MannKind Corporation
Industry: Company
DescriptionMannKind Corporation is a biopharmaceutical company focusing on the discovery, development, and commercialization of therapeutic products for diseases such as diabetes and pulmonary arterial hypertension. Based in Westlake Village, California, the company was founded in February 1991. CEO: Michael Castagna Headquarters: Westlake Village, California, United States Founder: Alfred E. Mann Number of employees: 250
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MannKind Corporation Employees
Employee
Years
Job
Industry
Steven Lasko Steven Lasko's MannKind Corporation Experience September 2014 - December 2014
Job Commissioning and Qualification Lead Consultant at Amgen
Industry Pharmaceuticals
Experience
Amgen February 2015 - Present
MannKind Corporation September 2014 - December 2014
Neutrogena (Johnson & Johnson) December 2013 - June 2014
Intel Corporation July 2013 - December 2013
Neutrogena (Johnson & Johnson) July 2011 - July 2013
Novartis October 2009 - April 2011
Genentech September 2008 - September 2009
ZymoGenetics January 2008 - September 2008
Nastech Pharmaceutical October 2006 - November 2007
Pfizer February 2006 - October 2006
Skills
Validation, Project Engineering, FDA GMP, Pharmaceutical Industry, Quality Assurance, Quality System, Compliance, CIP systems, SIP, Project Management, R&D, Process Engineering, Steam, Environmental Awareness, Water Quality, Biotechnology Industry, Processes Development, Plant Start Up, Fillers, Manufacturing, Computer System..., Change Control, V&V, FDA, Technology Transfer
Education
Purdue University 2000 — 2002
MS, Chemical Engineering
Michigan Technological University 1993 — 1997
BS, Chemical Engineering
Niles North High School 1989 — 1993
Amgen February 2015 - Present
MannKind Corporation September 2014 - December 2014
Neutrogena (Johnson & Johnson) December 2013 - June 2014
Intel Corporation July 2013 - December 2013
Neutrogena (Johnson & Johnson) July 2011 - July 2013
Novartis October 2009 - April 2011
Genentech September 2008 - September 2009
ZymoGenetics January 2008 - September 2008
Nastech Pharmaceutical October 2006 - November 2007
Pfizer February 2006 - October 2006
Skills
Validation, Project Engineering, FDA GMP, Pharmaceutical Industry, Quality Assurance, Quality System, Compliance, CIP systems, SIP, Project Management, R&D, Process Engineering, Steam, Environmental Awareness, Water Quality, Biotechnology Industry, Processes Development, Plant Start Up, Fillers, Manufacturing, Computer System..., Change Control, V&V, FDA, Technology Transfer
Education
Purdue University 2000 — 2002
MS, Chemical Engineering
Michigan Technological University 1993 — 1997
BS, Chemical Engineering
Niles North High School 1989 — 1993
Jason Valenta's MannKind Corporation Experience July 2005 - April 2012
Job Director / Head of Automation at Sanofi
Industry Pharmaceuticals
Experience
Sanofi January 2014 - Present
Genzyme April 2012 - Present
MannKind Corporation July 2005 - April 2012
MannKind Corporation July 2005 - August 2008
Global Automation Partners 2001 - July 2005
Dynapower Corporation 1999 - 2001
Wittmann Robot and Automation 1998 - 1999
Conveyco Technologies, Inc. 1996 - 1998
Bergmann Associates 1995 - 1996
Cadbury Schweppes 1994 - 1995
Skills
Allen Bradley, Process Control, Validation, PLC, Change Control, Automation, Control Systems Design, Reliability Engineering, GMP, Software Documentation, Computer System..., Testing, Process Automation, Process Optimization, PLC Programming, Project Management, Process Engineering, 21 CFR Part 11, Commissioning, Electricians, Process Improvement, GAMP, Engineering, Manufacturing, Contract Management, Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Integration, Management, Instrumentation, V&V, Cross-functional Team..., FDA, DCS, GxP, MES
Education
Rochester Institute of Technology
BS, Engineering
Western Connecticut State University
MBA
Sanofi January 2014 - Present
Genzyme April 2012 - Present
MannKind Corporation July 2005 - April 2012
MannKind Corporation July 2005 - August 2008
Global Automation Partners 2001 - July 2005
Dynapower Corporation 1999 - 2001
Wittmann Robot and Automation 1998 - 1999
Conveyco Technologies, Inc. 1996 - 1998
Bergmann Associates 1995 - 1996
Cadbury Schweppes 1994 - 1995
Skills
Allen Bradley, Process Control, Validation, PLC, Change Control, Automation, Control Systems Design, Reliability Engineering, GMP, Software Documentation, Computer System..., Testing, Process Automation, Process Optimization, PLC Programming, Project Management, Process Engineering, 21 CFR Part 11, Commissioning, Electricians, Process Improvement, GAMP, Engineering, Manufacturing, Contract Management, Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Integration, Management, Instrumentation, V&V, Cross-functional Team..., FDA, DCS, GxP, MES
Education
Rochester Institute of Technology
BS, Engineering
Western Connecticut State University
MBA
Norayr Telyan Norayr Telyan's MannKind Corporation Experience March 2014 - Present
Job Senior Director External Manufacturing at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation March 2014 - Present
NorTel Consulting January 2012 - March 2014
Schering-Plough / Merck &Co. 2005 - December 2011
Schering-Plough Pharmaceuticals 2003 - 2005
Schering-Plough Corporation 2001 - 2003
Reckitt & Colman 1998 - 2001
Colgate Palmolive / Mennen 1984 - 1998
Skills
GMP, Technology Transfer, Pharmaceutical Industry, FDA, Process Simulation, Product Development, CAPA
Education
New York University
M.S
MannKind Corporation March 2014 - Present
NorTel Consulting January 2012 - March 2014
Schering-Plough / Merck &Co. 2005 - December 2011
Schering-Plough Pharmaceuticals 2003 - 2005
Schering-Plough Corporation 2001 - 2003
Reckitt & Colman 1998 - 2001
Colgate Palmolive / Mennen 1984 - 1998
Skills
GMP, Technology Transfer, Pharmaceutical Industry, FDA, Process Simulation, Product Development, CAPA
Education
New York University
M.S
Sandra Madrid Sandra Madrid's MannKind Corporation Experience March 2008 - April 2011
Job Project Manager Onsite at PepsiCo
Industry Design
Experience
Southern Graphic Systems January 2013 - Present
Sandra Madrid April 2011 - December 2012
MannKind Corporation March 2008 - April 2011
Southern Graphic Systems March 2001 - March 2008
Aquent February 1999 - June 2003
The Buzz Company February 1999 - March 2001
Bill Young Productions November 1997 - January 1999
Kaleidoscope Communications September 1996 - November 1997
Skills
Packaging, Graphic Design, Project Management, Adobe Creative Suite, Art Direction, Logo Design, Graphics, InDesign, Corporate Identity, Pre-press, Brochures, Advertising, Cross-functional Team..., Product Development, Photoshop, Posters, Image Manipulation, Marketing, Adobe Acrobat, Creative Direction, Business Cards, Layout, Brand Development, Concept Development, Branding, Corporate Branding, Visual Communication, QuarkXPress, Branding & Identity, Branding
Education
Houston Community College 1994 — 1996
AAS, Technical Communications
University of North Texas 1991 — 1994
Southern Graphic Systems January 2013 - Present
Sandra Madrid April 2011 - December 2012
MannKind Corporation March 2008 - April 2011
Southern Graphic Systems March 2001 - March 2008
Aquent February 1999 - June 2003
The Buzz Company February 1999 - March 2001
Bill Young Productions November 1997 - January 1999
Kaleidoscope Communications September 1996 - November 1997
Skills
Packaging, Graphic Design, Project Management, Adobe Creative Suite, Art Direction, Logo Design, Graphics, InDesign, Corporate Identity, Pre-press, Brochures, Advertising, Cross-functional Team..., Product Development, Photoshop, Posters, Image Manipulation, Marketing, Adobe Acrobat, Creative Direction, Business Cards, Layout, Brand Development, Concept Development, Branding, Corporate Branding, Visual Communication, QuarkXPress, Branding & Identity, Branding
Education
Houston Community College 1994 — 1996
AAS, Technical Communications
University of North Texas 1991 — 1994
Sandra M. Wear Sandra M. Wear's MannKind Corporation Experience May 2004 - February 2006
Job Managing Director, Chance Magazine New York, NY
Industry Program Development
Experience
Chance Magazine LLC 2014 - Present
Desire To Retire, LLC January 2007 - Present
The Multiple Myeloma Research Foundation April 2007 - June 2012
Endpoint Research LTD March 2006 - January 2007
MannKind Corporation May 2004 - February 2006
Purdue Pharma September 2002 - April 2004
Quintiles November 1997 - September 2002
Pfizer (formerly Pharmacia/UpJohn) November 1989 - October 1997
Credit Valley Hospital June 1986 - October 1989
Skills
Clinical Research, Clinical Monitoring, Regulatory Requirements, Team Leadership, Business Process..., Team Facilitation, Presenter, People Skills, Teamwork, Oral & Written..., Highly detail oriented, Logical Approach, Comprehensive Planning, Problem Solving, Negotiation, Operational Risk..., Financial Analysis, Enthusiast, Believer, Building Relationships, Building Customer..., Motivational Speaking, Conversation
Education
Mohawk College
Associate's degree, Registered Nursing/Registered Nurse, Dean's Honors List
Chance Magazine LLC 2014 - Present
Desire To Retire, LLC January 2007 - Present
The Multiple Myeloma Research Foundation April 2007 - June 2012
Endpoint Research LTD March 2006 - January 2007
MannKind Corporation May 2004 - February 2006
Purdue Pharma September 2002 - April 2004
Quintiles November 1997 - September 2002
Pfizer (formerly Pharmacia/UpJohn) November 1989 - October 1997
Credit Valley Hospital June 1986 - October 1989
Skills
Clinical Research, Clinical Monitoring, Regulatory Requirements, Team Leadership, Business Process..., Team Facilitation, Presenter, People Skills, Teamwork, Oral & Written..., Highly detail oriented, Logical Approach, Comprehensive Planning, Problem Solving, Negotiation, Operational Risk..., Financial Analysis, Enthusiast, Believer, Building Relationships, Building Customer..., Motivational Speaking, Conversation
Education
Mohawk College
Associate's degree, Registered Nursing/Registered Nurse, Dean's Honors List
Lisa (Newhouse) Newhouse-Hernandez's MannKind Corporation Experience August 2004 - April 2009
Job Horse manager and trainer
Industry Higher Education
Experience
Hernandez ranch manager May 2013 - Present
Cal Poly Pomona July 2012 - January 2013
University of Southern California February 2010 - January 2013
MannKind Corporation August 2004 - April 2009
California Institute of Technology June 2002 - July 2004
Skills
In Vivo, Lifesciences, Animal Models, Veterinary, Animal Work, GLP, Toxicology, Science, Animal Welfare, Animal Husbandry, Laboratory Animal..., Animal Behavior, IACUC, Veterinary Medicine, Sop, Regulatory Affairs, FDA
Education
Los Angeles Pierce College 2002 — 2004
A.S, Veterinary Technology 2004
Los Angeles Pierce College 2000 — 2004
AS, Veterinary Technology
Palmdale High School 1985 — 1989
High School Diploma
Hernandez ranch manager May 2013 - Present
Cal Poly Pomona July 2012 - January 2013
University of Southern California February 2010 - January 2013
MannKind Corporation August 2004 - April 2009
California Institute of Technology June 2002 - July 2004
Skills
In Vivo, Lifesciences, Animal Models, Veterinary, Animal Work, GLP, Toxicology, Science, Animal Welfare, Animal Husbandry, Laboratory Animal..., Animal Behavior, IACUC, Veterinary Medicine, Sop, Regulatory Affairs, FDA
Education
Los Angeles Pierce College 2002 — 2004
A.S, Veterinary Technology 2004
Los Angeles Pierce College 2000 — 2004
AS, Veterinary Technology
Palmdale High School 1985 — 1989
High School Diploma
Patricia R. Mayer, Ph.D. Patricia R. Mayer, Ph.D.'s MannKind Corporation Experience June 2008 - June 2012
Job Vice President Regulatory Affairs at Perosphere Inc.
Industry Biotechnology
Experience
Perosphere Inc. July 2014 - Present
PRM Regulatory Strategy Consulting LLC July 2012 - July 2014
MannKind Corporation June 2008 - June 2012
Purdue Pharma July 2007 - June 2008
Berlex Laboratories / Bayer Healthcare June 2001 - May 2007
Schering AG, Berlin Germany / Bayer Healthcare November 1999 - May 2001
Schering AG, Berlin Germany / Bayer Healthcare September 1997 - October 1999
Schering AG, Berlin Germany / Bayer Healthcare April 1996 - August 1997
Skills
Regulatory Strategy, Drug Development..., Clinical Development, Regulatory Submissions, IND / NDA, Risk Management, FDA Meetings /..., Labeling, Clinical Compliance, GCP, Drug Development, IND, Medical Compliance, FDA, Clinical Trials, Pharmacovigilance, NDA, Strategy, Oncology, Biotechnology, Regulatory Affairs, eCTD, Pharmaceutical Industry, Sop, GMP, CMC, CAPA, Medical Affairs, Biopharmaceuticals, Clinical Research, Drug Safety, CRO, Regulatory Requirements, Technology Transfer, Drug Discovery, Medical Writing, 21 CFR Part 11, Pharmaceutics, Lifesciences, Immunology, Pharmacology, Validation, Quality Assurance, GLP, Life Sciences, SOP
Education
Eberhard-Karls University, Tuebingen, Germany 1984 — 2005
Ph.D., Cell Biology
Oregon State University 1988 — 1989
Perosphere Inc. July 2014 - Present
PRM Regulatory Strategy Consulting LLC July 2012 - July 2014
MannKind Corporation June 2008 - June 2012
Purdue Pharma July 2007 - June 2008
Berlex Laboratories / Bayer Healthcare June 2001 - May 2007
Schering AG, Berlin Germany / Bayer Healthcare November 1999 - May 2001
Schering AG, Berlin Germany / Bayer Healthcare September 1997 - October 1999
Schering AG, Berlin Germany / Bayer Healthcare April 1996 - August 1997
Skills
Regulatory Strategy, Drug Development..., Clinical Development, Regulatory Submissions, IND / NDA, Risk Management, FDA Meetings /..., Labeling, Clinical Compliance, GCP, Drug Development, IND, Medical Compliance, FDA, Clinical Trials, Pharmacovigilance, NDA, Strategy, Oncology, Biotechnology, Regulatory Affairs, eCTD, Pharmaceutical Industry, Sop, GMP, CMC, CAPA, Medical Affairs, Biopharmaceuticals, Clinical Research, Drug Safety, CRO, Regulatory Requirements, Technology Transfer, Drug Discovery, Medical Writing, 21 CFR Part 11, Pharmaceutics, Lifesciences, Immunology, Pharmacology, Validation, Quality Assurance, GLP, Life Sciences, SOP
Education
Eberhard-Karls University, Tuebingen, Germany 1984 — 2005
Ph.D., Cell Biology
Oregon State University 1988 — 1989
David Townson David Townson's MannKind Corporation Experience 2010 - 2011
Job Head, Program Office at Novartis
Industry Pharmaceuticals
Experience
Novartis June 2015 - Present
Novartis February 2013 - Present
Upsher-Smith Laboratories 2012 - 2013
MannKind Corporation 2010 - 2011
MannKind Corp 2006 - 2010
Pfizer 2001 - 2006
Pfizer June 2001 - January 2004
Sanofi 1998 - 2001
Boehringer Ingelheim Pharmaceuticals 1991 - 1998
Skills
Strategic Planning, Product Development, Team Leadership, Project Portfolio..., Prioritization, Strategic Communications, Team Building, Cross-functional Team..., Pharmaceuticals, Biotechnology, Value Based Management, Portfolio Optimization, Risk Management, Forecasting, Business Strategy, Due Diligence, Program Management, Process Improvement, Medical Devices, Strategy, Pharmaceutical Industry, Organization &..., Project Management, Product Management, Management, Drug Development, FDA, Business Development, Business Intelligence, Oncology, Leadership, R&D
Education
Walden University 1999 — 2004
Ph.D., Applied Management and Decision Sciences
State University of New York Empire State College 1994 — 1997
Master's degree, Business
Long Island University 1986 — 1987
Graduate Certificate, Information Technology Applications
State University of New York College at Fredonia 1981 — 1985
Bachelor's degree, Environmental Science
Novartis June 2015 - Present
Novartis February 2013 - Present
Upsher-Smith Laboratories 2012 - 2013
MannKind Corporation 2010 - 2011
MannKind Corp 2006 - 2010
Pfizer 2001 - 2006
Pfizer June 2001 - January 2004
Sanofi 1998 - 2001
Boehringer Ingelheim Pharmaceuticals 1991 - 1998
Skills
Strategic Planning, Product Development, Team Leadership, Project Portfolio..., Prioritization, Strategic Communications, Team Building, Cross-functional Team..., Pharmaceuticals, Biotechnology, Value Based Management, Portfolio Optimization, Risk Management, Forecasting, Business Strategy, Due Diligence, Program Management, Process Improvement, Medical Devices, Strategy, Pharmaceutical Industry, Organization &..., Project Management, Product Management, Management, Drug Development, FDA, Business Development, Business Intelligence, Oncology, Leadership, R&D
Education
Walden University 1999 — 2004
Ph.D., Applied Management and Decision Sciences
State University of New York Empire State College 1994 — 1997
Master's degree, Business
Long Island University 1986 — 1987
Graduate Certificate, Information Technology Applications
State University of New York College at Fredonia 1981 — 1985
Bachelor's degree, Environmental Science
Oliver DeMelo Oliver DeMelo's MannKind Corporation Experience April 2006 - February 2011
Job Hello!
Industry Retail
Experience
Desigual 2012 - Present
Parexel March 2011 - March 2012
MannKind Corporation April 2006 - February 2011
Skills
SOP, FDA, GMP, 21 CFR Part 11, Medical Devices, Validation, Pharmaceutical Industry, Manufacturing, Regulatory Affairs, SAP ERP, CAPA, Quality Assurance, Cross-functional Team..., Materials Management, Sop, Supply Chain Management, Biotechnology, Quality System, ISO, Process Improvement, Change Control, Continuous Improvement
Education
Western Connecticut State University 2004 — 2006
Bachelor's degree, Computer Science
New England Institute of Technology 2002 — 2004
Associate's degree, Computer Science
Desigual 2012 - Present
Parexel March 2011 - March 2012
MannKind Corporation April 2006 - February 2011
Skills
SOP, FDA, GMP, 21 CFR Part 11, Medical Devices, Validation, Pharmaceutical Industry, Manufacturing, Regulatory Affairs, SAP ERP, CAPA, Quality Assurance, Cross-functional Team..., Materials Management, Sop, Supply Chain Management, Biotechnology, Quality System, ISO, Process Improvement, Change Control, Continuous Improvement
Education
Western Connecticut State University 2004 — 2006
Bachelor's degree, Computer Science
New England Institute of Technology 2002 — 2004
Associate's degree, Computer Science
Robyn Walsh Robyn Walsh's MannKind Corporation Experience July 2010 - Present
Job Quality Assurance Manager at MannKind Corporation
Industry Medical Devices
Experience
MannKind Corporation July 2010 - Present
MannKind Corporation April 2005 - July 2010
Tepnel Lifecodes August 2002 - April 2005
National Disease Research Interchange January 2000 - May 2002
Skills
GMP, Quality System, SOP, FDA, Validation, Change Control, Pharmaceutical Industry, 21 CFR Part 11, Computer System..., CAPA, Quality Assurance, Biotechnology, Regulatory Affairs, Medical Devices
Education
Thomas Jefferson University 1997 — 2000
MS, Genetics
Haverford College 1993 — 1997
BS, Biology, Biochemistry
MannKind Corporation July 2010 - Present
MannKind Corporation April 2005 - July 2010
Tepnel Lifecodes August 2002 - April 2005
National Disease Research Interchange January 2000 - May 2002
Skills
GMP, Quality System, SOP, FDA, Validation, Change Control, Pharmaceutical Industry, 21 CFR Part 11, Computer System..., CAPA, Quality Assurance, Biotechnology, Regulatory Affairs, Medical Devices
Education
Thomas Jefferson University 1997 — 2000
MS, Genetics
Haverford College 1993 — 1997
BS, Biology, Biochemistry
Julie David Julie David's MannKind Corporation Experience October 2005 - April 2011
Job RA/QA Document Control Associate at Engineering Research Group
Industry Pharmaceuticals
Experience
ENGINEERING RESEARCH GROUP February 2014 - Present
NEW MILFORD BOARD OF EDUCATION May 2013 - February 2014
MANNKIND CORPORATION October 2005 - April 2011
DAIICHI SANKYO (formerly Daiichi Pharmaceutical) 1995 - 2005
PFIZER (formerly American Cyanamid) 1990 - 1995
MORGAN STANLEY (formerly Dean Witter Reynolds) January 1985 - January 1990
Skills
Research, Management, Leadership, Department Budgeting, Training, Staff Development, Change Management, Building Relationships, Vendor Relationships, Team Building, Team Leadership, Volunteering, Event Planning, Clinical Trials, Ovid, Reference Manager, Pharmaceutical Industry, FDA, Problem Solving, Conflict Resolution, Mentoring, Medical Writing, GMP, Biotechnology, CRO, Product Development, Quality Assurance, Regulatory Affairs, Oncology, Cross-functional Team..., Sop, Medical Devices, Clinical Development, Regulatory Submissions, Data Management, Validation, 21 CFR Part 11, Pharmaceutics, Drug Discovery, Lifesciences, SOP
Education
Long Island University
Master's, Library Science
ENGINEERING RESEARCH GROUP February 2014 - Present
NEW MILFORD BOARD OF EDUCATION May 2013 - February 2014
MANNKIND CORPORATION October 2005 - April 2011
DAIICHI SANKYO (formerly Daiichi Pharmaceutical) 1995 - 2005
PFIZER (formerly American Cyanamid) 1990 - 1995
MORGAN STANLEY (formerly Dean Witter Reynolds) January 1985 - January 1990
Skills
Research, Management, Leadership, Department Budgeting, Training, Staff Development, Change Management, Building Relationships, Vendor Relationships, Team Building, Team Leadership, Volunteering, Event Planning, Clinical Trials, Ovid, Reference Manager, Pharmaceutical Industry, FDA, Problem Solving, Conflict Resolution, Mentoring, Medical Writing, GMP, Biotechnology, CRO, Product Development, Quality Assurance, Regulatory Affairs, Oncology, Cross-functional Team..., Sop, Medical Devices, Clinical Development, Regulatory Submissions, Data Management, Validation, 21 CFR Part 11, Pharmaceutics, Drug Discovery, Lifesciences, SOP
Education
Long Island University
Master's, Library Science
Christopher Scanlon's MannKind Corporation Experience June 2004 - July 2010
Job Principal Package Engineer PepsiCola / Lipton Partnerships
Industry Food & Beverages
Experience
PepsiCo April 2011 - Present
Bausch & Lomb July 2010 - April 2011
Mannkind Corporation June 2004 - July 2010
Purdue Pharma 1994 - 2004
Covidien October 1989 - December 1993
Skills
Validation, Manufacturing, Product Development, V&V, CAPA, Quality System, Injection Molding, 21 CFR Part 11, Biotechnology, Blow Molding, Change Control, Consumer Products, Commercialization, Continuous Improvement, Contract Manufacturing, DMAIC, Design Control, Design of Experiments, Engineering, Engineering Management, ISO, ISO 13485, Lean Manufacturing, Management, Materials, Plastics, Process Engineering, Process Improvement, Process Simulation, Product Launch, Project Management, Quality Assurance, Quality Auditing, Quality Management, Root Cause Analysis, Six Sigma, Solidworks, Sop, Supply Chain, Testing, Technology Transfer
Education
University of New Haven 2001 — 2003
Executive Master of Science in Engineering Management
University of New Haven 1996 — 1998
MBA
Rhode Island School of Design 1984 — 1989
BFA
Westminster School 1981 — 1984
GED
PepsiCo April 2011 - Present
Bausch & Lomb July 2010 - April 2011
Mannkind Corporation June 2004 - July 2010
Purdue Pharma 1994 - 2004
Covidien October 1989 - December 1993
Skills
Validation, Manufacturing, Product Development, V&V, CAPA, Quality System, Injection Molding, 21 CFR Part 11, Biotechnology, Blow Molding, Change Control, Consumer Products, Commercialization, Continuous Improvement, Contract Manufacturing, DMAIC, Design Control, Design of Experiments, Engineering, Engineering Management, ISO, ISO 13485, Lean Manufacturing, Management, Materials, Plastics, Process Engineering, Process Improvement, Process Simulation, Product Launch, Project Management, Quality Assurance, Quality Auditing, Quality Management, Root Cause Analysis, Six Sigma, Solidworks, Sop, Supply Chain, Testing, Technology Transfer
Education
University of New Haven 2001 — 2003
Executive Master of Science in Engineering Management
University of New Haven 1996 — 1998
MBA
Rhode Island School of Design 1984 — 1989
BFA
Westminster School 1981 — 1984
GED
Howard Hoffman, MD Howard Hoffman, MD's MannKind Corporation Experience April 2013 - Present
Job Vice President, Regulatory Affairs at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation April 2013 - Present
Daiichi Sankyo 2004 - December 2012
Bristol-Myers Squibb 1995 - 2004
G.D.Searle 1994 - 1995
Bristol-Myers Squibb 1987 - 1993
Bristol-Myers Squibb 1984 - 1987
Skills
Regulatory Affairs, Clinical Trials, Regulatory Submissions, Drug Development, Pharmacovigilance, Oncology, IND, FDA, GCP, Biotechnology, Medical Affairs, CRO, Therapeutic Areas, Clinical Research, Regulatory Requirements, NDA, Medical Writing, Sop, Clinical Development, Clinical Pharmacology, Pharmaceutics, Diabetes, Medicine, Clinical Study Design, Biopharmaceuticals, Biologics, eCTD, Infectious Diseases, Vaccines, Pharmacology, Drug Discovery, 21 CFR Part 11, CMC, R&D, Immunology, Technology Transfer, Lifesciences, Neurology, Drug Safety, CTMS, GLP, Dermatology, GMP, Pharmacokinetics, Toxicology, SOP, Life Sciences
Education
New York Medical College
MD
MannKind Corporation April 2013 - Present
Daiichi Sankyo 2004 - December 2012
Bristol-Myers Squibb 1995 - 2004
G.D.Searle 1994 - 1995
Bristol-Myers Squibb 1987 - 1993
Bristol-Myers Squibb 1984 - 1987
Skills
Regulatory Affairs, Clinical Trials, Regulatory Submissions, Drug Development, Pharmacovigilance, Oncology, IND, FDA, GCP, Biotechnology, Medical Affairs, CRO, Therapeutic Areas, Clinical Research, Regulatory Requirements, NDA, Medical Writing, Sop, Clinical Development, Clinical Pharmacology, Pharmaceutics, Diabetes, Medicine, Clinical Study Design, Biopharmaceuticals, Biologics, eCTD, Infectious Diseases, Vaccines, Pharmacology, Drug Discovery, 21 CFR Part 11, CMC, R&D, Immunology, Technology Transfer, Lifesciences, Neurology, Drug Safety, CTMS, GLP, Dermatology, GMP, Pharmacokinetics, Toxicology, SOP, Life Sciences
Education
New York Medical College
MD
Amanda Cuomo Amanda Cuomo's MannKind Corporation Experience 2010 - 2011
Job Administrator at Etsy
Industry Writing and Editing
Experience
Etsy August 2015 - Present
Fordham University April 2015 - June 2015
Hotsand AP August 2014 - April 2015
Method November 2014 - November 2014
Chobani November 2012 - May 2014
Chobani, Inc. July 2013 - October 2013
Jefferies & Company 2011 - 2012
MannKind Corporation 2010 - 2011
MBL Communications 2009 - 2009
Asbury Park Press May 2008 - August 2008
Skills
QuickBooks, Microsoft Word, Microsoft Office, Editing, Microsoft Excel, Pharmaceutical Industry, Databases, Proofreading, Diabetes, Data Management, PowerPoint, Research, Software Documentation, Data Entry, Social Media, Management, Event Planning, Public Relations, Leadership, Marketing, Customer Service, Communication, Event Management, Social Networking, WordPress, Squarespace, Oracle Database, Clinical Data Management
Education
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2009
B.A., Journalism & Media Studies
Etsy August 2015 - Present
Fordham University April 2015 - June 2015
Hotsand AP August 2014 - April 2015
Method November 2014 - November 2014
Chobani November 2012 - May 2014
Chobani, Inc. July 2013 - October 2013
Jefferies & Company 2011 - 2012
MannKind Corporation 2010 - 2011
MBL Communications 2009 - 2009
Asbury Park Press May 2008 - August 2008
Skills
QuickBooks, Microsoft Word, Microsoft Office, Editing, Microsoft Excel, Pharmaceutical Industry, Databases, Proofreading, Diabetes, Data Management, PowerPoint, Research, Software Documentation, Data Entry, Social Media, Management, Event Planning, Public Relations, Leadership, Marketing, Customer Service, Communication, Event Management, Social Networking, WordPress, Squarespace, Oracle Database, Clinical Data Management
Education
Rutgers, The State University of New Jersey-New Brunswick 2007 — 2009
B.A., Journalism & Media Studies
Geoffrey von Holten Geoffrey von Holten's MannKind Corporation Experience October 2013 - Present
Job Process Engineering Consultant at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation October 2013 - Present
GvH Consulting, Inc. February 2009 - Present
Shire HGT August 2011 - October 2013
OPK Biotech, LLC April 2011 - August 2011
MannKind Corporation October 2010 - April 2011
Shire HGT July 2009 - September 2010
MannKind Corporation August 2004 - July 2009
Bosch October 2003 - October 2006
Validation and Process Associates July 2002 - August 2003
Skills
Commissioning, Process Validation, Cleaning Validation, Validation, Process Engineering, Process Improvement, Engineering, Chromatography, Sop, GAMP, GMP, CAPA, V&V, Change Control, Pharmaceutical Industry, Quality System, Biotechnology, 21 CFR Part 11, Continuous Improvement, Manufacturing, Computer System..., FDA, Testing, Software Documentation, Technology Transfer, Process Simulation, R&D, GxP, Biopharmaceuticals, ISO 13485, Quality Control, Process Optimization, Aseptic Processing, Medical Devices, Quality Auditing, Regulatory Affairs, Pharmaceutics, Filtration, Lifesciences, Quality Assurance
Education
Northeastern University 1997 — 2002
BS, Chemical Engineering
MannKind Corporation October 2013 - Present
GvH Consulting, Inc. February 2009 - Present
Shire HGT August 2011 - October 2013
OPK Biotech, LLC April 2011 - August 2011
MannKind Corporation October 2010 - April 2011
Shire HGT July 2009 - September 2010
MannKind Corporation August 2004 - July 2009
Bosch October 2003 - October 2006
Validation and Process Associates July 2002 - August 2003
Skills
Commissioning, Process Validation, Cleaning Validation, Validation, Process Engineering, Process Improvement, Engineering, Chromatography, Sop, GAMP, GMP, CAPA, V&V, Change Control, Pharmaceutical Industry, Quality System, Biotechnology, 21 CFR Part 11, Continuous Improvement, Manufacturing, Computer System..., FDA, Testing, Software Documentation, Technology Transfer, Process Simulation, R&D, GxP, Biopharmaceuticals, ISO 13485, Quality Control, Process Optimization, Aseptic Processing, Medical Devices, Quality Auditing, Regulatory Affairs, Pharmaceutics, Filtration, Lifesciences, Quality Assurance
Education
Northeastern University 1997 — 2002
BS, Chemical Engineering
Margaret (Maggie) Price, MPA, BS Margaret (Maggie) Price, MPA, BS's MannKind Corporation Experience September 2007 - April 2011
Job Senior Clinical Data Manager
Industry Biotechnology
Experience
MannKind Corporation September 2007 - April 2011
MannKind Corporation March 2005 - May 2007
PRA International November 2004 - February 2005
Forest Laboratories, Inc July 2001 - September 2004
Novartis, Merck and Johnson and Johnson April 2000 - June 2001
Quintiles Inc. January 1997 - January 2001
Merck 2000 - 2001
St. Barnabas Hospital June 1986 - March 1997
Exxon Corporation May 1986 - September 1988
Skills
Therapeutic Areas, Document Management, Oncology
Education
Seton Hall University 1990 — 1996
MPA, Public Administration-Healthcare
Kean University 1982 — 1986
BS, Management Science
Kean University 1982 — 1986
Bachelor of Science (BS), Management Science
Union High School
MannKind Corporation September 2007 - April 2011
MannKind Corporation March 2005 - May 2007
PRA International November 2004 - February 2005
Forest Laboratories, Inc July 2001 - September 2004
Novartis, Merck and Johnson and Johnson April 2000 - June 2001
Quintiles Inc. January 1997 - January 2001
Merck 2000 - 2001
St. Barnabas Hospital June 1986 - March 1997
Exxon Corporation May 1986 - September 1988
Skills
Therapeutic Areas, Document Management, Oncology
Education
Seton Hall University 1990 — 1996
MPA, Public Administration-Healthcare
Kean University 1982 — 1986
BS, Management Science
Kean University 1982 — 1986
Bachelor of Science (BS), Management Science
Union High School
John Riesenberger John Riesenberger's MannKind Corporation Experience 2008 - 2009
Job President at Consilium Partners, Inc.
Industry Pharmaceuticals
Experience
Ontario Institute for Cancer Research 2013 - Present
Pearson North America 2006 - Present
Consilium Partners, Inc. 2000 - Present
Thunderbird School of Global Management 2010 - 2012
MannKind Corporation 2008 - 2009
Shaw Science Partners, Inc. 2001 - 2007
Pharmacia & Upjohn 1995 - 1999
The Upjohn Company 1972 - 1995
Skills
Strategic Planning, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Oncology, International Business, Global Marketing, Competitive Intelligence, Forecasting, Market Analysis, Commercialization, Lifesciences, Strategy, Competitive Analysis, Product Marketing, Market Research, Product Launch, Pharmaceutical Sales, Marketing Management, Market Development, Medical Devices, Product Development, Marketing Strategy, Segmentation, Start-ups, Market Planning, Life Sciences
Education
Harvard Business School 1989 — 1989
International Senior Management Program
Hofstra University 1970 — 1975
MBA
Hofstra University 1966 — 1970
B.S., Economics-Business
Ontario Institute for Cancer Research 2013 - Present
Pearson North America 2006 - Present
Consilium Partners, Inc. 2000 - Present
Thunderbird School of Global Management 2010 - 2012
MannKind Corporation 2008 - 2009
Shaw Science Partners, Inc. 2001 - 2007
Pharmacia & Upjohn 1995 - 1999
The Upjohn Company 1972 - 1995
Skills
Strategic Planning, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Oncology, International Business, Global Marketing, Competitive Intelligence, Forecasting, Market Analysis, Commercialization, Lifesciences, Strategy, Competitive Analysis, Product Marketing, Market Research, Product Launch, Pharmaceutical Sales, Marketing Management, Market Development, Medical Devices, Product Development, Marketing Strategy, Segmentation, Start-ups, Market Planning, Life Sciences
Education
Harvard Business School 1989 — 1989
International Senior Management Program
Hofstra University 1970 — 1975
MBA
Hofstra University 1966 — 1970
B.S., Economics-Business
Hao Ren Hao Ren's MannKind Corporation Experience 2005 - July 2011
Job Associate Director of Biostatistics and Statistical Programming at Covance
Industry Pharmaceuticals
Experience
Covance 2011 - Present
MannKind Corporation 2005 - July 2011
Skills
Clinical Trials, Pharmaceutical Industry, Clinical Development, Clinical Data Management, Regulatory Submissions, CDISC, Statistical Programming, Oncology, Biostatistics, GCP, EDC, Biotechnology, CRO, SAS programming, FDA, Drug Development, CTMS, Diabetes, Oracle Clinical, Regulatory Affairs, Pharmacokinetics, SAS
Education
Peking University 1994 — 1998
Bachelor, mathematics
Covance 2011 - Present
MannKind Corporation 2005 - July 2011
Skills
Clinical Trials, Pharmaceutical Industry, Clinical Development, Clinical Data Management, Regulatory Submissions, CDISC, Statistical Programming, Oncology, Biostatistics, GCP, EDC, Biotechnology, CRO, SAS programming, FDA, Drug Development, CTMS, Diabetes, Oracle Clinical, Regulatory Affairs, Pharmacokinetics, SAS
Education
Peking University 1994 — 1998
Bachelor, mathematics
Tim Fitzpatric's MannKind Corporation Experience January 2002 - April 2003
Job Senior Field Service Representative at General Electric Co.
Industry Utilities
Experience
General Electric Co. September 2003 - Present
MannKind Corporation January 2002 - April 2003
Skills
FDA, GMP
Education
Ohio University 1995 — 2000
General Electric Co. September 2003 - Present
MannKind Corporation January 2002 - April 2003
Skills
FDA, GMP
Education
Ohio University 1995 — 2000
Sharyl Barrett Sharyl Barrett's MannKind Corporation Experience September 2005 - September 2009
Job Quality Control Supervisor at AkzoNobel Coatings
Industry Pharmaceuticals
Experience
AkzoNobel Coatings August 2014 - Present
PURiLUM LLC (IOTO USA) February 2014 - August 2014
Metrics, Inc. October 2012 - February 2014
DSM Pharmaceutical 2009 - 2010
MannKind Corporation September 2005 - September 2009
RTI International 1998 - 2001
Skills
HPLC, Analytical Chemistry, LIMS, Chemistry, Chromatography, cGMP, Spectroscopy, R&D, Validation, 21 CFR Part 11, Manufacturing, Testing, Analysis, Research, Troubleshooting, Microsoft Office, GMP, Gas Chromatography, UV, GLP, USP, UV/Vis, Sop, Dissolution, LC-MS, IR, Technology Transfer, FDA, FTIR, Cleaning Validation, CAPA, Karl Fisher, Empower, Biopharmaceuticals, Trackwise, Change Control, Formulation, GC-MS, GxP, Pharmaceutical Industry, V&V, Pharmaceutics, Drug Development, Analytical Method..., Biotechnology, Laboratory, IND, Chemstation, ICP-OES, Flame AA
Education
Southern Connecticut State University 2007 — 2008
Master's degree, Chemistry
North Carolina Central University 1996 — 2001
BS, Chemistry
JH Rose High School 1992 — 1996
JH Rose High School 1992 — 1996
High School Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
JH Rose High School
AkzoNobel Coatings August 2014 - Present
PURiLUM LLC (IOTO USA) February 2014 - August 2014
Metrics, Inc. October 2012 - February 2014
DSM Pharmaceutical 2009 - 2010
MannKind Corporation September 2005 - September 2009
RTI International 1998 - 2001
Skills
HPLC, Analytical Chemistry, LIMS, Chemistry, Chromatography, cGMP, Spectroscopy, R&D, Validation, 21 CFR Part 11, Manufacturing, Testing, Analysis, Research, Troubleshooting, Microsoft Office, GMP, Gas Chromatography, UV, GLP, USP, UV/Vis, Sop, Dissolution, LC-MS, IR, Technology Transfer, FDA, FTIR, Cleaning Validation, CAPA, Karl Fisher, Empower, Biopharmaceuticals, Trackwise, Change Control, Formulation, GC-MS, GxP, Pharmaceutical Industry, V&V, Pharmaceutics, Drug Development, Analytical Method..., Biotechnology, Laboratory, IND, Chemstation, ICP-OES, Flame AA
Education
Southern Connecticut State University 2007 — 2008
Master's degree, Chemistry
North Carolina Central University 1996 — 2001
BS, Chemistry
JH Rose High School 1992 — 1996
JH Rose High School 1992 — 1996
High School Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
JH Rose High School
Hui Shao Hui Shao's MannKind Corporation Experience May 2002 - May 2003
Job Yes, I know antibodies.
Industry Biotechnology
Experience
Stem CentRx August 2011 - Present
Amgen March 2010 - August 2011
Amgen September 2008 - February 2010
Amgen June 2006 - August 2008
Agensys May 2003 - May 2006
MannKind Corporation May 2002 - May 2003
Skills
Monoclonal Antibodies, Assay Development, Antibodies, ELISA, Cell, Protein Chemistry, Western Blotting, FACS, Molecular Cloning, PCR, RT-PCR, SDS-PAGE
Education
Université de Sherbrooke 1998 — 2000
M.Sc., Microbiology, Molecular Biology
Nanjing University 1988 — 1992
B.Sc., Biology
Stem CentRx August 2011 - Present
Amgen March 2010 - August 2011
Amgen September 2008 - February 2010
Amgen June 2006 - August 2008
Agensys May 2003 - May 2006
MannKind Corporation May 2002 - May 2003
Skills
Monoclonal Antibodies, Assay Development, Antibodies, ELISA, Cell, Protein Chemistry, Western Blotting, FACS, Molecular Cloning, PCR, RT-PCR, SDS-PAGE
Education
Université de Sherbrooke 1998 — 2000
M.Sc., Microbiology, Molecular Biology
Nanjing University 1988 — 1992
B.Sc., Biology
Rakesh Govindapur Rakesh Govindapur's MannKind Corporation Experience March 2012 - April 2014
Job Sr. SAS Programmer Consultant
Industry Pharmaceuticals
Experience
NPS Pharmaceuticals April 2014 - Present
MannKind Corporation March 2012 - April 2014
NPS Pharmaceuticals February 2011 - February 2012
Applied Clinical Intelligence November 2008 - February 2011
Skills
21 CFR Part 11, Clinical Development, CRO, GCP, Clinical Data Management, Pharmaceutical Industry, Clinical Trials, EDC, SAS, Oncology, Biotechnology
Education
Texas A&M University, Texas
Master of Science (MS), Computer Science
Jawaharlal Nehru Technological University
NPS Pharmaceuticals April 2014 - Present
MannKind Corporation March 2012 - April 2014
NPS Pharmaceuticals February 2011 - February 2012
Applied Clinical Intelligence November 2008 - February 2011
Skills
21 CFR Part 11, Clinical Development, CRO, GCP, Clinical Data Management, Pharmaceutical Industry, Clinical Trials, EDC, SAS, Oncology, Biotechnology
Education
Texas A&M University, Texas
Master of Science (MS), Computer Science
Jawaharlal Nehru Technological University
Jennifer Whitney's MannKind Corporation Experience November 2008 - January 2009
Job Editorial project leader at Mercer
Industry Marketing and Advertising
Experience
Mercer January 2009 - Present
MannKind Corporation November 2008 - January 2009
Embryon 2005 - 2009
Rodman Publishing October 2005 - October 2008
BLC 2003 - 2005
CommonHealth 2000 - 2003
Ingenix 1998 - 2000
Advanstar Communications 1996 - 1998
North Jersey Newspapers 1995 - 1996
Skills
Editing, Writing, Editorial, QuarkXPress, Copy Editing, Magazines, Newsletters, Marketing Communications, Word, Research, Copywriting, Advertising, Journalism, Marketing Strategy, Layout, Newspaper, Publishing, InDesign, Press Releases, Digital Media, Proofreading, Strategic Communications, Microsoft Word
Education
Iona College 1997 — 2002
MS, Journalism
State University of New York at New Paltz 1990 — 1994
Bachelor of Science (BS), Journalism
northern valley regional 1990 — 1990
Mercer January 2009 - Present
MannKind Corporation November 2008 - January 2009
Embryon 2005 - 2009
Rodman Publishing October 2005 - October 2008
BLC 2003 - 2005
CommonHealth 2000 - 2003
Ingenix 1998 - 2000
Advanstar Communications 1996 - 1998
North Jersey Newspapers 1995 - 1996
Skills
Editing, Writing, Editorial, QuarkXPress, Copy Editing, Magazines, Newsletters, Marketing Communications, Word, Research, Copywriting, Advertising, Journalism, Marketing Strategy, Layout, Newspaper, Publishing, InDesign, Press Releases, Digital Media, Proofreading, Strategic Communications, Microsoft Word
Education
Iona College 1997 — 2002
MS, Journalism
State University of New York at New Paltz 1990 — 1994
Bachelor of Science (BS), Journalism
northern valley regional 1990 — 1990
John J. Weidner John J. Weidner's MannKind Corporation Experience 2005 - 2011
Job Principal Scientist | Program Director | Solving Problems then telling the story with the data
Industry Biotechnology
Experience
John Weidner May 2012 - Present
MannKind Corporation 2005 - 2011
Emisphere Technologies 1999 - 2005
Searle 1997 - 1998
Hoechst Marion Roussel 1995 - 1997
Skills
Problem Solving, Troubleshooting, Process Improvement, Medicinal Chemistry, Process Chemistry, Chemistry, Organic Chemistry, Project Management, Management, Mentoring, Team Leadership, HPLC, Organic Synthesis, Technology Transfer, Drug Discovery, Synthetic Organic..., LC-MS, Parallel Synthesis, Technology Management, Chromatography, GLP, Cross-functional Team..., Biopharmaceuticals, Sop, Biotechnology, GMP, Pharmaceutics, Drug Development, Laboratory, NMR
Education
Marist College 2014 — 2014
Advanced Certificate in Business Analytics, Information Science/Studies, 4.0 GPA
University of Nebraska-Lincoln 1989 — 1995
Ph.D., Synthetic Organic Chemistry
Iowa State University 1985 — 1988
Bachelor of Science (BS), Chemistry
John Weidner May 2012 - Present
MannKind Corporation 2005 - 2011
Emisphere Technologies 1999 - 2005
Searle 1997 - 1998
Hoechst Marion Roussel 1995 - 1997
Skills
Problem Solving, Troubleshooting, Process Improvement, Medicinal Chemistry, Process Chemistry, Chemistry, Organic Chemistry, Project Management, Management, Mentoring, Team Leadership, HPLC, Organic Synthesis, Technology Transfer, Drug Discovery, Synthetic Organic..., LC-MS, Parallel Synthesis, Technology Management, Chromatography, GLP, Cross-functional Team..., Biopharmaceuticals, Sop, Biotechnology, GMP, Pharmaceutics, Drug Development, Laboratory, NMR
Education
Marist College 2014 — 2014
Advanced Certificate in Business Analytics, Information Science/Studies, 4.0 GPA
University of Nebraska-Lincoln 1989 — 1995
Ph.D., Synthetic Organic Chemistry
Iowa State University 1985 — 1988
Bachelor of Science (BS), Chemistry
Chen, Yang Chen, Yang's MannKind Corporation Experience May 2013 - Present
Job statistical programmer (contractor) at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation May 2013 - Present
Celgene April 2011 - May 2013
Sunovion Pharmaceuticals Inc. September 2009 - April 2011
Forest Laboratories August 2006 - September 2009
PPD June 2005 - August 2006
Skills
CDISC, Clinical Trials, Biostatistics, EDC, CRO, 21 CFR Part 11, SAS, GCP, Clinical Development, SAS programming, Pharmaceutical Industry, FDA
Education
The Ohio State University 2001 — 2005
Master, Applied Statistics
Peking University 1996 — 2001
BS, Environmental Science
Nanshan High School
High School
MannKind Corporation May 2013 - Present
Celgene April 2011 - May 2013
Sunovion Pharmaceuticals Inc. September 2009 - April 2011
Forest Laboratories August 2006 - September 2009
PPD June 2005 - August 2006
Skills
CDISC, Clinical Trials, Biostatistics, EDC, CRO, 21 CFR Part 11, SAS, GCP, Clinical Development, SAS programming, Pharmaceutical Industry, FDA
Education
The Ohio State University 2001 — 2005
Master, Applied Statistics
Peking University 1996 — 2001
BS, Environmental Science
Nanshan High School
High School
Joe Kocinsky's MannKind Corporation Experience August 2003 - Present
Job VP Pharmaceutical Technology at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation August 2003 - Present
Schering-Plough Research Institute 1987 - 2003
Skills
Drug Development, Pharmaceutical Industry, FDA
Education
Seton Hall University 1988 — 1992
MBA
New Jersey Institute of Technology 1985 — 1987
MS BioMedE
New Jersey Institute of Technology 1981 — 1985
BS ChE
MannKind Corporation August 2003 - Present
Schering-Plough Research Institute 1987 - 2003
Skills
Drug Development, Pharmaceutical Industry, FDA
Education
Seton Hall University 1988 — 1992
MBA
New Jersey Institute of Technology 1985 — 1987
MS BioMedE
New Jersey Institute of Technology 1981 — 1985
BS ChE
Joe Guarneri's MannKind Corporation Experience July 2005 - Present
Job Scientist at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation July 2005 - Present
Clairol January 1999 - July 2005
Zotos International (subsidiary of Shiseido USA) March 1995 - January 1999
Shaw Mudge & Co. January 1988 - March 1995
Education
Sacred Heart University 1998 — 2001
BS, Biology
MannKind Corporation July 2005 - Present
Clairol January 1999 - July 2005
Zotos International (subsidiary of Shiseido USA) March 1995 - January 1999
Shaw Mudge & Co. January 1988 - March 1995
Education
Sacred Heart University 1998 — 2001
BS, Biology
Winnie Woo Winnie Woo's MannKind Corporation Experience February 2002 - October 2006
Job Analytical chemist in career transition to be an amazing STEM educator
Industry Higher Education
Maryanne Visconti Gottfried's MannKind Corporation Experience 2003 - 2004
Job President, MVG Consulting Services, Inc.
Industry Pharmaceuticals
Experience
MVG Consulting Services, Inc. August 1998 - Present
Acambis September 2003 - 2008
MannKind Corporation 2003 - 2004
Cubist Pharmaceuticals 1999 - 2003
Serono 1998 - 2002
Nitinol Medical Technologies 1997 - 1998
Vertex Pharmaceuticals 1995 - 1997
Copley Pharmaceuticals 1995 - 1995
Repligen Corporation 1992 - 1995
PAREXEL 1989 - 1992
Skills
Biotechnology, GCP, Clinical Development, Clinical Trials, Pharmaceutical Industry, Medical Writing, Oncology
Education
Lesley University 1994 — 1996
MS, Business Management
Boston State College 1976 — 1981
BS, Biology
Hull High School
MVG Consulting Services, Inc. August 1998 - Present
Acambis September 2003 - 2008
MannKind Corporation 2003 - 2004
Cubist Pharmaceuticals 1999 - 2003
Serono 1998 - 2002
Nitinol Medical Technologies 1997 - 1998
Vertex Pharmaceuticals 1995 - 1997
Copley Pharmaceuticals 1995 - 1995
Repligen Corporation 1992 - 1995
PAREXEL 1989 - 1992
Skills
Biotechnology, GCP, Clinical Development, Clinical Trials, Pharmaceutical Industry, Medical Writing, Oncology
Education
Lesley University 1994 — 1996
MS, Business Management
Boston State College 1976 — 1981
BS, Biology
Hull High School
Esmeralda Flash Esmeralda Flash's MannKind Corporation Experience February 2006 - December 2007
Job Global Sourcing Manager, Marketing & Sales at Boehringer Ingelheim
Industry Pharmaceuticals
Experience
Boehringer Ingelheim October 2012 - Present
Boehringer Ingelheim Pharmaceuticals March 2011 - October 2012
Boehringer Ingelheim Pharmaceuticals November 2009 - March 2011
Boehringer Ingelheim Pharmaceuticals September 2009 - November 2009
MannKind Corporation February 2006 - December 2007
Skills
Ariba, Strategic Sourcing, SAP, Contract Management, Global Sourcing, Management, Budgets, Outsourcing, Training, Contract Negotiation, Supply Management, Vendor Management, Software Documentation, Purchasing, Procurement, Negotiation, Market Research, Cross-functional Team...
Education
University of California, Irvine 2010 — 2011
Sacred Heart University 2006 — 2010
Bachelor's Degree
Boehringer Ingelheim October 2012 - Present
Boehringer Ingelheim Pharmaceuticals March 2011 - October 2012
Boehringer Ingelheim Pharmaceuticals November 2009 - March 2011
Boehringer Ingelheim Pharmaceuticals September 2009 - November 2009
MannKind Corporation February 2006 - December 2007
Skills
Ariba, Strategic Sourcing, SAP, Contract Management, Global Sourcing, Management, Budgets, Outsourcing, Training, Contract Negotiation, Supply Management, Vendor Management, Software Documentation, Purchasing, Procurement, Negotiation, Market Research, Cross-functional Team...
Education
University of California, Irvine 2010 — 2011
Sacred Heart University 2006 — 2010
Bachelor's Degree
Kathi Young Kathi Young's MannKind Corporation Experience April 2008 - May 2011
Job Human Resource Business Partner: SR Generalist, Talent & Organizational Management
Industry Human Resources
Experience
The Linde Group April 2012 - Present
MannKind Corporation April 2008 - May 2011
Wyeth Pharmaceuticals November 2006 - November 2007
Kathleen Young 2002 - 2006
Union Carbide Corp. 1993 - 2001
Skills
Talent Management, Performance Management, Change Management, Organizational..., Human Resources, Employee Relations, Organizational Design, Leadership, Cross-functional Team..., Coaching, Program Management, Management, Vendor Management, Project Planning, MBTI, Instructional Design, Succession Planning, Onboarding, Deferred Compensation, Talent Acquisition, HRIS, Personnel Management, Employee Engagement
Education
University of New Haven 2000 — 2003
MA, IOP, Industrial & Org. Psych
New York University
MSW, Indus. & Clinical SW
Ohio Wesleyan University
BA, Sociology/Psychology
The Linde Group April 2012 - Present
MannKind Corporation April 2008 - May 2011
Wyeth Pharmaceuticals November 2006 - November 2007
Kathleen Young 2002 - 2006
Union Carbide Corp. 1993 - 2001
Skills
Talent Management, Performance Management, Change Management, Organizational..., Human Resources, Employee Relations, Organizational Design, Leadership, Cross-functional Team..., Coaching, Program Management, Management, Vendor Management, Project Planning, MBTI, Instructional Design, Succession Planning, Onboarding, Deferred Compensation, Talent Acquisition, HRIS, Personnel Management, Employee Engagement
Education
University of New Haven 2000 — 2003
MA, IOP, Industrial & Org. Psych
New York University
MSW, Indus. & Clinical SW
Ohio Wesleyan University
BA, Sociology/Psychology
Maria Cangialosi Maria Cangialosi's MannKind Corporation Experience November 2007 - April 2011
Job Executive Adminstrative Assistant at BASF Corporation
Industry Chemicals
Experience
BASF Corporation January 2015 - Present
Bussola & Ralph International November 2013 - 2015
Bayer March 2012 - November 2013
MannKind Corporation November 2007 - April 2011
Skills
Pharmaceutical Industry, Strategic Planning, Finance, Administrative..., Lotus Notes, Outlook, Budgets, Administrative..., Clinical Trials, Management, Travel Arrangements, Spreadsheets, Access, Microsoft Excel, SAP, OSHA Regulations, Construction Management, Real Estate Project..., Project Management, Microsoft Word, Microsoft Project, C-Level Executive..., Adobe Creative Suite, Adobe Acrobat
Education
Rutgers, The State University of New Jersey-Newark
Associate's degree, Paralegal & Accounting
BASF Corporation January 2015 - Present
Bussola & Ralph International November 2013 - 2015
Bayer March 2012 - November 2013
MannKind Corporation November 2007 - April 2011
Skills
Pharmaceutical Industry, Strategic Planning, Finance, Administrative..., Lotus Notes, Outlook, Budgets, Administrative..., Clinical Trials, Management, Travel Arrangements, Spreadsheets, Access, Microsoft Excel, SAP, OSHA Regulations, Construction Management, Real Estate Project..., Project Management, Microsoft Word, Microsoft Project, C-Level Executive..., Adobe Creative Suite, Adobe Acrobat
Education
Rutgers, The State University of New Jersey-Newark
Associate's degree, Paralegal & Accounting
Alicia Rossiter Alicia Rossiter's MannKind Corporation Experience January 2008 - December 2010
Job Executive Director / MultiProgram Head, Integrated Medical Safety. Oncology. Novartis
Industry Pharmaceuticals
Experience
Novartis November 2012 - Present
Bayer HealthCare January 2011 - November 2012
MannKind Corporation January 2008 - December 2010
MannKind Corporation May 2007 - January 2008
MannKind Corporation November 2006 - April 2007
PAREXEL January 2002 - October 2006
PAREXEL June 2001 - January 2002
PAREXEL July 1999 - June 2001
PAREXEL October 1998 - June 1999
PAREXEL January 1998 - October 1998
Skills
Pharmacovigilance, Risk Management, Signal Detection, Clinical Safety, Drug Safety, Global Drug Development, Medical Monitoring, New Drug Applications, RMPs and REMs, GCP, Diabetes, CRO, Regulatory Affairs, Clinical Research, Endocrinology, Therapeutic Areas, Oncology, Pharmaceutical Industry, Drug Development, Clinical Development, Clinical Trials, Regulatory Submissions
Education
Harvard University 1988 — 1991
Fellowship Clinical Pharmacology, Clinical Pharmacology
Universidad Central de Venezuela 1978 — 1985
Medical Doctor, Medicine
Novartis November 2012 - Present
Bayer HealthCare January 2011 - November 2012
MannKind Corporation January 2008 - December 2010
MannKind Corporation May 2007 - January 2008
MannKind Corporation November 2006 - April 2007
PAREXEL January 2002 - October 2006
PAREXEL June 2001 - January 2002
PAREXEL July 1999 - June 2001
PAREXEL October 1998 - June 1999
PAREXEL January 1998 - October 1998
Skills
Pharmacovigilance, Risk Management, Signal Detection, Clinical Safety, Drug Safety, Global Drug Development, Medical Monitoring, New Drug Applications, RMPs and REMs, GCP, Diabetes, CRO, Regulatory Affairs, Clinical Research, Endocrinology, Therapeutic Areas, Oncology, Pharmaceutical Industry, Drug Development, Clinical Development, Clinical Trials, Regulatory Submissions
Education
Harvard University 1988 — 1991
Fellowship Clinical Pharmacology, Clinical Pharmacology
Universidad Central de Venezuela 1978 — 1985
Medical Doctor, Medicine
Blake Burrell, MS, RAC Blake Burrell, MS, RAC's MannKind Corporation Experience 2007 - 2011
Job Senior Director, Regulatory Affairs at ACADIA Pharmaceuticals Inc.
Industry Pharmaceuticals
Experience
ACADIA Pharmaceuticals Inc. 2014 - Present
ACADIA Pharmaceuticals Inc. 2013 - 2014
Forest Laboratories 2011 - 2013
MannKind Corporation 2007 - 2011
MannKind Corporation 2004 - 2007
MannKind Corporation 2002 - 2004
MannKind Corporation 2001 - 2002
MannKind Corporation 1999 - 2001
MannKind Corporation 1997 - 1999
PepsiCo 1995 - 1996
Skills
IND, FDA, Regulatory Affairs, GMP, Regulatory Submissions, NDA, CMC, NDS, IMPD, CTA, MAA, Change Control, Medical Devices, Inhalation, Combination Products, Solid Oral Dosage Forms, Regulatory Strategy..., Annual Reports, Product Lifecycle..., Post Approval Changes, ICH guidelines, USP, Performance Management, Staff Management, Pre-Approval Inspection, ROW, Negotiation, FDA Meetings, Pharmaceutical..., API, Impurities, Polymorphism, Small Molecules, Commercialization, DSUR, Scale Up, Validation, 21 CFR Part 11, Pharmaceutical Industry, Clinical Development, Biotechnology, CAPA, Technology Transfer, Regulatory Requirements, Product Development, CRO, Pharmaceutics, Analytical Chemistry, Cleaning Validation, Sop
Education
Long Island University, Brooklyn Campus 2008 — 2011
M.S., Drug Regulatory Affairs
SUNY Purchase 1992 — 1996
B.S., Chemistry
ACADIA Pharmaceuticals Inc. 2014 - Present
ACADIA Pharmaceuticals Inc. 2013 - 2014
Forest Laboratories 2011 - 2013
MannKind Corporation 2007 - 2011
MannKind Corporation 2004 - 2007
MannKind Corporation 2002 - 2004
MannKind Corporation 2001 - 2002
MannKind Corporation 1999 - 2001
MannKind Corporation 1997 - 1999
PepsiCo 1995 - 1996
Skills
IND, FDA, Regulatory Affairs, GMP, Regulatory Submissions, NDA, CMC, NDS, IMPD, CTA, MAA, Change Control, Medical Devices, Inhalation, Combination Products, Solid Oral Dosage Forms, Regulatory Strategy..., Annual Reports, Product Lifecycle..., Post Approval Changes, ICH guidelines, USP, Performance Management, Staff Management, Pre-Approval Inspection, ROW, Negotiation, FDA Meetings, Pharmaceutical..., API, Impurities, Polymorphism, Small Molecules, Commercialization, DSUR, Scale Up, Validation, 21 CFR Part 11, Pharmaceutical Industry, Clinical Development, Biotechnology, CAPA, Technology Transfer, Regulatory Requirements, Product Development, CRO, Pharmaceutics, Analytical Chemistry, Cleaning Validation, Sop
Education
Long Island University, Brooklyn Campus 2008 — 2011
M.S., Drug Regulatory Affairs
SUNY Purchase 1992 — 1996
B.S., Chemistry
Karen Moraleda's MannKind Corporation Experience June 2004 - Present
Job Process Technology Engineer at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation June 2004 - Present
Unilever May 2002 - May 2004
Corning Incorporated August 2000 - December 2001
Bristol-Myers Squibb. Worldwide Beauty Care Division (Clairol). January 2000 - August 2000
Bristol-Myers Squibb. Worldwide Beauty Care Division (Clairol) August 1999 - January 2000
Skills
Technology Transfer, Process Optimization, Process Improvement, Troubleshooting, Team Leadership, Pharmaceutics, Validation, GMP, Trackwise, Process Engineering, CAPA, R&D, Pharmaceutical Industry, Cleaning Validation, 21 CFR Part 11, Quality System, Cross-functional Team..., Biopharmaceuticals, FDA, Process Simulation, Engineering, Product Development, HPLC, Biotechnology, Manufacturing, Computer System..., Quality Auditing, Software Documentation, Root Cause Analysis, GxP, Continuous Improvement, ISO, Design of Experiments, Change Control, Testing, ISO 13485, Sop, Laboratory
Education
Michigan State University 1997 — 1999
BS, Chemical Engineering
Michigan State University - The Lyman Briggs School 1994 — 1997
BS, Physiology
MannKind Corporation June 2004 - Present
Unilever May 2002 - May 2004
Corning Incorporated August 2000 - December 2001
Bristol-Myers Squibb. Worldwide Beauty Care Division (Clairol). January 2000 - August 2000
Bristol-Myers Squibb. Worldwide Beauty Care Division (Clairol) August 1999 - January 2000
Skills
Technology Transfer, Process Optimization, Process Improvement, Troubleshooting, Team Leadership, Pharmaceutics, Validation, GMP, Trackwise, Process Engineering, CAPA, R&D, Pharmaceutical Industry, Cleaning Validation, 21 CFR Part 11, Quality System, Cross-functional Team..., Biopharmaceuticals, FDA, Process Simulation, Engineering, Product Development, HPLC, Biotechnology, Manufacturing, Computer System..., Quality Auditing, Software Documentation, Root Cause Analysis, GxP, Continuous Improvement, ISO, Design of Experiments, Change Control, Testing, ISO 13485, Sop, Laboratory
Education
Michigan State University 1997 — 1999
BS, Chemical Engineering
Michigan State University - The Lyman Briggs School 1994 — 1997
BS, Physiology
Amy Jepson, PMP Amy Jepson, PMP's MannKind Corporation Experience March 2005 - April 2011
Job Director, IS Business Partnering Quality Management at Boehringer Ingelheim Pharmaceuticals
Industry Pharmaceuticals
Experience
Boehringer Ingelheim Pharmaceuticals June 2011 - Present
MannKind Corporation March 2005 - April 2011
ArisGlobal July 2004 - February 2005
Purdue Pharmaceutical July 2001 - June 2004
Transamerica Leasing August 1996 - December 2000
Unilever December 1990 - August 1996
Accenture January 1988 - November 1990
Education
Lehigh University
B.S., Finance, Journalism
Boehringer Ingelheim Pharmaceuticals June 2011 - Present
MannKind Corporation March 2005 - April 2011
ArisGlobal July 2004 - February 2005
Purdue Pharmaceutical July 2001 - June 2004
Transamerica Leasing August 1996 - December 2000
Unilever December 1990 - August 1996
Accenture January 1988 - November 1990
Education
Lehigh University
B.S., Finance, Journalism
Gerry Fitzgerald Gerry Fitzgerald's MannKind Corporation Experience June 2008 - May 2011
Job Strategic Consultant (Healthcare) at Ab Initio
Industry Information Technology and Services
Experience
Ab Initio May 2011 - Present
MannKind Corporation June 2008 - May 2011
GlaxoSmithKline September 2001 - March 2008
SmithKline Beecham January 1998 - September 2001
SmithKline Beecham June 1995 - December 1997
SmithKline Beecham March 1988 - June 1995
Wyeth Laboratories May 1985 - March 1988
Biogen February 1983 - March 1985
Skills
ERP, Six Sigma, Computer System..., Supply Chain, Manufacturing, Biotechnology, Pharmaceutics, Management, Strategy, Software Documentation, Change Management, Business Process..., Integration, Lifesciences, R&D, Business Intelligence, GMP, SAP, IT Strategy, Leadership, Outsourcing, Enterprise Software, Forecasting, Pharmaceutical Industry, FDA, Supply Chain Management, Quality System, Business Process, Procurement, Cross-functional Team..., Testing, Project Management, Consulting, Negotiation, Process Improvement, Project Portfolio..., Strategic Sourcing, Quality Assurance
Education
Villanova University 2008 — 2009
Certificate, Lean Six Sigma Master Black Belt
McGill University 1985 — 1988
MBA, International Business & Information Technology
Massachusetts Institute of Technology 1978 — 1983
MS, Biochemical Engineering
Massachusetts Institute of Technology 1978 — 1982
BS, Biology
Massachusetts Institute of Technology 1978 — 1982
BS, Chemical Engineering
York Suburban HS 1974 — 1978
Ab Initio May 2011 - Present
MannKind Corporation June 2008 - May 2011
GlaxoSmithKline September 2001 - March 2008
SmithKline Beecham January 1998 - September 2001
SmithKline Beecham June 1995 - December 1997
SmithKline Beecham March 1988 - June 1995
Wyeth Laboratories May 1985 - March 1988
Biogen February 1983 - March 1985
Skills
ERP, Six Sigma, Computer System..., Supply Chain, Manufacturing, Biotechnology, Pharmaceutics, Management, Strategy, Software Documentation, Change Management, Business Process..., Integration, Lifesciences, R&D, Business Intelligence, GMP, SAP, IT Strategy, Leadership, Outsourcing, Enterprise Software, Forecasting, Pharmaceutical Industry, FDA, Supply Chain Management, Quality System, Business Process, Procurement, Cross-functional Team..., Testing, Project Management, Consulting, Negotiation, Process Improvement, Project Portfolio..., Strategic Sourcing, Quality Assurance
Education
Villanova University 2008 — 2009
Certificate, Lean Six Sigma Master Black Belt
McGill University 1985 — 1988
MBA, International Business & Information Technology
Massachusetts Institute of Technology 1978 — 1983
MS, Biochemical Engineering
Massachusetts Institute of Technology 1978 — 1982
BS, Biology
Massachusetts Institute of Technology 1978 — 1982
BS, Chemical Engineering
York Suburban HS 1974 — 1978
Edith Lewis-Rogers Edith Lewis-Rogers's MannKind Corporation Experience March 2005 - March 2006
Job
Industry Pharmaceuticals
Experience
ESLR Associates, LLC April 2008 - Present
SMHW Associates LLC March 2006 - April 2008
Mannkind Corporation March 2005 - March 2006
META Solutions March 2003 - March 2006
Novartis Consumer Health December 1996 - January 2003
Hoffmann-La Roche September 1992 - September 1993
Ciba Consumer 1988 - 1992
FDA 1977 - 1983
Education
Pace University - Lubin School of Business 1981 — 1986
MBA
Rutgers University-New Brunswick 1972 — 1976
BS
ESLR Associates, LLC April 2008 - Present
SMHW Associates LLC March 2006 - April 2008
Mannkind Corporation March 2005 - March 2006
META Solutions March 2003 - March 2006
Novartis Consumer Health December 1996 - January 2003
Hoffmann-La Roche September 1992 - September 1993
Ciba Consumer 1988 - 1992
FDA 1977 - 1983
Education
Pace University - Lubin School of Business 1981 — 1986
MBA
Rutgers University-New Brunswick 1972 — 1976
BS
Andre Lowe Andre Lowe's MannKind Corporation Experience September 2006 - December 2007
Job Microbiologist at USDA/FADDL/APHIS
Industry Research
Experience
USDA/FADDL/APHIS July 2011 - Present
Pfizer December 2007 - August 2011
Adjunct Professor at Eastern Connecticut State University January 2010 - 2010
Goodwin College May 2009 - 2009
MannKind Corporation September 2006 - December 2007
Centers for Disease Control November 2004 - September 2006
New York University November 2002 - October 2004
New York University September 2003 - April 2004
Biddle Point Pharmacy August 1999 - April 2002
Johnson C. Smith University June 1999 - April 2002
Skills
Cell Culture, ELISA, Molecular Biology, Drug Discovery, Western Blotting, Assay Development, In Vitro, Lifesciences, Biochemistry, Cell Biology, In Vivo, PCR, Microbiology, Immunoassays, RT-PCR, qPCR, Molecular Cloning, Cell, DNA extraction
Education
New York University 2002 — 2004
MS, Molecular Biology
Johnson C. Smith University - JCSU 1998 — 2002
B.S, Biology
USDA/FADDL/APHIS July 2011 - Present
Pfizer December 2007 - August 2011
Adjunct Professor at Eastern Connecticut State University January 2010 - 2010
Goodwin College May 2009 - 2009
MannKind Corporation September 2006 - December 2007
Centers for Disease Control November 2004 - September 2006
New York University November 2002 - October 2004
New York University September 2003 - April 2004
Biddle Point Pharmacy August 1999 - April 2002
Johnson C. Smith University June 1999 - April 2002
Skills
Cell Culture, ELISA, Molecular Biology, Drug Discovery, Western Blotting, Assay Development, In Vitro, Lifesciences, Biochemistry, Cell Biology, In Vivo, PCR, Microbiology, Immunoassays, RT-PCR, qPCR, Molecular Cloning, Cell, DNA extraction
Education
New York University 2002 — 2004
MS, Molecular Biology
Johnson C. Smith University - JCSU 1998 — 2002
B.S, Biology
Heather Oder's MannKind Corporation Experience July 2004 - April 2005
Job Manager of ERP Business Systems
Industry Chemicals
Experience
Pharmco-AAPER January 2012 - Present
Pharmco-AAPER November 2007 - January 2012
Dunn Data Company April 2005 - November 2007
MannKind Corporation July 2004 - April 2005
VitalWorks May 2002 - July 2004
Ethan Allen 1999 - 2002
National Retail Services 1997 - 1999
Nutmeg Federal Savings Bank 1995 - 1997
Skills
Accounting, Financial Reporting, Accounts Payable, Accounts Receivable, General Ledger, Cash, Payroll, Reconciliation, Invoicing, Forecasting, Journal Entries, Navision, Crystal Reports, Microsoft Office, JD Edwards, GAAP, Reconciliations, Excel, Variance Analysis, Great Plains Software, Revenue Recognition, Financial Accounting, Financial Analysis, Access, Accruals, Consolidation, Financial Statements, Bank Reconciliation, Sales Tax, Year-end Close, FRx, Expenses, Pivot Tables, Accounting System, Financial Systems, Accpac, Balance Sheet, ERP, Monthly Close, Budget Process, Databases, Analysis, Vlookup, QlikView, Microsoft Excel, Account Reconciliation, Fixed Assets, Finance, Data Analysis, Business Process
Education
Western Connecticut State University 2001 — 2004
MBA, Business
Western Connecticut State University 1994 — 1998
BBA, Accounting and Finance
Pace University 1993 — 1994
Transferred to WCSU, Accounting
Edward R. Murrow 1990 — 1993
Regents HS Diploma, Accounting
Pharmco-AAPER January 2012 - Present
Pharmco-AAPER November 2007 - January 2012
Dunn Data Company April 2005 - November 2007
MannKind Corporation July 2004 - April 2005
VitalWorks May 2002 - July 2004
Ethan Allen 1999 - 2002
National Retail Services 1997 - 1999
Nutmeg Federal Savings Bank 1995 - 1997
Skills
Accounting, Financial Reporting, Accounts Payable, Accounts Receivable, General Ledger, Cash, Payroll, Reconciliation, Invoicing, Forecasting, Journal Entries, Navision, Crystal Reports, Microsoft Office, JD Edwards, GAAP, Reconciliations, Excel, Variance Analysis, Great Plains Software, Revenue Recognition, Financial Accounting, Financial Analysis, Access, Accruals, Consolidation, Financial Statements, Bank Reconciliation, Sales Tax, Year-end Close, FRx, Expenses, Pivot Tables, Accounting System, Financial Systems, Accpac, Balance Sheet, ERP, Monthly Close, Budget Process, Databases, Analysis, Vlookup, QlikView, Microsoft Excel, Account Reconciliation, Fixed Assets, Finance, Data Analysis, Business Process
Education
Western Connecticut State University 2001 — 2004
MBA, Business
Western Connecticut State University 1994 — 1998
BBA, Accounting and Finance
Pace University 1993 — 1994
Transferred to WCSU, Accounting
Edward R. Murrow 1990 — 1993
Regents HS Diploma, Accounting
Robb Pagarigan's MannKind Corporation Experience August 2005 - September 2007
Job
Industry Research
Experience
Regulus Therapeutics April 2012 - Present
University of Connecticut Health Center October 2007 - November 2011
MannKind Corporation August 2005 - September 2007
TSRI February 1999 - July 2005
Stratagene 1998 - 1999
Skills
Small Animal: Surgery,..., Molecular Biology:..., Cell Biology: tissue..., Equipmnt: SEM,..., Cell, Cell Biology, Molecular Biology
Education
Palm Beach Atlantic University 1993 — 1997
BS, Biology
Regulus Therapeutics April 2012 - Present
University of Connecticut Health Center October 2007 - November 2011
MannKind Corporation August 2005 - September 2007
TSRI February 1999 - July 2005
Stratagene 1998 - 1999
Skills
Small Animal: Surgery,..., Molecular Biology:..., Cell Biology: tissue..., Equipmnt: SEM,..., Cell, Cell Biology, Molecular Biology
Education
Palm Beach Atlantic University 1993 — 1997
BS, Biology
Sam Shum Sam Shum's MannKind Corporation Experience November 2007 - Present
Job Senior Director at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation November 2007 - Present
Abbott Laboratories / Kos Pharmaceuticals January 2000 - November 2007
Beohringer Ingelheim Pharmaceuticals Inc. March 1993 - January 2000
Ames Laboratory June 1988 - March 1993
Hong Kong Adventist College June 1983 - June 1988
Skills
Research & Development..., Regulatory Sciences, Particle Sizing..., Separation Sciences, Orally Inhaled and..., Particle Size, Drug Development, Pharmaceutics, Nasal, Pharmaceutical Industry, Drug Delivery, Technology Transfer, Separations, GLP, Science, FDA, Analytical Chemistry, GMP, Regulatory Submissions, HPLC, LC-MS, Chromatography, Medical Devices, Validation, CMC, Biotechnology, Clinical Development, Drug Discovery, 21 CFR Part 11, Sop, Formulation, Biopharmaceuticals, CRO, GxP, LIMS, Pharmacokinetics, V&V, Regulatory Affairs, Cleaning Validation, Bioanalysis, Change Control, CAPA, SOP
Education
Iowa State University
Ph.D., Analytical Chemistry
Union College (NE)
B.S., Chemistry and Mathematics
University of Nebraska-Lincoln
M.S., Physical Chemistry
MannKind Corporation November 2007 - Present
Abbott Laboratories / Kos Pharmaceuticals January 2000 - November 2007
Beohringer Ingelheim Pharmaceuticals Inc. March 1993 - January 2000
Ames Laboratory June 1988 - March 1993
Hong Kong Adventist College June 1983 - June 1988
Skills
Research & Development..., Regulatory Sciences, Particle Sizing..., Separation Sciences, Orally Inhaled and..., Particle Size, Drug Development, Pharmaceutics, Nasal, Pharmaceutical Industry, Drug Delivery, Technology Transfer, Separations, GLP, Science, FDA, Analytical Chemistry, GMP, Regulatory Submissions, HPLC, LC-MS, Chromatography, Medical Devices, Validation, CMC, Biotechnology, Clinical Development, Drug Discovery, 21 CFR Part 11, Sop, Formulation, Biopharmaceuticals, CRO, GxP, LIMS, Pharmacokinetics, V&V, Regulatory Affairs, Cleaning Validation, Bioanalysis, Change Control, CAPA, SOP
Education
Iowa State University
Ph.D., Analytical Chemistry
Union College (NE)
B.S., Chemistry and Mathematics
University of Nebraska-Lincoln
M.S., Physical Chemistry
Christopher Rhodes Christopher Rhodes's MannKind Corporation Experience 1992 - 1998
Job President and CEO at Drug Delivery Experts
Industry Biotechnology
Experience
Drug Delivery Experts May 2014 - Present
Sensulin, LLC February 2014 - Present
Christopher A Rhodes & Associates January 2011 - Present
Biopharmaceutical Industry 2005 - Present
SKS Ocular, LLC July 2011 - November 2012
Amylin Pharmaceuticals 2004 - 2011
Guilford Pharmaceuticals 1998 - 2004
MannKind Corporation 1992 - 1998
Skills
Drug Development, Drug Discovery, Clinical Development, Biotechnology, Pharmaceutical Industry, Drug Delivery, Formulation, FDA, Clinical Trials, Biopharmaceuticals, R&D, Regulatory Submissions, Pharmaceutical Research, Technology Transfer, Pharmaceutical process..., Manufacturing, Marketing, GMP, Analytical Chemistry, Cancer, Chemistry, Medical Devices, Cross-functional Team..., IND, Biologics, Protein Chemistry, Oncology, Commercialization, Validation, Pharmaceutics, Biochemistry, Sop, Lifesciences, Strategic Planning, GLP
Education
Yale University 1991 — 1992
Post Doc
University of California, Los Angeles 1985 — 1991
Ph.D.
New York University 1981 — 1985
B.S.
Drug Delivery Experts May 2014 - Present
Sensulin, LLC February 2014 - Present
Christopher A Rhodes & Associates January 2011 - Present
Biopharmaceutical Industry 2005 - Present
SKS Ocular, LLC July 2011 - November 2012
Amylin Pharmaceuticals 2004 - 2011
Guilford Pharmaceuticals 1998 - 2004
MannKind Corporation 1992 - 1998
Skills
Drug Development, Drug Discovery, Clinical Development, Biotechnology, Pharmaceutical Industry, Drug Delivery, Formulation, FDA, Clinical Trials, Biopharmaceuticals, R&D, Regulatory Submissions, Pharmaceutical Research, Technology Transfer, Pharmaceutical process..., Manufacturing, Marketing, GMP, Analytical Chemistry, Cancer, Chemistry, Medical Devices, Cross-functional Team..., IND, Biologics, Protein Chemistry, Oncology, Commercialization, Validation, Pharmaceutics, Biochemistry, Sop, Lifesciences, Strategic Planning, GLP
Education
Yale University 1991 — 1992
Post Doc
University of California, Los Angeles 1985 — 1991
Ph.D.
New York University 1981 — 1985
B.S.
Bojan Prokic Bojan Prokic's MannKind Corporation Experience August 2010 - May 2011
Job Biopharmaceutical Engineering Professional
Industry Pharmaceuticals
Experience
BioMarin May 2011 - Present
MannKind Corporation August 2010 - May 2011
IPS-Integrated Project Services, Inc. August 2009 - August 2010
MannKind Corporation November 2007 - August 2009
Sandoz March 2005 - November 2007
Materials Modification June 2002 - March 2005
North Carolina State University - Chemical Engineering Department June 2000 - June 2002
North Carolina State University - Chemical Engineering Department May 2001 - August 2001
Skills
Technology Transfer, Chemical Engineering, Validation, GMP, V&V, Laboratory, CAPA, Change Control, Fermentation, Process Engineering
Education
North Carolina State University 1997 — 2002
BS, Chemical Engineering
North Carolina State University 1997 — 2001
BS, Chemistry
BioMarin May 2011 - Present
MannKind Corporation August 2010 - May 2011
IPS-Integrated Project Services, Inc. August 2009 - August 2010
MannKind Corporation November 2007 - August 2009
Sandoz March 2005 - November 2007
Materials Modification June 2002 - March 2005
North Carolina State University - Chemical Engineering Department June 2000 - June 2002
North Carolina State University - Chemical Engineering Department May 2001 - August 2001
Skills
Technology Transfer, Chemical Engineering, Validation, GMP, V&V, Laboratory, CAPA, Change Control, Fermentation, Process Engineering
Education
North Carolina State University 1997 — 2002
BS, Chemical Engineering
North Carolina State University 1997 — 2001
BS, Chemistry
Diane Palumbo's MannKind Corporation Experience November 2004 - Present
Job Corporate Vice President, HR at MannKind Corporation
Industry Biotechnology
Experience
MannKind Corporation November 2004 - Present
Crystal Coaching and Consulting January 2003 - October 2004
Amgen 1991 - 2003
Unisys January 1989 - April 1991
Skills
Executive Development, Executive Search, Leadership Development, Organizational..., Executive Coaching, Executive Pay, Succession Planning, Human Resources, Biopharmaceuticals, Personnel Management, Pharmaceutical Industry, Oncology, Employee Relations, Training, Change Management, Strategic Planning, Talent Acquisition, Organizational Design, Recruiting, Leadership, HR Consulting, Strategy, Deferred Compensation, Talent Management, HRIS, Employee Benefits, Management, Coaching
Education
St. John's University 1973 — 1981
Bachelor of Science and MBA
MannKind Corporation November 2004 - Present
Crystal Coaching and Consulting January 2003 - October 2004
Amgen 1991 - 2003
Unisys January 1989 - April 1991
Skills
Executive Development, Executive Search, Leadership Development, Organizational..., Executive Coaching, Executive Pay, Succession Planning, Human Resources, Biopharmaceuticals, Personnel Management, Pharmaceutical Industry, Oncology, Employee Relations, Training, Change Management, Strategic Planning, Talent Acquisition, Organizational Design, Recruiting, Leadership, HR Consulting, Strategy, Deferred Compensation, Talent Management, HRIS, Employee Benefits, Management, Coaching
Education
St. John's University 1973 — 1981
Bachelor of Science and MBA
Stephen Unger,CPA Stephen Unger,CPA's MannKind Corporation Experience June 2012 - Present
Job Associate Director of FP&A, R&D & Commercial Operations at MannKind Corporation
Industry Pharmaceuticals
Experience
FP&A and Accounting Consulting Services October 2015 - Present
MannKind Corporation June 2012 - Present
Cancer Genetics Inc. March 2011 - June 2012
MannKind Corporation November 2007 - April 2011
Datascope June 2004 - November 2007
Skills
Financial Reporting, GAAP, CPA, Sarbanes-Oxley Act, Auditing, SEC filings, Financial Analysis, Forecasting, Accounting, Internal Controls, Consolidation, Budgets, Managerial Finance, Finance, Sarbanes-Oxley, Valuation, Financial Audits, Internal Audit
Education
Seton Hall University
BS, Accounting
FP&A and Accounting Consulting Services October 2015 - Present
MannKind Corporation June 2012 - Present
Cancer Genetics Inc. March 2011 - June 2012
MannKind Corporation November 2007 - April 2011
Datascope June 2004 - November 2007
Skills
Financial Reporting, GAAP, CPA, Sarbanes-Oxley Act, Auditing, SEC filings, Financial Analysis, Forecasting, Accounting, Internal Controls, Consolidation, Budgets, Managerial Finance, Finance, Sarbanes-Oxley, Valuation, Financial Audits, Internal Audit
Education
Seton Hall University
BS, Accounting
Demetria Collins's MannKind Corporation Experience 2011 - 2012
Job Senior Clinical Research Associate at Independent Contractor
Industry Pharmaceuticals
Experience
Independent Contractor March 2014 - Present
ICON plc February 2013 - March 2014
Execupharm November 2011 - February 2013
Aerotek August 2011 - March 2012
MannKind Corporation 2011 - 2012
ReSearch Pharmaceutical Services June 2010 - August 2011
Quintiles November 2006 - June 2010
University of Chicago February 1997 - November 2006
University of Chicago February 1997 - November 2006
Skills
Endocrinology, Oncology, Cardiology
Education
Roosevelt University 1993 — 1996
Bachelors of Science, Biology
Roosevelt University 1992 — 1996
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Computer Learning Center
Independent Contractor March 2014 - Present
ICON plc February 2013 - March 2014
Execupharm November 2011 - February 2013
Aerotek August 2011 - March 2012
MannKind Corporation 2011 - 2012
ReSearch Pharmaceutical Services June 2010 - August 2011
Quintiles November 2006 - June 2010
University of Chicago February 1997 - November 2006
University of Chicago February 1997 - November 2006
Skills
Endocrinology, Oncology, Cardiology
Education
Roosevelt University 1993 — 1996
Bachelors of Science, Biology
Roosevelt University 1992 — 1996
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Computer Learning Center
Catherine Simpson, MS, MPM Catherine Simpson, MS, MPM's MannKind Corporation Experience August 2005 - November 2007
Job at University of North Carolina Chapel Hill
Industry Research
Experience
University of North Carolina December 2008 - Present
Diosynth Biotechnology June 2008 - December 2008
GlaxoSmithKline January 2008 - June 2008
MannKind Corporation August 2005 - November 2007
Amgen June 2004 - May 2005
Skills
Cell, Assay Development, Molecular Biology, Biotechnology, Drug Discovery, PCR, ELISA, Protein Chemistry, Biochemistry, Cell Biology, High Throughput..., Western Blotting, Tissue Culture, Protein Purification, GMP, Validation, Project Management, In Vitro, Cell Based Assays, Protein Expression, Enzyme Kinetics, Purification, Enzyme Assays, Lifesciences, pro
Education
Western Carolina University 2012 — 2015
Master's degree, Project Management
Southeastern Louisiana University 2001 — 2003
MS, Biology
Southeastern Louisiana University 1994 — 2000
BS, Chemistry
Southeastern Louisiana University 1994 — 2000
BS, Biology
University of North Carolina December 2008 - Present
Diosynth Biotechnology June 2008 - December 2008
GlaxoSmithKline January 2008 - June 2008
MannKind Corporation August 2005 - November 2007
Amgen June 2004 - May 2005
Skills
Cell, Assay Development, Molecular Biology, Biotechnology, Drug Discovery, PCR, ELISA, Protein Chemistry, Biochemistry, Cell Biology, High Throughput..., Western Blotting, Tissue Culture, Protein Purification, GMP, Validation, Project Management, In Vitro, Cell Based Assays, Protein Expression, Enzyme Kinetics, Purification, Enzyme Assays, Lifesciences, pro
Education
Western Carolina University 2012 — 2015
Master's degree, Project Management
Southeastern Louisiana University 2001 — 2003
MS, Biology
Southeastern Louisiana University 1994 — 2000
BS, Chemistry
Southeastern Louisiana University 1994 — 2000
BS, Biology
Megan Harney Megan Harney's MannKind Corporation Experience January 2015 - Present
Job QC Associate II at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation January 2015 - Present
Entegris May 2014 - January 2015
ATMI April 2010 - January 2015
Qualimax LLC August 2008 - April 2010
Skills
R&D, Characterization, Analytical Chemistry, Spectroscopy, Design of Experiments, Chemistry, Wet Chemistry, Validation, UV/Vis, Materials Science, FTIR, Microbiology, Gram Staining, Ion Chromatography, MOC, TOC, Document Management, Inventory Control, KBM / Six Sigma, ICP-OES, Karl Fisher, Stability Testing, Bench Work, SOP Development, Work Instructions, GLP, GMP, Aseptic Technique, Streak Plating, Serial Dilutions, Cell Culture, HPLC, SOP, CAPA, FDA, Gas Chromatography, Chromatography, Formulation, Process Simulation
Education
Sacred Heart University 2003 — 2007
BS, Biology
MannKind Corporation January 2015 - Present
Entegris May 2014 - January 2015
ATMI April 2010 - January 2015
Qualimax LLC August 2008 - April 2010
Skills
R&D, Characterization, Analytical Chemistry, Spectroscopy, Design of Experiments, Chemistry, Wet Chemistry, Validation, UV/Vis, Materials Science, FTIR, Microbiology, Gram Staining, Ion Chromatography, MOC, TOC, Document Management, Inventory Control, KBM / Six Sigma, ICP-OES, Karl Fisher, Stability Testing, Bench Work, SOP Development, Work Instructions, GLP, GMP, Aseptic Technique, Streak Plating, Serial Dilutions, Cell Culture, HPLC, SOP, CAPA, FDA, Gas Chromatography, Chromatography, Formulation, Process Simulation
Education
Sacred Heart University 2003 — 2007
BS, Biology
Donald Preiss Donald Preiss's MannKind Corporation Experience June 2015 - Present
Job Project Leader, IT at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation June 2015 - Present
MannKind Corporation March 2012 - June 2015
MannKind Corporation October 2010 - March 2012
MannKind Corporation February 2010 - December 2010
PepsiCo September 2009 - February 2010
Watson Pharmaceuticals August 2005 - 2009
Skills
Titration, UV-Vis, HPLC, IR spectroscopy, Extractions, Word, JD Edwards, Excel, SAP, PowerPoint, Outlook, Visio, Dissolution, LIMS, Chromatography, Validation, SOP, Chemstation, cGMP, Wet Chemistry, Analytical Chemistry, GMP, Spectroscopy, GC/MS, GLP, TLC, CAPA, USP, Chemistry, Biotechnology, Quality Assurance, Pharmaceuticals, Mass Spectrometry, Analytical Techniques, Process Validation, 21 CFR Part 11, IR, UV, Calibration, Documentation, Troubleshooting, Testing, QC, Change Control, Computer System..., Validations, Biochemistry, GxP, Gas Chromatography, Empower
Education
Quinnipiac University 2001 — 2005
Biochemistry, Chemistry, Physics, Biology, Microbiology, Biochemistry, Physical Chemistry, Organic Chemistry
MannKind Corporation June 2015 - Present
MannKind Corporation March 2012 - June 2015
MannKind Corporation October 2010 - March 2012
MannKind Corporation February 2010 - December 2010
PepsiCo September 2009 - February 2010
Watson Pharmaceuticals August 2005 - 2009
Skills
Titration, UV-Vis, HPLC, IR spectroscopy, Extractions, Word, JD Edwards, Excel, SAP, PowerPoint, Outlook, Visio, Dissolution, LIMS, Chromatography, Validation, SOP, Chemstation, cGMP, Wet Chemistry, Analytical Chemistry, GMP, Spectroscopy, GC/MS, GLP, TLC, CAPA, USP, Chemistry, Biotechnology, Quality Assurance, Pharmaceuticals, Mass Spectrometry, Analytical Techniques, Process Validation, 21 CFR Part 11, IR, UV, Calibration, Documentation, Troubleshooting, Testing, QC, Change Control, Computer System..., Validations, Biochemistry, GxP, Gas Chromatography, Empower
Education
Quinnipiac University 2001 — 2005
Biochemistry, Chemistry, Physics, Biology, Microbiology, Biochemistry, Physical Chemistry, Organic Chemistry
Jenneen DeFiore Jenneen DeFiore's MannKind Corporation Experience August 2005 - October 2006
Job Sr. Projec Manager at PPD
Industry Pharmaceuticals
Experience
PPD June 2012 - Present
Roche September 2010 - June 2012
Hoffmann-La Roche October 2006 - August 2010
MannKind Corporation August 2005 - October 2006
Nathan Kline Institute March 2003 - August 2005
St. Vincent's Hospital September 2001 - June 2003
Skills
Clinical Trials, Clinical Research, CTMS, Pharmaceutical Industry, EDC, GCP, CRO, Biotechnology, Clinical Development, Clinical Operations, Cross-functional Team..., Diabetes, ICH-GCP, Lifesciences, Patient Recruitment, Protocol, Quality Assurance, Regulatory Submissions, Sop
Education
Manhattanville College 2005 — 2006
MA, Writing
Manhattanville College 1998 — 2001
BA, Biolgoy, Physics
PPD June 2012 - Present
Roche September 2010 - June 2012
Hoffmann-La Roche October 2006 - August 2010
MannKind Corporation August 2005 - October 2006
Nathan Kline Institute March 2003 - August 2005
St. Vincent's Hospital September 2001 - June 2003
Skills
Clinical Trials, Clinical Research, CTMS, Pharmaceutical Industry, EDC, GCP, CRO, Biotechnology, Clinical Development, Clinical Operations, Cross-functional Team..., Diabetes, ICH-GCP, Lifesciences, Patient Recruitment, Protocol, Quality Assurance, Regulatory Submissions, Sop
Education
Manhattanville College 2005 — 2006
MA, Writing
Manhattanville College 1998 — 2001
BA, Biolgoy, Physics
Stacy Carlisle's MannKind Corporation Experience March 2007 - March 2008
Job Program Manager @ Time Inc. at Yoh, A Day & Zimmermann Company
Industry Human Resources
Experience
Yoh, A Day & Zimmermann Company September 2014 - Present
Yoh, A Day & Zimmermann Company March 2014 - September 2014
Yoh, A Day & Zimmermann Company March 2011 - February 2014
Alpha Physician Search October 2009 - June 2010
Fiore and Associates March 2008 - February 2009
MannKind Corporation March 2007 - March 2008
Golden Triangle Optometric Center May 2004 - March 2007
Skills
Talent Acquisition, Talent Management, Managed Services, Organizational Structure, SAP, Marketing Communications, Temporary Staffing, Permanent Placement, Labor Management, Recruiting, Account Management, Account Reconciliation, Newsletter Production, Process Improvement, Problem Solving, Team Building, Team Leadership, Independent Contractors, Business Development, Compensation Analysis, Human Resources, Leadership, Management, Vendor Management, Job Analysis, CRM, Budgets
Education
National University
Bachelor of Business Administration (BBA), Concentration, Marketing
Yoh, A Day & Zimmermann Company September 2014 - Present
Yoh, A Day & Zimmermann Company March 2014 - September 2014
Yoh, A Day & Zimmermann Company March 2011 - February 2014
Alpha Physician Search October 2009 - June 2010
Fiore and Associates March 2008 - February 2009
MannKind Corporation March 2007 - March 2008
Golden Triangle Optometric Center May 2004 - March 2007
Skills
Talent Acquisition, Talent Management, Managed Services, Organizational Structure, SAP, Marketing Communications, Temporary Staffing, Permanent Placement, Labor Management, Recruiting, Account Management, Account Reconciliation, Newsletter Production, Process Improvement, Problem Solving, Team Building, Team Leadership, Independent Contractors, Business Development, Compensation Analysis, Human Resources, Leadership, Management, Vendor Management, Job Analysis, CRM, Budgets
Education
National University
Bachelor of Business Administration (BBA), Concentration, Marketing
Traci Centofanti Traci Centofanti's MannKind Corporation Experience October 2012 - Present
Job Director, IT at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation October 2012 - Present
MannKind Corporation 2005 - October 2012
Purdue Pharma 1999 - 2004
Diversified Investment Advisors 1990 - 1999
Skills
21 CFR Part 11, Pharmaceutical Industry, Validation, Computer System..., FDA, Leadership, Data Management, Change Control, Technology Transfer, Quality Assurance, Sop, GxP, Training, CTMS, Quality System, GMP, Team Building, Software Documentation, Management, Lifesciences, Biotechnology, LIMS, Project Management, CAPA, Compliance, Cross-functional Team..., Document Management, Medical Devices, Clinical Trials, Clinical Data Management
Education
Pace University 1999 — 2010
BS, Technology Systems
MannKind Corporation October 2012 - Present
MannKind Corporation 2005 - October 2012
Purdue Pharma 1999 - 2004
Diversified Investment Advisors 1990 - 1999
Skills
21 CFR Part 11, Pharmaceutical Industry, Validation, Computer System..., FDA, Leadership, Data Management, Change Control, Technology Transfer, Quality Assurance, Sop, GxP, Training, CTMS, Quality System, GMP, Team Building, Software Documentation, Management, Lifesciences, Biotechnology, LIMS, Project Management, CAPA, Compliance, Cross-functional Team..., Document Management, Medical Devices, Clinical Trials, Clinical Data Management
Education
Pace University 1999 — 2010
BS, Technology Systems
Ray Larnerd Ray Larnerd's MannKind Corporation Experience 2006 - 2011
Job Chief Financial Officer at ComNet Communications
Industry Construction
Experience
ComNet Communications November 2014 - Present
DGC Capital Contracting Corp. March 2013 - October 2014
Main Enterprises Inc. August 2011 - January 2013
MannKind Corporation 2006 - 2011
Consultant 2005 - 2006
CONSUMERS PETROLEUM OF CT, INC 2003 - 2005
THE TYREE ORGANIZATION, LTD January 1998 - January 2002
HARTFORD PROVISION CO., INC January 1990 - January 1998
Edward Isaacs 1981 - 1982
Education
Central High School
Central High School
Sacred Heart University
Bachelor of Arts, Accounting
Sacred Heart University
Masters of Business Administration, Finance
ComNet Communications November 2014 - Present
DGC Capital Contracting Corp. March 2013 - October 2014
Main Enterprises Inc. August 2011 - January 2013
MannKind Corporation 2006 - 2011
Consultant 2005 - 2006
CONSUMERS PETROLEUM OF CT, INC 2003 - 2005
THE TYREE ORGANIZATION, LTD January 1998 - January 2002
HARTFORD PROVISION CO., INC January 1990 - January 1998
Edward Isaacs 1981 - 1982
Education
Central High School
Central High School
Sacred Heart University
Bachelor of Arts, Accounting
Sacred Heart University
Masters of Business Administration, Finance
Dana Wheeler Dana Wheeler's MannKind Corporation Experience 2007 - 2008
Job Senior Manager, Data Management at Sunovion Pharmaceuticals Inc.
Industry Pharmaceuticals
Experience
Sunovion Pharmaceuticals Inc. August 2008 - Present
MannKind Corporation 2007 - 2008
Bristol-Myers Squibb October 2002 - April 2007
Hoffmann-La Roche July 2000 - May 2002
Forest Laboratories 2002 - 2002
PPD July 1998 - July 2000
Skills
Clinical Data Management
Education
Kean University 1992 — 1997
BS, Biology
Sunovion Pharmaceuticals Inc. August 2008 - Present
MannKind Corporation 2007 - 2008
Bristol-Myers Squibb October 2002 - April 2007
Hoffmann-La Roche July 2000 - May 2002
Forest Laboratories 2002 - 2002
PPD July 1998 - July 2000
Skills
Clinical Data Management
Education
Kean University 1992 — 1997
BS, Biology
Carlos Cintron's MannKind Corporation Experience 2006 - 2009
Job Director Quality Assurance at Cubist Pharmaceuticals
Industry Biotechnology
Experience
Cubist Pharmaceuticals February 2012 - Present
Organogenesis August 2009 - February 2012
MannKind Corporation 2006 - 2009
Exelixis 2004 - 2006
ConvaTec (A Bristol-Myers Squibb Co.) 2001 - 2004
Johnson & Johnson 1995 - 2001
GynoTech Inc. 1993 - 1995
Medi + Physics (An Amersham Radiopharmaceutical Co.) 1990 - 1993
Baxter 1985 - 1990
Skills
FDA, GMP, CAPA, Biotechnology, Validation, Quality System, Change Control, Pharmaceutical Industry, Medical Devices, GLP
Education
Jones International University 2004 — 2007
M.B.A., International Enterprise Management
Inter-American University of Puerto Rico-Metropolitan Campus
B.S., Biology, Chemistry and Physics
Cubist Pharmaceuticals February 2012 - Present
Organogenesis August 2009 - February 2012
MannKind Corporation 2006 - 2009
Exelixis 2004 - 2006
ConvaTec (A Bristol-Myers Squibb Co.) 2001 - 2004
Johnson & Johnson 1995 - 2001
GynoTech Inc. 1993 - 1995
Medi + Physics (An Amersham Radiopharmaceutical Co.) 1990 - 1993
Baxter 1985 - 1990
Skills
FDA, GMP, CAPA, Biotechnology, Validation, Quality System, Change Control, Pharmaceutical Industry, Medical Devices, GLP
Education
Jones International University 2004 — 2007
M.B.A., International Enterprise Management
Inter-American University of Puerto Rico-Metropolitan Campus
B.S., Biology, Chemistry and Physics
Dilip Bhumralkar's MannKind Corporation Experience June 2007 - December 2007
Job
Industry Pharmaceuticals
Experience
Incedis Therapeutics March 2008 - Present
MannKind Corporation June 2007 - December 2007
Pfizer, Inc. September 2005 - June 2007
Pfizer, Inc. December 2003 - September 2005
Pfizer, Inc. August 2000 - December 2003
Agouron Pharmaceuticals December 1998 - August 2000
Alanex Corporation February 1996 - December 1998
Karmanos Cancer Institute January 1995 - February 1996
Education
Wayne State University 1989 — 1994
Nagpur University 1978 — 1985
Texas A&M University
Incedis Therapeutics March 2008 - Present
MannKind Corporation June 2007 - December 2007
Pfizer, Inc. September 2005 - June 2007
Pfizer, Inc. December 2003 - September 2005
Pfizer, Inc. August 2000 - December 2003
Agouron Pharmaceuticals December 1998 - August 2000
Alanex Corporation February 1996 - December 1998
Karmanos Cancer Institute January 1995 - February 1996
Education
Wayne State University 1989 — 1994
Nagpur University 1978 — 1985
Texas A&M University
Susan Haas, PMP's MannKind Corporation Experience May 2009 - September 2011
Job Independent Contractor
Industry Pharmaceuticals
Experience
Self-employed August 2015 - Present
National Paralegal College May 2015 - Present
Self-employed March 2015 - Present
Mesoblast September 2011 - January 2015
MannKind Corporation May 2009 - September 2011
MannKind Corporation April 2008 - May 2009
Celgene Corporation October 2007 - April 2008
Pfizer, Inc. September 2004 - September 2007
Cardinal Health PD October 2003 - August 2004
Emisphere Technologies April 1991 - May 2003
Skills
Pharmaceutical Industry, Cross-functional Team..., PMP, Leadership, Project Portfolio..., Project Manager..., Clinical Development, Clinical Trials, Drug Development, Project Management, Six Sigma, Biopharmaceuticals, Team Leadership, Medical Devices, FDA, Biotechnology, Project Planning, Technology Transfer, Clinical Operations, CRO, Management, Lifesciences, R&D, GMP, IND, Regulatory Affairs, Medical Affairs, Program Management, 21 CFR Part 11, CTMS, Oncology, GCP, Infectious Diseases, Validation, Sop, Immunology, Therapeutic Areas, EDC, Regulatory Submissions, Computer System..., Clinical Monitoring, Commercialization, SOP, Life Sciences, Collaborative Problem...
Education
The Graduate Center, City University of New York 1973 — 1975
MA, Organic Chemistry
Queens College 1969 — 1973
BA (Magna Cum Laude), Chemistry
HILI 1957 — 1969
Elementary through High School
Self-employed August 2015 - Present
National Paralegal College May 2015 - Present
Self-employed March 2015 - Present
Mesoblast September 2011 - January 2015
MannKind Corporation May 2009 - September 2011
MannKind Corporation April 2008 - May 2009
Celgene Corporation October 2007 - April 2008
Pfizer, Inc. September 2004 - September 2007
Cardinal Health PD October 2003 - August 2004
Emisphere Technologies April 1991 - May 2003
Skills
Pharmaceutical Industry, Cross-functional Team..., PMP, Leadership, Project Portfolio..., Project Manager..., Clinical Development, Clinical Trials, Drug Development, Project Management, Six Sigma, Biopharmaceuticals, Team Leadership, Medical Devices, FDA, Biotechnology, Project Planning, Technology Transfer, Clinical Operations, CRO, Management, Lifesciences, R&D, GMP, IND, Regulatory Affairs, Medical Affairs, Program Management, 21 CFR Part 11, CTMS, Oncology, GCP, Infectious Diseases, Validation, Sop, Immunology, Therapeutic Areas, EDC, Regulatory Submissions, Computer System..., Clinical Monitoring, Commercialization, SOP, Life Sciences, Collaborative Problem...
Education
The Graduate Center, City University of New York 1973 — 1975
MA, Organic Chemistry
Queens College 1969 — 1973
BA (Magna Cum Laude), Chemistry
HILI 1957 — 1969
Elementary through High School
Robert Baughman's MannKind Corporation Experience October 2012 - Present
Job Sr. Vice President, Clinical Sciences at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation October 2012 - Present
MannKind Corporation January 2012 - October 2012
MannKind Corporation December 2005 - December 2011
MannKind Corporation December 2003 - November 2005
Emisphere Technologies December 2002 - December 2003
Emisphere Technologies September 1991 - May 2002
Skills
Clinical Trials, Pharmacokinetics, Pharmacodynamics, Clinical Development, Drug Development, IND, Biotechnology, Drug Discovery, Regulatory Submissions
Education
University of California, San Francisco 1974 — 1982
PharmD, PhD, Clinical Pharmacy, Pharmacokinetics
Loyola Marymount University
B.Sc., Biology/Chemistry
MannKind Corporation October 2012 - Present
MannKind Corporation January 2012 - October 2012
MannKind Corporation December 2005 - December 2011
MannKind Corporation December 2003 - November 2005
Emisphere Technologies December 2002 - December 2003
Emisphere Technologies September 1991 - May 2002
Skills
Clinical Trials, Pharmacokinetics, Pharmacodynamics, Clinical Development, Drug Development, IND, Biotechnology, Drug Discovery, Regulatory Submissions
Education
University of California, San Francisco 1974 — 1982
PharmD, PhD, Clinical Pharmacy, Pharmacokinetics
Loyola Marymount University
B.Sc., Biology/Chemistry
Colin Bergin's MannKind Corporation Experience June 2015 - Present
Job Manager, Alliance Management at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation June 2015 - Present
MannKind Corporation September 2007 - June 2015
Forest Laboratories, Inc January 2006 - August 2007
Boehringer Ingelheim Pharmaceuticals, Inc April 2000 - January 2006
Catalytica Pharmaceuticals 1998 - 1999
Skills
Packaging Engineering, Pharmaceutical Industry, Validation, Product Development, CAPA, Technology Transfer, Product Launch, Program Management, Project Management, Quality Assurance, Management, FDA, Commercialization, Six Sigma, Computer System..., Sop, Packaging, Drug Development, Testing, Biotechnology, Change Control, Continuous Improvement, Manufacturing, Process Improvement, Process Simulation, Medical Devices, Cross-functional Team..., 21 CFR Part 11, Clinical Development, GxP, GMP, Clinical Trials, R&D, V&V, Quality System, GLP
Education
Rochester Institute of Technology 1993 — 1999
Walter Panas High School
MannKind Corporation June 2015 - Present
MannKind Corporation September 2007 - June 2015
Forest Laboratories, Inc January 2006 - August 2007
Boehringer Ingelheim Pharmaceuticals, Inc April 2000 - January 2006
Catalytica Pharmaceuticals 1998 - 1999
Skills
Packaging Engineering, Pharmaceutical Industry, Validation, Product Development, CAPA, Technology Transfer, Product Launch, Program Management, Project Management, Quality Assurance, Management, FDA, Commercialization, Six Sigma, Computer System..., Sop, Packaging, Drug Development, Testing, Biotechnology, Change Control, Continuous Improvement, Manufacturing, Process Improvement, Process Simulation, Medical Devices, Cross-functional Team..., 21 CFR Part 11, Clinical Development, GxP, GMP, Clinical Trials, R&D, V&V, Quality System, GLP
Education
Rochester Institute of Technology 1993 — 1999
Walter Panas High School
Alicia Labana's MannKind Corporation Experience 2004 - 2004
Job Manager of Data Management at InClin
Industry Pharmaceuticals
Experience
InClin May 2015 - Present
Gilead Sciences March 2014 - May 2015
Eisai July 2012 - February 2014
Becton Dickinson October 2010 - May 2011
Labana Data Management Services March 2006 - April 2009
BD February 2006 - April 2009
MannKind Corporation 2004 - 2004
Purdue Pharma 2000 - 2004
Novartis February 1998 - December 1999
Pfizer February 1997 - February 1998
Skills
Pharmaceutical Industry, CTMS, GCP, CRO, Sop, Clinical Development, Lifesciences, Clinical Research, Regulatory Affairs, Biotechnology, EDC, Clinical Data Management, Software Documentation, Process Improvement, Validation, Regulatory Submissions, Oncology, 21 CFR Part 11, FDA, ICH-GCP, Clinical Trials
Education
Skidmore College 1991 — 1995
BA, Bio/Psy
InClin May 2015 - Present
Gilead Sciences March 2014 - May 2015
Eisai July 2012 - February 2014
Becton Dickinson October 2010 - May 2011
Labana Data Management Services March 2006 - April 2009
BD February 2006 - April 2009
MannKind Corporation 2004 - 2004
Purdue Pharma 2000 - 2004
Novartis February 1998 - December 1999
Pfizer February 1997 - February 1998
Skills
Pharmaceutical Industry, CTMS, GCP, CRO, Sop, Clinical Development, Lifesciences, Clinical Research, Regulatory Affairs, Biotechnology, EDC, Clinical Data Management, Software Documentation, Process Improvement, Validation, Regulatory Submissions, Oncology, 21 CFR Part 11, FDA, ICH-GCP, Clinical Trials
Education
Skidmore College 1991 — 1995
BA, Bio/Psy
Jennifer Whitcomb's MannKind Corporation Experience June 2014 - Present
Job QC Associate III at MannKind Corporation
Industry Research
Experience
MannKind Corporation June 2014 - Present
NSF Pharmalytica March 2014 - June 2014
Boehringer Ingelheim 2010 - June 2013
Boehringer Ingelheim 2008 - December 2009
Unilever September 2007 - May 2008
Chemtura December 2000 - June 2007
Skills
Quality Assurance, Chemistry, Validation, Regulatory Submissions, CAPA, 21 CFR Part 11, LIMS, Purification, LC-MS, Six Sigma, Microsoft Office
Education
Southern Connecticut State University 1994 — 1998
Bachelor of Science (BS), Biology
MannKind Corporation June 2014 - Present
NSF Pharmalytica March 2014 - June 2014
Boehringer Ingelheim 2010 - June 2013
Boehringer Ingelheim 2008 - December 2009
Unilever September 2007 - May 2008
Chemtura December 2000 - June 2007
Skills
Quality Assurance, Chemistry, Validation, Regulatory Submissions, CAPA, 21 CFR Part 11, LIMS, Purification, LC-MS, Six Sigma, Microsoft Office
Education
Southern Connecticut State University 1994 — 1998
Bachelor of Science (BS), Biology
Jeffery Brimmer's MannKind Corporation Experience August 2009 - June 2010
Job Sr. Computer Validation PM at Regeneron Pharmaceuticals
Industry Pharmaceuticals
Experience
Regeneron Pharmaceuticals February 2012 - Present
Boehringer Ingelheim June 2010 - December 2011
MannKind Corporation August 2009 - June 2010
MannKind Corp June 2007 - August 2009
Wyeth Research August 2006 - May 2007
Wyeth Research January 2004 - July 2006
Wyeth Research 2000 - 2004
Wyeth Vaccines 1997 - 1999
Skills
Computer System..., cGMP, GMP, SOP, Quality Systems, 21 CFR Part 11, CAPA, LIMS, Pharmaceuticals, Quality Assurance, Compliance, Testing, FDA, Change Control, Sop, Software Documentation, GxP, GLP, Pharmaceutical Industry, Quality System, Validation, V&V, SDLC, Biotechnology
Education
Iona College
MS, Computer Science
State University of New York at Albany
BS, Biology Major, Chemistry Minor
Regeneron Pharmaceuticals February 2012 - Present
Boehringer Ingelheim June 2010 - December 2011
MannKind Corporation August 2009 - June 2010
MannKind Corp June 2007 - August 2009
Wyeth Research August 2006 - May 2007
Wyeth Research January 2004 - July 2006
Wyeth Research 2000 - 2004
Wyeth Vaccines 1997 - 1999
Skills
Computer System..., cGMP, GMP, SOP, Quality Systems, 21 CFR Part 11, CAPA, LIMS, Pharmaceuticals, Quality Assurance, Compliance, Testing, FDA, Change Control, Sop, Software Documentation, GxP, GLP, Pharmaceutical Industry, Quality System, Validation, V&V, SDLC, Biotechnology
Education
Iona College
MS, Computer Science
State University of New York at Albany
BS, Biology Major, Chemistry Minor
Bill Punia's MannKind Corporation Experience January 2007 - April 2009
Job Asc. Director Supply Chain Management/Production Planning at Novartis Pharmaceuticals Corporation
Industry Pharmaceuticals
Experience
Novartis July 2011 - Present
Dey Pharma L.P September 2010 - July 2011
Sepracor September 2009 - August 2010
MannKind Corporation January 2007 - April 2009
Roche Molecular Systems November 2000 - January 2007
Skills
Cross-functional Team..., Pharmaceutical Industry, Process Improvement, Supply Chain, Forecasting, Management, Manufacturing, Supply Chain Management, Procurement, Strategic Sourcing, Purchasing, FDA, Quality System, Strategic Planning, Strategy, Leadership, Sales Operations, Negotiation
Education
Montclair State University
Bachelors in Science, Biology, General
University of Phoenix
MBA
Novartis July 2011 - Present
Dey Pharma L.P September 2010 - July 2011
Sepracor September 2009 - August 2010
MannKind Corporation January 2007 - April 2009
Roche Molecular Systems November 2000 - January 2007
Skills
Cross-functional Team..., Pharmaceutical Industry, Process Improvement, Supply Chain, Forecasting, Management, Manufacturing, Supply Chain Management, Procurement, Strategic Sourcing, Purchasing, FDA, Quality System, Strategic Planning, Strategy, Leadership, Sales Operations, Negotiation
Education
Montclair State University
Bachelors in Science, Biology, General
University of Phoenix
MBA
Alexander Khaw's MannKind Corporation Experience November 2007 - June 2009
Job Managing Consultant at Integrated Commissioning & Qualification, Corp.
Industry Biotechnology
Experience
Integrated Commissioning & Qualification, Corp. October 2014 - Present
Integrated Commissioning & Qualification, Corp. August 2011 - October 2014
Lonza August 2010 - August 2011
Valsource November 2007 - July 2010
MannKind Corporation November 2007 - June 2009
Amgen November 2005 - November 2007
Skills
Validation
Education
Northeastern University 2000 — 2005
Chemical Engineering
BC High
Integrated Commissioning & Qualification, Corp. October 2014 - Present
Integrated Commissioning & Qualification, Corp. August 2011 - October 2014
Lonza August 2010 - August 2011
Valsource November 2007 - July 2010
MannKind Corporation November 2007 - June 2009
Amgen November 2005 - November 2007
Skills
Validation
Education
Northeastern University 2000 — 2005
Chemical Engineering
BC High
Donna Kiely's MannKind Corporation Experience October 2004 - Present
Job Director, GxP Quality Audit Program and Supplier Quality at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation October 2004 - Present
Purdue Pharma 1998 - 2004
Malcolm Pirnie 1987 - 1998
Skills
GMP, GCP, Toxicology, Quality Assurance, ISO, Auditing, GLP, Pharmaceutical Industry, R&D, Manufacturing, GxP, 21 CFR Part 11, Computer System..., IND, CAPA, FDA, Sop, LIMS, Regulatory Submissions, Validation, Bioanalysis, Cleaning Validation, Drug Development, Quality Auditing, Clinical Trials, V&V, Biopharmaceuticals, Analytical Chemistry, SOP, Change Control, Biotechnology, Laboratory, Regulatory Affairs, Oncology, Pharmaceutics, LC-MS, Drug Discovery, CRO, GAMP, Quality System, Technology Transfer
Education
Northern Arizona University 1982 — 1987
BS, Microbiology, Chemistry
MannKind Corporation October 2004 - Present
Purdue Pharma 1998 - 2004
Malcolm Pirnie 1987 - 1998
Skills
GMP, GCP, Toxicology, Quality Assurance, ISO, Auditing, GLP, Pharmaceutical Industry, R&D, Manufacturing, GxP, 21 CFR Part 11, Computer System..., IND, CAPA, FDA, Sop, LIMS, Regulatory Submissions, Validation, Bioanalysis, Cleaning Validation, Drug Development, Quality Auditing, Clinical Trials, V&V, Biopharmaceuticals, Analytical Chemistry, SOP, Change Control, Biotechnology, Laboratory, Regulatory Affairs, Oncology, Pharmaceutics, LC-MS, Drug Discovery, CRO, GAMP, Quality System, Technology Transfer
Education
Northern Arizona University 1982 — 1987
BS, Microbiology, Chemistry
Darin Lee's MannKind Corporation Experience March 2006 - October 2007
Job Principal Scientist at aTyr Pharma
Industry Biotechnology
Experience
aTyr Pharma January 2014 - Present
aTyr Pharma August 2011 - December 2013
Ambrx March 2009 - August 2011
Ambrx February 2008 - March 2009
MannKind Corporation March 2006 - October 2007
Cangene Corporation September 2005 - February 2006
Cangene Corporation September 2003 - August 2005
Inex Pharmaceuticals September 1996 - August 1997
MIGENIX Inc. May 1995 - December 1995
Education
University of Alberta 1998 — 2003
Ph.D., Biochemistry
Simon Fraser University 1993 — 1998
B.Sc., Biochemistry
aTyr Pharma January 2014 - Present
aTyr Pharma August 2011 - December 2013
Ambrx March 2009 - August 2011
Ambrx February 2008 - March 2009
MannKind Corporation March 2006 - October 2007
Cangene Corporation September 2005 - February 2006
Cangene Corporation September 2003 - August 2005
Inex Pharmaceuticals September 1996 - August 1997
MIGENIX Inc. May 1995 - December 1995
Education
University of Alberta 1998 — 2003
Ph.D., Biochemistry
Simon Fraser University 1993 — 1998
B.Sc., Biochemistry
Jill Hadley's MannKind Corporation Experience October 2006 - April 2007
Job Experienced Global Clinical Supplies Professional
Industry Pharmaceuticals
Experience
Sunovion Pharmaceuticals Inc. November 2012 - Present
J. Hadley Consulting Services April 2010 - October 2012
Celgene March 2009 - April 2010
Schering-Plough Research Institute March 2008 - March 2009
Novartis June 2007 - December 2007
Procter & Gamble Pharmaceuticals February 2005 - September 2007
MannKind Corporation October 2006 - April 2007
Schering-Plough Research Institute July 2002 - May 2004
Clinical Trial Services September 1999 - April 2001
Almedica Services Corp. January 1992 - September 1999
Skills
Operations Management, GMP, Clinical Trials, Pharmaceutical Industry, CRO, FDA
Education
Purdue University
Bachelor of Science (B.S.), Food Science
Sunovion Pharmaceuticals Inc. November 2012 - Present
J. Hadley Consulting Services April 2010 - October 2012
Celgene March 2009 - April 2010
Schering-Plough Research Institute March 2008 - March 2009
Novartis June 2007 - December 2007
Procter & Gamble Pharmaceuticals February 2005 - September 2007
MannKind Corporation October 2006 - April 2007
Schering-Plough Research Institute July 2002 - May 2004
Clinical Trial Services September 1999 - April 2001
Almedica Services Corp. January 1992 - September 1999
Skills
Operations Management, GMP, Clinical Trials, Pharmaceutical Industry, CRO, FDA
Education
Purdue University
Bachelor of Science (B.S.), Food Science
Dana Bland's MannKind Corporation Experience August 2006 - August 2011
Job Consultant Medical Writer
Industry Pharmaceuticals
Experience
Merck December 2013 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson January 2013 - December 2013
Merck May 2011 - January 2013
MannKind Corporation August 2006 - August 2011
Skills
Medical Writing, Clinical Trials, Pharmaceutical Industry, Clinical Development, Oncology, Regulatory Submissions, Clinical Research, Clinical Study Design, FDA, Protocol, Drug Development, Sop, GCP, Regulatory Affairs, Medical Affairs, CTMS, IND, SOP
Education
Rutgers University-New Brunswick 1993 — 1999
PharmD, BS, Pharmacy
Merck December 2013 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson January 2013 - December 2013
Merck May 2011 - January 2013
MannKind Corporation August 2006 - August 2011
Skills
Medical Writing, Clinical Trials, Pharmaceutical Industry, Clinical Development, Oncology, Regulatory Submissions, Clinical Research, Clinical Study Design, FDA, Protocol, Drug Development, Sop, GCP, Regulatory Affairs, Medical Affairs, CTMS, IND, SOP
Education
Rutgers University-New Brunswick 1993 — 1999
PharmD, BS, Pharmacy
George Tonelli's MannKind Corporation Experience June 2005 - October 2014
Job VP of Clinical Operations
Industry Pharmaceuticals
Experience
Galmed Pharmaceuticals Ltd. March 2015 - Present
MannKind Corporation June 2005 - October 2014
Innapharma January 2003 - May 2005
Innapharma 2000 - 2002
Innapharma 1997 - 2000
Skills
CTMS, Clinical Development, GCP, Clinical Trials, Sop, Clinical Data Management, CRO, Drug Development, Pharmaceutical Industry, EDC, FDA, Regulatory Submissions, Clinical Monitoring, Clinical Research, Clinical Operations, SOP, Medical Writing, Oncology, Biotechnology, Therapeutic Areas, Lifesciences
Education
Rutgers, The State University of New Jersey-New Brunswick
BS
Galmed Pharmaceuticals Ltd. March 2015 - Present
MannKind Corporation June 2005 - October 2014
Innapharma January 2003 - May 2005
Innapharma 2000 - 2002
Innapharma 1997 - 2000
Skills
CTMS, Clinical Development, GCP, Clinical Trials, Sop, Clinical Data Management, CRO, Drug Development, Pharmaceutical Industry, EDC, FDA, Regulatory Submissions, Clinical Monitoring, Clinical Research, Clinical Operations, SOP, Medical Writing, Oncology, Biotechnology, Therapeutic Areas, Lifesciences
Education
Rutgers, The State University of New Jersey-New Brunswick
BS
Pamela Krueger's MannKind Corporation Experience 2002 - 2004
Job Manager of Research PK at Regeneron Pharmaceuticals
Industry Biotechnology
Experience
Regeneron Pharmaceuticals January 2014 - Present
Regeneron Pharmaceuticals January 2011 - January 2014
Regeneron Pharmaceuticals December 2004 - January 2011
MannKind Corporation 2002 - 2004
Regeneron Pharmaceuticals May 2001 - November 2002
Immunotherapy, Inc. June 1997 - April 2001
Skills
Biotechnology, Drug Discovery, ELISA, Immunology, Assay Development, Cell Culture, Monoclonal Antibodies, Protein Chemistry, Drug Development, Western Blotting, Cell, Biopharmaceuticals, GLP, Protein Purification, Flow Cytometry
Education
Rutgers, The State University of New Jersey-New Brunswick 1991 — 1995
Animal Science
Huntington High School
Regeneron Pharmaceuticals January 2014 - Present
Regeneron Pharmaceuticals January 2011 - January 2014
Regeneron Pharmaceuticals December 2004 - January 2011
MannKind Corporation 2002 - 2004
Regeneron Pharmaceuticals May 2001 - November 2002
Immunotherapy, Inc. June 1997 - April 2001
Skills
Biotechnology, Drug Discovery, ELISA, Immunology, Assay Development, Cell Culture, Monoclonal Antibodies, Protein Chemistry, Drug Development, Western Blotting, Cell, Biopharmaceuticals, GLP, Protein Purification, Flow Cytometry
Education
Rutgers, The State University of New Jersey-New Brunswick 1991 — 1995
Animal Science
Huntington High School
Al Borsavage's MannKind Corporation Experience April 2006 - April 2011
Job Inventory Control/Stockroom Supervisor at United Technologies
Industry Warehousing
Experience
United Technologies May 2015 - Present
Mountain High Organics, Inc. December 2014 - March 2015
Neeltran, Inc. December 2012 - December 2014
Boehringer Ingelheim October 2011 - October 2012
MannKind Corporation April 2006 - April 2011
Givaudan Flavors Corp December 2002 - March 2006
Boehringer Ingelheim Pharmaceuticals January 1980 - August 2002
Skills
Warehouse Management, Inventory Management, Manufacturing Support, ERP System Expertise, WMS expertise, Regulated environments, International Logistics, Forklift Trainer, Import/Export, ISO/FDA, Safety, Manufacturing, Regulations, Supply Chain Management, Forklift Operator, Continuous Improvement, GMP, Sop, ERP, FDA, International Trade, Logistics, Supply Chain, Inventory Control, Change Control, Procurement, Purchasing, Quality Assurance, 21 CFR Part 11, Six Sigma, ISO, Start-ups, Warehousing, 3PL, Process Improvement, Shipping, Lean Manufacturing, CAPA, Quality Control, Team Building, Validation, Operations Management, Quality System, Cross-functional Team..., Quality Auditing, Materials Management, Transportation, Distribution Center..., Leadership, Quality Management
Education
Post University 2008 — 2012
AA Business, Management
Carmel High School
Rice High School
Western Connecticut State Univ.Teikyo Post University
Business Administration
United Technologies May 2015 - Present
Mountain High Organics, Inc. December 2014 - March 2015
Neeltran, Inc. December 2012 - December 2014
Boehringer Ingelheim October 2011 - October 2012
MannKind Corporation April 2006 - April 2011
Givaudan Flavors Corp December 2002 - March 2006
Boehringer Ingelheim Pharmaceuticals January 1980 - August 2002
Skills
Warehouse Management, Inventory Management, Manufacturing Support, ERP System Expertise, WMS expertise, Regulated environments, International Logistics, Forklift Trainer, Import/Export, ISO/FDA, Safety, Manufacturing, Regulations, Supply Chain Management, Forklift Operator, Continuous Improvement, GMP, Sop, ERP, FDA, International Trade, Logistics, Supply Chain, Inventory Control, Change Control, Procurement, Purchasing, Quality Assurance, 21 CFR Part 11, Six Sigma, ISO, Start-ups, Warehousing, 3PL, Process Improvement, Shipping, Lean Manufacturing, CAPA, Quality Control, Team Building, Validation, Operations Management, Quality System, Cross-functional Team..., Quality Auditing, Materials Management, Transportation, Distribution Center..., Leadership, Quality Management
Education
Post University 2008 — 2012
AA Business, Management
Carmel High School
Rice High School
Western Connecticut State Univ.Teikyo Post University
Business Administration
Richard Petrucci, MD's MannKind Corporation Experience March 2008 - January 2013
Job New York State Medical Director at WellCare
Industry Health, Wellness and Fitness
Experience
WellCare January 2013 - Present
MannKind Corporation March 2008 - January 2013
MannKind Corp April 2007 - April 2008
sanofi-aventis U.S. 2003 - 2007
Oxford Health Plans 1995 - 2004
Skills
Clinical Research, Managed Care, Pharmaceutical Industry, Clinical Development, Clinical Trials, Diabetes, Oncology, Medicaid, Biotechnology, Medicare, Utilization Management, Health Economics, Regulatory Submissions, Medical Affairs, Lifesciences, Pharmacology, IND, Drug Development, CRO, Healthcare
Education
New York Medical College 1980 — 1984
Doctor of Medicine (MD)
Williams College 1975 — 1979
Biology, General
WellCare January 2013 - Present
MannKind Corporation March 2008 - January 2013
MannKind Corp April 2007 - April 2008
sanofi-aventis U.S. 2003 - 2007
Oxford Health Plans 1995 - 2004
Skills
Clinical Research, Managed Care, Pharmaceutical Industry, Clinical Development, Clinical Trials, Diabetes, Oncology, Medicaid, Biotechnology, Medicare, Utilization Management, Health Economics, Regulatory Submissions, Medical Affairs, Lifesciences, Pharmacology, IND, Drug Development, CRO, Healthcare
Education
New York Medical College 1980 — 1984
Doctor of Medicine (MD)
Williams College 1975 — 1979
Biology, General
Anders Boss's MannKind Corporation Experience VP Medical AffairsRheologics2001 - 2003
Job Chief Medical Officer at MannKind Corporation
Industry Biotechnology
Experience
MannKind Corporation VP Medical AffairsRheologics2001 - 2003
Takeda Pharmaceuticals 2000 - 2002
Novo Nordisk June 1987 - April 1999
Education
University of London 1987 — 1990
MFPM, Pharmaceutical Medicine
Københavns Universitet 1973 — 1981
MannKind Corporation VP Medical AffairsRheologics2001 - 2003
Takeda Pharmaceuticals 2000 - 2002
Novo Nordisk June 1987 - April 1999
Education
University of London 1987 — 1990
MFPM, Pharmaceutical Medicine
Københavns Universitet 1973 — 1981
Sue Afonso-Smith's MannKind Corporation Experience 2005 - 2006
Job General Principal at Validation Solutions, LLP
Industry Pharmaceuticals
Experience
Validation Solutions, LLP ConsultantCelgene2007 - 2012
MannKind Corporation 2005 - 2006
Berlex 2002 - 2005
Education
Rutgers University-New Brunswick 1991 — 1998
Penn State University 1986 — 1990
BS, Biology
Validation Solutions, LLP ConsultantCelgene2007 - 2012
MannKind Corporation 2005 - 2006
Berlex 2002 - 2005
Education
Rutgers University-New Brunswick 1991 — 1998
Penn State University 1986 — 1990
BS, Biology
Destardi Moye-Sherman, PhD, PMP's MannKind Corporation Experience 2003 - 2007
Job Director Program Management at Idera Pharmaceuticals
Industry Pharmaceuticals
Experience
Idera Pharmaceuticals September 2015 - Present
Shire/ViroPharma Incorporated October 2013 - December 2014
Merck September 2007 - October 2013
Mannkind Corporation 2003 - 2007
Emisphere Technologies 1998 - 2003
Texas A&M University 1992 - 1998
Kraft General Foods 1990 - 1992
Skills
Drug Development, Drug Discovery, Technology Transfer, R&D, Oncology, Due Diligence, Process Improvement, Clinical Development, FDA, Pharmaceutical Industry, Biotechnology, Organic Chemistry, GMP, CRO, HPLC, Regulatory Submissions, Chemistry, GLP, Sop, 21 CFR Part 11, Pharmaceutics, IND, Biopharmaceuticals, CMC, GCP, Validation, Clinical Trials, SOP, Cross-functional Team..., Project Management, Product Development, Clinical Research
Education
Texas A&M University 1992 — 1998
Ph. D., Chemistry
Howard University 1986 — 1990
BS, Chemistry
JH Rose High 1983 — 1986
Idera Pharmaceuticals September 2015 - Present
Shire/ViroPharma Incorporated October 2013 - December 2014
Merck September 2007 - October 2013
Mannkind Corporation 2003 - 2007
Emisphere Technologies 1998 - 2003
Texas A&M University 1992 - 1998
Kraft General Foods 1990 - 1992
Skills
Drug Development, Drug Discovery, Technology Transfer, R&D, Oncology, Due Diligence, Process Improvement, Clinical Development, FDA, Pharmaceutical Industry, Biotechnology, Organic Chemistry, GMP, CRO, HPLC, Regulatory Submissions, Chemistry, GLP, Sop, 21 CFR Part 11, Pharmaceutics, IND, Biopharmaceuticals, CMC, GCP, Validation, Clinical Trials, SOP, Cross-functional Team..., Project Management, Product Development, Clinical Research
Education
Texas A&M University 1992 — 1998
Ph. D., Chemistry
Howard University 1986 — 1990
BS, Chemistry
JH Rose High 1983 — 1986
Kim Carrera's MannKind Corporation Experience December 2005 - April 2009
Job Development Associate II at Mannkind Corporation
Industry Pharmaceuticals
Experience
Mannkind Corporation December 2005 - April 2009
Animal Medical Center of East County 2000 - 2002
Cozycroft Pet Hospital 1998 - 1999
Magic mountain 1994 - 1998
Education
San Diego State University-California State University 1999 — 2002
BS, Biology
Mannkind Corporation December 2005 - April 2009
Animal Medical Center of East County 2000 - 2002
Cozycroft Pet Hospital 1998 - 1999
Magic mountain 1994 - 1998
Education
San Diego State University-California State University 1999 — 2002
BS, Biology
Donna Gale's MannKind Corporation Experience January 2002 - Present
Job at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation January 2002 - Present
MannKind Corp January 2002 - October 2010
Purdue Pharma January 1987 - December 2001
Revlon Healthcare (currently sanofi aventis) 1976 - 1986
Education
Sarah Lawrence College 1973 — 1976
ba
MannKind Corporation January 2002 - Present
MannKind Corp January 2002 - October 2010
Purdue Pharma January 1987 - December 2001
Revlon Healthcare (currently sanofi aventis) 1976 - 1986
Education
Sarah Lawrence College 1973 — 1976
ba
Susan Zolnier's MannKind Corporation Experience August 2007 - Present
Job Admin Asst at Mannkind Corporation
Industry Pharmaceuticals
Experience
Mannkind Corporation August 2007 - Present
MannKind Corporation 2007 - Present
Reed Exhibitions October 1999 - May 2006
Cognizant Technology Solutions 1994 - 1999
New York Daily News 1985 - 1989
New York Daily News 1976 - 1985
Education
Katharine Gibbs School 1988 — 1989
Administrative
Packer Collegiate Institute 1963 — 1967
Associates
Mannkind Corporation August 2007 - Present
MannKind Corporation 2007 - Present
Reed Exhibitions October 1999 - May 2006
Cognizant Technology Solutions 1994 - 1999
New York Daily News 1985 - 1989
New York Daily News 1976 - 1985
Education
Katharine Gibbs School 1988 — 1989
Administrative
Packer Collegiate Institute 1963 — 1967
Associates
David Mercando's MannKind Corporation Experience May 2014 - Present
Job Sr. Manager Technical Service Process at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation May 2014 - Present
Merck August 2012 - Present
Merck October 2010 - August 2012
Schering-Plough November 1998 - June 2011
Merck 1998 - 2009
Union Camp Corporation June 1988 - June 1998
Skills
V&V, Sop, Aseptic Processing, Computer System..., Deviations, Engineering, Design of Experiments, GLP, R&D, Analytical Chemistry, Quality Assurance, Chromatography, HPLC, Six Sigma, Regulatory Requirements, Pharmaceutics, Emulsions, Granulation, Investigation, Encapsulation, Validation, Technology Transfer, Liquids, Semi-solids, Biotechnology, Biochemistry, Commissioning, Derivatives, FMEA, GMP, Inspection, Kaizen, Quality System, Quality Control, SEM, Visio, Pharmaceutical Industry, Process Improvement
Education
Rutgers University-New Brunswick 1990 — 1998
BSChemE, Chemical Engineering
University of Delaware 1983 — 1988
BSCS, Chemistry
MannKind Corporation May 2014 - Present
Merck August 2012 - Present
Merck October 2010 - August 2012
Schering-Plough November 1998 - June 2011
Merck 1998 - 2009
Union Camp Corporation June 1988 - June 1998
Skills
V&V, Sop, Aseptic Processing, Computer System..., Deviations, Engineering, Design of Experiments, GLP, R&D, Analytical Chemistry, Quality Assurance, Chromatography, HPLC, Six Sigma, Regulatory Requirements, Pharmaceutics, Emulsions, Granulation, Investigation, Encapsulation, Validation, Technology Transfer, Liquids, Semi-solids, Biotechnology, Biochemistry, Commissioning, Derivatives, FMEA, GMP, Inspection, Kaizen, Quality System, Quality Control, SEM, Visio, Pharmaceutical Industry, Process Improvement
Education
Rutgers University-New Brunswick 1990 — 1998
BSChemE, Chemical Engineering
University of Delaware 1983 — 1988
BSCS, Chemistry
Rod Woods's MannKind Corporation Experience 2007 - April 2011
Job Director Quality Control at International Vitamin Corporation
Industry Pharmaceuticals
Experience
Intergel Pharmaceuticals Division International Vitamin Corporation September 2011 - Present
MannKind Corporation 2007 - April 2011
Mannkind Corporation 2004 - 2006
MannKind Corporation 2000 - 2004
Pharmaceutical Discovery Corporation 1994 - 2000
Nepera 1984 - 1994
Skills
Analytical R&D, Quality Management, Business Development, Analytical Method..., Process Analytical..., Quality Control, Strategic Thinking, Spectroscopy, Gas Chromatography, HPLC, Team Building, Team Leadership, Solid Oral Dosage Forms, Dry Powder Inhalers, Quality System, Quality Auditing, API manufacturing, Scale Up, Generic Drugs, NDA, CMC development, Design of Experiments, Drug Delivery, Biotechnology Industry, dietary supplements, Analytical Chemistry, GMP, Validation, Technology Transfer, FDA, GLP, Pharmaceutical Industry, Chemistry, R&D, Quality Assurance, Chromatography, IND, LIMS, Sop, Dissolution, GxP, Computer System..., V&V, 21 CFR Part 11, Cleaning Validation, Change Control, Supplements, SOP
Education
Seton Hall University
Ph. D., Chemistry Analytical
Intergel Pharmaceuticals Division International Vitamin Corporation September 2011 - Present
MannKind Corporation 2007 - April 2011
Mannkind Corporation 2004 - 2006
MannKind Corporation 2000 - 2004
Pharmaceutical Discovery Corporation 1994 - 2000
Nepera 1984 - 1994
Skills
Analytical R&D, Quality Management, Business Development, Analytical Method..., Process Analytical..., Quality Control, Strategic Thinking, Spectroscopy, Gas Chromatography, HPLC, Team Building, Team Leadership, Solid Oral Dosage Forms, Dry Powder Inhalers, Quality System, Quality Auditing, API manufacturing, Scale Up, Generic Drugs, NDA, CMC development, Design of Experiments, Drug Delivery, Biotechnology Industry, dietary supplements, Analytical Chemistry, GMP, Validation, Technology Transfer, FDA, GLP, Pharmaceutical Industry, Chemistry, R&D, Quality Assurance, Chromatography, IND, LIMS, Sop, Dissolution, GxP, Computer System..., V&V, 21 CFR Part 11, Cleaning Validation, Change Control, Supplements, SOP
Education
Seton Hall University
Ph. D., Chemistry Analytical
Lymari Ortiz's MannKind Corporation Experience October 2007 - March 2009
Job Quality Assurance Professional
Industry Pharmaceuticals
Experience
Actavis September 2013 - Present
CorePharma LLC February 2013 - September 2013
CorePharma LLC February 2012 - February 2013
Actavis May 2009 - February 2012
MannKind Corporation October 2007 - March 2009
Watson Laboratories, Inc December 2005 - October 2007
Watson Laboratories, Inc February 2004 - December 2005
Eli Lilly August 2003 - February 2004
Skills
cGMP, CAPA, Validation, SOP, Sop, Chromatography, Dissolution, Technology Transfer, Lifesciences, GMP, GAMP, Change Control, HPLC, Regulatory Affairs, FDA, Quality Assurance, Software Documentation, Aseptic Processing, GxP, Pharmaceutics, LIMS, UV, Gas Chromatography, Quality Control, USP, UV/Vis, GLP, Pharmaceutical Industry, 21 CFR Part 11, Quality Auditing, Biopharmaceuticals, ISO 13485, Medical Devices, Cleaning Validation, Regulatory Submissions, Quality System, Analytical Chemistry, Drug Development, Laboratory, Computer System..., Biotechnology, V&V, GCP, Chemistry, Regulatory Requirements, Trackwise, Formulation
Education
Rhode Island College 2000 — 2003
B.A., Chemistry
Actavis September 2013 - Present
CorePharma LLC February 2013 - September 2013
CorePharma LLC February 2012 - February 2013
Actavis May 2009 - February 2012
MannKind Corporation October 2007 - March 2009
Watson Laboratories, Inc December 2005 - October 2007
Watson Laboratories, Inc February 2004 - December 2005
Eli Lilly August 2003 - February 2004
Skills
cGMP, CAPA, Validation, SOP, Sop, Chromatography, Dissolution, Technology Transfer, Lifesciences, GMP, GAMP, Change Control, HPLC, Regulatory Affairs, FDA, Quality Assurance, Software Documentation, Aseptic Processing, GxP, Pharmaceutics, LIMS, UV, Gas Chromatography, Quality Control, USP, UV/Vis, GLP, Pharmaceutical Industry, 21 CFR Part 11, Quality Auditing, Biopharmaceuticals, ISO 13485, Medical Devices, Cleaning Validation, Regulatory Submissions, Quality System, Analytical Chemistry, Drug Development, Laboratory, Computer System..., Biotechnology, V&V, GCP, Chemistry, Regulatory Requirements, Trackwise, Formulation
Education
Rhode Island College 2000 — 2003
B.A., Chemistry
Dilip Raghunathan's MannKind Corporation Experience February 2012 - January 2014
Job
Industry Pharmaceuticals
Experience
Accenture January 2014 - Present
MannKind Corporation February 2012 - January 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2010 - June 2012
Amgen March 2010 - August 2010
MannKind Corporation 2008 - 2010
Kendle International 2007 - 2008
Various 2004 - 2007
Skills
CRO, CDISC, Clinical Data Management, Clinical Trials, EDC, Oracle Clinical, Biostatistics, SDTM, SAS, Data Management, 21 CFR Part 11, SAS programming, GCP, Pharmaceutical Industry, Validation, Clinical Research, Biotechnology, ADAMS, define xml, Oncology Clinical..., Diabetes, Statistical Programming, Oncology, CTMS, Clinical Development, ICH-GCP, Regulatory Submissions, CRF design, FDA, Computer System..., Drug Development, Lifesciences, Sop, Therapeutic Areas, Inform, Protocol, Life Sciences, SAS Programming, SOP
Education
New York University - Leonard N. Stern School of Business 2011 — 2013
Masters, Business and Information Systems
Rutgers University-New Brunswick
Bachelors, Biomedical Engineering
Accenture January 2014 - Present
MannKind Corporation February 2012 - January 2014
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2010 - June 2012
Amgen March 2010 - August 2010
MannKind Corporation 2008 - 2010
Kendle International 2007 - 2008
Various 2004 - 2007
Skills
CRO, CDISC, Clinical Data Management, Clinical Trials, EDC, Oracle Clinical, Biostatistics, SDTM, SAS, Data Management, 21 CFR Part 11, SAS programming, GCP, Pharmaceutical Industry, Validation, Clinical Research, Biotechnology, ADAMS, define xml, Oncology Clinical..., Diabetes, Statistical Programming, Oncology, CTMS, Clinical Development, ICH-GCP, Regulatory Submissions, CRF design, FDA, Computer System..., Drug Development, Lifesciences, Sop, Therapeutic Areas, Inform, Protocol, Life Sciences, SAS Programming, SOP
Education
New York University - Leonard N. Stern School of Business 2011 — 2013
Masters, Business and Information Systems
Rutgers University-New Brunswick
Bachelors, Biomedical Engineering
Raymond Innocenti's MannKind Corporation Experience September 2006 - August 2009
Job Senior Manager Outsourcing at Purdue Pharma L.P.
Industry Pharmaceuticals
Experience
Purdue Pharma L.P. January 2015 - Present
ReSearch Pharmaceutical Services July 2013 - Present
Boehringer-Ingelheim April 2013 - July 2013
Forest Laboratories December 2012 - April 2013
Novartis February 2012 - December 2012
Cardiovascular Research Foundation July 2010 - September 2011
Schering-Plough September 2009 - July 2010
MannKind Corporation September 2006 - August 2009
Berlex 2004 - 2006
Abbott Laboratories August 2004 - December 2004
Skills
Contract Management, Negotiation, Managerial Finance, Clinical Trials, CRO, Pharmaceutical Industry, Biotechnology, CTMS, Oncology, Clinical Development, Clinical Research, GCP, Regulatory Affairs, Cross-functional Team..., FDA, Contract Negotiation, Project Management, Medical Devices, Sop, Data Management, Strategy, Quality Assurance, Vendor Management, Outsourcing, Strategic Sourcing, Leadership, EDC, Management
Education
Baruch College/CUNY 1991 — 1993
MPA, Public Administration
Rutgers, The State University of New Jersey-New Brunswick 1985 — 1991
BA, Political Science
Purdue Pharma L.P. January 2015 - Present
ReSearch Pharmaceutical Services July 2013 - Present
Boehringer-Ingelheim April 2013 - July 2013
Forest Laboratories December 2012 - April 2013
Novartis February 2012 - December 2012
Cardiovascular Research Foundation July 2010 - September 2011
Schering-Plough September 2009 - July 2010
MannKind Corporation September 2006 - August 2009
Berlex 2004 - 2006
Abbott Laboratories August 2004 - December 2004
Skills
Contract Management, Negotiation, Managerial Finance, Clinical Trials, CRO, Pharmaceutical Industry, Biotechnology, CTMS, Oncology, Clinical Development, Clinical Research, GCP, Regulatory Affairs, Cross-functional Team..., FDA, Contract Negotiation, Project Management, Medical Devices, Sop, Data Management, Strategy, Quality Assurance, Vendor Management, Outsourcing, Strategic Sourcing, Leadership, EDC, Management
Education
Baruch College/CUNY 1991 — 1993
MPA, Public Administration
Rutgers, The State University of New Jersey-New Brunswick 1985 — 1991
BA, Political Science
Joann Lukasik's MannKind Corporation Experience September 2013 - Present
Job Senior Manager, QA Training & Document Change Control & Compliance at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation September 2013 - Present
Ben Venue Laboratories August 2011 - September 2013
Boehringer Ingelheim August 2011 - September 2013
APP Pharmaceuticals March 1998 - July 2011
Skills
Validation, GMP, Sop, Pharmaceutical Industry, Change Control, Quality System, 21 CFR Part 11, Quality Assurance, Technical Writing, LIMS, Aseptic Processing, Training, FDA, Software Documentation, CAPA, ISO 13485, Training Delivery, Medical Devices, Instructor-led Training, Technical Training, GxP, Employee Training, V&V, Computer System..., Learning Management..., FDA GMP, Biotechnology, Regulatory Requirements, Quality Auditing, Aseptic Technique, Biopharmaceuticals, Training Facilitation
Education
Houghton College
BS, Business Management
MannKind Corporation September 2013 - Present
Ben Venue Laboratories August 2011 - September 2013
Boehringer Ingelheim August 2011 - September 2013
APP Pharmaceuticals March 1998 - July 2011
Skills
Validation, GMP, Sop, Pharmaceutical Industry, Change Control, Quality System, 21 CFR Part 11, Quality Assurance, Technical Writing, LIMS, Aseptic Processing, Training, FDA, Software Documentation, CAPA, ISO 13485, Training Delivery, Medical Devices, Instructor-led Training, Technical Training, GxP, Employee Training, V&V, Computer System..., Learning Management..., FDA GMP, Biotechnology, Regulatory Requirements, Quality Auditing, Aseptic Technique, Biopharmaceuticals, Training Facilitation
Education
Houghton College
BS, Business Management
Elizabeth Bella's MannKind Corporation Experience 2006 - 2006
Job Senior Accounting Systems Analyst at Regeneron Pharmaceuticals
Industry Information Technology and Services
Experience
Regeneron Pharmaceuticals May 2013 - Present
Goodrich Corporation 2006 - October 2012
MannKind Corporation 2006 - 2006
The Premcor Refining Group 2003 - 2006
Modem Media 1998 - 2002
Skills
Sarbanes-Oxley Act, ERP, Requirements Analysis, Process Improvement, Visio, Business Analysis, Integration, Oracle Applications, Analysis, Access, Change Management, Business Intelligence, SQL, Oracle, Project Planning, Project Management, Software Documentation, SharePoint, SAP, Team Leadership, Business Process..., PeopleSoft, Business Process, Cognos, Oracle E-Business Suite, SDLC, Business Objects, Data Warehousing, Databases, Crystal Reports, MS Project, Oracle Discoverer, IT Strategy, Vendor Management, PMP, CRM, Hyperion Enterprise
Education
Pace University 1982 — 1984
BS, General Accounting
Adirondack Community College 1980 — 1982
Associate's degree, Accounting and Business/Management
Regeneron Pharmaceuticals May 2013 - Present
Goodrich Corporation 2006 - October 2012
MannKind Corporation 2006 - 2006
The Premcor Refining Group 2003 - 2006
Modem Media 1998 - 2002
Skills
Sarbanes-Oxley Act, ERP, Requirements Analysis, Process Improvement, Visio, Business Analysis, Integration, Oracle Applications, Analysis, Access, Change Management, Business Intelligence, SQL, Oracle, Project Planning, Project Management, Software Documentation, SharePoint, SAP, Team Leadership, Business Process..., PeopleSoft, Business Process, Cognos, Oracle E-Business Suite, SDLC, Business Objects, Data Warehousing, Databases, Crystal Reports, MS Project, Oracle Discoverer, IT Strategy, Vendor Management, PMP, CRM, Hyperion Enterprise
Education
Pace University 1982 — 1984
BS, General Accounting
Adirondack Community College 1980 — 1982
Associate's degree, Accounting and Business/Management
David Bilheimer's MannKind Corporation Experience September 2008 - Present
Job Vice President, Diabetes at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation September 2008 - Present
Novartis Pharmaceuticals Corp. January 2007 - September 2008
Merck, Inc. 1992 - 2007
UT Southwestern Medical Center at Dallas July 1973 - September 1992
National Institutes of Health July 1969 - June 1973
Skills
Clinical Development, Pharmaceutical Industry, Diabetes, Drug Development, Clinical Trials, Internal Medicine, Medical Affairs, Biochemistry, Infectious Diseases, Medicine, Biotechnology, Medical Education, Oncology, GCP, Therapeutic Areas, Protocol, Pharmacovigilance
Education
University of Pennsylvania School of Medicine 1963 — 1967
MD, Medicine
Muhlenberg College 1959 — 1963
B.S., Sc.D.(hon), Natural Sciences
MannKind Corporation September 2008 - Present
Novartis Pharmaceuticals Corp. January 2007 - September 2008
Merck, Inc. 1992 - 2007
UT Southwestern Medical Center at Dallas July 1973 - September 1992
National Institutes of Health July 1969 - June 1973
Skills
Clinical Development, Pharmaceutical Industry, Diabetes, Drug Development, Clinical Trials, Internal Medicine, Medical Affairs, Biochemistry, Infectious Diseases, Medicine, Biotechnology, Medical Education, Oncology, GCP, Therapeutic Areas, Protocol, Pharmacovigilance
Education
University of Pennsylvania School of Medicine 1963 — 1967
MD, Medicine
Muhlenberg College 1959 — 1963
B.S., Sc.D.(hon), Natural Sciences
Dianne Gobin's MannKind Corporation Experience November 2005 - January 2013
Job Pharmaceutical Program Management
Industry Pharmaceuticals
Experience
Boehringer Ingelheim January 2013 - Present
MannKind Corporation November 2005 - January 2013
IVAX Pharmaceuticals February 2003 - November 2005
IVAX Pharmaceuticals April 2001 - February 2003
IVAX Pharmaceuticals September 1998 - April 2001
Skills
Medical Devices, GMP, Pharmaceuticals, Compliance, Quality Systems, Product Development, Change Management, Quality Assurance, 21 CFR Part 11, Strategic Planning, Regulatory Affairs, Planning, FDA
Education
Pace University - Lubin School of Business 1996 — 2000
MBA, Marketing, International Business
Fort Lee High School 1986 — 1989
Boehringer Ingelheim January 2013 - Present
MannKind Corporation November 2005 - January 2013
IVAX Pharmaceuticals February 2003 - November 2005
IVAX Pharmaceuticals April 2001 - February 2003
IVAX Pharmaceuticals September 1998 - April 2001
Skills
Medical Devices, GMP, Pharmaceuticals, Compliance, Quality Systems, Product Development, Change Management, Quality Assurance, 21 CFR Part 11, Strategic Planning, Regulatory Affairs, Planning, FDA
Education
Pace University - Lubin School of Business 1996 — 2000
MBA, Marketing, International Business
Fort Lee High School 1986 — 1989
Daniel Giannini's MannKind Corporation Experience VP, Human ResourcesMannKind CorporationMay 2012 - Present
Job VP, Human Resources at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation VP, Human ResourcesMannKind CorporationMay 2012 - Present
Gilead Sciences 1998 - 2006
Bayer Pharmaceuticals November 1979 - April 1997
Skills
Deferred Compensation, HRIS, Biotechnology, Succession Planning, Pharmaceutical Industry
Education
Sacred Heart University 1964 — 1968
BA, Psychology
MannKind Corporation VP, Human ResourcesMannKind CorporationMay 2012 - Present
Gilead Sciences 1998 - 2006
Bayer Pharmaceuticals November 1979 - April 1997
Skills
Deferred Compensation, HRIS, Biotechnology, Succession Planning, Pharmaceutical Industry
Education
Sacred Heart University 1964 — 1968
BA, Psychology
Toni Demes's MannKind Corporation Experience July 2007 - March 2009
Job Owner at Antonia Consulting LLC (currently retired)
Industry Pharmaceuticals
Experience
Antonia Consulting LLC April 2007 - Present
MannKind Corporation July 2007 - March 2009
Pfizer December 2003 - December 2006
Pfizer 2001 - December 2003
Pfizer 1997 - 2001
Pfizer 1993 - 1997
Pfizer 1986 - 1993
Skills
Pharmaceutical Industry, Clinical Research, Clinical Trials, Copy Editing, Proofreading
Education
New York University 1988 — 1991
AAS, Business
CareerStep
Medical Transcription
Antonia Consulting LLC April 2007 - Present
MannKind Corporation July 2007 - March 2009
Pfizer December 2003 - December 2006
Pfizer 2001 - December 2003
Pfizer 1997 - 2001
Pfizer 1993 - 1997
Pfizer 1986 - 1993
Skills
Pharmaceutical Industry, Clinical Research, Clinical Trials, Copy Editing, Proofreading
Education
New York University 1988 — 1991
AAS, Business
CareerStep
Medical Transcription
Jennifer Alto's MannKind Corporation Experience June 2000 - May 2002
Job Senior Manager of Clinical Operations (North America) at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL December 2012 - Present
PAREXEL April 2008 - December 2012
PAREXEL November 2004 - April 2008
PAREXEL June 2002 - November 2004
MannKind Corporation June 2000 - May 2002
Skills
CTMS, CRO, EDC, Clinical Trials, ICH-GCP, GCP, Clinical Research, Clinical Development, Clinical Monitoring, Regulatory Affairs, Therapeutic Areas, Sop, Pharmaceutical Industry, Project Management, Outlook, Clinical Data Management, Oncology, Supervisory Experience, Regulatory Submissions, Endocrinology, Employee Management, Employee Training, Interviewing Skills, Clinical Site Monitoring, Time Management, Budget Monitoring, Drug Development, FDA, Report Writing, Expense Management, Protocol, Pharmacovigilance, Vaccines, Rheumatology, Clinical Trial..., Timekeeping, Inform, Infectious Diseases, Performance Management, Performance Metrics, Proposal Preparation, Kaizen
Education
Trend Business College 1990 — 1991
Business
Montana State University-Bozeman 1989 — 1990
PAREXEL December 2012 - Present
PAREXEL April 2008 - December 2012
PAREXEL November 2004 - April 2008
PAREXEL June 2002 - November 2004
MannKind Corporation June 2000 - May 2002
Skills
CTMS, CRO, EDC, Clinical Trials, ICH-GCP, GCP, Clinical Research, Clinical Development, Clinical Monitoring, Regulatory Affairs, Therapeutic Areas, Sop, Pharmaceutical Industry, Project Management, Outlook, Clinical Data Management, Oncology, Supervisory Experience, Regulatory Submissions, Endocrinology, Employee Management, Employee Training, Interviewing Skills, Clinical Site Monitoring, Time Management, Budget Monitoring, Drug Development, FDA, Report Writing, Expense Management, Protocol, Pharmacovigilance, Vaccines, Rheumatology, Clinical Trial..., Timekeeping, Inform, Infectious Diseases, Performance Management, Performance Metrics, Proposal Preparation, Kaizen
Education
Trend Business College 1990 — 1991
Business
Montana State University-Bozeman 1989 — 1990
Eleanore De Boo's MannKind Corporation Experience June 2005 - April 2011
Job Solutions Consultant at Process Stream
Industry Pharmaceuticals
Experience
Shionogi Pharma (formerly Sciele Pharma) June 2011 - March 2014
MannKind Corporation June 2005 - April 2011
Reckitt Benckiser August 1990 - June 2005
Education
Ramapo College of New Jersey
Bachelors of Science - Business Administration
Shionogi Pharma (formerly Sciele Pharma) June 2011 - March 2014
MannKind Corporation June 2005 - April 2011
Reckitt Benckiser August 1990 - June 2005
Education
Ramapo College of New Jersey
Bachelors of Science - Business Administration
Kim Otterbach's MannKind Corporation Experience January 2007 - September 2010
Job Sr. Manager of Clinical data systems at St. Judes Medical
Industry Pharmaceuticals
Experience
St. Jude Medical September 2010 - Present
MannKind Corporation January 2007 - September 2010
MannKind Corporation January 2006 - January 2007
MannKind Corporation January 2002 - January 2006
ClinCap January 1998 - January 2002
IPR 1989 - 2002
Skills
Clinical Data Management, Validation, Clinical Trials, Cross-functional Team..., EDC, Oracle Clinical, Clinical Research, FDA, Data Management, CRO, Software Documentation, CTMS, Computer System..., Management, Clinical Development, Microsoft Office, Database Administration, SAS, Program Management, Pharmaceutical Industry, Regulatory Submissions, Databases, Oncology, Biotechnology, Citrix, 21 CFR Part 11
Education
Lynn University 1988 — 1992
BS, Behavioral Science
Lynn University
BS, behavioral science
University of Hartford
MS, Experimental neurobiology
University of Hartford
MSC, Experimental
St. Jude Medical September 2010 - Present
MannKind Corporation January 2007 - September 2010
MannKind Corporation January 2006 - January 2007
MannKind Corporation January 2002 - January 2006
ClinCap January 1998 - January 2002
IPR 1989 - 2002
Skills
Clinical Data Management, Validation, Clinical Trials, Cross-functional Team..., EDC, Oracle Clinical, Clinical Research, FDA, Data Management, CRO, Software Documentation, CTMS, Computer System..., Management, Clinical Development, Microsoft Office, Database Administration, SAS, Program Management, Pharmaceutical Industry, Regulatory Submissions, Databases, Oncology, Biotechnology, Citrix, 21 CFR Part 11
Education
Lynn University 1988 — 1992
BS, Behavioral Science
Lynn University
BS, behavioral science
University of Hartford
MS, Experimental neurobiology
University of Hartford
MSC, Experimental
Michael Gaddis, LEED AP's MannKind Corporation Experience January 2003 - July 2007
Job Project Director at Compass Development Services
Industry Facilities Services
Experience
Compass Development Services August 2014 - Present
W Times Square Hotel 2009 - 2014
Starwood Hotels & Resorts Worldwide, Inc. 2007 - 2009
MannKind Corporation January 2003 - July 2007
Starwood Hotels & Resorts Worldwide, Inc. November 2002 - February 2003
Photronics, Inc. 1994 - 2002
Photronics, Inc. 1990 - 1994
GTE - Tactical Systems Division 1988 - 1990
GTE Government Systems 1985 - 1988
Skills
Continuous Improvement, Manufacturing, Construction, Project Management, Budgets, Contract Management, Management, Commissioning, Engineering, Project Planning, Contract Negotiation, Facilities Management, Cost Control, Process Scheduler, Validation, Leadership, Human Resources, Program Management, HVAC, Cross-functional Team..., Troubleshooting, Training, Quality Control, Start-ups, Sop, Team Building
Education
Villanova University
Bachelor Mechanical Engineering
Northeastern University
Certificate of Professional Achievement, Building and Construction Technology
Compass Development Services August 2014 - Present
W Times Square Hotel 2009 - 2014
Starwood Hotels & Resorts Worldwide, Inc. 2007 - 2009
MannKind Corporation January 2003 - July 2007
Starwood Hotels & Resorts Worldwide, Inc. November 2002 - February 2003
Photronics, Inc. 1994 - 2002
Photronics, Inc. 1990 - 1994
GTE - Tactical Systems Division 1988 - 1990
GTE Government Systems 1985 - 1988
Skills
Continuous Improvement, Manufacturing, Construction, Project Management, Budgets, Contract Management, Management, Commissioning, Engineering, Project Planning, Contract Negotiation, Facilities Management, Cost Control, Process Scheduler, Validation, Leadership, Human Resources, Program Management, HVAC, Cross-functional Team..., Troubleshooting, Training, Quality Control, Start-ups, Sop, Team Building
Education
Villanova University
Bachelor Mechanical Engineering
Northeastern University
Certificate of Professional Achievement, Building and Construction Technology
Melissa Heitmann's MannKind Corporation Experience 2007 - Present
Job Process Engineer at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation 2007 - Present
Hudson Highlands Veterinary Medical Group 2003 - 2007
Proton Energy Systems 2001 - 2003
Education
Rensselaer Polytechnic Institute 1997 — 2001
BS, Chemical Engineering
MannKind Corporation 2007 - Present
Hudson Highlands Veterinary Medical Group 2003 - 2007
Proton Energy Systems 2001 - 2003
Education
Rensselaer Polytechnic Institute 1997 — 2001
BS, Chemical Engineering
Stella Albert's MannKind Corporation Experience 2006 - 2009
Job Stella Albert
Industry Biotechnology
Experience
Baxter BioScience May 2009 - August 2010
MannKind Corporation 2006 - 2009
Baxter BioScience 1999 - 2006
Skills
Validation, CAPA, GLP, GMP, Biotechnology, HPLC, Drug Development, Assay Development
Education
Odessa National 'I.I. Mecnikov' University
MS, Chemistry and Biology
Baxter BioScience May 2009 - August 2010
MannKind Corporation 2006 - 2009
Baxter BioScience 1999 - 2006
Skills
Validation, CAPA, GLP, GMP, Biotechnology, HPLC, Drug Development, Assay Development
Education
Odessa National 'I.I. Mecnikov' University
MS, Chemistry and Biology
Sayuri Yatsubo's MannKind Corporation Experience November 2004 - April 2009
Job Staff Scientist at Quest Diagnostics
Industry Biotechnology
Experience
Quest Diagnostics June 2014 - Present
Quest Diagnostics November 2013 - June 2014
Quest Diagnostics August 2010 - November 2013
Quest Diagnostics June 2009 - August 2010
Mannkind Corporation November 2004 - April 2009
Skills
Assay Development, Molecular Biology, Western Blotting, Immunology, Drug Development, ELISA, Protein Chemistry, Molecular & Cellular..., Cancer Genomics, Biotechnology, Mechanism Of Action..., DNA sequencing, SNP genotyping, RT-PCR, recombinant DNA..., Flow Cytometry, High Throughput, CAP/CLIA, Biochemistry, Clinical Trials, Validation, Life Sciences, PCR
Education
Occidental College 2001 — 2003
Bachelor of Arts (B.A.), Biochemistry
Quest Diagnostics June 2014 - Present
Quest Diagnostics November 2013 - June 2014
Quest Diagnostics August 2010 - November 2013
Quest Diagnostics June 2009 - August 2010
Mannkind Corporation November 2004 - April 2009
Skills
Assay Development, Molecular Biology, Western Blotting, Immunology, Drug Development, ELISA, Protein Chemistry, Molecular & Cellular..., Cancer Genomics, Biotechnology, Mechanism Of Action..., DNA sequencing, SNP genotyping, RT-PCR, recombinant DNA..., Flow Cytometry, High Throughput, CAP/CLIA, Biochemistry, Clinical Trials, Validation, Life Sciences, PCR
Education
Occidental College 2001 — 2003
Bachelor of Arts (B.A.), Biochemistry
Eric S. Bahnsen's MannKind Corporation Experience May 2007 - November 2014
Job Senior Programmer Analyst II at PPD
Industry Pharmaceuticals
Experience
PPD December 2014 - Present
MannKind Corporation May 2007 - November 2014
Research Pharmaceutical Services, Inc. – Contract to Perm - Mannkind Corporation November 2006 - May 2007
Bioforce Solutions – Contract Position - Organon USA June 2006 - November 2006
MILLENNIX an IT&E International Group Company (now Averion) April 2002 - June 2006
Skills
Biostatistics, SAS programming, SAS, Pharmaceutical Industry, CRO, Clinical Development, Clinical Trials, Clinical Research, Clinical Data Management, Data Management, EDC, 21 CFR Part 11, Validation, CDISC, SDTM, Oracle Clinical, GCP, SOP, Diabetes
Education
Penn State University 1984 — 1988
Bachelor of Science (BS), Management
PPD December 2014 - Present
MannKind Corporation May 2007 - November 2014
Research Pharmaceutical Services, Inc. – Contract to Perm - Mannkind Corporation November 2006 - May 2007
Bioforce Solutions – Contract Position - Organon USA June 2006 - November 2006
MILLENNIX an IT&E International Group Company (now Averion) April 2002 - June 2006
Skills
Biostatistics, SAS programming, SAS, Pharmaceutical Industry, CRO, Clinical Development, Clinical Trials, Clinical Research, Clinical Data Management, Data Management, EDC, 21 CFR Part 11, Validation, CDISC, SDTM, Oracle Clinical, GCP, SOP, Diabetes
Education
Penn State University 1984 — 1988
Bachelor of Science (BS), Management
Flordeliza Nabong, MD's MannKind Corporation Experience October 2007 - April 2009
Job Senior Medical Director at Global Safety and Pharmacovigilance, PharmaNet/i3
Industry Pharmaceuticals
Experience
Global Safety and Pharmacovigilance, PharmaNet/i3 October 2011 - Present
I3 January 2011 - October 2011
OSI Pharmaceuticals August 2010 - January 2011
Hoffmann-La Roche, Inc April 2009 - January 2011
MannKind Corporation October 2007 - April 2009
Mayne Pharma 2006 - 2007
Sentrx 2004 - 2006
Skills
Pharmacovigilance, Oncology, Clinical Trials, Pharmaceutical Industry, Regulatory Affairs, Clinical Research
Education
Manila Central University 1987 — 1991
Doctor of Medicine
University of Santo Tomas
Bachelor of Science in Biology
Global Safety and Pharmacovigilance, PharmaNet/i3 October 2011 - Present
I3 January 2011 - October 2011
OSI Pharmaceuticals August 2010 - January 2011
Hoffmann-La Roche, Inc April 2009 - January 2011
MannKind Corporation October 2007 - April 2009
Mayne Pharma 2006 - 2007
Sentrx 2004 - 2006
Skills
Pharmacovigilance, Oncology, Clinical Trials, Pharmaceutical Industry, Regulatory Affairs, Clinical Research
Education
Manila Central University 1987 — 1991
Doctor of Medicine
University of Santo Tomas
Bachelor of Science in Biology
Vincenzo Maddalena's MannKind Corporation Experience 2006 - 2007
Job Senior Clinical Study Manager at Eisai
Industry Pharmaceuticals
Experience
Eisai June 2012 - June 2015
Roche Pharmaceuticals April 2007 - May 2012
MannKind Corporation 2006 - 2007
Wyeth 2004 - 2006
ICN Pharmaceuticals 2001 - 2002
Skills
•GCP/GMP Knowledge, •CRO Managing..., •Global Project..., •Study Phase I to IV, •Multiple Vendor..., •Team Building &..., •IVRS Proficiency, •Clinical Trial..., CTMS, Clinical Trials, CRO, Clinical Development, GCP, ICH-GCP, Clinical Research, Pharmaceutical Industry, Sop, EDC, Clinical Operations, Regulatory Submissions, GMP, FDA, Protocol, SOP, Oncology, Biotechnology, Drug Development
Education
Manhattanville College 1997 — 2001
BS - Biology
Eisai June 2012 - June 2015
Roche Pharmaceuticals April 2007 - May 2012
MannKind Corporation 2006 - 2007
Wyeth 2004 - 2006
ICN Pharmaceuticals 2001 - 2002
Skills
•GCP/GMP Knowledge, •CRO Managing..., •Global Project..., •Study Phase I to IV, •Multiple Vendor..., •Team Building &..., •IVRS Proficiency, •Clinical Trial..., CTMS, Clinical Trials, CRO, Clinical Development, GCP, ICH-GCP, Clinical Research, Pharmaceutical Industry, Sop, EDC, Clinical Operations, Regulatory Submissions, GMP, FDA, Protocol, SOP, Oncology, Biotechnology, Drug Development
Education
Manhattanville College 1997 — 2001
BS - Biology
David Olenski's MannKind Corporation Experience November 2006 - September 2008
Job Product Manager at Tosoh Bioscience LLC
Industry Chemicals
Experience
Tosoh Bioscience LLC August 2015 - Present
Monroe Energy, LLC October 2013 - August 2015
PAC June 2011 - October 2013
Intertek September 2009 - June 2011
Lakeland Central School District September 2008 - June 2009
MannKind Corporation November 2006 - September 2008
Ciba April 1999 - November 2006
Skills
Analytical Chemistry, Gas Chromatography, Chemistry, HPLC, UV/Vis, Chromatography, GC-MS, Mass Spectrometry, Spectroscopy, ICP, FTIR, Wet Chemistry, Sulfur and Nitrogen..., Validation, Calibration, Instrumentation, Laboratory, GMP, LIMS, Polymers, Organic Chemistry, UV
Education
NYU 2001 — 2003
Master's degree, Chemistry
Mercy College 2008 — 2010
Master's degree, Education
SUNY Oswego 1994 — 1998
Bachelor's degree, Chemistry
Tosoh Bioscience LLC August 2015 - Present
Monroe Energy, LLC October 2013 - August 2015
PAC June 2011 - October 2013
Intertek September 2009 - June 2011
Lakeland Central School District September 2008 - June 2009
MannKind Corporation November 2006 - September 2008
Ciba April 1999 - November 2006
Skills
Analytical Chemistry, Gas Chromatography, Chemistry, HPLC, UV/Vis, Chromatography, GC-MS, Mass Spectrometry, Spectroscopy, ICP, FTIR, Wet Chemistry, Sulfur and Nitrogen..., Validation, Calibration, Instrumentation, Laboratory, GMP, LIMS, Polymers, Organic Chemistry, UV
Education
NYU 2001 — 2003
Master's degree, Chemistry
Mercy College 2008 — 2010
Master's degree, Education
SUNY Oswego 1994 — 1998
Bachelor's degree, Chemistry
Kathyann Hayden's MannKind Corporation Experience 2005 - 2007
Job Quality Assurance
Industry Biotechnology
Experience
Dendreon April 2011 - Present
Progenics Pharmaceuticals 2007 - 2011
MannKind Corporation 2005 - 2007
PepsiCo 2004 - 2005
Skills
CAPA, GMP, Sop, Validation, 21 CFR Part 11, Biotechnology, Aseptic Processing, GLP, V&V, FDA, Pharmaceutical Industry, Change Control, LIMS, Technology Transfer, GxP
Education
Pace University-Pleasantville/Briarcliff Campus
Bachelor of Science (BS), BioChemistry
Dendreon April 2011 - Present
Progenics Pharmaceuticals 2007 - 2011
MannKind Corporation 2005 - 2007
PepsiCo 2004 - 2005
Skills
CAPA, GMP, Sop, Validation, 21 CFR Part 11, Biotechnology, Aseptic Processing, GLP, V&V, FDA, Pharmaceutical Industry, Change Control, LIMS, Technology Transfer, GxP
Education
Pace University-Pleasantville/Briarcliff Campus
Bachelor of Science (BS), BioChemistry
Kimberly McNamara's MannKind Corporation Experience July 2006 - August 2008
Job Accounts Payable Specilist (APS) at Ipsos NA
Industry Accounting
Experience
Ipsos NA 2010 - Present
Sperry Rail Service September 2008 - June 2010
MannKind Corporation July 2006 - August 2008
Modzelewski's Towing June 2005 - June 2006
Car Land Auto Body, Inc May 2003 - September 2004
Levine Automotive August 2002 - April 2003
Union Carbide Corporation June 1999 - May 2002
Union Carbide Corporation September 1996 - December 1999
Union Carbide Corporation January 1996 - May 1999
Skills
Invoicing, Microsoft Excel, Microsoft Word, Payroll, Accounts Payable, PowerPoint, Account Reconciliation
Education
Post University 2007 — 2011
Associates Degree, HR Managament, 3.54
Norwalk Community College 1993 — 1993
Certified Nurses Aid, B
Henry Abbott Technical High School 1980 — 1984
Mechanical Drafting and Mechanical Drafting CAD/CADD
Ipsos NA 2010 - Present
Sperry Rail Service September 2008 - June 2010
MannKind Corporation July 2006 - August 2008
Modzelewski's Towing June 2005 - June 2006
Car Land Auto Body, Inc May 2003 - September 2004
Levine Automotive August 2002 - April 2003
Union Carbide Corporation June 1999 - May 2002
Union Carbide Corporation September 1996 - December 1999
Union Carbide Corporation January 1996 - May 1999
Skills
Invoicing, Microsoft Excel, Microsoft Word, Payroll, Accounts Payable, PowerPoint, Account Reconciliation
Education
Post University 2007 — 2011
Associates Degree, HR Managament, 3.54
Norwalk Community College 1993 — 1993
Certified Nurses Aid, B
Henry Abbott Technical High School 1980 — 1984
Mechanical Drafting and Mechanical Drafting CAD/CADD
Spencer Kinsey's MannKind Corporation Experience September 2006 - Present
Job Director Device Technology at Mannkind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation September 2006 - Present
aVisionary Company May 2002 - September 2006
Bio-Plexus (ICU Medical) July 1993 - May 2002
Skills
Biotechnology, Lifesciences, Pharmaceutics, CAPA, GMP, 21 CFR Part 11, Pharmaceutical Industry, Sop, FDA, Medical Devices, Validation, V&V, Regulatory Submissions, Drug Discovery, Biopharmaceuticals, GLP, R&D, Drug Development, Technology Transfer, Clinical Trials, CRO, GxP, Change Control, Regulatory Affairs, LIMS
Education
University of Connecticut 1990 — 1993
Bachelor of Science (BS), Mechanical Engineering
Rensselaer Polytechnic Institute 1988 — 1990
Mechanical Engineering
MannKind Corporation September 2006 - Present
aVisionary Company May 2002 - September 2006
Bio-Plexus (ICU Medical) July 1993 - May 2002
Skills
Biotechnology, Lifesciences, Pharmaceutics, CAPA, GMP, 21 CFR Part 11, Pharmaceutical Industry, Sop, FDA, Medical Devices, Validation, V&V, Regulatory Submissions, Drug Discovery, Biopharmaceuticals, GLP, R&D, Drug Development, Technology Transfer, Clinical Trials, CRO, GxP, Change Control, Regulatory Affairs, LIMS
Education
University of Connecticut 1990 — 1993
Bachelor of Science (BS), Mechanical Engineering
Rensselaer Polytechnic Institute 1988 — 1990
Mechanical Engineering
Jessica Robison's MannKind Corporation Experience January 2006 - October 2010
Job Senior Manager Accounting at Kythera Biopharmaceuticals
Industry Pharmaceuticals
Experience
Kythera Biopharmaceuticals October 2010 - Present
MannKind Corporation January 2006 - October 2010
KPMG Audit 2003 - 2005
Skills
Financial Reporting, Auditing, Accounting, Financial Analysis, Sarbanes-Oxley Act, SEC filings, Technical Accounting..., SEC Filings, Sarbanes-Oxley, Financial Accounting, Due Diligence, GAAP, Internal Controls, US GAAP, Finance
Education
Loyola Marymount University, College of Business Administration 2000 — 2003
BS, Accounting and BA, Business Administration emphasis in Finance
Kythera Biopharmaceuticals October 2010 - Present
MannKind Corporation January 2006 - October 2010
KPMG Audit 2003 - 2005
Skills
Financial Reporting, Auditing, Accounting, Financial Analysis, Sarbanes-Oxley Act, SEC filings, Technical Accounting..., SEC Filings, Sarbanes-Oxley, Financial Accounting, Due Diligence, GAAP, Internal Controls, US GAAP, Finance
Education
Loyola Marymount University, College of Business Administration 2000 — 2003
BS, Accounting and BA, Business Administration emphasis in Finance
Rodrigo Laureano's MannKind Corporation Experience 2001 - 2006
Job Principal Scientist at Pfizer
Industry Pharmaceuticals
Experience
Pfizer January 2015 - Present
Celgene August 2008 - December 2014
Schering-Plough Pharmaceuticals 2006 - 2008
MannKind Corporation 2001 - 2006
Skills
GLP, Toxicology, Biotechnology, Drug Discovery, Pharmaceutical Industry, GMP, Validation, IND, Analytical Chemistry, Assay Development, Biopharmaceuticals, CRO, Clinical Development, Drug Development, HPLC, LC-MS, Pharmacokinetics, Sop, UV/Vis, LIMS
Education
Quinnipiac University 2001 — 2004
M.S.
The University of Connecticut 1996 — 2000
B.S., Physiology and Neurobiology
Pfizer January 2015 - Present
Celgene August 2008 - December 2014
Schering-Plough Pharmaceuticals 2006 - 2008
MannKind Corporation 2001 - 2006
Skills
GLP, Toxicology, Biotechnology, Drug Discovery, Pharmaceutical Industry, GMP, Validation, IND, Analytical Chemistry, Assay Development, Biopharmaceuticals, CRO, Clinical Development, Drug Development, HPLC, LC-MS, Pharmacokinetics, Sop, UV/Vis, LIMS
Education
Quinnipiac University 2001 — 2004
M.S.
The University of Connecticut 1996 — 2000
B.S., Physiology and Neurobiology
Jacqueline Lapotosky's MannKind Corporation Experience April 2003 - Present
Job Manager, Human Resources, MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation April 2003 - Present
Ingersoll-Rand/The Torrington Company August 1989 - March 2003
Skills
Personnel Management, FDA, Succession Planning, Sop, GMP, Pharmaceutical Industry, Process Improvement, Human Resources, Manufacturing, Deferred Compensation, Team Building, Performance Management, Executive Pay, Cross-functional Team..., Validation, Medical Devices, Leadership Development, Talent Management, Continuous Improvement, 21 CFR Part 11, Training, Change Management, Strategic Planning, Employee Relations, Talent Acquisition, Software Documentation, Biotechnology, Onboarding, Project Management, Organizational..., ISO, HRIS, SOP
Education
Post University
Business/Human Resources
MannKind Corporation April 2003 - Present
Ingersoll-Rand/The Torrington Company August 1989 - March 2003
Skills
Personnel Management, FDA, Succession Planning, Sop, GMP, Pharmaceutical Industry, Process Improvement, Human Resources, Manufacturing, Deferred Compensation, Team Building, Performance Management, Executive Pay, Cross-functional Team..., Validation, Medical Devices, Leadership Development, Talent Management, Continuous Improvement, 21 CFR Part 11, Training, Change Management, Strategic Planning, Employee Relations, Talent Acquisition, Software Documentation, Biotechnology, Onboarding, Project Management, Organizational..., ISO, HRIS, SOP
Education
Post University
Business/Human Resources
Brendan Laurenzi's MannKind Corporation Experience Research Associate IIMannKind CorporationJuly 2005 - June 2008
Job Engineer at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation Research Associate IIMannKind CorporationJuly 2005 - June 2008
Skills
SOP, Validation, Manufacturing, cGMP, FDA
Education
Rensselaer Polytechnic Institute 2001 — 2005
bachelors, Biomedical Engineering
MannKind Corporation Research Associate IIMannKind CorporationJuly 2005 - June 2008
Skills
SOP, Validation, Manufacturing, cGMP, FDA
Education
Rensselaer Polytechnic Institute 2001 — 2005
bachelors, Biomedical Engineering
Vishakha Patel's MannKind Corporation Experience September 2014 - Present
Job QC Associate III at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation September 2014 - Present
Silarx Pharmaceutical INC. December 2013 - September 2014
Innoteq Inc. November 2013 - December 2013
WATSON LABORATORIES INC February 1991 - December 2010
Watson Pharmaceuticals 1991 - 2010
NATIONAL DAIRY DEVELOPMENT BOARD (NDDB) January 1983 - January 1990
Skills
GLP, LIMS, HPLC, Dissolution, UV, TLC, USP, Chromatography, Time Management, Analytical Chemistry, cGMP, Validation, QC, Chemistry, FDA, Process Validation, Change Control, Titration, Quality Auditing, Analytical Techniques, Microsoft Word, Empower, Method Transfer, Stability Testing, Karl Fisher, Word, Excel, PowerPoint, Planning, SOP, Wet Chemistry, Chemstation, GC/MS, IR, UV-Vis, IR spectroscopy, GMP, 21 CFR Part 11, Pharmaceuticals, LC-MS, CAPA, Gas Chromatography, Spectroscopy, pH meter, Reverse Phase, JD Edwards, FTIR, Laboratory, Dissolution Testing, UV/Vis
Education
Sardar Patel University 1979 — 1981
MSC, Food & Nutrition
Sardar Patel University 1976 — 1981
M.SC, Home) Foods & Nutrition
Medical Laboratory Technology, Bombay School of Medical Technology
Sardar Patel University
B.SC, Home) Foods & Nutrition
MannKind Corporation September 2014 - Present
Silarx Pharmaceutical INC. December 2013 - September 2014
Innoteq Inc. November 2013 - December 2013
WATSON LABORATORIES INC February 1991 - December 2010
Watson Pharmaceuticals 1991 - 2010
NATIONAL DAIRY DEVELOPMENT BOARD (NDDB) January 1983 - January 1990
Skills
GLP, LIMS, HPLC, Dissolution, UV, TLC, USP, Chromatography, Time Management, Analytical Chemistry, cGMP, Validation, QC, Chemistry, FDA, Process Validation, Change Control, Titration, Quality Auditing, Analytical Techniques, Microsoft Word, Empower, Method Transfer, Stability Testing, Karl Fisher, Word, Excel, PowerPoint, Planning, SOP, Wet Chemistry, Chemstation, GC/MS, IR, UV-Vis, IR spectroscopy, GMP, 21 CFR Part 11, Pharmaceuticals, LC-MS, CAPA, Gas Chromatography, Spectroscopy, pH meter, Reverse Phase, JD Edwards, FTIR, Laboratory, Dissolution Testing, UV/Vis
Education
Sardar Patel University 1979 — 1981
MSC, Food & Nutrition
Sardar Patel University 1976 — 1981
M.SC, Home) Foods & Nutrition
Medical Laboratory Technology, Bombay School of Medical Technology
Sardar Patel University
B.SC, Home) Foods & Nutrition
Frederick Okech's MannKind Corporation Experience 2007 - 2011
Job Sr. Microbiologist at Dendreon
Industry Pharmaceuticals
Karin Andersen's MannKind Corporation Experience 2005 - 2011
Job Director, Quality Control at SanMar Laboratories
Industry Pharmaceuticals
Experience
San-Mar Laboratories January 2012 - July 2012
MannKind Corporation 2005 - 2011
Skills
CAPA, Pharmaceutical Industry, GMP, Validation, 21 CFR Part 11, USP, Sop, FDA, LIMS, GxP, Change Control, GLP, HPLC, Biopharmaceuticals, Analytical Chemistry, Quality System, V&V, Cleaning Validation, Aseptic Processing, Technology Transfer
Education
Purchase College, SUNY 1995 — 2005
MS, BS, Nutrition, Biology, Chemistry
San-Mar Laboratories January 2012 - July 2012
MannKind Corporation 2005 - 2011
Skills
CAPA, Pharmaceutical Industry, GMP, Validation, 21 CFR Part 11, USP, Sop, FDA, LIMS, GxP, Change Control, GLP, HPLC, Biopharmaceuticals, Analytical Chemistry, Quality System, V&V, Cleaning Validation, Aseptic Processing, Technology Transfer
Education
Purchase College, SUNY 1995 — 2005
MS, BS, Nutrition, Biology, Chemistry
Christina Bryan's MannKind Corporation Experience June 2006 - Present
Job Manager, Human Resources at MannKind Corporation
Industry Pharmaceuticals
Experience
MannKind Corporation June 2006 - Present
Data Inc September 2003 - June 2006
CHB Consulting January 2001 - September 2003
Entex IT Services/Siemens April 1998 - January 2001
Coopers & Lybrand April 1995 - April 1998
Skills
Recruiting, Employee Relations, Human Resources, Performance Management, Industrial Relations, HRIS
Education
Hofstra University
BA cum laude, Spanish
MannKind Corporation June 2006 - Present
Data Inc September 2003 - June 2006
CHB Consulting January 2001 - September 2003
Entex IT Services/Siemens April 1998 - January 2001
Coopers & Lybrand April 1995 - April 1998
Skills
Recruiting, Employee Relations, Human Resources, Performance Management, Industrial Relations, HRIS
Education
Hofstra University
BA cum laude, Spanish
Lorie Cox's MannKind Corporation Experience June 2003 - Present
Job
Industry Pharmaceuticals
Experience
MannKind Corporation June 2003 - Present
Dover Chemical Corp August 1991 - February 2003
Education
Hood College
BA, Biology
MannKind Corporation June 2003 - Present
Dover Chemical Corp August 1991 - February 2003
Education
Hood College
BA, Biology
Harnisha Dalwadi's MannKind Corporation Experience 2002 - 2003
Job Senior Director, Medical Writing at Pharmacyclics
Industry Biotechnology
Experience
Pharmacyclics March 2015 - Present
Pharmacyclics May 2013 - Present
Amgen August 2005 - May 2013
UCLA 2004 - 2005
UCLA 2003 - 2005
MannKind Corporation 2002 - 2003
UCLA 1997 - 2002
National Institutes of Health 1996 - 1997
Skills
Cancer, Clinical Trials, Vaccines, Research, Clinical Study Design, Protocol, Editing, Oncology, Clinical Development, Immunology, Drug Discovery, Molecular Biology, Drug Development, Medical Writing, IND, Biopharmaceuticals, Regulatory Submissions, Cancer Research, Medical Affairs
Education
University of California, Los Angeles 1997 — 2002
PhD, Pathology and Laboratory Medicine
Rensselaer Polytechnic Institute 1992 — 1996
BS, Molecular Biology
Pharmacyclics March 2015 - Present
Pharmacyclics May 2013 - Present
Amgen August 2005 - May 2013
UCLA 2004 - 2005
UCLA 2003 - 2005
MannKind Corporation 2002 - 2003
UCLA 1997 - 2002
National Institutes of Health 1996 - 1997
Skills
Cancer, Clinical Trials, Vaccines, Research, Clinical Study Design, Protocol, Editing, Oncology, Clinical Development, Immunology, Drug Discovery, Molecular Biology, Drug Development, Medical Writing, IND, Biopharmaceuticals, Regulatory Submissions, Cancer Research, Medical Affairs
Education
University of California, Los Angeles 1997 — 2002
PhD, Pathology and Laboratory Medicine
Rensselaer Polytechnic Institute 1992 — 1996
BS, Molecular Biology
Joseph Sulner's MannKind Corporation Experience 1998 - 2001
Job Biology Instructor at Bergen County Community College
Industry
Experience
Bergen County Community College September 2005 - Present
Celgene October 2002 - February 2005
MannKind Corporation 1998 - 2001
Skills
Biochemistry, Biotechnology, Teaching, FDA, Clinical Development, Clinical Research, Curriculum Development, Life Sciences, Microsoft Office, Team Building
Education
Rutgers, The State University of New Jersey-Newark 1978 — 1984
PhD, Zoological Sciences
Bergen County Community College September 2005 - Present
Celgene October 2002 - February 2005
MannKind Corporation 1998 - 2001
Skills
Biochemistry, Biotechnology, Teaching, FDA, Clinical Development, Clinical Research, Curriculum Development, Life Sciences, Microsoft Office, Team Building
Education
Rutgers, The State University of New Jersey-Newark 1978 — 1984
PhD, Zoological Sciences
Emmanuel (Manny) Lozada's MannKind Corporation Experience November 2014 - Present
Job Inventory coordinator @ MannKind Corp.
Industry Pharmaceuticals
Experience
MannKind Corporation November 2014 - Present
FuelCell Energy June 2009 - November 2014
Watson Pharmaceuticals June 2005 - July 2008
Lavi Industries 2004 - 2006
Skills
Lean Manufacturing, Continuous Improvement, Process Engineering, Root Cause Analysis, Manufacturing, Six Sigma, Kaizen, 5S, Value Stream Mapping, SPC, MRP, Quality System, Production Planning
Education
Johnson and Wales University
MannKind Corporation November 2014 - Present
FuelCell Energy June 2009 - November 2014
Watson Pharmaceuticals June 2005 - July 2008
Lavi Industries 2004 - 2006
Skills
Lean Manufacturing, Continuous Improvement, Process Engineering, Root Cause Analysis, Manufacturing, Six Sigma, Kaizen, 5S, Value Stream Mapping, SPC, MRP, Quality System, Production Planning
Education
Johnson and Wales University
Karen Ellerman's MannKind Corporation Experience January 2007 - July 2010
Job Principal Medical Writer, Diabetes at Sanofi
Industry Pharmaceuticals
Experience
Sanofi January 2014 - Present
Novartis Oncology August 2010 - January 2014
Mannkind Corporation January 2007 - July 2010
Skills
Diabetes, Medical Writing, Clinical Development, CRO, Pharmacovigilance, Therapeutic Areas, Oncology, IND, Neurology, Publication Planning, Infectious Diseases, Clinical Trials, Medical Affairs, GCP, Regulatory Submissions, Pharmaceutical Industry, Regulatory Affairs, Medical Communications
Education
Medical University of South Carolina
PhD, Cellular and molecular pathobiology
University of Wisconisn-Milwaukee
BS, Medical laboratory science
Sanofi January 2014 - Present
Novartis Oncology August 2010 - January 2014
Mannkind Corporation January 2007 - July 2010
Skills
Diabetes, Medical Writing, Clinical Development, CRO, Pharmacovigilance, Therapeutic Areas, Oncology, IND, Neurology, Publication Planning, Infectious Diseases, Clinical Trials, Medical Affairs, GCP, Regulatory Submissions, Pharmaceutical Industry, Regulatory Affairs, Medical Communications
Education
Medical University of South Carolina
PhD, Cellular and molecular pathobiology
University of Wisconisn-Milwaukee
BS, Medical laboratory science
NK Chung's MannKind Corporation Experience January 2008 - April 2011
Job Analytical Chemist (professional Services Provider for Smiths Detection) at Scientific Search
Industry Defense & Space
Experience
Scientific Search September 2011 - August 2014
MannKind Corporation January 2008 - April 2011
On Assignment July 2007 - January 2008
U.S. Army Reserve September 1998 - March 2005
Skills
Gas Chromatography, HPLC, Microsoft Office, GC-MS, RF troubleshooting, Laboratory, 21 CFR Part 11, Analysis, Analytical Chemistry, Chemistry, Formulation, FDA, GMP, Research, Sop
Education
Pace University 2012 — 2014
Master of Science (MS), Environmental Science
Marist College 2004 — 2007
Bachelor of Science (BS), Chemistry
Scientific Search September 2011 - August 2014
MannKind Corporation January 2008 - April 2011
On Assignment July 2007 - January 2008
U.S. Army Reserve September 1998 - March 2005
Skills
Gas Chromatography, HPLC, Microsoft Office, GC-MS, RF troubleshooting, Laboratory, 21 CFR Part 11, Analysis, Analytical Chemistry, Chemistry, Formulation, FDA, GMP, Research, Sop
Education
Pace University 2012 — 2014
Master of Science (MS), Environmental Science
Marist College 2004 — 2007
Bachelor of Science (BS), Chemistry
William Killian's MannKind Corporation Experience September 2014 - Present
Job at
Industry Pharmaceuticals
Experience
MannKind Corporation September 2014 - Present
RK Manufacturing June 2013 - Present
RK Manufacturing June 2012 - June 2013
MannKind Corporation September 2006 - April 2011
St. Vincent Medical Center February 2000 - September 2006
Skills
21 CFR Part 11, CAPA, Change Control, FDA, GMP, ISO 13485, Medical Devices, Pharmaceutical Industry, Quality Assurance, Quality System, SOP, V, Validation
Education
Housatonic Community College 1996 — 2005
Associate's degree, General Studies
Stratford High School 1991 — 1995
High School Diploma
MannKind Corporation September 2014 - Present
RK Manufacturing June 2013 - Present
RK Manufacturing June 2012 - June 2013
MannKind Corporation September 2006 - April 2011
St. Vincent Medical Center February 2000 - September 2006
Skills
21 CFR Part 11, CAPA, Change Control, FDA, GMP, ISO 13485, Medical Devices, Pharmaceutical Industry, Quality Assurance, Quality System, SOP, V, Validation
Education
Housatonic Community College 1996 — 2005
Associate's degree, General Studies
Stratford High School 1991 — 1995
High School Diploma
Virginia Drap's MannKind Corporation Experience March 2007 - April 2011
Job Chemist at Teva Pharmaceuticals
Industry Pharmaceuticals
Experience
Teva Pharmaceuticals April 2011 - Present
MannKind Corporation March 2007 - April 2011
RTI International 1996 - 2004
Skills
GMP, GLP, Analytical Chemistry, Pharmaceutical Industry, SOP, FDA, UV/Vis, Validation, LIMS, HPLC, LC-MS, Biotechnology, Chemistry
Education
North Carolina State University 1994 — 1995
Bachelor's Degree, Chemistry
University of Connecticut 1987 — 1991
Bachelor of Science (BS), Music Education
Newtown High School, Sandy Hook, CT 1983 — 1987
Teva Pharmaceuticals April 2011 - Present
MannKind Corporation March 2007 - April 2011
RTI International 1996 - 2004
Skills
GMP, GLP, Analytical Chemistry, Pharmaceutical Industry, SOP, FDA, UV/Vis, Validation, LIMS, HPLC, LC-MS, Biotechnology, Chemistry
Education
North Carolina State University 1994 — 1995
Bachelor's Degree, Chemistry
University of Connecticut 1987 — 1991
Bachelor of Science (BS), Music Education
Newtown High School, Sandy Hook, CT 1983 — 1987
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY