Azzur Group
Industry: Company
DescriptionFounded: 2010 Subsidiaries: 3Seed Marketing, Design & Interactive,
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Azzur Group Employees
Azzur Group August 2014 - Present
Consulting Services June 2014 - October 2014
GluMetrics, Inc. November 2011 - September 2013
Glumetrics, Inc. August 2007 - November 2011
Glumetrics, Inc. May 2005 - August 2007
Terumo Cardiovascular Systems 1999 - 2005
3M Health Care 1992 - 1999
Skills
Medical Devices, R&D, Cross-functional Team..., Design Control, Validation, FDA, Biomedical Engineering, Product Development, ISO 13485, CAPA, Quality System, V&V, Project Management, Strategic Planning, Statistics, Chemistry, ISO 14971, Process Improvement, Biomaterials, Polymers, GLP, GMP, Lifesciences, Sop, Clinical Development, Clinical Research, Clinical Trials, Six Sigma, Software Documentation, 21 CFR Part 11, Manufacturing, Quality Control, HPLC, GCP, CTMS, Start-ups, Problem Solving, Process Simulation, Commercialization, Biotechnology, Sensors, Regulatory Affairs, Quality Assurance, Design of Experiments, Analytical Chemistry, FDA GMP, Product Launch, Quality Systems, Process Development, Life Sciences
Education
University of California, Irvine - The Paul Merage School of Business 2011 — 2013
Master of Business Administration (M.B.A.), Health Care Executive, 3.87 GPA
University of California, Berkeley
B.S., Chemistry
American Society for Quality
Certified Six Sigma Black Belt Refresher Course
University of California, Irvine - Extension
Project Management
Azzur Group November 2014 - Present
Amgen 2015 - 2015
Amgen 2015 - 2015
Lyophilization Services of New England October 2011 - November 2014
OPK Biotech, LLC March 2010 - October 2011
Skills
Biotechnology, Molecular Biology, PCR, Cell Culture, Microbiology, Biochemistry, Purification, DNA, ELISA, Western Blotting, HPLC, Genetics, GMP, SDS-PAGE, Chromatography, Immunology, Chemistry, SOP, Fermentation, Science, Protein Purification, cGMP, Diagnostics, Cell Biology
Education
Boston University 2014 — 2018
Bachelor's Degree, Clinical Laboratory Science/Medical Technology/Technologist
Middlesex Community College 2007 — 2012
Associate's degree, Biotechnology
Middlesex Community College 2007 — 2011
As, Biotechnology
Johnson & Johnson - via Axelon August 2014 - Present
Azzur Group December 2012 - August 2014
PSC Biotech 2012 - 2012
Skills
Microsoft Office, Excel, Word, Matlab, Validation, GMP, Software Documentation, Change Control, Troubleshooting, Engineering, Technical Writing, Quality Assurance, AutoCAD, Data Analysis, Medical Devices, FDA, CAPA, 21 CFR Part 11, Sop, Testing, Quality System, Biopharmaceuticals
Education
UC Berkeley 2008 — 2012
Bachelor of Science (B.Sc.), Chemical Engineering
UC Berkeley 2008 — 2012
Bachelor of Science (B.Sc.), Nuclear Engineering
Azzur Group November 2014 - Present
The Klingaman Group April 2013 - January 2015
The Klingaman Group September 2013 - June 2014
The Klingaman Group February 2013 - December 2013
Amcor January 2009 - February 2013
Permaswage June 2008 - September 2008
City of Santa Ana September 2006 - April 2008
Skills
Project Management, Solidworks, Lean Manufacturing, Management, Analysis, Supply Chain, Process Improvement, Manufacturing, AutoCAD, Procurement, Industrial Engineering, Microsoft Office, Continuous Improvement, Management Consulting, Business Strategy, Operations Management, 5S, Logistics, Warehousing, Six Sigma, Supply Chain..., Process Flow..., Process Engineering, Proposal Writing, Supply Chain Management, Cross-functional Team..., Procurement Contracts, Capital Projects, Asset Management, Documentation Practices, DMAIC, Engineering, Contract Negotiation, Facilities Management, Quality Management, Product Development, Root Cause Analysis, Project Planning, Value Stream Mapping, Process Scheduler, Kaizen, 21 CFR Part 11, Computerized Systems, CAPA, Change Control, Commissioning
Education
California State Polytechnic University-Pomona 2005 — 2009
Bachelor of Science, Industrial and Manufacturing Engineering
Azzur Group February 2013 - Present
MedImmune February 2013 - Present
Azzur Group December 2011 - February 2012
Johnson & Johnson January 2011 - December 2011
IPS September 2007 - December 2011
Integrated Project Services September 2007 - December 2011
Shire HGT 2010 - 2010
Skills
GAMP, Computer System..., Cleaning Validation, V&V, 21 CFR Part 11, GxP, Validation, Change Control, GMP, Commissioning, Sop, Quality Auditing, Quality Assurance, Process Engineering, CAPA, Biopharmaceuticals, GLP, Aseptic Processing, LIMS, FDA, SOP
Education
Rosemont College 2004 — 2007
Bachelor's degree, Biochemistry
Bryn Mawr College 2000 — 2003
Azzur Group February 2015 - Present
Azzur Group December 2014 - February 2015
Adagio Medical Inc. January 2014 - December 2014
Teco Diagnostics June 2013 - January 2014
The Scripps Research Institute June 2012 - September 2012
Sanford-Burnham Medical Research Institute June 2009 - August 2009
Skills
Solidworks, R&D, Transfection, Laboratory, Plasmid Isolation, Phage Display, Cell, Validation, Western Blotting, Quality Control, Microsoft Excel, Microsoft Office, Microsoft Word, FDA GMP
Education
University of California, Irvine 2010 — 2014
Bachelor of Science (B.S.), Biomedical Engineering
Torrey Pines High School 2006 — 2010
High school diploma
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
Azzur Group June 2013 - December 2014
Cody Laboratories, Inc. September 2012 - February 2013
Self-Employed March 2012 - May 2012
Self Employed May 2011 - August 2011
Dendreon July 2009 - April 2011
Dendreon August 2008 - June 2009
Diligere Consortium, Inc. April 2000 - December 2007
KMI/PAREXEL, Inc. 1991 - 1993
Skills
21 CFR Part 11, Pharmaceutical Industry, Computer System..., Validation, FDA, Quality Assurance, CSV, Regulatory Requirements, Change Control, Software Documentation, Lifesciences, CAPA, GxP, GCP, Biotechnology, GLP, GAMP, GMP, Sop, Quality System, V&V, ISO 13485, LIMS, Biopharmaceuticals, Quality Auditing, Quality Control, Regulatory Affairs, Document Management, Technology Transfer, Aseptic Processing, Cross-functional Team..., ISO, Pharmaceutics, Cleaning Validation, Process Simulation
Education
Colorado School of Mines 1991 — 1992
Engineering, General Engineering with Specialty in Chemistry
Acosta Sales & Marketing September 2015 - Present
Professional Human Resources Consultant December 2014 - June 2015
Azzur Group August 2014 - November 2014
PSC Biotech April 2013 - July 2014
Gilead Sciences January 2005 - February 2008
United Stationers November 2003 - December 2005
ACCO Brands July 1998 - February 2000
Avery Dennison Label and Packaging Materials January 1989 - January 1999
Skills
Team Leadership, Organization, HR Policies, Recruitment, Union Avoidance, Coaching, Employee Relations, Recruiting, Human Resources, HR Software, Employee Benefits, Policy, Leadership, Interviews, Onboarding, Succession Planning, Hiring, Performance Management, Personnel Management, Talent Management
Education
University of Phoenix
Bachelor of Science (BS), Business Administration and Management, General
University of Phoenix
Bachelor of Science (B.S.), Business Administration and Management, General
Azzur Group July 2013 - Present
OPK Biotech LLC June 2010 - June 2013
Crosspoint Engineering September 2008 - June 2010
Biopure 1994 - 1998
Skills
Validation, Engineering, Cross-functional Team..., Automation, Biotechnology, Risk Management, Control Systems Design, Cleaning Validation, Risk Assessment, GMP, FDA, CAPA, V&V, Quality System, Change Control, Computer System..., 21 CFR Part 11, Pharmaceutical Industry
Education
University of New Hampshire
Quality BioResources April 2014 - Present
US Army May 1999 - Present
Azzur Group April 2014 - November 2014
Center for Disease Detection April 2012 - March 2014
QTC - A Lockheed Martin Company September 2011 - April 2012
Talecris August 2006 - March 2011
Stough Enterprises/PlasmaCare May 2002 - August 2006
SAIC January 2000 - January 2002
Skills
Quality Assurance, GMP, FDA, Process Improvement, Validation, Operations Management, Quality Auditing, Auditing, Biotechnology, CAPA, Quality Management, Root Cause Analysis, Continuous Improvement, cGMP, Compliance, Quality Systems, Document Management, TQM, SOP, Documentation, Lean Manufacturing, Life Sciences, Inspection, Process Development, Manufacturing, Problem Solving, Technical Writing, Quality System, Sop, Cross-functional Team..., Regulatory Affairs, Pharmaceutical Industry, Management, Medical Devices, Software Documentation, Process Simulation, Quality Control, Training, Leadership, Data Analysis, 21 CFR Part 11, Clinical Trials, Microbiology, Change Control, Project Management, Lifesciences
Education
Kaplan University-Davenport Campus 2014 — 2016
Master’s Degree, Homeland Security and Emergency Management
Michigan State University 1993 — 1998
Bachelors of Science, Microbiology
United States Army Reserve
Azzur Group April 2015 - Present
Azzur Group October 2014 - March 2015
Azzur Group LLC June 2012 - September 2014
Azzur Group May 2009 - May 2012
Azzur Group June 2007 - May 2009
Micro-Clean, Inc. April 2002 - June 2007
Lucent Technologies (Agere Systems) January 1998 - March 2002
Skills
GMP, ISO, Commissioning, Organization, European Union, FDA, Change Control, Validation, Quality Assurance, Project Planning, Troubleshooting, Sop, CAPA, Technology Transfer, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, Process Simulation, Testing, Six Sigma, Software Documentation, Quality System, Medical Devices, GxP, Computer System..., Cross-functional Team..., Manufacturing, Quality Control, GAMP, Quality Management, Management, GLP, Regulatory Affairs, Process Engineering, Root Cause Analysis, Quality Auditing, Regulatory Requirements, Calibration, Document Management, ISO 13485, SOP
Education
Cornell University 2014 — 2016
Executive Leadership
Lincoln Technical Institute-Allentown 1996 — 1998
Associate of Arts and Sciences (A.A.S.), Electrical and Electronics Engineering
Azzur Group May 2015 - Present
INNOCEAN USA December 2014 - April 2015
Power Training Institute August 2014 - December 2014
American Cancer Society May 2013 - August 2014
Skills
Microsoft Office 2008..., Microsoft Office Xp, PowerPoint, Microsoft Excel, Time Management, Data Entry, Customer Service, Sales, Telephone Skills, French, Food, Bookkeeping, Filing, Wine, Outlook, Administrative..., Critical Thinking, Facebook, Social Networking, Event Planning, Microsoft Word, Office Management, Social Media, Teamwork, Community Outreach, Recruiting, Event Management, Fundraising, Microsoft Office
Education
University of California, Santa Barbara
Bachelor's degree
Azzur Group January 2015 - Present
cGMP Validation LLC March 2007 - January 2015
Actavis 2002 - 2007
Genentech 1999 - June 2002
Bayer 1996 - 1998
Calypte Biomedical 1995 - 1996
Biowhittaker Inc. 1992 - 1995
Skills
21 CFR Part 11, Computer System..., Validation, GMP, CAPA, ISO 13485, Medical Devices, LIMS, ISO 14971, FDA, Software Quality..., Document Management, Software Documentation, Laboratory Automation, Cloud Computing, Risk Management, Risk Assessment, HIPAA, SAP, Software Project..., MS Project, Regression Testing, ERP, Software Engineering, Data Security, SaaS, System Testing, Computer Security, Risk Mitigation, IT Auditing, Healthcare IT, IT Governance, IT Outsourcing, Life Sciences, Software Design, Compliance Audits, Software Development..., 21CFR Part 820, 21CFR Part 210/ 211, ISO 62304, HIPAA Security Rule, Data Privacy, Laboratory Experience, Healthcare Compliance, cGMP, Pharmaceuticals, SOP/ Policy Development, Integration Testing, Quality Systems, V&V
Education
Hood College 1993 — 2000
MS, Biology
Radford University 1987 — 1991
BS, Biology, Chemistry
Azzur Group June 2015 - Present
Fujifilm Diosynth Biotechnologies May 2014 - June 2015
Biomanufacturing Training and Education Center January 2013 - May 2014
Novartis Vaccines and Diagnostics May 2013 - August 2013
Mamtek U.S. May 2011 - August 2011
North Carolina State University August 2010 - May 2011
Thar Pharmaceuticals June 2009 - August 2009
Skills
Aseptic Technique, Chemistry, Process Engineering, Filtration, Biofuels, DNA, Spectroscopy, Protein Purification, Purification, Laboratory, Media Prep, Autoclaving, Autoclave, Buffer Prep, Ultracentrifugation, Tangential flow..., Bio-Rad TC20 cell..., Sartorius Wave..., Vi-CELL, Akta Avant..., Ultrafiltration, JMP, Unicorn, Minitab
Education
North Carolina State University
Bachelor's Degree, Biological Engineering Concentrating in Bioprocessing, Minor: Biomanufacturing, 3.12
Central Catholic High School 2005 — 2009
High School, 4.0
Azzur Group October 2014 - Present
AccuRounds August 2014 - October 2014
Pfizer June 2013 - August 2013
Skills
Chemical Engineering, Microsoft Office, Superpro Designer, Aspen Custom Modeler, Microsoft Visio, Adobe Creative Suite, EconExpert, Matlab, IR spectroscopy, Distillation, Adsorption, Liquid-liquid Extraction, Leadership, Microsoft Word, GMP
Education
University of New Hampshire 2010 — 2014
Bachelor of Science, Chemical Engineering
Canton High School 2006 — 2010
IPS-Integrated Project Services, Inc. November 2014 - Present
Azzur Group June 2013 - October 2014
Integrated Project Services September 2008 - June 2013
Skills
Project Engineering, Construction Management, Construction, Primavera P6, Project Estimation, Commissioning, Microsoft Office 2007, AutoCAD, Engineering, MEP, CPM Scheduling
Education
Drexel University 2007 — 2013
Bachelor's degree, Construction Management
Azzur Group September 2015 - Present
Azzur Group April 2014 - September 2014
Chemtura April 2013 - September 2013
Skills
Chemistry, GMP, Time Management, Validation, GLP, Computer System..., Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel, Public Speaking
Education
Drexel University 2012 — 2015
Bachelor's degree, Chemistry
Drew University 2010 — 2012
Chemistry, 3.3
Peak Performance Global Services, LLC January 2014 - Present
PharmEng Technology January 2012 - January 2014
Biogen Idec 2010 - 2011
Azzur Group 2010 - 2011
Sanofi Pasteur 2006 - 2011
Jacobs Engineering 2003 - 2005
cGMP Validation LLC 2000 - 2003
Merck 1994 - 2002
Raytheon Engineers 1990 - 1998
United States Air Force 1976 - 1982
Skills
Business Development, Project Management, Team Building, Computer System..., Change Control, V&V, 21 CFR Part 11, Validation, GxP, CAPA, FDA, GMP, Sop, Biopharmaceuticals, Pharmaceutical Industry, Quality Management, Biotechnology, GAMP, Quality System, Management, Vaccines, Manufacturing, Commissioning, Technology Transfer, Aseptic Processing, Six Sigma, GLP, Industrial Engineering, Regulatory Affairs, Project Engineering, Root Cause Analysis, Medical Devices, Quality Assurance, Quality Control, Cleaning Validation, ISO 13485, Engineering, Strategy, Pharmaceutics, LIMS, Process Simulation, Regulatory Requirements, Lifesciences, Regulatory Submissions, Quality Auditing, Process Engineering, R&D, Drug Development, Document Management, People Skills
Education
Lehigh County Community College 1978 — 1982
Business Management
Troy State University 1977 — 1978
Business Management
ChiefOptimizer September 2015 - Present
Azzur Group September 2015 - Present
ChiefOptimizer January 2011 - Present
Wave Dispersion Technologies, Inc. January 2012 - Present
InnoviMobile April 2015 - Present
RideScout (Sold to Daimler) September 2013 - September 2014
Wave Disperson Technologies, Inc. January 2005 - December 2011
Education
Wesleyan University
Bachelor of Arts (BA)
University of Hartford
Master of Science (MS)
Michigan State University
Certificate
Northwestern University September 2015 - Present
Azzur Group October 2014 - August 2015
University of Massachusetts Lowell July 2014 - September 2014
Analog Devices January 2011 - January 2014
Skills
Microsoft Office, Process Validation, Chemical Vapor..., Photolithography, VBA, Matlab, Polymath, Minitab, cGMP manufacturing, CMMS, Nanomaterials, Process Engineering
Education
University of Massachusetts Lowell 2010 — 2014
Bachelor's Degree, Chemical Engineering
Azzur Group November 2014 - Present
BioSPEQ, Inc, an Azzur Group Company March 2014 - November 2014
BioSPEQ October 2013 - March 2014
BioSPEQ November 2012 - September 2013
Acceleron Pharma January 2011 - August 2011
Nano-Terra, LLC January 2010 - June 2010
Procter & Gamble January 2009 - June 2009
Unilever June 2008 - August 2008
Skills
Aseptic Technique, HPLC, UV/Vis, Cell Culture, Biotechnology, Chemical Engineering, Osmometer, Nanodrop, Particle Size, Aspen Plus, Fluent, Product Design, Process Engineering, Nanoparticles, Validation, Quality Assurance, GMP, Analytical Chemistry, Laboratory, Quality System
Education
Northeastern University 2007 — 2012
Bachelor of Science (BS), Chemical Engineering
Azzur Group March 2015 - Present
Baxter BioScience June 2014 - March 2015
UCLA Department of Chemical Engineering, Yi Tang June 2013 - June 2014
UCLA Department of Neurology, Daniel Geschwind August 2012 - June 2013
Skills
Matlab, Microsoft Excel, Bacterial Transformation, Bacterial Cell Culture, Gel Electrophoresis, SDS-PAGE, Microsoft Word, PowerPoint, C++, Pro II, Microsoft Visio, Aseptic Gowning, PCR, Protein Expression, Column Chromatography, UV/Vis, GxP, Simulink, Chemical Engineering
Education
University of California, Los Angeles 2010 — 2014
BS, Chemical and Biomolecular Engineering
BIOLASE, Inc. July 2015 - Present
Azzur Group April 2015 - July 2015
Cla-Val May 2014 - April 2015
Alcon, a Novartis company May 2011 - September 2013
UC Irvine March 2013 - June 2013
UC Irvine September 2012 - January 2013
California Baptist University August 2009 - May 2011
California Baptist University September 2008 - May 2009
Skills
Mechanical Engineering, Solidworks, Matlab, Engineering, CAD, Pro Engineer, Finite Element Analysis, Inventor, R&D, Medical Devices, Surgical Instruments, Biomedical Engineering, Design for Manufacturing, Manufacturing, Heat Transfer, Thermodynamics, AutoCAD, Labview, Machine Design, Machining, GD&T, Design of Experiments, Biotechnology, Microsoft Office, Microsoft Excel, Mathematica, ISO 13485, FDA, Mechanism Generator, LabVIEW, SolidWorks, Geometric Dimensioning
Education
University of California, Irvine 2012 — 2014
Master of Science (MSME), Mechanical Engineering
California Baptist University 2007 — 2012
Bachelor of Science (BSME), Mechanical Engineering
Azzur Group July 2015 - Present
Triton Engineering Student Council April 2014 - Present
UC San Diego May 2014 - June 2015
UC San Diego Nanoengineering Lab February 2013 - May 2014
La Jolla Bioengineering Institute September 2013 - December 2013
Lone Star Steakhouse September 2010 - September 2012
Law Offices of Lee R Goldberg October 2010 - May 2011
UC Irvine Neurobiology Research Lab June 2009 - August 2009
Skills
Nanotechnology, Nanofabrication, Research, Customer Service, Microsoft Word, Public Speaking, Matlab, Physics, Nanoparticles, Leadership, Engineering, Project Management, AFM, Solar Cells, Organic Solar Cells, Spin Coating, Peer Tutoring, Photovoltaics, Semiconductors, Organic Semiconductors, Microsoft Office, Microsoft Excel, Characterization, Data Analysis, PowerPoint
Education
University of California, San Diego 2012 — 2015
Bachelor of Science (B.S.), Nanoengineering, 3.68
Orange Coast College 2010 — 2012
Associate of Science (A.S.), Engineering, 3.72
Aliso Niguel High School 2006 — 2010
High School Diploma, 4.01
St. Georges
St. Georges
Azzur Group September 2014 - Present
Genentech November 2013 - August 2014
High Throughput Laboratory at Northwestern University January 2011 - June 2013
Project on Children's Thinking at Northwestern University September 2009 - January 2011
Skills
Matlab, Biomedical Engineering, Data Analysis, Mandarin, Access, PowerPoint, Minitab, Microsoft Excel, Microsoft Word, Statistics, Mathematica, Research, Cell Culture, Solidworks, PCR, Experimental Design, CAD, FEM analysis, FMEA, cGMP practices, cGMP manufacturing, Bioprocessing, Quality Assurance, Quality Control, Medical Devices, 5S, Manufacturing, Lean Manufacturing, FDA
Education
Northwestern University 2009 — 2013
Bachelor of Science, Biomedical Engineering
Barry-Wehmiller Design Group February 2014 - Present
Azzur Group March 2013 - January 2014
Brad Shives Consulting November 2011 - March 2013
Lonza March 2008 - November 2011
BLS Contracting June 2001 - March 2008
Huntzberry Brothers March 2006 - October 2007
Sytel, Inc 1996 - 2002
US Army 1991 - 1991
US Army 1991 - 1991
Skills
Biotechnology, Lifesciences, Cell Culture, Microsoft Office, Microsoft Excel, Pharmaceutical Industry, Project Management, Strategic Planning, PowerPoint, Quality Assurance, Management, Leadership, Validation, Process Improvement, Contract Management, Team Building, Business Development, Biopharmaceuticals, Sop, FDA, Change Control, 21 CFR Part 11, Quality Control, Computer System..., GxP
Education
Frostburg State University 1988 — 1991
Bachelor of Science (BS), Health and Physical Education/Fitness
Lonza
Greenbelt - Lean Six Sigma
Azzur Group March 2014 - Present
OPK Biotech, LLC November 2011 - December 2013
Lantheus Medical Imaging January 2010 - November 2011
Skills
AutoCAD, PIDs, PFD, cGMP practices, Process Engineering, Chemical Engineering, Radiation Safety, Validation, GMP, CAPA, FDA, 21 CFR Part 11, Sop, Change Control, Teamwork, Biopharmaceuticals, Purification, Chromatography, HPLC, Aseptic Processing, Cleaning Validation, Process Simulation, Biotechnology, V&V, Technology Transfer, GxP
Education
University of New Hampshire 2005 — 2009
B.S., Chemical Engineering
Boston Architectural College
AutoCAD I-2D
Integrity Consulting January 2015 - Present
Enhanced Compliance Inc. August 2014 - December 2014
Azzur Group October 2013 - June 2014
MedImmune January 2011 - September 2013
Centocor July 2010 - December 2010
Model Metrics April 2010 - July 2010
Eisai August 2008 - May 2010
Par Pharmaceutical January 2008 - July 2008
Bristol-Myers Squibb August 2007 - December 2007
GE Healthcare April 2007 - August 2007
Skills
Software Quality..., Computer System..., 21 CFR Part 11, FDA, GxP, Change Control, Quality Assurance, CAPA, Oral & Written..., Validation, Medical Devices, Pharmaceutics, Quality Auditing, Regulatory Affairs, ISO 13485, Software Documentation, V&V, GMP, Sop, SDLC, Biotechnology, LIMS, Document Management, Pharmaceutical Industry, Cross-functional Team..., Process Improvement, Lifesciences, Quality System, GLP, GAMP, Regulatory Requirements, GCP, Biopharmaceuticals, Quality Control, Protocol, Testing, SOP
Education
Wheaton College 1977 — 1979
Accounting and Finance
Oral Roberts University 1973 — 1977
BS, CSC, Math
Azzur Group August 2013 - February 2015
Checker Cab May 2010 - February 2013
Environmental Tectonics Corp July 2007 - April 2009
Skills
Sop, Pharmaceutical Industry, GMP, Quality Assurance, Software Documentation, Transportation, Validation, Logistics, 21 CFR Part 11, V, Microsoft Office, Customer Service, Microsoft Excel, Microsoft Word, Salesforce.com..., QuickBooks, Quicken, FDCPA, Travel Arrangements, Business Travel, Travel Management, Collections, Office Administration, Back Office, Employee Benefits
Education
Community College of Philadelphia 2009 — 2015
Business Administration and Management, General
George Washington High School
Medtronic Spinal & Biologics November 2014 - Present
Medtronic, Inc. June 2012 - November 2014
AZZUR GROUP October 2011 - August 2012
Celgene Corporation - LifeBank August 2011 - December 2011
New York Blood Center April 2008 - July 2010
Progenitor Cell Therapy L.L.C May 2005 - April 2008
Wyeth Pharmaceuticals May 2004 - April 2005
Schering-Plough Corporation February 2003 - April 2004
Curative Health Services January 2000 - February 2003
Curative Health Services July 1998 - December 1999
Skills
FDA, GMP, Sop, Validation, CAPA, Biotechnology, Change Control, Pharmaceutical Industry, 21 CFR Part 11, Lifesciences, Quality System, Quality Assurance, Aseptic Processing, GxP, GLP, V&V, Regulatory Affairs, Medical Devices, LIMS, Computer System..., Laboratory, Quality Auditing, Quality Control, ISO 13485, Quality Management, Microbiology, Process Improvement, Deviations, Calibration, Biopharmaceuticals, Trackwise, Testing, HPLC, GAMP, Cleaning Validation, Technology Transfer, Manufacturing, FDA GMP, Regulatory Requirements, Regulatory Submissions, Design Control, Chromatography, Root Cause Analysis, GCP, Analytical Chemistry, ISO, Life Sciences
Education
Lycoming College 1987 — 1991
BA, Biology
Temple University
Partial Masters, Pharmaceutical Quality Control
Technical Needs August 2015 - Present
Azzur Group January 2015 - May 2015
Dartmouth-Hitchcock September 2013 - November 2014
Dartmouth College January 2012 - November 2014
TDB Communications December 2012 - April 2013
Keystone Financial Co. January 2011 - June 2011
State Street School August 2010 - June 2011
SAU #88 October 1994 - June 2008
Skills
Organizational..., Computer Literate, Public Speaking, Customer Relations, Budgeting, Fundraising, Organization &..., Budgets, Critical Thinking, Research, Music, Report Development, Account Management, Administrative..., Administrative Work, Customer Service, New Business Development, Process Improvement, Grant Writing, Microsoft Office, Project Planning, Event Planning, Time Management, Nonprofits, Community Outreach, Social Networking, Data Entry, Administration, Teaching, Team Building, Management, Strategic Planning, Microsoft Excel, Healthcare, Program Development, Leadership, Training, Marketing, Policy, Microsoft Word, Social Media, Sales, PowerPoint, Problem Solving, Editing
Education
Grand Canyon University 2011 — 2013
M.C.S., Master Degree in Christian Studies, 3.8
Lesley University 1992 — 1994
M.Ed., Master of Special Education, 3.7
Ithaca College 1979 — 1983
B. Med., Vocal Music Education
Lebanon High School, New Hampshire 1975 — 1979
High School, Diploma
Azzur Group March 2013 - Present
OPK Biotech February 2010 - March 2013
Shire HGT October 2007 - February 2010
Genentech December 2003 - October 2007
Pfizer June 2001 - December 2003
Pfizer December 2000 - June 2001
CSL Behring June 2000 - December 2000
Biopure December 1997 - June 2000
PAREXEL (KMI) November 1994 - December 1997
Skills
21 CFR Part 11, Computer System..., Validation, GMP, Change Control, CAPA, FDA, V&V, Sop, GAMP, Quality System, GxP, Aseptic Processing, Biotechnology, Technology Transfer, Cleaning Validation, Quality Assurance, Biopharmaceuticals, Quality Control, Chromatography, Trackwise
Education
Boston College - Wallace E. Carroll Graduate School of Management 1999 — 2001
MBA
Worcester Polytechnic Institute 1990 — 1994
Bachelors of Science, BioMechanical Engineering
Azzur Group April 2015 - Present
University of Massachusetts Amherst September 2012 - December 2014
Fluid Structure Interactions Laboratory November 2012 - May 2013
CFAM Technologies May 2012 - July 2012
Industrial Aerodynamics Laboratory September 2011 - December 2011
Skills
Matlab, SolidWorks, ANSYS, Fluid Mechanics, Finite Element Analysis, Engineering, Microsoft Office, Simulations, LabVIEW, Problem Solving, Leadership
Education
University of Massachusetts, Amherst 2012 — 2014
Bachelor of Science (B.S.), Mechanical Engineering
Beverly Flight Center 2010 — 2012
Flight Operations, Private Pilot Certificate
University of Massachusetts Lowell 2010 — 2011
Bachelor's Degree, Mechanical Engineering
Revere High School 2006 — 2010
High School
Azzur Group May 2014 - Present
BioSPEQ November 2012 - Present
Teva Pharmaceuticals November 2010 - November 2012
Teva Parenteral Medicines November 2009 - November 2010
A. D. Brown Corporation, General Engineering Contractors 2005 - November 2009
Baxter Healthcare 2000 - 2005
Baxter Healthcare 1998 - 1998
Skills
Manufacturing, Engineering, Validation, GMP, FDA, CAPA, V&V, Quality System, Change Control, Technology Transfer, Sop, Pharmaceutical Industry, Biotechnology, Cleaning Validation, Medical Devices, 21 CFR Part 11, Six Sigma, Lean Manufacturing, Biopharmaceuticals, Maintenance, Critical Systems, Water, HVAC, Trackwise, Aseptic Processing, Regulatory Requirements, Quality Auditing, SOP
Education
Iowa State University 1995 — 2000
B.S., Chemical Engineering
crystal lake central
Johnson & Johnson September 2012 - Present
Azzur Group 2014 - 2014
Siemens Healthcare March 2012 - August 2012
Medimedia, USA April 2008 - February 2012
IPS July 2007 - April 2008
MediMedia USA September 2005 - June 2007
Stelex 2000 - 2005
Skills
Quality Assurance, 21 CFR Part 11, Validation, Business Process, Requirements Gathering, Change Control, Project Management, CAPA, Team Leadership, Software Documentation, Program Management, Medical Devices, Process Improvement, Computer System..., Requirements Analysis, Siebel, Oracle, Cross-functional Team..., SQL, FDA, GxP, Integration, Pharmaceutical Industry, SDLC, Visio, GMP, Software Quality..., Business Analysis, LIMS, Process Engineering, SharePoint, Testing
Education
Drexel University 1998 — 2001
Master's degree, Information Systems
Drexel University 1991 — 1996
Bachelor of Science (BS), Biology
Integra LifeSciences August 2015 - Present
Azzur Group March 2012 - August 2015
Integra LifeSciences July 2014 - November 2014
West-Ward Pharmaceuticals March 2012 - February 2014
Bristol Myers Squibb 2011 - March 2012
Integrated Project Services (IPS) 2007 - August 2011
Cardiovascular Research Foundation September 2007 - May 2011
Unilife Corporation November 2010 - April 2011
Forest Laboratories August 2010 - February 2011
Wyeth 2007 - 2009
Skills
Process Validation, Computer System..., 21 CFR Part 11, Validation, SOP, GMP, cGMP, GxP, GAMP, V&V, Sop, Quality Assurance, GLP, CAPA, Testing, Quality Auditing, FDA, Pharmaceutical Industry, Commissioning, Medical Devices, Quality Management, Manufacturing, Change Control, Biopharmaceuticals, Cleaning Validation, Aseptic Processing, Protocol Development, Building Automation
Education
Rutgers College of Engineering
Bachelor's degree, Chemical and Biochemical Engineering
Middlesex County College
Associate of Science (AS), Chemical Engineering
Azzur Group January 2015 - March 2015
Neolpharma S.A. de C.V: May 2014 - November 2014
BMS December 2013 - January 2014
Pfizer Barceloneta February 2013 - September 2013
Benevue Pharma November 2010 - December 2010
Patheon Pharma September 2009 - December 2009
Catalent Pharma Solutions August 2008 - November 2008
Invensys Validation Technology March 2007 - June 2008
Skanska Pharma February 2004 - March 2007
Foster Wheeler February 2001 - February 2004
Skills
Validation, Quality Systems, Cleaning Validation, SOP, Process Validation, Commissioning, HVAC, CAPA, GMP, cGMP, Quality Assurance, Pharmaceuticals, Biotechnology, Auditing, Compliance, LIMS, Six Sigma, Documentation, Testing, Computer System..., Investigations, 21 CFR Part 11, Automation, Lean Manufacturing, Medical Devices, Validations, Analysis, GAMP, Change Control, V&V, Software Documentation, Pharmaceutical Industry, Private Investigations, Sop, Quality System, FDA, HPLC, Quality Control, Analytical Chemistry, Manufacturing, Quality Auditing, GxP, Process Simulation, ISO 13485, ISO, Root Cause Analysis, Aseptic Processing, Biopharmaceuticals, Trackwise, Calibration
Education
Universidad Politecnica de PR 1989 — 1996
B.S, Engineering; Industrial Engineering
Universidad Inter Americana de Puerto Rico Chemist 1983 — 1984
BS, Natural Science; Chemistry
University of South Florida 1977 — 1982
Chemistry
Azzur Group May 2014 - Present
BioSPEQ July 2012 - Present
Shire HGT December 2008 - June 2012
Amgen August 2003 - December 2008
Baxter BioScience August 2000 - June 2003
Skills
Process Validation, cGMP, Disposables, Cleaning Validation, CMC, Biotech Manufacturing, Aseptic Processing, Technology Transfer, Regulatory Submissions, Extractables and..., Cold Chain..., Validation Maintenance, Validation, V&V, Biotechnology, GMP, Quality Control, Biopharmaceuticals, 21 CFR Part 11, Change Control, FDA, Computer System..., CAPA, Pharmaceutics, Sop, Pharmaceutical Industry, LIMS, SOP
Education
University of Minnesota-Twin Cities 1997 — 2000
HBTI, Kanpur 1993 — 1997
B. Tech, Biochemical Engineering
BJB College 1990 — 1993
Azzur Group May 2014 - Present
Experis Manpower February 2014 - March 2014
Versa Engineering & Technology September 2013 - January 2014
TalentBurst, Inc. (Consultant) January 2013 - June 2013
PharmEng Technology November 2008 - September 2011
InfoQuest Consulting Group December 2010 - February 2011
Ryzen Solutions (Broncus Technologies, Inc.) July 2008 - November 2009
Tac Worldwide (Genentech) January 2008 - March 2008
Adecco Technical (Novartis, Inc., Bayer Healthcare) July 2007 - October 2007
Genentech November 2005 - July 2006
Skills
Validation, GMP, FDA, Sop, Quality System, CAPA, Quality Assurance, V&V, Biotechnology, Medical Devices, Biopharmaceuticals, LIMS, Computer System..., Software Documentation, Quality Control, Clinical Trials, GAMP, Change Control, 21 CFR Part 11, ISO 13485, HPLC, Pharmaceutics, Laboratory, GLP, GxP, Regulatory Affairs, Technology Transfer, Regulatory Requirements, Pharmaceutical Industry, Cleaning Validation, Chemistry, Regulatory Submissions, Lifesciences, Document Management, GCP, R&D, Technical Writing, SOP, Life Sciences
Education
San Diego State University-California State University
Bachelor's Degree, Chemistry
Skyline College 2007 — 2007
Biotechnoloy Manufacturing Certificate, BioManufacturing / Biotechnology
St. Michael's High, Los Angeles, CA
MicroWorks, Inc. November 2010 - Present
Azzur Group October 2014 - February 2015
Grifols/Biomat USA, Inc. October 2008 - November 2010
Baxter Biopharmaceutical Solutions April 2007 - October 2008
TYCO Healthcare Mallinckrodt Imaging July 2006 - December 2006
CellzDirect; Austin, TX May 2005 - July 2006
MicroPharm, Inc. and Micropharm Consulting, Inc.; St. Charles, IL and Georgetown, TX April 1995 - May 2005
Fujisawa USA, Inc., Melrose Park, IL February 1993 - April 1995
Kendall McGaw (B.Braun) April 1987 - September 1988
Allergan Medical Optics 1985 - 1987
Skills
GLP, Pharmaceutical Industry, Validation, Quality System, CAPA, GMP, Quality Assurance, LIMS, Quality Control, Biotechnology, FDA, Aseptic Technique, Aseptic Processing, Cross-functional Team..., Microbiology, Environmental Monitoring, Laboratory, Pharmaceutical..., HPLC
Education
California State University-Long Beach 1979 — 1983
Bachelor of Science, Microbiology, General
Azzur Group August 2014 - Present
Merck January 2012 - April 2014
Merck July 2008 - January 2012
Garlock Sealing Technologies June 2007 - August 2007
Saint-Gobain Abrasives May 2006 - August 2006
Skills
Manufacturing, Change Control, Engineering, GMP, Vaccines, Validation, Sterilization, Chromatography, Quality Assurance, Six Sigma, Sop, Technology Transfer, Quality Control, Filtration, CAPA, Deviation Management, SOP, Pharmaceutical Industry, FDA
Education
Rensselaer Polytechnic Institute 2004 — 2008
B.S., Chemical and Biological Engineering
St. Peter Marian
Azzur Group February 2015 - Present
Actavis Inc. (Watson Pharmaceuticals) July 2006 - January 2015
Viral Genetics January 2006 - March 2006
Watson Pharmaceuticals June 2005 - December 2005
Baxter International Inc. October 2004 - May 2005
Skills
Cleaning Validation, Process Validation, GMP, Change Control, Technology Transfer, CAPA, LIMS, SOP development, Deviation Investigation, 21 CFR Part 11, Trackwise, JMP, SOP, FDA, Validation, Pharmaceutical Industry, V&V, Quality System, Deviations, GLP, GxP, Sop, TrackWise, Computer System..., V, ICH Guidelines
Education
Florida Agricultural and Mechanical University 2000 — 2004
Masters, Chemistry
Gujarat University 1996 — 1998
Chemistry
Depuy-Synthes - Companies of Johnson & Johnson April 2014 - Present
Azzur Group May 2013 - April 2014
NextDocs April 2012 - March 2013
ePharmaSolutions January 2010 - March 2012
Wyeth January 2009 - June 2009
CSC April 2008 - November 2008
First Consulting Group 2001 - 2008
Skills
Quality Assurance, SDLC, Testing, SharePoint, Requirements Analysis, Software Documentation, Validation, Document Management, 21 CFR Part 11, Computer System..., Requirements Gathering, Pharmaceutical Industry, Business Analysis, System Testing, GxP, Documentum, Software Development, Integration, Process Improvement, Software Validation, Sop, Change Control, Project Management, Test Director, FirstDoc, Cross-functional Team..., Compliance, Agile, SOP, Software Quality..., Software Project..., Consulting, Enterprise Software, FDA, CAPA, Clinical Trials, Leadership, Documentation, IT Strategy, Life Sciences, Business Process, Quality System
Education
Immaculata University 2004 — 2007
BS, Information Technology
Azzur 2013 - Present
Azzur Group January 2010 - Present
CQV LLC January 2008 - December 2009
ACME RailRoad Co., Inc. 2006 - 2009
Stelex Inc. 1987 - September 2005
Vital Signs 2003 - 2004
w.p. carey 1987 - 1992
Robec Distributors 1986 - 1987
Skills
Validation, FDA, Medical Devices, Quality Assurance, Cross-functional Team..., Pharmaceutical Industry, Process Improvement, GMP, Business Strategy, Project Management, New Business Development, Quality System, Start-ups, Enterprise Content..., Team Building, Strategic Planning, Contract Negotiation, Document Management, SaaS, Enterprise Software
Education
Temple University 1982 — 1987
BA, computer science
JLL February 2015 - Present
Laporte Consultants March 2014 - December 2014
Azzur Group July 2012 - March 2014
Trinitas Regional Medical Center June 2006 - December 2009
Skills
21 CFR Part 11, V&V, Change Control, Computer System..., Validation, CAPA, GxP, GMP, FDA, GAMP, Sop, Aseptic Processing, Quality System, Technology Transfer, Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Quality Assurance, Medical Devices, GLP, Quality Auditing, Regulatory Affairs, LIMS, Technical Documentation, Vaccines
Education
Montclair State University 2002 — 2007
Bachelor of Science (BS), Biology, General
Ocean County College
Associate of Science (A.S.), Biology, General
O'Connor & Associates April 2014 - Present
KPIT March 2015 - June 2015
Apex Systems June 2014 - December 2014
Azzur Group October 2013 - December 2013
Experis May 2012 - October 2013
CSC August 2011 - May 2012
William Scotsman August 2009 - December 2010
O'Connor Consulting, Inc. October 1999 - October 2009
Catholic Relief Services October 1999 - October 2009
Catholic Relief Services October 1999 - October 2009
Skills
Financial Systems, Budgets, Project Management, Project Planning, ERP, JD Edwards, Payroll Systems, Management, Payroll, Analysis, PMO, Training, System Administration, Program Management, Strategy, Databases, Integration, Strategic Planning, Vendor Management, Networking, Leadership, Procurement, Business Intelligence, Information Technology, Business Analysis, Business Process, IT Management, SDLC, SharePoint, Software Documentation, Visio, Business Process..., PMP, PeopleSoft, MS Project, CRM, Process Improvement, IT Strategy, Resource Management, Requirements Analysis, Change Management, Project Portfolio..., ITIL, Project Delivery, Disaster Recovery, IT Service Management, Software Project..., Consulting
Education
Corning Community College
AAS, Computer Science
Corning Community College
Associate Degree, Applied Science; Computer Sciences
Notre Dame High School
Azzur Group June 2010 - Present
Carzo and Associates 2009 - 2010
AMEC May 2004 - July 2009
Phoenix Imperative, Inc. July 1997 - May 2004
Skills
Validation, cGMP, Commissioning, V&V, GMP, CAPA
Education
Penn State University 1992 — 1996
BS, Engineering
Azzur Group July 2013 - Present
The Dennis Group June 2010 - July 2013
Tufts University January 2010 - May 2010
Biogen Idec June 2009 - August 2009
Biogen Idec June 2008 - August 2008
Skills
Engineering, Process Design, PFD, PIDs, Process Descriptions, Commissioning, AutoCAD, PowerPoint, Excel, Word, Project Engineering
Education
Tufts University 2006 — 2010
Bachelor of Science, Chemical and Biological Engineering
Azzur Group June 2014 - Present
National University July 2012 - June 2014
Laerdal Medical May 2011 - August 2012
General Photonics June 2009 - March 2012
General Photonics March 2008 - June 2009
Quickly Café July 2006 - June 2009
Handicapper.net July 2004 - September 2006
South Pasadena and San Marino YMCA March 2004 - July 2006
Education
National University 2013 — 2014
Master of Science (MS), Computer Science
California State Polytechnic University 2004 — 2009
Bachelor of Science, Electronics and Computer Engineering Technology
Temple City High School 2000 — 2004
High School Degree
Azzur Group June 2013 - Present
Lonza July 2011 - June 2013
Skills
Validation, Chromatography, GMP, Manufacturing, Protein Purification, Engineering, Finite Element Analysis, COMSOL, Biotechnology, Active Pharmaceutical..., Column Chromatography, Column Packing, Clean Rooms, Document Review, UF/DF, Solidworks, CAPA, Purification, V&V
Education
Boston University 2007 — 2011
Bachelor's Degree, Mechanical Engineering
St. Johns High School (Shrewsbury) 2003 — 2007
Azzur Group April 2015 - Present
Validation Technologies, Inc. July 2008 - January 2015
USDM September 2010 - February 2011
Skills
Cleaning Validation, Validation, Autoclave, LIMS, Pharmaceutical Industry, 21 CFR Part 11, V&V, Aseptic Processing, CAPA, GAMP, Computer System..., SOP, FDA, CIP, Change Control, Trackwise, GMP, Manufacturing, GxP, GLP
Education
California Polytechnic State University-San Luis Obispo
Azzur Group August 2015 - Present
Glycan Connections May 2014 - July 2015
East Boston Savings Bank July 2012 - May 2014
New England Rehabilition Hospital June 2011 - April 2013
Skills
Microsoft Office, Molecular Biology, Biotechnology, PCR, Microsoft Excel, PowerPoint, Research, Cell Culture, Microsoft Word, Lifesciences, Biochemistry, Microbiology, Western Blotting, Teamwork, Gel Electrophoresis, Customer Service, SDS-PAGE, Life Sciences
Education
University of New Hampshire 2010 — 2014
BS, Biochemistry and Molecular Biology
Azzur Group 2015 - Present
Bristol-Myers Squibb 2010 - 2015
Lonza 2007 - 2010
Amgen 2006 - 2007
Baxter International Inc. 2003 - 2006
Skills
ASQ Member, • Knowledge of federal..., Extensive training..., Pharmaceutical Industry, GMP, Validation, Sop, FDA, 21 CFR Part 11, CAPA, Change Control, Regulatory Affairs, GLP, Clinical Trials, Computer System..., Biotechnology, V&V, GCP, Quality System, Clinical Development, HPLC, GxP, Quality Assurance, Internal Audit, External Audit, Biopharmaceuticals, LIMS
Education
Chaffey College 2005 — 2006
Biological and Physical Sciences