Alpha Therapeutic Corp.
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Alpha Therapeutic Corp. Employees
Employee
Years
Job
Industry
Lance Hagler Lance Hagler's Alpha Therapeutic Corp. Experience 1981 - 1988
Job Consultant Scientist at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company May 2014 - Present
Baxter Phamaceutical Solutions LLC August 2012 - May 2014
Baxter Biopharma Solutions January 2011 - August 2012
Eli Lilly August 2002 - January 2011
Holister-Stier Laboratories December 1988 - July 2002
Alpha Therapeutic Corp 1981 - 1988
Skills
V&V, Technology Transfer, GMP, Sop, 21 CFR Part 11, Sterilization, FDA, Change Control, GLP, CAPA, Aseptic Processing, Validation, GxP, Pharmaceutical Industry, Biotechnology, Biopharmaceuticals, Computer System...
Education
California State University-Northridge 1975 — 1980
BA, Biology
Eli Lilly and Company May 2014 - Present
Baxter Phamaceutical Solutions LLC August 2012 - May 2014
Baxter Biopharma Solutions January 2011 - August 2012
Eli Lilly August 2002 - January 2011
Holister-Stier Laboratories December 1988 - July 2002
Alpha Therapeutic Corp 1981 - 1988
Skills
V&V, Technology Transfer, GMP, Sop, 21 CFR Part 11, Sterilization, FDA, Change Control, GLP, CAPA, Aseptic Processing, Validation, GxP, Pharmaceutical Industry, Biotechnology, Biopharmaceuticals, Computer System...
Education
California State University-Northridge 1975 — 1980
BA, Biology
Judith Klein, PhD, MSPH, MBA Judith Klein, PhD, MSPH, MBA's Alpha Therapeutic Corp. Experience January 1998 - January 2000
Job Business and Public Health Professional
Industry Biotechnology
Experience
Amgen Inc October 2003 - Present
Amgen Inc January 2000 - October 2003
Alpha Therapeutic Corp. January 1998 - January 2000
Children's Hospital January 1986 - January 1998
University of California January 1985 - January 1986
Skills
Data Analysis, Teaching - Adjunct..., Curriculum Development, Contract Negotiation, Strategic Sourcing, Operations, Relationship Mgmt, Quality Assurance, Analysis, Project Management, Clinical Trials, Management, Cross-functional Team..., Sop, Clinical Research, Outsourcing, Biotechnology, Protocol, Clinical Development, CRO, Drug Development, Lifesciences, Pharmaceutical Industry, Biopharmaceuticals, GCP, SOP, Life Sciences
Education
Walden University 2006 — 2010
Doctor of Philosophy
National University
Master
McGill University
Bachelor of Science
Amgen Inc October 2003 - Present
Amgen Inc January 2000 - October 2003
Alpha Therapeutic Corp. January 1998 - January 2000
Children's Hospital January 1986 - January 1998
University of California January 1985 - January 1986
Skills
Data Analysis, Teaching - Adjunct..., Curriculum Development, Contract Negotiation, Strategic Sourcing, Operations, Relationship Mgmt, Quality Assurance, Analysis, Project Management, Clinical Trials, Management, Cross-functional Team..., Sop, Clinical Research, Outsourcing, Biotechnology, Protocol, Clinical Development, CRO, Drug Development, Lifesciences, Pharmaceutical Industry, Biopharmaceuticals, GCP, SOP, Life Sciences
Education
Walden University 2006 — 2010
Doctor of Philosophy
National University
Master
McGill University
Bachelor of Science
Mike Dubinsky Mike Dubinsky's Alpha Therapeutic Corp. Experience 1998 - 2000
Job Consultant & Instructor at UC Berkeley, Clinical Trial Topics
Industry Biotechnology
Experience
University of California, Berkeley May 2007 - Present
PM Dubinsky January 2007 - Present
Chiron(formerly) 2006 - Present
UC Berkeley Extension April 2009 - August 2013
Chiron 2003 - 2006
Wyeth Pharmaceuticals 2002 - 2003
SangStat Medical Corporation 2000 - 2001
Alpha Therapeutics Corporation (Now Grifols Biologicals) 1998 - 2000
Alpha Therapeutic Corp. 1998 - 2000
US Food & Drug Administration 1991 - 1998
Skills
Biotechnology, DNA sequencing, FDA, Lifesciences, Clinical Trials, GCP, Regulatory Affairs, Regulatory Submissions, 21 CFR Part 11, Quality Assurance, GLP, GxP, GMP, Biopharmaceuticals, Immunology, Sop, Drug Development, Clinical Research, Validation, Clinical Development, Drug Discovery, CAPA, Technology Transfer, Infectious Diseases, Vaccines, Microbiology, Protocol, Life Sciences
Education
University of Maryland College Park 1964 — 1969
BS, Microbiology
University of California, Berkeley May 2007 - Present
PM Dubinsky January 2007 - Present
Chiron(formerly) 2006 - Present
UC Berkeley Extension April 2009 - August 2013
Chiron 2003 - 2006
Wyeth Pharmaceuticals 2002 - 2003
SangStat Medical Corporation 2000 - 2001
Alpha Therapeutics Corporation (Now Grifols Biologicals) 1998 - 2000
Alpha Therapeutic Corp. 1998 - 2000
US Food & Drug Administration 1991 - 1998
Skills
Biotechnology, DNA sequencing, FDA, Lifesciences, Clinical Trials, GCP, Regulatory Affairs, Regulatory Submissions, 21 CFR Part 11, Quality Assurance, GLP, GxP, GMP, Biopharmaceuticals, Immunology, Sop, Drug Development, Clinical Research, Validation, Clinical Development, Drug Discovery, CAPA, Technology Transfer, Infectious Diseases, Vaccines, Microbiology, Protocol, Life Sciences
Education
University of Maryland College Park 1964 — 1969
BS, Microbiology
Jim Vinyard Jim Vinyard's Alpha Therapeutic Corp. Experience February 1996 - September 2000
Job Senior Recruiter, Employment Specialist
Industry Staffing and Recruiting
Experience
Talon Recruiting Services April 2006 - Present
Alternative Community Training 2005 - Present
JobFinders Employment Services December 2000 - March 2006
Alpha Therapeutic Corp. February 1996 - September 2000
JobFinders Employment Services August 1992 - January 1996
City of Columbia, Missouri 1990 - 1992
American Red Cross 1988 - 1990
Education
University of Missouri 1985 — 1989
Business Administration, Business
Talon Recruiting Services April 2006 - Present
Alternative Community Training 2005 - Present
JobFinders Employment Services December 2000 - March 2006
Alpha Therapeutic Corp. February 1996 - September 2000
JobFinders Employment Services August 1992 - January 1996
City of Columbia, Missouri 1990 - 1992
American Red Cross 1988 - 1990
Education
University of Missouri 1985 — 1989
Business Administration, Business
Loren Michalski Loren Michalski's Alpha Therapeutic Corp. Experience August 1982 - December 2003
Job CPA, Controller, Risk Manager
Industry Accounting
Experience
Exelon Wind & Solar June 2011 - Present
Eurofins October 2004 - January 2011
Alpha Therapeutic Corp August 1982 - December 2003
Skills
Auditing
Education
California State Polytechnic University-Pomona 1974 — 1978
BS, Accounting
Exelon Wind & Solar June 2011 - Present
Eurofins October 2004 - January 2011
Alpha Therapeutic Corp August 1982 - December 2003
Skills
Auditing
Education
California State Polytechnic University-Pomona 1974 — 1978
BS, Accounting
Hilda Halabi Hilda Halabi's Alpha Therapeutic Corp. Experience August 1996 - June 2003
Job Biotech/Pharma Consultant Professional
Industry Biotechnology
Experience
WGA Consulting, LLC October 2014 - May 2015
Gilead Sciences February 2012 - June 2014
Johnson & Johnson June 2010 - November 2010
Amgen August 2008 - July 2009
Amgen August 2006 - August 2008
Baxter BioScience January 2005 - June 2006
Amgen February 2004 - December 2004
Alpha Therapeutic Corp August 1996 - June 2003
UCLA Medical Center July 1988 - July 1996
Skills
FDA, CAPA, Validation, Quality Assurance, Change Control, Biotechnology, Cross-functional Team..., GMP, Quality System, Regulatory Requirements, Biopharmaceuticals, 21 CFR Part 11, V&V, GxP, Quality Control, Aseptic Processing, Root Cause Analysis, GLP, LIMS, Computer System..., Technology Transfer, Cleaning Validation, Laboratory, Regulatory Affairs
Education
Brunel University London 1973 — 1976
M.Sc., Applied Immunology
WGA Consulting, LLC October 2014 - May 2015
Gilead Sciences February 2012 - June 2014
Johnson & Johnson June 2010 - November 2010
Amgen August 2008 - July 2009
Amgen August 2006 - August 2008
Baxter BioScience January 2005 - June 2006
Amgen February 2004 - December 2004
Alpha Therapeutic Corp August 1996 - June 2003
UCLA Medical Center July 1988 - July 1996
Skills
FDA, CAPA, Validation, Quality Assurance, Change Control, Biotechnology, Cross-functional Team..., GMP, Quality System, Regulatory Requirements, Biopharmaceuticals, 21 CFR Part 11, V&V, GxP, Quality Control, Aseptic Processing, Root Cause Analysis, GLP, LIMS, Computer System..., Technology Transfer, Cleaning Validation, Laboratory, Regulatory Affairs
Education
Brunel University London 1973 — 1976
M.Sc., Applied Immunology
Paul Glidden Paul Glidden's Alpha Therapeutic Corp. Experience 1989 - 2000
Job Nanotechnology Gold Nanorods
Industry Biotechnology
Experience
La Jolla Nanomedical September 2015 - Present
Self Employed July 2000 - Present
NanoSmart Pharmaceuticals, Inc. January 2012 - December 2012
BioVascular Inc July 2005 - April 2010
Angiosyn Inc July 2003 - July 2005
ISTA Pharmaceuticals 2000 - 2003
Alpha Therapeutic Corp 1989 - 2000
Skills
Nanotechnology, Gold nanorods, Antibody Drug Conjugates, Pharmaceutical Industry, Clinical Development, Biopharmaceuticals, Biotechnology, Pharmacology, Drug Discovery, Oncology, GMP, GLP, Drug Development, FDA, Toxicology, Entrepreneurship, Clinical Trials, R&D, Lifesciences, Technology Transfer, CRO, Regulatory Submissions, Drug Delivery, Assay Development, Validation, Life Sciences, Medical Devices, Formulation, Chemistry, Clinical Research, Protein Chemistry, IND, Regulatory Affairs, Commercialization, Biochemistry, Pharmacokinetics
Education
University of California, Irvine 1991 — 1997
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology, College of Medicine
Oregon State University 1985 — 1989
BS, Biochemistry and Biophysics
La Jolla Nanomedical September 2015 - Present
Self Employed July 2000 - Present
NanoSmart Pharmaceuticals, Inc. January 2012 - December 2012
BioVascular Inc July 2005 - April 2010
Angiosyn Inc July 2003 - July 2005
ISTA Pharmaceuticals 2000 - 2003
Alpha Therapeutic Corp 1989 - 2000
Skills
Nanotechnology, Gold nanorods, Antibody Drug Conjugates, Pharmaceutical Industry, Clinical Development, Biopharmaceuticals, Biotechnology, Pharmacology, Drug Discovery, Oncology, GMP, GLP, Drug Development, FDA, Toxicology, Entrepreneurship, Clinical Trials, R&D, Lifesciences, Technology Transfer, CRO, Regulatory Submissions, Drug Delivery, Assay Development, Validation, Life Sciences, Medical Devices, Formulation, Chemistry, Clinical Research, Protein Chemistry, IND, Regulatory Affairs, Commercialization, Biochemistry, Pharmacokinetics
Education
University of California, Irvine 1991 — 1997
Doctor of Philosophy (Ph.D.), Pharmacology and Toxicology, College of Medicine
Oregon State University 1985 — 1989
BS, Biochemistry and Biophysics
Liza Ramos Cook Liza Ramos Cook's Alpha Therapeutic Corp. Experience January 1996 - January 1997
Job Senior Consultant at Booz Allen Hamilton
Industry Management Consulting
Experience
Booz Allen Hamilton December 2010 - Present
Pfeiffer Treatment Center October 2008 - August 2009
Alpha Therapeutic Corp January 1996 - January 1997
Alpha Plasma Center January 1995 - January 1996
Ramos Clinic January 1990 - January 1994
Skills
Government, Program Management, Strategic Planning, Non-profits, Program Development, Vendor Management, Management Consulting, Healthcare, Business Analysis, Fundraising, Project Planning, Team Building, Adobe Connect, SharePoint, Analysis, Meeting Planning, Webinar Development, Government Contracting, Collaborative Problem..., Online Research, Client Relations Skills, Training, Data Analysis, Process Improvement, Requirements Analysis, Business Development, Strategy, Management, Business Process..., Project Management, Leadership, Change Management, Consulting, Microsoft Office, Business Strategy, Integration
Education
Stetson University 1996 — 1999
Bachelor of Arts Degree, Psychology
O'Gorman High School 1990 — 1994
High School Diploma
Booz Allen Hamilton December 2010 - Present
Pfeiffer Treatment Center October 2008 - August 2009
Alpha Therapeutic Corp January 1996 - January 1997
Alpha Plasma Center January 1995 - January 1996
Ramos Clinic January 1990 - January 1994
Skills
Government, Program Management, Strategic Planning, Non-profits, Program Development, Vendor Management, Management Consulting, Healthcare, Business Analysis, Fundraising, Project Planning, Team Building, Adobe Connect, SharePoint, Analysis, Meeting Planning, Webinar Development, Government Contracting, Collaborative Problem..., Online Research, Client Relations Skills, Training, Data Analysis, Process Improvement, Requirements Analysis, Business Development, Strategy, Management, Business Process..., Project Management, Leadership, Change Management, Consulting, Microsoft Office, Business Strategy, Integration
Education
Stetson University 1996 — 1999
Bachelor of Arts Degree, Psychology
O'Gorman High School 1990 — 1994
High School Diploma
Lamar Cousin Lamar Cousin's Alpha Therapeutic Corp. Experience March 1999 - December 2003
Job Manager at American Red Cross
Industry Nonprofit Organization Management
Experience
American Red Cross January 2008 - Present
American Red Cross May 2007 - Present
American Red Cross May 2004 - Present
American Red Cross May 2004 - May 2006
American Red Cross May 2004 - May 2005
Alpha Therapeutic Corp March 1999 - December 2003
Alpha Therapeutic Corp/Baxter Plasma January 1999 - January 2003
donor center January 2000 - January 2002
Alpha Therapeutic Corp January 1999 - January 2002
United States Air Force February 1992 - August 1998
Skills
Cost of Non Conformance, Stat a Matrix, Training, Management, Process Improvement, Quality Assurance, Data Analysis, Auditing, Quality Auditing, Human Resources, Nonprofits, Leadership, Team Building, Strategic Planning, Microsoft Office, Program Management, Customer Service
Education
Youngstown State University 2001 — 2001
Associates Degree, Medical Laboratory
Youngstown State University 1989 — 2000
Associates degree, Medical Laboratory Technology
Community College of the Air Force 1992 — 1998
Associate of Arts (AA), Medical Laboratory
American Red Cross January 2008 - Present
American Red Cross May 2007 - Present
American Red Cross May 2004 - Present
American Red Cross May 2004 - May 2006
American Red Cross May 2004 - May 2005
Alpha Therapeutic Corp March 1999 - December 2003
Alpha Therapeutic Corp/Baxter Plasma January 1999 - January 2003
donor center January 2000 - January 2002
Alpha Therapeutic Corp January 1999 - January 2002
United States Air Force February 1992 - August 1998
Skills
Cost of Non Conformance, Stat a Matrix, Training, Management, Process Improvement, Quality Assurance, Data Analysis, Auditing, Quality Auditing, Human Resources, Nonprofits, Leadership, Team Building, Strategic Planning, Microsoft Office, Program Management, Customer Service
Education
Youngstown State University 2001 — 2001
Associates Degree, Medical Laboratory
Youngstown State University 1989 — 2000
Associates degree, Medical Laboratory Technology
Community College of the Air Force 1992 — 1998
Associate of Arts (AA), Medical Laboratory
Rubik Hartounian Rubik Hartounian's Alpha Therapeutic Corp. Experience September 2002 - February 2003
Job Senior Manager, Internal Audit & Training at Medtronic
Industry Medical Devices
Experience
Medtronic September 2014 - Present
Allergan September 2009 - August 2014
Allergan May 2007 - September 2009
KC Pharmaceuticals March 2003 - April 2007
Alpha Therapeutic Corp. September 2002 - February 2003
Skills
ISO 13485, Validation, ISO 14971, CQA, Microbiology, Aseptic Processing, Risk Management, GMP, Sterilization, CAPA, FDA, Quality System, ISO 17025, ISO 11137, Eudralex Chapter 4, EU GMP Part I, EU GMP Part II, CSV, Sterility Assurance, Medical Devices, Pharmaceutical Industry, IPEC, ICH guidelines, USP, GHTF, GxP, Regulatory Affairs, Quality Assurance, V&V, 21 CFR Part 11, GLP, Quality Auditing, Change Control, Design Control, Quality Control
Education
California State University, Los Angeles 1996 — 1999
BS, Microbiology
Medtronic September 2014 - Present
Allergan September 2009 - August 2014
Allergan May 2007 - September 2009
KC Pharmaceuticals March 2003 - April 2007
Alpha Therapeutic Corp. September 2002 - February 2003
Skills
ISO 13485, Validation, ISO 14971, CQA, Microbiology, Aseptic Processing, Risk Management, GMP, Sterilization, CAPA, FDA, Quality System, ISO 17025, ISO 11137, Eudralex Chapter 4, EU GMP Part I, EU GMP Part II, CSV, Sterility Assurance, Medical Devices, Pharmaceutical Industry, IPEC, ICH guidelines, USP, GHTF, GxP, Regulatory Affairs, Quality Assurance, V&V, 21 CFR Part 11, GLP, Quality Auditing, Change Control, Design Control, Quality Control
Education
California State University, Los Angeles 1996 — 1999
BS, Microbiology
Catherine Kavanagh, Ph.D Catherine Kavanagh, Ph.D's Alpha Therapeutic Corp. Experience 1994 - 2003
Job Director, Global Quality Validation at Bayer Healthcare
Industry Biotechnology
Experience
Bayer HealthCare June 2015 - Present
Grifols biologicals Inc. July 2003 - June 2015
Alpha Therapeutic Corp 1994 - 2003
Skills
GMP, Validation, 21 CFR Part 11, FDA, Aseptic Processing, V&V, Cleaning Validation, Computer System..., GLP, CAPA, Biopharmaceuticals, GxP, Sop, Pharmaceutical Industry, Biotechnology, GAMP, Microbiology, Regulatory Affairs, Quality Assurance, Quality Control, Change Control, Sterilization, Quality Auditing, Regulatory Requirements, Purification, Pharmaceutics, ISO 13485, Quality System, Chromatography, Lyophilization, LIMS, SOP, Trackwise, Technology Transfer
Education
National University of Ireland 1987 — 1992
Doctor of Philosophy (PhD), Plant Biotechnology / Genetic Engineering
University College Cork 1983 — 1987
Bachelor of Science (B.Sc.), Plant Biotechnology, Microbiology
Bayer HealthCare June 2015 - Present
Grifols biologicals Inc. July 2003 - June 2015
Alpha Therapeutic Corp 1994 - 2003
Skills
GMP, Validation, 21 CFR Part 11, FDA, Aseptic Processing, V&V, Cleaning Validation, Computer System..., GLP, CAPA, Biopharmaceuticals, GxP, Sop, Pharmaceutical Industry, Biotechnology, GAMP, Microbiology, Regulatory Affairs, Quality Assurance, Quality Control, Change Control, Sterilization, Quality Auditing, Regulatory Requirements, Purification, Pharmaceutics, ISO 13485, Quality System, Chromatography, Lyophilization, LIMS, SOP, Trackwise, Technology Transfer
Education
National University of Ireland 1987 — 1992
Doctor of Philosophy (PhD), Plant Biotechnology / Genetic Engineering
University College Cork 1983 — 1987
Bachelor of Science (B.Sc.), Plant Biotechnology, Microbiology
Peter Sun's Alpha Therapeutic Corp. Experience April 1998 - June 2003
Job
Industry Banking
Experience
CTBC Bank (Formerly Chinatrust Bank USA) April 2014 - Present
Chinatrust Bank USA (CTBC Bank) April 2011 - April 2014
Chinatrust Bank USA April 2008 - April 2011
Chinatrust Bank USA January 2006 - April 2008
Far East National Bank June 2005 - January 2006
Alpha Therapeutic Corp April 1998 - June 2003
Education
UCLA Anderson School of Management 2003 — 2006
University of California, Los Angeles 1988 — 1998
CTBC Bank (Formerly Chinatrust Bank USA) April 2014 - Present
Chinatrust Bank USA (CTBC Bank) April 2011 - April 2014
Chinatrust Bank USA April 2008 - April 2011
Chinatrust Bank USA January 2006 - April 2008
Far East National Bank June 2005 - January 2006
Alpha Therapeutic Corp April 1998 - June 2003
Education
UCLA Anderson School of Management 2003 — 2006
University of California, Los Angeles 1988 — 1998
Charles H. Davis's Alpha Therapeutic Corp. Experience November 1980 - September 1992
Job Regulatory Science Professional
Industry Pharmaceuticals
Experience
Sarah Cannon Research Institute December 2013 - Present
Teva Parenteral Medicines, Inc. December 2010 - July 2011
Abingdon Life Sciences May 2008 - December 2010
Santarus Inc. 2004 - 2008
Arena Pharmaceuticals 2002 - 2003
Maxim Pharmaceuticals 1999 - 2002
Sonus Pharmaceuticals, Inc. 1992 - 1999
Alpha Therapeutic Corp. November 1980 - September 1992
Skills
Clinical Development, IND, Drug Development, Regulatory Affairs, CRO, Regulatory Submissions, Pharmaceutical Industry, FDA, Oncology, Biotechnology, SOP, Sop
Education
University of California, Berkeley 1965 — 1969
Bachelor of Science (BS), Organic Chemistry
Sarah Cannon Research Institute December 2013 - Present
Teva Parenteral Medicines, Inc. December 2010 - July 2011
Abingdon Life Sciences May 2008 - December 2010
Santarus Inc. 2004 - 2008
Arena Pharmaceuticals 2002 - 2003
Maxim Pharmaceuticals 1999 - 2002
Sonus Pharmaceuticals, Inc. 1992 - 1999
Alpha Therapeutic Corp. November 1980 - September 1992
Skills
Clinical Development, IND, Drug Development, Regulatory Affairs, CRO, Regulatory Submissions, Pharmaceutical Industry, FDA, Oncology, Biotechnology, SOP, Sop
Education
University of California, Berkeley 1965 — 1969
Bachelor of Science (BS), Organic Chemistry
Dan Takasugi's Alpha Therapeutic Corp. Experience 1997 - July 2003
Job Deputy Director Donor Center Logistics at Grifols Biomat USA Inc.
Industry Pharmaceuticals
Experience
Grifols - Biomat USA Inc. September 2012 - Present
Grifols - Biomat USA, Inc. July 2003 - September 2012
Alpha Therapeutic Corp. 1997 - July 2003
Alpha Therapeutic Corp. 1995 - 1997
Alpha Therapeutic Corp. March 1993 - 1995
Education
California State University-Los Angeles
B.S., Accounting
Grifols - Biomat USA Inc. September 2012 - Present
Grifols - Biomat USA, Inc. July 2003 - September 2012
Alpha Therapeutic Corp. 1997 - July 2003
Alpha Therapeutic Corp. 1995 - 1997
Alpha Therapeutic Corp. March 1993 - 1995
Education
California State University-Los Angeles
B.S., Accounting
Kenneth Laderman, Ph.D.'s Alpha Therapeutic Corp. Experience April 1998 - August 2002
Job Director of Biopharmaceutical Manufacturing at Bausch + Lomb
Industry Pharmaceuticals
Experience
Bausch + Lomb April 2007 - Present
Halsa Pharmaceuticals 2000 - Present
City of Hope August 2002 - April 2007
Alpha Therapeutic Corp April 1998 - August 2002
Caltech 1992 - 1996
Cetus Corporation 1987 - 1988
Skills
Biotechnology, Lifesciences, Pharmaceutical Industry, Clinical Trials, FDA, Immunology, Regulatory Affairs, Cell Culture, Technology Transfer, Molecular Biology, GMP, Drug Development, Protein Chemistry, Clinical Development, Validation, CAPA, GLP, Biopharmaceuticals, Commercialization, Regulatory Submissions, Life Sciences, SOP, R&D
Education
The Johns Hopkins University 1988 — 1992
Ph.D., Biology
Pomona College 1982 — 1986
BA, History and Biology
Bausch + Lomb April 2007 - Present
Halsa Pharmaceuticals 2000 - Present
City of Hope August 2002 - April 2007
Alpha Therapeutic Corp April 1998 - August 2002
Caltech 1992 - 1996
Cetus Corporation 1987 - 1988
Skills
Biotechnology, Lifesciences, Pharmaceutical Industry, Clinical Trials, FDA, Immunology, Regulatory Affairs, Cell Culture, Technology Transfer, Molecular Biology, GMP, Drug Development, Protein Chemistry, Clinical Development, Validation, CAPA, GLP, Biopharmaceuticals, Commercialization, Regulatory Submissions, Life Sciences, SOP, R&D
Education
The Johns Hopkins University 1988 — 1992
Ph.D., Biology
Pomona College 1982 — 1986
BA, History and Biology
Tinna Kwan's Alpha Therapeutic Corp. Experience 1996 - 1998
Job Director Clinical Operations at ACADIA Pharmaceuticals Inc.
Industry Pharmaceuticals
Experience
ACADIA Pharmaceuticals Inc. August 2015 - Present
Allergan February 2014 - June 2015
Allergan March 2010 - February 2014
Allergan February 2009 - March 2010
Allergan Pharmaceuticals 2002 - February 2009
Cancer International Research Group 2001 - 2002
Alpha Therapeutic Corp 1996 - 1998
Alpha Therapeutic Corp 1996 - 1998
Skills
CTMS, Clinical Development, Clinical Trials, Clinical Operations, Urology, Pharmaceutical Industry, ICH-GCP, GCP, Clinical Research, Clinical Monitoring, CRO, EDC, Healthcare, Ophthalmology
Education
University of Arizona
Ph.D., Nursing
ACADIA Pharmaceuticals Inc. August 2015 - Present
Allergan February 2014 - June 2015
Allergan March 2010 - February 2014
Allergan February 2009 - March 2010
Allergan Pharmaceuticals 2002 - February 2009
Cancer International Research Group 2001 - 2002
Alpha Therapeutic Corp 1996 - 1998
Alpha Therapeutic Corp 1996 - 1998
Skills
CTMS, Clinical Development, Clinical Trials, Clinical Operations, Urology, Pharmaceutical Industry, ICH-GCP, GCP, Clinical Research, Clinical Monitoring, CRO, EDC, Healthcare, Ophthalmology
Education
University of Arizona
Ph.D., Nursing
Lorraine Peddada's Alpha Therapeutic Corp. Experience 1980 - 2003
Job Associate Director at Grifols Biologicals Inc.
Industry Pharmaceuticals
Experience
Grifols Biologicals Inc. 2002 - 2008
Alpha Therapeutic Corp. 1980 - 2003
Alpha Therapeutics Corporation/Grifols USA 1980 - 2003
Skills
Pharmaceutical Industry, FDA, Biotechnology, GLP, GMP, Biopharmaceuticals, Sop, 21 CFR Part 11, Change Control, Validation, Regulatory Affairs
Education
Grambling State University 1965 — 1969
Bachelor's Degree, Biology
Grifols Biologicals Inc. 2002 - 2008
Alpha Therapeutic Corp. 1980 - 2003
Alpha Therapeutics Corporation/Grifols USA 1980 - 2003
Skills
Pharmaceutical Industry, FDA, Biotechnology, GLP, GMP, Biopharmaceuticals, Sop, 21 CFR Part 11, Change Control, Validation, Regulatory Affairs
Education
Grambling State University 1965 — 1969
Bachelor's Degree, Biology
Claude Miller's Alpha Therapeutic Corp. Experience 2000 - 2004
Job VP Regulatory Affairs at Fresenius Medical Care
Industry Pharmaceuticals
Experience
Fresenius Medical Care 2008 - Present
Genitope Corporation 2004 - 2008
Alpha Therapeutic Corp 2000 - 2004
Skills
CAPA
Education
California State University-Long Beach 1969 — 1975
MS, Microbiology
Fresenius Medical Care 2008 - Present
Genitope Corporation 2004 - 2008
Alpha Therapeutic Corp 2000 - 2004
Skills
CAPA
Education
California State University-Long Beach 1969 — 1975
MS, Microbiology
Larry Gayleard's Alpha Therapeutic Corp. Experience 1988 - 2003
Job Independent Biotechnology Professional
Industry Biotechnology
Experience
Larry Gayleard Consulting Services 2008 - Present
Osmetech Molecular Diagnostics 2003 - 2007
Motorola Life Sciences 2003 - 2005
Alpha Therapeutic Corp. 1988 - 2003
Skills
FDA, Validation, CAPA, Manufacturing, GMP, Medical Devices, 21 CFR Part 11, Quality Assurance, Change Control, Quality System, ISO 13485, V&V, Biotechnology, Technology Transfer
Education
University of California, Irvine
Larry Gayleard Consulting Services 2008 - Present
Osmetech Molecular Diagnostics 2003 - 2007
Motorola Life Sciences 2003 - 2005
Alpha Therapeutic Corp. 1988 - 2003
Skills
FDA, Validation, CAPA, Manufacturing, GMP, Medical Devices, 21 CFR Part 11, Quality Assurance, Change Control, Quality System, ISO 13485, V&V, Biotechnology, Technology Transfer
Education
University of California, Irvine
Prabir Bhattacharya's Alpha Therapeutic Corp. Experience 1987 - 2001
Job Biotechnology Professional
Industry Biotechnology
Experience
GSK 2001 - 2006
Alpha Therapeutics Corporation (Now Grifols Biologicals) 1990 - 2001
Alpha Therapeutic Corp. 1987 - 2001
Education
University of Calcutta
Ph.D, Biochemistry
GSK 2001 - 2006
Alpha Therapeutics Corporation (Now Grifols Biologicals) 1990 - 2001
Alpha Therapeutic Corp. 1987 - 2001
Education
University of Calcutta
Ph.D, Biochemistry
Jim Raney's Alpha Therapeutic Corp. Experience 2000 - 2003
Job Project Supervisor at Grifols Biologicals Inc
Industry Biotechnology
Experience
Grifols Biologicals Inc. 2013 - Present
Grifols Biologicals Inc July 2003 - February 2013
Alpha Therapeutic Corp 2000 - 2003
Skills
GMP, FDA, Troubleshooting, CAPA, Change Control, Sop, Quality Assurance, Validation, Pharmaceutical Industry, V&V, 21 CFR Part 11, Regulatory Affairs, GLP, Technology Transfer, Quality System, Biotechnology, Regulatory Requirements, Regulatory Submissions, SOP
Education
ASH 1968 — 1970
HS
California State University-Los Angeles
BA, Psychology
Grifols Biologicals Inc. 2013 - Present
Grifols Biologicals Inc July 2003 - February 2013
Alpha Therapeutic Corp 2000 - 2003
Skills
GMP, FDA, Troubleshooting, CAPA, Change Control, Sop, Quality Assurance, Validation, Pharmaceutical Industry, V&V, 21 CFR Part 11, Regulatory Affairs, GLP, Technology Transfer, Quality System, Biotechnology, Regulatory Requirements, Regulatory Submissions, SOP
Education
ASH 1968 — 1970
HS
California State University-Los Angeles
BA, Psychology
Janine Nesbit's Alpha Therapeutic Corp. Experience 1980 - 1987
Job Retired Attorney
Industry Real Estate
Experience
Research Affiliates 2002 - 2010
Jacobs Engineering 1993 - 1998
Rutter, O'Sullivan, Green & Hobbs 1988 - 1993
Alpha Therapeutic Corp. 1980 - 1987
Skills
Corporate Law, International Law, Commercial Litigation, Compliance, Real Estate, Contract Negotiation, Corporate Governance, Investments, Litigation, Civil Litigation, Mediation, Appeals, Legal Research, Legal Writing, Securities, Legal Issues
Education
Loyola Law School, Loyola Marymount University
Juris Doctorate
UCLA
Research Affiliates 2002 - 2010
Jacobs Engineering 1993 - 1998
Rutter, O'Sullivan, Green & Hobbs 1988 - 1993
Alpha Therapeutic Corp. 1980 - 1987
Skills
Corporate Law, International Law, Commercial Litigation, Compliance, Real Estate, Contract Negotiation, Corporate Governance, Investments, Litigation, Civil Litigation, Mediation, Appeals, Legal Research, Legal Writing, Securities, Legal Issues
Education
Loyola Law School, Loyola Marymount University
Juris Doctorate
UCLA
Craig Mastenbaum's Alpha Therapeutic Corp. Experience 1993 - 1997
Job Senior Director Contract Manufacturing at Impax Laboratories
Industry Pharmaceuticals
Experience
Impax Laboratories October 2014 - Present
Oso BioPharmaceuticals Manufacturing, LLC January 2011 - October 2014
Dendreon January 2009 - April 2010
Hollister-Stier Laboratories 2004 - 2008
Chiron Corporation 2001 - 2004
Bayer/Hollister-Stier Labs 1997 - 2001
Alpha Therapeutic Corp 1993 - 1997
ESI Pharmaceuticals 1987 - 1993
Wyeth 1985 - 1987
Skills
Biopharmaceuticals, Technology Transfer, GMP, FDA, CAPA, Aseptic Processing, Sop, Microbiology, Sterilization, Contract Manufacturing, Validation, Cell Culture, Process Improvement, Lyophilization, Strategic Forecasting, Risk Management, syringes, Site Management, Business Development, Negotiation, Manufacturing, 21 CFR Part 11
Education
Gonzaga University - School of Business Administration 2004 — 2006
MBA
Rutgers University – Camden 1980 — 1984
BA, Microbiology
Impax Laboratories October 2014 - Present
Oso BioPharmaceuticals Manufacturing, LLC January 2011 - October 2014
Dendreon January 2009 - April 2010
Hollister-Stier Laboratories 2004 - 2008
Chiron Corporation 2001 - 2004
Bayer/Hollister-Stier Labs 1997 - 2001
Alpha Therapeutic Corp 1993 - 1997
ESI Pharmaceuticals 1987 - 1993
Wyeth 1985 - 1987
Skills
Biopharmaceuticals, Technology Transfer, GMP, FDA, CAPA, Aseptic Processing, Sop, Microbiology, Sterilization, Contract Manufacturing, Validation, Cell Culture, Process Improvement, Lyophilization, Strategic Forecasting, Risk Management, syringes, Site Management, Business Development, Negotiation, Manufacturing, 21 CFR Part 11
Education
Gonzaga University - School of Business Administration 2004 — 2006
MBA
Rutgers University – Camden 1980 — 1984
BA, Microbiology
John Oleson's Alpha Therapeutic Corp. Experience April 1985 - April 1991
Job President, Chief Engineer at Stainless Motors, Inc.
Industry Machinery
Experience
Stainless Motors, Inc. January 1988 - Present
Alpha Therapeutic Corp April 1985 - April 1991
Disk Media May 1984 - April 1985
Strongtec Corp September 1980 - August 1983
Martin Marietta Aerospace October 1979 - August 1980
Skills
Mechanical Engineering, Technical Leadership, Organizational..., SolidWorks, AutoCAD, Business Development, Invention, Product Innovation
Education
California Polytechnic State University-San Luis Obispo 1976 — 1979
Engineer’s Degree, Mechanical Engineering
Stainless Motors, Inc. January 1988 - Present
Alpha Therapeutic Corp April 1985 - April 1991
Disk Media May 1984 - April 1985
Strongtec Corp September 1980 - August 1983
Martin Marietta Aerospace October 1979 - August 1980
Skills
Mechanical Engineering, Technical Leadership, Organizational..., SolidWorks, AutoCAD, Business Development, Invention, Product Innovation
Education
California Polytechnic State University-San Luis Obispo 1976 — 1979
Engineer’s Degree, Mechanical Engineering
Merry Mariano's Alpha Therapeutic Corp. Experience October 1995 - December 2003
Job Sr. Quality Systems Specialist at Medtronic Spine & Biologics
Industry Hospital & Health Care
Experience
Medtronic Spine & Biologics October 2012 - Present
American Esoterics Laboratories December 2007 - October 2012
AEL Microbiology Lab February 2004 - December 2007
Alpha Therapeutic Corp. October 1995 - December 2003
Skills
Laboratory Medicine, Microbiology, Infectious Diseases, Immunology, Quality System, Medical Devices, Hematology, Blood Bank
Education
The University of Memphis
University of Tennessee-Health Science Center
BS, Medical Technology
Medtronic Spine & Biologics October 2012 - Present
American Esoterics Laboratories December 2007 - October 2012
AEL Microbiology Lab February 2004 - December 2007
Alpha Therapeutic Corp. October 1995 - December 2003
Skills
Laboratory Medicine, Microbiology, Infectious Diseases, Immunology, Quality System, Medical Devices, Hematology, Blood Bank
Education
The University of Memphis
University of Tennessee-Health Science Center
BS, Medical Technology
A.J. Winkelman's Alpha Therapeutic Corp. Experience January 1981 - December 1983
Job President at PSCPreferred Services Corporation
Industry
Experience
PSC-Preferred Services Corporation August 1987 - Present
American Red Cross January 1983 - December 1987
Alpha Therapeutic Corp January 1981 - December 1983
Divison of Bristol Meyers - Unitek Corporation January 1979 - December 1981
Baxter Hearthcare Corp - Hyland Therapeutics Division January 1969 - December 1979
Upjohn Pharmaceutical Company January 1966 - December 1969
Bank of America January 1965 - December 1966
Skills
Marketing, Forecasting, Sales, Time Management, Manufacturing, Loans, Estate Planning, Hospitals, International..., Trusts, Strategic Planning, Marketing Strategy
Education
Brigham Young University
Bachelor of Business Administration (B.B.A.), Business, Management, Marketing, and Related Support Services
Glendale Community College
Associate of Arts and Sciences (A.A.S.), Pre-Dental
Pepperdine University, The George L. Graziadio School of Business and Management
Master of Business Administration (MBA), Business, Management, Marketing, and Related Support Services
PSC-Preferred Services Corporation August 1987 - Present
American Red Cross January 1983 - December 1987
Alpha Therapeutic Corp January 1981 - December 1983
Divison of Bristol Meyers - Unitek Corporation January 1979 - December 1981
Baxter Hearthcare Corp - Hyland Therapeutics Division January 1969 - December 1979
Upjohn Pharmaceutical Company January 1966 - December 1969
Bank of America January 1965 - December 1966
Skills
Marketing, Forecasting, Sales, Time Management, Manufacturing, Loans, Estate Planning, Hospitals, International..., Trusts, Strategic Planning, Marketing Strategy
Education
Brigham Young University
Bachelor of Business Administration (B.B.A.), Business, Management, Marketing, and Related Support Services
Glendale Community College
Associate of Arts and Sciences (A.A.S.), Pre-Dental
Pepperdine University, The George L. Graziadio School of Business and Management
Master of Business Administration (MBA), Business, Management, Marketing, and Related Support Services
Amy Feliciano's Alpha Therapeutic Corp. Experience September 1973 - June 2003
Job Sr Manager at Baxter International Inc.
Industry Pharmaceuticals
Experience
Baxter International Inc. April 2004 - Present
Baxter International Inc. April 2004 - Present
Alpha Therapeutic Corp September 1973 - June 2003
Education
Adamson University
Chemistry
Baxter International Inc. April 2004 - Present
Baxter International Inc. April 2004 - Present
Alpha Therapeutic Corp September 1973 - June 2003
Education
Adamson University
Chemistry
George Tin's Alpha Therapeutic Corp. Experience 1985 - 1997
Job Consultant
Industry Pharmaceuticals
Experience
Self-employed Senior executive of Quality Assurance/Control with proven strengths in managing product and process quality throughout product Lifecycle in the Pharmaceutical industry. Demonstrated successfully both technical and management abilities in research and development, quality control operation, quality assurance systems, quality risk management, regulatory compliance and validation of both clinical and commercial products in both domestic and international markets. Have built strong teams of Quality professionals to support manufacturing of quality and safe products. Possess good interpersonal and analytical skills with strong attention to details.Director Worldwide QA Drugs and BiologicsAllergan Inc.2005 - 2015
Chiron Corporation 1999 - 2004
Aviron 1998 - 1999
Alpha Therapeutic Corp 1985 - 1997
Skills
Change Control, Technology Transfer, Pharmaceutical Industry, Quality System, Quality Assurance, Regulatory Requirements, Validation, Process Validation, Quality Control, LIMS Management, Laboratory, CMO Quality Management, Failure Investigation, Material Quality..., Analytical Method...
Education
Case Western Reserve University
Doctor of Philosophy (Ph.D.), BioPhysical Chemistry
Self-employed Senior executive of Quality Assurance/Control with proven strengths in managing product and process quality throughout product Lifecycle in the Pharmaceutical industry. Demonstrated successfully both technical and management abilities in research and development, quality control operation, quality assurance systems, quality risk management, regulatory compliance and validation of both clinical and commercial products in both domestic and international markets. Have built strong teams of Quality professionals to support manufacturing of quality and safe products. Possess good interpersonal and analytical skills with strong attention to details.Director Worldwide QA Drugs and BiologicsAllergan Inc.2005 - 2015
Chiron Corporation 1999 - 2004
Aviron 1998 - 1999
Alpha Therapeutic Corp 1985 - 1997
Skills
Change Control, Technology Transfer, Pharmaceutical Industry, Quality System, Quality Assurance, Regulatory Requirements, Validation, Process Validation, Quality Control, LIMS Management, Laboratory, CMO Quality Management, Failure Investigation, Material Quality..., Analytical Method...
Education
Case Western Reserve University
Doctor of Philosophy (Ph.D.), BioPhysical Chemistry