Protocol Link, Inc.
Address: 175 E Hawthorn Pkwy # 210, Vernon Hills, IL 60061 Phone: (847) 549-0390Place name: : Website: : : : : : Category: Website: http://www.protocollink.com/ Category: University Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?
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Protocol Link, Inc. Employees
Protocol Link, Inc. January 2015 - Present
Sage Global Staffing, Inc. October 2012 - December 2014
Protocol Link, Inc. October 2012 - December 2014
Duke's Alehouse and Kitchen June 2008 - December 2013
Financial Management Systems (FMS) May 2007 - August 2007
Financial Management Systems (FMS) May 2006 - August 2006
Skills
Adobe Design Programs, Microsoft Word, Access, Microsoft Excel, Microsoft Office, PowerPoint, Invoicing, Time Management, Google Analytics, QuickBooks, Payroll, Efficient, Problem Solving, Computer Literate, Website Updating, Self Starter, Team Leadership, Project Planning, Budgets, Research, Event Management, Personal Productivity, Organizing, Adaptive, Creativity, Teamwork, Public Speaking, Goal Oriented, Planning, Writing, Budgeting, Management, Analysis
Education
University of Illinois at Urbana-Champaign 2005 — 2009
B.A., Economics
Prairie Ridge High School 2001 — 2005
Protocol Link, Inc. January 1996 - Present
Protocol Link, Inc. January 1996 - December 2003
Jacobs Sverdrup March 1994 - January 1996
Fluor Daniel April 1993 - March 1994
Fujisawa March 1989 - March 1993
Milex Pharmaceuticals August 1983 - February 1989
Skills
Global Quality and..., FDA Inspection Liaison, cGMP and PAI Audits, QA/QC and RA Management, Pharmaceutical Drug..., Medical Device..., API - Drug Substance..., ICH and WHO Compliance, Validation Master Plans, Process Validation, Cleaning Validation, CDER / CBER Submissions, cGMP Compliance /..., Personnel Training..., GMP, V&V, FDA, Regulatory Affairs, Validation, Technology Transfer, Quality Assurance, Pharmaceutical Industry, Contract Manufacturing, eCTD, ISO 13485, Manufacturing, CAPA, Aseptic Processing, Medical Devices, Biotechnology, Microbiology, Sop, Quality Auditing, Regulatory Requirements, Pharmacovigilance, GxP, Quality System, Sterilization, Biopharmaceuticals, R&D, Strategy, Quality Control, Regulatory Submissions, Quality Management, Trackwise, Design Control, Commercialization, ANDA, Oncology, Lean Manufacturing
Education
IIT 2002 — 2004
M.S., Microbiology & Genetic Engineering
Gujarat University 1980 — 1981
M.S., Industrial Microbiology
Gujarat University 1978 — 1979
B.S., Microbiology & Chemistry
Protocol Link, Inc. April 2015 - Present
Christine Shumard-Sauer LLC September 2014 - March 2015
Starlims Corporation September 2011 - August 2014
Abbott January 2011 - October 2011
Abbott June 2008 - June 2011
Abbott June 2006 - June 2008
Abbott May 2005 - June 2006
Abbott December 2003 - April 2006
Abbott April 1998 - August 2003
Abbott December 1996 - April 1998
Skills
Medical Devices, Pharmaceutical Industry, FDA, Quality System, ISO 13485, Regulatory Affairs, GMP, Process Improvement, Six Sigma, Design Control, Quality Assurance, Strategy, Product Development, Product Launch, Cross-functional Team..., Biotechnology, Risk Management, Biopharmaceuticals, Clinical Development, Lifesciences, 21 CFR Part 11, Quality Management, Life Sciences
Education
University of South Florida College of Medicine 1984 — 1990
Doctor of Philosophy (Ph.D.), Biochemistry and Molecular Biology
University of the Sciences in Philadelphia 1980 — 1984
Bachelor's Degree, Biology (Microbiology/Immunology/Chemistry minor)
Cloaked Therapeutics LLC May 2012 - Present
Prompt Praxis Laboratories LLC May 2011 - Present
Pharma Phriendly LLC April 2010 - Present
APP Pharmaceuticals, LLC February 2008 - March 2010
Protocol Link, Inc. April 2004 - February 2008
Apotex Corp 1996 - 2000
Skills
Pharmaceutical Industry, Start-ups, Lifesciences, Quality System, Validation, HPLC, Regulatory Affairs, Microbiology, GMP, Cross-functional Team..., Clinical Development, Drug Delivery, Leadership, 21 CFR Part 11, FDA, Drug Development, Management, Analytical Chemistry, Drug Discovery, Sop, Medical Devices, Technology Transfer, Clinical Trials, GLP, Chemistry, Formulation, CAPA, Biotechnology, Chromatography, Oncology, CRO, Pharmaceutics, R&D, Regulatory Submissions, Generic Programming, Biopharmaceuticals, Change Control, Regulatory Requirements, V&V, CMC, SOP, Life Sciences
Education
The University of Kansas 1987 — 1992
PhD, Pharmaceutical Chemistry
Protocol Link, Inc. March 1998 - Present
Skills
Regulatory Affairs..., Quality and..., NDA / ANDA / DMF..., Medical Device..., Manufacturing,..., Test Method..., Cleaning Validation, Stability Testing..., Regulatory Submissions, FDA, GMP, Regulatory Affairs, Laboratory, Analytical Chemistry, Quality Assurance, CAPA, Validation, GLP, Pharmaceutical Industry, IND, Biopharmaceuticals, Lifesciences, Biotechnology, Sop, V&V, Quality Auditing, Technology Transfer, Drug Development, Change Control, HPLC, ISO 13485, 21 CFR Part 11, Regulatory Requirements, Clinical Development, Pharmaceutics, Quality System, Product Development, Medical Devices, Cleaning Validation, SOP
Education
Purdue University 1981 — 1986
Ph.D., Chemistry
Bradley University 1977 — 1981
BS, Chemistry
Protocol Link, Inc. February 2013 - Present
Protocol Link, Inc. September 2010 - February 2013
Protocol Link, Inc. April 2007 - September 2010
Accountemps January 2007 - April 2007
Accountemps September 2006 - November 2006
Skills
GAAP, Accounting, Financial Reporting, Managerial Finance, Financial Accounting, Financial Statements, Internal Audit, Internal Controls, Cost Accounting, Forecasting, Budgets, Payroll, Accounts Receivable, Accounts Payable, ADP Payroll, QuickBooks, Project Management, Project Accounting, Project Finance, Project Planning, Microsoft Office, Bookkeeping, MS Project, Deltek, Accpac, Quicken, CAPA, FDA, eCTD, Validation, SOP, Computer System..., Quality Auditing, Quality Assurance
Education
Pace University-Pleasantville/Briarcliff Campus 2001 — 2005
Bachelors, Public Accounting
Catalent Pharma Solutions July 2014 - Present
Catalent Pharma Solutions December 2012 - June 2014
Catalent Pharma Solutions September 2011 - December 2012
Protocol Link, Inc. 2010 - June 2011
Protocol Link, Inc. 2003 - 2005
Abbott Laboratories 2002 - 2003
Skills
Validation, GMP, Quality Assurance
Education
Illinois Institute of Technology 1993 — 1997
Bachelor of Science (B.S.), Chemical Engineering
Sage Global Staffing March 2013 - Present
Protocol Link, Inc. March 2013 - 2014
Abbott Biotechnology LTD June 2005 - May 2010
Abbott June 2004 - June 2005
Abbott May 2001 - May 2004
Abbott September 1997 - April 2001
Skills
Pharmaceutical Industry, Business Process..., Quality Assurance, Management, Validation, Team Leadership, GMP, Project Coordination, Quality Control, Sop, Quality System, Testing, Biotechnology, SOP, 21 CFR Part 11, CAPA, FDA
Education
University of Illinois at Urbana-Champaign 1987 — 1991
Bachelor's degree, Biology, General
Cardinal Health Regulatory Sciences March 2015 - Present
Protocol Link, Inc. February 2007 - February 2015
Clearant, Inc. 2005 - 2007
Sartorius 2002 - 2005
Pall Life Sciences 1993 - 2000
Skills
Validation, CAPA, GMP, Pharmaceutical Industry, Quality Assurance, Regulatory Submissions, FDA, Medical Devices, Technical Writing, Filtration, ISO 13485, eCTD, Process Improvement, Microsoft Office, Manufacturing, Aseptic Processing, Technology Transfer, Biopharmaceuticals, V&V, Compliance, Complaint Investigations, CMC, Qualification, Strategy, Microbiology, Change Control, SOP, Deviation Management, Quality System, Regulatory Affairs, MS Office, Outlook, Lotus Notes, eCTDXpress, Documentum, SharePoint, ISI Toolbox, Adobe Acrobat
Education
Roosevelt University 1990 — 1994
MBA, International Business
Iowa State University 1983 — 1986
BS, Chemical Engineering
College of Lake County 1981 — 1983
Pre-Engineering
St Mary
St Mary
Horizon Pharma, Inc. February 2014 - Present
Horizon Pharma, Inc. January 2014 - February 2014
Horizon Pharma April 2012 - January 2014
Protocol Link, Inc. April 2011 - April 2012
Abbott Laboratories February 2008 - April 2011
Ferro Corporation April 2006 - February 2008
Ferro Corporation April 2004 - 2008
Skills
GMP, CAPA, Pharmaceutical Industry, Validation, Sop, LIMS, Analytical Chemistry, FDA, HPLC, USP, Chromatography, Quality Assurance, Change Control, Document Management, Gas Chromatography, Wet Chemistry, Regulatory Submissions, IND, Method Development, Pharmaceutics, Quality Auditing, ANDA
Education
Purdue University 2010 — 2010
Certification, Regulatory and Quality Compliance
Illinois State University 1999 — 2003
B.S., Chemistry
Federal Communications Commission February 2015 - July 2015
Federal Communications Commission November 2013 - July 2015
Protocol Link, Inc. July 2012 - November 2013
Google March 2011 - June 2012
Google May 2010 - June 2011
Skills
Strategic Partnerships, Mobile Advertising, Online Advertising, Advertising Operations, Digital Strategy, Digital Marketing, Advertising, Mobile Devices, Integrated Marketing, Monetization, Mobile Marketing, SEM, Analytics
Education
Stanford University 2005 — 2009
BA, Political Science
Sage Global Staffing, Inc. January 2004 - Present
Protocol Link, Inc. March 2000 - Present
Abbott Diagnostics March 1986 - December 2000
Skills
Pharmaceuticals, cGMP, Aseptic Processing, Regulatory Affairs, Compliance, Quality Auditing, Compliance Audits, Pharmaceutical Industry, Technology Transfer, CAPA, GLP, Validation, ISO 13485, GMP, Sop, 21 CFR Part 11, V&V, FDA, Chemistry, Quality Assurance, R&D, Change Control, Biotechnology, Cross-functional Team..., Regulatory Submissions, Medical Devices, Cleaning Validation, Manufacturing, Quality System, Biopharmaceuticals, Commercialization
Education
Rush University 1984 — 1986
Bachelor of Science (B.S.), Medical Technology
Horizon Pharma plc July 2015 - Present
World Financial Group (WFG) December 2013 - Present
Aerotek January 2015 - July 2015
Sage Global Staffing, Inc. September 2012 - January 2015
Illinois Army National Guard August 2007 - October 2014
Army National Guard 2007 - 2014
Protocol Link, Inc. August 2012 - August 2012
Baxter Healthcare October 2010 - June 2012
Restaurant.com May 2010 - October 2010
Colorado Technical University March 2009 - August 2009
Skills
Leadership, Teamwork, Quality Assurance, Microsoft Word, Microsoft Office, Healthcare, PowerPoint, Project Management, Project Planning, Microsoft Excel, Human Resources, Training, Environmental Monitoring, Validation, CAPA, Regulatory Affairs, eCTD, Software Validation, Time Management, Document Management, Military Experience, Military, Military Leadership, NDA, Pharmaceutical Industry, LIMS, GMP, GDP, SOP, Complaint Investigations, Remediation, Investion, Root Cause Analysis, Aseptic Technique, Quality Assurance Review, Technical Writing, Regulatory Submissions, Licensed Life Insurance..., Life Insurance, Term Life Insurance, Permanent Life Insurance
Education
Eastern Illinois University 2003 — 2008
Bachelors, Biological Sciences, Military Science
Harper College 2009 — 2010
N/A, Microbiology
James B. Conant High School 1999 — 2003
self-employed August 2014 - Present
US WorldMeds, LLC December 2010 - July 2014
US WorldMeds, LLC March 2010 - December 2010
Akorn, Inc October 2009 - April 2010
US WorldMeds, LLC February 2009 - March 2010
Protocol Link, Inc. October 2009 - February 2010
US WorldMeds, LLC October 2007 - October 2008
Morton Grove Pharmaceuticals, Inc. May 2004 - October 2007
Fujisawa Healthcare, Inc. (aka Astellas Pharma, USA, Inc,) April 1999 - May 2004
Unimed Pharmaceuticals, Inc. February 1997 - April 1999
Skills
Regulatory Affairs, FDA, Pharmaceutical Industry, Pharmaceutics, Regulatory Requirements, Regulatory Submissions, Product Launch, 21 CFR Part 11
Education
University of Minnesota-Twin Cities 1962 — 1966
Bachelor in Chemistry, chemistry, B+
Zicam, Inc. (dba Matrixx Initiatives, Inc.) October 2006 - Present
Matrixx Initiatives, Inc / Zicam LLC 2006 - Present
Chesapeake Biological Laboratories Inc. August 2005 - January 2006
Protocol Link, Inc. 2001 - 2006
LJF Consultinc. 2001 - 2006
Alpharma 2002 - 2004
Akorn, Inc 1996 - 2001
Steris/Schein Pharma 1992 - 1996
Schein Pharmaceuticals 1992 - 1995
Fujisawa 1988 - 1992
Skills
FDA, Quality Assurance, Validation, CAPA, Technology Transfer, Sop, GMP, Change Control, Quality System, 21 CFR Part 11, Regulatory Affairs, Pharmaceutics, V&V, Regulatory Requirements, GLP, GxP, Microbiology, Quality Auditing, Quality Control, Lifesciences, Product Development, Pharmaceutical Industry, Biotechnology, Computer System..., Medical Devices, Testing, Quality Management, LIMS, Regulatory Submissions, ISO 13485, Cleaning Validation, GAMP, ISO, Clinical Development, Root Cause Analysis, Sterilization, Laboratory, Manufacturing, Biopharmaceuticals, Aseptic Processing, HPLC, GCP, R&D, Trackwise, CRO, Clinical Trials, Analytical Chemistry, USP, FDA GMP, Process Simulation
Education
State University of New York College at Buffalo 1969 — 1973
BA, Biology
Astellas Pharma October 2013 - Present
Astellas US Technologies, Inc. January 2007 - October 2013
Delta Pharma August 2006 - January 2007
REMX IT STAFFING September 2005 - June 2006
Protocol Link, Inc. July 2002 - September 2005
Skills
GMP, Change Control, Quality System, Validation, Computer System..., Quality Assurance, Sop, Quality Control, FDA, Pharmaceutical Industry, V&V, Cross-functional Team..., 21 CFR Part 11, Software Documentation, Trackwise, SAP, Quality Auditing, Process Improvement, CAPA, Aseptic Processing, GLP, Cleaning Validation, Continuous Improvement, GxP, GAMP, Regulatory Submissions, ISO 13485, GCP, Regulatory Requirements, Regulatory Affairs, LIMS, IND, Technology Transfer, Biopharmaceuticals, FDA GMP, ICH guidelines, Pharmacovigilance, Pharmaceutics, Clinical Trials, Clinical Development, SOP development, Protocol, HPLC, CTMS, Analytical Chemistry, Biotechnology, CRO, ICH-GCP, CQA, Drug Development
Education
Trinity International University 2007 — 2009
Protocol Link, Inc. May 2014 - Present
doTERRA April 2014 - Present
River Bend Nature Center March 2013 - Present
Skills
FDA, GMP, Quality System, CAPA, Quality Assurance, Medical Devices, ISO 13485, Regulatory Affairs, Sop, Quality Management, ISO, Pharmaceutical Industry, Quality Control, 21 CFR Part 11, Process Improvement, Change Control, Iso 9000, SPC, Validation, Quality Auditing, ISO 14971, Design Control, Analytical Chemistry, Computer System..., GLP, Laboratory, FMEA, 21 CFR, Biomedical Engineering, SAP, Contract Manufacturing, Product Launch, Kaizen, Cross-functional Team..., Supplier Quality, Continuous Improvement, Project Management, Root Cause Analysis, Testing, Product Development, Lean Manufacturing, DMAIC, Leadership, Software Documentation, Operational Excellence, FDA GMP, Auditing, Raw Materials, Trackwise, V&V
Education
Keller Graduate School of Management of DeVry University 1997 — 2003
MBA
Keller Graduate School of Management of DeVry University 1997 — 2003
MBA
University of Wisconsin-Parkside 1986 — 1990
BS Biology
RAPS Chicago Chapter
bioMerieux September 2015 - Present
IBA June 2013 - July 2015
Protocol Link, Inc. April 2012 - June 2013
Baxter Healthcare June 2011 - April 2012
Baxter October 2007 - June 2011
Baxter Healthcare December 2005 - October 2007
Abbott Laboratories July 2003 - August 2005
Searle/Pharmacia April 2001 - June 2003
Searle/Pharmacia November 1999 - April 2001
Searle April 1997 - November 1999
Skills
CAPA, Aseptic Processing, FDA, Change Control, 21 CFR Part 11, Validation, Pharmaceutical Industry, GMP, Quality System, Regulatory Affairs, Contract Manufacturing, Environmental Monitoring, Microbiology, Endotoxin, Annual Reports, Quality Assurance, clinical supply..., USP, Training, Critical Systems, Batch Records, Batch Release, Auditing
Education
Loyola University Chicago 1986 — 1989
bs in biology, microbiology
North Park University 1984 — 1986
biology
Protocol Link, Inc. August 2001 - Present
Independent November 1999 - August 2001
Griffith Analytical November 1998 - November 1999
Abbott Laboratories July 1991 - November 1998
Skills
Quality Assurance, FDA, Regulatory Affairs, Microbiology, Medical Devices, Laboratory, Lifesciences, Pharmaceutics, Validation, Sop, Pharmaceutical Industry, CAPA, 21 CFR Part 11
Education
Michigan State University 1982 — 1986
BS
Protocol Link, Inc. August 2012 - Present
Protocol Link, Inc. June 2010 - August 2012
Protocol Link, Inc. June 2006 - June 2010
Skills
CAPA, Sop, Validation, FDA, Quality Assurance, Photoshop, Project Management, Enterprise Software, GMP, Root Cause Analysis, Leadership, Microsoft Office, Microsoft Exchange, Regulatory Affairs, Regulatory Submissions, Cost Management, Pharmaceutical Industry, Economics, Logo Design, Web Design, Marketing, Computer Hardware, Computer Maintenance, Quality System, Testing, Change Control, Medical Devices, SOP, Cross-functional Team..., Management, 21 CFR Part 11
Education
Northern Illinois University - College of Business 2009 — 2012
Master of Business Administration (MBA), Marketing
Western Illinois University 2002 — 2006
Bachelor of Business, Economics
Dist 25 2006 - Present
Protocol Link, Inc. 2002 - 2004
JPMorgan Chase 1996 - 2000
Skills
Microsoft Office, Teaching
Education
University of Illinois at Chicago
Bachelor of Science (BS), Finance, General