Pacific BioDevelopment
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Pacific BioDevelopment Employees
Employee
Years
Job
Industry
Jennifer Bruce Jennifer Bruce's Pacific BioDevelopment Experience April 2008 - April 2009
Job Quality Assurance & Quality Control
Industry Pharmaceuticals
Experience
CMC Biologics March 2015 - Present
Grifols Diagnostic Solutions, Inc. (formerly Novartis Vaccines & Diagnostics) February 2013 - March 2015
Raptor Pharmaceutical August 2012 - January 2013
Aduro BioTech, Inc. August 2011 - July 2012
Jazz Pharmaceuticals April 2009 - December 2009
Pacific BioDevelopment April 2008 - April 2009
KaloBios, Inc. 2006 - 2008
CoTherix, Inc. 2005 - 2006
VaxGen, Inc. 2003 - 2005
FibroGen, Inc. 2000 - 2002
Skills
CMC, GxP, Auditing, Training, Management, CRO, Biotechnology, FDA, Sop, Pharmaceutical Industry, GMP, Validation, CAPA, Lifesciences, Change Control, Regulatory Affairs, Clinical Trials, GLP, Quality Assurance, Clinical Research, Clinical Development, Regulatory Requirements, Technology Transfer, IND, GCP, Biopharmaceuticals, Computer System..., Regulatory Submissions, Drug Development, Vaccines, Quality System, V&V, 21 CFR Part 11, Life Sciences, SOP, Cleaning Validation, Aseptic Processing
Education
California Institute of Integral Studies
MA, Integral Counseling Psychology
San Jose State University
BA, Biological Sciences, minor Chemistry
CMC Biologics March 2015 - Present
Grifols Diagnostic Solutions, Inc. (formerly Novartis Vaccines & Diagnostics) February 2013 - March 2015
Raptor Pharmaceutical August 2012 - January 2013
Aduro BioTech, Inc. August 2011 - July 2012
Jazz Pharmaceuticals April 2009 - December 2009
Pacific BioDevelopment April 2008 - April 2009
KaloBios, Inc. 2006 - 2008
CoTherix, Inc. 2005 - 2006
VaxGen, Inc. 2003 - 2005
FibroGen, Inc. 2000 - 2002
Skills
CMC, GxP, Auditing, Training, Management, CRO, Biotechnology, FDA, Sop, Pharmaceutical Industry, GMP, Validation, CAPA, Lifesciences, Change Control, Regulatory Affairs, Clinical Trials, GLP, Quality Assurance, Clinical Research, Clinical Development, Regulatory Requirements, Technology Transfer, IND, GCP, Biopharmaceuticals, Computer System..., Regulatory Submissions, Drug Development, Vaccines, Quality System, V&V, 21 CFR Part 11, Life Sciences, SOP, Cleaning Validation, Aseptic Processing
Education
California Institute of Integral Studies
MA, Integral Counseling Psychology
San Jose State University
BA, Biological Sciences, minor Chemistry
Dan Linehan Dan Linehan's Pacific BioDevelopment Experience October 2006 - October 2011
Job Senior Quality Consultant at Pacific BioDevelopment
Industry Biotechnology
Experience
Pacific BioDevelopment, LLC April 1999 - Present
Advanced BioHealing 2010 - 2012
Pacific BioDevelopment October 2006 - October 2011
Cerimon Pharmaceuticals February 2009 - July 2010
ArmaGen Technologies October 2008 - May 2010
Cerimon Pharmaceuticals 2006 - 2009
Kalypsys 2007 - 2008
Limerick 2005 - 2006
VaxGen 2004 - 2006
Biogen Idec 2003 - 2004
Education
University of California, San Francisco 1981 — 1982
Non-matriculating Student, Pharmacy
University at Buffalo 1972 — 1975
G Company 75th Infantry (Ranger) 1969 — 1970
Pacific BioDevelopment, LLC April 1999 - Present
Advanced BioHealing 2010 - 2012
Pacific BioDevelopment October 2006 - October 2011
Cerimon Pharmaceuticals February 2009 - July 2010
ArmaGen Technologies October 2008 - May 2010
Cerimon Pharmaceuticals 2006 - 2009
Kalypsys 2007 - 2008
Limerick 2005 - 2006
VaxGen 2004 - 2006
Biogen Idec 2003 - 2004
Education
University of California, San Francisco 1981 — 1982
Non-matriculating Student, Pharmacy
University at Buffalo 1972 — 1975
G Company 75th Infantry (Ranger) 1969 — 1970
Nancy Mize's Pacific BioDevelopment Experience 2003 - 2011
Job GENOGEN Inc
Industry Biotechnology
Experience
Genogen Inc. 2012 - Present
Mize Consulting 2002 - Present
Pacific BioDevelopment 2003 - 2011
Hyseq Genomics 1999 - 2002
Alza 1992 - 1997
Genentech 1990 - 1992
EMBL: European Molecular Biology Laboratory 1989 - 1991
Skills
Clinical, Personalized Medicine, Life Sciences, Entrepreneurship, Lifesciences, Biotechnology, Genomics, Clinical Research, EDC, FDA, Protocol, Drug Discovery, Pharmaceutical Industry, Proteomics, R&D, Biomarkers, Molecular Biology, Biopharmaceuticals, Cell Biology, Drug Development, Regulatory Affairs, GMP, Clinical Development, Assay Development, Protein Chemistry, Regulatory Submissions, Strategy, Drug Delivery, Bioinformatics
Education
Genentech & EMBL 1988 — 1991
postdoctoral studies, Cell Biology
University of California, San Francisco - School of Medicine 1982 — 1988
PhD, Human Physiology, Cell & Molecular Biology
University of California, Berkeley - Walter A. Haas School of Business
Certificate, Bioentrepreneurship
University of California, San Francisco - School of Medicine
Pharmacokinetics & Pharmacogenetics Certificate, PK & PGx
University of California, Berkeley
B.S., Biology
Genogen Inc. 2012 - Present
Mize Consulting 2002 - Present
Pacific BioDevelopment 2003 - 2011
Hyseq Genomics 1999 - 2002
Alza 1992 - 1997
Genentech 1990 - 1992
EMBL: European Molecular Biology Laboratory 1989 - 1991
Skills
Clinical, Personalized Medicine, Life Sciences, Entrepreneurship, Lifesciences, Biotechnology, Genomics, Clinical Research, EDC, FDA, Protocol, Drug Discovery, Pharmaceutical Industry, Proteomics, R&D, Biomarkers, Molecular Biology, Biopharmaceuticals, Cell Biology, Drug Development, Regulatory Affairs, GMP, Clinical Development, Assay Development, Protein Chemistry, Regulatory Submissions, Strategy, Drug Delivery, Bioinformatics
Education
Genentech & EMBL 1988 — 1991
postdoctoral studies, Cell Biology
University of California, San Francisco - School of Medicine 1982 — 1988
PhD, Human Physiology, Cell & Molecular Biology
University of California, Berkeley - Walter A. Haas School of Business
Certificate, Bioentrepreneurship
University of California, San Francisco - School of Medicine
Pharmacokinetics & Pharmacogenetics Certificate, PK & PGx
University of California, Berkeley
B.S., Biology
Dr. Catherine Lucas's Pacific BioDevelopment Experience January 2009 - Present
Job Consultant, Vice President, Technical Development at IGM Biosciences
Industry Biotechnology
Experience
IGM Biosciences November 2012 - Present
Pacific BioDevelopment January 2009 - Present
Lucas Consulting November 2008 - Present
Trinity Biosystems June 2007 - November 2008
Johnson & Johnson 2001 - 2006
ALZA Corporation January 2000 - 2001
ALZA Corporation September 1995 - December 1999
Cell Genesys 1993 - 1995
Genentech 1985 - 1993
Daryl Laboratories, Inc. 1983 - 1985
Skills
Biotechnology, Project Portfolio..., Project Execution, International Project..., Product Development, Product Management, research and development, Project Management, Biopharmaceuticals, Lifesciences, Immunology, Pharmaceutical Industry, Drug Development, Clinical Development, Start-ups, Vaccines, Analytical Chemistry, GMP, Medical Devices, Microbiology, FDA, Clinical Trials, Drug Delivery, Formulation, R&D, Assay Development, Leadership, Protein Chemistry, Strategy, Drug Discovery, Life Sciences
Education
Stanford University 1978 — 1980
Post Doc
Université Pierre et Marie Curie (Paris VI) 1970 — 1978
PhD
IGM Biosciences November 2012 - Present
Pacific BioDevelopment January 2009 - Present
Lucas Consulting November 2008 - Present
Trinity Biosystems June 2007 - November 2008
Johnson & Johnson 2001 - 2006
ALZA Corporation January 2000 - 2001
ALZA Corporation September 1995 - December 1999
Cell Genesys 1993 - 1995
Genentech 1985 - 1993
Daryl Laboratories, Inc. 1983 - 1985
Skills
Biotechnology, Project Portfolio..., Project Execution, International Project..., Product Development, Product Management, research and development, Project Management, Biopharmaceuticals, Lifesciences, Immunology, Pharmaceutical Industry, Drug Development, Clinical Development, Start-ups, Vaccines, Analytical Chemistry, GMP, Medical Devices, Microbiology, FDA, Clinical Trials, Drug Delivery, Formulation, R&D, Assay Development, Leadership, Protein Chemistry, Strategy, Drug Discovery, Life Sciences
Education
Stanford University 1978 — 1980
Post Doc
Université Pierre et Marie Curie (Paris VI) 1970 — 1978
PhD
Debbie Tanguay's Pacific BioDevelopment Experience July 2009 - September 2009
Job Marketing Specialist at Bailard, Inc.
Industry Marketing and Advertising
Experience
Bailard, Inc. September 2014 - Present
Streetline, Inc. July 2013 - July 2014
Streetline, Inc. January 2011 - June 2013
Streetline, Inc. June 2010 - December 2010
Pacific BioDevelopment July 2009 - September 2009
Cal Poly State University March 2009 - June 2009
Skills
Marketing, Marketing Communications, Social Media, Event Planning, Copywriting, Marketing Strategy, Market Research, Blogging, Internet of Things, Competitive Analysis, Project Management, Public Relations, Email Marketing, WordPress, Newsletters, SaaS, CRM, Start-ups, SEO, Salesforce.com, Cision, Photoshop, Digital Marketing, Marketing Automation, Google Analytics, Content Marketing, Creative Writing, Executive Communications, Microsoft Office, InDesign, Thought Leadership, Data Analysis, Lead Generation
Education
California Polytechnic State University-San Luis Obispo
B.S., Economics, Marketing Management Concentration
Notre Dame High School - Belmont, California 2001 — 2005
High School
Bailard, Inc. September 2014 - Present
Streetline, Inc. July 2013 - July 2014
Streetline, Inc. January 2011 - June 2013
Streetline, Inc. June 2010 - December 2010
Pacific BioDevelopment July 2009 - September 2009
Cal Poly State University March 2009 - June 2009
Skills
Marketing, Marketing Communications, Social Media, Event Planning, Copywriting, Marketing Strategy, Market Research, Blogging, Internet of Things, Competitive Analysis, Project Management, Public Relations, Email Marketing, WordPress, Newsletters, SaaS, CRM, Start-ups, SEO, Salesforce.com, Cision, Photoshop, Digital Marketing, Marketing Automation, Google Analytics, Content Marketing, Creative Writing, Executive Communications, Microsoft Office, InDesign, Thought Leadership, Data Analysis, Lead Generation
Education
California Polytechnic State University-San Luis Obispo
B.S., Economics, Marketing Management Concentration
Notre Dame High School - Belmont, California 2001 — 2005
High School
Mariana Nielsen Mariana Nielsen's Pacific BioDevelopment Experience January 2006 - October 2013
Job Quality Consultant at ISQP Consulting LLC
Industry Biotechnology
Experience
ISQP Consulting LLC September 2015 - Present
Celladon Corporation October 2013 - July 2015
Pacific BioDevelopment January 2006 - October 2013
Independent Consultant (ties to ComplianceNet, Goorsky and Associates, Regulatory Interlinx) May 1996 - December 2005
Amgen August 1994 - April 1996
Synergen, Inc. August 1992 - August 1994
Genentech May 1984 - July 1992
Skills
Biotechnology, Validation, SOP, Pharmaceutical Industry, Technology Transfer, FDA, Biopharmaceuticals, Quality System, GMP, Life Sciences
Education
UC Santa Cruz 1986 — 1987
BA, Computer Science and Writing
ISQP Consulting LLC September 2015 - Present
Celladon Corporation October 2013 - July 2015
Pacific BioDevelopment January 2006 - October 2013
Independent Consultant (ties to ComplianceNet, Goorsky and Associates, Regulatory Interlinx) May 1996 - December 2005
Amgen August 1994 - April 1996
Synergen, Inc. August 1992 - August 1994
Genentech May 1984 - July 1992
Skills
Biotechnology, Validation, SOP, Pharmaceutical Industry, Technology Transfer, FDA, Biopharmaceuticals, Quality System, GMP, Life Sciences
Education
UC Santa Cruz 1986 — 1987
BA, Computer Science and Writing
Joyce Chiarenza, CCCP's Pacific BioDevelopment Experience March 2000 - December 2012
Job
Industry Biotechnology
Experience
Hyperion Therapeutics, Inc 2012 - 2014
Pacific BioDevelopment March 2000 - December 2012
Onyx Pharmaceuticals 2010 - 2011
Nuvelo 2006 - 2008
Scios 2000 - 2007
Genentech 1983 - 2000
Genentech 1983 - 2000
Skills
Regulatory Affairs, Quality Assurance, FDA, Pharmaceutical Industry, Biotechnology, Lifesciences, Strategy, Quality Control, Clinical Trials, GMP, Clinical Development, Biopharmaceuticals, Validation, CAPA, Technology Transfer, R&D, Regulatory Submissions, Drug Development, Cross-functional Team..., CTMS, GLP, GxP, Clinical Research, Medical Devices, Sop, ISO 13485, Quality System, GCP, Oncology, Quality Auditing, Commercialization
Education
California State University-Northridge 1968 — 1970
BS
Hyperion Therapeutics, Inc 2012 - 2014
Pacific BioDevelopment March 2000 - December 2012
Onyx Pharmaceuticals 2010 - 2011
Nuvelo 2006 - 2008
Scios 2000 - 2007
Genentech 1983 - 2000
Genentech 1983 - 2000
Skills
Regulatory Affairs, Quality Assurance, FDA, Pharmaceutical Industry, Biotechnology, Lifesciences, Strategy, Quality Control, Clinical Trials, GMP, Clinical Development, Biopharmaceuticals, Validation, CAPA, Technology Transfer, R&D, Regulatory Submissions, Drug Development, Cross-functional Team..., CTMS, GLP, GxP, Clinical Research, Medical Devices, Sop, ISO 13485, Quality System, GCP, Oncology, Quality Auditing, Commercialization
Education
California State University-Northridge 1968 — 1970
BS
Lester Thomas's Pacific BioDevelopment Experience January 1997 - September 1999
Job Director Regulatory Affairs at Pearl Therapeutics
Industry Biotechnology
Experience
Pearl Therapeutics July 2015 - Present
GlaxoSmithKline June 2007 - June 2015
Syngenta Biotechnology January 2005 - June 2006
Nektar Therapeutics September 1999 - December 2002
Pacific BioDevelopment January 1997 - September 1999
XOMA Corporation November 1994 - January 1997
Johnson & Johnson April 1992 - November 1994
Bayer April 1991 - April 1992
Skills
Orphan Drugs, Monoclonal Antibodies, Pharmaceutics, Regulatory Affairs, Regulatory Submissions, Biotechnology, Clinical Development, FDA, Medical Devices, Pharmaceutical Industry, Ophthalmics, Respiratory Products, CNS disorders, Formulation, IND, Strategy, Clinical Trials, Life Sciences
Education
University of Colorado Boulder 1985 — 1989
BA
Mercersburg Academy 1982 — 1985
Pearl Therapeutics July 2015 - Present
GlaxoSmithKline June 2007 - June 2015
Syngenta Biotechnology January 2005 - June 2006
Nektar Therapeutics September 1999 - December 2002
Pacific BioDevelopment January 1997 - September 1999
XOMA Corporation November 1994 - January 1997
Johnson & Johnson April 1992 - November 1994
Bayer April 1991 - April 1992
Skills
Orphan Drugs, Monoclonal Antibodies, Pharmaceutics, Regulatory Affairs, Regulatory Submissions, Biotechnology, Clinical Development, FDA, Medical Devices, Pharmaceutical Industry, Ophthalmics, Respiratory Products, CNS disorders, Formulation, IND, Strategy, Clinical Trials, Life Sciences
Education
University of Colorado Boulder 1985 — 1989
BA
Mercersburg Academy 1982 — 1985
larry kleinman's Pacific BioDevelopment Experience May 1997 - December 2005
Job CEO at Kleinman Consulting
Industry Biotechnology
Experience
Kleinman Consulting January 2005 - Present
Pacific BioDevelopment May 1997 - December 2005
Genentech, Inc June 1989 - April 1997
United States Public Health Service September 1968 - September 1988
Education
Northeastern University 1965 — 1967
MS, Industrial Pharmacy
Fordham University 1960 — 1965
Kleinman Consulting January 2005 - Present
Pacific BioDevelopment May 1997 - December 2005
Genentech, Inc June 1989 - April 1997
United States Public Health Service September 1968 - September 1988
Education
Northeastern University 1965 — 1967
MS, Industrial Pharmacy
Fordham University 1960 — 1965
Marshall Dinowitz's Pacific BioDevelopment Experience 2000 - December 2013
Job Retired Senior Consultant at Pacific BioDevelopment
Industry Pharmaceuticals
Experience
Pacific BioDevelopment 2000 - December 2013
Genitope 1999 - 2001
Genentech 1987 - 1999
Skills
Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Lifesciences, Drug Development, Technology Transfer, Drug Discovery, Clinical Development, FDA, R&D, GLP, Validation, GMP, Regulatory Affairs, Change Control, CAPA, GxP, Regulatory Submissions, 21 CFR Part 11, CRO, Vaccines, Microbiology
Education
NCI Postdoctoral Fellow, Institute for Molecular Virology, St. Louis University, Saint Louis, MO 1967 — 1969
NCI Postdoctoral Fellow, Molecular Biology
The Johns Hopkins University
Sc.D., Pathobiology, Virology
University of Maryland College Park
B.S., Zoology, Physical Sciences
Pacific BioDevelopment 2000 - December 2013
Genitope 1999 - 2001
Genentech 1987 - 1999
Skills
Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Lifesciences, Drug Development, Technology Transfer, Drug Discovery, Clinical Development, FDA, R&D, GLP, Validation, GMP, Regulatory Affairs, Change Control, CAPA, GxP, Regulatory Submissions, 21 CFR Part 11, CRO, Vaccines, Microbiology
Education
NCI Postdoctoral Fellow, Institute for Molecular Virology, St. Louis University, Saint Louis, MO 1967 — 1969
NCI Postdoctoral Fellow, Molecular Biology
The Johns Hopkins University
Sc.D., Pathobiology, Virology
University of Maryland College Park
B.S., Zoology, Physical Sciences
Karen Sutherlin's Pacific BioDevelopment Experience 2000 - Present
Job Independent Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Pacific BioDevelopment 2000 - Present
Education
San Francisco State University 1963 — 1966
Pacific BioDevelopment 2000 - Present
Education
San Francisco State University 1963 — 1966