Amgen Manufacturing Limited
Industry: Company
DescriptionFounded: 1991 Parent organization: AmgenFeedbackDisclaimer Claim this knowledge panel Knowledge ResultSee photos Moved, closed, or was never hereReportAmgen Manufacturing LimitedWebsiteDirections Saved (0) Saved Save 27 Google reviews Corporate office Address: Juncos, 00777, Puerto Rico Hours: Open now · Add full hours Unable to add this file. Please check that it is a valid photo.Website: Phone: : : : : Category: Place name: : : Hours: Website: http://amgen.com/ Category: Corporate office Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?Add missing informationAdd phone number Unable to add this file. Please check that it is a valid photo. Add business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question
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Amgen Manufacturing Limited Employees
Amgen Manugacturing, Limited July 2011 - Present
Amgen Manufacturing, Limited May 1992 - June 2011
Skills
Compensation & Benefit, Market Analysis, Benefits Management, Employee Benefits, Deferred Compensation, Benefits Design, Retirement Benefits, Employee Wellness..., Vendor Management, Compensation, Compensation Planning, Compensation Strategies, Human Resources, HR Policies, HRIS, SAP HR, Personnel Management, Policy Writing, Talent Acquisition, Workforce Planning, Talent Management, HR Consulting, Onboarding, Management, Benefits Administration, Compensation, Performance Management, Succession Planning
Education
Universidad del Turabo
Master of Business Administration (MBA), Management with Minor in Human Resources
University del Turabo
MBA, Human Resources
University of Puerto Rico - Rio Piedras
Bachelors Degree, Business Administration
Amgen Manufacturing Limited December 2011 - Present
Purdue University August 2011 - November 2011
Purdue University August 2006 - August 2011
Skills
HPLC, Protein Chemistry, Analytical Chemistry, Protein Purification, UV/Vis, Chromatography, Biochemistry, Chemistry, Molecular Biology, PCR, Western Blotting, Protein Expression, ELISA, SDS-PAGE, Gel Electrophoresis, Molecular Cloning, Cell Biology, Experimental Design, GMP, Cell Culture, Laboratory
Education
Purdue University 2006 — 2011
Doctor of Philosophy (Ph.D.), Chemistry-Biochemistry
Universidad de Puerto Rico 2001 — 2006
Bachelor's degree, Chemistry
Miguel A Rubio, CSP and Associates 2003 - Present
Amgen Manufacturing Limited 2002 - 2003
Pharmacia 2000 - 2002
Johnson & Johnson 1998 - 2000
Motorola Electrónica de PR 1995 - 1998
Schering Plough Products, Inc. 1988 - 1995
Eli Lilly Industries, Inc. 1986 - 1988
Eli Lilly industries, Inc. 1985 - 1986
Dupont, Savannah River Plant 1982 - 1985
Skills
ISO 14001, Environmental Auditing, Environmental Compliance, EHS, Root Cause Analysis, Industrial Hygiene, Industrial Safety, Safety Management..., Environmental Awareness, Environmental..., Hazardous Waste..., Ergonomics, Risk Assessment, Process Safety, Management, HAZWOPER, Waste Management, Hazard Recognition, Occupational Health, Training, Accident Investigation, Hazard Analysis, Hazardous Materials, Environmental..., ISO, Continuous Improvement, Environmental Impact..., RCRA
Education
University of Puerto Rico-Mayaguez 1977 — 1982
Bachelor's degree, Chemical Engineering
Amgen Manufacturing Limited April 2014 - Present
Amgen Manufacturing Limited June 2012 - April 2014
Boston Scientific February 2011 - June 2012
Patheon Inc. May 2008 - February 2011
Edwards Lifesciences January 2007 - May 2008
Edwards Lifesciences April 2004 - January 2008
Eli Lilly and Company February 1992 - April 2004
Skills
Process Engineering, Injection Molding, Project Engineering, Sterilization, Manufacturing..., V&V, CAPA, FDA, Validation, Medical Devices, Design of Experiments, GMP, Quality System, Commercialization, ISO 13485, Continuous Improvement, Cross-functional Team..., Lean Manufacturing, Technology Transfer, Change Control, DMAIC, Design Control, Engineering, ISO, Pharmaceutical Industry, Six Sigma
Education
Inter-American University of Puerto Rico-San Germán Campus 1997 — 2000
MBA, Finance
University of Puerto Rico-Mayaguez 1985 — 2000
BS, Chemical Engineering
UGHS 1985 1982 — 1985
High School, High School/Secondary Diplomas and Certificates
The Ohio State University, Dr. Ghadiali’s Laboratory August 2013 - Present
Caribbean Computing Center for Excellence June 2013 - July 2013
AMGEN Manufacturing Limited January 2013 - May 2013
Orthopaedic Research Group of UPRM August 2010 - May 2013
Medtronic Spinal & Biologics August 2012 - December 2012
SAFE SMART SURFACE DESIGNS LLC June 2012 - August 2012
G.E.A.R. May 2011 - May 2012
Bio-imaging and Advanced Biomechanics Laboratory June 2011 - August 2011
SAE Supermileage Team of UPRM January 2009 - April 2009
Skills
Biomedical Engineering, COMSOL, Microsoft Office, Solidworks, Matlab, Data Analysis, Bilingual, NX 7.0, Mimics, Mechanical Engineering
Education
The Ohio State University 2013 — 2018
Doctor of Philosophy (Ph.D.), Biomedical/Medical Engineering, 3.45
University of Puerto Rico-Mayaguez 2007 — 2013
Bachelor of Science (BS), Mechanical Engineering, 3.52
Architectural Design Collaborative June 2014 - Present
AMGEN Manufacturing Limited April 2013 - June 2014
CMA Architects & Engineers February 2012 - April 2013
Sierra, Cardona & Ferrer Architects July 2007 - January 2012
Skills
Sustainable Design, Architectural Design, LEED AP, Design Research, Adaptive Reuse, AutoCAD, Space planning, Submittals, Construction Drawings, Architectural Drawings, LEED, Revit, Green Building, Mixed-use
Education
University of Puerto Rico 2003 — 2005
Master in Architecture, Architecture
University of Puerto Rico 1998 — 2002
Bachelor in Environmental Design, Architecture
BRITISH ACADEMY OF FILM & TELEVISION ARTS LOS ANGELES April 2012 - Present
Don Pedro Cigars June 2008 - March 2012
AMGEN MANUFACTURING LIMITED October 2006 - September 2008
PATHEON/MOVA PHARMACEUTICAL CORPORATION April 2005 - September 2006
Skills
Sarbanes-Oxley (SOX)..., Bilingual: English &..., Financial Analysis, Event Planning, Financial Modeling, Management, Finance, Start-ups, Strategic Financial..., Leadership, Customer Service, Strategic Planning, Budgets, Marketing, Marketing Strategy, Training, Internal Controls, Cash Flow, Accounting
Education
Regis University 1997 — 1999
Master of Business Administration (MBA), Finance, General, 3.72
Gilead Sciences February 2015 - Present
Merck August 2012 - February 2015
Independent Contractor May 2012 - June 2012
Amgen July 2011 - April 2012
Amgen September 2010 - April 2012
Amgen March 2009 - September 2010
Amgen Manufacturing, Limited April 2007 - March 2009
Amgen April 2005 - April 2007
St. Jude Children's Research Hospital February 2004 - April 2005
Temple University 1998 - 2004
Skills
SDS-PAGE, Protein Chemistry, qPCR, ELISA, DNA, Assay Development, Biotechnology, Cell, Biochemistry, Monoclonal Antibodies, Molecular Biology, Biopharmaceuticals, Immunoassays, GMP, Technology Transfer, Cell Biology, PCR, Gel Electrophoresis, LIMS, Laboratory, Mammalian Cell Culture, CAPA, HPLC, Protein Expression, Western Blotting, Lifesciences, Southern Blot, Cell Culture, Antibodies, Immunology, RT-PCR, Virology, Molecular Cloning, Microbiology, Laboratory Automation, Bioassay, Purification, Science, Validation, Chromatography, In Vitro, Analytical Chemistry, GLP, Transfection, Tissue Culture, Signal Transduction, Aseptic Technique, Bacterial Transformation, Fluorescence, RNA isolation
Education
Temple University School of Medicine 1997 — 2004
Ph.D., Microbiology and Immunology
University of Puerto Rico, Mayaguez 1991 — 1996
BS, Biology/Pre-Medical Sciences
Amgen 2007 - Present
Amgen Manufacturing, Limited April 2005 - Present
Education
Boston University
AMGEN Manufacturing Limited March 2014 - Present
Amgen Manufacturing, Limited April 2005 - April 2014
Schering-Plough 2002 - 2005
Universidad Interamericana de Puerto Rico Recinto de Bayamon 2000 - 2002
Biowell 1998 - 2000
Skills
Environmental Awareness, Chemistry, Quality Control, Human Resources, CAPA, Testing, Media Preparation, Laboratory, Science, Food Science, GMP, Biotechnology, Environmental Monitoring, Aseptic Processing, LIMS
Education
Universidad del Turabo 2015 — 2017
Master of Business Administration (MBA), Project Management
Universidad Interamericana de Puerto Rico 1991 — 1997
BS, Major on Microbiology/Minor on Chemistry
Hospitales HIMA•San Pablo November 2011 - Present
Hospitales HIMA•San Pablo April 2008 - November 2011
Amgen Manufacturing, Limited September 2005 - November 2007
Iron Age Corporation October 2002 - September 2005
Ethicon, Inc. April 1993 - August 2002
Skills
Data Center, Data Warehousing, Active Directory, DHCP, Microsoft Exchange, Office 365, Backup Solutions, Data Protection Manager, Veritas, Hyper-V, Virtualization, System Center Suite, Windows Server, IT Operations, Computer Repair, HP Storage, Storage Management, Networking, Lync, Tax Accounting, Tax Preparation, Accounts Receivable, GMP, Iso 9000, FDA GMP, Microsoft Office, 3PAR, HP EVA, DPM, Microsoft Virtual Server, Microsoft Server..., HP Blade, HP Proliant
Education
Universidad del Turabo 1994 — 2000
Bachelor of Business Administration (BBA), Accounting
Iniciativa Comunitaria, Inc. April 2007 - July 2013
Amgen Manufacturing Limited December 2006 - March 2007
Baxter Healthcare January 2005 - March 2006
Iniciativa Comunitaria, Inc. January 1999 - October 2004
Checkpoint Systems January 1994 - May 1994
Skills
Employee Relations, Organizational..., Performance Management, Employee Engagement, HR Policies, Human Resources, Talent Management, HR Consulting, Employment Law, Leadership Development, Employee Benefits, Policy, Employee Training, EEOC, Change Management, FMLA, New Hire Orientations, Temporary Placement, Labor Relations, Job Analysis, Personal Development, Organizational Design, Personnel Management, Workforce Planning, Training, Conflict Resolution, Benefits Administration, Job Descriptions, Performance Appraisal, Leadership, Recruiting, Talent Acquisition, Strategic Planning, Management, Strategic HR, Job Evaluation, Compensation & Benefit, Interviews, Payroll
Education
Pontifical Catholic University of Puerto Rico-Ponce 1997 — 2002
Master in Business Administration, Human Resources Management/Personnel Administration, General
Escuela Avanzada de RH
University of Puerto Rico-Ponce
Bachelor Office Systems
Amgen manufacturing limited January 2002 - August 2008
McNeil Consumer Healthcare January 2000 - May 2002
Skills
Change Control, Biotechnology, FDA, SDS-PAGE, Fermentation, Quality System, HPLC, Chromatography, Purification, Regulatory Affairs, LIMS, GMP, Quality Control
Education
Universidad del Turabo 2000 — 2003
Universidad de Puerto Rico 1995 — 1999
bachelor, Microbiology
Amgen Manufacturing Limited May 2004 - Present
Predictive Technology, Inc. November 2000 - October 2006
United State Army February 1978 - March 2006
Infrared Inspection Services, Inc. November 1998 - December 2004
Skills
Computer Literacy, Root Cause Analysis, Maintenance Management, Reliability, Predictive Maintenance, Preventive Maintenance, Training, Lean Manufacturing, Manufacturing, Troubleshooting, Process Improvement, FMEA, Maintenance & Repair, Automation, Factory, Management, Inspection, Electricians, RCM, Facilities Management, Customer Service
Education
University of Phoenix 2005 — 2007
MBA, Technology Management
University of Phoenix 2003 — 2004
BSB, Management
University of Phoenix 2003 — 2003
AA, Technical Studies
Instituto Universal de Puerto Rico 1994 — 1994
Electrician, Electrical Technology
US Army Signal School 1989 — 1989
Telecommunication Operation Chief, Telecommuniations & Information System
Amgen Manufacturing Limited January 2015 - Present
Skills
Supply Chain Management
Education
Inter-American University of Puerto Rico-San Germán Campus
Master of Business Administration (MBA), Industrial Management / HR Management
University of Puerto Rico-Mayaguez
BSIE, Industrial Engineering
Colegio de La Milagrosa, Mayagüez, PR
NNE Pharmaplan September 2013 - Present
Merck Sharp & Dohme June 2010 - September 2013
Cook Pharmica October 2007 - May 2010
Amgen Manufacturing Limited 2005 - 2007
Skills
Biopharmaceuticals, GMP, Aseptic Processing, Filtration, Biotechnology, Sop, Validation, Fermentation, Technology Transfer, V&V, Chromatography, CAPA, FDA, Change Control, Cell Culture, Aseptic Technique, Purification, Cleaning Validation, 21 CFR Part 11, Protein Purification, Trackwise, Formulation, LIMS, Cell, Vaccines, cGMP manufacturing, MES, GLP, CIP, Deviations, SOP, TrackWise, Quality System, Computer System..., GxP
Education
The Johns Hopkins University 2007 — 2010
Masters of Science, Biotechnology
Universidad de Puerto Rico 2000 — 2005
Bioengineering, Industrial Biotechnology
Amgen Manufacturing Limited November 2013 - November 2014
URS Corporation May 2013 - August 2013
Skills
Microsoft Office, Team Leadership, Customer Service, Leadership, Teamwork, Microsoft Excel
Education
Universidad del Turabo 2010 — 2016
Mechanical Engineering
Genentech June 2015 - Present
Amgen Manufacturing Limited June 2014 - July 2015
Skills
Skilled at Pro/ENGINEER, Skilled at MATLAB, Bilingual, Leadership, Highly responsible, High level of initiative, Works Well in Groups, Manufacturing, Engineering, SolidWorks, AutoCAD
Education
University of Puerto Rico-Mayaguez 2009 — 2015
Barchelor of Science, Mechanical Engineering
Catalent Pharma Solutions 2015 - Present
Brooks Academy of Science and Engineering August 2013 - October 2014
Amgen March 2010 - May 2012
Amgen Manufacturing Limited January 2006 - March 2010
Skills
Biotechnology, Life Sciences, Cell Culture, Molecular Biology, Biochemistry, Assay Development, Biopharmaceuticals, Technology Transfer, Bioreactor, GMP, GLP, 5S, Process Automation, Fermentation Process..., Process Improvement, FDA, LIMS, Non-Conforming
Education
University of Puerto Rico School of Medicine 2006 — 2009
Master's Degree, Biochemistry and Nutrition, 3.64
University of Puerto Rico-Mayaguez 2000 — 2005
Bachelor's Degree, Industrial Biotechnology, 3.31
Amgen Manufacturing Limited 2006 - Present
Do it Best Company 2002 - 2006
Environmental Quality Board 1999 - 2002
Department of Natural and Environmental Resources 1997 - 1999
Skills
Environmental Awareness, Microsoft Office, Sustainability, Project Management, Research, Microsoft Excel, Customer Service, Strategic Planning, Environmental..., Environmental Impact..., Environmental Compliance, Microsoft Word, Risk Assessment, Construction, Project Planning, Budgets, Water, Engineering
Education
University of Puerto Rico- Mayaguez Campus 1993 — 1996
B.S, Chemical Engineering- Magna Cum Laude
Universidad del Turabo 2004 — 2007
Master of Science (M.S.), Environmental Management
InspIrAct Now PresidentInspirAct Now2005 - Present
Amgen Manufacturing Limited 1992 - 2005
Skills
Life Coaching, Business Coaching, Personal Development, Executive Coaching, Emotional Intelligence
Education
Universidad de Puerto Rico 1983 — 1988
BS, Industrial microbiology
Amgen Manufacturing, Limited August 2006 - Present
Eli Lilly and Company June 1996 - July 2006
Skills
GMP, Technology Transfer, FDA, Biopharmaceuticals, Validation, 21 CFR Part 11, Change Control, CAPA, Regulatory Affairs, Biotechnology, Aseptic Processing, CMC, V&V, Regulatory Submissions, Pharmaceutical Industry, Sop
Education
Inter-American University of Puerto Rico-Metropolitan Campus 1996 — 2000
Master of Business Administration (MBA), Industrial Management, Master's Degree
University of Puerto Rico-Rio Piedras 1982 — 1988
Bachelor of Science (BS), Chemistry
Amgen Manufacturing Limited November 2004 - Present
Cordis LLC September 2002 - November 2004
Cordis 1999 - 2002
Skills
Project Management, DMAIC, FDA, GMP, Validation, Risk Management, Change Control, Statistical Tools, CAPA, Medical Devices, R&D, Quality System, Aseptic Processing, Technical Writing
Education
Florida International University 1999 — 2001
MSEM, Engineering Management, Biomedical Engineering
University of Puerto Rico, Mayaguez 1992 — 1997
BSChE, Chemical Engineering
Amgen March 2011 - Present
Amgen September 2007 - March 2011
Amgen Manufacturing Limited July 2005 - August 2007
Amgen 2001 - 2005
Amgen September 1997 - 2001
Amgen 1992 - 1997
Skills
Biotechnology, Validation, FDA, Chromatography, Cell Culture, Manufacturing, CAPA, Biopharmaceuticals, Project Management, Technology Transfer, GMP, Process Engineering, Pharmaceutical Industry, Product Development, Program Management
Education
Oregon State University 1986 — 1993
BS, Chemical Engineering
Benson Polytechnic High School 1982 — 1986
Electronics
Amgen June 2013 - Present
Amgen September 2009 - May 2013
Amgen, Inc. 2007 - August 2009
Amgen Manufacturing Limited 2002 - 2007
Amgen 1995 - 2002
Skills
Biopharmaceuticals, Biotechnology, GMP, FDA, Validation, CAPA, Aseptic Processing, Technology Transfer, Sop, Change Control, Pharmaceutical Industry, Lifesciences, 21 CFR Part 11, Quality System, Purification, GLP, V&V, Cell Culture, Fermentation, Protein Purification, Aseptic Technique, LIMS, Trackwise, Chromatography, Cleaning Validation, Computer System..., Monoclonal Antibodies
Education
University of California, Davis 1991 — 1995
B.S., Biological Sciences
Ojai Valley School 1980 — 1991
Compliance Masters, Inc. July 2001 - Present
Bayer HealthCare October 2010 - Present
Amgen Manufacturing Limited 2001 - Present
Biogen February 2004 - June 2004
Bayer January 2000 - August 2001
Alpha Therapeutics Corporation/Grifols USA 1996 - 2000
Baxter Healthcare, Hyland Division September 1988 - August 1996
Skills
Technology Transfer, Validation, GMP, Biotechnology, FDA, Pharmaceutical Industry, GxP, Purification, Biopharmaceuticals, Lifesciences, Protein Chemistry, Quality System, Cell Culture, Quality Assurance, Process Simulation, V&V, Cleaning Validation, Quality Control, Medical Devices, Change Control, Cell, CAPA, 21 CFR Part 11, Sop, GLP, Computer System..., GAMP, Drug Development, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, LIMS, Clinical Development, Vaccines, Chromatography, ISO 13485, Clinical Trials, HPLC
Education
University of Minnesota-Twin Cities 1978 — 1984
PhD, Genetics and Cell Biology, Cell Surface Chemistry
University of Minnesota Duluth 1977 — 1978
MS, Biology, Embryology, Thyroid Development
Makerere University 1969 — 1972
B.Ed, Education, Biology
Commissioning Agents, Inc June 2014 - Present
Amgen Manufacturing Limited September 2013 - February 2014
Abbot Medical Optics June 2013 - September 2013
Bristol-Myers Squibb January 2011 - March 2013
Bristol-Myers Squibb May 2010 - December 2010
Bristol-Myers Squibb June 2009 - May 2010
Bristol-Myers Squibb 2006 - January 2009
Amgen Pharmaceuticals September 2005 - January 2006
Ivax Pharmaceuticals April 2005 - September 2005
Elli Lilly, Inc. September 2004 - March 2005
Skills
GMP, Validation, 21 CFR Part 11, Sop, Quality Assurance, Biotechnology, Computer System..., Change Control, Aseptic Processing, CAPA, GAMP, GxP, Pharmaceutical Industry, FDA, Manufacturing, Biopharmaceuticals, Quality System, Pharmaceutical Packaging, SOP
Education
Inter-American University of Puerto Rico-Metropolitan Campus 1990 — 1995
Master's, MBA
US ARMY Intern Training Center 1982 — 1983
N/A, Quality and Reliability Engineering
University of Puerto Rico - Mayaguez Campus 1977 — 1982
Bachellor's, Chemical Engineering
Amgen, Inc. November 2007 - Present
Amgen Manufacturing Limited December 2005 - November 2007
Amgen Manufacturing Limited November 2003 - November 2005
Amgen, Inc November 2000 - November 2003
Amgen, Inc. April 1998 - November 2000
Skills
GMP, Pharmaceutical Industry, Change Control, Quality Assurance, Process Simulation, Process Improvement, Risk Management, Strategy, Mergers & Acquisitions, Auditing, Healthcare, Business Strategy, Sop, Strategic Planning, Data Analysis, Cross-functional Team..., Clinical Development, Software Documentation, Quality Management, Manufacturing, Forecasting, CAPA, Technology Transfer, Continuous Improvement, Validation, Lean Manufacturing, Management, Commercialization, Biopharmaceuticals, Change Management, GLP, FDA, Medical Devices, Project Management, Biotechnology, Product Development, Supply Chain, Lifesciences, SAP, Leadership, Six Sigma, V&V, Enterprise Risk..., Process Engineering, Risk Assessment, Regulatory Affairs, Operational Excellence, Quality System, 21 CFR Part 11, Quality Auditing
Education
Florida State University 1991 — 1997
BS, Psychology & Biology
Freelance March 2014 - Present
Oficina de Servicios Legislativos - San Juan Capitol April 2011 - March 2014
PanAmerican Language 2004 - 2010
Amgen Manufacturing, Limited 2004 - 2007
Premier Euro RSCG 2004 - 2004
Skills
Spanish <> English..., Skill in..., Proofreading, Editing, Microsoft Office, Technical Translation, Foreign Languages, Language Services, Multilingual, Translation, Spanish, Legal Translation, Interpreting, Research, Public Relations, French, Language Teaching
Education
Programa Graduado en Traducción, Universidad de PR 2006 — 2012
Master's Degree, Translation
Purdue University 1999 — 2002
Bachelor of Arts (B.A.), Communication / Minor in French
Biogen Idec September 2008 - Present
Biogen Idec September 2008 - November 2010
Amgen 2003 - 2008
Amgen Rhode Island 2003 - 2008
Amgen 1997 - 2008
Amgen Manufacturing Limited 1997 - 2003
Abbott Diagnostics 1991 - 1997
Skills
GMP, CAPA, Quality Assurance, Validation, Biopharmaceuticals, Change Control, 21 CFR Part 11, Quality System, LIMS, GxP, Medical Devices, Aseptic Processing, FDA, Technology Transfer, Quality Control, V&V, Cleaning Validation, Quality Auditing, Sop, GLP, SOP
Education
Universidad de Puerto Rico
Amgen Manufacturing Limited October 2006 - Present
Bristol-Myers Squibb June 2001 - October 2006
Skills
LIMS, Equipment Qualification, Technology Transfer, IR, Raman, Analytical Methods..., Analytical Method..., GMP, Pharmaceutical Industry, GLP, Biotechnology, Biopharmaceuticals, Validation
Education
Purdue University 1995 — 2000
PhD, Chemistry
Inter-American University of Puerto Rico-San Germán Campus 1990 — 1994
BS, Chemistry
LifeCell Corporation February 2015 - Present
LifeCell Corporation March 2013 - February 2015
LifeCell Corporation June 2010 - April 2013
Veridex, LLC February 2008 - February 2010
AMGEN Manufacturing Limited February 2005 - August 2007
Skills
GMP, Quality System, Quality Assurance, Medical Devices, Aseptic Processing, CAPA, FDA, ISO 13485, Validation, 21 CFR Part 11, Change Control, Biotechnology, Trackwise, Six Sigma, Minitab, Cell Culture, GxP, Aseptic Technique, Design Control, Sop, V&V, 21 CFR, FDA GMP, Computer System..., Quality Control, Quality Auditing, Cleaning Validation, Root Cause Analysis, CQA, DMAIC, Microbiology, Contract Manufacturing, ISO 14971
Education
Universidad del Turabo 2011 — 2013
Master Business Administration, Material Management and Control
Raritan Valley Community College 2009 — 2010
Certificate, Six Sigma Green Belt
Raritan Valley Community College 2009 — 2009
Certificate, Six Sigma Yellow Belt
Universidad de Puerto Rico 2000 — 2007
Bachelor, Microbiology
Amgen October 2013 - Present
Amgen September 2012 - October 2013
AMGEN Manufacturing Limited March 2004 - October 2012
Skills
Manufacturing, SAP, ERP, Aseptic Processing, Cell Culture, MES, GMP, Sop, CAPA, Technology Transfer, 21 CFR Part 11, LIMS, Supply Chain, Start-ups, Biotechnology, Pharmaceutical Industry, cGMP manufacturing, Biopharmaceuticals, Change Control, FDA, Validation, Continuous Improvement, Cross-functional Team...
Education
University of Phoenix 2007 — 2010
MBA, Human Resource Management
Universidad de Puerto Rico 1998 — 2003
Bachelor of Applied Science (B.A.Sc.), Biology/Biological Sciences, General, 3.62
Lilly del Caribe, Inc June 2014 - January 2015
Amgen June 2013 - June 2014
Amgen Manufacturing Limited April 2011 - August 2012
Pfizer 2007 - 2007
Verlex in Seatle, WA 2006 - 2006
Schering 2001 - 2004
Education
University of Bridgeport 1978 — 1979
Master of Science (M.S.), Biology, General
Universidad de Puerto Rico 1966 — 1971
Bachelor's degree, B.S. Biology
Food and Drug Administration March 2010 - Present
San Juan Bautista School of Medicine 2008 - 2010
Amgen Manufacturing Limited 2005 - 2007
Abbott Laboratories 2002 - 2005
Skills
Pharmacology, In Vitro, FDA, Toxicology, Laboratory, Neuroscience, Medical Devices, Regulatory Affairs, Quality Control, Chemistry, Validation, Assay Development, CAPA, Electrophysiology, Biotechnology, Biochemistry, Project Management, Infectious Diseases, Inspection, Complaint Investigations, Product Complaints, Recalls, Regulatory Submissions, Regulatory Compliance
Education
University of Puerto Rico School of Medicine
Ph.D., Pharmacology and Toxicology
Universidad de Puerto Rico
BS, General Sciences
Global Automation Partners April 2005 - Present
Amgen Manufacturing Limited January 2003 - March 2005
Skills
Automation, Process Control, Validation, Visual Basic, MES, Batch Processing, Project Management, Process Automation, Testing, Troubleshooting, SQL, Programming, SAP XI, TWS, Computer System...
Education
Polytechnic University of Puerto Rico 1996 — 1999
Masters of Science, Engineering Management
Universidad de Puerto Rico 1987 — 1992
Bachelor of Science, Computer Engineering
Pac Tech International May 2014 - Present
Amgen Manufacturing, Limited May 2013 - May 2014
PR-LSAMP August 2010 - December 2011
Borders September 2007 - September 2009
Skills
Chemistry, Laboratory, Research, Microsoft Office, PowerPoint, Windows, Microsoft Word, Mac OS, Microsoft Excel, Outlook, PASX-Werum, SAT, LIMS, cGMP practices, cGMP manufacturing, GMP, FDA GMP, GDP, Manufacturing, Six Sigma, Quality Control, SOP, Microbiology, HPLC
Education
Interamerican University of Puerto Rico 2008 — 2012
Bachelor of Science (B.S.), Chemistry; Minor in Mathematics, 3.51
Polytechnic University of Puerto Rico 2007 — 2008
Chemical Engineering
Universidad de Puerto Rico 2004 — 2006
Chemical Engineering