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
Astellas Pharma June 2014 - Present
Astellas Pharma June 2011 - June 2014
Astellas Pharma December 2009 - June 2011
Agensys February 2010 - June 2010
MannKind Corporation 2002 - 2009
Skills
Immunology, Drug Discovery, Drug Development, Research, ELISA, Biotechnology, GLP, Lifesciences, Oncology, Assay Development, Pharmaceutical Industry, Molecular Biology, Cell Culture, Cell, Western Blotting
Education
UCLA 1996 — 2000
B.S., Microbiology and Molecular Genetics
Genentech March 2015 - Present
Hyde Engineering + Consulting December 2013 - March 2015
Medicis July 2012 - November 2013
CRB Consulting Engineers January 2011 - April 2012
MannKind Corporation July 2000 - December 2010
MannKind Corporation July 2000 - December 2010
Skills
GMP, Validation, Sop, FDA, 21 CFR Part 11, CAPA, Cleaning Validation, V&V, Technology Transfer, Biotechnology, Pharmaceutical Industry, Biopharmaceuticals, Process Simulation, Change Control, Quality System, Manufacturing, Process Engineering, Process Improvement, Commissioning, GLP, LIMS, GxP, Aseptic Processing, Computer System..., Continuous Improvement, Quality Assurance, Quality Control, ISO, Chromatography, Cross-functional Team..., Process Optimization, Drug Delivery, Regulatory Affairs, HPLC, Pharmaceutics
Education
The University of Connecticut 1996 — 2000
BS, Physiology Neurobiology / Mollecular and Cellular Biology
Boehringer Ingelheim October 2012 - Present
Boehringer Ingelheim Pharmaceuticals 2011 - October 2012
MannKind Corporation 2008 - October 2011
MannKind Corporation 2006 - 2008
Watson Pharmaceuticals 2006 - 2006
Johnson & Johnson May 2005 - August 2005
Skills
Clinical Development, CTMS, CRO, GCP, Clinical Trials, Pharmaceutical Industry, EDC, Clinical Data Management, Data Management, Drug Development, Sop, Regulatory Submissions, Oncology, ICH-GCP, Clinical Monitoring, Therapeutic Areas, Pharmacovigilance, Clinical Research, Medical Affairs, Medical Writing, Oracle Clinical
Education
University at Buffalo 2001 — 2005
BS, Biotechnology, Biochemical Pharmacology
The United Illuminating Company December 2008 - Present
MannKind Corporation January 2007 - August 2008
Pitney Bowes September 2004 - January 2007
Sikorsky Aircraft November 1998 - April 2004
Executone June 1994 - July 1998
Starter November 1992 - June 1994
Skills
Analysis, Energy, Process Improvement, Research, Business Analysis, Strategic Planning, Change Management, Management, Program Management, Financial Analysis, Business Process..., SAP, Financial Modeling, Forecasting, Risk Management, Budgets, Variance Analysis, Access, Project Management
Education
University of New Haven 1990 — 1992
Bachelor of Science (BS), Financial Accounting
SCCC, New Haven 1986 — 1989
Associate of Science (A.S.), Accounting and Finance
Biogen 2015 - Present
Synta Pharmaceuticals 2012 - 2014
Lantheus Medical Imaging 2010 - 2012
Molecular Insight Pharmaceuticals 2009 - 2010
Dyax Corporation 2007 - 2009
Acorda Therapeutics 2004 - 2007
Mannkind Corporation 2001 - 2004
Boehringer Ingelheim Pharmaceuticals 1999 - 2001
Muro Pharmaceuticals, Inc. 1999 - 1999
PAREXEL 1993 - 1999
Skills
Clinical Trials, Clinical Development, Oncology, CRO, GCP, Pharmaceutical Industry, Biotechnology, CTMS, Clinical Research, EDC, Lifesciences, Drug Development, Sop, Clinical Operations, Regulatory Submissions, Clinical Monitoring, SOP
Education
University of Massachusetts, Amherst
MPH, Epidemiology
Wheaton College (MA)
Bachelor of Arts, Biology
Amgen October 2013 - Present
Los Angeles October 2011 - June 2013
MannKind Corporation January 2005 - May 2011
Vasgene Therapeutics January 2003 - January 2005
Skills
Cell, Signal Transduction, In Vitro, Assay Development, In Vivo, Oncology, Drug Discovery, Antibodies, Protein Chemistry, Histology, Biomarkers, Drug Development, Immunology, Immunoassays, Cell Culture, Molecular Biology, Western Blotting, ELISA, Biotechnology, Biopharmaceuticals, GLP, Clinical Development, Vaccines, Clinical Trials, Immunohistochemistry, Biochemistry, Pharmacology
Education
University of California, Los Angeles 1997 — 2001
PhD, Biochemistry, Molecular and Medical Pharmacology
UCLA
Bachelor of Science (BS), Biochemistry
Cognisus Marketing Solutions May 2011 - Present
Valeritas September 2014 - July 2015
Pursuit-Solutions March 2014 - September 2014
VALERITAS February 2013 - October 2013
MANNKIND Corporation August 2006 - October 2011
SCHERING- PLOUGH December 2004 - September 2006
MEDPOINTE (Now Meda) 2003 - 2004
AVENTIS (Now Sanofi) 1991 - 2003
E&J GALLO WINERY December 1987 - December 1991
Skills
Product Marketing, Product Launch, Marketing Strategy, Segmentation, Market Research, Cross-functional Team..., Marketing Management, Product Management, Strategic Planning, Market Analysis, Marketing Research, Pharmaceutical Industry, Management, Leadership, Strategy, Sales Operations, Marketing, Competitive Analysis, Sales, Market Planning, Pharmaceutical Sales
Education
College of Commerce, Rathmines, Dublin, Ireland
Diploma in Advanced Business Studies / Diploma in Business Studies, Marketing & Finance
Trinity College, Dublin
Bachelor of Business Science, Marketing, Finance
ABC Laboratories,Inc. March 2012 - March 2014
MannKind Corporation June 2005 - April 2011
ASML January 1996 - November 2003
Skills
FDA, Gas Chromatography, R&D, V&V, USP, Biochemistry, UV/Vis, Quality System, TLC, Quality Control, Empower, Spectroscopy, Technology Transfer, Chemistry, Cleaning Validation, Titration, Chemstation, 21 CFR Part 11, IR, Karl Fisher, Medical Devices, LC-MS, FTIR, Laboratory, Formulation, Analytical Method..., Drug Discovery
Education
University of Gdansk 1972 — 1977
M.Sc in Chemistry, Chemistry
GE Capital August 2014 - Present
GE Capital August 2011 - August 2014
GE Capital May 2011 - July 2011
MannKind Corporation March 2010 - February 2011
University of Connecticut May 2009 - December 2009
MannKind Corporation June 2008 - March 2009
The Mayflower Inn & Spa May 2003 - November 2008
Skills
Data Analysis, Finance, Analysis, Matlab, Forecasting, Management, Sop, Microsoft Office, Microsoft Excel
Education
University of Connecticut 2005 — 2009
Bachelor's of Arts, Economics
Pomperaug Regional High School 2001 — 2005
High School Diploma
Actavis plc March 2010 - Present
Mannkind Biopharmaceuticals October 2007 - April 2010
MannKind Corporation April 2005 - September 2007
Hollister September 2003 - April 2005
Takeda Pharmaceuticals 2000 - 2003
PAREXEL 1998 - 2000
Pharmacia & Upjohn 1994 - 1998
Upjohn 1989 - 1994
Skills
Medical Writing, Clinical Development, Clinical Trials, Pharmaceutical Industry, CRO, Clinical Operations, Outsourcing, Sop, Clinical Research, Drug Development, Regulatory Submissions, Cross-functional Team..., Pharmaceutics
Education
Western Michigan University - Haworth College of Business 1989 — 1993
MBA, Marketing/Finance
Southern Illinois University, Carbondale 1967 — 1972
BA, Biological Sciences
Glenbrook North HS 1963 — 1966
St Norbert's
MannKind Corporation January 2005 - Present
MannKind Corporation April 2003 - January 2005
Schlumberger January 2001 - January 2003
Skills
Chemistry, Analytical Chemistry, Validation, Raman, HPLC
Education
Southern Connecticut State University
Western Connecticut State University
Bachelor's degree, Chemistry
PathKonnect Consulting Inc July 2013 - Present
Warner Chilcott/Actavis July 2013 - Present
MannKind Corporation October 2010 - June 2013
Smith Hanley Consulting Group February 2002 - June 2013
Eisai April 2010 - October 2010
Medarex October 2007 - April 2010
Abbott Labs November 2002 - October 2007
Novartis September 2001 - September 2002
Skills
Clinical Data Management, EDC, Clinical Trials, Data Management, 21 CFR Part 11, CTMS, Pharmaceutical Industry, Oracle Clinical, FDA, CDISC, Oncology, Clinical Development, SAS, Inform, GCP, CRO, Sop, SDTM, Clinical Research, Protocol, Data Validation, Databases, Project Management, Planning, CRF design, I-Review, Validation, Regulatory Submissions, Biotechnology, Cross-functional Team..., ICH-GCP, Lifesciences, Infectious Diseases, Database Design, Resource Management, Strategic Planning, Budget Management, QlikView, Data Modeling, Management, Data Analysis, Leadership, Consulting, Data Integration
Education
ICFAI Business School 1996 — 1998
Master of Business Administration (MBA), Finance and Information Technology
University of Pune 1992 — 1996
Bachelor of Commerce (B.Com.), Accounting and Business/Management
Hertz Equipment Rental August 2011 - Present
MannKind Corporation 2007 - April 2011
Genentech 2006 - 2007
Pfizer 2005 - 2006
IBM 2004 - 2004
Witco/Crompton Corporation 1998 - 2002
Skills
Valuation, Forecasting, Analysis, Cross-functional Team..., Budgets, Financial Analysis, Strategic Financial..., Hyperion Planning, Smartview, Strategy, Finance, Management, Financial Modeling, Leadership, Managerial Finance, Program Management, Project Management, ERP, Vendor Management, Accounting, Team Leadership, Variance Analysis
Education
Yale University - Yale School of Management 2003 — 2005
MBA, Finance and Marketing
University of Iowa 1991 — 1997
PhD, Chemistry
Transgenomic, Inc. December 2010 - Present
PGXHEALTH July 2007 - December 2010
Unilever January 2007 - July 2007
MannKind Corporation January 2006 - January 2007
Skills
Biotechnology, Validation, Lifesciences, Microsoft Office, GMP, Microsoft Excel, Clinical Research, Bioanalysis, Life Sciences, Sequencing, Chemistry, Laboratory Skills, PCR, Laboratory, DNA, Quality Control, R&D, Pharmaceutical Industry, Chromatography, Genotyping, Research, SOP
Education
Southern Connecticut State University 2001 — 2006
B.S, BIO-CHEMISTRY
J&J May 2011 - Present
MannKind Corporation July 2005 - June 2011
Pfizer, Inc. 2004 - 2005
Bayer Pharmaceuticals January 2000 - August 2004
Yale University School of Medicine 1993 - 1999
Skills
Cross-functional Team..., Drug Development, Oncology, Pharmaceutical Industry, Strategy, Clinical Development, Biotechnology, Clinical Trials, IND, FDA, Therapeutic Areas, Product Development, CRO, Biopharmaceuticals, Regulatory Submissions, GCP, Program Management, Medical Devices, Product Launch, Launching New Brands, Commercialization, Marketing
Education
University of New Haven 2002 — 2004
MBA
University of Connecticut 1990 — 1993
BS, Molecular Cell Biology
University of Rhode Island 1989 — 1990
North Branford High School 1985 — 1989
DuPont 2013 - 2013
Bristol-Myers Squibb 2012 - 2012
University of Connecticut August 2008 - May 2010
MannKind Corporation February 2007 - April 2009
Schering Plough Corporation October 2002 - April 2006
Rexall Sundown 1998 - 2002
DirecTV 1997 - 1998
Skills
Financial Analysis, Budgeting, Strategic Planning, Planning, Financial Modeling, Forecasting, Accounting, Cost Accounting, Monthly Reporting, Process Improvement, Analysis, Team Building, SOX, Supply Chain Management, Business Analysis, Excel, Contract Negotiation, Team Leadership, Inventory Management, Financial Reporting, Competitive Analysis, Valuation, Manufacturing, Financial Management, Financial Planning, Strategy, Budgets, Microsoft Excel, Project Planning, Finance, Management, Leadership, Business Strategy, Product Development, Managerial Finance, Cross-functional Team..., Business Planning, Change Management, Due Diligence, Program Management, Sarbanes-Oxley Act, Strategic Financial..., Supply Chain
Education
The University of Connecticut School of Business 2008 — 2010
MBA, Finance
Western Connecticut State University 1988 — 1991
Ancell School of Business, B.S., Law
Johnson & Johnson 2009 - Present
Cougar Biotechnology April 2008 - 2009
MannKind Corporation May 2007 - April 2008
CFHC, Inc. 2003 - 2007
Education
University of California, Los Angeles
MPH, School of Public Health
University of California, Los Angeles
BS, Biology
ARRENDEE LLC January 2011 - Present
ARRENDEE LLC June 2003 - February 2011
Aptuit Consulting, Inc. June 2007 - March 2009
MannKind Corporation March 2001 - March 2003
Pharmacia & Upjohn October 1994 - March 2001
Pharmacia 1994 - 2000
Ferring Pharmaceuticals June 1982 - October 1994
Skills
Academic and Medical..., Medical Writing, Clinical Development, Biotechnology, Regulatory..., Regulatory Affairs, Drug Development, Publication planning, commercial strategies, clinical trial..., transfer value..., client relationship..., medical marketing, Technical Consulting, Pharmaceutics, Lifesciences, Clinical Research, Life Sciences, Pharmaceutical Industry, Medical Devices, Clinical Trials, CRO, Pharmacovigilance, FDA
Education
University of Michigan - Rackham Graduate School 1967 — 1971
Ph.D., Zoology/Reproductive Endocrinology
MannKind Corporation October 2010 - Present
MannKind Corporation January 2007 - October 2010
Aptuit May 2006 - December 2006
Ethicon May 2005 - May 2006
Schering-Plough Research Institute June 2003 - August 2003
Church and Dwight June 2002 - August 2002
Skills
FDA, Manufacturing, Computer System..., R&D, Cross-functional Team..., IND, Validation, Technology Transfer, 21 CFR Part 11, Sop, Pharmaceutical Industry, GMP, Pharmaceutics, CAPA, Process Simulation, GLP, Medical Devices, Regulatory Submissions, V&V, Regulatory Affairs, Quality System, Chemistry, Biotechnology, Change Control, GxP, Biopharmaceuticals, CMC, Contract Manufacturing, Clinical Development, Drug Development, Clinical Trials, CRO, LIMS, Product Development
Education
Stevens Institute of Technology 2008 — 2010
Graduate Certificate, Bio-process Systems in Pharmaceutical Manufacturing
Stevens Institute of Technology 2007 — 2009
Graduate Certificate, Project Engineering in Pharmaceutical Manufacturing
Stevens Institute of Technology 2007 — 2009
Graduate Certificate, Pharmaceutical Manufacturing Systems
Stevens Institute of Technology 2005 — 2009
Masters, Chemical Engineering
Stevens Institute of Technology 2001 — 2006
Bachelors of Engineering, Chemical Engineering
American University of Rome 2003 — 2003
Study Abroad, Art of Antiquity
MannKind Corporation April 2008 - Present
Genelabs Technologies, Inc. April 2007 - January 2009
VaxGen, Inc. March 2006 - April 2008
Cell Genesys, Inc. June 1996 - June 2005
Diasonics Ultrasound, Inc. June 1989 - June 1996
ComputerLand November 1986 - June 1989
Price Waterhouse January 1981 - November 1986
Skills
Biotechnology, Pharmaceutical Industry, Medical Devices, Lifesciences, Clinical Development, Biopharmaceuticals, Technology Transfer, Finance, Accounting, Cross-functional Team..., Venture Capital, SEC filings, CRO, Commercialization, Strategy, Regulatory Affairs, FDA, Clinical Trials, Drug Development, Cancer, Oncology, Drug Discovery, Due Diligence, Mergers & Acquisitions, Life Sciences
Education
University of California, Berkeley 1977 — 1981
BA, Economics
Los Angeles Zoo June 2013 - Present
Cedars-Sinai Medical Center June 2012 - Present
Cedars-Sinai Medical Center July 2009 - June 2012
MannKind Corporation March 2006 - April 2009
GlaxoSmithKline February 2003 - February 2006
Wyeth July 2001 - December 2002
DuPont Pharmaceuticals March 2000 - June 2001
DuPont Pharmaceuticals June 1999 - March 2000
Skills
CPIA certified, April..., GLP, Toxicology, Lifesciences, Pharmacology, CRO, Laboratory, In Vivo, IRB, Pharmacokinetics
Education
University of Delaware 1995 — 1999
Bachelor of Science, Animal Science Minor: Spanish
Regeneron Pharmaceuticals April 2013 - Present
Ben Venue Laboratories [A subsidiary of Boehringer Ingelheim] May 2011 - March 2013
MannKind Corporation 2009 - March 2011
MannKind Corporation 2000 - 2009
Brown & Williamson Tobacco 1996 - 2000
Skills
Program Management, Validation, 21 CFR Part 11, Change Control, Risk Management, GMP, Technology Transfer, Pharmaceutical Industry, Sop, FDA, Biotechnology, Regulatory Affairs, CMC, Project Management, GLP, Clinical Trials, CAPA, Cross-functional Team..., MS Project, Auditing, Clinical Supplies, Program Budgeting, Clinical Suppy Modeling, Device master File, Design Review, Combination Products, Inhal, Generic Drugs, Brand Drugs, Quality Control, Regulatory Submissions, Quality Assurance, R&D, Clinical Research, Medical Devices, Drug Development, Chromatography, HPLC, Formulation, Pharmaceutics, LIMS, GxP, V&V, Cleaning Validation, Aseptic Processing, Chemistry, Clinical Development, Process Simulation, CRO, Drug Discovery
Education
University of Michigan 1993 — 1997
BS, Chemistry
LKM Resources August 2007 - Present
MannKind Corporation October 2006 - August 2007
Gap Inc. April 2006 - May 2007
Diageo November 2005 - March 2006
Applied Products Technical Resources November 2001 - August 2005
Approach Inc 1995 - 1997
Skills
Technical Recruiting, Talent Acquisition, Human Resources, Recruiting, Management, Talent Management, Temporary Placement, Sourcing, Contract Recruitment, Onboarding, Vendor Management, College Recruiting, Quality Assurance
Education
University at Buffalo
Foothills Consulting Group April 2011 - Present
MannKind Corporation July 2007 - April 2009
MannKind Corporation 2002 - 2006
Skills
Recruiting, Technical Recruiting, Talent Acquisition, Sourcing, Program Management, Staffing Services, Internet Recruiting, Vendor Management, Screening, Training, Benefits Negotiation, Contract Recruitment, SDLC, Onboarding, College Recruiting, Screening Resumes, Human Resources, Applicant Tracking..., Interview Preparation, Resource Management, CRM, IT Recruitment, Employee Training, Employee Relations, Talent Management, Interviewing Skills, Performance Management, HRIS, Management, Research, Networking, Interviews, Process Improvement, Temporary Placement, Team Building, Leadership, PeopleSoft, Information Technology, Staff Augmentation
Education
University of California, Los Angeles
B.S.
Ellipse Technologies, Inc. December 2014 - Present
Therapeutics Inc. March 2014 - December 2014
MannKind Corporation October 2009 - October 2013
MannKind Corporation June 2007 - October 2009
Independent Consultant 1998 - 2007
Bausch + Lomb 1997 - 1998
Novartis Ophthalmics 1994 - 1997
IOLAB Corporation (a J&J Company) 1992 - 1994
Skills
Clinical Trials, CRO, Clinical Monitoring, GCP, FDA, Ophthalmology, Clinical Research, Protocol, Clinical Development, CTMS, Cross-functional Team..., Endocrinology, Medical Writing, Diabetes, Pharmacology, Pharmacokinetics, Oncology, Pharmaceutical Industry, Drug Development, Site Rescue, Study Budgeting, Department Leadership, Training, Internal &..., Monitoring Plan..., Clinical Study Report..., Therapeutic Areas, Leadership, Regulatory Submissions
Education
University of California, Riverside 1986 — 1990
BS, Biochemistry
Horizon Pharma March 2015 - Present
Vetter Development Services USA April 2011 - March 2015
MannKind Corporation April 2008 - April 2011
Fisher Clinical Services August 2007 - April 2008
Abbott Laboratories July 2006 - August 2007
Abbott Laboratories August 2000 - July 2006
Kforce February 2000 - August 2000
Great Lakes Analytical March 1999 - February 2000
Skills
GMP, Validation, Pharmaceutical Industry, FDA, CAPA, Quality System, SOP, 21 CFR Part 11, Change Control, Medical Devices, domestic &...
Education
Southern Illinois University, Carbondale 1996 — 1998
BA, Biological Sciences
Pharma Resource Group, Inc. July 2015 - Present
Barry-Wehmiller Design Group September 2011 - July 2015
MannKind Corporation February 2008 - September 2011
Saybrook Consulting 2007 - 2008
Cardinal Health July 2004 - November 2006
Integrated Project Services April 2003 - June 2004
Cardinal Health August 1998 - March 2003
Johnson & Johnson October 1996 - July 1998
Johnson & Johnson January 1992 - September 1996
Johnson & Johnson October 1988 - December 1991
Skills
Packaging Engineering, Packaging, Validation, Medical Devices, Pharmaceutical Industry, Technology Transfer, Business Development, Lifesciences, Project Management, Engineering, Manufacturing, FDA, Leadership, Contract Manufacturing, Quality System, GMP, Pharmaceutics, Six Sigma, Process Engineering, Sop, Continuous Improvement, Automation, GAMP, Life Sciences, Biotechnology, Cross-functional Team..., Quality Assurance, 21 CFR Part 11, Change Control, CAPA, Regulatory Affairs, Operations Management, ISO 13485, V&V, Biopharmaceuticals, R&D, GxP, Pharmaceuticals, cGMP
Education
Thomas Edison State College
Bachelor of Science; Business Administration, Operations Management
SmithSolve September 2015 - Present
Zoetis (Formerly a Division of Pfizer, Inc.) 2011 - 2015
PDR Network, LLC 2010 - 2011
MannKind Corporation 2008 - 2010
Joslin Diabetes Center 2001 - 2007
Manning, Selvage & Lee Public Relations, subsidiary of Publicis 2001 - 2002
SoftWatch, Inc Pre-IPO Internet Start-Up 2000 - 2001
Pfizer Inc 1990 - 2000
Skills
Product Launch, Pharmaceutical Industry, Strategy, Marketing Strategy, Strategic Planning, Management, Cross-functional Team..., Biotechnology, Leadership, Marketing, Market Planning, Product Marketing, Digital Marketing, Business Development, Integrated Marketing, Direct Marketing, Budgets, Managed Care, Oncology, Business Alliances
Education
New York University - Leonard N. Stern School of Business 1989 — 1991
MBA Master of Business Administration
The George Washington University - School of Business 1983 — 1987
BBA Bachelor of Business Adminstration, Marketing
Ridgewood High School
Alexion Pharmaceuticals, Inc. September 2014 - Present
NSF International March 2013 - September 2014
NSF International June 2011 - March 2013
Charles River Laboratories April 2011 - June 2011
MannKind Corporation October 2010 - June 2011
Skills
UV, HPLC, USP, GLP, Gas Chromatography, Validation, Analytical Chemistry, TLC, Empower, Sop, Chromatography, FTIR, GMP, Biotechnology, LIMS, Life Sciences, Pharmaceutics, SOP, UV/Vis, Laboratory, Pharmaceutical Industry
Education
University of Florida 2012 — 2014
Master of Science (M.S.), Pharmaceutical Sciences
University of Hartford 2006 — 2010
Bachelor, Biochemistry
MedSource December 2013 - Present
MannKind Corporation December 2010 - October 2013
MannKind Corporation March 2007 - December 2010
MannKind Corporation March 2003 - March 2007
CTL ImmunoTherapies March 2000 - March 2003
Skills
FDA, Biotechnology, CRO, Sop, Pharmaceutical Industry, Immunology, Clinical Research, Clinical Development, IND, Lifesciences, CTMS, GLP, Validation, EDC, Clinical Trials, Drug Development, Medical Devices, Oncology, Infectious Diseases, GMP, Regulatory Affairs, Clinical Monitoring, GCP
Education
University of California, Los Angeles 1995 — 1997
BSc, Microbiology and Molecular Genetics
Novel Laboratories, Inc. 2013 - Present
Executive Committee, INTFG (Inhalation and Nasal Technology Focus Group of AAPS) November 2013 - Present
MicroDose Therapeutx (Teva) 2008 - 2012
MicroDose Technologies 2008 - 2009
MannKind Corporation 2007 - 2008
Battelle Memorial Institute 2001 - 2006
Skills
HPLC, GLP, Analytical Chemistry, GMP, Validation, Pharmaceutical Industry, Formulation, Gas Chromatography, R&D, Drug Delivery, UV/Vis, Pharmaceutics, Lifesciences, Product Development, Design of Experiments, Chemistry, Biotechnology, Research, Science, CRO, Purification, Chromatography, Data Analysis, Clinical Development, Biopharmaceuticals, Sop, Assay Development, Spectroscopy, Characterization, Medical Devices, LC-MS, Protein Chemistry, FDA, Change Control, Laboratory, Biochemistry, Vaccines, Drug Development, cGMP, Formulation Development, Pharmaceutical..., Process Development, Manufacturing, Pharmaceutical Research, NDA and ANDA, Nasal Sprays, Dry Powder Inhalation..., Management, ANDA, Life Sciences
Education
Wayne State University 1994 — 2000
Ph.D., Analytical Chemistry
University of Peradeniya 1985 — 1993
B.Sc. (Hons.), Chemistry (major), Physics (minor)
Royal College 1978 — 1985
G.C.E. (A/L), Mathematics
Self Employed 2014 - Present
FCS Laboratory LLC 2014 - 2014
sABER Bioscience 2013 - 2013
Dendreon Corporation 2009 - 2012
MDS Pharma Services 2004 - 2009
MannKind Corporation 2002 - 2004
Skills
Assay Development, Drug Discovery, ELISA, Biotechnology, High Throughput..., Immunology, GLP, Immunoassays, Management, Antibodies, Analytical Methods..., Drug Development, Molecular Biology, Flow Cytometry, Tissue Culture, Cell Biology, Sop, Technology Transfer, Biochemistry, Method Transfer, Cross-functional Team..., Laboratory Automation, Oncology, Compound Screening, Luminex, Protein Purification, Product Development, Cell Signaling, Quality Control, PBMC isolation, Project Management, Clinical Research, Biologics, Cell Therapy, Mechanism Of Action..., Hybridoma, Cellular Assays, Protein Expression, ICH guidelines, Receptors, Pre-clinical Studies, Cancer Cell Biology, Talent Management, Team-oriented, Process Improvement, Process Efficiency, Transcriptional..., Enzyme Assays, Binding Assays, Cytotoxicity
Education
University of California, Los Angeles 1993 — 2001
PhD, Microbiology and Molecular Genetics
University of California, Santa Barbara 1989 — 1993
B. A. with Distinction, Microbiology
ProPharma Group March 2015 - Present
LabAnswer July 2014 - January 2015
iTrend November 2012 - November 2014
QPharma, Inc. November 2013 - February 2014
Prime Technologies June 2013 - October 2013
Regeneron Pharmaceuticals August 2011 - May 2013
Mannkind Corporation June 2006 - April 2011
Breachway Solutions 2004 - 2006
Purdue Pharma 1999 - 2004
Copley Pharmaceutical January 1994 - November 1999
Skills
Validation, 21 CFR Part 11, Pharmaceutical Industry, Computer System..., FDA, Change Control, Sop, GMP, Quality Assurance, GxP, LIMS, Process Improvement, Cross-functional Team..., GLP, CAPA, Business Analysis, MS Project, V&V, Project Management, R&D, Clinical Trials, Quality System, Biopharmaceuticals, Biotechnology, CRO, Software Documentation, Start-ups, Quality Control, Drug Discovery, Regulatory Submissions, Drug Development, Pharmaceutics, Technology Transfer, Lifesciences, Regulatory Affairs, EDC, CTMS, Clinical Development, GCP, Process Simulation, Regulatory Requirements, Data Management, Medical Devices, Clinical Data Management, Pharmacovigilance, Oncology, SOP
Education
Syracuse University
Bachelor's degree
Villanova University 2010 — 2010
Certificate, Six Sigma Certified
Pacific Mesothelioma Center at PHLBI 2012 - Present
MannKind Corporation 2006 - 2011
University of Southern California 2001 - 2006
Education
University of Southern California
PhD, Immunology
Leaders in Pharmaceuticals Manufacturing Supply Chain in the Greater New York City Area 2012 - Present
Edward J Oestreicher LLC 2010 - Present
International Partnership for Microbicides 2009 - 2010
MannKind Corporation 2008 - 2009
Pfizer 1995 - 2007
Ohmeda Pharmaceuticals 1992 - 1995
Bausch & Lomb Pharmaceuticals 1989 - 1992
Skills
Process Improvement, Compliance, Acquisition Integration, Manage Complex Projects, Problem Solving, Project Management, Cost Management, Cross-functional Team..., Contract Manufacturing, Financial Risk, Innovation, Kaizen, Leadership, Lifesciences, Key Performance..., Negotiation, Non-profits, New Business Development, Outsourcing, Quality Management, Renovation, Restructuring, Strategic Planning, Customer Service, Yield Management, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Project 10, Plant Management, People Development, Performance Management, Project Planning, New Product Roll Out, Training, Personnel Development, Mentoring, Coaching Staff, Capital Budgeting, Managing Multi-Million..., Vendor Management, Purchasing, Supply Chain Management, Logistics, S&OP implementation, Regulatory Requirements, FDA GMP, EMEA, EPA, OSHA
Education
Thomas More College
BA, Biology, Chemistry
University of Cincinnati
MS, Microbiology/Chemistry/Engineering
The Macerich Company 2008 - Present
Alexander's For Hair 2010 - 2015
The Women's Foundation of California 2006 - 2011
MannKind Corporation 2007 - 2008
Deloitte & Touche 1994 - 2007
Skills
CPA, SEC filings, Sarbanes-Oxley Act, Financial Reporting, Accounting, Auditing, Due Diligence, Financial Analysis, Mergers, Budgets, Strategic Planning, Process Improvement, Forecasting, Managerial Finance, Financial Modeling, IT Audit, Internal Controls, Business Strategy, Project Management, Management Consulting, Financial Statements, Finance, Strategic Financial..., Executive Management, Mergers & Acquisitions
Education
University of California, Los Angeles - The Anderson School of Management 1999 — 2002
Master of Business Administration (MBA), Business Administration, Management and Operations
University of Southern California 1991 — 1994
Bachelor of Science (BS), Accounting
Biodel Inc. December 2014 - Present
Biodel Inc. August 2012 - December 2014
Biodel Inc. July 2010 - September 2012
Bedford Particle Technology July 2009 - July 2010
MannKind Corporation December 1991 - July 2009
Skills
Technology Transfer, Pharmaceutical Industry, Biotechnology, GLP, V&V, Drug Delivery, Validation, Pharmaceutics, Formulation, Chemistry, GMP, Biopharmaceuticals, HPLC, FDA, Sop, Laboratory, Clinical Development, Protein Chemistry, Aseptic Processing, Analytical Chemistry, Regulatory Affairs, Bioanalysis, CMC, Assay Development, CRO, Immunology, Pharmacokinetics, Clinical Trials, Pharmaceutical Research, LC-MS, ELISA, Drug Development, USP, Vaccines, UV/Vis, Chromatography, Lifesciences, Drug Discovery, IND, 21 CFR Part 11, Regulatory Submissions, Cleaning Validation, Purification, Regulatory Requirements, LIMS, GxP, CAPA, GCP, Toxicology, Computer System...
Education
State University of New York at New Paltz
B.S., Biology
Cooley LLP July 2015 - Present
UC San Diego Extension May 2014 - Present
AccuDx Corporation July 2008 - July 2015
Baker Donelson November 2008 - June 2013
Initio Fuels May 2011 - May 2013
PetroAlgae July 2008 - May 2011
XLTech Group October 2005 - July 2008
MannKind Corporation September 2004 - October 2005
LabCorp 1996 - 1997
Skills
Registered Patent Agent, Series 79 Registered..., Patents, Registered Patent..., Technology Transfer, Patent Prosecution, Intellectual Property, R&D, Analysis, Patentability, Biotechnology, Prosecution, Strategic Planning, Molecular Biology, Licensing, Strategy, Due Diligence, Lifesciences, Trade Secrets, Patent Applications, Trademarks, Life Sciences
Education
University of California, Los Angeles 1997 — 2004
PhD, Microbiology, Immunology, & Molecular Genetics
University of California, San Diego 1993 — 1997
BSc, Animal Physiology/Neuroscience
inVentiv Health July 2013 - Present
The Medicines Company May 2009 - June 2013
MannKind Corporation July 2008 - May 2009
Nycomed August 2007 - June 2008
Altana Pharma October 2005 - August 2007
Skills
Medical Affairs, Clinical Trials, Biotechnology, Clinical Development, Pharmaceutical Industry, Drug Development, Regulatory Affairs, Medical Writing, Clinical Research, GCP, CTMS, CRO, Pharmacovigilance, Oncology, Regulatory Submissions, ICH-GCP
Education
MannKind Corporation February 2014 - Present
Boehringer Ingelheim August 1998 - August 2013
Skills
HPLC, Biotechnology, Pharmaceutical Industry, GLP, GMP, Validation, FDA, Sop, Drug Discovery, Clinical Development
Education
University of New Haven 2006 — 2007
Tocagen Inc June 2008 - Present
Mannkind Corporation June 2002 - October 2007
AgraQuest, Inc. November 2000 - June 2002
CytoCulture October 1999 - June 2000
Lawrence Livermore National Laboratory September 1993 - September 1999
Skills
Fermentation, Cell Culture, Cell, Purification, Protein Chemistry, GMP, Biotechnology, Assay Development, GLP, Mammalian Cell Culture, Microbiology, Laboratory
Education
University of California, Davis 1986 — 1991
Ph.D., Microbiology (Specialty in Biochemical Engineering)
Sara Dorfman Smith, LLC March 2007 - Present
Otsuka Pharmaceutical Development & Commercialization September 2004 - March 2007
3M Pharmaceuticals June 2003 - April 2004
MannKind Corporation July 2001 - February 2003
Genentech 1998 - 2001
Skills
GMP, Validation, Biotechnology, Sop, Quality Management, Quality Assurance, CAPA, Biopharmaceuticals, Clinical Development, GLP, Clinical Trials, GxP, Pharmaceutical Industry, FDA, Quality Auditing, Quality Control, Laboratory, Life Sciences, Management, CRO, GCP, GDP, Pharmaceutical, Regulatory
Education
University of California, Davis 1993 — 1998
Henry M Gunn High School 1989 — 1993
Novartis July 2012 - Present
Alkermes September 2011 - June 2012
MannKind Corporation July 2007 - September 2010
University of Florida August 2004 - May 2006
Boehringer Ingelheim March 1997 - July 2004
Skills
Pharmacokinetics, Drug Development, Clinical Development, Drug Discovery, Oncology, In Vivo, Pharmaceutical Industry, Clinical Pharmacology, Pharmaceutics, Clinical Trials, CRO, Sop, Pharmacology, Regulatory Submissions, GCP
Education
University of Florida 2004 — 2009
Ph.D., Pharmaceutical Sciences
Conceptual Analytics Biotech Services, LLC 2013 - Present
MannKind Corporation 2006 - 2011
Armstrong Pharmaceuticals 2002 - 2005
IVAX Corporation 1994 - 2002
Skills
GMP, USP, Sop, FDA, Validation, HPLC, CAPA, UV, GLP, 21 CFR Part 11, Technology Transfer, Pharmaceutical Industry, LIMS, Dissolution, Analytical Chemistry, Formulation, Drug Delivery, Generic Programming, CMC, Chromatography, Inhalation, Change Control, R&D, Cleaning Validation, V&V, Regulatory Submissions, Drug Development, GxP, Computer System..., IND, Biopharmaceuticals, SOP
Education
ICAM
University of Miami
Master's degree and Ph.D. Candidate
MannKind Corporation Sr DirectorEmisphere Technologies1998 - 2006
Education
The Ohio State University 1980 — 1982
Post Doc, Chemistry
Texas A&M University 1976 — 1978
PhD, Chemistry
Amgen 2015 - Present
Amgen February 2006 - December 2014
Corus Pharma (acquired by Gilead) 2003 - 2006
MannKind Corporation 2000 - 2003
Skills
Regulatory Submissions, Clinical Development, Drug Development, Medical Affairs, Clinical Trials, Biotechnology, Oncology, Market Access, Pharmaceutical Industry, Immunology, Infectious Diseases, Pharmacovigilance, Clinical Research, Biopharmaceuticals, IND, Drug Discovery, GCP, Hematology, Health Economics, Medicine, Therapeutic Areas, Medical Writing, CTMS, Nephrology, CRO, Biomarkers, Rheumatology, Cancer, Clinical Study Design
Education
University of Southern California 1992 — 1997
Doctor of Medicine (M.D.), Medicine (MD), Epidemiology (PhD)
University of California, Los Angeles 1983 — 1988
B.S., Cybernetics
Mylan November 2014 - Present
MannKind Corporation March 2008 - October 2014
Novo Nordisk November 2006 - March 2008
Nektar Therapeutics 2000 - 2006
Genentech September 1996 - December 2000
West Pharmaceutical Services 1995 - 1996
STV January 1992 - 1995
Skills
Business Strategy, Business Innovation, Employee Engagement, Technology Transfer, Validation, FDA, Process Simulation, Pharmaceutics, GMP, CAPA, V&V, Manufacturing, Pharmaceutical Industry, Aseptic Processing, Biotechnology, 21 CFR Part 11, Change Control, Cleaning Validation, GxP, Process Engineering, Pharmaceutical..., Cross-functional Team..., Design Control, Combination Products, Dry Powder Inhalers, SOP, cGMP, Pharmaceuticals, Process Development
Education
UNC Kenan-Flagler Business School 2012 — 2014
Master of Business Administration (M.B.A.)
University of Pennsylvania
BS, Mechanical Engineering
MannKind Corporation December 2006 - February 2010
Pfizer, Inc. July 2004 - December 2006
Boehringer-Ingelheim Pharmaceuticals, Inc. January 1999 - June 2004
Skills
GLP, Sop, Technology Transfer, 21 CFR Part 11, Biotechnology, Analytical Chemistry, LIMS, Pharmaceutical Industry, Drug Development, Validation, CAPA, FDA, GMP, V&V, HPLC
Education
University of Kansas 1992 — 1997
MS, Chemical Engineering
University of Notre Dame 1984 — 1988
BS, Chemical Engineering
MannKind Corporation June 2005 - September 2015
Kendro Laboratory Products May 1995 - November 2003
Dupont Co. 1979 - 1995
Skills
Medical Devices, Validation, Engineering, cGMP, Injection Molding, Device Quality, GMP, 21 CFR Part 11, CAPA, Manufacturing, V&V, FDA, Quality System, Continuous Improvement, Cross-functional Team..., Product Development, Quality Assurance, R&D, Quality Management, Lean Manufacturing, Quality Control, Design Control, ISO, ISO 13485, Risk Assessment, Process Improvement, Change Control, Process Simulation, Design of Experiments, Engineering Management, Technology Transfer, Sop, GxP, Process Engineering, Six Sigma
Education
University of Bridgeport 1975 — 1979
B.S.BioMedical Engineering
MannKind Corporation Director QABayer HealthCareOctober 1989 - August 2004
Bayer Corporation 1989 - 2004
Bayer Health Care 1989 - 1995
Skills
Validation, GxP, Cleaning Validation, Chromatography, Biotechnology, Pharmaceutical Industry, LIMS, GLP, Quality Assurance, Quality Control, CAPA, 21 CFR Part 11, Analytical Chemistry, ISO, Aseptic Processing, GMP, Change Control, UV, Quality System, V&V, Regulatory Submissions, USP, HPLC, Quality Management, Computer System..., Technology Transfer, Quality Auditing, FDA, Regulatory Affairs, Sop, Biopharmaceuticals, GCP, Trackwise
Education
University of New Hampshire 1983 — 1989
PhD, Analytical Chemistry
Covidien April 2013 - Present
Covidien January 2012 - April 2013
MannKind Corporation March 2005 - April 2011
Skills
Pharmaceutical Industry, Medical Devices, Sop, Chromatography, FDA, HPLC, GMP, 21 CFR Part 11, Manufacturing, Software Documentation, GLP, Analytical Chemistry, Gas Chromatography, Chemstation, Clinical Development, Quality Control, LIMS, Protein Chemistry, Pharmaceutics, USP, CAPA, IND, Clinical Trials, Biotechnology, Laboratory, Regulatory Submissions, Validation, Testing, V, Quality Assurance, GxP, Empower, Change Control
Education
University of Connecticut 2000 — 2004
PerkinElmer, Inc. April 2015 - Present
Covidien May 2013 - March 2015
Superior Plating March 2012 - May 2013
MannKind Corporation September 2006 - April 2011
Alexion Pharmaceuticals March 2005 - September 2006
Bayer Corporation April 1997 - January 2005
Skills
GMP, FDA, Documentation, Process Improvement, SAP, cGMP, Excel, Microsoft Office, Word, Inventory Management, Compliance, PowerPoint, Scheduling, Outlook, Pharmaceuticals, Customer Service, 21 CFR Part 11, SOP, Calibration, GLP, Database Administration, Contract Management, Administrative Support, Coordination, Sop, Document Review, Pharmaceutical Industry, Software Documentation, Microsoft Excel, Process Scheduler, Microsoft Word, Administrative..., V&V, Validation, CAPA, GxP, Cleaning Validation, Change Control, UV, Quality Control, Manufacturing, Chromatography, Analytical Chemistry, HPLC, Trackwise, Quality Assurance, Biopharmaceuticals, USP, Regulatory Submissions, Biotechnology
Education
University of Phoenix
BS, Business Manangement
Schocken Consulting July 2013 - Present
Shire HGT July 2009 - July 2013
MannKind Corporation March 2005 - June 2009
Purdue Pharma 2001 - 2005
Oread, Inc., April 1998 - June 2000
Oread, Inc January 1997 - April 1998
Springborn Laboratories, Inc., March 1992 - January 1997
Springborn Laboratories, Inc. June 1989 - March 1992
Skills
21 CFR Part 11, Sop, GMP, CAPA, FDA, Validation, Pharmaceutical Industry, Computer System..., Change Control, Quality System, GxP, GLP, Biotechnology, Quality Assurance, Regulatory Submissions, GCP, Medical Devices, Biopharmaceuticals, Quality Auditing, HPLC, Regulatory Requirements, Analytical Chemistry, Clinical Trials, CRO, Clinical Development, ISO
Education
University of Massachusetts Boston 2007 — 2016
MEd, Instructional Design
The University of Connecticut 2000 — 2006
Bachelor's degree, Health & Science
Ultragenyx Pharmaceutical Inc. August 2015 - Present
Amgen Inc. July 2004 - August 2015
Kendle International September 2003 - July 2004
MannKind Corporation June 2002 - September 2003
Skills
Medical Writing, Oncology, Clinical Development, Biotechnology, Immunology, HTA, Dossiers, Medical Communications, Publications, Value Propositions, Rheumatology, Metabolic Bone Disease, Healthcare Reimbursement, Clinical Trials, Regulatory Affairs, Medical Affairs, Pharmaceutical Industry, Drug Development
Education
University of California, Los Angeles
Doctor of Philosophy (PhD), Molecular Biology
University of California, Los Angeles
Bachelor of Science (BS), Biology, General
Bristol-Myers Squibb September 2007 - Present
MannKind Corporation 2002 - 2007
MicroMet (formerly CancerVax, formerly Cell Matrix) May 2000 - June 2002
Massachusetts Department of Public Health May 1998 - April 2000
Skills
Drug Discovery, Biotechnology, Molecular Biology, Cell Culture, Immunology, ELISA, Western Blotting, PCR, Assay Development, Protein Expression, In Vitro, SDS-PAGE, High Throughput..., Immunoassays, Flow Cytometry, Transfection, Protein Chemistry
Education
University of Rochester 1994 — 1998
Microbiology & Immunology
MannKind Corporation 2011 - Present
MannKind Corporation April 2009 - Present
MannKind Corporation December 2006 - March 2009
Skills
Clinical Trials, Pharmaceutical Industry, Clinical Development, Biotechnology, CRO, CTMS, GCP, EDC, SOP
Education
Dorothy Snyder School of Nursing
Union County College
MannKind Corporation August 2007 - Present
Cytec Industries Inc. 1987 - 2007
Cytec Industries formerly American Cyanamid 1986 - 2007
Skills
R&D, Six Sigma, Manufacturing, Technology Transfer, Process Development, GMP, Process Improvement, cGMP, Chemical Engineering, Process Engineering, Problem Solving, Team Building, Design of Experiments, FDA, Strategic Planning, Engineering, Team Leadership, Program Management, Pharmaceuticals, Excel, Chemicals, Plastics, Business Strategy, Validation, Budgeting, Microsoft Office, Cross-functional Team..., Process Optimization, Troubleshooting, Operations Management, Data Analysis, Process Validation, Root Cause Analysis, Continuous Improvement, Polymers, Product Development, CAPA, Quality Assurance, Supply Chain, Process Simulation, Pharmaceutical Industry, V&V, Chemistry, Change Control, Sop
Education
The University of Connecticut School of Business 1991 — 1995
MBA, Operations Management
Tufts University 1983 — 1987
BSChE, Chemical Engineering
Alexion Pharmaceuticals, Inc. March 2015 - Present
Acorda Therapeutics, Inc. October 2012 - March 2015
MannKind Corporation March 2010 - September 2012
MannKind Corporation May 2005 - March 2010
Progenics Pharmaceuticals 2003 - 2005
Skills
CAPA, GLP, cGMP, GMP, GCP, ISO, Supplier Quality
Education
St. Joseph College 2005 — 2008
MS, Biology
SUNY Oneonta 1999 — 2003
BS, Biology and Chemistry
MannKind Corporation January 2012 - Present
Pfizer Inc. December 2000 - December 2010
AstraZeneca 1986 - 2000
Education
University of Maryland College Park 1974 — 1977
MS, Chemistry
Worcester Polytechnic Institute 1970 — 1974
BS, Chemistry
Catalent Pharma Solutions September 2014 - Present
Catalent Pharma Solutions March 2012 - Present
Catalent Pharma Solutions April 2011 - March 2012
MannKind Corporation June 2006 - February 2011
Watson Pharmaceuticals 2005 - 2006
Dur-A-Flex, Inc. May 2002 - February 2005
Skills
Sop, LIMS, R&D, Technology Transfer, Biotechnology, GMP, Drug Development, Cell, GLP, Clinical Development, HPLC, Cross-functional Team..., Pharmaceutical Industry, Validation, V&V, Regulatory Affairs, Analytical Chemistry, Lifesciences, Clinical Trials, FDA, FTIR, Project Management, Drug Discovery, Program Management, CRO, Chromatography, Biopharmaceuticals, Pharmaceutics, Regulatory Submissions
Education
University of New Haven 1999 — 2009
BS, EMBA, Chemistry, Biology, Executive Masters in Business Administration
University of Tennessee-Health Science Center 2008 — 2008
Graduate Certificate, Aseptic Technique and Parenterals Medications for Experimental Pharmacology
Yale University School of Medicine 2000 — 2002
Oncology
Pfizer September 2014 - Present
MannKind Corporation July 2004 - September 2014
Agensys 1999 - 2004
Incyte Pharmaceuticals 1998 - 1999
Skills
Immunology, Cell Biology, Drug Discovery, Pre-clinical Studies, Biochemistry, Oncology R&D, Molecular Biology, Cell, Oncology, Protein Chemistry, Biotechnology, Signal Transduction, Assay Development, In Vitro, In Vivo, Antibodies, Pharmaceutical Industry, Drug Development, Clinical Development
Education
University of California, Los Angeles 1994 — 1998
Post doctoral, Oncology and Immunology
University of Virginia 1991 — 1994
Post Doctoral Fellowship, Cellular and Molecular Immunology
MannKind Corporation September 2006 - Present
Boehringer Ingelheim Pharmaceuticals September 1982 - September 2006
Skills
GMP, Contract Manufacturing, Packaging Engineering, Cross-functional Team..., Packaging, CAPA, Medical Devices, Sop, Pharmaceutical Industry, Analytical Chemistry, Continuous Improvement, FDA, Change Control, R&D, Validation, Regulatory Submissions, Technology Transfer, 21 CFR Part 11, Manufacturing, Product Development, Biotechnology, Process Improvement, Pharmaceutics, Regulatory Affairs, ISO, Quality System, Lifesciences, Supply Chain, Commercialization, ISO 13485
Education
University of Connecticut 1978 — 1982
BSE, Mechanical/Materials Engineering
PerkinElmer May 2009 - Present
MannKind Corporation August 2005 - May 2009
Biomatic Inc. August 2002 - August 2005
Bayer HealthCare 1999 - 2002
SRI International 1992 - 1999
Skills
GMP, Validation, Sop, GLP, 21 CFR Part 11, CAPA, HPLC, GxP, FDA, USP, Biotechnology, Gas Chromatography, Pharmaceutical Industry, V&V, LIMS, Chromatography, Change Control, Quality System, Technology Transfer, UV/Vis, Lifesciences, Analytical Chemistry, Chemistry, Biopharmaceuticals, UV, Cleaning Validation, Calibration, Quality Control, Laboratory, SOP
Education
University of California, Santa Cruz 1987 — 1991
BA, Biology
MannKind Corporation June 2008 - Present
Watson Pharmaceuticals April 1998 - June 2008
Education
University of Missouri-Rolla 1996 — 1998
Master of Science, Analytical Chemistry
Shire Pharmaceuticals January 2014 - Present
Choice Project Management, LLC December 2012 - Present
Johnson & Johnson December 2012 - December 2013
Validant March 2011 - December 2012
MannKind Corporation January 2008 - April 2011
MannKind Corporation January 2008 - February 2011
Bristol-Myers Squibb April 1993 - December 2007
UTC Carrier Air Conditioning Corporation December 1986 - February 1992
Skills
GMP Compliance, Project Controls, Code Compliance, Analytics, Process Improvement, Project Management, Strategic Planning, MS Project, Primavera P6, AutoCAD, DDC & HVAC Systems, Energy Management, SharePoint, GMP, Microsoft Office, Green Belt, PMP, Contract Management, Program Management, Quality Control, Quality Assurance, Project Control, Management, Manufacturing, Validation, Microsoft Project, 21 CFR Part 11, Six Sigma, Project Planning, Cross-functional Team..., Sop, FDA, HVAC, Software Documentation, Microsoft Excel, Analysis, Leadership, Engineering, Business Process..., Biotechnology, Code Enforcement, Technology Transfer
Education
University of Hartford 1998 — 2000
MSEE, Graduate Study
University of Connecticut 1980 — 1985
BSEE, Electrical Engineering / Computer Science
R Edward Branson Associates LLC August 2010 - Present
R. E. Branson 2009 - Present
Wake Forest Institute for Regenerative Medicine September 2011 - May 2013
Intercell USA 2010 - December 2010
MannKind Corporation 2006 - 2009
Biolex 2001 - 2006
Covance April 1999 - November 2000
R. Edward Branson Associates 1997 - 1999
Cephalon, Inc 1993 - 1996
Bio-Response, Inc 1987 - 1990
Skills
Organizational..., Biopharmaceuticals, cGMP, Technology Transfer, GMP, Operations Management, Manufacturing, FDA, Process Improvement, Process Validation, Team Building, Change Management, Start-ups, Commissioning, Biotechnology, SOP, Process Development, Auditing, Strategic Planning, GLP, Budgeting, Cross-functional Team..., Medical Devices, Problem Solving, Cell Culture, Team Leadership, Documentation, Process Optimization, CMC, GTP, V&V, Project Management, FDA GMP, Sop, Software Documentation, Pharmaceutical Industry, Regulatory Affairs, Quality System, CAPA, Quality Assurance, Change Control, 21 CFR Part 11, Lifesciences, R&D, Clinical Trials, GxP, Quality Control, Life Sciences
Education
University of North Carolina at Chapel Hill
PhD Biochemistry, Protein structure
MannKind Corporation May 2012 - Present
Johnson Matthey 2010 - 2012
Education
University of Tennessee-Knoxville 1993 — 1997
PhD
Tsinghua University
Bachelor's degree
Astellas Pharma April 2011 - Present
Agensys April 2011 - Present
BN Immunotherapeutics June 2008 - March 2011
Mannkind Corporation 2003 - 2008
Skills
ELISA, Immunology, Cell Biology, Assay Development, Molecular Biology, Cell, Flow Cytometry, Cell Culture, Western Blotting, Drug Discovery, GLP
Education
University of California, San Diego
B.S., Biology: Biochemistry and Cell Biology
Joseph E. Brooks & Associates January 2012 - September 2012
MannKind Corporation September 2004 - April 2009
Seavest Inc. October 2002 - July 2004
Montanari Construction July 2001 - August 2002
Gullans & Brooks Associates, Inc. November 1999 - June 2001
Tradition Financial Services March 1997 - November 1999
Phibro USA July 1994 - March 1997
Hill Petroleum May 1986 - August 1989
Seligman & Latz, Inc. September 1981 - March 1985
Skills
Outlook, Budgets, Travel Arrangements, Heavy Calendaring, Executive Level..., Project Planning, Microsoft Office, C-Level Executive..., Bill Reconciliation, Creative Events, Venue Search, Launch Parties, Recruiting, Travel Planning, Special Events..., Meeting Coordination &..., Recruiting Coordination, Facebook, Pinterest, Instagram, LinkedIn, Research, Customer Oriented, Multi Tasking, High Level Of..., Intuitive
Education
University of Arizona 1974 — 1977
Special Education/Nutrition
MannKind Corporation December 2007 - Present
ALZA Corporation 2005 - 2007
GPSG (J&J) 2005 - 2007
Johnson & Johnson (Alza) 2004 - 2007
Skills
Validation, GMP, CAPA, FDA, Change Control, Sop, Technology Transfer, 21 CFR Part 11, Pharmaceutical Industry, V&V, Medical Devices, Computer System..., Cleaning Validation, Quality System, Design of Experiments
Education
The University of Connecticut School of Business 2012 — 2014
MBA Candidate 2014
University of California, Irvine 1995 — 1998
B.S., Chemical Engineering
Connolly LLC January 2015 - Present
Frette INC. March 2014 - January 2015
Gain Capital October 2012 - March 2014
New York City Economic Development Corporation October 2009 - October 2012
NYCEDC October 2009 - October 2010
Independent Consultant June 2009 - September 2009
Mannkind Corporation December 2006 - May 2009
Consultant December 2006 - May 2009
NYFIX February 2004 - December 2006
Skills
ERP, Sarbanes-Oxley Act, Microsoft SQL Server, Great Plains Software, Accounting, Crystal Reports, SQL, Project Management, Software Documentation, Business Analysis, Microsoft Dynamics, Management, Project Planning, Analysis, Databases, Testing, Financial Reporting
Education
University of Massachusetts, Amherst
AS, Business Management
Western Connecticut State University
BA, Physics
Pharma Job January 2015 - Present
Novartis July 2010 - September 2014
MannKind Corporation December 2007 - July 2010
The Endocrine Society 2004 - 2007
Novo Nordisk A/S 2003 - 2007
Children's Mercy Hospital 1990 - 2003
Skills
Clinical Research, Diabetes, Endocrinology, Pediatrics, Medical Devices, Clinical Development, Clinical Trials, Drug Development, Continuous Glucose..., Medical Writing, Pharmaceutical Industry, Biotechnology, Oncology, Insulin Pumps, Medical Affairs, FDA, Medicine, GCP, Pharmacovigilance, CTMS, Infectious Diseases, Therapeutic Areas, Critical Care, CRO, Internal Medicine, Neurology, Cardiology, Nephrology, Dermatology, Regulatory Submissions
Education
University of Oklahoma College of Medicine 1969 — 1974
MD, Medicine
Thomas Jefferson School 1960 — 1964
High School diploma
MannKind Corporation April 2001 - Present
MannKind Corporation 2001 - 2010
Diagnostic Products Corporation September 1991 - April 2001
DPC 1991 - 2001
Skills
Drug Discovery, Drug Development, Purification, HPLC, Peptide Synthesis, LC-MS, GLP, Chromatography, Characterization, Assay Development, Peptides, Drug Delivery, Protein Chemistry, Analytical Chemistry
Education
University of Rajasthan 1984 — 1989
M.S., Organic chemistry
None March 2009 - Present
Pharm-Olam International September 2007 - April 2009
MannKind Corporation 2005 - 2009
MannKind Corporation 2005 - 2006
Education
Universidad de Panamá 1978 — 1983
BS
MannKind Corporation April 2010 - Present
MannKind Corporation April 2004 - June 2010
Adhesives Research, Inc. 1996 - 2006
Education
University of Southern California 2000 — 2004
BS, Business
MannKind Corporation January 2011 - April 2015
Medarex March 2004 - December 2010
Skills
EDC, Clinical Data Management, GCP, Oncology, Clinical Trials, Protocol, Oracle Clinical, Clinical Development, Pharmaceutical Industry, Data Management, Diabetes, CRF design, 21 CFR Part 11, SOP, CRO, Rheumatoid Arthritis, Ulcerative Colitis, Immunotherapy, Project Management, Project Planning, Microsoft Project, Database Design, Database Administration, Time Management, Project Team Management
Education
University of Phoenix 2009 — 2011
Bachelor’s Degree in Science, Information Technology/Database Admnistration, GPA 3.56
University of Phoenix 2007 — 2009
Associate’s Degree in Science, Information Technology/Visual Communication, GPA 3.57
New Horizons Computer Learning Center 2010 — 2011
Certification, IT Systems Administrator
Baptist Medical Center July 2013 - Present
Florida Department of Law Enforcement January 2012 - July 2013
Florida Department of Health February 2010 - January 2012
University of Florida August 2007 - February 2010
MannKind Corporation 2006 - 2007
Skills
PCR, DNA, Molecular Biology, LIMS, Laboratory, Cell Culture, GLP, DNA extraction, Microbiology, Science, Lifesciences, Microscopy, Quality Control, Histology, GMP, Cell, Pharmaceutical Industry, Pathology, Protein Purification, RT-PCR, Medical Devices, Immunology, Immunohistochemistry, Forensic Analysis, Infectious Diseases, Laboratory Medicine, Life Sciences
Education
University of Florida 2007 — 2009
M.S., Pharmacy
University of Connecticut 2001 — 2006
B.S., Molecular & Cell Biology
MedImmune January 2011 - Present
ATCC August 2005 - January 2011
MannKind Corporation November 2001 - July 2005
City of Hope December 1998 - November 2001
Skills
Immunology, Cell based assays, Flow cytometry, Tissue culture, Hybridomas, Cell, In Vivo, Flow Cytometry, Immunoassays, Tissue Culture, Antibodies, GLP, ELISA, Assay Development, FACS, In Vitro, Vaccines
Education
Université de Montpellier 1993 — 1998
M.Sc, Immunology
Baxter International Inc. January 2015 - Present
Baxter International Inc. July 2012 - January 2015
PSC Biotech March 2012 - July 2012
PolyPeptide Laboratories June 2007 - March 2012
MannKind Corporation May 2004 - September 2004
Baxter Healthcare May 2003 - September 2003
Skills
Validation, GMP, Cleaning Validation, Process Validation, cGMP, CAPA, SOP, FDA, Change Control, Pharmaceuticals, Purification, R&D, Technology Transfer, 21 CFR Part 11, Calibration, Troubleshooting, Commissioning, Root Cause Analysis, V&V, Pharmaceutical Industry, GLP, Sop, Aseptic Processing
Education
University of California, Los Angeles 2001 — 2006
BS, Chemical Engineering
MannKind Corporation January 2007 - Present
New York Medical College September 1988 - Present
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Development, Oncology, Drug Development, Clinical Research, Diabetes, Biotechnology, Medical Affairs, Therapeutic Areas, CRO, Regulatory Submissions, Drug Discovery, Pharmaceutics, Immunology, Biostatistics, Drug Delivery, Medicine, Medical Writing, Vaccines, Pharmacology, Cancer, Infectious Diseases, Lifesciences, Clinical Study Design, Pharmacovigilance, Life Sciences, GCP
Education
The Maharaja Sayajirao University of Baroda 1975 — 1979
MD, DCH, Pediatircs, Pulmonology
Vubiquity (formerly Avail-TVN) June 2010 - Present
MannKind Corporation 2006 - 2008
Dick Clark Productions 2000 - 2006
S.L. Fusco, Inc. 1998 - 2000
Arthur Andersen, LLP 1993 - 1998
Education
University of California, Los Angeles
Bachelor of Arts
Biodel Inc. 2004 - Present
MannKind Corporation 2001 - 2003
Pharmaceutical Discovery Corp 1998 - 2001
Skills
Drug Development, Clinical Development, Technology Transfer, Biotechnology, Drug Delivery, Pharmaceutical Industry, Formulation, GLP, Validation, GMP, Clinical Trials, CRO, HPLC, V&V, Medical Devices, Biopharmaceuticals, Pharmaceutics, 21 CFR Part 11, Sop, FDA, Clinical Research, CMC, Regulatory Affairs
Education
University of Connecticut 1992 — 1998
PhD, Pharmaceutics
The University of Connecticut 1979 — 1983
Bachelor of Science (BS), Biology, General
Achillion Pharmaceuticals February 2011 - Present
Dogwood Pharmaceuticals October 2010 - December 2011
MannKind Corporation October 2002 - May 2008
Bayer Corporation 1995 - 2002
Skills
Quality Assurance, GMP, Clinical Development, HPLC, FDA, CAPA, Pharmaceutical Industry, Regulatory Affairs, GLP, 21 CFR Part 11, Validation, Computer System..., Change Control, Biopharmaceuticals, Biotechnology, GCP, Sop, Technology Transfer, Regulatory Submissions, V&V, GxP
Education
University of New Haven
Bachelor of Science (BS), Chemistry and Forensic Science
Bachem August 2014 - Present
Bachem February 2006 - Present
MannKind Corporation March 2003 - January 2006
CTL Immunotherapies January 2000 - March 2003
Skills
HPLC, Analytical Chemistry, Mass Spectrometry, Chromatography, GMP, GLP, LC-MS, Purification, Validation, R, Research, Sop, Peptide Synthesis, Assay Development, Oncology, Quality Assurance, Chemistry, Biotechnology, Organic Chemistry, Pharmaceutical Industry, Protein Chemistry, Drug Discovery
Education
University of California, Santa Barbara
Catalent Pharma Solutions June 2012 - Present
Catalent Pharma Solutions April 2011 - June 2012
MannKind Corporation April 2005 - April 2011
AAIPharma Services Corp. December 1996 - March 2005
Oneida Research Services June 1994 - November 1996
Skills
Chemistry, GMP, CRO, GLP, Pharmaceutical Industry, LIMS, Technology Transfer, Sop, HPLC, Cross-functional Team..., Formulation, Drug Development, FDA, Lifesciences, Biotechnology, 21 CFR Part 11, Validation, Analytical Chemistry, Clinical Development, R&D, Pharmaceutics, CAPA, Chromatography, Regulatory Affairs, Biopharmaceuticals, Regulatory Submissions, V&V, GxP, Change Control, Computer System..., Clinical Trials, Drug Discovery, Quality System, SOP, Life Sciences
Education
East Carolina University - College of Business 2011 — 2014
MBA
University of New Haven 2010 — 2011
MBA
University of North Carolina at Wilmington 1998 — 2001
MS, Chemistry
State University of New York College at Oneonta 1991 — 1994
BA, Chemistry
Utica College 1990 — 1991
Chemistry
Alexion Pharmaceuticals, Inc. January 2015 - Present
Alexion Pharmaceuticals, Inc. July 2012 - December 2014
Alexion Pharmaceuticals April 2011 - July 2012
MannKind Corporation September 2010 - February 2011
University of Connecticut September 2009 - May 2010
Skills
HPLC, GMP, USP, TLC, LC-MS, Chemstation, IR, UV/Vis, Empower, UV, Clinical Trials, Biotechnology, Pharmaceutical Industry, Pharmacology, Analytical Chemistry, SOP, Validation, Chromatography, FDA, 21 CFR Part 11, CAPA, LIMS, Technology Transfer, GLP, Chemistry, Gas Chromatography, Team Leadership, Biopharmaceuticals
Education
University of St. Joseph 2013 — 2017
Master of Science (M.S.), Biochemistry, Biophysics and Molecular Biology
University of Connecticut 2006 — 2010
B.S., Chemistry, Mathematics
ARYZTA LLC June 2011 - July 2012
MannKind Corporation March 2005 - February 2011
R.C Bigelow June 2004 - November 2004
Bayer Corporation December 1989 - December 2003
Bayer Corporation December 1984 - November 1989
Bayer Corporation January 1980 - December 1984
Skills
Sop
Education
Albertus Magnus College 2002 — 2004
Bachelor's Degree, Business
University of New Haven 1999 — 2001
Associate's Degree, Business
Covidien October 2011 - Present
MannKind Corporation January 2004 - February 2011
Bayer Pharmaceuticals September 1997 - December 2003
Bayer Pharmaceuticals December 1988 - September 1997
Skills
GMP, Sop, CAPA, FDA, 21 CFR Part 11, LIMS, Validation, Analytical Chemistry, HPLC, Pharmaceutical Industry, USP, Process Improvement, Software Documentation, V&V, Quality Auditing, GLP, Dissolution, Change Control, Quality System
Education
Southern Connecticut State University 1984 — 1988
Bachelor of Science, Education
South Central Comminity College 1983 — 1984
Education
Boehringer Ingelheim November 2014 - Present
Siemens Healthcare August 2008 - November 2014
MannKind Corporation December 2006 - August 2008
PepsiCo July 2006 - December 2006
D'Arcangelo & Co., LLP October 2005 - June 2006
Skills
Financial Reporting, Forecasting, Auditing, Variance Analysis, Mergers & Acquisitions
Education
State University of New York at New Paltz
MBA, Finance
MannKind Corporation April 2007 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Windows, Research, Teaching
Education
University of Bucharest
Biology/Biological Sciences, General
Western Connecticut State University
Master of Arts (MA), Biology and Environmental Sciences
KTR Consulting April 2009 - Present
MannKind Corporation 2002 - 2009
Cytovax Biotechnologies November 2000 - March 2002
Consortium for Plasma Science, LLC May 1999 - November 2000
Battelle Memorial Institute, Pharmaceutical and Biotechnology Group July 1996 - May 1999
Stanford University, Department of Medicine, Division of Infectious Diseases and Geographic Medicine June 1989 - July 1996
Stanford University, Department of Medicine, Division of Endocrinology and Metabolism June 1987 - June 1989
Skills
Biotechnology, Pharmaceutical Industry, Molecular Biology, Clinical Development, Biopharmaceuticals, Drug Discovery, Lifesciences, Clinical Trials, Regulatory Affairs, Medical Devices, R&D, Immunology, Clinical Research, Regulatory Submissions, Translational Medicine, Biomarkers, Drug Development, Technology Transfer, Medical Writing, Oncology
Education
University of California, Berkeley 1983 — 1987
Post-Doctoral Fellow, Molecular Genetics
University of Manitoba 1980 — 1983
Doctor of Philosophy (Ph.D.), Developmental and Molecular Biology
Max-Planck Institute for Experimental Medicine, Department of Molecular Biology, Göttingen, Germany 1980 — 1982
Ph.D. Student, Molecular and Developmental Biology
University of Manitoba 1977 — 1980
Master of Science (M.Sc.), Genetics
University of Manitoba 1973 — 1977
Bachelor of Science (B.Sc.), Zoology/Animal Biology
none September 2014 - Present
MannKind Corporation September 2014 - Present
Boehringer Ingelheim February 2006 - August 2014
Joule Technical January 1996 - February 2006
Skills
Have worked in the..., Maintenance, Construction, Process Improvement, Project Management, Team Building, GMP
Education
State University of New York at Delhi 1984 — 1986
Associate of Occupational Science Degree, Electrical Technology, 3.95 GPA
Somers NY High School 1984 1980 — 1984
Bristol-Myers Squibb January 2008 - Present
Bristol-Myers Squibb January 2008 - Present
Charles River Laboratories September 2005 - June 2007
MannKind Corporation December 2004 - June 2005
The Connecticut Agricultural Experiment Station May 2004 - November 2004
Skills
Pharmaceutical Industry, Biotechnology, Management, Microsoft Office, GMP, Life Sciences, Clinical Trials, Strategic Planning, Clinical Research, Oncology
Education
University of Connecticut 2002 — 2004
Bachelor of Science, Animal Sciences
University of Connecticut
Bachelor of Science (BS), Animal Sciences
Car Parts International BV December 2013 - Present
MannKind Corporation September 2003 - March 2011
Education
University of Phoenix 2006 — 2010
Business, Management, Marketing, and Related Support Services