Baxter BioScience
Industry: Company
DescriptionBaxalta is a biopharmaceutical company founded on 1 July 2015 after its parent company, Baxter International, spun off biopharmaceutical division. The company began its operation with a revenue of $6 billion. CEO: Ludwig N. Hantson (1 Jul 2015–) Number of employees: 16,000 Founded: 2015 Subsidiaries: Asklepios BioPharmaceutical, Inc., Baxalta US Inc., Parent organization: Shire
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Baxter BioScience Employees
Otsuka Pharmaceutical Companies (U.S.) January 2015 - Present
Amgen August 2004 - December 2014
Baxter BioScience January 2001 - August 2004
Gen-Probe August 1998 - December 2001
Molecular Biosystems 1994 - August 1998
Skills
Biotechnology, FDA, Validation, Aseptic Processing, CAPA, GMP, Change Control, V&V, Technology Transfer, Quality System, Medical Devices
Education
San Diego State University-California State University
Biology, Molecular Biology
San Diego State University-California State University
Master of Business Administration (MBA), Production and Operations Management
Sony Pictures Entertainment July 2015 - Present
Sony Pictures Entertainment October 2010 - July 2015
Lucky Karma Studios September 2008 - October 2010
Johnson & Johnson - Consumer Products Company April 2006 - September 2008
Baxter BioScience April 2004 - March 2006
KBM Chemical Company, Inc. December 2000 - July 2004
Skills
Strategic Sourcing, Financial Modeling, Budgeting, P&L Management, Production, Post Production, Complex Analysis, Strategic Planning
Education
Northwestern University - Kellogg School of Management 2013 — 2015
Master of Business Administration (MBA)
New York Film Academy
University of California, Berkeley
Minor
Abbott Vascular Devices September 2006 - Present
Amgen April 2006 - August 2006
Amgen formerly Abgenix October 2003 - April 2006
Abgenix October 2002 - October 2003
Baxter BioScience October 2001 - November 2002
Baxter BioScience July 1998 - October 2001
Silliker November 1996 - June 1998
Diagnostic Laboratories Services/Accupath Hawaii January 1992 - April 1996
Skills
CAPA, FDA, GMP, Validation, Biotechnology, GLP, Sop, Change Control, 21 CFR Part 11, LIMS, Biopharmaceuticals, Aseptic Processing, Microbiology, Pharmaceutical Industry, Medical Devices, GxP, ELISA, Laboratory, Quality Control, SOP
Education
Southwestern University (PH) 1986 — 1990
BS, Medical Technology
Vellez College 1984 — 1986
University of Maryland Greenebaum Cancer Center (UMGCC) June 2013 - Present
University of Maryland School of Medicine; Human Research Protections Office (HRPO) March 2011 - June 2013
Siemens Healthcare Diagnostics June 2010 - February 2011
Baxter Bioscience September 2005 - October 2009
George Washington University January 2004 - September 2005
VA Maryland Health Care System January 2003 - January 2004
Wellstat Biologics April 2000 - January 2003
Skills
GLP, Sop, GMP, Biotechnology, Vaccines, FDA, Regulatory Affairs, Purification, Lifesciences, Clinical Trials, Microbiology, SDS-PAGE, ELISA, Protein Purification, Cell Culture
Education
Johns Hopkins School of Medicine 2009 — 2010
Masters of Science, Regulatory Affairs
Morgan State University 1994 — 1999
Bachelors of Science, Biology
Amgen April 2010 - Present
Baxter BioScience July 2007 - April 2010
Amgen June 2005 - July 2007
Skills
Change Control, Biotechnology, Sop, GMP, Aseptic Processing, Trackwise, Aseptic Technique, SOP authoring, Regulatory Submissions, Document Management, Outlook, Microsoft Excel, Concur, Data Management, Technical Writing, PowerPoint, Microsoft Office, Administrative..., Visio, Training, Biopharmaceuticals, FDA, Regulatory Affairs, CMC, IND, Cell Culture, eCTD, GDP, CMC Regulatory Affairs, cGMP manufacturing, Deviations, cGMP practices, CIP, Biologics, Sterilization, Regulatory Requirements, SOP, TrackWise
Education
Moorpark College
Palomar College
Microsoft applications Certificate
Bell Falla & Associates LLC November 2011 - Present
Harris Interactive Inc. January 2010 - November 2011
Baxter BioScience February 2008 - October 2009
Amgen January 2000 - December 2007
AstraZeneca January 1994 - January 2000
United Drugs January 1993 - February 1994
Merck August 1989 - November 1991
Skills
Biotechnology, Pharmaceutical Industry, Oncology, Market Research, Healthcare, Pricing, Corporate Training, Competitive Analysis, Product Development, Competitive Intelligence, Strategy, Commercialization, Business Planning, Marketing Research, Leadership, Segmentation, Product Launch, Marketing, Brand Management, Global Marketing, Market Analysis, Customer Insight, Business Development, Market Access, Cross-functional Team..., Pharmaceutical Sales, Medical Devices
Education
Penn State University 1986 — 1988
MS, Neurophysiology
Penn State University
Master of Science (M.S.), Neurophysiology
LabCorp August 2013 - Present
Baxter BioScience April 2009 - August 2013
Skills
FDA, CAPA, Sop, 21 CFR Part 11, GMP, Validation, Quality System, Quality Auditing, Change Control, GLP, Quality Assurance, FDA GMP, SOP, Quality Management, Pharmaceutical Industry, Process Improvement, Medical Devices
Education
Pfeiffer University 2006 — 2008
Master, Health Administration
UNC Greensboro 1999 — 2001
Bachelor of Science, Biology
Lash Group (AmerisourceBergen) May 2012 - Present
Baxter Healthcare 2009 - 2012
Baxter Healthcare 2006 - 2008
Baxter BioScience 2006 - 2006
Baxter BioScience 2004 - 2006
Baxter Healthcare 2002 - 2004
Baxter Healthcare 1999 - 2002
Skills
Financial Planning, Financial Analysis, Forecasting, Strategy Development, Competitive Analysis, Financial Modeling, Financial Reporting, Business Analysis, Market Analysis, Product Management, Sales Support, Strategy, Strategic Financial..., Sales Operations, Analysis, Business Process..., Strategic Planning, Product Launch, Finance, Cross-functional Team..., Pricing
Education
Northwestern University - Kellogg School of Management 2003 — 2006
MBA
Miami University 1995 — 1999
B.S.
Pennini Vineyards May 2005 - Present
Cangene February 2008 - November 2012
Cangene Winnipeg February 2008 - November 2012
Talecris Plasma Resources October 2006 - February 2008
Talecris 2006 - 2008
Biolife 1999 - 2007
Baxter Healthcare Corp February 2001 - May 2006
Baxter BioScience April 1998 - May 2006
Sera-Tec December 1999 - February 2001
NABI Biomedical September 1996 - July 1999
Skills
Pharmaceutical Industry, Validation, Regulatory Affairs, Project Management, Process Improvement, Operations Management, Team Building, Change Management, Management, Training, Change Control, Leadership, Human Resources, Team Management, Budgets
Education
Metrocrest Medical 1990 — 1992
Paramedicine, Emergency Medicine
Wisdom Montessori 1986 — 1987
Teaching, Montessori Teacher Education
University of Maryland College Park 1979 — 1980
Prince George's Community College 1975 — 1979
Centers for Disease Control and Prevention May 2009 - Present
Emory University August 2007 - December 2008
AtheroGenics November 2001 - June 2007
Unigen Pharmaceuticals November 2000 - October 2001
Baxter BioScience January 1999 - November 2000
Amgen June 1996 - April 1998
Monsanto March 1989 - May 1996
Washington University School of Medicine June 1987 - March 1989
Skills
Analytical Methods..., Robotics, Drug Discovery, ELISA, Protein Chemistry, Immunoassays, Biology, Assay Development, HPLC, Biotechnology, GLP, Purification, Lifesciences, Chromatography, Infectious Diseases
Education
Southern Illinois University, Edwardsville 1983 — 1987
BS, Biological Sciences
MEDA October 2009 - Present
MEDA June 2005 - September 2009
MEDA August 2002 - June 2005
Baxter BioScience 2000 - 2002
Skills
LIMS, cGMP, GLP, Validation, Environmental Monitoring, Microbiology, Pharmaceuticals, Quality Systems, CAPA, Auditing, Microsoft Office, USP, Technical Writing, Training &..., GMP, Quality System, Pharmaceutical Industry, FDA, Change Control, Aseptic Technique, Cleaning Validation, cGMP manufacturing, Sop, Biopharmaceuticals, 21 CFR Part 11, Regulatory Affairs, Biotechnology, HPLC, Technology Transfer, Lifesciences, Aseptic Processing, Analytical Chemistry, Life Sciences, SOP
Education
Michigan State University 1996 — 1999
B.S.
Baxalta Inc. January 2008 - Present
Baxter BioScience October 2000 - January 2008
eBioCare.com, Inc August 1999 - September 2000
Bayer HealthCare September 1997 - August 1999
Boehringer Mannhiem Corp November 1994 - September 1997
Syntex Labs September 1992 - November 1994
Douglas Aircraft Company July 1987 - September 1992
Skills
Pharmaceutical Sales, Cardiology, Product Launch, Cross-functional Team..., Market Development, Managed Care, Pharmaceutical Industry, Sales Effectiveness, Home Infusion, Market Access, Sales Operations, Healthcare, Home Care, Hospitals, Selling, Sales, Capital Equipment, Strategic Planning, Biotechnology, Urology, Medical Devices, Pharmacy
Education
Purdue University 1983 — 1987
Bachelor of Science Degree, Industrial Engineering
Pepperdine University 1988 — 1990
Masters Degree, Business Administration
BioScrip, Inc. May 2015 - Present
athenahealth January 2012 - May 2015
Baxter BioScience 2005 - 2011
Aventis 2003 - 2005
sanofi-aventis 2001 - 2005
Open Ratings, Inc. 1999 - 2001
Skills
Healthcare Information..., Hospitals, Biotechnology, Pharmaceutical Sales, Managed Care, Sales Operations, Selling, Healthcare, Sales, B2B, EHR, Revenue Cycle Management, Cloud Computing, Pulmonology, Gastroenterology, Product Launch, CRM, Cardiology, Account Management, Salesforce.com, Management, Strategic Planning
Education
Siena College
B of A, English and Spanish
.
Avid Bioservices February 2015 - Present
Agensys January 2010 - October 2014
Life Technologies April 2007 - October 2008
RAD TECHNOLOGIES October 2006 - February 2007
BIOELECTRONICS CORP. September 2005 - October 2006
FLOW SOLUTIONS April 2005 - September 2005
Baxter BioScience March 1995 - July 2004
Amgen February 1990 - March 1995
Skills
Cell Culture, Bioreactors, Supervisory Skills, GMP, Biotechnology, Sop, Technology Transfer, Validation, CAPA, FDA, LIMS, 21 CFR Part 11, GLP, V&V, Change Control, Process Simulation, Aseptic Technique, Clinical Development, Biopharmaceuticals, Cell, Protein Chemistry, SOP, Pharmaceutical Industry, Filtration, ISO, Aseptic Processing, Laboratory, Drug Development, Manufacturing, Six Sigma, Quality Assurance, Cross-functional Team..., Microbiology, Clinical Trials, Medical Devices, Bioreactor, ISO 13485, Monoclonal Antibodies
Education
Moorpark College 1985 — 1986
General
Self-employed October 2009 - Present
Baxter BioScience August 2007 - June 2009
TAP Pharmaceuticals July 2006 - August 2007
TAP Pharmaceuticals March 2004 - July 2006
TAP Pharmaceuticals March 2003 - February 2004
Merck, Inc. November 1986 - January 2002
Skills
Managed Care, Pharmaceutical Industry, Oncology, Cross-functional Team..., Sales Effectiveness, Product Launch, Pharmaceutical Sales
Education
Northwestern University - Kellogg School of Management 1997 — 2000
MBA, Marketing, Strategy, Organizational Behavior
Purdue University School of Pharmacy 1979 — 1984
Pharmacy, Pharmacy major; Marketing, Psychology minors
Cepheid August 2011 - April 2015
Genentech July 2010 - August 2011
Baxter BioScience August 2007 - February 2009
Amgen July 2003 - July 2007
Agilent Technologies April 2000 - June 2003
Hewlett-Packard January 1996 - March 2000
Skills
Ariba, Procurement, Purchasing, Supply Chain Management, Cross-functional Team..., Strategic Sourcing, Project Management, Quality Assurance, Strategic Planning, Contract Negotiation, SAP, Supply Management, Process Improvement, MRP, Product Development, Supply Chain, Negotiation, Materials Management, Strategy
Education
Saint Mary's College of California
B.A., Management
Institute for Supply Management
Certified Purchasing Manager Certificate
Baxter BioScience March 2010 - Present
OsteoMed 2005 - March 2010
Copy Service and Supply July 2004 - May 2005
CheckCare Systems June 2002 - July 2004
Skills
Operating Room, Sales, Surgeons, Capital Equipment, Disposables, Surgical Instruments, B2B, Cardiology, Direct Sales, Market Development, Medical Devices, Orthopedic, Product Launch, Sales Operations, Training, Urology, Sales Effectiveness, Hospitals, Healthcare, Medical Sales, Surgery, Orthopedics
Education
North Carolina State University 1998 — 2002
BA, English
University of Pittsburgh 1997 — 1999
English
CardioNet June 2013 - Present
iRhythm Technologies, Inc. January 2011 - Present
Baxter BioScience June 2008 - December 2010
Kos / Abbott March 2002 - June 2008
AstraZeneca February 2000 - June 2003
S&S Dental November 1998 - January 2000
Skills
Hospitals, Medical Devices, Oncology, Cardiology, Healthcare, Consultative Selling, Sales Presentations, New Business Development, Cardiac, Pharmaceutical Sales, Interventional Radiology, Vascular Surgery, Neurosurgery, Orthopedic, Operating Room, Selling, Market Development, Medical Sales, Product Launch, Sales, Sales Operations
Education
Old Dominion University 1990 — 1995
Bachelor of Science
PRA International June 2012 - Present
Baxter BioScience December 2008 - June 2012
Baxter BioScience December 2006 - November 2008
Point Therapeutics March 2004 - December 2006
Poinit Therapeutics 2003 - 2006
Skills
Clinical Trial..., Protocol Development, GCP, CRO, Clinical Monitoring, CTMS, Protocol, Clinical Trials, Oncology, Clinical Development, Clinical Research, Clinical Operations, Regulatory Affairs, Clinical Data Management, Infectious Diseases, ICH-GCP, Medical Writing, Phase I, Therapeutic Areas, FDA, EDC, Sop, Pharmaceutical Industry, Regulatory Submissions, Drug Development, Clinical Study Design
Education
Saint Anselm College 1998 — 2002
Bachelor's degree, Psychology
Gracenote September 2009 - Present
318, Inc. January 2008 - September 2009
Innoventive Software March 2005 - March 2008
Jungle Software July 2003 - October 2006
Baxter BioScience October 2001 - June 2003
Professional Tutors of America January 2001 - June 2003
Lightmotive September 1999 - December 2000
Endeavor May 1997 - August 1999
Skills
Agile Methodologies, Competitive Analysis, Entertainment, Strategic Partnerships, Data Science, R, Marketing Strategy, Television, Product Management, Databases, Budgets, Digital Media, Content Management, Social Media Marketing, Film, Product Development, Management, Mobile Devices, Online Advertising, Digital Marketing, New Media, Digital Distribution, Content Strategy, Product Marketing, Start-ups, Publishing, Digital Strategy, Online Marketing, Video Production, Budgeting, Public Speaking, Marketing, SEO, Post Production, Video, Analytics
Education
University of California, Los Angeles - The Anderson School of Management 2008 — 2011
MBA
Northwestern University 1989 — 1993
BS Speech, Radio/Television/Film
Coursera
Jones Lang LaSalle March 2011 - December 2012
St. Jude Medical July 2006 - December 2009
Baxter BioScience May 2002 - May 2003
Fusion Medical December 1999 - May 2002
Life Systems, Inc. March 1996 - December 1999
Skills
Real Estate, Property Management, Corporate Real Estate, Selling, Lease Negotiations, Leases, New Business Development, Real Estate Transactions, Contract Negotiation, Tenant, Medical Devices, Sales, Brokerage, Residential Homes, Investment Properties, Negotiation, Asset Management, Commercial Real Estate, Location Intelligence, Due Diligence, Marketing, Lease Administration, Tenant Representation, Real Estate Development, Disposition, Cardiology, Product Launch, Market Development, Healthcare
Education
Purdue University 1986 — 1991
B.S.Business, Business/Marketing
Edwards Lifesciences August 2009 - March 2014
CH2M HILL June 2004 - December 2007
Boston Scientific 2006 - 2007
Baxter Bioscience 1998 - 2002
Education
University of Miami - School of Business 2002 — 2004
MBA
San Francisco State University 1992 — 1997
Bio-Engineering
SCA Americas March 2003 - Present
SCA Americas November 2010 - September 2012
SCA Americas May 2007 - October 2010
SCA Americas 2003 - 2008
Baxter Bioscience 2000 - 2003
LA Works 2000 - 2000
Maltin Plack Group 1998 - 2000
Bobrick Washroom Equipment 1989 - 1998
Skills
Product Management, Product Marketing, Technical Project..., Product Launch, Customer Insight, Competitive Analysis, Management, Consumer Products, Strategy, Business Development, Market Planning, Business Planning, Key Account Development, Leadership, Sales Operations, Market Research, Product Development, Pricing, Marketing, Marketing Management, Pricing Strategy, Market Analysis, Cross-functional Team..., Sales
Education
University of Nevada Las Vegas Lee Business School 2004 — 2007
MBA, Marketing
Ryerson University 1988 — 1990
Interior Design, Interior Design
York University 1980 — 1984
BFA, Fine Arts, Dance
Vincent Massey 1975 — 1980
SSHGD, English Language and Literature, General
Baxter BioScience June 2008 - Present
Skills
Biotechnology, Protein Purification, GLP, R&D, Biochemistry, ELISA, Immunoassays, Minitab, Continuous Improvement, Six Sigma, DMAIC, FDA, Molecular Biology
Education
University of California, Los Angeles 2005 — 2007
Bachelor, Biochemistry
Pasadena City College
Sandoz August 2014 - Present
Baxter Healthcare July 2012 - July 2014
Baxter Healthcare July 2012 - February 2013
Novartis September 2011 - June 2012
Amgen 2006 - 2011
Baxter BioScience 1999 - 2006
UCSB 1997 - 1998
Skills
PLC Programming, DCS, Delta V, Emerson DeltaV, Allen Bradley, PLC Allen Bradley, Modicon, Intellution, iFix, Validation, Computer System..., Project Engineering, MS Project, Biotechnology, MBA, Project Management, HMIs, Commission, Batch Programming, GAMP, Root Cause Analysis, FMEA, 21 CFR Part 11, Process Control, PLC, Process Engineering, Process Simulation, FDA, GMP, Technology Transfer, Quality Assurance, Software Documentation, Aseptic Processing, Sop, Change Control, Biopharmaceuticals, Automation, Calibration, MES, GxP, Quality System, Microsoft Project
Education
Pepperdine University, The George L. Graziadio School of Business and Management 2007 — 2010
MBA, Business Administration
University of California, Santa Barbara 1997 — 1998
MS, Engineering
Al-Jami'ah Al-Urdunia 1992 — 1997
BS, Engineering
Gilead Sciences May 2014 - Present
Biomedix Validation, Inc. October 2004 - Present
BAXTER BIOSCIENCE June 2013 - May 2014
Finesse Solutions January 2013 - June 2013
Bayer HealthCare 2011 - February 2013
Novartis Vaccines and Diagnostics 2006 - 2007
Fluor 2005 - 2007
Nektar January 2002 - 2003
Cell Genesys 2002 - 2003
Genzyme 1999 - 2002
Skills
Validation, Computer System..., GMP, Change Control, cGMP, Process Validation, CAPA, Biotechnology, GAMP, FDA, Calibration, 21 CFR Part 11, Medical Devices, GxP, Automation, QC, Quality Systems, Process Development, Instrumentation, Cleaning Validation, Pharmaceuticals, Commissioning, Quality Assurance, Process Control, Documentation, SOP, Process Engineering, Aseptic Processing, Life Sciences, Engineering, CIP, Technology Transfer, DeltaV, GLP, Biopharmaceuticals, Root Cause Analysis, DCS, Continuous Improvement, SDLC, Document Management, PLC, MES, Troubleshooting, V&V, Software Documentation, Sop, Pharmaceutical Industry, LIMS, Trackwise, ISO 13485
Education
Odessa State Polytechnic University 1978 — 1984
MS, Electrical and Electronics Engineering
Baxter International Inc. November 2013 - Present
Pharmavite 2009 - Present
Baxter BioScience 2005 - 2009
V. Suarez & Co. 2000 - 2005
Novartis Pharmaceuticals. 1991 - 1998
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Research, Windows, Outlook, Teaching, HTML, Public Speaking, Budgets, Strategic Planning, Management, Supply Chain, Supply Chain Management
Education
Pontifical Catholic University of Puerto Rico, School of Law
Bachelors Degree, Accounting, Cost Management
Capricor Therapeutics, Inc. February 2015 - Present
Baxter BioScience January 2008 - February 2015
SIGA Technologies Inc. February 2005 - December 2007
Biosyn Inc. January 2003 - February 2005
Skills
GCP, Regulatory Affairs, Clinical Development, FDA, GMP, GLP, Project Management, Biotechnology, Pharmaceutical Industry, Manufacturing, Intellectual Property, Molecular Biology, Biopharmaceuticals, R&D, Cross-functional Team..., Clinical Research, Drug Development
Education
Smith College
B.A., Biological Sciences
The Johns Hopkins University
M.S., Biotechnology
CIRTEC Medical Systems June 2012 - Present
Jenny Kahn, PHR 2006 - Present
DBM January 2009 - March 2010
Jones Lang LaSalle November 2007 - April 2008
Boston Scientific Corp July 2007 - September 2007
Baxter BioScience November 2006 - July 2007
University Of Phoenix December 2002 - January 2006
Drake Beam Morin September 2001 - August 2002
SensArray January 2001 - April 2001
Mattson Technology July 2000 - December 2000
Skills
Applicant Tracking..., Recruiting, Training, Sourcing, Technical Recruiting, Interviews, Human Resources, Career Counseling, Resume Writing, Program Management, Contract Recruitment, Strategic Sourcing, Medical Devices, Screening, Talent Acquisition, College Recruiting, Leadership, Management, Internet Recruiting, Start-ups, Talent Management, Coaching, Networking
Education
DeAnza College
Associate of Arts, General Education
San Jose State University
BS, Business-Marketing
Onyx Pharmaceuticals November 2014 - Present
Real Staffing April 2014 - September 2014
Aerotek September 2013 - April 2014
Genentech, Inc. June 2012 - August 2013
Kelly Services October 2011 - June 2012
Baxter BioScience December 2010 - November 2011
Atribord & Associés May 2010 - December 2010
Genentech February 2007 - June 2009
Almac Group November 2005 - December 2006
Gentiae Clinical Research 2003 - 2005
Skills
Oncology, Clinical Trials, Biotechnology, GCP, CTMS, Clinical Development, Project Management, Budgets, Clinical Research, CRO, FDA, Process Improvement, Drug Development, Sop, Biopharmaceuticals, Neurology, SOP, EDC
Education
International School of Management 2009 — 2012
MBA (In progress), International Business
San Francisco State University 1998 — 2002
BA, English/Creative Writing
Thomas Downey High School
Thomas Downey High School
Alpharma Engineering ManagerICIFebruary 2005 - August 2006
Baxter BioScience February 2002 - February 2005
Milliken and Company 1985 - 1992
Education
Mississippi State University 1980 — 1987
Braille Institute of America August 2015 - Present
Milken Institute January 2014 - December 2014
Atypical Brands, LLC July 2013 - January 2014
Volunteers of America Los Angeles November 2011 - November 2012
Livingreen January 2008 - October 2010
California Hardware September 2007 - May 2009
Bitemark Records November 2006 - September 2007
Wooden Window, Inc. October 2005 - October 2006
Baxter BioScience May 2004 - April 2005
Brighter Pictures/Endemol February 2003 - December 2003
Skills
Social Media, Online Marketing, Sales Trainings, Customer Service, Team Building, Customer Relations, Database Management, E-commerce, Online Communities, Web Services, Social Networking, Non-profits, Fundraising, Strategic Negotiations, New Media, Film Production, Newsletters, Volunteer Recruiting, Non-profit Volunteer, Social Media Marketing, Sales Presentations, Sales Management, Green Building, Green Marketing, Trade Shows, Marketing Strategy, Sales, Management, Customer Support, Sustainability, Email Marketing, SEO, Online Advertising, Integrated Marketing, Event Management, Event Planning, Marketing, Brand Development, Content Strategy, Lead Generation, Community Outreach, Web Marketing, Brand Management, Marketing Management, Strategy, Relationship Marketing, B2B, Web Content Management, Direct Marketing, Social Marketing
Education
San Francisco State University 1994 — 1996
ArjoHuntleigh May 2014 - Present
Campaign Hilda Solis for County Supervisor April 2014 - Present
Long Beach Fire Department August 2012 - Present
Long Beach Fire Department "CERT" 2009 - 2015
Long Beach Fire Department "CERT" 2009 - 2015
Law offices of Michael Colmenares February 2013 - October 2013
Long Beach Police Department 2009 - March 2013
Baxter BioScience December 2011 - June 2012
TIMEC INC. / WellTech Safety September 2010 - May 2012
International Brotherhood Of Electrical Workers (IBEW) Local 11 December 2005 - February 2007
Skills
Risk Assessment, Quality Assurance, Strategic Planning, Safety Management..., Change Management, Root Cause Analysis, Investigation, Training, Project Planning, Energy, Contract Management, Testing, Manufacturing, Inspection, Supervisory Skills, Process Engineering, Analysis, Construction, Risk Management, GMP, Accident Investigation, Engineering, Electricians, Process Improvement, Industrial Safety, Procurement, Metal Fabrication, Project Management, Hazardous Waste..., Operations Management, EHS, Lean Manufacturing, Auditing, Time Management, Management, Quality System, Continuous Improvement, Refinery, Leadership
Education
Los Angeles Trade-Technical College (LATTC) 2012 — 2013
Associate of Science (A.S.), Plant Process Technology
American National Red Cross 2012 — 2012
CERTIFICATE, CPR/FIRST AID/AED Automated External Defibrillator. "Training and Certification"
Los Angeles Trade-Technical College (LATTC) 2011 — 2012
CERTIFICATE, Plant Process Technology
Health Science Associates (HSA) 2011 — 2011
California Department of Public Health Certificate, Lead Abatement
Creation World Safety 2010 — 2010
Certification, OSHA Safety Training / Health & Safety Training
Occupational Safety Councils of America (OSCA) 2010 — 2010
Certifications, OSHA Safety Training / Health & Safety Training
Federal Highway Administration Construction Apprenticeship Pathways Program 2009 — 2009
Certifications, OSHA Safety Training / Health & Safety Training
Electrical Training Institute (ETI) "NJATC/NECA" 2006 — 2007
Certifications, Safety Training (Electrical Apprentice)
Mt. San Antonio College 2000 — 2002
Cert, Computer Information Systems
Colegio Bautista
Banner Medical Group August 2014 - Present
UCSf Fresno July 2009 - June 2014
Amgen December 2002 - July 2004
Baxter BioScience January 2002 - December 2002
Skills
Aseptic Processing, Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, General Surgery, Aseptic Technique, Sop, LIMS, GMP, FDA, CAPA, Purification, Validation, GLP, Clinical Research, Protein Purification, Healthcare, Surgery
Education
Michigan State University College of Human Medicine 2005 — 2009
Doctor of Medicine (MD), Medicine
Pepperdine University 1997 — 2001
Bachelor of Science, Natural Sciences
KaVo Kerr Group October 2013 - Present
Dentsply 2013 - 2013
Dentsply 2010 - 2013
Cohera Medical July 2008 - October 2010
Polymer Science February 2008 - July 2008
King Pharmaceuticals June 2004 - February 2008
Pfizer October 2003 - March 2004
Baxter BioScience May 2001 - December 2001
Skills
ISO 13485, cGMP, Auditing, Clinical Trials, ISO 14971, Supplier Management, Procedure Development, FDA, Regulatory Affairs, Quality Systems, Medical Devices, 510 K, Regulatory Submissions, CE marking, Quality System, CAPA, Quality Control..., GMP, Quality Assurance, Sop, Supply Management, Aseptic Processing, Quality Control, Trackwise, Regulatory Requirements, Validation, ISO, V&V, Change Control, Quality Management, GxP, Quality Auditing, Supplier Quality, Pharmaceutical Industry, Sterilization, 21 CFR Part 11, Design Control, R&D, 21 CFR, Laboratory, GLP, SOP
Education
Oakland University 1998 — 2001
BS, Biology
Oakland Community College 1995 — 1998
Associates, Liberal Arts
Waife & Associates, Inc. 2015 - Present
Allergan 2014 - 2015
Allergan 2004 - 2014
Allergan 2001 - 2004
Baxter BioScience 1999 - 2001
Cocensys 1997 - 1999
Paragon Biomedical 1996 - 1997
IBRD-Rostrum 1985 - 1996
Skills
Clinical Development, Pharmaceutical Industry, Cross-functional Team..., Clinical Trials, CRO, FDA, Biotechnology, CTMS, 21 CFR Part 11, GCP, Clinical Research, R&D, Validation, Sop, Information Technology, Regulatory Submissions, Medical Devices, Regulatory Affairs, Life Sciences, Drug Development, Lifesciences, CAPA, Oncology, GMP, Technology Management, Informatics, Biopharmaceuticals, Strategic Planning, Executive Management, Clinical Data Management, Change Control, GLP, Quality Assurance, Drug Discovery, Business Planning, Cardiology, Regulatory Requirements, Quality System, Business Process..., Protocol, GxP, Commercialization, Process Optimization, Technology Transfer, Analytics, Project Management, SOP, Strategy, Process Improvement, Management
Education
University of California, Irvine 1977 — 1982
BS
University of California, Irvine 1977 — 1982
BS
Pacific States University 1980 — 1980
MBA
RUN-WithIT September 2014 - Present
Independent Consulting May 2011 - Present
Haemonetics September 2004 - April 2011
Baxter BioScience February 2002 - September 2004
Maxum Development October 1995 - September 2001
Baxter Healthcare October 1992 - October 1995
PolyScience September 1991 - September 1992
Skills
Quality Assurance, Testing, Process Improvement, Requirements Analysis, SDLC, Software Quality..., Agile Methodologies, Requirement..., Business Process, Cross-functional Team..., Software Documentation, Analysis, Business Analysis, Team Building, Software Project..., Visio, Training, Risk Analysis, Quality Management, Integration, Medical Devices, ISO 13485, Continuous Improvement, MS Project, Six Sigma, Software Engineering, Start-ups, SQL, Software Development, Validation, CAPA, Communication, PowerPoint, Software Measurement, JIRA
Education
Northwestern University 1987 — 1991
BS, Electrical Engineering
Northwestern University
Bachelor's degree
Hyde Engineering + Consulting January 2015 - Present
Amgen April 2011 - December 2014
Amgen April 2009 - April 2011
Amgen October 2005 - April 2009
CimQuest (Subcontracted to Amgen) October 2004 - October 2005
Baxter Bioscience July 2003 - October 2004
CAPE Software 1998 - 2003
Wunderlich-Malec 2001 - 2002
Skills
Validation, FDA, Technology Transfer, V&V, Process Simulation, Sop, Process Engineering, Computer System..., Chromatography, Cleaning Validation, Automation, Software Documentation, Biotechnology, Biopharmaceuticals, 21 CFR Part 11, Fermentation, Pharmaceutical Industry, PLC, SOP
Education
Rice University 1993 — 1999
BS, Chemical Engineering
MedImmune November 2011 - Present
Aerotek April 2011 - November 2011
Baxter BioScience April 2009 - December 2010
NOVAVAX, INC November 2006 - April 2009
QVS DESIGN, INC June 2005 - September 2006
National Science Foundation July 2002 - January 2004
Skills
GCP
Education
Salisbury University 2001 — 2005
BS, Biology
Helsinn Oncology August 2013 - Present
R.Williams Electric January 2011 - July 2013
Baxter BioScience April 2009 - December 2010
MGI Pharma (Eisai Inc.) January 2005 - April 2009
Accurate Medical August 2003 - December 2004
Propst Pharmaceuticals June 2001 - July 2003
Genentech January 1992 - December 1997
Skills
Oncology, Hematology, Cardiology, Endocrinology, Surgery, Pediatrics, Pulmonology, Anesthesia, Critical Care, Emergency Medicine, Strategic Planning, Mentoring, Coaching, Budgeting, Talent Management, Managed Care, Hospitals, Infectious Diseases, Biotechnology, Pharmaceuticals, Urology, Product Launches, Neurology, Pharmaceutical Sales, Allergy, Account Management, Product Launch, Sales Management, Public Speaking, Hiring, Pain Management, Selling, Rheumatology, Budgets, Pharmaceutical Industry, Healthcare, Hospital Sales, Gastroenterology, Buy & Bill, Nephrology, Diabetes
Education
Midwestern State University
Bachelor of Science (BS), Criminal Justice/Police Science
The University of Texas at Austin
University of Alabama
New York University August 2014 - Present
Crump Institute UCLA February 2012 - August 2014
Baxter BioScience February 2013 - December 2013
Istituto Superiore di Sanità July 2011 - September 2011
Skills
Biotechnology, Analytical Chemistry, GMP, HPLC, Pharmaceutical Industry, Microsoft Office, Microsoft Word, PowerPoint, Research, Microsoft Excel
Education
New York University 2014 — 2019
Doctor of Philosophy (Ph.D.), Chemistry
University of California, Los Angeles 2010 — 2014
Bachelor of Science (B.S.), Chemistry
BioMarin Pharmaceutical Inc. December 2013 - August 2014
Ventana Medical Systems September 2012 - October 2012
Roche Molecular Systems April 2010 - September 2010
Neugenesis Corporation February 2010 - March 2010
Baxter BioScience September 2007 - April 2008
Novartis Oncology June 2007 - July 2007
Genitope April 2006 - June 2006
Bio-Rad Laboratories March 2005 - May 2006
FibroGen February 2000 - April 2003
Valentis June 1998 - January 2000
Skills
SDS-PAGE, ELISA, Purification, Cell Culture, Protein Chemistry, Protein Purification, Western Blotting, Chromatography, Assay Development, Biopharmaceuticals, Cell Biology, PCR, Fermentation, Protein Expression, Biotechnology, Biochemistry, HPLC, AKTA, Antibodies, Cancer, UV/Vis, Virology, GLP, DNA, GMP, In Vitro, Multiprotein complex..., LIMS
Education
San Francisco State University 1986 — 1991
Bachler of Science, Biomedical Sciences, General
Baxter BioScience October 2007 - Present
Baxter 2000 - 2005
Skills
Excel, Word, PowerPoint, LIMS, HPLC, UV-Vis, Chemstation, GMP, CAPA
Education
Messiah College 1993 — 1997
BS, Environmental Science
Boeing March 2012 - Present
Diageo March 2010 - July 2011
Baxter BioScience September 2006 - March 2010
Baxter BioScience March 2005 - August 2006
Baxter BioScience March 2004 - February 2005
Baxter BioScience March 2002 - February 2004
Avecia June 1999 - February 2002
Schlumberger October 1998 - February 1999
Skills
Continuous Improvement, Lean Manufacturing, DMAIC, Kaizen, Kaizen Facilitation, 5S, Value Stream Mapping, TPM, Minitab, Microsoft Office, Change Management, Supply Chain, Manufacturing, MS Project, GMP, Problem Solving, Process Improvement, Supervisory Skills, Materials Management, Inventory Management, Investigations, Team Leadership, Budget Management, Technical Writing, Training Skills, Procedure Manuals, JD Edwards, SAP, Production Planning, Manufacturing Management, Six Sigma, CAPA, Kanban, Mistake Proofing (Poka..., ERP, MRP, Root Cause Analysis, Pareto Analysis, Biotechnology, Alcoholic Beverages, Aerospace Manufacturing, Hydraulic Fracturing, Well Stimulation, Strategic Planning, Presenting Solutions, Analysis, Networking, Quality System, Training, FMEA
Education
Penn State University 1993 — 1998
BS, Chemical Engineering
Brandywine High School
Baxter International Inc. November 2014 - Present
Baxter International Inc. September 2012 - Present
Baxter BioScience May 2006 - Present
Baxter Healthcare August 2001 - May 2006
Aon Hewitt May 2000 - August 2000
Skills
Operating Room, Orthopedic, Capital Equipment, Medical Devices, Surgeons, Market Development, Management, Sales Effectiveness, Product Launch, General Surgery, Biologics, Product Development, Surgery, Competitive Analysis, Spine, Biotechnology, Healthcare, Cardiology
Education
Northwestern University - Kellogg School of Management 2014 — 2015
Master of Business Administration (M.B.A.) - Executive Program, Finance / Marketing, Year 1
University of Illinois at Urbana-Champaign - College of Business 1998 — 2001
BS Finance, Finance + Accounting
Katie Kalk Consulting May 2009 - Present
Baxter BioScience July 2008 - May 2009
BrightStar Partners 2006 - 2009
Infor January 1999 - November 2006
Dekko Heating Technologies 1997 - 1999
Katie Kalk Consulting 1996 - 1999
Sullair Corporation 1985 - 1996
Katie Kalk Accounting September 1981 - March 1985
Skills
Cognos, Oracle, Integration, Data Warehousing, ETL, Business Intelligence, Enterprise Software, Business Analysis, Cognos ReportNet, SQL, Microsoft SQL Server, ERP, Process Improvement, JD Edwards, Software Documentation, Cubes, T-SQL, Requirements Analysis, Financial Reporting, Hyperion Enterprise
Education
Purdue University 1977 — 1984
Michigan City Rogers
Amgen August 2011 - Present
Zodiac Pool Systems, Inc. June 2008 - October 2011
Baxter BioScience 2005 - 2008
Amgen 1992 - 2004
Skills
Time Management, Management, Concur, Outlook, Analysis, Customer Satisfaction, Administrative..., Budgets, Teamwork, PowerPoint, Microsoft Excel, Microsoft Word, Pharmaceutical Industry, Microsoft Office, Cross-functional Team..., Process Improvement
Education
Moorpark College
Business
Amec Foster Wheeler October 2013 - Present
Boehringer Ingelheim February 2012 - October 2013
Yonkers Industries, Inc April 2004 - February 2012
Amgen 2006 - 2007
Genentech 2004 - 2007
Baxter BioScience 2004 - 2006
CRB April 1994 - April 2004
CRS Sirrine 1988 - 1994
Skills
Engineering, GMP, Project Management, Validation, Biotechnology, Change Control, FDA, Pharmaceutical Industry, Process Engineering, CAPA
Education
North Carolina State University 1982 — 1988
BSME, Heat Transfer, Fluid Dynamics, Thermodynamics
Baxter International Inc. June 2014 - Present
Softcom Systems Inc February 2005 - Present
CCH, a part of Wolters Kluwer January 2014 - May 2014
Caterpillar Inc. June 2012 - December 2013
Northern Trust August 2010 - June 2012
OfficeMax March 2010 - July 2010
Baxter BioScience September 2009 - February 2010
OfficeMax March 2009 - September 2009
Baxter BioScience December 2008 - March 2009
OfficeMax July 2008 - October 2008
Skills
Data Warehousing, ETL, Oracle, Business Intelligence, Data Modeling, Datastage, Teradata, Data Integration, Unix Shell Scripting, Testing, Data Analysis, Business Objects, Microsoft SQL Server, IBM IS BigInsights, SQL, SAP Data Services, IBM IS Streams, Big Data, Cognos, Cognos Data manager, BODS, Shell Scripting, AWS kinesis, Python, AWS Redshift
Education
Osmania University 2000 — 2002
Master's, Computer Science
University of New Orleans
Master’s Degree, Computer Science
Amgen January 2009 - Present
Amgen, Inc. June 2006 - January 2009
Amgen March 2004 - June 2006
Baxter BioScience 1998 - 2004
Baxter BioScience 1984 - 2004
Baxter Healthcare 1984 - 2004
Skills
Human Resources, Talent Management, Succession Planning, Deferred Compensation, Onboarding, Performance Management, Employee Relations, Workforce Planning, Talent Acquisition, Pharmaceutical Industry, HRIS, Organizational..., Organizational Design, Employee Engagement, Change Management
Education
Southern Illinois University, Carbondale
Business Administration and Management, General
Federal Data Systems September 2014 - Present
SMS Data Products Group, Inc. July 2005 - September 2014
ITA 2005 - 2010
ITA 2005 - 2010
CherryRoad Technologies 2003 - 2004
Baxter BioScience 2003 - 2004
CAE Link 1986 - 1992
Skills
CISSP, Information Assurance, Security, Network Security, Catalyst Switches, Juniper, Firewalls, Cisco Technologies, Network Engineering, Switches, Network Architecture, Data Center, Networking, Integration, Security+, Information Security, TCP/IP, Disaster Recovery, BGP, Computer Security, Systems Engineering, Routers, Troubleshooting, CCNA, ITIL, DoD, Network Design
Education
Penn State University 1981 — 1985
BS, EET
Sanofi - CEPiA April 2014 - Present
Self October 2012 - April 2014
Baxter BioScience October 2007 - October 2012
Baxter/Epic Therapeutics January 2006 - October 2007
Baxter August 2003 - December 2005
Baxter May 2002 - December 2005
Diosynth July 2000 - May 2002
Pfizer 1995 - July 2000
American Cyanamid 1989 - 1993
Skills
Process Improvement, Program Management, Quality Assurance, Six Sigma, Project Management, Management, MS Project, Product Development, Manufacturing, Lean Manufacturing, Business Development, Budgets, Project Planning, Integration, Process Simulation, Logistics, GMP, R&D, Proposal Writing, Cross-functional Team..., Medical Devices, Clinical Trials, Strategy, Biotechnology, FDA, Pharmaceutical Industry, Technology Transfer, Biopharmaceuticals
Education
University of Nebraska-Lincoln 1996 — 1998
MBA, International Business
New York Medical College 1989 — 1993
MS, Microbiology and Immunology
University at Albany, SUNY 1986 — 1989
BS, Combined
State University of New York at New Paltz 1985 — 1986
Transfer, Biology
Genentech March 2011 - Present
Genentech April 2010 - March 2011
Genentech July 2004 - March 2009
Baxter BioScience June 2004 - January 2005
Skills
GMP, Biotechnology, Validation, GLP, FDA, LIMS, SOP, CAPA, Biopharmaceuticals, Change Control, 21 CFR Part 11, Quality Assurance, Cross-functional Team..., Quality Control, Pharmaceutical Industry, Life Sciences, Microbiology, Management
Education
San Francisco State University, College of Business 2005 — 2007
MBA, Business
University of California, Santa Barbara 1998 — 2003
Bachelor of Arts (B.A.), Biological Sciences and Asian American Studies
Hoover High School
Baxter International Inc. November 2012 - Present
Baxter October 2008 - November 2012
Baxter BioScience March 2007 - October 2008
Baxter Healthcare June 2005 - February 2007
Skills
Kanban, Pharmaceutics, CAPA, Change Control, V&V, FDA, Validation, GMP, Quality System
Education
North Carolina State University 1994 — 1997
Bachelor of Science, Chemical Engineering
Baxalta March 2014 - Present
Baxter BioScience September 2011 - March 2014
Baxter Bio Science February 2009 - September 2011
Baxter Bioscience-Los Angeles January 2007 - February 2009
Baxter BioScience August 2005 - January 2007
Baxter Healthcare July 2001 - August 2005
Skills
Management, Operational Excellence, Packaging, CAPA, Formulation, Aseptic Processing, Manufacturing, FDA, Supply Chain Management, Lyophilization, GMP, Sop, Change Control, Cross-functional Team..., Validation, Pharmaceutical Industry, Lean Manufacturing, Quality Assurance, Biotechnology
Education
University of Arkansas at Little Rock 1999 — 2001
MBA
Southern Arkansas University 1991 — 1995
Bachelor of Science (B.S.), Biology/Biological Sciences, Chemistry
Baxter Healthcare November 2011 - Present
Baxter BioScience April 2009 - December 2011
Baxter BioScience July 2006 - March 2009
Baxter BioScience October 1998 - December 2005
Baxter BioScience September 1997 - October 1999
Skills
Lean Manufacturing, Six Sigma, CAPA, FDA, GMP, Quality System, Validation, Change Control, SOP, Pharmaceutical Industry, 21 CFR Part 11, Cross-functional Team..., Continuous Improvement, Quality Assurance
Education
Northern Arizona University 1993 — 1997
Baxter International Inc. January 2013 - Present
Baxter Healthcare December 2010 - January 2013
Baxter August 2009 - December 2010
Baxter BioScience January 2008 - August 2009
Dendreon October 2006 - June 2007
Zymogenetics July 2002 - October 2006
Skills
Validation, Black Belt, Lean Manufacturing, Six Sigma, Process Simulation, Sop, Cleaning Validation
Education
North Carolina State University 1993 — 1998
Ph.D., Biochemistry
Washington State University 1984 — 1990
BS, Biology - Genetics and Cell Biology
Amgen December 2013 - Present
Amgen February 2012 - December 2012
Standard Insurance Company April 2008 - January 2009
Baxter BioScience May 2002 - September 2005
JWT INSIDE 1998 - 2001
BSA Advertising 1996 - 1997
Skills
Coaching, Project Planning, Software Documentation, Public Speaking, Process Improvement, Project Management, Event Planning, Program Management, Leadership Development, Organizational..., Technical Writing, Organizational..., Training, Account Management, Instructional Design, Leadership
Education
San Diego State University-California State University 1984 — 1986
BA, English
San Diego State University-California State University
English , English
Baxalta April 2013 - Present
Baxter International Inc. January 2010 - April 2013
Baxter Bioscience January 2007 - January 2010
Skills
Variance Analysis, Sarbanes-Oxley Act, GMP, JD Edwards, Cross-functional Team..., Forecasting, Biotechnology, Business Process..., Finance, Financial Analysis, Financial Modeling, Financial Reporting, Internal Controls, Medical Devices, Process Improvement, Strategic Financial...
Education
San Diego State University-California State University 2004 — 2006
MBA, Finance
University of California, Berkeley 1997 — 2001
BA, Integrative Biology
Baxter BioScience February 2007 - Present
Amgen August 2004 - February 2007
Education
Minnesota State University, Mankato 2001 — 2004
Baxter BioScience 2002 - 2004
Skills
Six Sigma, Purchasing, Supply Chain Management, Process Improvement, Forecasting, Procurement, Manufacturing, Strategic Sourcing, Supply Chain, Logistics Management, SAP, Lean Manufacturing, Cross-functional Team..., Continuous Improvement, Inventory Management
Education
Michigan State University 1986 — 1990
Bachelor of Science, School of Business, Materials & Logistics Management
CCO Sweet! March 2014 - Present
Edelman February 2012 - March 2014
Baxter BioScience March 2008 - December 2011
Kennedy Communications Consulting March 2005 - September 2008
Amgen 2003 - 2005
Genentech February 1997 - December 2002
Lena Chow Advertising March 1988 - October 1994
MDL Information Systems 1985 - 1988
Skills
Internal Communications, Media Relations, Public Relations, Philanthropy, Global Communications, Patient Advocacy, Social Media, Corporate Branding, Brand Communication, Advertising, Change Management, Healthcare, Financial Communications, Life Sciences, Executive Communications, Issues Management, Communication Training, Lifesciences, Integrated Marketing, Strategy, Reputation Management, Marketing Communications, Message Development, Crisis Management, Corporate Social..., Marketing, Strategic Communications, Corporate Communications, Press Releases, Fundraising, Crisis Communications, Strategic Planning, Social Media Marketing, Messaging, Public Affairs
Education
San Jose State University
Bachelor's degree
Baxter Bioscience. January 2015 - Present
Amgen August 2010 - January 2015
Amgen June 2007 - August 2010
Amgen April 2006 - June 2007
Amgen November 2003 - April 2006
Allergan June 1998 - November 2003
Allergan 1997 - 2003
Allergan June 1997 - June 1998
Skills
Biotechnology, Validation, Lifesciences, Biopharmaceuticals, Pharmaceutical Industry, FDA, GMP, Technology Transfer, CAPA, SOP
Education
Pepperdine University, The George L. Graziadio School of Business and Management
Hospira, a Pfizer Company June 2012 - Present
Baxter BioScience January 2009 - June 2012
Amylin January 2008 - January 2009
Amgen October 2006 - October 2007
Cambrex North Brunswick, Inc. January 1998 - October 2006
Celgene Corporation July 1996 - January 1998
Skills
R&D, Drug Product, Biotechnology, Clinical Development, V&V, GMP, Chemistry, Characterization, Medical Devices, Technology Transfer, Validation, FDA, Change Control, Pharmaceutical Industry, Formulation, Filtration, Sop, GLP, Regulatory Submissions, Lyophilization, Lifesciences, Process Simulation, Chromatography, Pharmaceutics, Quality System, HPLC, Regulatory Affairs, Purification, Protein Chemistry, Engineering, Product Development, CAPA, Chemical Engineering, Drug Development, UV/Vis, Biologics, Aseptic Processing, Commercialization, Cell Culture, Aseptic Technique, Biopharmaceuticals, Drug Discovery, Analytical Chemistry, Manufacturing, Cross-functional Team..., Process Engineering, 21 CFR Part 11
Education
Rutgers, The State University of New Jersey-New Brunswick 2002 — 2004
MBA, General Management
University of Mumbai
BChemEng, Chemical Engineering
University of Pittsburgh
PhD, Chemical and Bio-chemical Engineering
UCLA July 2012 - Present
Moorpark College January 2010 - June 2012
PQC Consulting, Inc. March 2009 - August 2010
Baxter BioScience February 2008 - September 2008
Amgen, Inc May 2002 - October 2007
Amgen April 1998 - May 2002
Amgen December 1991 - April 1998
W. R. Grace & Co. August 1987 - December 1991
Skills
Pharmaceutical Industry, Validation, Biopharmaceuticals, Cross-functional Team..., FDA, Protein Chemistry, GMP, Drug Discovery, Operations Management, Biotechnology, Product Development, Life Sciences, Manufacturing, Process Simulation, Chemical Engineering, Laboratory, Engineering, Technology Transfer, Regulatory Affairs, Chemistry, Technical Writing, Protein Purification, Clinical Trials, Lifesciences, Chromatography
Education
University of Wisconsin-Madison 1982 — 1987
PhD, Chemical Engineering
Michigan Technological University 1978 — 1982
BS, Chemical Engineering
Baxter BioScience January 2010 - Present
Silver Lake Research Corporation January 2006 - July 2008
Education
Pepperdine University 2001 — 2005
PaxVax, Inc. March 2014 - Present
PaxVax, Inc. March 2014 - December 2014
Baxter BioScience January 2009 - March 2014
OncoGenex Pharmaceuticals July 2006 - July 2008
OncoGenex Pharmaceuticals December 2003 - July 2006
Inex Pharmaceuticals September 2000 - December 2003
Forbes Medi-Tech Inc. September 1999 - September 2000
Novopharm January 1997 - September 1999
Novopharm September 1990 - December 1996
Education
Simon Fraser University
Master's degree, Toxicology
The University of Calgary
Bachelor's of Science, Biochemistry
IDT Biologika, Corp. June 2015 - Present
Aeras March 2013 - June 2015
SAIC-Frederick April 2008 - March 2013
Lonza Baltimore February 2007 - March 2008
Cambrex Bio Science Baltimore October 2002 - 2007
Baxter BioScience March 2001 - September 2002
Baxter Hyland Immuno August 2000 - February 2001
North American Vaccine November 1996 - July 2000
Seragen, Inc 1987 - 1996
Michigan Biotechnology Institute 1985 - 1987
Skills
Fermentation, Technology Transfer, Cell Culture, Biotechnology, Process Development, Purification, Vaccines, DNA, GMP, Process Validation, Filtration, Biopharmaceuticals, Protein Chemistry, recombinant DNA..., Microbiology, HPLC, Chromatography, Manufacturing, Validation, Sop, Lifesciences, Downstream Processing, Science, Change Control, Assay Development, Process Simulation, Biochemistry, V&V, Life Sciences, SOP
Education
University of Hawaii at Manoa 1978 — 1983
Ph.D, Microbiology
Rensselaer Polytechnic Institute 1976 — 1977
M.S., Biology
Rensselaer Polytechnic Institute 1972 — 1976
B.S., Biology
WHS 1968 — 1972
Louis Burdick, Consultant March 2008 - Present
Baxter BioScience 2007 - 2008
Processes Unlimited, Inc. – Bakersfield, CA. July 2006 - February 2007
Lloyd’s Register Serentec, Inc. – Raleigh, NC. September 2005 - May 2006
Emerson – Austin, TX April 2005 - September 2005
Cornerstone Controls May 2003 - November 2004
Al Meer Technical Services Co. W.L.L. – Ahmadi, Kuwait 2002 - 2003
Gilman Engineering & Manufacturing Co. LLC – Janesville, WI 2001 - 2002
Alza Corporation – Palo Alto, CA January 2001 - July 2001
Black & Veatch / Pritchard – Shedgum, Saudi Arabia 2000 - 2001
Education
San Jose State University 1970 — 1973
BSEE, Electrical Engineering
GlaxoSmithKline Biologicals October 2008 - Present
Precept Life Sciences 2006 - September 2008
Iomai Corporation 2004 - 2006
Iomai Corporation 2003 - 2004
Baxter Bioscience 2002 - 2003
Baxter BioScience 2002 - 2003
Baxter Bioscience 2001 - 2002
Skills
Clinical Research, CTMS, GCP, Biotechnology, Vaccines, Clinical Trials, Clinical Development, CRO, ICH-GCP
Education
University of Maryland University College 2001 — 2005
Masters of Science, Biotechnology Studies
Salisbury University 1996 — 2000
Bachelors of Science, Environmental Health and Safety
Amgen April 2010 - Present
Baxter BioScience 1997 - 2003
Skills
Validation, Contract Manufacturing, Manufacturing Operations, Aseptic Processing, cGMP
Education
San Diego State University-California State University
Baxalta July 2015 - Present
Baxter BioScience April 2013 - July 2015
Baxter BioScience March 2004 - April 2013
Medtronic 2000 - 2004
Becton Dickinson 1981 - 1999
Skills
Medical Devices, Biotechnology, Cross-functional Team..., R&D, FDA, Clinical Development, Design Control, Product Launch, Biopharmaceuticals, Pharmaceutical Industry, V&V, Lifesciences, GMP, Drug Delivery
Education
NYU Stern School of Business 1995 — 1999
MBA, General Management
Rensselaer Polytechnic Institute 1975 — 1981
BS, Biomedical Engineering
Baxter International Inc. January 2014 - Present
Baxter Healthcare October 2013 - December 2013
Baxter BioScience 2007 - October 2013
Baxter Healthcare June 2007 - November 2011
Celsis International plc 2006 - 2007
Skills
Marketing Strategy, Market Research, Brand Development, Product Launch, Marketing, Management, Leadership, Budgets, Global Marketing, Medical Devices, Pharmaceutical Industry, Cross-functional Team..., Segmentation, Commercialization, Market Development
Education
Northwestern University - Kellogg School of Management 2002 — 2004
MBA, Marketing
University of Illinois at Urbana-Champaign 1990 — 1994
Accounting
Actavis April 2012 - Present
Harmony Labs February 2011 - April 2012
Sanofi Pasteur July 2010 - March 2011
BioConvergence LLC April 2009 - June 2010
Invensys Validation Technologies January 2008 - April 2009
Sanofi Pasteur 2008 - 2009
Baxter October 2003 - January 2008
Roche Diagnostics 2008 - 2008
Baxter BioScience February 2002 - October 2003
Skills
Sop, GMP, Change Control, HPLC, 21 CFR Part 11, Cleaning Validation, Laboratory, Analytical Chemistry, UV/Vis, UV, Quality Control, Technical Writing, CAPA, FDA, Pharmaceutical Industry, Validation
Education
Oakland University
Mitchell Statistical 2014 - Present
Amgen 2005 - October 2014
Baxter BioScience 2002 - 2005
Charles R Drew University / UCLA 2000 - 2002
Kaiser Permanente Center for Health Research 1998 - 2000
OHSU 1994 - 1998
Veterans affairs medical center 1993 - 1998
OHSU 1993 - 1994
Lewis and Clark College 1992 - 1993
UC Santa Barbara 1986 - 1992
Skills
FDA, CAPA, GMP, Validation, Sop, Quality Auditing, V&V, Change Control, Manufacturing, Biotechnology, Quality System, Biopharmaceuticals, ISO 13485, Aseptic Processing, 21 CFR Part 11, Computer System..., Technology Transfer, GLP, Regulatory Requirements, Cleaning Validation, GxP, SOP, Pharmaceutical Industry, Life Sciences, Quality Assurance, Management, Regulatory Affairs, Medical Devices
Education
University of California, Santa Barbara 1986 — 1992
Doctor of Philosophy (Ph.D.), Experimental Psychology
San Diego State University-California State University
Master of Arts (M.A.), Primatology
UC San Diego
Bachelor of Arts (B.A.), Cognitive Psychology and Psycholinguistics
Chaminade Prep School
Prep school diploma
Ericsson July 2014 - Present
Ericsson January 2013 - July 2014
Ericsson July 2012 - January 2013
Ericsson January 2010 - July 2012
DIRECTV October 2006 - March 2010
Wyoming Air National Guard June 2002 - June 2008
Comcast August 2006 - October 2006
Baxter BioScience December 2004 - May 2006
StarTek February 2004 - December 2004
Skills
Satellite, Troubleshooting, IP, Broadcast Engineering, Testing, MPEG-4, Broadcast Television, Compression, Technical Writing, Encoders, Multiplexers, ATSC, IP Multicast, Project Management..., Computers, Server Management
Education
Regis University 2006 — 2009
NA, Computer Networks & eSecurity
University of Wyoming 2003 — 2006
NA, Computer Engineering
Jackson Hole High School 1998 — 2002
Bayer HealthCare September 2014 - Present
Baxter BioScience March 2011 - August 2014
Baxter BioScience October 2010 - March 2011
Bio-Rad Laboratories March 2008 - October 2010
Bayer HealthCare August 2005 - March 2008
Industrial Design & Construction Inc. (IDC), CH2M Hill February 2004 - June 2005
Aventis Behring June 2003 - February 2004
Baxter BioScience 2002 - June 2003
Taiwan Fine Chemicals 2001 - 2002
Wyeth Pharmaceuticals 2000 - 2000
Skills
CAPA, GxP, Validation, V&V, Manufacturing, Sop, Change Control, GMP, Biotechnology, FDA, R&D, 21 CFR Part 11, Aseptic Processing, ISO 13485, Purification, Quality Assurance, Quality Control, Quality System, SOP, Management
Education
Lehigh University 2000 — 2002
Master of Engineering (M.Eng.), Chemical Engineering (Biochemical concentration with minor emphasis in Polymer Engineering)
New Jersey Institute of Technology 1997 — 2000
Bachelor of Science (B.S.), Chemical Engineering
Phillips Academy Andover
The Harker School
Mills College July 2012 - Present
Mills College November 2009 - June 2012
Applied Materials 2005 - November 2009
ChemTrace 2000 - 2005
Baxter Bioscience Hayward 1995 - 2000
Baxter BioScience April 1991 - December 1999
Skills
Cross-functional Team..., Process Improvement, Program Management, Operations Management, Change Management, Project Management, Strategic Planning, Six Sigma, FDA, Product Marketing, Team Building, Quality Assurance
Education
Saint Mary's College of California 1995 — 1997
MBA, Business Administration
University of Wisconsin-La Crosse 1971 — 1975
Bachelor of Science (BS), Biology, General
LISI AEROSPACE May 2014 - Present
Baxter International Inc. September 2013 - March 2014
Cablofil Legrand North America November 2010 - September 2013
DynaPump, Inc. September 2007 - December 2008
Baxter BioScience November 2003 - September 2007
Siemens October 2000 - August 2003
Lennox International October 1997 - October 2000
Crane Controls 1995 - 1997
Skills
Lean Manufacturing, Industrial Engineering, Kaizen, 5S, Six Sigma, Manufacturing, Root Cause Analysis, SPC, Kanban, DMAIC, MRP, Value Stream Mapping, Engineering, Process Improvement, Continuous Improvement, GMP, MS Project, Toyota Production System, Product Design, FMEA, Supply Chain, Manufacturing..., Operational Excellence, Quality Management, JIT, ISO, Minitab, Quality System, Aerospace, SMED, Design of Experiments, Green Belt, Time Study, Manufacturing Operations, Poka Yoke, TPM, OEE, ISO 13485
Education
Stanford University
BS, Industrial Engineering
Baxter Bioscience July 2010 - Present
MAP Pharmaceuticals February 2008 - Present
MAP Pharmaceuticals 2008 - Present
Map Pharmaceuticals 2008 - Present
engineer 1990 - 2015
MAP Pharmaceuticals 2008 - 2008
MAP Pharmaceuticals 2008 - 2008
MAP Pharmaceuticals 2008 - 2008
MAP Pharmaceuticals 2008 - 2008
Map Pharmaceuticals 2008 - 2008
Skills
FDA, Medical Devices, GMP, Design of Experiments, ISO 13485, Design Control, Validation, V&V, Quality System, CAPA, Cross-functional Team..., Clinical Development, Continuous Improvement, FMEA, Pharmaceutical Industry, Biotechnology, Packaging, R&D, Process Simulation, Change Control, 21 CFR Part 11, ISO 14971, SPC, Computer System..., Biopharmaceuticals, Sop
Education
San Jose State University
SAFC Pharma (Sigma-Aldrich) March 2008 - Present
Millipore December 2005 - February 2008
Synbiotics Corporation October 2004 - December 2005
Baxter BioScience December 2000 - December 2001
Skills
Software Documentation, CAPA, GMP, FDA, Technology Transfer, Quality Control
Education
Northeastern University 2011 — 2012
Master of Science (MS), Regulatory Affairs for Drugs, Biologics, and Medical Devices
University of California, San Diego 2005 — 2005
Certification, Regulatory Affairs and Quality Assurance
Saint Paul University 1995 — 1999
Bachelors of Science, Biology
Circassia April 2015 - Present
Durata Therapeutics February 2013 - March 2015
Baxter Healthcare March 2011 - February 2013
Baxter Healthcare June 2010 - June 2011
Baxter Healthcare February 2009 - June 2010
Baxter BioScience November 2004 - February 2009
TAP January 2003 - October 2004
CVS Caremark Corporation 2001 - 2002
Searle 1997 - 2001
Hamilton Communications Group 1996 - 1997
Skills
Product Launch, Marketing Management, Marketing Strategy, Product Marketing, Product Management, Integrated Marketing, Marketing Communications, Digital Marketing, Direct to Consumer, DTC, Brand Management, Positioning, Relationship Marketing, Public Relations, Pharmaceutical Sales, Sales Management, Marketing, Hospital Sales, Global Marketing, Pharmaceutical Industry, Strategy
Education
Northwestern University 1979 — 1983
Bachelor of Arts (B.A.), Economics
Exelon January 2010 - Present
SunGard January 2008 - January 2010
Prometric 2004 - 2007
Baxter BioScience August 1999 - October 2004
Skills
SDLC, Business Analysis, Requirements Analysis, SQL, Integration, Microsoft SQL Server, Agile Methodologies, C#, Data Analysis, .NET, Oracle
Education
St. Mary's College of Maryland 1988 — 1992
BA, Molecular Biology
ProteoGenex January 2002 - Present
Baxter BioScience January 1973 - January 1994
Baxter Healthcare 1989 - 1994
Baxter Hyland 1973 - 1994
Skills
Immunology, Oncology, Infectious Diseases, Cell
Education
San Diego State University-California State University 1969 — 1972
BS, Microbiology
Avail Medical Products April 2004 - Present
Baxter BioScience 2009 - 2012
Avail Medical 2004 - 2008
Avail Medical 2004 - 2008
Avail Medical Products, a Flextronics Medical company 2004 - 2008
Skills
ISO 13485, FDA, Validation, Medical Devices, Design Control, CAPA, Quality System, Cross-functional Team..., V&V, R&D, Six Sigma, GMP, FMEA, Product Development, Design of Experiments
Education
New York University - Polytechnic School of Engineering 2015 — 2019
Doctor of Philosophy (Ph.D.), Biomedical/Medical Engineering
New York University - Polytechnic School of Engineering
Ph.D, BioEngineering
Baxter Bioscience Operations AnalystBaxter BioscienceOctober 2007 - Present
Merck and Company February 1991 - June 1998
Education
Saint Joseph's University 1995 — 1998
MBA
Rutgers University – Camden 1984 — 1988
Emergent BioSolutions November 2004 - Present
Baxter BioScience September 1994 - October 2004
Skills
CAPA, Validation, Medical Devices, Biotechnology, GMP, Aseptic Processing, Technology Transfer, Quality Assurance, Six Sigma, Change Control, FDA, GAMP, LIMS, 21 CFR Part 11, R&D, Biopharmaceuticals, Regulatory Submissions, Vaccines, GLP, V&V, Quality Control, Analytical Chemistry, Process Simulation, Lifesciences, Fermentation, Pharmaceutical Industry, Quality System, GxP, Sop, ISO 13485, Cleaning Validation, Computer System..., Regulatory Affairs
Education
Michigan State University 1990 — 1993
M.S., Chemical Engineering
Michigan State University 1988 — 1990
B.S., Chemical Engineering
Amgen October 2006 - Present
Baxter BioScience 2001 - 2006
Skills
Change Control, 21 CFR Part 11, CAPA, Aceptic Processing, Biotechnology, LIMS, MES, SAP, Sop, Column Chromatography, Fermentation, Fractionation, Centrifugation, Homogenization, Purification, Microsoft Office, Photoshop CS5, CIP, SIP, six sigma, Human Performance, Visio, Autoclave, Dependable Team Player, Troubleshooting
Education
Mt. San Antonio College 2000 — 2001
12 semester hours, Criminal Justice and Corrections
EMCOR Government Services February 2015 - Present
EMS Training Institute February 2011 - Present
EMT Skills Instructor January 2011 - Present
Medical & Safety Management Inc June 2008 - Present
Leading Industry February 2013 - July 2014
Esterline Mason Control Systems August 2011 - February 2013
On-Call Medic January 2008 - December 2012
Johanson Technology, Inc. November 2009 - August 2011
Santa Monica UCLA Medical Center November 2009 - December 2009
Baxter BioScience January 2006 - June 2009
Skills
Troubleshooting, Manufacturing, Six Sigma, Operations Management, Continuous Improvement, Quality Assurance, Facilities Management, Inspection, Process Improvement, Root Cause Analysis, Validation, GMP, Project Management, Sop, Quality System, Preventive Maintenance, Software Documentation, Hazardous Materials, Cross-functional Team..., Commissioning, Change Management, Organizational..., FDA, Maintenance & Repair, Supervisory Skills, Process Scheduler, Lean Manufacturing, Management, Quality Management, Leadership, Hazardous Waste..., Budgets, EHS, ISO, Training, Process Engineering, Quality Control, MS Project, Emergency Management, Change Control, CAPA, Kaizen, Engineering, Calibration, Incident Command, HAZWOPER, DMAIC, Quality Auditing, Electronics, Medical Devices
Education
Moorpark College 2008 — 2008
Certificate, Emergency Medical Technician
Belford University 2003 — 2005
Bachelor of Business Administration, Project Management, 3.19
BioMarin Pharmaceutical Inc. October 2013 - Present
BioMarin October 2011 - October 2013
Genentech June 2011 - October 2011
Novartis Corporation January 2011 - June 2011
Genentech Inc June 2009 - January 2011
Theravance Inc February 2009 - June 2009
Elan Corporation June 2008 - February 2009
Theravance Inc February 2005 - May 2008
Baxter Bioscience February 2002 - August 2004
Fusion Medical Technologies November 1999 - February 2002
Skills
HPLC, Chromatography, Analytical Chemistry, GMP, Protein Chemistry, Mass Spectrometry, Purification, Protein Purification, GLP, ELISA, SDS-PAGE, Capillary..., Biotechnology, Validation, SOP, Laboratory, FDA, Western Blotting, Life Sciences, R&D, Assay Development, Gas Chromatography, Pharmaceutical Industry, Clinical Development, Drug Discovery, Antibodies
Education
Sonoma State University
Sonoma State University
Bachelor of Science, Cellular Biology
Sonoma State University
Bachelor of Science, Cellular Biology
Kaiser Foundation Health Plan June 2011 - Present
Kaiser Foundation Health Plan August 2007 - June 2011
Los Angeles Unified School District September 2005 - June 2007
Baxter BioScience July 2004 - January 2006
Skills
Data Analysis, Data Warehousing, Databases, Database Design, Business Intelligence, Crystal Reports, Excel, SQL, SQL Server, Microsoft Office, Analysis, Data Management, Access, Research, Writing, Application Development, Documentation, Requirements Analysis, Business Analysis, Data Modeling, Database Administration, Data Warehouse..., VBA, Data Migration, Cognos, T-SQL, Database Development, Business Process, Data Mining, Analytics, SSRS
Education
Rice University 1987 — 1990
Bachelor of Arts (B.A.), Computer Science
Hillsboro High School
Amgen May 2011 - November 2011
Baxter BioScience May 2000 - October 2010
Skills
Change Control, FDA
Education
Pierce College
Baxter BioScience November 2011 - Present
Baxter BioScience September 2009 - October 2011
AVL July 2008 - March 2009
TU Graz August 2007 - June 2008
TU Graz August 2003 - July 2007
Education
Technische Universität Graz 2003 — 2007
Dr. tech., Chemistry
Northwestern University 2001 — 2003
Chemistry
University of Illinois at Chicago 2000 — 2001
MSc, Chemistry
University of Belgrade 1991 — 1997
BSc, Chemistry
FDA April 2012 - Present
Henry M Jackson Foundation February 2011 - March 2012
Baxter 2010 - 2011
Baxter BioScience 2009 - 2010
Baxter 2007 - 2009
PDA November 2004 - April 2005
Eli Lilly 2003 - 2004
KMI (now PAREXEL Consulting) 2002 - 2003
Parenteral Drug Association 2000 - 2002
North American Vaccine (AMVAX) 1997 - 2000
Skills
Software Documentation, GMP, Quality Assurance, Purification, Validation, 21 CFR Part 11, FDA, Sop, Pharmaceutical Industry, Training, Biotechnology, Leadership, Change Control, CAPA, Clinical Trials, Fermentation, Lifesciences, Vaccines, Medical Devices, GLP, Regulatory Affairs, Life Sciences, SOP
Education
Southern University and Agricultural and Mechanical College at Baton Rouge 1994 — 1996
biology
Baxter BioScience
Skills
HPLC, Wet Chemistry, Chemstation, UV-Vis, Analytical Chemistry, NMR, Titration, LIMS, cGMP, Chromatography, Methods Development, DSC
Education
San Jose State University
BS with Concentration in Material Science
Baxter Bioscience September 2013 - July 2015
TVS inc January 2013 - September 2013
Engineer at Bosch Packaging Technology March 2010 - February 2011
PR Pharmaceuticals December 2006 - June 2008
Bosch Packaging Technology May 2002 - December 2006
Chesapeake Biological Labs June 2001 - February 2002
Advanced Instruments, Inc. April 1997 - March 2001
Skills
Process validation,..., Validation, V&V, Medical Devices, GMP, FDA, SOP, GLP, Computer System..., Manufacturing, CAPA, Pharmaceutical Industry, Biotechnology, Quality System, GAMP
Education
Purdue University 1993 — 1997
BS, Chemistry/Chemical Engineering
Genzyme July 2011 - Present
Bristol-Myers Squibb February 2007 - June 2011
Centocor November 2004 - February 2007
Baxter BioScience November 2001 - November 2004
W.L. Gore & Associates June 2000 - June 2001
Education
Penn State University 1995 — 2000
BS, Chemical Engineering
Worcester Polytechnic Institute
MS, Bioscience Administration
ImpediMed January 2011 - Present
Neomatrix September 2009 - October 2010
Advanced Radiation Therapy January 2009 - September 2009
Proxima/Cytyc/Hologic September 2003 - May 2006
Baxter BioScience October 1999 - September 2003
Hall Surgical/Zimmer Small bone equipment 1996 - 1999
Storz Ophthalmics/Bausch and Lomb Surgical 1992 - 1996
Education
Southern Methodist University 1987 — 1991
BA, Political Science
Boehringer Ingelheim Manufacturing DirectorNovartisApril 2011 - April 2015
Genzyme January 2010 - January 2011
Arbor Vita Corporation March 2009 - January 2010
Baxter BioScience January 2003 - March 2009
Baxter December 1990 - December 2002
Skills
Lean Manufacturing, Biotechnology, CAPA, GMP, FDA, Management, Purification, Manufacturing, Biopharmaceuticals, Sop, Change Management, Continuous Improvement, Validation, Aseptic Processing, Quality Assurance, Change Control, Technology Transfer, Cell Culture, Lifesciences, Contract Manufacturing, Fermentation, Chromatography, Six Sigma, Monoclonal Antibodies, cGMP practices, Certified Green Belt, Quality System, Cross-functional Team..., Value Stream Mapping, Life Sciences, SOP
Education
San Jose State University 1980 — 1985
BA, Biology
PPD May 2015 - Present
PPD May 2009 - May 2015
Pharmaceutical Product Development June 2007 - May 2009
Human Genome Sciences September 2003 - June 2007
Baxter BioScience December 2001 - September 2003
Albany Molecular Research October 2000 - December 2001
Skills
Analytical Chemistry, HPLC, GMP, Chromatography, Validation, Protein Chemistry, Assay Development, Sop, Purification, Chemistry, Drug Discovery, Gas Chromatography, Gel Electrophoresis, Formulation, Laboratory, Quality Control, Vaccines, High Throughput..., Quality System, Spectrophotometry, Peptides, Testing, Leadership, Biopharmaceuticals, Technology Transfer, SOP, LIMS
Education
Michigan State University 1998 — 2000
M.S., Environmental Chemistry
Michigan State University 1993 — 1998
B.S., Chemistry
Kedrion Biopharma, Inc July 2013 - Present
Guiheen and Associates, LLC July 2011 - July 2013
Baxter Healthcare Corp 2010 - 2011
Baxter BioScience 1997 - 2009
Education
Rutgers University
Bachelor of Business Administration (B.B.A.)
Baxter BioScience August 2014 - Present
REM Services December 2011 - July 2014
Baxter BioScience June 2008 - December 2011
REM Services June 2001 - May 2008
Education
North Carolina State University 1997 — 2001
BS, Chemical Engineering
Baxalta July 2015 - Present
Baxter Bioscience November 1999 - July 2015
Baxter Healthcare November 1999 - 2008
Merck June 1997 - May 1999
Merck May 1994 - June 1997
Merck February 1990 - May 1994
The Children's Hospital of Philadelphia June 1988 - February 1990
Skills
GMP, Quality Assurance, Validation, FDA, Change Control, Root Cause Analysis, Manufacturing, Cross-functional Team..., Vaccines, Process Improvement, Six Sigma, Process Engineering, Software Documentation, Computer System..., V&V, ISO 13485, Technology Transfer, ELISA, Regulatory Requirements, ISO, Operational Excellence, Auditing, Clinical Trials, Microbiology, Process Simulation, Quality Control, Value Stream Mapping, Purification, Process Control, Kaizen, Medical Devices, DMAIC, Lyophilization, Calibration, Minitab, 21 CFR Part 11, GLP, EDC, Root Cause Analysis,...
Education
Saint Joseph's University 1996 — 1998
MBA, Marketing
Rutgers, The State University of New Jersey-Camden 1985 — 1988
BS, biology
Boehringer Ingelheim July 2011 - October 2013
Sanofi Pasteur 2009 - 2010
Biotest Pharmaceuticals Corporation 2009 - 2009
Baxter BioScience 2007 - 2008
Apotex Inc. 2003 - 2007
Highland Equipment Ltd 2002 - 2003
Apv 2000 - 2002
GEA Process Engineering China Limited (Wholly owned subsidary of GEA Group) 1994 - 2000
Skills
Piping, Biopharmaceuticals, ASME, Pressure Vessels, Stress Analysis, Tanks, P&ID, Pumps, Valves, Plant Design, HVAC, Boilers, Pipelines, Cyber Security, Biotechnology, Calculations, Inspection, Fabrication, Heat Exchangers, Vaccines, Plumbing, Monoclonal Antibodies, Commissioning, Steam, Fermentation, Antibodies, Pharmaceuticals, Technology Transfer, Therapeutics, Generics, Formulation Development, Pharmaceutical Industry, Generic Programming, Process Engineering, Validation, GMP, Change Control, Formulation, Process Simulation, FDA, Computer System..., GxP, 21 CFR Part 11, GAMP, V&V, CAPA
Education
Seneca College of Applied Arts and Technology 2010 — 2011
Certificate
Hubei University of Technology 1981 — 1985
Bachelor
St. Jude Medical Center August 2013 - Present
St Jude Medical Center March 2009 - August 2013
Baxter BioScience 2007 - March 2009
Baxter BioScience 2007 - 2009
Baxter Healthcare 1994 - 2009
Baxter Healthcare 2000 - 2007
Baxter Healthcare 2000 - 2006
Skills
Lean Manufacturing, Supply Chain Management, Strategic Planning, FDA, Six Sigma, Quality System, CAPA, Medical Devices, GMP, Continuous Improvement, Cross-functional Team..., DMAIC, Strategy, Project Planning, Kaizen, Supply Chain, Leadership, Process Improvement, Healthcare, Management, Hospitals
Education
University of Southern California - Marshall School of Business 1997 — 2000
MBA, Business
Northwestern University 1990 — 1994
BS, BioMedical Engineering
Paragon Bioservices, Inc. May 2014 - Present
TASTE THE VEGGIES October 2013 - Present
Jerk~N~Fish Catering, LLC March 2011 - Present
Emergent BioSolutions June 2013 - April 2014
Emergent BioSolutions July 2012 - April 2014
PharmAthene April 2011 - April 2012
Baxter BioScience August 2007 - January 2011
Baxter BioScience September 2001 - August 2007
South Carolina Department of Health and Environmental Control December 1998 - September 2001
Skills
Validation, Training, Analysis, Quality System, Chromatography, GMP, FDA, Quality Assurance, Leadership, Analytical Chemistry, Microbiology, Change Control, Laboratory, Sop, GxP, Quality Control, Management, Vaccines, Gas Chromatography, Software Documentation, HPLC, Biopharmaceuticals, Budgets, CAPA, Manufacturing, Chemistry, Human Resources, Lean Manufacturing
Education
South Carolina State University 1989 — 1994
BS, Biology
Baxter BioScience May 2009 - August 2010
MannKind Corporation 2006 - 2009
Baxter BioScience 1999 - 2006
Skills
Validation, CAPA, GLP, GMP, Biotechnology, HPLC, Drug Development, Assay Development
Education
Odessa National 'I.I. Mecnikov' University
MS, Chemistry and Biology
Baxter BioScience August 2010 - Present
Covidien April 2008 - August 2010
Yellow Book USA July 2001 - April 2008
Health South August 1999 - July 2001
Skills
Sales, Leadership, Medical Devices, Product Launch, Account Management, Operating Room, Customer Service, Sales Operations, Healthcare, Urology, Cross-functional Team...
Education
West Virginia University 1998 — 1999
MS, Sports Medicine
Penn State University 1993 — 1998
BS, Kinesiology
James Hardie Building Products August 2014 - Present
Imerys January 2011 - August 2014
Baxter BioScience June 2009 - June 2010
Rio Tinto Minerals (US Borax) November 2007 - February 2009
Lockheed Martin August 2006 - November 2007
Du-All Safety, LLC. August 2003 - August 2006
Du-All Safety, LLC. August 2003 - August 2006
San Jose State University August 1999 - December 2005
Skills
Safety Management..., EHS, Environmental Awareness, Hazardous Waste..., Hazardous Materials, Industrial Safety, Industrial Hygiene, Occupational Health, Risk Assessment, Workplace Safety, Hazard Recognition, Environmental Compliance, Inspection, Safety Training, Process Safety, Environmental..., Training, Risk Management, Emergency Management, Hazard Analysis, Accident Investigation, Mining, ISO 14001, Behavior Based Safety, ISO, Root Cause Analysis
Education
San Jose State University
Bachelors, Chemistry
US Bioservices--Amerisource Bergen Specialty Group October 2010 - Present
McKesson Specialty Care Solutions 2007 - 2010
P4 Healthcare September 2006 - August 2007
Pharmion 2004 - 2006
Baxter Bioscience 2001 - 2004
Skills
Cross-functional Team..., Leadership, Oncology, Team Building, Managed Care, Marketing, Health Economics, Account Management, Pharmacy, Project Management
Education
Penn State University 1985 — 1989
Bachelor of Arts, English
Penn State University 1985 — 1989
Medtronic November 2014 - Present
3M Pharmaceuticals November 2010 - October 2014
3M Health Care March 2010 - November 2010
Baxter BioScience April 2009 - August 2009
Skills
Process Engineering, Root Cause Analysis, Validation, Manufacturing, Six Sigma, Research, Design of Experiments, Lean Manufacturing, Product Development, FMEA, Matlab, FDA, CAPA
Education
University of California, Los Angeles 2004 — 2008
BS, Chemical Engineering, Biomedical Engineering
Lowell High School
National Taiwan University
EndoChoice November 2014 - Present
Synthes October 2010 - November 2014
Ameritox 2008 - 2010
LifeCell Corporation March 2007 - January 2008
Power Medical Interventions 2007 - 2008
Baxter BioScience 2001 - 2007
Skills
Surgical Instruments, Medical Devices, Market Development, Medical Sales, Product Launch, Sales Management, Team Leadership, Experienced Speaker, Biologics, Wound Care, Biotechnology, General Surgery, Trauma Surgery, Cardiothoracic Surgery, Neurosurgery, Human Anatomy, Surgery, Surgeons, Sales Operations, Sales, Pharmaceutical Sales, Operating Room, Marketing, Disposables, Cardiology, Capital Equipment, Cross-functional Team..., Account Management, Sales Process, Sales Force Development, Healthcare, Sales Effectiveness, Hospitals, Urology
Education
Bonner Springs High School
Pittsburg State University
Biology, Biology and Chemistry
University of Kansas
biology, biology and chemistry
Baxalta June 2013 - Present
Baxter BioScience 2007 - 2013
Baxter BioScience 1999 - 2007
Gen Probe 1996 - 1999
Skills
FDA, CAPA, Quality Assurance, GMP, Change Control, Quality System, Validation, Sop, Aseptic Processing, GxP, V&V, LIMS, GLP, SOP, 21 CFR Part 11
Education
Point Loma Nazarene University 1990 — 1994
B.A., Biology
Valeritas, Inc. January 2011 - Present
Valeritas September 2002 - January 2011
Baxter BioScience 2002 - 2002
Fusion Medical Technologies 1997 - 2002
Aradigm Corporation 1995 - 1997
Cygnus Therapeutic Systems 1990 - 1995
Ciba-Geigy 1985 - 1990
3M 1980 - 1985
Skills
Medical Devices, Design Control, Pharmaceutical Industry, Technology Transfer, ISO 13485, GMP, FDA, Regulatory Affairs, Engineering, Product Development, Process Engineering
Education
Rensselaer Polytechnic Institute 1976 — 1980
BS, Chemical Engineering
Thermo Fisher Scientific June 2011 - Present
Genentech March 2011 - July 2011
Novartis Pharmaceuticals June 2010 - October 2010
Baxter May 2008 - July 2010
Baxter BioScience May 2008 - December 2008
City of San Jose - Environmental Services Department September 2007 - April 2008
Skills
GMP, Validation, Manufacturing, Sop, Purification, Self-driven, Chromatography, CAPA, Lean Manufacturing, V&V, Microsoft Excel, Process Simulation, cGMP, 5S, Process Validation, Process Development, Word, PowerPoint, Excel, Documentation, FMEA, Protein Purification, Filtration, SAP, Surface Chemistry, ISO, KPI Reports, Performance Metrics, TRACKWISE, Metrics Reporting, Biotechnology, Life Sciences, SOP, Process Improvement, Cross-functional Team..., PCR, Technology Transfer, Six Sigma
Education
San Jose State University 2003 — 2007
BA, Biological Sciences
Los Rios Community College District January 2015 - Present
Santa Clarita Community College District June 2010 - January 2015
Baxter BioScience May 2009 - June 2010
Nestle USA 1990 - 2009
Skills
Cross-functional Team..., Sourcing, Supply Management, Coaching, Purchasing, Supplier Negotiation, Supply Chain, Procurement, Strategic Sourcing, Risk Management, FDA, Materials, Supply Chain Management, Supplier Evaluation, Forecasting, Spend Analysis, Inventory Management, Supplier Development, MRP, Materials Management, Global Sourcing, Strategic Planning, Public Speaking
Education
San Diego State University-California State University
Bachelor of Science, Business / Production and Operations Management
Santa Barbara City College
Associate of Science, Computer Science and Economics
University of Phoenix
M.B.A., Business Management - Marketing
Oakland Community College June 2012 - Present
Oakland Community College March 2006 - May 2012
Baxter BioScience August 1996 - August 2003
Veltri International 1993 - 1995
Education
University of Phoenix - Southfield Campus 1996 — 1998
Master of Arts, Organizational Management
Oakland University 1988 — 1993
Bachelor of Science, Human Resources Development
Pacira Pharmaceuticals, Inc. November 2013 - Present
GlaxoSmithKline February 2011 - November 2013
Baxter BioScience September 2006 - February 2011
Esoterix, Inc August 2004 - September 2006
University of Redlands August 2003 - June 2004
Skills
Biotechnology, HPLC, Cell Culture, FDA, Purification, Pharmaceutical Industry, Sop, Lifesciences, GLP, Chemistry, GMP, Validation, Clinical Research, Data Management, Data Analysis, Molecular Biology, Regulatory Affairs, Medical Devices, Technical Writing, Column Chromatography, Chromatography, Aseptic Processing, Biopharmaceuticals, Trackwise, Filtration, Aseptic Technique, Protein Purification, cGMP manufacturing
Education
Pepperdine University, The George L. Graziadio School of Business and Management 2008 — 2009
MBA, Leadership and Organizational Change
University of Redlands 2000 — 2004
B.S., Biology
Amgen August 2011 - October 2011
Golden State Medical Supply April 2011 - May 2011
Consolidated Laboratory Service June 2009 - April 2010
Welnavigate October 2005 - May 2008
Baxter Bioscience October 2002 - May 2005
Medical Analysis Systems January 2002 - August 2002
Amgen August 1995 - August 2001
Physicians Clinical Laboratory October 1988 - September 1995
Education
Moorpark College
Associate of Arts; a BS degree, biology
Baxter Healthcare January 2012 - Present
Baxter BioScience February 2005 - December 2011
Baxter Healthcare February 2001 - July 2005
US Surgical November 1989 - July 2001
Skills
Surgeons, Operating Room, Disposables, Medical Devices, Urology, Neurosurgery, Orthopedic, General Surgery, Surgical Instruments, Cardiology, Interventional..., Surgery, Sales Effectiveness, Market Development, Hospital Sales, Product Launch, Pharmaceutical Sales, OB/GYN, Neurology, Sales Force Development, Vascular, Medical Sales, Vascular Surgery, Interventional Radiology, Gastroenterology, Cath Lab, Pulmonology, ENT, Endocrinology, Capital Equipment Sales, Spine, Biologics, Operating Room Sales, Oncology, Orthopedics
Education
Robert Morris University 1983 — 1987
Bachelor's degree, Marketing
GenMark Diagnostics 2014 - Present
DiscoveRx 2008 - 2014
Baxter BioScience 2007 - 2008
Skills
Molecular Biology, Cell Culture, ELISA, Biotechnology, PCR, Microbiology, Lifesciences, Cell Biology, Transient Transfection, Stability Studies, Immunofluorescence, Troubleshooting, Flow Cytometry, Cell Signaling, Cell Based Assays, Mammalian Cell Culture, Bacterial Culture, Bacterial Identification, Protein Expression, Western analysis, Ligand Binding, Endotoxin, Bioburden, Sterility Assurance, Environmental Testing, Drug Discovery, High Throughput..., SOP Authoring, SOP Development, Validation
Education
San Jose State University 2008 — 2011
MA, Biological Science
San Jose State University 2002 — 2007
BS, Microbiology
Validant August 2013 - Present
CURE Pharmaceutical, LLC May 2012 - July 2013
Stellar Biotechnologies March 2011 - May 2012
Boston Scientific September 2008 - March 2011
Invitrogen inc January 2008 - September 2008
Amgen Inc November 2002 - October 2007
Baxter BioScience May 2001 - November 2002
YTC America January 1999 - January 2000
Biosource international, inc January 1994 - January 1998
Amgen, Inc January 1993 - January 1994
Skills
Quality System, Validation, GMP, Quality Assurance, Manufacturing, FDA, Auditing, ISO 13485, Product Development, Quality Control, Process Improvement, CAPA, 21 CFR Part 11, V&V, Change Control
Education
National University
Clinical Affairs
University of California, Santa Barbara
Bachelor's Degree, Medical Microbiology and Genetic Engineering
Baxter BioScience July 2010 - December 2010
Education
Old Dominion University 2005 — 2010
Science, Biochemistry, Sociology(Minor)
Lucy Basch Photography October 2011 - Present
Cerexa August 2009 - September 2011
Huttoe Group 2006 - 2009
Baxter BioScience 2003 - 2006
Skills
Pharmaceutical Industry, Venture Capital, Strategic Planning, Operations Management, Data Management, Biotechnology, Project Management, FDA, Digital Photography, Clinical Trials, Clinical Development, Sop, Clinical Research, Regulatory Submissions, GCP
Education
Miami Dade College
University of California, Berkeley
Amazon December 2012 - Present
Vans April 2012 - December 2012
Torn and Glasser July 2011 - January 2012
Nongshim America April 2006 - April 2011
FedEx Ground June 2004 - April 2006
Baxter Bioscience October 2003 - June 2004
Subaru of Indiana Automotive August 1989 - August 2003
Skills
Budgets, Manufacturing, Management, Troubleshooting, Maintenance Management, Inventory Management, Training, Production Planning, SAP, Warehousing, Purchasing, Maintenance & Repair, Testing, Leadership, Facilities Management, Supply Chain, Factory, Process Improvement, Automation, Inspection, Inventory Control
Education
Purdue University Calumet 1980 — 1989
EET
Baxalta October 2007 - Present
Baxter Healthcare/BioScience December 2010 - June 2013
Baxter BioScience October 2007 - January 2010
Amgen November 2002 - November 2007
Amgen November 2002 - October 2007
Amgen November 2002 - October 2007
VWR INTERNATIONAL May 2000 - November 2002
Applied Silicone Corporation September 1992 - May 2000
Skills
FDA, CAPA, Change Control, GMP, cGMP manufacturing, Aseptic Processing, Biopharmaceuticals, SOP, Trackwise, 21 CFR Part 11, V&V, Medical Devices, Cleaning Validation, Lyophilization, Pharmaceutical Industry, Deviations, cGMP practices, Root Cause Analysis, LIMS, ISO 13485, Aseptic Technique, Biotechnology, FDA GMP, Downstream Processing, Fermentation, Validation, Regulatory Affairs, GxP, Technology Transfer, Quality System, batch release
Education
Oxnard College 1995 — 1999
Associate’s Degree, Liberal Arts and Sciences/Liberal Studies
Collabera September 2013 - Present
ABASSIAN MARRACHE LLP July 2010 - April 2013
ANKER, REED, HYMES, SCHREIBER & COHEN October 2007 - February 2010
BAXTER BIOSCIENCE October 2002 - June 2006
COTKIN, COLLINS & GINSBURG - GINSBURG, STEPHAN, ORINGHER & RICHMAN - WOOD, LUCKSINGER & EPSTEIN - FL August 1983 - September 2001
Skills
20+ years of civil..., Medical Malpractice..., Insurance Defense/Bad..., Banking/Mortgage/Foreclo..., Personal Injury..., Landlord/Tenant Law, Entertainment/Copyright..., Enforcement Of Judgments, Judgment Collections, Real Estate Litigation, Probate Litigation
Education
Montebello High School
High School Diploma, Required Studies, 12
Moorpark College
English Literature