Complya Consulting Group
Industry: Company
DescriptionFounded: 2007 Parent organization: PharmaLex GmbH
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Complya Consulting Group Employees
Employee
Years
Job
Industry
Timothy A Mayhew Timothy A Mayhew's Complya Consulting Group Experience 2010 - Present
Job Accomplished Life Sciences Quality Systems Leader
Industry Biotechnology
Experience
Complya Consulting Group 2010 - Present
TMQ Consulting 2001 - Present
PrimeraDX, Inc. February 2011 - October 2013
Anika Therapeutics 2005 - 2008
Avecia Biotechnology 2003 - 2005
Organogenesis 1999 - 2001
Genzyme Biosurgery 1993 - 1999
Skills
CAPA, FDA, GMP, Medical Devices, ISO 13485, Validation, Quality System, Biotechnology, 21 CFR Part 11, Change Control, V&V, Pharmaceutical Industry, Regulatory Affairs, Technology Transfer, Sop, Manufacturing, R&D, Continuous Improvement, Quality Assurance, Quality Auditing, Lifesciences, Biopharmaceuticals, Computer System..., Design Control, GxP, GLP, Regulatory Requirements, Commercialization, Six Sigma, ISO 14971, Quality Control, Regulatory Submissions, Testing, Aseptic Processing, ISO, Clinical Trials, LIMS, Contract Manufacturing, 21 CFR, Biologics, GCP, SOP, Life Sciences
Education
Boston University - School of Management
MBA, Business
Kettering University
BSME, Mechanical Engneering
Complya Consulting Group 2010 - Present
TMQ Consulting 2001 - Present
PrimeraDX, Inc. February 2011 - October 2013
Anika Therapeutics 2005 - 2008
Avecia Biotechnology 2003 - 2005
Organogenesis 1999 - 2001
Genzyme Biosurgery 1993 - 1999
Skills
CAPA, FDA, GMP, Medical Devices, ISO 13485, Validation, Quality System, Biotechnology, 21 CFR Part 11, Change Control, V&V, Pharmaceutical Industry, Regulatory Affairs, Technology Transfer, Sop, Manufacturing, R&D, Continuous Improvement, Quality Assurance, Quality Auditing, Lifesciences, Biopharmaceuticals, Computer System..., Design Control, GxP, GLP, Regulatory Requirements, Commercialization, Six Sigma, ISO 14971, Quality Control, Regulatory Submissions, Testing, Aseptic Processing, ISO, Clinical Trials, LIMS, Contract Manufacturing, 21 CFR, Biologics, GCP, SOP, Life Sciences
Education
Boston University - School of Management
MBA, Business
Kettering University
BSME, Mechanical Engneering
Roland Bizanek Roland Bizanek's Complya Consulting Group Experience January 2011 - April 2014
Job Senior Consultant at Drug Development Resources
Industry Pharmaceuticals
Experience
Validant January 2015 - Present
Drug Development Resources September 2012 - Present
Compass Pharma Consulting, LLC September 2011 - Present
Anika Therapeutics July 2014 - January 2015
NextPharma July 2013 - April 2014
Complya Consulting Group January 2011 - April 2014
Ebewe Pharma December 2011 - December 2012
The Quantic Group, Ltd August 2011 - December 2012
AVEO Pharmaceuticals January 2011 - August 2011
Biogen Idec August 2007 - December 2010
Skills
Investigations, Compliance, Validation, Process Improvement, Process Optimization, Medical Devices, Regulatory Submissions, Continuous Improvement, Troubleshooting, Quality Assurance, Quality Management, Contract Manufacturing, GxP, Change Management, FDA, Quality Systems, Quality Auditing, Pharmaceuticals, Root Cause Analysis, Biotechnology, Operational Excellence, Problem Solving, Technology Transfer, Supplier Management, ISO 13485, GMP, Auditing, GCP, Clinical Trials, Regulatory Requirements, Quality System, Pharmaceutical Industry, 21 CFR Part 11, V&V, CAPA, Change Control, Biopharmaceuticals, Supply Management, Regulatory Affairs, Pharmaceutics, Computer System..., Sop, Clinical Development, GLP, Process Simulation, Manufacturing, LIMS, Aseptic Processing, Drug Development, R&D
Education
Northwestern University 2004 — 2006
Masters of Science, Product Development
University of Münster 1981 — 1990
Dr. rer. nat. (Ph.D.), Chemistry
Validant January 2015 - Present
Drug Development Resources September 2012 - Present
Compass Pharma Consulting, LLC September 2011 - Present
Anika Therapeutics July 2014 - January 2015
NextPharma July 2013 - April 2014
Complya Consulting Group January 2011 - April 2014
Ebewe Pharma December 2011 - December 2012
The Quantic Group, Ltd August 2011 - December 2012
AVEO Pharmaceuticals January 2011 - August 2011
Biogen Idec August 2007 - December 2010
Skills
Investigations, Compliance, Validation, Process Improvement, Process Optimization, Medical Devices, Regulatory Submissions, Continuous Improvement, Troubleshooting, Quality Assurance, Quality Management, Contract Manufacturing, GxP, Change Management, FDA, Quality Systems, Quality Auditing, Pharmaceuticals, Root Cause Analysis, Biotechnology, Operational Excellence, Problem Solving, Technology Transfer, Supplier Management, ISO 13485, GMP, Auditing, GCP, Clinical Trials, Regulatory Requirements, Quality System, Pharmaceutical Industry, 21 CFR Part 11, V&V, CAPA, Change Control, Biopharmaceuticals, Supply Management, Regulatory Affairs, Pharmaceutics, Computer System..., Sop, Clinical Development, GLP, Process Simulation, Manufacturing, LIMS, Aseptic Processing, Drug Development, R&D
Education
Northwestern University 2004 — 2006
Masters of Science, Product Development
University of Münster 1981 — 1990
Dr. rer. nat. (Ph.D.), Chemistry
Andrew Torchia Andrew Torchia's Complya Consulting Group Experience April 2010 - May 2013
Job Quality Assurance Consultant at Eliassen Group
Industry Biotechnology
Experience
Eliassen Group February 2014 - Present
Complya Consulting Group April 2010 - May 2013
Shire Pharmaceuticals September 2010 - March 2011
Shire Pharmaceuticals July 2009 - April 2010
Shire Pharmaceuticals September 2008 - June 2009
Genzyme May 1998 - November 2007
Bose Corporation September 1988 - March 1998
Bose Corporation September 1988 - March 1997
Bose Corporation September 1988 - March 1997
Skills
CAPA, Quality System, Quality Assurance, GMP, Change Control, Computer System..., Quality Auditing, SPC, Data Analysis, Batch Record Review, Validation Review, Quality Systems, QA Compliance, TrackWise, Root Cause Analysis, Six Sigma, Microsoft Office, JMP, ASQ CQE, ASQ CPGP, ASQ CQA, Supplier Quality, Continuous Improvement, ASQ CSSGB, Six Sigma Green Belt
Education
Northeastern University
BS, Electrical Engineering
Eliassen Group February 2014 - Present
Complya Consulting Group April 2010 - May 2013
Shire Pharmaceuticals September 2010 - March 2011
Shire Pharmaceuticals July 2009 - April 2010
Shire Pharmaceuticals September 2008 - June 2009
Genzyme May 1998 - November 2007
Bose Corporation September 1988 - March 1998
Bose Corporation September 1988 - March 1997
Bose Corporation September 1988 - March 1997
Skills
CAPA, Quality System, Quality Assurance, GMP, Change Control, Computer System..., Quality Auditing, SPC, Data Analysis, Batch Record Review, Validation Review, Quality Systems, QA Compliance, TrackWise, Root Cause Analysis, Six Sigma, Microsoft Office, JMP, ASQ CQE, ASQ CPGP, ASQ CQA, Supplier Quality, Continuous Improvement, ASQ CSSGB, Six Sigma Green Belt
Education
Northeastern University
BS, Electrical Engineering
Deb Neckorcuk, CQA Deb Neckorcuk, CQA's Complya Consulting Group Experience Independent ConsultantQuality Executive Partners, IncJune 2014 - June 2015
Job Quality Assurance Consultant to the Pharma, Biotech and Medical Device industries
Industry Pharmaceuticals
Experience
Complya Consulting Group Independent ConsultantQuality Executive Partners, IncJune 2014 - June 2015
Anika Therapeutics September 2012 - March 2014
Pfizer June 2011 - July 2012
Pfizer (formerly Wyeth Biotech) September 2005 - June 2011
Boston Analytical 1992 - September 2005
Skills
GMP, Quality System, Pharmaceutical Industry, Biotechnology, Medical Devices, Quality System..., CAPA, FDA, Validation, Technology Transfer, Continuous Improvement, Quality Remediation, V&V, Quality Assurance, Sop, Aseptic Processing, ISO 13485, Quality Control, Clinical Trials, Cleaning Validation, Method validaiton, ICH guidelines, cGMPs, Trackwise, Testing, Laboratory, Quality Control..., Dispositon, Change Control, SOP
Education
State University of New York at Buffalo
BA, Chemisty
Complya Consulting Group Independent ConsultantQuality Executive Partners, IncJune 2014 - June 2015
Anika Therapeutics September 2012 - March 2014
Pfizer June 2011 - July 2012
Pfizer (formerly Wyeth Biotech) September 2005 - June 2011
Boston Analytical 1992 - September 2005
Skills
GMP, Quality System, Pharmaceutical Industry, Biotechnology, Medical Devices, Quality System..., CAPA, FDA, Validation, Technology Transfer, Continuous Improvement, Quality Remediation, V&V, Quality Assurance, Sop, Aseptic Processing, ISO 13485, Quality Control, Clinical Trials, Cleaning Validation, Method validaiton, ICH guidelines, cGMPs, Trackwise, Testing, Laboratory, Quality Control..., Dispositon, Change Control, SOP
Education
State University of New York at Buffalo
BA, Chemisty
Chris Riel Chris Riel's Complya Consulting Group Experience August 2014 - January 2015
Job Director Quality Assurance at Voyager Therapeutics, Inc.
Industry Biotechnology
Experience
Voyager Therapeutics, Inc. February 2015 - Present
Complya Consulting Group August 2014 - January 2015
Shire HGT October 2010 - February 2014
Shire HGT September 2010 - October 2010
Pfizer (Formerly Wyeth) January 2002 - April 2010
Wyeth January 2001 - January 2002
Wyeth (Formerly Genetics Institute, Inc.) January 1998 - January 2001
Genetics Institute, Inc. January 1988 - January 1998
Baxter Healthcare 1986 - 1988
Baxter Healthcare 1985 - 1986
Skills
Biopharmaceuticals, Quality Control, Quality System, Quality Auditing, FDA, Cross-functional Team..., GMP, Biotechnology, Leadership, Quality Assurance, Project Management, 21 CFR Part 11, Pharmaceutical Industry, Technology Transfer, Product Development, Manufacturing, Sop, Drug Development
Education
University of Rhode Island
Bachelor of Science Pharmacy
Voyager Therapeutics, Inc. February 2015 - Present
Complya Consulting Group August 2014 - January 2015
Shire HGT October 2010 - February 2014
Shire HGT September 2010 - October 2010
Pfizer (Formerly Wyeth) January 2002 - April 2010
Wyeth January 2001 - January 2002
Wyeth (Formerly Genetics Institute, Inc.) January 1998 - January 2001
Genetics Institute, Inc. January 1988 - January 1998
Baxter Healthcare 1986 - 1988
Baxter Healthcare 1985 - 1986
Skills
Biopharmaceuticals, Quality Control, Quality System, Quality Auditing, FDA, Cross-functional Team..., GMP, Biotechnology, Leadership, Quality Assurance, Project Management, 21 CFR Part 11, Pharmaceutical Industry, Technology Transfer, Product Development, Manufacturing, Sop, Drug Development
Education
University of Rhode Island
Bachelor of Science Pharmacy
Robert Cembrola Robert Cembrola's Complya Consulting Group Experience September 2011 - Present
Job Senior Consultant, Complya Consulting Group
Industry Biotechnology
Experience
Complya Consulting Group September 2011 - Present
Formatech, Inc. 2002 - 2011
Skills
CAPA, Quality Control, Aseptic Processing, GMP, Sop, Analytical Chemistry, Performance Metrics, Biotechnology, Validation, Document Management, FDA, Change Control, Pharmaceutical Industry, Quality Auditing, Regulatory Submissions, Quality System, Medical Devices, Technology Transfer, GxP, V&V, LIMS, 21 CFR Part 11, Biopharmaceuticals, Regulatory Affairs, GLP, Quality Assurance, Lifesciences
Education
Kyoto University
Postdoctoral Fellow, Polymer Chemistry
Rochester Institute of Technology
Bachelor's Degree, Chemistry
University of Massachusetts, Amherst
Doctor of Philosophy (PhD), Polymer Chemistry
Complya Consulting Group September 2011 - Present
Formatech, Inc. 2002 - 2011
Skills
CAPA, Quality Control, Aseptic Processing, GMP, Sop, Analytical Chemistry, Performance Metrics, Biotechnology, Validation, Document Management, FDA, Change Control, Pharmaceutical Industry, Quality Auditing, Regulatory Submissions, Quality System, Medical Devices, Technology Transfer, GxP, V&V, LIMS, 21 CFR Part 11, Biopharmaceuticals, Regulatory Affairs, GLP, Quality Assurance, Lifesciences
Education
Kyoto University
Postdoctoral Fellow, Polymer Chemistry
Rochester Institute of Technology
Bachelor's Degree, Chemistry
University of Massachusetts, Amherst
Doctor of Philosophy (PhD), Polymer Chemistry
David Vario David Vario's Complya Consulting Group Experience February 2015 - May 2015
Job Sr. Director, Quality Systems & Compliance
Industry Biotechnology
Experience
Lantheus Medical Imaging September 2015 - Present
Vario Consulting, LLC February 2015 - Present
Complya Consulting Group February 2015 - May 2015
ImmunoGen, Inc. April 2012 - January 2015
PolyMedex Discovery Group / Foster Corporation May 2010 - April 2012
Bristol-Myers Squibb September 2007 - May 2010
Genzyme Corporation April 2004 - September 2007
Wyeth September 2002 - April 2004
Abbott Laboratories / Medisense Products July 1997 - September 2002
FCI Burndy Electrical July 1994 - July 1997
Skills
Medical Devices, Quality Assurance, FDA, Auditing, CAPA, Regulatory Affairs, Life Sciences, Quality Systems, Compliance, ISO 13485, Continuous Improvement, Validation, Six Sigma, cGMP, Lean Manufacturing, Process Validation, Quality Auditing, Change Control, Document Management, GxP, Design Control, QSR, Quality Management, ISO, Supplier Quality, Biotechnology, Complaint Handling, Software Validation, 5S, Process Improvement, Root Cause Analysis, Quality System, V&V, GMP, Iso 9000, Lifesciences, Sop, 21 CFR Part 11, Computer System..., Manufacturing, 21 CFR, Aseptic Processing, Trackwise, LIMS, GLP, Biopharmaceuticals, Testing, SOP, Pharmaceutical Industry
Education
Northeastern University 1982 — 1987
Bachelor of Science Degree, College of Engineering Technology (Mechanical)
Daniel Webster College 1996 — 1998
Certificate, PC Network Administration
Lantheus Medical Imaging September 2015 - Present
Vario Consulting, LLC February 2015 - Present
Complya Consulting Group February 2015 - May 2015
ImmunoGen, Inc. April 2012 - January 2015
PolyMedex Discovery Group / Foster Corporation May 2010 - April 2012
Bristol-Myers Squibb September 2007 - May 2010
Genzyme Corporation April 2004 - September 2007
Wyeth September 2002 - April 2004
Abbott Laboratories / Medisense Products July 1997 - September 2002
FCI Burndy Electrical July 1994 - July 1997
Skills
Medical Devices, Quality Assurance, FDA, Auditing, CAPA, Regulatory Affairs, Life Sciences, Quality Systems, Compliance, ISO 13485, Continuous Improvement, Validation, Six Sigma, cGMP, Lean Manufacturing, Process Validation, Quality Auditing, Change Control, Document Management, GxP, Design Control, QSR, Quality Management, ISO, Supplier Quality, Biotechnology, Complaint Handling, Software Validation, 5S, Process Improvement, Root Cause Analysis, Quality System, V&V, GMP, Iso 9000, Lifesciences, Sop, 21 CFR Part 11, Computer System..., Manufacturing, 21 CFR, Aseptic Processing, Trackwise, LIMS, GLP, Biopharmaceuticals, Testing, SOP, Pharmaceutical Industry
Education
Northeastern University 1982 — 1987
Bachelor of Science Degree, College of Engineering Technology (Mechanical)
Daniel Webster College 1996 — 1998
Certificate, PC Network Administration
Sandra F. McManus Sandra F. McManus's Complya Consulting Group Experience February 2011 - Present
Job Sr. Quality Assurance Consultant at Complya Consulting Group
Industry Pharmaceuticals
Experience
Complya Consulting Group February 2011 - Present
Global Biotech June 2008 - April 2010
Pfizer (Previously Wyeth) October 1997 - April 2010
Biotech External Supply September 2005 - June 2008
Wyeth September 2001 - September 2005
Stockholm, Sweden November 1999 - September 2001
Wyeth (Previously Genetics Institute) October 1997 - November 1999
ImmuLogic Pharmaceutical Corporation October 1995 - October 1997
ImmuLogic June 1995 - October 1997
Biopure September 1993 - October 1995
Skills
GMP, Validation, FDA, CAPA, GxP, Sop, Biotechnology, Pharmaceutical Industry, Quality System, 21 CFR Part 11, V&V, Aseptic Processing, Technology Transfer, Change Control, GLP, Regulatory Affairs, Biopharmaceuticals, LIMS, Quality Assurance, Quality Auditing, Quality Control, Regulatory Submissions, Regulatory Requirements, GCP, Vaccines, Trackwise, Six Sigma, SOP, Cleaning Validation, Clinical Trials, Document Management, Contract Manufacturing, IND, ISO 13485, Lifesciences, Manufacturing, Microbiology, Pharmaceutics, ISO
Education
North Carolina State University 1983 — 1987
B.S, Microbiology
Complya Consulting Group February 2011 - Present
Global Biotech June 2008 - April 2010
Pfizer (Previously Wyeth) October 1997 - April 2010
Biotech External Supply September 2005 - June 2008
Wyeth September 2001 - September 2005
Stockholm, Sweden November 1999 - September 2001
Wyeth (Previously Genetics Institute) October 1997 - November 1999
ImmuLogic Pharmaceutical Corporation October 1995 - October 1997
ImmuLogic June 1995 - October 1997
Biopure September 1993 - October 1995
Skills
GMP, Validation, FDA, CAPA, GxP, Sop, Biotechnology, Pharmaceutical Industry, Quality System, 21 CFR Part 11, V&V, Aseptic Processing, Technology Transfer, Change Control, GLP, Regulatory Affairs, Biopharmaceuticals, LIMS, Quality Assurance, Quality Auditing, Quality Control, Regulatory Submissions, Regulatory Requirements, GCP, Vaccines, Trackwise, Six Sigma, SOP, Cleaning Validation, Clinical Trials, Document Management, Contract Manufacturing, IND, ISO 13485, Lifesciences, Manufacturing, Microbiology, Pharmaceutics, ISO
Education
North Carolina State University 1983 — 1987
B.S, Microbiology
Sarah Wesley Sarah Wesley's Complya Consulting Group Experience July 2015 - Present
Job Project Manager at Complya Consulting Group
Industry Biotechnology
Experience
Complya Consulting Group July 2015 - Present
Complya Consulting Group July 2014 - July 2015
Edward M. Kennedy Institute for the United States Senate April 2013 - July 2014
Edward M. Kennedy Institute for the United States Senate July 2011 - April 2013
US Fish and Wildlife Service September 2010 - May 2011
Edward M. Kennedy Institute for the United States Senate May 2010 - August 2010
Ecole de la Trinité January 2010 - May 2010
Office of US Senator Edward M. Kennedy May 2008 - September 2009
Skills
Public Relations, Program Development, Political Campaigns, Leadership, Creative Writing, Politics, Prospect Research, French, Project Management, Web Content Management, Social Media, Organizational..., Little Green Light (LGL), Marketing, Event Planning, Event Management, Community Outreach, Public Speaking, International Relations, Editing, Teaching, Microsoft Office, Research, Nonprofits, Cultural Diversity, Data Analysis, Newsletters, Copy Editing, Database Management, HTML Editing, Proposal Writing, Business Development
Education
University of Massachusetts, Amherst 2007 — 2011
Bachelor of Arts (B.A.), Political Science, French & Francophone Studies, International Relations, Modern European Studies
Université Denis Diderot (Paris VII) 2010 — 2010
French Cultural Studies & French Language
New England Conservatory of Music
Vocal Performance, School of Continuing Education
Complya Consulting Group July 2015 - Present
Complya Consulting Group July 2014 - July 2015
Edward M. Kennedy Institute for the United States Senate April 2013 - July 2014
Edward M. Kennedy Institute for the United States Senate July 2011 - April 2013
US Fish and Wildlife Service September 2010 - May 2011
Edward M. Kennedy Institute for the United States Senate May 2010 - August 2010
Ecole de la Trinité January 2010 - May 2010
Office of US Senator Edward M. Kennedy May 2008 - September 2009
Skills
Public Relations, Program Development, Political Campaigns, Leadership, Creative Writing, Politics, Prospect Research, French, Project Management, Web Content Management, Social Media, Organizational..., Little Green Light (LGL), Marketing, Event Planning, Event Management, Community Outreach, Public Speaking, International Relations, Editing, Teaching, Microsoft Office, Research, Nonprofits, Cultural Diversity, Data Analysis, Newsletters, Copy Editing, Database Management, HTML Editing, Proposal Writing, Business Development
Education
University of Massachusetts, Amherst 2007 — 2011
Bachelor of Arts (B.A.), Political Science, French & Francophone Studies, International Relations, Modern European Studies
Université Denis Diderot (Paris VII) 2010 — 2010
French Cultural Studies & French Language
New England Conservatory of Music
Vocal Performance, School of Continuing Education
Angela Forget Angela Forget's Complya Consulting Group Experience October 2011 - July 2012
Job QS/RC Manager at STERIS Isomedix Services
Industry Biotechnology
Experience
STERIS Isomedix Services November 2014 - Present
Genzyme October 2011 - August 2012
Complya Consulting Group October 2011 - July 2012
Skills
Aseptic Processing, Cell Culture, Microbiology, Quality Control, Raw Material..., Aseptic Technique, Analytical Method..., Environmental Monitoring, cGMP practices, Clean Rooms, Biotechnology, Bioprocess, Chemistry, Bioassay, Mycology, Cytotoxicity, Technology Transfer, Standards Compliance, Endotoxin, Virology, Metrics Reporting, OOS, OOL and OOT...
Education
East Tennessee State University 1985 — 1989
Bachelor's degree, Microbiology, General
STERIS Isomedix Services November 2014 - Present
Genzyme October 2011 - August 2012
Complya Consulting Group October 2011 - July 2012
Skills
Aseptic Processing, Cell Culture, Microbiology, Quality Control, Raw Material..., Aseptic Technique, Analytical Method..., Environmental Monitoring, cGMP practices, Clean Rooms, Biotechnology, Bioprocess, Chemistry, Bioassay, Mycology, Cytotoxicity, Technology Transfer, Standards Compliance, Endotoxin, Virology, Metrics Reporting, OOS, OOL and OOT...
Education
East Tennessee State University 1985 — 1989
Bachelor's degree, Microbiology, General
Ben Osorio Ben Osorio's Complya Consulting Group Experience December 2012 - December 2012
Job Vice President, Compliance and Quality Assurance at Achillion Pharmaceuticals
Industry Pharmaceuticals
Experience
Achillion Pharmaceuticals May 2014 - Present
Valeant Pharmaceuticals North America LLC May 2013 - October 2013
Braeburn Pharmaceuticals, Inc January 2013 - May 2013
Complya Consulting Group December 2012 - December 2012
Progenics Pharmaceuticals, Inc. July 2005 - September 2012
Forest Laboratories 2001 - July 2005
The P.F. Laboratories Inc. (Purdue Pharma) 1984 - 2001
Berlex Laboratories 1979 - 1984
Skills
Quality Management, Pharmaceutical Quality..., GMP Compliance, Quality System, Global Alliance..., Change Control, Quality Auditing, Software Quality..., Supplier Quality, Quality Control, Analytical Method..., Pharmaceutical Industry, Deviation and OOS..., Biopharmaceuticals, Technology Transfer, GMP, Quality Assurance, CAPA, Sop, Analytical Chemistry, 21 CFR Part 11, GCP, Laboratory, GLP, FDA, Validation, Biotechnology, Manufacturing, Regulatory Submissions, Computer System..., Strategic Alliances, Document Management, CRO, IND, GxP, Regulatory Requirements, Lifesciences, R&D, Life Sciences, SOP, V
Education
Seton Hall University 1986 — 1989
M.B.A., Business (Finance)
Seton Hall University
M.S., Chemistry (Analytical)
City University of New York-John Jay College of Criminal Justice 1974 — 1979
B.S., Forensic Science
Achillion Pharmaceuticals May 2014 - Present
Valeant Pharmaceuticals North America LLC May 2013 - October 2013
Braeburn Pharmaceuticals, Inc January 2013 - May 2013
Complya Consulting Group December 2012 - December 2012
Progenics Pharmaceuticals, Inc. July 2005 - September 2012
Forest Laboratories 2001 - July 2005
The P.F. Laboratories Inc. (Purdue Pharma) 1984 - 2001
Berlex Laboratories 1979 - 1984
Skills
Quality Management, Pharmaceutical Quality..., GMP Compliance, Quality System, Global Alliance..., Change Control, Quality Auditing, Software Quality..., Supplier Quality, Quality Control, Analytical Method..., Pharmaceutical Industry, Deviation and OOS..., Biopharmaceuticals, Technology Transfer, GMP, Quality Assurance, CAPA, Sop, Analytical Chemistry, 21 CFR Part 11, GCP, Laboratory, GLP, FDA, Validation, Biotechnology, Manufacturing, Regulatory Submissions, Computer System..., Strategic Alliances, Document Management, CRO, IND, GxP, Regulatory Requirements, Lifesciences, R&D, Life Sciences, SOP, V
Education
Seton Hall University 1986 — 1989
M.B.A., Business (Finance)
Seton Hall University
M.S., Chemistry (Analytical)
City University of New York-John Jay College of Criminal Justice 1974 — 1979
B.S., Forensic Science
Joseph Consiglio Joseph Consiglio's Complya Consulting Group Experience June 2014 - Present
Job Director of Business Development at Complya Consulting Group
Industry Biotechnology
Experience
Complya Consulting Group June 2014 - Present
Harvard Apparatus Regenerative Technology May 2012 - June 2014
Harvard Apparatus - Regenerative Medicine Division July 2010 - April 2012
Harvard Apparatus July 2006 - July 2010
The Wilmark Group January 2006 - July 2006
Marine Biological Laboratory January 2005 - January 2006
University of Connecticut 1997 - 2004
Skills
New Business Development, Regenerative Medicine, Tissue Engineering, Cell Therapy, Physiology, Capital Equipment, Strategic Partnerships, Competitive Analysis, Biotechnology, Medical Devices, Lifesciences, Product Development, Product Management, Stem Cells, Cell, Cell Culture, Cell Biology, Cross-functional Team..., Commercialization, Molecular Biology, Life Sciences, R&D, Pharmaceutical Industry, Management, Regulatory Affairs, Technology Transfer, Business Development
Education
The University of Connecticut 1997 — 2004
Ph.D., Physiology and Neurobiology
The University of Connecticut 1997 — 2003
M.S., Physiology and Neurobiology
Kean University 1993 — 1997
B.A., Psychology
Complya Consulting Group June 2014 - Present
Harvard Apparatus Regenerative Technology May 2012 - June 2014
Harvard Apparatus - Regenerative Medicine Division July 2010 - April 2012
Harvard Apparatus July 2006 - July 2010
The Wilmark Group January 2006 - July 2006
Marine Biological Laboratory January 2005 - January 2006
University of Connecticut 1997 - 2004
Skills
New Business Development, Regenerative Medicine, Tissue Engineering, Cell Therapy, Physiology, Capital Equipment, Strategic Partnerships, Competitive Analysis, Biotechnology, Medical Devices, Lifesciences, Product Development, Product Management, Stem Cells, Cell, Cell Culture, Cell Biology, Cross-functional Team..., Commercialization, Molecular Biology, Life Sciences, R&D, Pharmaceutical Industry, Management, Regulatory Affairs, Technology Transfer, Business Development
Education
The University of Connecticut 1997 — 2004
Ph.D., Physiology and Neurobiology
The University of Connecticut 1997 — 2003
M.S., Physiology and Neurobiology
Kean University 1993 — 1997
B.A., Psychology
Bill Traynham Bill Traynham's Complya Consulting Group Experience September 2010 - Present
Job Vice President of Operations at Complya Consulting Group
Industry Pharmaceuticals
Experience
Complya Consulting Group September 2010 - Present
Concert Pharmaceuticals May 2008 - September 2010
Oscient Pharmaceuticals September 2006 - May 2008
Wyeth Pharmaceuticals 2003 - 2006
Control Delivery Systems 2002 - 2003
Bristol-Myers Squibb 1995 - 2002
Skills
GMP, GxP, 21 CFR Part 11, Auditing, CAPA
Education
Saint Joseph's College 1991 — 1995
Bachelors, Biology and Chemistry
Complya Consulting Group September 2010 - Present
Concert Pharmaceuticals May 2008 - September 2010
Oscient Pharmaceuticals September 2006 - May 2008
Wyeth Pharmaceuticals 2003 - 2006
Control Delivery Systems 2002 - 2003
Bristol-Myers Squibb 1995 - 2002
Skills
GMP, GxP, 21 CFR Part 11, Auditing, CAPA
Education
Saint Joseph's College 1991 — 1995
Bachelors, Biology and Chemistry
Coreen Reed's Complya Consulting Group Experience June 2011 - September 2014
Job Quality Assurance Specialist at Concert Pharmaceuticals
Industry Biotechnology
Experience
Concert Pharmaceuticals September 2014 - Present
Complya Consulting Group June 2011 - September 2014
Lonza Biologics September 2010 - March 2011
Nerac January 1999 - July 2009
Pronova Biopolymers May 1995 - January 1999
Education
Saint Michael's College 1989 — 1993
Concert Pharmaceuticals September 2014 - Present
Complya Consulting Group June 2011 - September 2014
Lonza Biologics September 2010 - March 2011
Nerac January 1999 - July 2009
Pronova Biopolymers May 1995 - January 1999
Education
Saint Michael's College 1989 — 1993
Bob Duane's Complya Consulting Group Experience January 2014 - November 2014
Job Head of Quality, Moderna
Industry Biotechnology
Experience
Complya Consulting Group January 2014 - November 2014
Pfizer June 2005 - November 2013
Skills
CAPA
Education
University of Connecticut 1971 — 1975
Complya Consulting Group January 2014 - November 2014
Pfizer June 2005 - November 2013
Skills
CAPA
Education
University of Connecticut 1971 — 1975
Paul Piscia's Complya Consulting Group Experience May 2009 - Present
Job Senior Quality Consultant at Complya Consulting Group
Industry Pharmaceuticals
Experience
Complya Consulting Group May 2009 - Present
Bristol Myers Squibb October 2001 - July 2007
Dupont Pharma January 1995 - October 2001
The DuPont Merck Pharmaceutical Company 1980 - 2001
DuPont Pharmaceuticals May 1980 - August 1986
Skills
Analytical Chemistry, HPLC, Pharmaceutical Industry, GMP, Validation, FDA, 21 CFR Part 11, R&D, V&V, UV/Vis, Quality Auditing, Biotechnology, GxP, LIMS, Quality System, GLP, Computer System..., Regulatory Affairs, Regulatory Submissions, Manufacturing, Chemistry, Aseptic Processing, Clinical Development, Biopharmaceuticals, Clinical Trials, Laboratory, Quality Control, Medical Devices, Quality Assurance, Regulatory Requirements, Drug Development, Lifesciences, Pharmaceutics, Cleaning Validation, Life Sciences, Chromatography, SOP, Technology Transfer, CAPA, Change Control
Education
Rivier College 1980 — 1984
MBA, General Business
Northeastern University 1965 — 1976
BS, Chemistry
Complya Consulting Group May 2009 - Present
Bristol Myers Squibb October 2001 - July 2007
Dupont Pharma January 1995 - October 2001
The DuPont Merck Pharmaceutical Company 1980 - 2001
DuPont Pharmaceuticals May 1980 - August 1986
Skills
Analytical Chemistry, HPLC, Pharmaceutical Industry, GMP, Validation, FDA, 21 CFR Part 11, R&D, V&V, UV/Vis, Quality Auditing, Biotechnology, GxP, LIMS, Quality System, GLP, Computer System..., Regulatory Affairs, Regulatory Submissions, Manufacturing, Chemistry, Aseptic Processing, Clinical Development, Biopharmaceuticals, Clinical Trials, Laboratory, Quality Control, Medical Devices, Quality Assurance, Regulatory Requirements, Drug Development, Lifesciences, Pharmaceutics, Cleaning Validation, Life Sciences, Chromatography, SOP, Technology Transfer, CAPA, Change Control
Education
Rivier College 1980 — 1984
MBA, General Business
Northeastern University 1965 — 1976
BS, Chemistry
Nicole Villari's Complya Consulting Group Experience May 2012 - Present
Job QA Consultant at Complya Consulting Group
Industry Biotechnology
Experience
Complya Consulting Group May 2012 - Present
Ipsen May 2011 - May 2012
Genzyme January 2007 - May 2011
RenaMed Biologics 2005 - 2006
Amgen 2002 - 2005
Skills
Quality Assurance, GMP, CAPA, Change Control, FDA, 21 CFR Part 11, Validation, Sop, Biotechnology, Biopharmaceuticals, LIMS, GxP, Pharmaceutical Industry, Trackwise
Education
University of Rhode Island 1997 — 2002
Bachelor of Science (B.S.), Microbiology
Complya Consulting Group May 2012 - Present
Ipsen May 2011 - May 2012
Genzyme January 2007 - May 2011
RenaMed Biologics 2005 - 2006
Amgen 2002 - 2005
Skills
Quality Assurance, GMP, CAPA, Change Control, FDA, 21 CFR Part 11, Validation, Sop, Biotechnology, Biopharmaceuticals, LIMS, GxP, Pharmaceutical Industry, Trackwise
Education
University of Rhode Island 1997 — 2002
Bachelor of Science (B.S.), Microbiology
Ann Boldrighini's Complya Consulting Group Experience February 2013 - March 2015
Job Senior Associate, RACMC at Genzyme, a Sanofi company
Industry Biotechnology
Experience
Genzyme, a Sanofi company April 2015 - Present
Complya Consulting Group February 2013 - March 2015
Biogen Idec October 2011 - February 2013
Mersana Therapeutics September 2009 - July 2011
Wyeth February 2009 - September 2009
Wyeth May 2008 - February 2009
Wyeth July 2007 - March 2008
Fidelity Investments February 2007 - July 2007
Wyeth September 2006 - December 2006
Bombardier Transportation January 2001 - August 2002
Skills
Validation, SOP, Pharmaceutical Industry, FDA, Regulatory Affairs, Biotechnology, GMP, Life Sciences, Regulatory Submissions, CAPA
Education
Northeastern University 2007 — 2008
MS, Regulatory Affairs
Middlebury College
MA, German
University of Massachusetts Lowell
Certificate, Technical Writing
University of Massachusetts, Amherst
BA, German
Genzyme, a Sanofi company April 2015 - Present
Complya Consulting Group February 2013 - March 2015
Biogen Idec October 2011 - February 2013
Mersana Therapeutics September 2009 - July 2011
Wyeth February 2009 - September 2009
Wyeth May 2008 - February 2009
Wyeth July 2007 - March 2008
Fidelity Investments February 2007 - July 2007
Wyeth September 2006 - December 2006
Bombardier Transportation January 2001 - August 2002
Skills
Validation, SOP, Pharmaceutical Industry, FDA, Regulatory Affairs, Biotechnology, GMP, Life Sciences, Regulatory Submissions, CAPA
Education
Northeastern University 2007 — 2008
MS, Regulatory Affairs
Middlebury College
MA, German
University of Massachusetts Lowell
Certificate, Technical Writing
University of Massachusetts, Amherst
BA, German
Donna Sokolski's Complya Consulting Group Experience December 2013 - Present
Job Quality Assurance Consultant at Complya Consulting Group
Industry Biotechnology
Experience
Complya Consulting Group December 2013 - Present
AMAG Pharmaceuticals, Inc. July 2011 - October 2012
AMAG Pharmaceuticals March 2009 - August 2011
Hyaluron, Inc. 2007 - 2008
Acusphere 2000 - 2007
Vertex Pharmaceuticals 1997 - 1999
Biogen, Inc. 1991 - 1993
Skills
Pharmaceuticals, 21 CFR Part 11, cGMP, FDA, GMP, Biotechnology, Quality Systems, Clinical Trials, Compliance, Quality Assurance, SOP, Clinical, Documentation, Software Documentation, Quality Control, Sop, V&V, Quality System, Change Control, Regulatory Affairs, Technology Transfer, CAPA, Drug Development, Clinical Development, Pharmaceutical Industry, Training
Education
Northeastern University
Complya Consulting Group December 2013 - Present
AMAG Pharmaceuticals, Inc. July 2011 - October 2012
AMAG Pharmaceuticals March 2009 - August 2011
Hyaluron, Inc. 2007 - 2008
Acusphere 2000 - 2007
Vertex Pharmaceuticals 1997 - 1999
Biogen, Inc. 1991 - 1993
Skills
Pharmaceuticals, 21 CFR Part 11, cGMP, FDA, GMP, Biotechnology, Quality Systems, Clinical Trials, Compliance, Quality Assurance, SOP, Clinical, Documentation, Software Documentation, Quality Control, Sop, V&V, Quality System, Change Control, Regulatory Affairs, Technology Transfer, CAPA, Drug Development, Clinical Development, Pharmaceutical Industry, Training
Education
Northeastern University
Jan DeLap's Complya Consulting Group Experience Technical ContractorBiogen Idec2012 - 2012
Job Quality Assurance Consultant at Complya Consulting Group
Industry Writing and Editing
Experience
Complya Consulting Group Technical ContractorBiogen Idec2012 - 2012
iRobot January 2010 - August 2010
Wyeth 2001 - 2008
Wyeth Pharmaceuticals 2001 - 2008
Education
University of Massachusetts Lowell 1994 — 1996
Certificate in Technical Writing, A
Complya Consulting Group Technical ContractorBiogen Idec2012 - 2012
iRobot January 2010 - August 2010
Wyeth 2001 - 2008
Wyeth Pharmaceuticals 2001 - 2008
Education
University of Massachusetts Lowell 1994 — 1996
Certificate in Technical Writing, A
Cyndie Gangi's Complya Consulting Group Experience November 2010 - December 2012
Job Associate Director, Regulatory Affairs at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec January 2013 - Present
Complya Consulting Group November 2010 - December 2012
Biogen Idec March 2007 - October 2010
Biogen Idec March 2004 - March 2007
Biogen Idec February 2002 - February 2004
Genpharm Inc. 2000 - 2002
Skills
IND, eCTD, Regulatory Affairs, FDA, Strategy, Regulatory Submissions, Biopharmaceuticals, Drug Development
Education
Queen's University 1993 — 1997
Bachelor of Science, Honours, Biochemistry
Biogen Idec January 2013 - Present
Complya Consulting Group November 2010 - December 2012
Biogen Idec March 2007 - October 2010
Biogen Idec March 2004 - March 2007
Biogen Idec February 2002 - February 2004
Genpharm Inc. 2000 - 2002
Skills
IND, eCTD, Regulatory Affairs, FDA, Strategy, Regulatory Submissions, Biopharmaceuticals, Drug Development
Education
Queen's University 1993 — 1997
Bachelor of Science, Honours, Biochemistry
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY