POINT Biomedical Corporation
Industry: Company
DescriptionFounded: 1996
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POINT Biomedical Corporation Employees
Medterials, Inc March 2013 - Present
iScience Interventional 1999 - 2012
Vasconnect 1999 - 2000
POINT Biomedical Corporation 1996 - 1999
Ross Design Works 1994 - 1996
Modified Polymer Components 1992 - 1994
Vitaphore Corporation 1985 - 1991
American Heyer Schulte 1981 - 1983
University of California, Santa Barbara 1979 - 1981
Skills
Start-ups, Medical Devices, R&D, FDA, ISO 13485, Design Control, Product Development, Prototyping, Testing, Manufacturing Transfer, Animal Surgery, Catheters, Drug Delivery Devices, Implants, Surgical Instruments, Medical Imaging, Drug Delivery, Manufacturing, V&V, Capital Equipment, Cardiology, Ophthalmology, Clinical Trials, Surgery, Biomaterials, Lifesciences, Quality System, CAPA, ISO 14971, Life Sciences
Education
University of California, Santa Barbara 1976 — 1981
Bachelor of Science (BS), Physics
Somerville High School 1972 — 1976
Onyx Pharmaceuticals December 2009 - February 2014
Onyx Pharmaceuticals March 2008 - December 2009
Onyx Pharmaceuticals November 2004 - March 2008
Novacea, Inc. 2002 - 2004
Cellegy Pharmaceuticals May 2001 - December 2002
POINT Biomedical Corporation January 2000 - April 2001
Covance June 1997 - January 2000
Quintiles April 1995 - May 1997
Matrix Pharmaceuticals A/S December 1993 - September 1994
Skills
Oncology, Clinical Development, Clinical Trials, CTMS, CRO, Biotechnology, GCP, Pharmaceutical Industry, EDC, Infectious Diseases, Clinical Research, Lifesciences, Medical Writing, FDA, Drug Development, Sop, 21 CFR Part 11, Biopharmaceuticals, Cancer, Cardiology, Clinical Data Management, Clinical Monitoring, Clinical Operations
Education
Santa Clara University 1989 — 1993
BS, Biology
MYCO Consulting September 2010 - Present
Talima Therapeutics Inc July 2006 - September 2010
Hutchison MediPharma November 2003 - September 2005
Pain Therapeutics, Inc 2002 - 2003
POINT Biomedical Corporation 2001 - 2002
Penederm March 1997 - February 2001
SEQUUS Pharmaceutical July 1993 - February 1997
ABAXIS April 1992 - April 1993
Scios February 1988 - February 1992
G.D. Searle/Monsanto March 1984 - February 1988
Skills
Analytical Chemistry, Validation, IND, GMP, cGMP, HPLC, Pharmaceuticals, Biotechnology, FDA, GLP, Quality Systems, Chromatography, SOP, Regulatory Submissions, QC, Product Development, Quality Management, Leadership, Start-ups, Pharmaceutical Industry, Chemistry, Quality Control, Formulation, Clinical Trials, Clinical Development, Technology Transfer, Regulatory Requirements, Assay Development, Biopharmaceuticals, Pharmaceutics, Drug Discovery, Drug Development, Gas Chromatography, Regulatory Affairs, V&V, CAPA, Lifesciences, R&D, Method Development, Oncology, Process Simulation, Life Sciences, Quality System
Education
Penn State University 1973 — 1977
Ph.D., Analytical Chemistry
Wilkes University 1971 — 1973
MS, Physical Organic Chemistry
Fu Jen Catholic University 1966 — 1970
BS, Chemistry
Medterials, Inc. January 2014 - Present
iScience Interventional November 2001 - January 2014
POINT Biomedical Corporation July 1996 - September 1999
Vitaphore Corporation March 1985 - September 1993
Skills
Medical Devices, FDA, Clinical Trials, Ophthalmology, Design Control, ISO 13485, R&D, Regulatory Affairs, Clinical Development, Clinical Research, Medical Imaging, Validation, V&V, Surgery, Biomedical Engineering, Biomaterials, Product Development, Cardiology, Biotechnology, Start-ups, Product Launch, Quality Assurance, CAPA, Drug Delivery, Capital Equipment, Pharmaceutical Industry, Hospitals, Market Development, Medicine, Commercialization, GMP, Optics, Healthcare, Orthopedic, Technology Transfer, Quality System
Education
California Institute of Technology 1974 — 1978
Bachelor of Science (BSc), Chemical Engineering, Chemistry
Clemson 1978 — 1980
MS, Biomaterials Engineering, Biochemistry
University of Southern California 1980 — 1981
Postgraduate Studies, Biochemistry
Genentech 2004 - Present
SangStat 2001 - 2004
IntraBiotics 2000 - 2001
POINT Biomedical Corporation 1998 - 2000
Celtrix Pharmaceuticals 1994 - 1998
Somatogen 1992 - 1993
Skills
Regulatory Affairs, Clinical Trials, Regulatory Submissions, Clinical Development, FDA, Biotechnology, Global Strategy, Diagnostics, Drug Development, Biopharmaceuticals, Pharmaceutical Industry, Biologics, Cross-functional Team..., CAPA, GMP, 21 CFR Part 11, Quality Assurance, GxP, Life Sciences, Hardware Diagnostics, Change Control, Oncology
Education
Santa Clara University - Leavey School of Business 1999 — 2002
MBA, Business Administration and Management, General
Colorado State University 1988 — 1992
BS, Biology
Brookfield High School 1984 — 1988
Brookfield High School
ZONARE Medical Systems, Inc. January 2013 - Present
Zonare Medical Systems May 2010 - January 2013
Ascent Healthcare Solutions June 2009 - October 2009
POINT Biomedical Corporation October 2007 - June 2008
POINT Biomedical November 2003 - October 2007
POINT Biomedical Corporation January 2001 - November 2003
Mallinckrodt Inc August 1999 - November 2000
ATL Ultrasound June 1997 - March 1999
ATL Ultrasound May 1995 - June 1997
Education
University of Phoenix 2000 — 2003
BS, Business Admin/Marketing
University of South Carolina Upstate 1987 — 1989
AS, General Studies
Alacrity Medical, LLC September 2013 - Present
Practical PM Solutions February 2013 - Present
CIRTEC Medical Systems April 2007 - January 2013
POINT Biomedical Corporation March 1999 - April 2007
Microsome May 1989 - May 1997
Skills
Design Control, ISO 13485, Medical Devices, FDA, R&D, V&V, Design of Experiments, CAPA, Quality System, Project Management, Project Planning, MS Project, Earned Value Management, Critical Path Management, Microencapsulation, Leadership, Program Management, Product Design, Mentoring, Product Development, Cross-functional Team..., Start-ups
Education
Purdue University
Bachelor of Science (BS), Mechanical Engineering
University of Washington
Master's Degree, Mechanical Engineering
Point Biomedical Corporation 2006 - Present
Education
San Jose State University
Microbiology, Minor in Chemistry
Supernus Pharmaceuticals, Inc. December 2005 - Present
Shire Laboratories, Inc. January 2003 - December 2005
POINT Biomedical Corporation 2001 - 2003
ALZA Corporation 1996 - 2001
Skills
Executive Management, Drug Delivery, Product Development, Intellectual Property, Pipeline Development, R&D, Pharmaceutical Industry, Drug Development, Biotechnology, Regulatory Affairs, SOP, Validation, Biopharmaceuticals, FDA
Education
The University of Kansas
Ph.D., Pharmaceutical Chemistry
The University of Kansas
M.S., Pharmaceutical Chemistry
University of Mumbai
M.Pharm., Bombay College of Pharmacy
University of Mumbai
B.Pharm., Bombay College of Pharmacy
DTZ December 2013 - Present
MedImmune May 2008 - December 2013
Bayer November 2006 - May 2008
WorldHeart August 2005 - November 2006
POINT Biomedical Corporation August 2002 - July 2005
Centaur Pharmaceuticals May 1997 - March 2002
Skills
Project Management, CAPA, FDA, GMP, Validation, V&V, Quality System, Process Simulation, Biotechnology, Sop, Pharmaceutical Industry, Technology Transfer, Medical Devices, Change Control, R&D, GLP, Biopharmaceuticals, Chemical Engineering, Design of Experiments, Solidworks, SOP, Troubleshooting
Education
San Francisco State University 2015 — 2019
Certificate, Project Management
Sharif University of Technology
MS, Chemical Engineering
University of Applied Science and Technology
BS, Chemical Engineering
Aptuit December 2013 - Present
University of California, San Francisco December 2000 - Present
ICON Clinical Research December 2010 - November 2013
ICON Clinical Research April 2010 - November 2010
ICON Medical Imaging August 2007 - April 2010
John Radcliffe Hospital November 2004 - November 2009
POINT Biomedical Corporation December 2000 - August 2007
Skills
Drug Development, Clinical Research, Oncology, CRO, Cardiology, Pharmaceutical Industry, Biotechnology, FDA, Clinical Trials, GCP, Executive Management, Clinical Development, Medical Affairs, Strategy, Medicine, CTMS, Biopharmaceuticals, Venture Capital, Lifesciences, Infectious Diseases, Medical Education, Pharmacovigilance, Therapeutic Areas, Neuroscience, Cardiovascular Imaging, Life Sciences, Informatics, Drug Discovery, Pharmaceutics
Education
American Board of Internal Medicine 2013 — 2013
Board Certification Cardiovascular Diseass
Columbia University - Columbia Business School 2011 — 2012
Exec MBA, Business
University of California, Berkeley - Walter A. Haas School of Business 2011 — 2012
Exec MBA, Business
American Board Internal Medicine 2000 — 2000
ABIM, Internal Medicine
University of California, San Francisco - School of Medicine 2000 — 2000
Cardiology, Echocardiography
General Medical Council, UK 1989 — 1999
Certificate Completion Specialist Training (Boards), Cardiology
University of London 1993 — 1995
MD, Medicine, Cardiology
Royal College of Physicians 1992 — 1992
FRCP, Medicine
St. Bartholomews' Hospital Medical College, University of London 1983 — 1989
MBBS (Distinction), Medicine
University of London 1983 — 1986
BSc, Immunology
POINT Biomedical Corporation October 2007 - July 2008
UIC Hospital October 2001 - October 2007
Education
Harper College 1999 — 2001
AAS, Cardiac Diagnostics
Bradley University 1997 — 1999
Nursing
Ventrus Biosciences 2013 - Present
Forest Laboratories, Inc., NJ 2012 - 2013
Mount Sinai Medical Center 2011 - 2012
Genentech May 2009 - November 2010
POINT Biomedical Corporation 2008 - 2008
ClinPhone January 2004 - January 2007
TrialTrac, Inc. May 1998 - January 2004
Sugen 1998 - 2000
Skills
Clinical Research, FDA, GCP, Oncology, EDC, Clinical Trials, CTMS, Clinical Trial..., Pharmaceuticals, Biotechnology, CRO, Pharmaceutical Industry, Medical Devices, Protocol, Clinical Monitoring, Sop
Education
National University of Ireland, Galway 1982 — 1986
BSc, Biochemistry
Nektar Therapeutics September 2014 - Present
Nektar Therapeutics February 2013 - September 2014
Nektar Therapeutics July 2011 - February 2013
Pietra Research LLC February 2005 - July 2011
Cerexa 2011 - 2011
Lantheus Medical Imaging 2009 - 2010
KaloBios 2008 - 2009
POINT Biomedical Corporation March 2007 - June 2008
Chiron Corporation 2005 - 2007
Chiron Corporation 2005 - 2007
Skills
Clinical Research, EDC, Therapeutic Areas, CTMS, CRO, Drug Development, Clinical Development, Clinical Trials, GCP, Infectious Diseases
Education
University of Detroit Mercy 1997 — 2000
BSN, Nursing
Montcalm Community College 1988 — 1991
ADN, Nursing
Beckman Coulter August 2014 - Present
American Peptide Company April 2014 - August 2014
American Peptide Company January 2012 - April 2014
American Peptide Company December 2005 - May 2009
POINT Biomedical Corporation May 2001 - September 2004
Mylan Bertek Pharmaceuticals 2000 - 2001
San Francisco General Hospital 1999 - 2000
Columbia Good Samaritan Hospital 1997 - 1999
Skills
Quality System, Validation, GLP, Quality Assurance, FDA, HPLC, Aseptic Processing, GMP, Microbiology, Change Control, Sop, CAPA, Deviations, Pharmaceutical Industry, Quality Auditing, Technology Transfer, Protein Purification, Cell Culture, Cleaning Validation, R&D, Biopharmaceuticals, Biotechnology, GxP, Quality Control, Regulatory Affairs, Software Documentation, Organic Chemistry, Purification, Analytical Chemistry, SOP
Education
San Francisco State University 1997 — 2000
MS, Biomedical Laboratory Science
San Jose State University 1992 — 1996
BS, Biology, Minor in Chemistry
GE Healthcare June 2010 - Present
Ambit Energy 2012 - 2012
GE Healthcare 2009 - 2010
Point Biomedical Corporation June 2007 - July 2008
GE Healthcare February 2006 - June 2007
GE Healthcare January 2004 - November 2005
GE Healthcare October 2001 - February 2004
Tyco Healthcare Mallinckrodt 1998 - 2003
Siemens 1998 - 1999
Skills
Professional Sales..., New Business Development, Territory Management, Territory Development, Contract Negotiation, Consultative Sales..., Creating sales programs..., Attracting, training..., Developing strong,..., Registered Diagnostic..., Sales Force Development, Coaching, Training, Ultrasound, Capital Equipment, Vascular, Cardiology, Radiology, Medical Imaging, Sales Management
Education
Bridgewater State College 1985 — 1989
Bachelor's degree, Exercise Physiology
Titan Pharmaceuticals 2014 - Present
Haemacure Corporation March 2007 - September 2010
POINT Biomedical Corporation March 2008 - December 2009
Bayer Pharmaceuticals 2004 - 2007
Bayer Corporation 2002 - 2004
Cornerstone of Bayer's specialty April 1999 - July 2002
Schein Pharmaceuticals 1999 - 2001
Bayer Corp. January 1996 - January 1999
Bayer Corp. January 1992 - January 1996
Bayer Corp January 1987 - January 1992
Skills
Mergers, Financial Reporting, Divestitures, Acquisition Integration, Strategic Planning, Integrations, Integration, Mergers & Acquisitions, Leadership, Project Management, Management, Cross-functional Team..., Product Development, Program Management, Accounting, Strategy, Project Planning, Marketing, Auditing, Business Planning, Forecasting, Human Resources, Business Strategy, Finance, Process Improvement, Business Process..., Executive Management, Change Management, Start-ups, Commercialization, Management Consulting, Pharmaceutical Industry
Education
University of California, Berkeley, Haas School of Business 1963 — 1968
MBA, Finance
University of California, Berkeley
B.S, Marketing
University of California, Berkeley
MBA, Finance
TLF Sales & Marketing, Inc. January 2009 - Present
POINT Biomedical Corporation 2008 - 2009
Cotherix 2004 - 2007
Scios 1995 - 2003
Skills
Biotechnology, Pharmaceutical Industry, Cardiology, Medical Affairs, Commercialization, Product Launch, Pharmaceutical Sales, Recruiting, Sales, Managed Care, Lifesciences
Education
North Dakota State University 1968 — 1972
BA, Speech & Business
Xoft, Inc. September 2009 - Present
Philips Healthcare 2013 - 2014
Philips Healthcare 2013 - 2014
Acusphere, Inc. 2004 - 2006
POINT Biomedical Corporation September 2002 - 2004
Skills
Medical Devices, Echocardiography, Hospitals, Product Launch, Healthcare Management, Surgery, Capital Equipment, Vascular, Cardiology, Pharmaceutical Industry, Radiology, Medical Imaging, Hardware Diagnostics, Clinical Research, Interventional Radiology, Healthcare, PACS, Surgeons, Healthcare Information..., Ultrasound, Clinical Trials, Market Development, Biotechnology, Interventional..., FDA, X-ray
Education
Southern Maine Community College 1997 — 1999
Associate of Science (A.S.), Cardiovascular Technology/Technologist
University of Maine