering, Microsoft SQL Server, ASP.NET, Testing, Cross-functional Team..., Data Analysis, Windows, Disaster Recovery, Team Leadership, IT Strategy, Agile Methodologies, C#, Team Building, Healthcare, Data Warehousing, Operations Management, ITIL, Business Development, Strategy, Agile Project Management, IT Management, Product Development, PMO, SOA
Education
Purdue University 1986 — 1991
Ph.D., Analytical Chemistry
Augustana College 1982 — 1986
B.A., Chemistry/Mathematics
John LoPiccolo's Isogen, LLC Experience March 2009 - July 2009
Job Experienced Operations and Quality Systems Management Executive
Industry Pharmaceuticals
Experience
JTL Consulting Services Inc. March 2015 - Present
JTL Consulting Services Inc. December 2014 - Present
JTL Consulting Services, Inc. March 2009 - Present
JTL Consulting Services April 2014 - January 2015
McNeil Consumer Healthcare November 2011 - December 2014
ValSource LLC October 2009 - October 2011
Schering-Plough Research Institute August 2009 - October 2009
Isogen LLC March 2009 - July 2009
Citadel Services Group, LLC March 2007 - July 2009
Schering-Plough 2001 - 2008
Skills
GMP, Validation, Quality Assurance, FDA, CAPA, Quality System, Pharmaceutical Industry, Biotechnology, Manufacturing, Sop, 21 CFR Part 11, Cross-functional Team..., Change Control, V&V, Process Improvement, Project Management, Regulatory Affairs, Biopharmaceuticals, GxP, Lean Manufacturing, Computer System..., Medical Devices, Pharmaceutics, Strategy, Root Cause Analysis, Document Management, Quality Management, Operations Management, Team Building, Strategic Planning, Six Sigma, Process Simulation, Compliance, cGMP, Lifesciences, Quality Control, R&D, Pharmaceuticals, Business Process..., Strategic Thinking, ISO 13485, Problem Solving, Coaching, Pharmaceutical Packaging, Compliance Remediation, Biotechnology Industry, Consent Decree, Medical Device..., Management, Quality Auditing
Education
Quinnipiac University 1981 — 1985
BS International Business Marketing, International Business/Trade/Commerce
Jackson Memorial
JTL Consulting Services Inc. March 2015 - Present
JTL Consulting Services Inc. December 2014 - Present
JTL Consulting Services, Inc. March 2009 - Present
JTL Consulting Services April 2014 - January 2015
McNeil Consumer Healthcare November 2011 - December 2014
ValSource LLC October 2009 - October 2011
Schering-Plough Research Institute August 2009 - October 2009
Isogen LLC March 2009 - July 2009
Citadel Services Group, LLC March 2007 - July 2009
Schering-Plough 2001 - 2008
Skills
GMP, Validation, Quality Assurance, FDA, CAPA, Quality System, Pharmaceutical Industry, Biotechnology, Manufacturing, Sop, 21 CFR Part 11, Cross-functional Team..., Change Control, V&V, Process Improvement, Project Management, Regulatory Affairs, Biopharmaceuticals, GxP, Lean Manufacturing, Computer System..., Medical Devices, Pharmaceutics, Strategy, Root Cause Analysis, Document Management, Quality Management, Operations Management, Team Building, Strategic Planning, Six Sigma, Process Simulation, Compliance, cGMP, Lifesciences, Quality Control, R&D, Pharmaceuticals, Business Process..., Strategic Thinking, ISO 13485, Problem Solving, Coaching, Pharmaceutical Packaging, Compliance Remediation, Biotechnology Industry, Consent Decree, Medical Device..., Management, Quality Auditing
Education
Quinnipiac University 1981 — 1985
BS International Business Marketing, International Business/Trade/Commerce
Jackson Memorial
Steve Tingley's Isogen, LLC Experience February 2008 - February 2009
Job VP Sales & Marketing; Bioprocessing at Repligen
Industry Biotechnology
Experience
Repligen March 2012 - Present
Repligen Corp March 2009 - March 2012
Isogen LLC February 2008 - February 2009
Novasep February 2007 - February 2008
BioProcessors November 2004 - January 2007
Millipore Corporation May 1985 - August 2003
Millipore, Molsheim, France 1988 - 1992
Skills
Biotechnology, Lifesciences, Purification, Medical Devices, Cell Culture, Chromatography, FDA, GMP, Validation, Pharmaceutical Industry, Business Development, Commercialization, Drug Discovery, Biochemistry, Technology Transfer, Start-ups, Biopharmaceuticals, Vaccines, Clinical Development, Marketing Strategy, R&D, Process Simulation, Product Management, Drug Development, Regulatory Affairs, Oncology, CRO, Molecular Biology, Protein Chemistry, Clinical Trials, Immunology, GLP, Assay Development, 21 CFR Part 11, Analytical Chemistry, Infectious Diseases, Cell, Chemistry, Sop, HPLC, Life Sciences
Education
University of Leeds 1976 — 1979
BSc Hons, Pharmacology
Repligen March 2012 - Present
Repligen Corp March 2009 - March 2012
Isogen LLC February 2008 - February 2009
Novasep February 2007 - February 2008
BioProcessors November 2004 - January 2007
Millipore Corporation May 1985 - August 2003
Millipore, Molsheim, France 1988 - 1992
Skills
Biotechnology, Lifesciences, Purification, Medical Devices, Cell Culture, Chromatography, FDA, GMP, Validation, Pharmaceutical Industry, Business Development, Commercialization, Drug Discovery, Biochemistry, Technology Transfer, Start-ups, Biopharmaceuticals, Vaccines, Clinical Development, Marketing Strategy, R&D, Process Simulation, Product Management, Drug Development, Regulatory Affairs, Oncology, CRO, Molecular Biology, Protein Chemistry, Clinical Trials, Immunology, GLP, Assay Development, 21 CFR Part 11, Analytical Chemistry, Infectious Diseases, Cell, Chemistry, Sop, HPLC, Life Sciences
Education
University of Leeds 1976 — 1979
BSc Hons, Pharmacology
Elena Cuthbertson's Isogen, LLC Experience March 2009 - July 2009
Job Product Regulatory Specialist at Ashland Inc.
Industry Biotechnology
Experience
Ashland Inc. March 2013 - Present
Rohm and Haas Electronic Materials/Dow Electronic Materials May 2011 - February 2013
United Water September 2010 - May 2011
Isogen LLC March 2009 - July 2009
Skills
Six sigma Green Belt, Quality Assurance, CAPA, ISO, GMP/QSR Trainer, Kaizen, Continuous Improvement, Value Stream Mapping, GMP, Quality System, Validation, FDA, Sop, Manufacturing, Biotechnology, Root Cause Analysis, Lean Manufacturing, Minitab, LIMS, 5S, Quality Auditing, Aseptic Processing, Purification, GLP, Cross-functional Team..., Certified Lead Auditor, Six Sigma, Regulatory Affairs, Regulatory Requirements, Regulatory Documentation, Regulatory Guidelines, DMF, FMA, FDA GMP, Process Simulation
Education
Cabrini College
BS, Medical Technology
Ashland Inc. March 2013 - Present
Rohm and Haas Electronic Materials/Dow Electronic Materials May 2011 - February 2013
United Water September 2010 - May 2011
Isogen LLC March 2009 - July 2009
Skills
Six sigma Green Belt, Quality Assurance, CAPA, ISO, GMP/QSR Trainer, Kaizen, Continuous Improvement, Value Stream Mapping, GMP, Quality System, Validation, FDA, Sop, Manufacturing, Biotechnology, Root Cause Analysis, Lean Manufacturing, Minitab, LIMS, 5S, Quality Auditing, Aseptic Processing, Purification, GLP, Cross-functional Team..., Certified Lead Auditor, Six Sigma, Regulatory Affairs, Regulatory Requirements, Regulatory Documentation, Regulatory Guidelines, DMF, FMA, FDA GMP, Process Simulation
Education
Cabrini College
BS, Medical Technology