Hyde Engineering + Consulting
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Hyde Engineering + Consulting Employees
Hyde Engineering + Consulting September 2015 - Present
Zimmer Biomet April 2015 - September 2015
Stevens Institute of Technology August 2014 - December 2014
Stevens Institute of Technology August 2013 - December 2014
Baroque Pharmaceuticals Pvt.Ltd., India July 2010 - June 2012
Surya Life Sciences January 2010 - June 2010
Skills
Microsoft Word, Research, Windows, English, Regulatory Affairs, R&D, Teaching, Photoshop, PowerPoint, Outlook, Microsoft Excel, Pharmaceutical Industry, Microsoft Office, Validation, Project Management, Event Planning, Minitab, Electronic Document, FMEA, Design of Experiments, Process Analytical..., HPLC, GMP, SOP, Pharmaceutics, Biotechnology, FDA, GLP, Formulation, Quality Assurance, Analytical Chemistry, UV/Vis, CAPA, Process Simulation, Root Cause Analysis, Quality Control, Cleaning Validation, Process Validation, Six Sigma, Change Control, Engineering, 21 CFR Part 11, Laboratory, V&V, Life Sciences, Manufacturing, Gas Chromatography, Chromatography, Quality System, Clinical Trials
Education
Stevens Institute of Technology 2013 — 2015
Masters in Mechanical Engineering, Pharmaceutical Manufacturing
University of Pune 2007 — 2011
Bachelor's degree, Pharmacy, First class
National Renewable Energy Laboratory January 2014 - Present
Sirius Computer Solutions January 2006 - August 2013
Hyde Engineering + Consulting 2010 - 2012
Skills
NetApp, VMware, Virtualization, Storage, Brocade, Data Center, Storage Virtualization, Servers, VMware ESX, Storage Solutions, Storage Management, HP, VMware Infrastructure, Cisco Technologies
Education
Colorado State University
Master of Business Administration (M.B.A.), Business Administration and Management, General
Highlands Ranch High School 1993 — 1997
Colorado State University
Bachelor of Business Management (B.B.M.), International Business
Hyde Engineering + Consulting January 2014 - June 2015
Hyde Engineering + Consulting August 2013 - January 2014
Coalfire Systems, Inc. June 2013 - August 2013
FirstBank June 2011 - March 2013
Leeds School of Business - Office of Diversity Affairs June 2010 - June 2011
Leeds School of Business - Office of Diversity Affairs August 2009 - June 2011
Skills
Student Development, Student Affairs, Student Leadership, Research, Higher Education, Market Research, Social Media Marketing, Social Media, Marketing, Facebook, Advertising, Salesforce.com, Microsoft Office, Customer Service, PowerPoint, Sales, Event Planning, Time Management, Mentoring, Leadership, Ethical Decision Making
Education
University of Colorado at Boulder - Leeds School of Business 2009 — 2013
B.S, Business Administration – Marketing
University of Colorado at Boulder - Journalism and Mass Communication
Advertising, a2b
Hyde Engineering + Consulting January 2014 - Present
Sartorius July 2011 - January 2014
WyzAnt Tutoring August 2011 - February 2013
Reservoirs Environmental Inc. December 2010 - July 2011
Mad Science October 2010 - March 2011
University of Tennessee August 2007 - August 2010
Missouri State University May 2007 - August 2007
University of Missouri June 2006 - August 2006
McDonald's September 2001 - June 2006
Missouri State University August 2004 - May 2006
Skills
Protein Chemistry, Biochemistry, HPLC, PCR, Cell Culture, Molecular Biology, Microbiology, Science, Western Blotting, Chemistry, Analytical Chemistry, Spectroscopy, Enzyme Kinetics, SDS-PAGE, Microscopy, Fluorescence..., RT-PCR, DNA extraction, Microsoft Excel, Research, Lifesciences, UV/Vis, Flow Cytometry, Site-directed..., Laboratory, Hemocytometer, Moisture Analysis, Isothermal Titration..., DNA electrophoresis, Site directed..., SigmaPlot, Quality Assurance, Genetics, Tutoring, Teaching, ISO 9001, Purification, Cell Biology, Fluorescence Microscopy, Life Sciences
Education
University of Tennessee-Knoxville 2007 — 2011
Master's of Science, Biochemistry, Cell, and Molecular Biology
Missouri State University 2003 — 2007
Bachelor's of Science, Cell and Molecular Biology, Chemistry
Hyde Engineering + Consulting September 2004 - Present
Skills
Process Improvement, Manufacturing, Quality Auditing, Start-ups, Biotechnology, Data Analysis, Process Engineering, Cross-functional Team...
Education
Metropolitan State College of Denver 1993 — 1995
BS, Accounting
Colorado State University 1980 — 1984
Wildlife Biology and Watershed Science, Freshman, Sophmore, and Junior yrs
Open to Biotech + Related Industry Opportunities April 2015 - Present
KBI Biopharma June 2014 - April 2015
Hyde Engineering + Consulting June 2013 - June 2014
Merck 2011 - 2012
Merck 2009 - 2011
Insmed 2006 - 2009
Paragon Analytics, a Division of Datachem Laboratories 2001 - 2005
Colorado HistoPrep 2001 - 2001
Skills
Validation, Biotechnology, Fermentation, Quality Assurance, CAPA, Chromatography, Six Sigma, Project Management, Change Control, Lean Manufacturing, cGMP manufacturing, Continuous Improvement, Supervisory Experience, Technology Transfer, Protein Purification, HPLC, SOP authoring, Aseptic Technique, Cleaning Validation, Quality System..., Equipment Commissioning, Equipment Qualification, FMEA, Protein Folding, Standardization, Processes Development, GMP
Education
University of Colorado at Boulder
BS, Biology/Biological Sciences, General
Villanova University
Project Management - Master Certificate
Hyde Engineering + Consulting December 2013 - Present
Hyde Engineering + Consulting January 2013 - November 2013
BIOCON LIMITED April 2011 - December 2012
BIOCON LIMITED August 2010 - March 2011
Reliance Life Sciences July 2007 - July 2010
Y Bio Inc. October 2006 - May 2007
Skills
Analysis, GMP, UV, Gel Electrophoresis, Microsoft Office, Quality Control, Sop, Biotechnology, Purification, V&V, Validation, Commissioning, Statistical Tools, Regulatory Guidelines, ICH guidelines, Change Control, Deviation Management, OOS, ISPE, ASME, TQM, ASTM standards, Process Automation, Building Automation, Quality Assurance, Quality System, Biopharmaceuticals, Nutraceuticals, Fermentation, Quality Management, Vaccines, Equipment Qualification, GLP, Formulation, CAPA, Computer System..., FDA, Aseptic Processing, Pharmaceutical Industry, Lifesciences, SOP, Life Sciences
Education
Birla Institute of Technology and Science 2010 — 2012
M.S., Quality Management
Anna University 2002 — 2006
B.Tech, Industrial Biotechology
St.Thomas Higher Secondary School, Gudalur, Nilgiris 2000 — 2002
XI, XII
Holy Cross Convent Matriculation School, Devarshola, Nilgiris 1988 — 2000
X
Hyde Engineering + Consulting July 1999 - Present
Skills
CIP, CIP Efficiency, CIP Improvement, SIP, GMP, Change Control, Technology Transfer, Biopharmaceuticals, Process Simulation, Validation, Bioprocess Design, CIP Remediation
Education
Kansas State University 1992 — 1999
Bachelor of Science, Chemical Engineering
Hyde Engineering + Consulting January 2014 - Present
GE Analytical Instruments May 2008 - January 2014
GE Analytical Instruments June 2002 - May 2008
Sievers Instruments June 1995 - May 2002
Skills
Project Management, PMP, MS Project, Management, Six Sigma, Biotechnology, Process Improvement, Process Simulation, Leadership, Cross-functional Team..., Engineering, GMP, R, Product Development
Education
University of Connecticut 1993 — 1995
Master of Science (M.S.), Chemical Engineering
University of Colorado Boulder 1988 — 1992
Bachelor of Science (B.S.), Chemical Engineering
Genentech March 2015 - Present
Hyde Engineering + Consulting December 2013 - March 2015
Medicis July 2012 - November 2013
CRB Consulting Engineers January 2011 - April 2012
MannKind Corporation July 2000 - December 2010
MannKind Corporation July 2000 - December 2010
Skills
GMP, Validation, Sop, FDA, 21 CFR Part 11, CAPA, Cleaning Validation, V&V, Technology Transfer, Biotechnology, Pharmaceutical Industry, Biopharmaceuticals, Process Simulation, Change Control, Quality System, Manufacturing, Process Engineering, Process Improvement, Commissioning, GLP, LIMS, GxP, Aseptic Processing, Computer System..., Continuous Improvement, Quality Assurance, Quality Control, ISO, Chromatography, Cross-functional Team..., Process Optimization, Drug Delivery, Regulatory Affairs, HPLC, Pharmaceutics
Education
The University of Connecticut 1996 — 2000
BS, Physiology Neurobiology / Mollecular and Cellular Biology
Exelis August 2015 - Present
Fresenius Kabi May 2015 - July 2015
Fresenius Kabi USA June 2014 - July 2015
Hyde Engineering + Consulting March 2014 - June 2014
Bausch + Lomb July 2012 - December 2013
Industrial Biofouling Science, LLC September 2009 - November 2013
Ethox Corp June 2007 - September 2009
Eastman Kodak January 2004 - May 2007
Eastman Kodak January 1996 - January 2004
Skills
R&D, Analytical Chemistry, Characterization, Cross-functional Team..., New Business Development, Microbiology, Fluorescence Microscopy, Biofilms, Technical Leadership, Commercialization, Problem Solving, Design of Experiments, Protein Chemistry, IR spectroscopy, Technology Transfer, Pharmaceutical Industry, Laboratory, Chemistry, Quality System, UV/Vis, CAPA, Process Simulation, Materials Science, Leadership, Manufacturing, Microscopy, V&V, Spectroscopy, Polymers, Biotechnology, Validation, Management, Medical Devices, Internal Audit, Lifesciences, Engineering, Surface Chemistry, Quality Control, Science, Nanotechnology, Materials, Internal reflection IR..., Contact angles/surface..., FTIR, Collaborative Problem...
Education
University at Buffalo 1978 — 1981
M.S., Biophysics
State University of New York College at Buffalo 1974 — 1978
B.A., Biology
LeMaitre Vascular November 2014 - Present
Hyde Engineering + Consulting May 2014 - November 2014
IntelligentMDx June 2013 - January 2014
Anika Therapeutics April 2012 - May 2013
EMD Millipore October 2010 - April 2012
Sanofi Pasteur 2008 - 2010
Biopure 2006 - 2008
Proteome Systems May 2004 - June 2006
Air Products and Chemicals May 2002 - May 2004
Skills
GMP, Validation, Biotechnology, Chromatography, Technology Transfer, CAPA, Sop, FDA, Purification, Aseptic Technique, Protein Purification, Filtration, Vaccines, Cleaning Validation, Chemical Engineering, Process Engineering, Biopharmaceuticals, Change Control, Design of Experiments, Aseptic Processing, R&D, V&V, Quality Assurance, Fermentation, 21 CFR Part 11, Cell Culture, LIMS, Molecular Biology, ELISA, Root Cause Analysis, GLP, Quality System, Pharmaceutical Industry, SOP
Education
Northeastern University 2005 — 2007
MS, Biotechnology
Penn State University 1997 — 2002
BS, Chemical Engineering
Hyde Engineering + Consulting May 2014 - Present
Amgen April 2013 - April 2014
Merck November 2010 - December 2012
ASDx Biosystems Inc October 2008 - May 2010
Endo Pharmaceuticals April 2007 - April 2008
Insmed January 2006 - March 2007
Amgen June 2003 - January 2006
Baxter November 1998 - December 2002
Synergen 1986 - 1994
Skills
GMP, Biotechnology, HPLC, Chromatography, Biopharmaceuticals, GLP, Protein Chemistry, Pharmaceutical Industry, Validation, Purification, Technology Transfer, 21 CFR Part 11, Assay Development, ELISA, Cell, Sop
Education
Colorado State University 1980 — 1984
Bachelor of Science (BSc), Microbiology
Pall Life Sciences June 2014 - Present
Coast-2-Coast Consulting, Inc January 2003 - June 2014
Hyde Engineering + Consulting June 2012 - December 2013
Hyde Engineering + Consulting June 2012 - February 2013
Novartis Animal Health January 2012 - June 2012
Genzyme August 2011 - January 2012
Zimmer TMT 2009 - 2011
Schering-Plough Corporation 2003 - 2009
Skills
CAPA, Validation, GMP, 21 CFR Part 11, Change Control, V&V, Sop, Quality System, ISO 13485, GxP, GLP, Pharmaceutical Industry, Biotechnology, Medical Devices, Technology Transfer, LIMS, Quality Assurance, Cleaning Validation, FDA Audits, FDA, Quality Control, Biopharmaceuticals, Aseptic Processing, Deviations, GAMP, HPLC, Lifesciences, Pharmaceutics, Quality Auditing, Trackwise, Vaccines, SOP
Education
UCSD 1986 — 1991
Bachelor of Science (BS), Biology, General
University of California at San Diego 1986 — 1991
Biology, Biochemistry, Biophysics and Molecular Biology
Hyde Engineering + Consulting January 1996 - Present
Warner Lambert July 1981 - January 1996
Skills
Validation, Change Control, Biotechnology, FDA, GMP, Technology Transfer, 21 CFR Part 11, Automation, V&V, R&D, Biopharmaceuticals, Six Sigma, Manufacturing, CAPA, Process Simulation, Sop, Aseptic Processing, Computer System..., Quality System, GxP
Education
Rockford University 1990 — 1994
MBA, Master Business Administration
University of Wisconsin-Eau Claire 1976 — 1980
BS, Chemistry, Business
Hyde Engineering + Consulting October 2014 - Present
Nine West Group June 2013 - August 2013
DSW April 2012 - March 2013
Lehigh Valley Health Network May 2012 - August 2012
Skills
Retail Sales, Biomedical Engineering, Research, Microsoft Office, Mammalian Cell Culture, cGMP practices, Cleaning Validation, Protocol Development, Summary Reports, Leadership, Public Speaking, Photoshop, Social Media, Matlab, Data Analysis
Education
Lehigh University 2010 — 2014
Bachelor of Science (BS), Bioengineering
Azzur Group June 2015 - Present
Zimmer October 2014 - June 2015
Hyde Engineering + Consulting November 2013 - August 2014
Stevens Pharmaceutical Research Center August 2012 - May 2013
Stevens Institute of Technology May 2010 - May 2011
Skills
Titrations, Spectrofluorometry, Polarimetry, Preparing Solutions, Gas Chromatography, Fourier Transform..., Atomic Absorption..., Microinjection of Cells, Agarose Gel..., PCR, HPLC, Matlab, Minitab, M-Files, Titration, Pharmaceutical Industry, Laboratory, Protein Chemistry, Antibodies, Cleaning Validation, Recruiters, FTIR, Quality Control, Formulation, GLP, Design of Experiments, UV/Vis, Chromatography, GMP, TOC, Sop, Gage R&R, FMEA, Process Capability, Risk Management, GAMP, Atomic Absorption, Validation, SOP, FDA
Education
Stevens Institute of Technology 2011 — 2013
Master of Science (M.S.), Pharmaceutical Manufacturing
Stevens Institute of Technology 2009 — 2013
Bachelor of Science (B.S.), Chemical Biology
Hyde Engineering + Consulting January 2015 - Present
Genzyme September 2011 - January 2015
Bristol-Myers Squibb June 2009 - September 2011
Bristol-Myers Squibb August 2008 - January 2009
Freudenberg-NOK June 2007 - August 2007
Skills
Validation, CAPA, FDA, Biotechnology, Sop, Chemical Engineering, Process Simulation, Biopharmaceuticals, Change Control, Cleaning Validation, Technology Transfer, GAMP, Aseptic Processing, Process Engineering, Quality System, Filtration, 21 CFR Part 11, Testing, Commissioning, Manufacturing, Product Development, Calibration, Quality Assurance, Engineering, Computer System..., FDA GMP, Root Cause Analysis, Design of Experiments, SOP
Education
University of Massachusetts Lowell 2005 — 2009
Bachelor of Science, Chemical Engineering
Sharp Corporation (dba Sharp Packaging Solutions) June 2013 - Present
Sharp Corporation (dba Sharp Packaging Solutions) December 2010 - May 2013
Hyde Engineering + Consulting June 2008 - May 2010
Merck December 2005 - December 2007
ValSource, LLC March 2003 - November 2005
Elan Pharmaceuticals October 2000 - September 2002
Air Products March 1998 - September 2000
Air Products October 1995 - February 1998
Silberline October 1993 - September 1995
Silberline October 1989 - September 1993
Skills
Product Development, Microsoft Office, Six Sigma, Software Documentation, Validation, Microsoft Excel, Manufacturing, Process Improvement, Quality Assurance, SAP, Engineering, Continuous Improvement, Lean Manufacturing, Process Engineering, Quality System, Procurement, GMP, FDA
Education
Lehigh University 1988 — 1993
Master of Science (MS), Chemical Engineering
Penn State University 1980 — 1984
Bachelor's Degree, Chemical Engineering
Alexion Pharmaceuticals, Inc. June 2015 - Present
Hyde Engineering + Consulting September 2013 - June 2015
Laureate Biopharmaceutical Services January 2013 - August 2013
Laureate Biopharmaceutical Services August 2012 - December 2012
Laureate Biopharmaceutical Services June 2011 - July 2012
Cornell Stable Isotope Laboratory February 2008 - May 2011
IonSense, Inc. May 2010 - January 2011
Skills
Chromatography, Aseptic Technique, Aseptic Processing, Protein Purification, Ultrafiltration, Nanofiltration, Biotechnology, Process Simulation, Lifesciences, GMP, Mass Spectrometry, Technology Transfer, FDA, Cell Culture, Purification, Biopharmaceuticals, Sop, Validation, Chemical Engineering, FDA GMP, 21 CFR Part 11, Cleaning Validation, Formulation, Filtration, Manufacturing, Bioreactor, GLP, Downstream Processing, Change Control, CAPA, Monoclonal Antibodies, Chemistry, HPLC, SDS-PAGE, Sterilization
Education
Cornell University 2007 — 2011
Bachelor of Science, Chemical Engineering
CQV Solutions March 2014 - Present
Hyde Engineering + Consulting January 2011 - March 2014
USA Trading May 2007 - August 2007
Skills
Process Engineering, Technology Transfer, Change Control, Validation, FDA, Process Simulation, GMP, Data Analysis, Chemical Engineering, Pharmaceutical Industry, Project Management, Process Improvement, Microsoft Office, Research, GAMP
Education
Cornell University 2005 — 2010
B.S., Engineering
Saint Johns High School 2001 — 2005
Hyde Engineering + Consulting December 2013 - Present
Hyde Engineering + Consulting December 2011 - December 2013
BiOZEEN December 2010 - May 2011
ITC R&D January 2010 - October 2010
Skills
Cell Culture, Fermentation, Validation, Downstream Processing, Biotechnology, Biopharmaceuticals, Purification, Microbiology, SOP
Education
VIT University 2008 — 2010
MSc, Biotechnology
Osmania University 2005 — 2008
BSc, Biotechnology, Microbiology, Chemistry
Sri Chaitanya Junior College 2003 — 2005
Intermediate, Botany, Zoology
St.John's Church High School 1996 — 2003
Agilent Technologies March 2015 - Present
Hyde Engineering + Consulting October 2014 - Present
Corden Pharma GmbH September 2011 - September 2014
Roche July 1999 - September 2011
Roche March 1998 - July 1999
Skills
Technical Writing, Quality Assurance, Change Control, FDA, Web Design, GMP, Validation, SOP, Quality System, FrameMaker, GxP, Technology Transfer, 21 CFR Part 11, CAPA, Computer System..., Pharmaceutical Industry, R&D, RoboHelp, Microsoft Word, Graphic Design, Visio, Process Simulation, Software Documentation, V&V, Regulatory Affairs, GLP, Pharmaceutics, Biotechnology, Lifesciences, LIMS, Process Analysis, Project Management, Life Sciences, Photoshop, Illustrator, Dreamweaver, Quality Auditing
Education
Front Range Community College
Associate Degree, Computer Information Systems
Front Range Community College
Certificate, Web Authoring
Front Range Community College
Certificate, Computer Network Support
SanDisk January 2014 - Present
M+W Group March 2011 - January 2014
M+W Group March 2011 - December 2013
Hyde Engineering + Consulting November 2010 - March 2011
Shaw Environmental, Inc. July 2006 - November 2010
Shaw Energy & Chemicals July 2006 - November 2010
Shaw Power- Nuclear July 2006 - November 2010
Skills
PFD, Chemical Engineering, P&ID, Project Engineering, Process Engineering, Plant Design, Engineering, Process Equipment, Refinery, HAZOP, Petrochemical, Water, FEED, Aspen Plus, Process Simulation, SharePoint, HAZOP Study, Factory, Project Management
Education
Stanford University Continuing Studies 2010 — 2011
Professional development courses-
Harvard University Extension School 2008 — 2009
Professional development courses-
Syracuse University 2004 — 2006
MS, Chemical Engineering
University of Mumbai 2000 — 2004
BE, Chemical Engineering; D J Sanghvi college of engineering
Hyde Engineering + Consulting October 2013 - Present
NUI Maynooth November 2007 - October 2012
Next Group PLC December 2003 - January 2008
Intel Corporation June 2004 - September 2004
Intel Corporation June 2003 - September 2003
Skills
Experimental Design, Experimental Research, Report Writing, Group Presentations, Technical Reports, Data Analysis, In Vivo, In Vitro, Neuroscience, Neurosurgery, Neurodegenerative..., Conference Speaking, Conference Presentations, Group Work, Physical Chemistry, Physics, Analytical Chemistry, Inorganic Chemistry, Biotechnology, Biochemistry, Biosensors, Sensors, Microsoft Office, Team Leadership, Team Management, Teaching, Testing, Teamwork, Grant Writing, Retail, Customer Service, Problem Solving, Youth Work, Characterization, Community Development, Solid State Physics, Device Physics, Process Improvement, Product Development, Medical Device R&D, IP, SOP development, GMP, Microscopy, UV/Vis, Science, Electrochemistry, Organic Chemistry, Scientific Writing, Neurodegeneration
Education
National University of Ireland, Maynooth 2007 — 2012
Doctor of Philosophy (Ph.D.), Bioanalytical Neurochemistry, Ph.D.
National University of Ireland, Maynooth 2003 — 2007
Bachelor of Science (B.Sc.) (Honours), Physics and Chemistry, 2.1
Salesian College Celbridge 1997 — 2003
Leaving Cert, Science, Maths and Language, 565 points out of 600
Connector Products Inc. January 2015 - Present
Connector Products Inc. February 2014 - January 2015
CraftBilt Manufacturing Company July 2012 - December 2013
Hyde Engineering + Consulting May 2011 - August 2011
Cedarbrook Country Club April 2001 - August 2010
Skills
Solidworks, ANSYS, Inventor, Simulink, Engineering, Matlab, Microsoft Office, Product Development, Microsoft Excel, Technology Transfer, PowerPoint, Microsoft Word, M2M, Microsoft Publisher, Autodesk Software, Sales Logix, Manufacturing, Six Sigma
Education
Arizona State University 2008 — 2012
Bachelor of Science, Mechanical Engineering
School of Architecture & Landscape 2007 — 2008
North Penn High School, PA 2004 — 2007
HS degree
Edmonds Engineering, Inc. May 2012 - Present
Hyde Engineering + Consulting 2007 - May 2012
BL Harbert International LLC 2004 - 2007
Ray Engineering Group 2001 - 2004
Sajjadieh Engineering Group, P.C. 1996 - 2001
Skills
CRM, Switchgear, Contract Management, Commissioning, Project Engineering, Process Scheduler, Construction, Proposal Writing, Electrical Engineering, HVAC, Submittals, Revit, Project Management, Power Distribution, High Voltage, Contractors, Engineering Design, Value Engineering, Project Coordination
Education
University of Alabama 1991 — 1995
BSEE, Electrical Engineering
Grifols January 2014 - Present
Hyde Engineering + Consulting 2004 - Present
Genentech August 2012 - November 2013
Bayer HealthCare January 2011 - June 2012
Genentech 2009 - March 2012
Jacobs Engineering 1997 - 2004
Burroughs Wellcome (now DSM Pharma) 1995 - 1997
Skills
GMP, Biopharmaceuticals, Process Engineering, Change Control, CAPA, Engineering, Project Management, Validation, Process Simulation, Commissioning, V&V, Cell Culture, Biotechnology
Education
North Carolina State University 1989 — 1993
BS, Chemical Engineering
Boehringer Ingelheim December 2013 - Present
Hyde Engineering + Consulting February 2012 - December 2013
Bayer May 2006 - February 2012
Johnson & Johnson December 2004 - January 2006
Skills
Commissioning, GMP, Process Engineering, Engineering, Manufacturing, Process Simulation, FDA, Change Control, Design of Experiments, Aseptic Processing, Cleaning Validation, CAPA, Technology Transfer, Quality System, Chromatography
Education
University of California, Berkeley 2002 — 2006
Bachelor, Mechanical Engineer
Validation Technologies, Inc. August 2014 - Present
Validation Technologies, Inc. April 2012 - August 2014
Validant February 2012 - April 2012
Hyde Engineering + Consulting May 2011 - August 2011
Pall Corporation August 2007 - July 2010
The Validation Company December 2006 - August 2007
Artes Medical February 2005 - August 2005
Biogen Idec August 2004 - December 2004
Skills
Engineering, Process Engineering, Validation, Cross-functional Team..., Manufacturing, Process Simulation, Software Documentation, Sop, V&V, Root Cause Analysis, Change Control, Biotechnology, Project Management, Testing, Chromatography, Technology Transfer, Quality Control, Quality Assurance, Filtration, GMP, Biopharmaceuticals, SOP
Education
University of California, San Diego 1999 — 2006
Bioengineering, Bioengineering & Design
La Jolla High School 1995 — 1999
Diploma, Physics
U.S. Cellular April 2015 - Present
Randstad Sourceright March 2014 - Present
Hyde Engineering + Consulting August 2013 - December 2013
Vertafore October 2012 - July 2013
Zones, Inc. June 2011 - October 2012
IQ Source January 2000 - May 2011
Education
Ithaca College 1983 — 1987
Bachelor of Science, Marketing
AT&T January 2014 - Present
AT&T October 2012 - December 2013
AT&T January 2012 - October 2012
AT&T August 2011 - January 2012
AT&T July 2010 - August 2011
Amgen 2009 - 2009
Hyde Engineering + Consulting June 2005 - May 2008
Skills
Cross-functional Team..., Project Management, Strategic Planning, Telecommunications, Process Improvement, Six Sigma, Strategy, Change Management, Operations Management, Team Leadership, Business Development, Program Management, Business Strategy, Management, Leadership, Leadership Development, Vendor Management, Data Analysis
Education
University of Virginia - Darden Graduate School of Business Administration 2008 — 2010
MBA
University of Pennsylvania 2001 — 2005
BSE, Bioengineering
Hyde Engineering + Consulting September 2013 - Present
CSC August 2011 - May 2013
RCM Technologies 2009 - 2011
IDG Tech Solutions, Inc. 2007 - 2009
Jacobs 2003 - 2007
Oracle 2001 - 2003
Washington Group (Raytheon) 1995 - 2001
Aker Kvaerner 1991 - 1995
Skills
Document Management, Compliance, Process Engineering, Requirements Analysis, Validation, Cross-functional Team..., Business Development, Program Management, Project Management, Lifesciences, Pharmaceutical Industry, Management, Salesforce.com, Start-ups
Education
Eastern Illinois University
BA, Economics
Hyde Engineering + Consulting August 2014 - Present
Sigma Space Corporation September 2010 - August 2014
Ledgent October 2005 - April 2010
MBNA August 2003 - August 2005
Skills
Aerospace, Sourcing, Recruiting, Applicant Tracking..., Technical Recruiting, Internet Recruiting, Talent Acquisition, Contract Recruitment, College Recruiting, Executive Search, Interviews, Resume Writing, SDLC, Permanent Placement, Recruitment Advertising, Vendor Management, PeopleSoft, Business Networking, Staff Augmentation, Job Fairs, Employee Engagement, Management, HRIS, Search, Social Networking, Hiring
Education
University of Delaware 1998 — 2002
BA
Charter School of Wilmington
Hyde Engineering + Consulting March 2013 - Present
Technology Commercialization Office February 2013 - March 2013
Athens Technical College August 2012 - December 2012
Complex Carbohydrate Research Center April 2008 - December 2012
University of Georgia August 2007 - May 2008
National Chemical Laboratory January 2007 - May 2007
Emcure Pharmaceuticals Limited June 2006 - July 2006
Skills
Process Improvement, Validation, Technical Writing, GMP, SOP, Cross-functional Team..., Chemistry, Science, Data Analysis, Laboratory, UV/Vis, Organic Synthesis, Research, NMR, Lifesciences, PCR, Organic Chemistry, Purification, Chromatography, Life Sciences, Microbiology, Teaching, Analytical Chemistry, Quality Assurance
Education
The University of Georgia 2007 — 2012
Doctor of Philosophy (PhD), Organic Chemistry
University of Pune 2005 — 2007
Master's degree, Organic Chemistry
Pune University 2002 — 2005
Bachelor of Science (B.Sc.), Chemistry
Endologix Inc June 2014 - Present
Hyde Engineering + Consulting June 2013 - June 2014
Henslee Recruiting Services January 2009 - May 2013
Covidien Vascular Therapies March 2009 - March 2013
Johnson & Johnson March 2005 - January 2009
Biosense Webster and Neutrogena (Johnson & Johnson) April 2006 - March 2007
Biosense Webster (Johnson & Johnson) April 2005 - April 2006
Kathryn Henslee Medical Device Recruitment Services December 2001 - April 2006
Search West March 1999 - March 2001
Skills
Direct Recruiting, Medical Devices, Collaborative Leadership, Team Building, Recruiting, Human Resources, Talent Management, Process Improvement, Sourcing, Start-ups, Management, Leadership, Interviews, Talent Acquisition, Program Management, Coaching, Strategy, Manufacturing, Healthcare, FDA, Sales, Quality Assurance, Hiring, Product Development, Team Management, Consulting, Validation, Marketing, Pharmaceutical Industry, Applicant Tracking..., Cross-functional Team..., R&D, Onboarding, ISO 13485, Building Relationships, Technical Recruiting, Strategic Sourcing, Training, Cold Calling, Internet Recruiting, Temporary Placement, Executive Search, College Recruiting
Education
Metropolitan State College of Denver 2010 — 2015
BA, Psychology, 3.8
Hyde Engineering + Consulting September 2011 - Present
PharmaSolutions, Inc. 2002 - Present
Emergent BioSolutions 2009 - August 2011
Biokinetics Inc. 2007 - 2008
Insmed 2004 - 2007
Validation Technologies, Inc. 2003 - 2004
Baxter Hemoglobin Therapeutics 1996 - 2003
Somatogen 1990 - 1996
Skills
GMP, Technology Transfer, Validation, Biotechnology, FDA, Biopharmaceuticals, Pharmaceutical Industry, GLP, CAPA, Lifesciences, Change Control, Quality System, Commissioning and..., Fill and Finish, Isolation Technology, Project Management, Cleaning Validation, Protocol Development, Autoclave Validation, EMEA /EudraLex..., Process Engineering, Process Development, Design of Experiments, Microbiology, Fermentation, V&V, Protocol, Process Simulation, Cell Culture, Manufacturing, Sop, 21 CFR Part 11, Protein Chemistry, Downstream Processing
Education
University of Colorado Boulder 1978 — 1983
Saguaro High School 1974 — 1978
Hyde Engineering + Consulting September 2015 - Present
Novavax November 2013 - September 2015
Tervela June 2012 - August 2012
Genzyme June 2011 - August 2011
Skills
Matlab, GMP, Downstream Processing, AKTA, Python, Technical Writing, ChemCAD, Unicorn, SOP
Education
University of Maryland College Park 2009 — 2013
Bachelor of Science (B.S.), Chemical Engineering
Framingham High School 2005 — 2009
Middough Inc. December 2014 - Present
Hyde Engineering + Consulting September 2013 - December 2014
Redwood Consulting June 2006 - September 2013
Fluor Corporation April 2001 - June 2006
Raytheon Engineers & Constructors February 1996 - April 2001
Raytheon Engineers &Constructors September 1988 - February 1996
Skills
Validation, Chemical Engineering, Manufacturing, Pharmaceuticals, Capital Projects, Pharmaceutical Industry, Process Engineering, Process Improvement, Engineering, R&D, GMP, Project Management, Biotechnology, Process Design, Process Simulation, Biopharmaceuticals, Process Optimization, Technology Transfer
Education
Villanova University 1991 — 1995
Chemical Engineering
Drexel University 1982 — 1987
BS, Chemical Engineering
Hyde Engineering + Consulting April 2014 - Present
Novartis May 2009 - January 2014
Novartis September 2007 - May 2009
Chiron Corporation January 2005 - September 2007
Chiron Corporation November 2000 - January 2005
Chiron Corporation June 1998 - November 2000
Chiron Corporation March 1997 - June 1998
Dey Laboratories January 1996 - March 1997
Dey Laboratories, Inc. February 1994 - January 1996
Dey Laboratories, Inc. July 1992 - February 1994
Skills
PMP® (Project..., RDBMS: Oracle 8i,..., Languages: SQL,..., ERP: Sound Knowledge of..., Testing: Test protocol..., P.O.S.T. (Police..., First Responder..., NASAR (National..., Validation, GMP, FDA, First Responder, Quality Assurance, 21 CFR Part 11, V&V, Cleaning Validation, FDA GMP, LIMS, Regulatory Affairs, Sop, Biopharmaceuticals, Computer System..., Biotechnology, Pharmaceutical Industry, SOP, Change Control
Education
California State University-Chico 1981 — 1985
Bachelor of Science (BS);, Microbiology
California State University-Chico 1981 — 1985
Minor, Computer Science
Hyde Engineering + Consulting July 2014 - Present
Integrated Design Group, Inc. July 2013 - January 2014
Nobis Engineering April 2011 - July 2013
SMPS Boston September 2008 - July 2011
GEI Consultants, Inc. November 2008 - March 2011
Jacobs Engineering Group January 1996 - November 2008
Edwards and Kelcey 1996 - 2006
Skills
Proposal Writing, Marketing Strategy, Marketing Communications, Sustainability, Business Development, New Business Development, Strategic Planning, Marketing, Collateral, Project Management, Event Planning, Budgets, Microsoft Office, Presentation Development, Public Relations, Project Planning, Advertising, Contract Negotiation, Corporate Communications, Customer Service, Lead Generation, Marketing Management, Social Media
Education
Northeastern University 1993 — 1998
B.S., Business Marketing
Hyde Engineering + Consulting October 2012 - Present
GE Analytical Instruments September 2009 - October 2012
GE Analytical Instruments February 2005 - September 2009
GE Analytical Instruments May 2001 - February 2005
GE Analytical Instruments January 1998 - May 2001
Skills
Technical Marketing, Product Management, Strategic Planning, Customer Support, Team Management, Collaborative Problem..., Product Development, Six Sigma, Technical Subject Matter, Market Analysis, Financial Analysis, Data Analysis, Research, Value Propositions, Water Treatment, Instrumentation, Cleaning Validation, Analytical Method..., Instrument Validation, FDA, GMP, Pharmaceutical Industry, R&D, Validation, Management, BPF, Biotechnology, Cross-functional Team...
Education
University of Colorado at Boulder 1992 — 1996
Bachelor of Science (BS), Chemical Engineering
Genzyme, a Sanofi company July 2015 - Present
Hyde Engineering + Consulting January 2013 - June 2015
Xcellerex Inc; Part of GE Healthcare Life Sciences June 2010 - January 2013
MILLIPORE (INDIA) PVT. LTD., September 2005 - April 2009
JD Industries July 2004 - June 2005
Skills
Validation, Biotechnology, Engineering, Quality Assurance, GMP, HPLC
Education
Visvesvaraya Technological University 2000 — 2004
B. Tech (BS), Chemical
Divine Providence Convent School
Karnatak University
Bayer HealthCare August 2014 - Present
Bayer HealthCare February 2012 - August 2014
Hyde Engineering + Consulting March 2012 - July 2012
Hyde Engineering + Consulting July 2011 - February 2012
Stevens Institute of Technology August 2009 - May 2011
Stevens Institute of Technology August 2009 - May 2011
J.B. CHEMICALS & PHARMACEUTICALS LTD. May 2008 - June 2009
Skills
CIP Validation, CIP PQ For Bio process, IQ-OQ-PQ-Protocol..., CIP PQ..., Kaye Validator-Parts..., Sop, Validation, Cleaning Validation, Quality Control, Chromatography, Regulatory Affairs, Manufacturing, Laboratory, Quality Assurance, Sterilization, FDA GMP, Protocol Design, Purification, Technology Transfer, V&V, SOP, FDA, GMP, Pharmaceutical Industry
Education
Stevens Institute of Technology 2009 — 2011
MS, Validation & Regulatory affairs
Genentech June 2014 - Present
Hyde Engineering + Consulting June 2014 - Present
Baxter International Inc. January 2014 - June 2014
Baxter International Inc. June 2011 - January 2014
Amphastar Pharmaceuticals, Inc. July 2009 - June 2011
UCSD Medical Center July 2007 - December 2008
Skills
Validation, FDA, Design Control, Quality System, Medical Devices, CAPA, ISO 13485, GMP, Biotechnology, Change Control, V&V, Biopharmaceuticals, 21 CFR Part 11, R&D, Sop, Design of Experiments, Pharmaceutical Industry, Aseptic Processing, Quality Assurance, Process Simulation, Biomedical Engineering, Computer System..., Lifesciences, Minitab, Quality Control, Root Cause Analysis, GAMP, Cleaning Validation, Calibration, HPLC, FMEA, Process Engineering, GLP, Technology Transfer, FDA GMP, Biomaterials, LIMS, Chromatography, Aseptic Technique, Yellow Belt, Green Belt, Trackwise, Fermentation, Purification, Laboratory, Gas Chromatography, DMAIC, UV/Vis, WebDAV, Emerson DeltaV
Education
University of California, San Diego
Terumo BCT May 2013 - Present
Hyde Engineering + Consulting February 2012 - May 2013
Sorin Group June 2009 - February 2012
Coram Healthcare August 2008 - July 2009
Coram Healthcare March 2004 - August 2008
Coram Healthcare March 2003 - March 2004
Skills
Market Research, Business Development, Project Management, Process Improvement, Vendor Management, Budget, Teamwork, Competitive Analysis, Product Launch, Marketing Strategy, Market Planning, Healthcare, Marketing, Data Analysis, Cross-functional Team..., Strategy, Medical Devices, Leadership, Marketing Communications, Sales Operations, Marketing Management, Market Analysis, Marketing Research, Project Planning, Budgets
Education
University of Colorado Denver 2004 — 2005
M.S., Marketing
University of Colorado Denver 2000 — 2004
B.S., Marketing, Economics, Political Science
Hyde Engineering + Consulting March 2014 - Present
Hyde Engineering + Consulting 2011 - 2014
Hyde Engineering + Consulting 2009 - 2011
Hyde Engineering + Consulting 2007 - 2009
Hyde Engineering + Consulting 2004 - 2007
Hyde Engineering + Consulting 1998 - 2004
Educational Discoveries, Inc. 1997 - 1998
Call Connect / Consumer Health, Inc. 1994 - 1997
Skills
Biotechnology, Validation, Pharmaceutical Industry, Business Development, GMP, Biopharmaceuticals, Change Control, FDA, Project Management, Technology Transfer, CAPA, Management, 21 CFR Part 11, Sop, R&D, Process Simulation, V&V, Health and Welfare..., Training, Recruiting, Global Immigration, Compensation, HR Metrics, Employee Relations, Employee Engagement, Employment Law..., SOP
Education
University of California, Los Angeles 1986 — 1991
M. ED, Education, B.A., Theater
University of California, Los Angeles 1986 — 1991
Master's degree, Education
DPS Engineering September 2015 - Present
Hyde Engineering + Consulting August 2013 - August 2015
NIST January 2012 - July 2013
NIST May 2011 - August 2011
Targeted Growth May 2010 - August 2010
Education
University of Colorado at Boulder 2009 — 2013
Bachelor of Science (B.S.), Chemical and Biological Engineering
TE Connectivity Medical November 2012 - Present
Abbott Vascular February 2012 - November 2012
PK Clean June 2011 - February 2012
Abbott Vascular Devices November 2008 - May 2010
Hyde Engineering + Consulting January 2007 - November 2008
Baxter Bioscience November 2005 - December 2006
UMCP Department of Chemical and Biomolecular Engineering December 2003 - May 2005
Skills
Product Design, Product Development, Six Sigma, Equipment Design, Voice of the Customer, Polymers, Medical Devices, Catheters, Process Engineering, Process Scale Up, Design Verification..., Validation, CAPA, Biotechnology, GMP, Chemistry, Technical Anaylsis and..., V&V, Bioinformatics, Business Development, Chemical Engineering, Client Relations, Economic Modeling, Fermentation, Manufacturing..., Environmental..., Hazardous Waste..., Renewable Energy, Renewable Resources, Waste Management, Alternative Fuels, Waste To Energy, Water Chemistry
Education
University of California, Berkeley 2010 — 2011
MS, Environmental Engineering
University of Maryland College Park 2000 — 2005
B.S., Chemical Engineering
Hyde Engineering + Consulting July 2014 - Present
Hyde Engineering + Consulting January 2005 - July 2014
Skills
Validation, CAPA, Biopharmaceuticals, CIP, Biotechnology, Cross-functional Team..., Change Control, FDA, GMP, Process Simulation, Sop, Technology Transfer, V, Fermentation, Aseptic Processing, SOP, Pharmaceutical Industry, V&V
Education
Colorado State University 1999 — 2003
BS, Chemical Engineering
Hyde Engineering + Consulting May 2015 - Present
PSC Biotech May 2013 - May 2015
Foster Wheeler Biokinetics, Inc. December 2010 - May 2013
Merck December 2009 - November 2010
Parsons September 2005 - November 2009
Skills
Validation, HVAC, MS Project, AutoCAD, Troubleshooting, Pro Engineer, Construction, Visio, Documentum, Autoclave, CAPA, Water Treatment, Commissioning, Engineering, Factory, GMP, Primavera P6, Computer System..., V&V, Quality Assurance, Project Engineering, Process Engineering, GAMP, Automation, Change Control, Manufacturing, Process Simulation, Root Cause Analysis, Quality System, FDA, Calibration, 21 CFR Part 11, Sop, Aseptic Processing, Biopharmaceuticals, Technology Transfer, Quality Management, Minitab, Six Sigma, Design of Experiments, Process Optimization, GxP, Quality Auditing, Cleaning Validation, Chemical Engineering, Process Control, ISO 13485, R&D, Quality Control, FMEA
Education
Walden University 2009 — 2012
MS, Systems Engineering (General)
Cork Institute of Technology 1999 — 2005
BS, Mechanical Engineering
Hyde Engineering + Consulting April 2015 - Present
Fresenius Kabi USA June 2013 - March 2015
Neelamegham Research Group November 2010 - January 2013
National Biochemicals Corporation April 2010 - August 2010
Skills
Systems Modeling of..., Mass Spectrometry, C, Python, Matlab, LaTeX, Process Improvement, Process Optimization, Process Control, Emacs, Linux, Process Modeling, Flux Analysis, Bioinformatics, Lyophilization, SEM, Confocal Microscopy, Protein Purification, Systems Biology, Validation, Chemical Engineering, R&D, R, Laboratory
Education
State University of New York at Buffalo 2010 — 2012
M.S., Chemical Engineering
University of Illinois at Urbana-Champaign 2005 — 2009
B.S., Chemical Engineering
Sift Science September 2014 - Present
Google August 2013 - September 2014
Randstad Finance & Accounting April 2013 - August 2013
Hyde Engineering + Consulting September 2012 - April 2013
University of California Cooperative Extension September 2011 - September 2012
Child Development Inc. April 2009 - September 2011
Skills
Recruiting, Interviews, Human Resources, Training, Applicant Tracking..., Sales, Sourcing, Management, Human Development, Phone Screening, Nonprofits, LinkedIn Recruiter, Customer Service, Marketing, Hiring, Employee Relations, Leadership, Temporary Staffing, College Recruiting, PowerPoint, Resume Writing
Education
University of California, Davis 2005 — 2009
B.S, Human Development
Amicus Solar Cooperative May 2015 - Present
RGS Energy January 2014 - March 2015
Excel Personnel May 2013 - August 2013
Hyde Engineering + Consulting September 2012 - April 2013
ASD Inc. May 2008 - August 2011
Witt Elementary PTO December 2004 - August 2008
GlobeImmune, Inc. February 2007 - October 2007
Westview Rec Center February 2004 - June 2005
Resources Trust Company July 1994 - May 1998
Express Press January 1993 - June 1994
Skills
Access, Marketing, Project Management, Data Entry, Email Marketing, Newsletters, Salesforce.com, HTML, Microsoft Excel, Microsoft Word, Corporate Communications, Creative Writing, Marketing Management, Databases, Windows, SQL, WordPress, Software Documentation, Microsoft Office
Education
University of Colorado Boulder 1985 — 1989
BS & BA, Business/Marketing and English/Creative Writing
University of Colorado Boulder 1985 — 1989
Bachelor of Business Administration (BBA), Marketing
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
Sanofi Pasteur February 2015 - Present
Hyde Engineering + Consulting February 2015 - Present
Nitrogen Genetics, LLC October 2013 - Present
The University of Texas at Austin September 2012 - September 2014
University of Georgia August 2006 - December 2011
DOE Center for Microbial and Plant Carbohydrates June 2004 - July 2006
Skills
Molecular Biology, Microbiology, Protein Purification, Protein Expression, Bacterial Genetics, X-ray crystallography, Lipopolysaccharide..., Lipids, Vaccines, Analytical Chemistry, Genetics, Biological Nitrogen..., Carbohydrate Structure, Endotoxin, Biochemistry, Protein Structure, Bioanalysis, PCR, Western Blotting, Biotechnology, Gel Electrophoresis
Education
The University of Georgia 2006 — 2011
Doctor of Philosophy (Ph.D.), Biochemistry and Molecular Biology
The University of Georgia 1999 — 2003
Bachelor of Science (B.S.), Microbiology, Minor in Music
PCI (Packaging Coordinators Inc) July 2015 - Present
MedImmune May 2013 - July 2015
MedImmune April 2012 - May 2013
ValSource, LLC June 2010 - September 2011
Hyde Engineering + Consulting March 2009 - June 2010
Omni National Bank June 2006 - March 2009
Colorcon February 2005 - May 2006
CE&IC July 1999 - January 2005
Skills
Validation, GMP, Process Engineering, Project Management, Instrumentation, Software Documentation, Biotechnology, Sop, Reviews, V&V, Commissioning, FDA, Manufacturing, Change Control, Engineering, Quality Control, CAPA, Lifesciences, Medical Devices, Life Sciences, Serialization
Education
University of Pennsylvania 1995 — 1999
BSE, Chemical Engineering
Hyde Engineering + Consulting March 2014 - Present
Shire Pharmaceuticals August 2013 - November 2013
Mt. Olive Pickle Company May 2012 - August 2012
North Carolina State University August 2010 - May 2012
North Carolina State University August 2010 - May 2012
Skills
Bioreactor, Data Analysis, Aseptic Technique, Cell Culture, Bacterial Culture, Biotechnology, ELISA, Chromatography, Affinity Chromatography, Size Exclusion, Agarose Gel..., Protein Purification, Protein Expression, DNA quantification, DNA ligation, Fermentation, BCA Protein Assay, HPLC, SDS-PAGE, Filtration, PCR primer design, PCR, Gene Expression, Centrifugation, Plasmid Isolation, cGMP practices, Hemocytometer, Cloning, Spectrophotometry, Pipetting, Bioreactor assembly, DNA purification, Western Blotting, Media Preparation, Cell Counting, Serial Dilutions, Quality Control, Quality Reporting, Column Chromatography, Enzyme Assays, Gel Electrophoresis, Protein Chemistry
Education
North Carolina State University 2009 — 2013
Bioprocessing Science, Minor: Food Science
Drexel, Barrell & Co. July 2013 - September 2014
Hyde Engineering + Consulting April 2013 - June 2013
InfoPrint Solutions Company February 2008 - January 2011
Feed Products, Denver, CO September 2002 - February 2008
Chuck Latham Associates, Inc. February 1994 - May 2002
Falcon Homes February 1993 - February 1994
Pacific West Homes June 1990 - January 1992
Self employed May 1985 - May 1987
Tele-Communications, Inc August 1984 - September 1985
Great West Life February 1984 - August 1984
Skills
PHR, Employee Relations, Human Resources, Recruiting, Talent Management, Onboarding, Benefits Administration, HRIS, Employee Benefits, Process Improvement, Payroll, Employee Handbooks, SPHR, Policy, Time Management, Talent Acquisition, Management, Applicant Tracking..., New Hire Orientations, Employee Engagement, Software Documentation, Personnel Management, Interviews, HR Policies, Workforce Planning, Technical Recruiting, Internet Recruiting, College Recruiting, Performance Management, ADP Payroll, Sourcing, Temporary Placement, Organizational..., Hiring, HR Consulting
Education
Regis University 2004 — 2007
Bacholor of Science, Business Administration: Human Resources
University of Phoenix 2002 — 2004
Business Administration and Management, General
Northglenn High School 1974 — 1977
Diploma, Business
Hyde Engineering + Consulting July 2014 - Present
Colorado School of Mines Club/IM Sports Department September 2009 - May 2014
University of Colorado Emergency Medical Services March 2013 - October 2013
University of Colorado Emergency Medical Services November 2010 - October 2013
Hyde Engineering + Consulting July 2013 - August 2013
Hyde Engineering + Consulting May 2012 - July 2012
Hyde Engineering + Consulting May 2011 - August 2011
Civil Air Patrol Ground Search and Rescue Service July 2006 - July 2010
Skills
GMP, Research, Cleaning Validation, Validation, Lifesciences, Engineering, Mineralogy, Chemistry, EMT, Cell Culture, Medical Devices, Statistics, Wilderness Search and..., Spanish, Life Sciences, Microbiology, V&V
Education
Colorado School of Mines 2009 — 2014
Bachelor of Science, Chemical and Biochemical Engineering
Red Rocks Community College
Intravenous Therapy Administration for EMTs
Front Range Community College
Certification, Emergency Medical Technician - Basic
Fairview High School 2005 — 2009
International Baccalaureate Diploma
Hyde Engineering + Consulting May 2015 - Present
PSC Biotech January 2015 - March 2015
PSC Biotech June 2014 - December 2014
Baxter International Inc. September 2013 - June 2014
Teco Diagnostics January 2013 - April 2013
Oxford Tutoring April 2012 - November 2012
University of California Riverside, Department of Bioengineering June 2012 - September 2012
University of California Riverside, Department of Bioengineering October 2009 - August 2012
University of California Riverside, Housing Services September 2008 - June 2009
Starbucks Coffee Company April 2008 - September 2008
Skills
Microscopy, Microsoft Office, Matlab, R&D, Data Analysis, Validation, GMP, Technical Writing, Data Collection, Team Leadership, Project Planning, Biomaterials, Protocol Design, Data Processing, Laboratory Safety, Image Analysis, IR spectroscopy, Methodology Development, Safety, Public Safety, Process Safety, Hydrogel Preparation, Risk Assessment, Timeline Development
Education
University of California, Riverside 2012 — 2013
Master of Science (M.S.), Bioengineering
University of California, Riverside 2008 — 2012
Bachelor of Science (B.S.), Bioengineering, 3.3
De La Salle High School 2004 — 2008
High School Degree
IRP Consulting January 2010 - Present
Sanofi February 2014 - March 2015
VALSPEC March 2013 - December 2013
Hyde Engineering + Consulting September 2011 - August 2012
Valspec February 2010 - August 2011
ENGINEERED ENERGY SOLUTIONS January 2009 - December 2009
Brock Solutions 2007 - 2008
Global Automation Partners 2005 - 2007
Eli Lilly 2003 - 2007
Coneco de Puerto Rico 2004 - 2005
Skills
Computer System..., Automation, Pharmaceutical Industry, GAMP, 21 CFR Part 11, Validation, Change Control, GMP, Lifesciences, Biotechnology, Project Management, FDA, GxP, Instrumentation, V&V, Technology Transfer, Process Automation, Commissioning, Biopharmaceuticals, CAPA, MES, Process Simulation, Sop, LIMS, Medical Devices, DCS, Process Engineering
Education
Harvard University, Harvard Extension School 2014 — 2016
Graduate Certificate, Strategic Management
University of Puerto Rico 1997 — 2001
BSEE, Electrical Engineering - Controls
Hyde Engineering + Consulting July 2013 - Present
Genzyme July 2012 - July 2013
Genzyme May 2012 - July 2012
Amgen April 2012 - May 2012
Genentech October 2011 - March 2012
Genentech October 2010 - October 2011
Centocor September 2010 - October 2010
GlaxoSmithKline June 2009 - September 2010
AdvantaPure May 2009 - June 2009
Lonza September 2008 - May 2009
Skills
Validation, GMP, Change Control, GAMP, Quality Assurance, Automation, Computer System..., Sop, V&V, Software Documentation, Commissioning, 21 CFR Part 11, Testing, Biopharmaceuticals, Trackwise, FDA GMP, WebDAV, PLC, FDA, CIP, HPLC, DeltaV Operate, Microsoft Excel, Team Building, MES, Engineering, Process Simulation, DCS, CAPA, Aseptic Processing, Cleaning Validation, Quality Control, Fermentation, LIMS, Technology Transfer, DeltaV Batch..., Visual Basic, Microsoft Access, GMP Training..., Change Management, Team Leadership, Leadership Development, Mentoring, DeltaV, Syncade, Consent Decree, Biotechnology, cGMP practices, Operations Management, Project Management
Education
Penn State University 2002 — 2007
B.S., Chemical Engineering, Minor in Bioengineering
Hyde Engineering + Consulting October 2011 - Present
Hospira November 2010 - October 2011
GlobeImmune, Inc. February 2008 - September 2010
JM Hyde Consulting July 2004 - February 2008
Sanofi Pasteur July 2004 - February 2008
Colorado State University August 2002 - June 2004
Skills
Cleaning Development, Process Development, Validation, GMP, Technology Transfer, FDA, Biotechnology, CAPA, V&V, Biopharmaceuticals, Chemical Engineering, Sop, Cleaning Validation, Process Engineering, Cell Culture, 21 CFR Part 11, Pharmaceutical Industry, Quality System, Aseptic Processing, Change Control, Fermentation, GAMP, Microbiology, Purification
Education
Colorado State University 2000 — 2004
Bachelor of Science, Chemical Engineering
Kansas City Art Institute 1998 — 2000
N/A, Fibers
Medtronic August 2014 - Present
OPX Biotechnologies, Inc. March 2012 - May 2014
Hyde Engineering + Consulting September 2002 - March 2012
Kansas State University August 1998 - June 2000
Owens Corning Fiberglas September 1996 - May 1998
Skills
Process Engineering, Validation, GMP, Commissioning, Engineering, Change Control, Biopharmaceuticals, Troubleshooting, P&ID, Vendor Management, Start-ups, Process Simulation, Fermentation, Quality Assurance, Manufacturing, FDA, Technology Transfer, Biotechnology, Quality System, CAPA, Pharmaceutical Industry
Education
James Cook University 2000 — 2001
Graduate Diploma, Marine Biology
Kansas State University 1998 — 2000
Masters of Science, Chemical Engineering
University of Dayton 1992 — 1996
BE, Chemical Engineering (minor Biology)
Shawnee Mission West 1988 — 1992
Hyde Engineering + Consulting April 2004 - Present
Genzyme January 2011 - Present
AMAG Pharmaceuticals January 2009 - December 2010
Skills
GMP, CAPA, Biopharmaceuticals, Chromatography, Aseptic Processing, CIP, Engineering, Change Control, GAMP, Sop, FDA, Biotechnology, Pharmaceutical Industry, Technology Transfer, Process Engineering, Engineering assessments, Statistics, Clean-In-Place, Project Management, Process Equipment, Troubleshooting
Education
Northeastern University
Bachelor's degree, Chemical Engineering
Northeastern University
MS, Engineering Management
KBI Biopharma May 2014 - Present
Merck Sharp & Dohme November 2009 - April 2014
Amgen June 2002 - November 2009
Hyde Engineering + Consulting August 1999 - June 2002
UOP LLC July 1997 - May 1999
Skills
Validation, GMP, FDA, Technology Transfer, Biotechnology, Change Control, CAPA, Pharmaceutical Industry, Biopharmaceuticals, Sop, Quality System, Process Simulation, Chromatography
Education
Colorado State University 1993 — 1997
B.S. Chemical Engineering, Biotech/environmental minor
Hyde Engineering + Consulting 2003 - Present
Skills
Process Engineering, Cleaning Validation, Validation, GMP, Biopharmaceuticals
Education
University of California, Davis
IPS January 2014 - Present
Kruger (VWS) September 2010 - January 2014
Kruger (VWS) 2007 - 2010
Hyde Engineering + Consulting March 2006 - December 2006
Koch Membrane Systems 2000 - 2006
Skills
Chemical Engineering, Process Engineering, Project Engineering, Commissioning, P&ID, Filtration, Process Simulation, Engineering, HAZOP, Process Design, Process Optimization, Water Treatment, Wastewater Treatment, Manufacturing, Process Control, Process Safety, GMP, Cleaning Validation
Education
Northeastern University 2002 — 2004
Master's degree, Engineering Management
Northeastern University 1995 — 2000
Bachelor's degree, Chemical Engineering
PSC Biotech January 2015 - Present
Hyde Engineering + Consulting September 2013 - January 2015
Teva Pharmaceuticals February 2012 - August 2013
Pacira Pharmaceuticals August 2008 - February 2012
Biosite June 2005 - August 2008
Nice-Pak Products 2001 - 2005
Johnson & Johnson 1999 - 2001
Skills
Validation, FDA, GMP, Manufacturing, V&V, Process Optimization, Six Sigma, Project Management, Medical Devices, Testing, Design of Experiments, CAPA, Quality System, Sop, ISO 13485, 21 CFR Part 11, Change Control, Technology Transfer, Cleaning Validation, Design Control, LIMS, GLP, SOP
Education
Michigan State University 1990 — 1995
BS, Packaging
Michigan State University 1990 — 1995
Bachelor of Science (BS), Packaging Science
Hyde Engineering + Consulting March 2015 - Present
Hyde Engineering + Consulting July 2013 - Present
McNeil Consumer Healthcare July 2013 - 2014
Amgen January 2011 - July 2013
Amgen August 2007 - January 2011
Amgen Inc. October 2005 - August 2007
Merial August 2005 - October 2005
Johnson & Johnson December 2003 - August 2005
Merck & Co. Inc March 1996 - December 2003
Skills
Validation, Cell Culture, Manufacturing, Cleaning Validation, Cross-functional Team..., Pharmaceutical Industry, Quality System, Technology Transfer, Process Engineering, 21 CFR Part 11, Change Control, Biopharmaceuticals, FDA, GMP, CAPA, Biotechnology
Education
The University of Georgia 1991 — 1993
BS, Microbiology
Kite Pharma, Inc. January 2015 - Present
Hyde Engineering + Consulting October 2013 - 2014
V2 Bio-Consulting June 2012 - September 2013
Boehringer Ingelheim February 2011 - March 2012
Amgen, Inc. April 2006 - March 2011
Abgenix, Inc. August 2002 - April 2006
Baxter BioScience 1994 - 2002
Skills
cGMP, Process Validation, Technology Transfer, CAPA, Change Control, Risk Assessment, Regulatory Audits, FACS analysis, Cell Banking, Mammalian Cell Culture, Performance Reviews, Technical Writing, Document Review, GMP, V&V, Sop, FDA, 21 CFR Part 11, Pharmaceutical Industry, Biotechnology, EHS, Cell Culture, LIMS, Validation, GxP, Aseptic Processing, GLP, Cross-functional Team..., CMC, Start-ups, Project Planning, Technical Project..., Strategic Planning, Manufacturing compliance, Computer System..., Cell, Vaccines, Clinical Development, Fermentation, Cleaning Validation, Drug Development, Chromatography, Lifesciences, Protein Chemistry, Protein Purification, Drug Discovery, SOP
Education
California State University-Hayward
BS, Biology
Onyx Pharmaceuticals September 2012 - Present
Hyde Engineering & Consulting July 2011 - September 2012
Hyde Engineering + Consulting 2010 - 2011
Acceleron Pharma 2008 - 2010
Bayer Healthcare 2005 - 2007
Alkermes 1998 - 2004
Skills
cGMP, CAPA, Change Control, Quality Assurance, Compliance, Investigations, Technical Reports, Validation, GMP Training, GMP, V&V
Education
Michigan State University 1988 — 1993
Bachelor of Science (BS), Zoology
Hyde Engineering + Consulting September 2015 - Present
Amgen 2005 - 2015
Aerotek 2005 - 2005
Skills
Biotechnology, Biopharmaceuticals, HPLC, LC-MS, Chromatography, Protein Purification, Purification, Protein Chemistry, Analytical Chemistry, Monoclonal Antibodies, GMP, GLP, Mass Spectrometry, Quality Control, LIMS, SDS-PAGE, Electronic Lab Notebooks, Protein Characterization, Peptide Mapping, LC-MS/MS, Root Cause Analysis, Method Development, Method Qualification, Production Support, Trend Analysis, Change Control, Process Improvement, Technical Transfers, Forced Degradation..., Product Characterization, Product Comparability, Product Qualification, Technical Reports, Project Management, Laboratory Support, In-gel Protein Digestion
Education
University of Colorado at Boulder 2001 — 2005
Bachelor's Degree, Biochemistry (Minor in Chemistry)
Hyde Engineering + Consulting December 2014 - Present
PharmaSys, Inc. February 2014 - December 2014
SBM Site Services, LLC February 2010 - February 2014
Chem Aid Laboratories January 2009 - February 2010
Pharma Insight Inc. May 2006 - January 2009
Washington Group International, Princeton, New Jersey May 2005 - December 2006
Fluor Enterprises Incorporated, South San Francisco, California September 2002 - August 2005
Imclone Systems Inc. September 2000 - May 2002
Education
East Stroudsburg University of Pennsylvania 1996 — 2000
Hyde Engineering + Consulting April 2015 - Present
HaloSource April 2008 - November 2014
Amgen July 2000 - October 2007
Bayer HealthCare 1993 - 2000
Skills
Process Engineering, Manufacturing, Process Simulation, Engineering, Contract Negotiation, Lean Manufacturing, Product Development, Cross-functional Team..., Team Building, Change Management, Strategic Planning, Process Improvement, SPC, Project Planning, Business Development, Process Development, Technology Transfer, Problem Solving, Budgeting, Continuous Improvement, FMEA, Chemical Engineering, Management
Education
University of California, Berkeley 1978 — 1983
BS Chem E
UC Berkeley 1978 — 1982
Bachelor's degree, Chemical Engineering
Genentech January 2015 - Present
Genentech July 2012 - Present
Hyde Engineering + Consulting March 2011 - July 2012
Hyde Engineering + Consulting December 2008 - March 2011
Hyde Engineering + Consulting April 2007 - December 2008
Skills
Process Engineering, Validation, Project Engineering, Commissioning, Technology Transfer, Process Simulation, Biopharmaceuticals, Chemical Engineering, Process Design, Fermentation, Aseptic Processing, CAPA, Change Control, Biotechnology, GMP, FDA, SOP
Education
University of California, Berkeley 2004 — 2006
BS, Chemical Engineering
American River College 2003 — 2004
Sanofi Pasteur May 2013 - Present
Hyde Engineering + Consulting 2013 - Present
University of Georgia August 2007 - August 2013
University of Georgia August 2007 - June 2008
National Chemical Laboratory (NCL) January 2007 - May 2007
Sandoz Pharmaceuticals June 2006 - July 2006
Indian Council for Agricultural research (ICAR) June 2005 - June 2005
Nielsen Media Research June 2001 - June 2004
Skills
Organic Chemistry, Organic Synthesis, Purification, NMR, Medicinal Chemistry, HPLC, Mass Spectrometry, Chemistry, Column Chromatography, UV/Vis, IR, Protein Purification, Differential Scanning..., Drug Discovery, Enzyme Kinetics, Formulation Development, Project Development, Technology Transfer, Asceptic Processing, Lifesciences, R&D, Characterization, Formulation, Life Sciences, Pharmaceutical Industry, Biotechnology, Protein Chemistry, Chromatography
Education
The University of Georgia 2007 — 2012
PhD, Organic Chemistry
Fergusson College 2005 — 2007
M.S, Organic Chemistry
Fergusson College 2002 — 2005
B.S, Biotechnology, Chemistry (double major)
Fergusson College 2000 — 2002
High School, Science
Hyde Engineering + Consulting October 2009 - Present
Hyde Engineering & Consulting 2015 - 2015
Hyde Engineering & Consulting 2015 - 2015
SAVIS, Inc. September 2006 - October 2009
Skills
Validation, GMP, Biotechnology, Calibration, Process Engineering, Troubleshooting, Biopharmaceuticals, Aseptic Processing, Purification, Pharmaceutical Industry, Cleaning Validation, Filtration, V&V, Technology Transfer, Change Control
Education
University of Illinois at Chicago 2002 — 2006
B.S., Chemical Engineering
Hyde Engineering + Consulting June 1998 - Present
Hyde Engineering + Consulting 1998 - Present
Education
University of Colorado Boulder 1983 — 1984
Travel Basque Country August 2013 - Present
Philippine Development Foundation (PhilDev) July 2013 - Present
ProPharma Group October 2013 - September 2014
Hyde Engineering + Consulting / Hyde Technical Services October 2010 - April 2013
Hyde Engineering + Consulting August 2005 - May 2010
Thomson Learning 2002 - 2004
Tallwood Venture Capital 2001 - 2002
Skills
Recruiting, Event Planning, Trade Shows, Client/Hiring Manager..., Talent Acquisition, Onboarding, New Hire Orientations, Employee Relations, LinkedIn Recruiter, Vendor Relationships, Business Development, Manufacturing, Management, Interviews, Marketing, Budgets, CRM, Project Management, Team Building, Pharmaceutical Industry, Biotechnology, Proposal Writing, Validation, Human Resources, Fundraising, Nonprofits, Travel Planning
Education
University of California, Berkeley 1996 — 2000
BA, Architecture
NDB
Hyde Engineering + Consulting October 2012 - Present
Hyde Engineering + Consulting September 2011 - October 2012
Hyde Engineering + Consulting October 2005 - September 2011
Hyde E+C 2005 - September 2011
J.M.Hyde 2006 - 2008
Skills
Process Development, Process Engineering, CIP, Cleaning Validation, Engineering, Process Inprovement,..., Process Simulation, Validation, Biopharmaceuticals, Change Control, V&V, CAPA, GMP, 21 CFR Part 11, Aseptic Processing, Biotechnology, Chemistry, Computer System..., Design of Experiments, FDA, GAMP, GLP, GxP, LIMS, Quality Assurance, Quality Auditing, Quality Control, Quality System, R&D, Regulatory Affairs, Sop, Technology Transfer
Education
Cleveland State University 2001 — 2003
MS, Chemical and Biomedical Engineering
National Institute of Technology Surat 1996 — 2000
BE - Chemical Engineering, Chemical Engineering
Hyde Engineering + Consulting January 2015 - Present
ValSource, LLC August 2012 - December 2014
LifeTek Solutions June 2005 - August 2012
O'Brien & Gere June 2004 - June 2005
Thomas Ladisch Associates 1990 - 2000
Skills
Aseptic Processing, Change Control, Instrumentation, Process Control, Validation, AutoCAD, Facilities Management, Construction Management, GMP, Engineering, Commissioning, FDA, 21 CFR Part 11, Quality System, Biopharmaceuticals, Project Engineering, Process Engineering, Engineering Management, GAMP, HAZOP, Computer System..., Biotechnology, Quality Assurance, Chemical Engineering, Sop, V&V, Microsoft Office, Process Equipment, Process Simulation, Factory, SOP
Education
Penn State University 1995 — 1999
Bachelor of Science (BS), Chemical Engineering
Hyde Engineering + Consulting September 2009 - Present
La Jolla Pharmaceutical Company March 2008 - April 2009
Genentech October 2005 - March 2008
Education
National University 2002 — 2004
MS, Forensic Science (Analytical Chemistry)
West Virginia University 1998 — 2002
BA, Biology
DPS Engineering July 2015 - Present
Genzyme March 2013 - July 2015
Hyde Engineering + Consulting June 2012 - March 2013
Integra LifeSciences November 2011 - June 2012
Hyde Engineering + Consulting May 2009 - November 2011
URS Corporation June 2008 - May 2009
Washington Group International 2004 - 2006
Skills
GMP, Validation, Project Management, Change Control, CAPA, Process Engineering, Process Improvement, FDA, Sop, Quality System, V&V, Pharmaceutical Industry
Education
Lock Haven University of Pennsylvania 1991 — 1995
B.S., Accounting
Roche Diagnostics October 2007 - Present
Hyde Engineering + Consulting 2004 - 2007
Independent Consultant 2004 - 2004
BASF 1998 - 2004
Hoechst Celanese 1990 - 1998
Elf Atochem 1989 - 1990
Wright Corporation 1984 - 1989
Skills
Process Validation, cGMP, Validation, Cleaning Validation, CQE, PMP, V&V, 21 CFR Part 11, Computer System..., GMP, CAPA, FDA, GAMP
Education
Lehigh University 1977 — 1982
BS, Chemical Engineering
Hyde Engineering + Consulting March 2014 - Present
Baxter Healthcare August 2011 - February 2014
Xerox February 2011 - July 2011
USC Nanomanufacturing Quality Control Lab June 2010 - March 2011
Entertainment Technology Center at USC November 2009 - February 2011
China Blue Restaurant January 2002 - December 2006
Oregon State University June 2005 - September 2005
Oregon State University June 2003 - September 2004
Skills
Leadership, Validation, GMP, GAMP, Green Belt, Delta V, Chemical Engineering, Six Sigma, Lean Manufacturing, Change Control, FMEA, DMAIC, Process Control, Process Automation, CAPA, Process Simulation, Minitab, Computerized Systems, Commissioning, Process Qualification, Pro II, Automation, Kaizen, Quality System, Continuous Improvement, Process Engineering, Manufacturing, Engineering, Pharmaceutical Industry, Biotechnology, Quality Assurance, Cleaning Validation, Biopharmaceuticals, V&V, R&D, Medical Devices, FDA
Education
University of Southern California 2007 — 2011
B.S.
Boehringer Ingelheim February 2015 - Present
McNeil Consumer Healthcare June 2013 - October 2014
Neutrogena August 2011 - June 2013
Teva Pharmaceuticals October 2010 - September 2011
Validation Technologies Inc. July 2008 - August 2010
Hyde Engineering + Consulting May 2005 - June 2008
Skills
GMP, Cleaning Validation, Validation, GLP, Deviations, FDA, CAPA, Sop, Biotechnology, Pharmaceutical Industry, Computer System..., GxP, Technical Writing, Change Control, 21 CFR Part 11, V&V, Aseptic Processing, ISO 13485, Quality Assurance, Vaccines, HPLC, Microbiology, Technology Transfer, SOP, Biopharmaceuticals, Cross-functional Team..., FDA GMP, Process Validation
Education
Northeastern University 1998 — 2001
B.S., Chemistry
EW Consulting, LLC August 2014 - Present
Organogenesis Inc. October 2013 - August 2014
Hyde Engineering + Consulting January 2010 - September 2013
URS Corporation 2004 - 2008
Pharmaplan-Valicor January 2004 - September 2004
Micro-Clean Inc. January 2002 - December 2003
Skills
Calibration, Environmental Monitoring, Sop, Medical Devices, 21 CFR Part 11, Validation, V&V, Change Control, Pharmaceutical Industry, Software Documentation, FDA, GMP, CAPA, Biotechnology, Computer System..., SOP, Aseptic Processing
Education
Penn State University 1992 — 1996
BS, Electrical Engineering Technology
Sequenom, Inc. June 2015 - Present
Castlight Health July 2014 - February 2015
Google April 2013 - April 2014
Hyde Engineering + Consulting February 2012 - April 2013
Hyde Engineering + Consulting August 2011 - February 2012
Safeway June 2009 - July 2011
Roche Diagnostics August 2007 - May 2009
Education
University of California, San Diego
BA, Sociology
Pall Life Sciences February 2015 - Present
Hyde Engineering + Consulting November 2013 - Present
Shire HGT October 2012 - October 2013
Joule Unlimited, Inc. April 2011 - October 2012
Pfizer August 2005 - April 2011
University of Massachusetts Amherst August 2004 - June 2005
STERIS Corporation May 2003 - August 2004
Akron Polymer Laboratories 2001 - 2003
Skills
SDS-PAGE, Transfection, Protein Purification, Cell Culture, ELISA, Protein Chemistry, Genetics, Tissue Culture, Cell, Protein Expression, In Vitro, Microbiology, PCR, Biotechnology, Immunology, Cell Biology, GLP, Drug Discovery, Flow Cytometry, Technology Transfer, Biochemistry, High Throughput..., In Vivo, Chromatography, Aseptic Technique, Cancer, Lifesciences, Assay Development, HPLC, Antibodies, Laboratory, Western Blotting, Purification, Mass Spectrometry, Monoclonal Antibodies, GMP, Biopharmaceuticals, Molecular Biology, Proteomics, Fermentation, Gel Electrophoresis, Vaccines, Downstream Processing, Validation, Bioprocessing, Filtration, Sop, Analytical Chemistry, Microscopy, LIMS
Education
Tufts University 2005 — 2007
Chemical Engineering
University of Massachusetts, Amherst 2004 — 2005
Microbiology
Wilkes University 1998 — 2000
B.Sc., Biology, Chemistry
Integra LifeSciences April 2015 - Present
Integra LifeSciences October 2013 - March 2015
Hyde Engineering + Consulting September 2012 - October 2013
Collagen Matrix, Inc. March 2011 - March 2012
Collagen Matrix, Inc January 2007 - August 2010
Collagen Matrix, Inc January 2006 - August 2010
Collagen Matrix, Inc September 2001 - August 2010
Lederle Labs May 1992 - August 1992
Skills
Technology Transfer, FDA, Validation, Medical Devices, Sop, Biotechnology, GMP, Quality System, R&D, Chemistry
Education
University of Maryland College Park 1996 — 2001
Ph.D, Biochemistry, Molecular and Cell Biology
University of Maryland 1992 — 2001
M.S, Biochemistry
University of Scranton 1988 — 1992
B.S, Chemistry
Immunomedics April 2012 - Present
Amethyst Technologies, LLC October 2009 - April 2012
Hyde Engineering + Consulting January 2007 - October 2009
Shaw Environmental, Inc. May 2006 - December 2006
Baird and Swanson Construction January 2005 - May 2006
Wyeth February 2004 - December 2004
Pfizer January 1999 - September 2002
Education
Stevens Institute of Technology 1997 — 2003
B.E, Chemical Engineering
Stevens Institute of Technology 1997 — 2003
B.A., Literature
Alera Labs, LLC July 2011 - Present
Hyde Engineering + Consulting 2012 - 2012
Wyeth Biotech March 2005 - November 2010
GSK 1999 - 2005
Skills
Pharmaceuticals, Quality Assurance, Compliance, Cleaning Validation, CAPA
Education
Novosibirsk State University (NSU) 1980 — 1988
MS, Chemistry
IRX Therapeutics November 2014 - Present
QPharma, Inc. January 2011 - June 2014
Hyde Engineering + Consulting 2009 - January 2011
WuXi AppTec 2007 - 2009
Merck 1998 - 2007
Skills
Validation, Biotechnology, Aseptic Processing, Process Simulation, Vaccines, Manufacturing, CIP, GMP, Biopharmaceuticals, Cleaning Validation, Change Control, Pharmaceutical Industry, 21 CFR Part 11, CAPA, Sop, Technology Transfer, Cell, Lifesciences, GLP, Cell Culture, LIMS, GxP, Quality System, SIP, Purification, Root Cause Analysis, Downstream Processing, Compliance, Project Management, Process Improvement, Autoclave, Computer System..., Sterilization, Formulation, SOP
Education
State University of New York at Stony Brook
B.S., Biology
Drexel University
Biomedical Sciences
Hyde Engineering + Consulting August 2013 - Present
Bayer HealthCare April 2011 - July 2013
PSI Control Systems July 2008 - April 2009
Genentech September 1993 - June 2008
Skills
FDA, Validation, GMP, Change Control, Biotechnology, Aseptic Processing, CAPA, Biopharmaceuticals, 21 CFR Part 11, Computer System..., Sop, Technology Transfer, V&V, Cleaning Validation, Fermentation, Pharmaceutical Industry, LIMS, Filtration, Purification, Medical Devices, Quality System, GAMP, GxP, Trackwise, Cell Culture, GLP, cGMP manufacturing, Vaccines, Aseptic Technique, Chromatography, Regulatory Affairs, Regulatory Requirements
Education
University of Notre Dame 1989 — 1993
B.S., Physics/Pre-Med
Baxalta April 2015 - Present
Pacira Pharmaceuticals, Inc. November 2012 - Present
PSC Biotech May 2012 - November 2012
Hyde Engineering + Consulting June 2011 - April 2012
Pfizer November 2010 - June 2011
Parsons November 2006 - June 2010
Amgen March 2004 - October 2005
CRB Consulting Engineers 2005 - 2005
Wyeth Biotech August 2000 - February 2004
Jacobs Engineering 2000 - 2004
Skills
CIP, V&V, Change Control, Validation, Process Simulation, Technology Transfer, GMP, FDA, Process Equipment, Sop, Quality System, Process Engineering, Cleaning Validation
Education
University of Cincinnati
Bachelor's Degree, Chemical Engineering
Thermo Fisher May 2015 - Present
Wellstat Management Company April 2014 - January 2015
Alcon, a Novartis company August 2013 - March 2014
Hyde Engineering + Consulting April 2013 - July 2013
Genzyme January 2013 - March 2013
Alcon, a Novartis company June 2012 - December 2012
SNC-Lavalin November 2011 - June 2012
BD January 2010 - October 2011
Covidien September 2007 - January 2010
Human Genome Sciences/GSK May 2001 - September 2007
Skills
Cleaning Validation, Validation, V&V, CAPA, GMP, Sterilization, Continuous Improvement, cGMP manufacturing, FMEA, Biopharmaceuticals, GAMP, Change Control, Sop, 21 CFR Part 11, Trackwise, FDA, Aseptic Processing, LIMS, Laboratory, Protocol, Equipment Qualification, Biotechnology, Quality Assurance, Pharmaceutical Industry, Quality Control, Computer System..., Manufacturing
Education
The Johns Hopkins University 2005 — 2007
MS, Biotechnology
University of Maryland Baltimore County 1999 — 2001
BS, Biology
University of Pittsburgh 1997 — 1999
Biology
Hyde Engineering + Consulting October 2012 - Present
CBR International Corp. July 2011 - September 2012
Northwestern University September 2009 - June 2011
Aktiv-Dry LLC February 2008 - September 2009
Skills
Biotechnology, Pharmaceuticals, Process Development, Life Sciences, Cell Culture, Molecular Biology, PCR, HPLC, Chemical Engineering, Western Blotting, Protein Purification, Cell Based Assays, Research, Biochemistry, Labview, Gel Electrophoresis, Technical Writing, Statistics, Data Analysis, Flow Cytometry, Cell Biology, Quality Assurance, Validation, HTML, Solidworks, Excel, Design of Experiments, Chromatography, Simulink, Process Simulation, Lifesciences, Pharmaceutical Industry, Microsoft Excel, CAPA, GLP, Regulatory Affairs, Experimental Design, Biopharmaceuticals, 21 CFR Part 11, Aspen Plus, Fermentation, Aseptic Technique, Technology Transfer, GMP, Chemistry, Laboratory, FDA, Protein Chemistry, Assay Development
Education
Northwestern University 2009 — 2010
M.S., Biotechnology
University of Colorado Boulder 2005 — 2009
B.S., Chemical and Biological Engineering
Allergan December 2012 - Present
Baxter Healthcare September 2010 - December 2012
Fluor April 2008 - August 2010
Hyde Engineering + Consulting March 2004 - March 2008
Amphastar Pharmaceuticals, Inc. November 2002 - March 2004
Skills
Validation, V&V, Process Engineering
Education
University of California, Irvine 1998 — 2002
Bachelors, Chemical Engineering
University of California, Irvine 1998 — 2002
Minor, Biomedical Engineering
Air Products and Chemicals December 2013 - Present
Air Products and Chemicals November 2010 - December 2013
Hyde Engineering + Consulting February 2010 - November 2010
Ampac Fine Chemicals January 2008 - February 2010
Vigon International March 2005 - January 2008
Skills
Chemical Engineering, Process Safety, Root Cause Analysis, FDA, Technology Transfer, Process Engineering, Process Simulation, GMP, Project Engineering, Manufacturing, Chemistry, Engineering, Continuous Improvement, Process Improvement, Validation, Instrumentation, Quality System, Pharmaceutical Industry, Process Optimization, Change Control, Distillation, Pilot Plant, Reaction Engineering, Cleaning Validation, Aseptic Processing, Chemical Processing, R, HPLC, Lean Manufacturing, Chromatography, Analytical Chemistry, CAPA, Gas Chromatography, Plant Operations, Minitab
Education
Penn State University 1999 — 2004
B.S., Chemical Engineering
Hyde Engineering + Consulting August 2015 - Present
Lonza July 2012 - August 2015
Lonza Biologics June 2010 - July 2012
Nanostructured Polymer Research Center May 2007 - May 2010
Skills
GMP, Sop, LIMS, SDS-PAGE, ELISA, Assay Development, Technology Transfer, Spectrophotometry, Chemical Engineering, Laboratory, Change Control, Matlab, Chemistry, Process Simulation, Chromatography, Cell Culture, Polymers, Protein Purification, Materials Science, Six Sigma, Gas Chromatography, SOP, Equipment Commissioning, CAPA
Education
University of New Hampshire 2013 — 2015
Industrial Statistics
University of New Hampshire 2006 — 2010
Bachelor of Science, Chemical Engineering
Hyde Engineering + Consulting June 2015 - Present
PSC Biotech April 2015 - June 2015
PSC Biotech January 2015 - April 2015
PSC Biotech July 2014 - December 2014
Baxter BioScience December 2012 - July 2014
Baxter BioScience October 2012 - November 2012
UC Santa Barbara June 2009 - September 2009
Skills
Microsoft Excel, Matlab, Mathematica, PowerPoint, C++, Microsoft Office, Microsoft Word, Social Media, Research, C, Strategic Planning, Customer Service, Photoshop, HTML, Outlook, Windows, Java, Team Building, Visio, Excel, MS Word, MS Access, LaTex, SAS, Origin, EViews, PC Hardware, R, Accelrys Visualizer, Refractometry, Gas Chromatography, FTIR, Affinity Chromatography, Ion Exchange..., Chemistry, Purification, Biotechnology
Education
Santa Susana High School
SSHS
SSHS
University of California, Santa Barbara 2007 — 2011
BS, Chemical Engineering
University of California, Santa Barbara 2011 — 2012
MA, Econoomics
Hyde Engineering + Consulting June 2012 - Present
Vans November 2011 - June 2012
Skills
Research, Microsoft Office, Social Media, Public Speaking, Politics, PowerPoint, Microsoft Excel, Microsoft Word, English, Political Science, Event Planning, Public Relations, Community Outreach, Editing, Photoshop, Fundraising, Teamwork, Customer Service
Education
San Jose City College 2010 — 2014
Hyde Engineering + Consulting June 2006 - Present
Skills
21 CFR Part 11, Validation, Computer System..., V&V, Biotechnology, GMP
Education
Regis University
Novartis September 2013 - Present
Hyde Engineering + Consulting October 2011 - September 2013
Barry-Wehmiller Design Group 2009 - October 2011
NCSRT 2007 - 2009
URS, formerly Washington Group Intl. 2001 - 2006
Aviron 2001 - 2001
GlaxoSmithKline 2000 - 2001
SP Pharmaceuticals 1992 - 2000
Skills
Validation, GMP, CAPA, FDA, Sop, 21 CFR Part 11, Pharmaceutical Industry, GxP, Quality Control, Quality Assurance, V&V, Change Control, GAMP, Biopharmaceuticals, Microbiology, Aseptic Processing, Quality Auditing, Biotechnology, Cleaning Validation, Computer System..., Technology Transfer, Quality System, Process Simulation, Vaccines, Chromatography, SOP, HPLC, LIMS, Lifesciences
Education
Ashford University
Masters, Organizational Management, International Business
Ashford University
Bachelors, Organizational Management, Environmental Science
Ball Aerospace December 2013 - Present
Hyde Engineering + Consulting September 2012 - December 2013
Dr. Charles Musgrave Research Group September 2011 - May 2012
TDA Research May 2009 - December 2009
Dr. William Medlin Research Laboratory January 2008 - May 2008
Skills
Gas Chromatography, Mass Spectrometry, FTIR, Quantum Chemistry, Aspen HYSYS, Aspen Plus, Mathematica, Labview, Matlab, Minitab, MathCAD
Education
University of Colorado at Boulder 2007 — 2012
Bachelor of Science (BS), Chemical Engineering
Hyde Engineering + Consulting October 2013 - Present
Commissioning Agents, Inc December 2006 - October 2013
JM Hyde Consulting May 2005 - December 2006
Skills
Control System..., Biotech Comminssioning..., Cleaning Validation, Critical and Support..., Process Waste Systems, Emerson DeltaV, RSLogix 5000, Nuclear, Commissioning, V&V, Quality Assurance, GMP, Validation, GAMP, Computer System..., Change Control, Software Documentation, CAPA, Aseptic Processing, FDA, GxP, 21 CFR Part 11, Biopharmaceuticals, Sop, Quality System, Trackwise
Education
Colorado State University 2000 — 2005
Bachelor of Science (B.S.), Chemical Engineering
Hyde Engineering + Consulting August 2009 - Present
Skills
Validation, V&V, Deviations, CAPA, Aseptic Processing, Protocol Development..., Execution of COP/CIP..., Biopharmaceuticals, Developing CIP Cycles, Clean Hold Validation, Mixing Validation, Change Control, Cleaning Validation, Fermentation, Authoring Batch Records..., Validation Sampling, GAMP, Filtration, FDA, Technology Transfer, Downstream Processing
Education
Syracuse University 1996 — 2000
Bachelor of Science (B.S.), Chemical Engineering