Tunnell Consulting
Address: 106, 1324, 900 E 8th Ave, King of Prussia, PA 19406 Hours: Closed ⋅ Opens 8:30AM Martin Luther King Jr. Day might affect these hoursMonday(Martin Luther King Jr. Day)8:30AM–5:30PMHours might differTuesday8:30AM–5:30PMWednesday8:30AM–5:30PMThursday8:30AM–5:30PMFriday8:30AM–5:30PMSaturdayClosedSundayClosedSuggest an edit Unable to add this file. Please check that it is a valid photo. Phone: (610) 337-0820: Place name: : : : Website: Category: : : Website: http://www.tunnellconsulting.com/ Category: Business management consultant 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. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Tunnell Consulting Posting publicly on the Web Write a review Reviews Be the first to review
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Tunnell Consulting Employees
Metrics, Inc. December 2013 - Present
Meadowlakes Management Group, LLC February 2012 - Present
Tunnell Consulting January 2013 - November 2013
Contract Pharmaceuticals Limited September 2008 - January 2012
Contract Pharmaceuticals Limited August 2005 - September 2008
Contract Pharmaceuticals Limited April 2000 - August 2005
Price Waterhouse Management Consultants December 1998 - April 2000
Eli Lilly and Company January 1998 - December 1998
Eli Lilly and Company May 1995 - January 1998
Skills
New product/service..., Leading change, Acquisition Integration, Supply Chain Management, GMP - Good..., Contract Negotiation, Contract Management, Process Improvement, Lean Manufacturing, New Business Development, Strategic Planning, Team Leadership, Operations Management, Financial Analysis, Entrepreneurial..., GMP, Strategy, Entrepreneurship, Pharmaceutical Industry, Leadership, Medical Devices, Management, Supply Chain, Mergers & Acquisitions, Business Development, Project Management, Business Strategy, ERP, Cross-functional Team..., Technology Transfer, P&L Management, CRM, FDA, Product Development
Education
Dartmouth College 2007 — 2007
Leadership & Strategic Impact, Tuck School of Business
Ivey Business School at Western University 1993 — 1995
MBA, Business Administration
The University of Western Ontario 1987 — 1991
HBSc, Mathematics and Statistics / Actuarial Science
The Cerneos Group February 2013 - Present
Eureka International Regulatory Services, LLC July 2010 - Present
North Shore Technology Council 2010 - 2012
Tunnell Consulting January 2007 - July 2010
On-Assignment July 2005 - July 2007
National Institutes of Health 2004 - 2005
San Diego State University 2002 - 2004
Skills
Medical Devices, Regulatory Affairs, FDA, Biotechnology, Validation, Lifesciences, GMP, Pharmaceutical Industry, Quality Assurance, Strategic Planning, Project Management, Quality System, Clinical Research, Regulatory Submissions, R&D, Technology Transfer, Research, 510(k), IND, CMC, SOP development, Training and Development, Consulting, In Vitro Diagnostics, ISO 13485, Design Controls, Regulatory Affairs..., Design Control, Hardware Diagnostics, Biopharmaceuticals, CAPA, Commercialization, GLP, IVD, Oncology, Pharmaceutics, Sop, Start-ups, Vaccines, CRO, Clinical Development, Clinical Trials, Drug Development, Immunology, Product Development, Strategy, Infectious Diseases, Drug Discovery, GCP, Protein Chemistry
Education
San Diego State University-California State University 2002 — 2004
MS, Regulatory Affairs, 3.71
University of California, San Diego 1988 — 2000
Certificate, Biomedical Regulatory Affairs
University of California, Santa Cruz
Bachelor of Arts (B.A.), Biochemistry and Molecular Biology
ChampdorLLC June 2013 - Present
UCB Pharma 2010 - June 2013
UCB 2007 - 2010
Penwest Pharmaceuticals 2006 - 2007
Tunnell Consulting 2005 - 2006
Purdue Pharma 1998 - 2005
Education
University of Connecticut 1980 — 1986
PhD, Chemistry
Alcon, a Novartis company April 2012 - Present
Tunnell Consulting February 2011 - April 2012
Green Pharma Consulting LLC February 2011 - April 2012
Shionogi Pharma (formerly Sciele Pharma) March 2010 - December 2010
Octagon Research Solutions July 2007 - January 2010
Hertz Rent a Car January 2007 - July 2007
Temple University September 2005 - December 2006
Skills
eCTD, FDA, IND, Quality Assurance, Regulatory Affairs, GMP, Publishing, Project Coordination, Electronic Submissions, Regulatory Submissions, Document Management, Medical Devices, Adobe Acrobat, MAA, Non-disclosure..., Sop, PowerPoint, Microsoft Office, Project Management, Pharmaceutical Industry
Education
Kennesaw State University 2011 — 2013
MS, Masters in Information Systems
Temple University 2003 — 2007
BA, Sociology, Business
Myrtle Consulting Group, LLC 2015 - Present
BMGI 2014 - 2015
Tunnell Consulting 2011 - 2014
Dun & Bradstreet 2009 - 2011
Strategic Leadership Resources, LLC 2009 - 2009
Becton, Dickinson and Company 2006 - 2009
Johnson & Johnson 2001 - 2006
Gateway 2000 - 2001
First Data Resources 1999 - 2000
US Air Force 1985 - 1999
Skills
Strategy, Six Sigma, Operational Excellence, Process Improvement, Leadership, Change Management, Lean Manufacturing, Program Management, Strategic Planning, Cross-functional Team..., Management Consulting, Project Coaching, Project Planning, Pharmaceutical Industry, Team Leadership, Project Management, Business Process..., Start-ups, Supply Chain Management, Business Strategy, Team Building, New Business Development, Lean Six Sigma, Process Consulting, Performance Excellence, Consulting, Continuous Improvement, Outsourcing, CRM, Management, Human Resources, Performance Improvement, Quality Management, Project Portfolio..., Manufacturing, Training, Coaching, Leadership Development, Recruiting, Strategy Facilitation, Strategic Leadership, Strategic Consulting, Strategic Thinking, Thought Leadership, Product Development, Sales Operations, Organizational..., Strategic Partnerships, Business Development, Sales Management
Education
University of Nebraska at Omaha
EMBA, Business Administration
Bellevue University
BS, Operations Management and Business Administration
Community College of the US Air Force
AAS, Logistics Management
Community College of the US Air Force
AAS, Personnel Management
Roece Pharmaceutical consultants Inc. October 2014 - Present
Roece Pharmaceutical Consultants Inc. September 2005 - Present
Genzyme December 2010 - October 2014
MedImmune June 2010 - October 2010
Bristol-Myers Squibb 2009 - 2010
Tunnell Consulting 2008 - 2010
Sanofi Pasteur 2007 - 2009
GSK 2007 - 2007
Cardinal Validation 2005 - 2006
Eli Lilly Core Dynamics inc and IPS 2002 - 2005
Skills
Heavy Equipment, Process Simulation, Troubleshooting, 21 CFR Part 11, Validation, FDA, Computer System..., V&V, GMP, Change Control, CAPA, GxP, Sop, Cleaning Validation, GLP, Pharmaceutical Industry, Quality System, Technology Transfer, LIMS, Regulatory Affairs, Medical Devices, ISO, Biotechnology, GAMP, Process Control, Quality Assurance, Regulatory Requirements, Biopharmaceuticals, Quality Control, Pharmaceutics, Vaccines, Manufacturing, Sterilization, SOP
Education
Universidad del Pacífico (PE) 1978 — 1978
MBA, Bussiness Administration
Pontificia Universidad Católica del Perú 1969 — 1975
BSCH, Organic Chemistry
Pontificia Universidad Católica del Perú 1969 — 1975
BSCH, Mechanical Engineering
ASQ Philadelphia Section 505 July 2009 - Present
PwC September 2004 - Present
PricewaterhouseCoopers LLP 2004 - Present
ASQ Philly 1998 - 2010
Hercules February 2003 - September 2004
Aetna US Healthcare July 1999 - July 2002
Tunnell Consulting 1997 - 1999
University of Medicine and Dentistry of NJ (UMDNJ/ State of New Jersey) July 1988 - September 1997
Penn State University September 1990 - May 1993
Skills
Supply Chain, Design of Experiments, Process Engineering, Lean Manufacturing, Management Consulting, Data Analysis, Executive Coaching, Vendor Management, Business Transformation, Training, Strategy, Business Strategy, Project Planning, Governance, Risk Management, Cross-functional Team..., Leadership, Organizational..., Project Portfolio..., Leadership Development, Performance Improvement, Six Sigma, Project Management, Performance Management, Team Building, Strategic Planning, Quality Management, Management, Analysis, Process Improvement, Coaching
Education
Temple University 1984 — 1993
Ph.D., Industrial/Organizational Psychology
Temple University 1982 — 1984
M. Ed., Organizational Psychology
University of Pennsylvania 1978 — 1981
Psychology
La Salle University 1973 — 1977
BA, Biology and Philosophy
Bethlehem Catholic HS 1969 — 1973
College Prep
PPD February 2015 - Present
Cardinal Health June 2012 - February 2015
Pharmalink Consulting January 2012 - July 2012
Tunnell Consulting October 2010 - January 2012
Merck January 2010 - October 2010
Johnson & Johnson April 2003 - January 2010
3-Dimensional Pharmaceuticals May 2001 - April 2003
Robert Guthrie Biochemical Genetics Laboratory October 1997 - August 1999
Bristol-Myers Squibb October 1997 - November 1998
SUNY College of Environmental Science and Forestry August 1993 - October 1996
Skills
Analytical Chemistry, Biochemistry, Organic Chemistry, Online Communications, Medicinal Chemistry, eCTD, CMC, Project Management, Regulatory Affairs, Medical Writing
Education
University at Buffalo 1999 — 2001
MS, Medicinal Chemistry
State University of New York College of Environmental Sciences and Forestry 1992 — 1996
BS, Chemistry Biochemistry
Aceto Corporation, Rising Pharmaceticals subsidiary January 2014 - Present
Johnson & Johnson February 2013 - January 2014
Tunnell Consulting, Inc. June 2012 - February 2013
Validant April 2012 - June 2012
TUNNELL CONSULTING August 2011 - March 2012
LUITPOLD PHARMACEUTICALS INC May 2003 - June 2011
ICON LABORATORIES March 2002 - May 2003
BRISTOL-MYERS SQUIBB (formerly DUPONT PHARMACEUTICALS) February 1998 - March 2002
BRISTOL-MYERS SQUIBB (formerly DUPONT PHARMACEUTICALS ) May 1995 - February 1998
HI-TECH PHARMACAL CO, INC February 1994 - March 1995
Skills
Regulatory Affairs, Pharmaceutical Industry, Vaccines, Quality Assurance, Quality Control, Pharmaceutics, Change Control, CAPA, FDA, GMP, Validation, Regulatory Compliance, Solid Oral Dosage Forms, Parenteral, Sterility Assurance, Medical Devices, ISO 13485, Strategy, ISO, Regulatory Requirements, Biopharmaceuticals, Quality Auditing, Sop, Biotechnology, Root Cause Analysis, V&V, Compliance, Technology Transfer, Aseptic Processing, Quality System, R&D, Computer System..., Cross-functional Team...
Education
CW Post, LIU 2000 — 2004
MBA, Management
St. John's University 1977 — 1981
MS, Industrial Pharmacy
Blue Wolf Capital Partners August 2015 - Present
Summit Pharma Solutions, LLC February 2012 - Present
Quintiles September 2011 - February 2012
Tunnell Consulting October 2001 - September 2011
New Hampshire Ball Bearings February 1999 - October 2001
The Timken Company December 1997 - February 1999
Torrington Company January 1995 - December 1997
Skills
Culture Change, Quality by Design, Design of Experiments, Six Sigma, Change Management, Statistics, Organizational..., Cross-functional Team..., Lean Manufacturing, Continuous Improvement, Operational Excellence, Technology Transfer, Pharmaceuticals, Manufacturing, Process Engineering, SPC, Process Improvement, Coaching, Pharmaceutical Industry, Quality System, Lifesciences, Strategy, Business Process..., FDA, V&V, Process Simulation, GMP, Business Process, Strategic Planning, DMAIC, Validation, Team Building, Value Stream Mapping, Sop, Quality Management, CAPA, Quality Assurance, Medical Devices, Biotechnology, SOP, Life Sciences
Education
University of New Hampshire 1999 — 2005
MS, Mathematics, Statistics
The University of Connecticut 1992 — 1997
BS, Chemical Engineering, Material Science Engineering
Teva Pharmaceutical June 2015 - Present
Astrazeneca Pharmaceutical January 2014 - March 2015
Boehringer Ingelheim April 2013 - December 2013
Tunnell Consulting August 2008 - April 2013
Endo Pharmaceuticals February 2007 - August 2008
Astrazeneca 2003 - 2007
Covance 1999 - 2003
The Rosen Group 1997 - 1999
Skills
Talent Acquisition, Technical Recruiting, Recruitment/Retention, Sourcing, Pipeline Building,..., Talent Management, Applicant Tracking..., AIRS CIR, Human Resources, Employee Relations, Interviews, Recruiting, Onboarding, Sop, Temporary Placement, Executive Search, Training, Biotechnology, GMP, Internet Recruiting, Pharmaceutical Industry, Personnel Management, Regulatory Affairs, Validation, Taleo, FDA, Pharmaceutics, College Recruiting, GLP, Contract Recruitment, Career Development, Employer Branding, Workforce Planning, Quality Assurance, Screening, Benefits Negotiation, Screening Resumes, Strategic Sourcing, 21 CFR Part 11, SOP
Education
Philadelphia University
MBA, Business and Marketing
Philadelphia University
Bachelor of Science Degree, Marketing and Management
Tunnell Consulting 2014 - Present
Merck Sante February 2014 - July 2014
Sanofi Pasteur October 2013 - January 2014
Patheon February 2013 - May 2013
JFS Pharma&Biotech Consulting November 2010 - February 2013
Merck Serono Aubonne Switzerland July 2009 - September 2010
Merck Serono Bari 2007 - 2009
Skills
GxP, CAPA, cGMP, Process Validation, FDA, Quality Systems, Regulatory Affairs, Validation, QC, Change Control, GMP, Quality Auditing, Pharmaceuticals, 21 CFR Part 11, Aseptic Processing, SOP, Biotechnology, Quality Assurance, Quality Management, Quality System, V&V, Sop, Pharmaceutical Industry, GLP, Technology Transfer, Biopharmaceuticals, Pharmaceutics, Regulatory Requirements, ISO 13485, GCP, Vaccines, Clinical Development, Computer System..., Drug Development, Cleaning Validation, Regulatory Submissions, Clinical Trials, HPLC, Pharmacovigilance, Analytical Chemistry, LIMS, Trackwise, Chromatography, BPF
Education
Université de Bourgogne 1968 — 1972
Master, Chemistry, Biology
University of Miami Tissue Bank December 2011 - May 2013
Quintiles July 2011 - December 2011
Tunnell Consulting July 2010 - June 2011
J. D. Cascio Consulting Associates, LLC March 2009 - June 2010
Akron Biotechnology, LLC July 2008 - February 2009
J. D. Cascio Consulting Associates, LLC June 2002 - June 2008
Theseus Imaging Corporation June 1998 - May 2002
Chimeric Therapies, Inc. June 1996 - May 1998
SyStemix, Inc. April 1993 - April 1996
Skills
Medical Devices, FDA, Quality Assurance, GMP, Technology Transfer, Compliance, Start-ups, Biotechnology, Operations Management, Change Management, Healthcare, Program Management, Team Building, Quality Management, Manufacturing, Supply Chain Management, Contract Negotiation, Procurement, Management Consulting, Executive Management, Organizational..., Inventory Management, Strategy Development, Quality System, Pharmaceutical Industry, Regulatory Affairs, Business Development, Quality Auditing, CAPA, Aseptic Processing, Tactical Planning, Training, Biopharmaceuticals, Biotechnology Industry, cGMP manufacturing, Pharmaceutical process..., Manufacturing Scale-up, Process Engineering, Tissue Banking, Quality Control, Regulatory Requirements, Strategy
Education
Southeastern Louisiana University
Bachelor of Science Degree, Clinical Laboratory Science / Medical Technology
Ochsner Medical Center
Specialist in Immunohematology - SBB(ASCP)
U.S. Public Health Service
Clinical Laboratory Scientist / Medical Technologist - MT(ASCP)
The Lancer Group June 2013 - Present
Program Lead December 2014 - December 2014
Program Lead September 2014 - September 2014
PAREXEL Consulting January 2008 - May 2013
Tunnell Consulting 2003 - 2008
American Red Cross December 2001 - May 2003
Aventis Pharmaceuticals April 1996 - December 2001
US Food and Drug Administration 1972 - 1986
Skills
FDA, Pharmaceutical Industry, Validation, Biotechnology, Quality Systems, FDA Inspection Readiness, Compliance Remediation, Quality Assurance, Training, Quality System, 21 CFR Part 11, GxP, Medical Devices, GCP, Clinical Development, Aseptic Processing, GMP, Pharmaceutics, Clinical Trials, Regulatory Submissions, Regulatory Requirements, Biopharmaceuticals, Computer System..., Strategy, CAPA, Cleaning Validation, Cross-functional Team..., Change Control, Technology Transfer, GAMP, Pharmacovigilance, Regulatory Affairs, Sop, R&D, Lifesciences, Quality Control, Quality Auditing, Quality Management, V&V, GLP, Drug Development, IND, CRO, Medical Writing, Vaccines, ISO 13485, Oncology, CTMS, Commercialization, Protocol
Education
Temple University
Bachelor's degree, Biochemistry and Molecular Biology
EY January 2015 - Present
Tunnell Consulting July 2012 - January 2015
Tunnell November 2011 - January 2015
Merck November 2009 - November 2011
Schering-Plough 2006 - November 2009
ScheringPlough Singapore 2003 - 2006
GSK 2000 - 2003
Skills
Six Sigma, Operational Excellence, Cross-functional Team..., Quality System, CAPA, GMP, Continuous Improvement, Project Management, Change Management, Lean Manufacturing, Process Improvement, FDA, Lean Thinking, Value Stream Mapping, Technology Transfer, Business Process..., Pharmaceutical Industry, Supply Chain, Program Management, Sop, Manufacturing, Quality Management, Strategy, Leadership, Operations Management, Management, Kaizen, Training
Education
University of Durham 2000 — 2003
MBA
University of Leeds 1995 — 1999
B.Eng (First Class Hon's), Manufacturing Systems with Management
Tunnell Consulting March 2008 - Present
AstraZeneca Pharmaceuticals March 2003 - March 2008
Merck November 2002 - March 2003
Kenexa 2000 - 2002
Management Recruiters International 1998 - 2000
Skills
Project Management..., PMP, Pharmaceutical Industry, Talent Acquisition, Applicant Tracking..., Talent Management, Technical Recruiting, Executive Search, Recruiting, Sourcing, Change Management, Internet Recruiting, Project Management, Process Improvement, Onboarding, Contract Recruitment, Vendor Management, Consulting, Organizational..., Coaching, Resource Management, Employee Relations, Leadership, Human Resources, Strategy, Management, Hiring, Interviews, Temporary Placement, Training, Staffing Services, Cross-functional Team..., Performance Management, Strategic Planning, Personnel Management, Screening Resumes
Education
Drexel University 1990 — 1995
B.S.
Amity Regional High School 1987 — 1990
Diploma
Mylan February 2015 - Present
Mylan May 2014 - February 2015
Operations & Quality Systems Improvement Experts (OQSIE) December 2013 - March 2014
Proasis Consulting LLC 1999 - March 2014
Boehringer Ingelheim 2011 - 2013
Tunnell Consulting 2009 - 2011
GlaxoSmithKline 2006 - 2008
W.L.Gore & Associates 2005 - 2006
Johnson & Johnson 2004 - 2005
Johnson & Johnson 2003 - 2004
Skills
Six Sigma, Management Consulting, Business Planning, Organizational Design, System Deployment, Strategy, Information Management, Program Management, Lean Manufacturing, Validation, GMP, Leadership, Operational Excellence, Business Process..., FDA, Supply Chain, Manufacturing, Business Process, Management, Strategic Planning, Sop, Change Management, Outsourcing, Pharmaceutical Industry, Quality Assurance, Project Management, Product Development, Start-ups, Training, Cross-functional Team..., R&D, Process Improvement, Business Strategy, Quality Control, Technology Transfer, Quality System, Business Transformation, Process Engineering, Business Development, Change Control, CAPA, 21 CFR Part 11, Biopharmaceuticals, V&V, SOP
Education
Juniata College
B.S., Bioanalytical Chemistry
BMGI February 2013 - Present
P&D Catalano Consulting November 2011 - Present
Tunnell Consulting March 2012 - December 2012
Kaplan University December 2008 - November 2011
Independant Consultant July 2008 - December 2008
Interpublic Group October 2004 - July 2008
First Data Resources August 2000 - September 2004
United States Air Force September 1980 - October 2000
Skills
Six Sigma, Continuous Improvement, Cross-functional Team..., Metrics, Change Management, Process Improvement, Team Building, Coaching, Business Process..., Microsoft Office, Data Analysis, Visio
Education
Embry-Riddle Aeronautical University 1992 — 1997
Community College of the Air Force 1984 — 1988
Applied Science, Pneudraulics
Tunnell Consulting March 2010 - Present
Polaris Compliance Consultants, Inc. August 2008 - Present
Omega Consulting, LLC July 2008 - Present
Enzon Pharmaceuticals 2005 - 2008
Alpharma 2002 - 2005
Alpharma 2001 - 2002
Alpharma 2001 - 2001
CasChem 1992 - 2001
Skills
Auditing, Investigations, Organizational..., GMP, Quality Systems, Quality Assurance, Biotechnology, Compliance, Manufacturing, cGMP, Technology Transfer, Validation, Pharmaceuticals, SOP, Process Validation, FDA, CAPA, Life Sciences, Change Control, Process Improvement, Continuous Improvement, Change Management, Quality Management, Quality Auditing, Documentation, ISO, Coaching, Operational Excellence, Problem Solving, Mentoring, Team Building, Budgeting, Management Consulting, Root Cause Analysis, QC, Aseptic Processing, Kaizen, Document Management, Cost Reduction, Process Optimization, TQM, Sop, Quality System, Pharmaceutical Industry, Lifesciences, Quality Control, Regulatory Requirements, Software Documentation, V&V, Chemistry
Education
Penn State University 1972 — 1975
Ph.D., Chemistry
State University of New York College at Cortland 1967 — 1972
B.S., Chemistry
The FDA Group, LLC February 2014 - Present
Becker & Associates Consulting, Inc. 2011 - Present
Tunnell Consulting 2008 - Present
Tri-Regulatory & Associates June 1996 - Present
Yancey 2015 - 2015
Yancey 2015 - 2015
Yancey 2015 - 2015
ConvaTec 2013 - 2013
ConvaTec 2013 - 2013
ConvaTec 2013 - 2013
Skills
FDA, GMP, cGMP, Validation, Quality Assurance, Quality Systems, Auditing, CAPA, Compliance, Medical Devices, Process Validation, Quality Auditing, Manufacturing, Document Management, Pharmaceuticals, ISO, ISO 13485, Biotechnology, Technology Transfer, Life Sciences, Risk Management, Regulatory Affairs, Continuous Improvement, Quality Management, SOP, Change Management, 21 CFR Part 11, GxP, Mentoring, Documentation, Change Control, Microsoft Office, Clinical, Quality System, V&V, Pharmaceutical Industry, Sop, Quality Control, Lifesciences, Computer System..., Design Control, Clinical Research, Software Documentation, Regulatory Submissions, Regulatory Requirements, GCP, Biopharmaceuticals, Clinical Trials, R&D, GLP
Education
University of Maine 1967 — 1972
Bachelor of Science (B.S.), Biology/Biological Sciences, General
University of Maine 1967 — 1971
Bachelor's degree, Biology/Biological Sciences, General
Bunkerhill Community College
EET, Electrical and Electronics Engineering
a-connect July 2012 - August 2013
Tunnell Consulting May 2008 - July 2012
Advanced Gelatin Technologies March 1997 - 2008
Midwest Stainless Process Systems June 2003 - February 2006
Gattefosse Corp August 1994 - March 1997
Sterling Winthrop 1992 - 1994
SmithKline August 1986 - June 1992
Skills
Strategic Planning, Operations Management, Biotechnology, Medical Devices, Business Strategy, Strategy, Pharmaceutics, Business Process..., Program Management, Lifesciences, Consulting, Validation, Team Building, Leadership, Project Management, Technology Transfer, Budgets, Mergers & Acquisitions, Process Engineering, Cross-functional Team..., Regulatory Affairs, FDA, Management, Start-ups, Entrepreneurship, Manufacturing, Risk Management, Business Intelligence, Business Transformation, PMO, Biopharmaceuticals, R&D, Quality Assurance, Quality System, Lean Manufacturing, Supply Chain, Life Sciences
Education
Mayes School of Business, University of the Sciences in Philadelphia 2002 — 2003
EMBA, Pharmaceutical Business
Eastern University 1996 — 1998
BA, Organizational Management
Data Machines, Inc March 2000 - Present
Omnialert.com 1999 - 2000
Tunnell Consulting 1996 - 1999
DuPont Merck Pharmaceutical Company January 1991 - August 1995
DuPont Pharmaceuticals June 1985 - December 1990
Skills
Project Portfolio..., IT Strategy, New Product Development, Pharmaceutical process..., Software Development, Management Consulting, Strategic Planning, Business Analytics, Business Strategy, Project Management, Product Development, Program Management, New Business Development, Process Improvement, Change Management, Business Analysis, Start-ups, Cross-functional Team..., Business Process..., Consulting, Entrepreneurship, Relational Databases
Education
University of Pennsylvania - The Wharton School 1996 — 1998
Master of Science in Engineering, Management of Technology
Drexel University 1980 — 1985
B.Sc., Chemistry
Conestoga High School
Tunnell Consulting, Inc. Human Resources AssociateTunnell ConsultingMay 2009 - September 2014
Tunnell Consulting March 1981 - May 2009
Skills
Pharmaceutical Industry, Pharmaceutics, FDA, Strategy, Biotechnology, Sop, GMP, Training, Medical Devices, Quality System, Recruiting, Onboarding, Strategic Planning, Human Resources, Performance Management
Education
Immaculata University 2001 — 2007
Bachelor, IT for Business
Tunnell Consulting December 2011 - Present
Stanley Black & Decker , Inc. January 2011 - December 2011
InfoLogix October 2007 - January 2011
Skills
Microsoft Dynamics SL, SEC filings, Process Improvement, Cash Flow, Hyperion Enterprise, General Ledger, Cost Accounting, Accounts Payable, PeopleSoft
Education
DeSales University 2005 — 2008
Accounting
GSam Consulting, LLC February 2012 - Present
Tunnell Consulting August 2010 - February 2012
Sam Consulting 2009 - August 2010
Millipore Corporation 2003 - 2008
Elan Pharmaceuticals 2000 - 2002
Watson Pharmaceuticals 1999 - 2000
Rhone-Poulenc Rorer 1996 - 1999
Wyeth 1992 - 1996
Ortho Clinical Diagnostics 1990 - 1992
DuPont 1985 - 1990
Skills
Validation, Technology Transfer, Six Sigma, ISO, Continuous Improvement, Design Control, Quality System, Quality Control, Medical Devices, Quality Management, Supplier Quality, Quality Assurance, CAPA, FDA, Quality Auditing, 21 CFR Part 11, GMP, Change Management, Product Development, Regulatory Affairs, Sop, Lifesciences, Biotechnology, R&D, Commercialization, Drug Development, SPC, GxP, Manufacturing, Process Improvement, Immunology, ISO 13485, Protein Chemistry, Regulatory Requirements, Vaccines, Clinical Development, Pharmaceutical Industry, Microbiology, V&V, Pharmaceutics, Process Simulation, Assay Development, Clinical Trials, Strategy, Biopharmaceuticals, GLP, Change Control, Regulatory Submissions, GCP, HPLC
Education
Penn State University 1976 — 1980
BS, Biology
Five Foot Giant Records July 2014 - Present
New Creed LLC May 2012 - Present
New Creed LLC January 2001 - Present
Tunnell Consulting June 2010 - April 2012
New Creed January 2001 - June 2010
New Creed LLC January 2001 - February 2010
Marsh 2007 - 2008
Chainlink Research January 2003 - 2007
sterling commerce 1999 - 2001
Tompkins Associates 1996 - 1999
Skills
Process Improvement, Logistics, Leadership, Management, Operational Excellence, Cross-functional Team..., Six Sigma, Operations Management, Continuous Improvement, Business Development, Process Engineering, Medical Devices, Technology Transfer, pharmaceutical..., auto identification, e-pedigree and..., chain of custody and..., Strategic Supplier..., oil and gas, food and beverage..., Supply Chain, Supply Chain Management, Program Management, Strategic Planning, Change Management, Business Process..., Business Strategy, Mergers, Supply Chain..., Contract Negotiation, Pharmaceutical..., Quality Management, Business Process, CRM, Quality Assurance, Quality System, Market Research, Project Planning, Warehousing, Team Leadership, Lean Manufacturing, Team Building, New Business Development, Start-ups, Coaching, Outsourcing, Business Analysis, Management Consulting, Training, Risk Management
Education
Northwestern University - Kellogg School of Management 1994 — 1994
Transportation
University of Cape Town 1985 — 1985
Marketing
Grosvenor Girls College
Validation Compliance Inc. July 2004 - Present
Lachman Consultant Services July 2012 - April 2013
Tunnell Consulting August 2009 - January 2010
Validation Technologies, Inc. July 2000 - July 2004
Invensys Validation Technologies October 1997 - July 2000
Jacobs Engineering January 1991 - October 1997
The Upjohn Company (now Pfizer) June 1979 - November 1990
Skills
FDA, Analytical Skills, Validation, Sop, Oncology, GMP, 21 CFR Part 11, Information Technology, Pharmaceutical Industry, Change Control, Technology Transfer, Computer System..., V&V, Quality Control, Pharmaceutics, Biopharmaceuticals, Quality Assurance, CAPA, Quality System, Quality Management, Clinical Development, GLP, GxP, Quality Auditing, Regulatory Affairs, Manufacturing, Regulatory Submissions, Cross-functional Team..., ISO, Biotechnology, Medical Devices, Six Sigma, GAMP, Operational Excellence, Lifesciences, Document Management, LIMS, Cleaning Validation, Vaccines, Formulation, Drug Development, Process Engineering, Aseptic Processing, Management, Process Simulation, Software Documentation, Laboratory, Automation, Regulatory Requirements, Clinical Trials
Education
University of Florida 1966 — 1970
Ph. D., Chemistry
Ida High School 1955 — 1960
University of Toledo
M.S., Chemistry
University of Toledo
B.S., Chemistry
Looking for new opportunities June 2015 - Present
Genpact Pharmalink at Major Pharma Company April 2012 - December 2014
The Quantic Group February 2012 - March 2012
Kelly Scientific Resources November 2008 - September 2011
Kelly Services December 2006 - October 2008
Tunnell Consulting July 2006 - December 2006
Kelly Services December 2005 - June 2006
Bristol-Myers Squibb September 2005 - March 2006
Valoit, Inc. August 2005 - September 2005
The Quantic Group June 2002 - June 2005
Skills
Online Communications, eCTD, GMP, Quality Assurance, cGMP, QC, Regulatory Strategy, Regulatory Filings, FDA, Strategy, Quality Control, Pharmaceutical Industry, Change Control, CAPA, Regulatory Affairs, Validation, Regulatory Submissions, Sop, Pharmaceutics, Quality Management, GxP, 21 CFR Part 11, Computer System..., GLP, Biopharmaceuticals, LIMS, Aseptic Processing, Biotechnology, Technology Transfer, Vaccines, Regulatory Requirements, GCP, Drug Development, Lifesciences, CRO, V&V, Quality System, Cleaning Validation, Laboratory, Analytical Chemistry, Medical Devices, Software Documentation, SOP
Education
La Salle University 1964 — 1968
BA
Msgr. Bonner H.S. 1960 — 1964
Diploma
US Army Reserve 1968 — 1974
Honorable Discharge
Comcast April 2013 - Present
Protiviti June 2011 - April 2013
Campbell Soup Company June 2010 - August 2010
Tunnell Consulting June 2009 - August 2009
University of Delaware 2009 - 2009
Skills
Sarbanes-Oxley Act, Auditing, Internal Controls, IT Audit, SOX 404, Internal Audit, Sarbanes-Oxley, Enterprise Risk..., Governance, Process Improvement, Business Process
Education
University of Delaware - Lerner College of Business and Economics 2007 — 2011
BS, MIS and Finance
A T0 Z Pharma Consulting January 2006 - Present
Tunnell Consulting, Inc. 2012 - 2014
Validant 2012 - 2012
Tunnell Consulting 2010 - 2012
Alpharma 2007 - 2009
Tunelle Consulting 2006 - 2007
Bristol-Myrs Squibb Co. 1996 - 2006
GlaxoSmithKline May 1978 - September 1996
Skills
Process Development, Generics, cGMP, Validation, Technology Transfer, Product Development, R&D, Formulation Development, Process Improvement, GMP, Generic Programming, Formulation, Process Simulation, FDA, V&V, Sop, Pharmaceutics, Pharmaceutical Industry, 21 CFR Part 11, GLP, HPLC, Regulatory Affairs, Manufacturing, Biotechnology, Change Control, Quality System, CAPA, Biopharmaceuticals, Regulatory Submissions, Lifesciences, Root Cause Analysis, GxP, Computer System..., Drug Development, Clinical Development, Medical Devices, Drug Delivery, Quality by Design, Regulatory Requirements, Chemistry, Vaccines, Clinical Trials, SOP
Education
New Jersey Institute of Technology 1979 — 1984
Masters, Chemistry
Signature Science, LLC May 2015 - Present
MRIGlobal December 2012 - May 2015
MRIGlobal October 2012 - May 2015
Tunnell Consulting June 2009 - October 2012
University of Texas Medical Branch, Infectious Diseases July 2003 - March 2009
Benaroya Research Institute June 2000 - July 2003
FMC Wyoming June 1992 - February 1994
Skills
Lifesciences, Virology, Molecular Biology, Microbiology, Validation, Biocontainment, Infectious Disease, Research Science, Bacteriology, Chemical Engineering, Virologist, Microbiologist, Science, Infectious Diseases, Laboratory Skills, Cell, Research, Laboratory, Cell Biology, PCR, Animal Models, In Vivo, Western Blotting
Education
The University of Texas Medical Branch at Galveston 2003 — 2009
Doctor of Philosophy (PhD), Infectious Diseases, Microbiology (Virology, Bacteriology) and Immunology
The University of Texas Health Science Center at Houston 2008 — 2009
Certificate of Public Health, Public Health and Infectious Diseases
University of Houston-Clear Lake 2007 — 2007
Advanced Management Certificate Program, Business, Management, Marketing, and Related Support Services
Washington State University 1997 — 2000
Bachelor of Science (B.S.), Microbiology (Infectious Diseases) and Animal Science
North Carolina State University 1987 — 1992
Bachelor of Science (B.S.), Chemical Engineering
Amtrak May 2014 - Present
WD Connell Consulting, LLC June 2011 - Present
Collaborative Consulting December 2011 - May 2014
Iroko Pharmaceuticals, LLC and Iroko Cardio International Sarl November 2008 - June 2011
Tunnell Consulting October 1998 - November 2008
Conrail Corporation September 1980 - October 1998
Ford Motor Company June 1978 - August 1980
Skills
Supply Chain, Pharmaceutical Industry, Logistics, Lifesciences, Transportation, ERP, 3PL, Supply Chain Management, Cross-functional Team..., Demand Planning, Six Sigma, Operations Management, Project Management, Contract Manufacturing, Business Strategy, Quality Assurance, Operational Excellence, Commercialization, Procurement, Supply Chain Operations, 21 CFR Part 11, Leadership, Strategy, Supply Chain..., Materials Management, Supply Management, Consulting, Management, FDA, Start-ups, Forecasting, Strategic Sourcing, Contract Negotiation, Value Stream Mapping, SAP, Change Management, GMP, Lean Manufacturing, Continuous Improvement, MRP, Process Improvement, Biotechnology, Pharmaceutics, Manufacturing, Inventory Management, Quality Management, Management Consulting, Quality System, Business Process..., Project Planning
Education
Indiana University of Pennsylvania 1990 — 1994
MBA
University of Maine 1974 — 1978
BS
University of Michigan
Lean Six Sigma
Process and Quality Consulting 2007 - Present
Tunnell Consulting July 1988 - September 2007
Skills
Operational Excellence, Process Improvement, Manufacturing, Six Sigma, Pharmaceuticals, Continuous Improvement, Strategy Development, Change Management, Organizational..., SPC, Strategic Planning, Life Sciences, Leadership Development, Business Process..., Management Consulting, Pharmaceutical Industry, Lifesciences, Strategy, FDA, GMP, Start-ups, Business Development, Medical Devices, Management, Consulting, Cross-functional Team..., Leadership, Business Transformation, Business Process, Process Engineering, Business Strategy, Quality Management
Education
Rensselaer Polytechnic Institute
Bachelor of Science (BS), Chemical Engineering
Temple University
MBA, Marketing
Parkwood Consulting, Inc. September 2011 - Present
Brooks International April 2014 - November 2014
Intenational Services Inc. January 2009 - October 2011
Quest Worldwide 2008 - 2008
The Highland Group 2007 - 2008
Tunnell Consulting 2004 - 2005
Solving International 2003 - 2004
Solving International 2003 - 2004
Solving International 2003 - 2004
The Highland Group 2002 - 2004
Skills
Business Transformation, Business Process..., Management Consulting, Organizational Design
Education
University of Kentucky 1963 — 1967
BA
Tunnell Consulting February 2000 - Present
Skills
Pharmaceutical Industry, Strategic Planning, Business Development, Business Strategy, Lifesciences, Salesforce.com..., Market Research, Organizational..., Microsoft Office, Competitive Analysis, Data Integrity, Marketing, Process Compliance
Education
Gwynedd-Mercy College 2004 — 2007
Bachelor of Science (BS), Business Administration, 3.8
Pfizer June 2014 - Present
Integrated Project Services December 2012 - May 2014
Tunnell Consulting January 2012 - December 2012
Kenexa April 2011 - December 2011
STV Incorporated March 2008 - April 2011
Kenexa April 2001 - April 2006
Kenexa 1997 - 2006
Skills
Partner Relationships, Direct Sourcing, Cold Calling, Executive Search, Process Improvement, Interviewing, Technical Recruiting, Recruitment/Retention, College Recruiting, Talent Acquisition, Project Delivery, Internet Recruiting, Full-cycle Recruiting, Applicant Tracking..., Direct Recruiting, Salary Negotiation, Candidate Screening, Contract Recruitment, Sales Recruitment, Creative Sourcing, Employer Branding, Talent Identification, Sourcing, Recruitment Technology, Professional Networking, Talent Management, Recruiting, Interviews, SDLC, Human Resources, Business Networking, Partner Management, Training, Screening Resumes, Benefits Negotiation, Leadership, New Hire Orientations, Strategy, Graduate Recruitment, Employee Relations, Temporary Placement, Hiring, Team Leadership, Management, HRIS, Consulting, CRM, Strategic Sourcing, Employee Benefits, Recruitment Advertising
Education
Lock Haven University of Pennsylvania 1987 — 1989
BA, International Relations
Lebanon Valley College 1985 — 1987
BS, International Relations
Tunnell Consulting May 2011 - Present
LECG Smart June 2010 - March 2011
Maaco Enterprises 1992 - May 2010
Maaco Enterprises 1989 - 1992
Maaco Enterprises 1985 - 1989
Maaco Enterprises 1986 - 1987
Maaco Enterprises 1980 - 1985
Skills
Accounts Receivable, Leadership, Accounts Payable, General Ledger, Accounting, Microsoft Excel, Customer Service, Financial Reporting, Invoicing, Strategic Planning, Data Entry, Microsoft Word
Education
Montgomery County Community College
Upper Merion High School
Teva Pharmaceuticals July 2014 - Present
University of Pennsylvania, Abramson Cancer Center December 2012 - July 2014
The RightThing, an ADP Company August 2011 - December 2012
Tunnell Consulting 2008 - 2011
TWC May 2007 - December 2007
Alpha Scientific August 2006 - February 2007
Pharmaceutical Clinical Associates January 2005 - July 2006
Kelly Scientific 2003 - 2004
Weichert Relocation Inc. 2001 - 2003
Acquisition Management Services 1995 - 1997
Skills
Talent Acquisition, College Recruiting, Internet Recruiting, Applicant Tracking..., Technical Recruiting, Executive Search, Contract Recruitment, Human Resources, Recruiting, Onboarding, Temporary Placement, Clinical Development, Employee Relations, Regulatory Affairs, Sourcing, Talent Management, Medical Devices, Consulting, Quality Assurance, Organizational..., Personnel Management, CRM, Leadership
Education
Saint Joseph's University 1989 — 1991
B.A., International Relations
Operations & Quality Systems Improvement Experts (OQSIE) January 2014 - Present
Stayma Consulting Services July 2012 - Present
QualiFactor Solutions LLC 2010 - Present
QSC 2010 - Present
Tunnell Consulting 2009 - 2011
Clarkston Consulting 2006 - 2009
UPS Supply Chain Solutions 2006 - 2007
Sciele Pharma 2004 - 2006
Tyco Healthcare 2003 - 2004
UCB Pharma 2001 - 2003
Skills
GMP, FDA, Validation, CAPA, Quality System, Pharmaceutical Industry, Quality Assurance, 21 CFR Part 11, Biotechnology, Quality Auditing, Change Control, Medical Devices, Sop, Regulatory Affairs, Lifesciences, ISO 13485, Pharmaceutics, Clinical Trials, Computer System..., GxP, Cold Chain, Supplier Quality, DEA, Strategy, Quality Management, GLP, Regulatory Submissions, Biopharmaceuticals, Quality Control, V&V, Technology Transfer, Vaccines, Supplier Quality..., Stability Programs, Auditing, Aseptic Processing, CRM, CRO, Cleaning Validation, GCP, ISO, Cross-functional Team..., R&D, Laboratory, Operational Excellence, GAMP, Process Simulation, Management, Quality Systems, DEA Compliance
Education
Georgia Southern University 1986 — 1990
Bachelor of Science, Biology
Tunnell Consulting November 2010 - Present
Western Michigan University September 2010 - Present
Perrigo December 2008 - January 2010
Pfizer September 1995 - December 2008
Skills
Validation, Medical Devices, GMP, Compliance, CMC Regulatory
Education
Andrews University 1992 — 1995
MS, Healthcare Administration
Nazareth College
BSN, Nursing
Tunnell Consulting, Inc. March 2012 - Present
Cini Consulting January 2011 - February 2012
Capgemini Consulting May 2010 - December 2010
IBM Global Business Services 2008 - 2010
Tunnell Consulting 2002 - 2008
Bristol Myers Squibb January 1999 - March 2001
Gemini Consulting 1996 - 1999
Shell R&D April 1991 - June 1996
Skills
Operational Excellence, Lean Manufacturing, Supply Chain, Pharmaceutical Industry, Supply Chain Management, Validation, Lifesciences, Quality System, Leadership, Six Sigma, Process Improvement, Strategy, Manufacturing, Management Consulting, GMP, Management, Process Engineering, Cross-functional Team..., Change Management, Process Simulation, FDA, Continuous Improvement, Start-ups, R&D, Quality Assurance, Consulting, Program Management, Technology Transfer, Project Management, Business Process..., Business Development
Education
University of Massachusetts, Amherst 1988 — 1991
PhD, Chemical Engineering
Cambridge Major Laboratories, Inc. April 2014 - Present
Nektar Therapeutics August 2012 - January 2014
Merial, A Sanofi Company August 2006 - July 2012
Andrx Pharmaceuticals June 2004 - August 2006
Tunnell Consulting September 2003 - June 2004
Yamanouchi Pharma. Tech. February 2002 - April 2003
Coelacanth Corp June 2000 - January 2002
Vertex Pharmaceuticals Inc December 1996 - June 2000
Gecko Systems 1998 - 2000
Bristol Myers Squibb May 1992 - December 1996
Skills
HPLC, Automation, Information Mapping, UV-Vis, Wet Chemistry, Robotics, Laboratory Automation, Instrument Development, NIR, Chemometrics, Chemical imaging, Process Analytical..., GLP, GMP, UV/Vis, Chromatography, Analytical Chemistry, Pharmaceutical Industry, FDA, Gas Chromatography, Drug Discovery, IR, Formulation, NIR spectroscopy, Dissolution, Validation
Education
The University of Texas at Dallas 1986 — 1988
Doctor, Chemistry
The University of Texas at Dallas 1984 — 1986
MS, Chemistry
Tarleton State University 1982 — 1984
B.S, Chem; Comp. Sci
Brazosport College 1978 — 1982
ProPharma Group March 2014 - Present
Illinois Institute of Technology Alumni Association 2010 - Present
Avarent LLC April 2012 - January 2014
Tunnell Consulting 2010 - March 2012
University of Illinois Alumni Association 2006 - 2012
ISPE 1992 - 2012
Stantec Consulting 2008 - 2010
AECOM Technology Corporation 2001 - 2008
Ernst & Young, LLP 1996 - 2001
Centeon (now CSL Behring) 1990 - 1996
Skills
FDA, Lifesciences, Biotechnology, Pharmaceutical Industry, GMP, Project Management, Cross-functional Team..., Strategic Planning, Process Improvement, Business Development, Data Analysis, Sop, Statistics, Process Engineering, Proposal Writing, Project Planning, Manufacturing, Business Strategy, Management Consulting, Strategy, Engineering, Software Documentation, Quality Control, Contract Negotiation, Validation, Chemistry, ISO 13485, Budgets, Program Management, Leadership, Management, Medical Devices, Forecasting, Quality System, Biopharmaceuticals, CAPA, Troubleshooting, Six Sigma, Design of Experiments, Process Simulation, Quality Assurance, Product Development, Regulatory Affairs, Quality Management, Analysis, Quality Auditing, Recruiting, Energy, New Business Development, Life Sciences
Education
University of Chicago Booth School of Business 1994 — 1996
M.B.A., Finance & Operations Management
Illinois Institute of Technology 1989 — 1991
B.S., Electrical and Computer Engineering
University of Illinois at Chicago 1980 — 1985
B.S., BioEngineering
National Society of Black Engineers August 2015 - Present
Magic Hat Consulting 2012 - Present
National Society of Black Engineers 2013 - 2014
Independent Consultant 2012 - 2013
Tunnell Consulting 2006 - 2011
INVISTA 2002 - 2005
DuPont 1998 - 2001
DuPont 1997 - 1998
DuPont 1994 - 1997
DuPont 1990 - 1993
Skills
Visionary, Transformational..., Business Strategy, Strategic Planning, Consulting, Project Management, Key Performance..., Mentoring, Team Management, People Management, Teaching, Training, Coaching, Hazard Analysis, Risk Assessment, Risk Management, Incident Investigation, Technical Writing, Problem Solving, Six Sigma, Lean Tools, Data Analysis, Minitab, Design of Experiments, Statistical Process..., Public Speaking, Negotiation, Microsoft Office, SPC, Process Improvement, Management, Business Process..., Operations Management, Change Management, Continuous Improvement, Manufacturing, Organizational..., Supply Chain, Black Belt, Process Engineering, Organizational..., Process Optimization, DMAIC, Process Simulation, Program Management, Quality Management, Root Cause Analysis, Quality Assurance, Cross-functional Team..., Strategy
Education
Georgia Institute of Technology 1982 — 1984
M.S., Chemical Engineering
California Institute of Technology 1978 — 1982
B.S., Chemical Engineering
Covidien September 2014 - November 2014
Gilead Sciences March 2014 - June 2014
Teva Pharmaceuticals March 2012 - November 2013
APP Pharamaceuticals July 2010 - December 2011
TUNNELL CONSULTING August 2009 - July 2010
HOSPIRA INC. October 2008 - July 2009
AMYLIN LLC October 2007 - June 2008
CARDINAL HEALTH April 2004 - September 2007
EMD Millipore December 2000 - April 2003
Skills
GMP, CAPA, Sop, Validation, Technology Transfer, Quality Assurance, Manufacturing, Pharmaceutical Industry, Six Sigma, Biotechnology, Process Improvement, FDA, Team Building, 21 CFR Part 11, Biopharmaceuticals, Aseptic Processing, ISO, Quality Control, Vaccines, Lyophilization, LIMS, Sterilization, Lean Manufacturing, Kaizen, Documentation, V&V, Quality System, Change Control, Software Documentation, GxP, Regulatory Affairs, SOP
Education
Middlesex Community College 1976 — 1980
Teva Pharmaceuticals July 2015 - Present
Turesol Staffing Solutions May 2014 - February 2015
Tunnell Consulting August 2012 - May 2014
Self-employed July 2007 - July 2012
Kenexa July 2003 - July 2007
LHK Partners, Inc. November 2001 - July 2003
Rodale Institute 1985 - 1987
Skills
Talent Acquisition, Applicant Tracking..., Recruitment/Retention, Interviewing, Talent Management, Onboarding, Executive Search, Contract Recruitment, Sourcing, Full-cycle Recruiting, Search, Hiring, Account Management, Cold Calling, Recruitment Advertising, Salary Negotiation, Screening, Internet Recruiting, Process Improvement, Direct Sourcing, Strategic Planning, College Recruiting, Employer Branding, Benefits Negotiation, Staffing Services, Recruiting, Employee Relations, RPO, Technical Recruiting, Training, Screening Resumes, Temporary Placement, Interviews, Human Resources, Employee Engagement, Taleo, BrassRing, Pharmaceutical Industry, Pharmaceutical Sales..., Leadership, Management, Permanent Placement, Personnel Management, CRM, IT Recruitment, Outsourcing, Candidate Generation, Temporary Staffing, HR Consulting, Workforce Planning
Education
Cabrini College
allentown central catholic
Latham BioPharm Group March 2015 - Present
US Department of Health and Human Services November 2013 - March 2015
US Department of Health and Human Services July 2011 - November 2013
US Department of Health and Human Services March 2009 - July 2011
Alburtylab Inc. November 2007 - June 2011
Tunnell Consulting May 2006 - February 2009
Midwest Research Institute February 2006 - January 2008
Midwest Research Institute April 2001 - February 2006
Aventis Pasteur (now sanofi pasteur) January 1999 - April 2001
Aventis Pasteur (now sanofi pasteur) February 1998 - December 1998
Skills
Program Management, Vaccines, Group Management, Life Sciences, Biotechnology, Infectious Diseases, Cell Culture, Negotiation, Contract Negotiation, Team Leadership, Lifesciences, Molecular Biology, Microbiology, GLP, Group Development, GMP, Leadership, Biopharmaceuticals, Laboratory, Virology, Purification, Hardware Diagnostics, Immunology, R&D, Drug Discovery, Strategy, Management, Clinical Development, Technology Transfer, Healthcare, Cell Biology, Cancer, Research, Drug Development, Cell, Clinical Trials, Protein Chemistry, Biochemistry, Pharmaceutical Industry, Project Management
Education
Tufts University 1980 — 1988
Ph.D.
Carnegie Mellon University 1976 — 1980
B.S.
Technology Consultant February 1998 - Present
Dilon Diagnostics June 2014 - April 2015
SciMedix, Inc. February 2012 - December 2012
Synarc November 2010 - January 2012
IRF/NIAID/NIH October 2010 - October 2011
Tunnell Consulting February 2008 - October 2010
Toshiba America Medical systems 2004 - 2007
CEDARS-SINAI MEDICAL CENTER, Imaging Department 1999 - 2004
LONG BEACH MEMORIAL MRI CENTER 1992 - 2002
Skills
Medical Imaging, MRI, Digital Imaging, Radiology, Clinical Research, X-ray, Nuclear Medicine, PACS, Medical Devices, Clinical Trials, DICOM, Physics, Molecular Imaging, Image Processing, Biomedical Engineering, Computed Tomography, Clinical Development, Cancer, Oncology, fMRI, Image Analysis, Lifesciences, Vascular, Cardiology, Healthcare Information..., Healthcare, Informatics, Medicine, Neuroscience, Hospitals, Radiation Therapy, Science, HIPAA, R&D, Plannning, Radiation Safety, Radiation, Microsoft Office, Surgery, EMR, Hardware Diagnostics, Signal Processing, Data Analysis, Biotechnology, Drug Development, Training/Education, Clinical MRI Application, Radiation Physics, Breast Imaging, Life Sciences
Education
University of California, Irvine - College of Medicine
PhD, Radiological Sciences, MRI
National Tsing Hua University
MS, Health Physics
National Tsing Hua University
BS, Nuclear Engineering
www.applied-stats.com March 2011 - Present
Tunnell Consulting 2011 - Present
Applied-Stats.com Consulting October 2007 - Present
Genentech June 2009 - 2011
Amgen January 2006 - November 2007
Amgen April 2003 - January 2006
Ore-Ida Foods (H.J.Heinz Co.) 1980 - 1997
Skills
Sampling lots for..., Stat. Proc. Control, Design & Analysis of...
Education
Harvard University 1970 — 1975
Ph.D., Biology
University of California, San Diego 1965 — 1969
B.A., Bioilogy
Tunnell Consulting 2002 - Present
Breite Consulting Associates 2000 - Present
Advanced Tissue Sciences 1994 - 2000
Hybritech Inc. 1985 - 1994
Beckman Coulter 1980 - 1985
Education
University of California, Santa Barbara 1970 — 1974
BA, Biochemistry
Ophthotech Corp. September 2014 - Present
Ophthotech Corp. December 2012 - Present
Ophthotech Corp. August 2007 - Present
Pharmasset, Inc. December 2005 - August 2007
Eyetech Pharmaceuticals, Inc. January 2002 - December 2005
Tunnell Consulting June 1997 - December 2001
Skills
Pharmaceutical Industry, Biotechnology, Lifesciences, Cross-functional Team..., Clinical Development, Drug Development, Drug Discovery, R&D, Commercialization, Medical Devices, Start-ups, Biopharmaceuticals, Business Strategy, Strategic Planning, Strategic Alliances, FDA, Project Management, Regulatory Affairs, Technology Transfer, CRO, Product Launch, Regulatory Submissions, Mergers & Acquisitions
Education
Columbia University - Columbia Business School 2007 — 2009
MBA
Drexel University 1996 — 1999
Master of Science, Engineering Management
State University of New York College at Geneseo 1992 — 1996
BS, Applied Physics
Kemwell Biopharma March 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2009 - February 2014
Tunnell Consulting December 2007 - August 2009
Diosynth Biotechnology May 1998 - December 2007
Skills
Biopharmaceuticals, Technology Transfer, Pharmacovigilance, Clinical Development, Biotechnology, Protein Chemistry, Pharmacology, Pharmaceutical Industry, Drug Development, Protein Purification, Oncology, GMP, Clinical Trials, Biochemistry, Pharmaceutics, IND, CTMS, Vaccines, Regulatory Affairs, Sop, LIMS, CAPA, GLP, Lifesciences, Monoclonal Antibodies, Validation, Chromatography, Fermentation, R&D, Regulatory Submissions, 21 CFR Part 11, GxP, Cell Culture, FDA, Commercialization, Analytical Chemistry, Formulation, Purification, Change Control, GCP, Drug Discovery, Medical Devices, Assay Development, Clinical Research, CRO
Education
University of Connecticut 1987 — 1994
Ph.D., Pharmaceutical Sciences
Delta Instrument Company August 2007 - Present
Tunnell Consulting 2006 - 2007
Quintiles 2003 - 2006
MRI 2002 - 2003
Delta Instrument Company 1994 - 2002
Skills
Pharmaceutical Industry, Biotechnology, Lifesciences, FDA, Validation, Medical Devices, GMP, Sop, Regulatory Affairs, Quality System, CAPA, 21 CFR Part 11, Strategic Planning, Clinical Research, R&D, Technology Transfer, Quality Assurance, Pharmaceutics, Analytical Chemistry, V&V, Quality Control
Education
Missouri State University 1989 — 1992
Bachelor of Science (BS), Chemistry
Iroko Pharmaceuticals, LLC December 2014 - Present
Iroko Pharmaceuticals LLC July 2008 - November 2014
Tunnell Consulting March 1999 - June 2008
Conrail September 1996 - March 1999
Albany International September 1991 - January 1996
Skills
Pharmaceutical Industry, Quality Assurance, Project Planning, CAPA, Quality System, Product Launch, Clinical Trials, Process Improvement, Biopharmaceuticals, Six Sigma, Regulatory Submissions, Competitive Intelligence, Supply Chain, Logistics, GxP, Vaccines, Leadership, Cross-functional Team..., Management, Supply Chain Management
Education
Temple University - Fox School of Business and Management 1996 — 1998
Master of Business Administration (M.B.A.), Operations Research
Universidad Nacional Autónoma de México 1985 — 1990
BS, Chemical Engineering
Colegio Tepeyac 1972 — 1985
High School Diploma
Easter Seals New Jersey January 2015 - Present
Iron Hill Capital December 2008 - Present
Primapax Group July 2008 - Present
Novartis January 2008 - July 2008
Novartis May 2007 - January 2008
Tunnell Consulting 2006 - 2007
Generamedix Inc February 2005 - May 2006
Bristol-Myers Squibb March 2004 - December 2004
Schering-Plough 1997 - 2004
Liposome Company June 1995 - May 1997
Skills
Pharmaceutical Industry, Business Development, Supply Chain, Lifesciences, Mergers & Acquisitions, Technology Transfer, Product Development, Cross-functional Team..., Six Sigma, FDA, Business Process..., Biopharmaceuticals, Life Sciences, Manufacturing, Regulatory Affairs, Business Strategy, Change Management, Commercialization
Education
Pace University - Lubin School of Business 1992 — 1994
MBA, Business Administration, Management and Operations
The Ohio State University 1985 — 1989
Bachelor of Science (BS), Chemical and Biomolecular Engineering
Tunnell Consulting June 2012 - August 2012
Cordis September 2005 - August 2011
Pfizer September 2003 - April 2004
Pfizer September 2003 - March 2004
Organon May 1992 - March 2003
Organon January 1992 - January 2003
Organon January 1992 - January 2003
Skills
Technical Writing, Technical Documentation, Stability Programs, cGDP, cGMP, cGLP, HPLC, HPLC, Sop, GMP, Validation, FDA, Quality Control, Formulation, GLP, Technology Transfer, UV, LIMS, Dissolution, V&V, Change Control, Pharmaceutics, Laboratory, IR, Cleaning Validation, SOP
Education
Fairleigh Dickinson University
M.B.A. (Master, Business Administration) Marketing
Fairleigh Dickinson University
M.B.A. (Master, Business Administration) Marketing
Tuskegee University
M.S. (Master of Science), Chemistry
Tuskegee University
B.S. (Bachelor of Science), Chemistry
Tuskegee University
B.S. (Bachelor of Science), Chemistry
Tuskegee University
M.S. (Master of Science), Chemistry
Tunnell Consulting 2002 - Present
Eisai Inc. 1997 - 2000
Wyeth Pharmaceutical 1990 - 1997
Glaxo Inc 1988 - 1990
Skills
Process Validation, cGMP, GMP, Validation, Technology Transfer, Pharmaceuticals, SOP, Sop, Pharmaceutical Industry, Change Control, FDA, 21 CFR Part 11, V&V, Cross-functional Team..., Biotechnology, CAPA, GLP, Regulatory Affairs, GxP, Cleaning Validation, Biopharmaceuticals, Quality Assurance, Quality System, Manufacturing
Education
North Carolina State University 1984 — 1985
McNeil Consumer Healthcare February 2013 - July 2015
Sanofi Pasteur March 2012 - August 2012
Sanofi Pasteur September 2010 - March 2012
Sanofi Pasteur January 2010 - September 2010
Sanofi Pasteur February 2009 - January 2010
Tunnell Consulting September 2007 - February 2009
Skills
FDA, GMP, Validation, Change Control, Quality System, Quality Control, GxP, Technology Transfer, CAPA, Pharmaceutical Industry, 21 CFR Part 11, Biotechnology, Root Cause Analysis, Vaccines, V&V, Aseptic Processing, SOP, Solid Oral Dosage Forms, Aseptic Technique
Education
Lehigh University 2010 — 2017
MBA - degree in progress, Project Management
Lafayette College 2003 — 2008
Bachelor of Arts, Mathematics
Pfizer January 2013 - Present
Pfizer July 2008 - January 2013
Tunnell Consulting March 2005 - July 2008
KMI Consulting, a subsidiary of Parexel International 2000 - 2005
Skills
Technology Transfer, Vaccines, Business Process..., Biotechnology, Business Strategy, Management, Pharmaceutical Industry, Regulatory Affairs, R&D, GxP, Project Management, Leadership, Strategy, FDA, Operational Excellence, 21 CFR Part 11, Cross-functional Team..., GMP, Medical Devices, Lifesciences, Clinical Development, Regulatory Submissions, CAPA, Process Improvement, Biopharmaceuticals, Clinical Trials, Change Control, V&V, Change Management, Six Sigma, Drug Development, Sop, Life Sciences, SOP
Education
University of Pennsylvania - The Wharton School 2012 — 2014
Master of Business Administration (MBA), 2012-2104
Cornell University 1992 — 1996
Bachelor's of Science, Biology, General
Tunnell Consulting April 2007 - Present
Reynolds & Reynolds August 1996 - September 2006
TAC Worldwide Companies March 1994 - August 1996
Skills
Human Resources, Training, Process Improvement, Coaching, Project Management, CRM, Technical Recruiting, Management, Payroll, Change Management, Team Building, Performance Management, Sales, New Business Development, Process Scheduler, Customer Satisfaction, Business Development, Organizational..., Quality Assurance, Customer Retention, New Hire Orientations, Interviews, Operations Management, Recruiting, Management Consulting, Negotiation, Talent Acquisition, Team Leadership, Employee Relations, Talent Management, Leadership Development, Applicant Tracking..., Vendor Management, Business Process..., Consulting, Employee Training, Leadership, Strategy, Strategic Planning, Program Management, Workshop Facilitation, Business Strategy, Sourcing, Employee Benefits, Customer Service, Onboarding, Cross-functional Team..., Healthcare, Microsoft Office, Account Management
Education
University of Delaware 1989 — 1993
BS, Human Resources Management
National Executive Service Corps 2005 - Present
Tunnell Consulting 2002 - 2004
GlaxoSmithKline 2000 - 2002
Block Drug 1997 - 2000
NYS Department of Economic Development 1990 - 1996
Sterling Drug, Inc. 1974 - 1989
Skills
Fundraising, Marketing Strategy, Strategy, Leadership Development, Organizational..., Strategic Planning, Management Consulting, Nonprofits, Change Management, Business Strategy, Pharmaceutical Industry, Cross-functional Team..., Process Improvement, Program Management, Public Speaking, Business Development, Event Planning, Market Research, Product Development, New Business Development, Non-profit Board..., Management, Technology Transfer, Message Development, Equities, Mergers & Acquisitions, Executive Search, Leadership, Marketing, Start-ups, Consulting, Training, Team Building, Social Media, Entrepreneurship, Human Resources, Executive Coaching, Organizational Design, Board Development, Contract Negotiation, Performance Management, Recruiting, Coaching
Education
Creighton University
MA, International Relations
Thunderbird School, Arizona State Unversity
MBA, International Business
Salient Solutions LLC March 2010 - Present
Salient Solutions LLC September 2009 - March 2010
Tunnell Consulting May 2006 - August 2009
Education
Rutgers University-New Brunswick
ViroPharma Incorporated 2009 - Present
Novartis Consumer Health February 2012 - April 2012
Laboratory Solutions May 2008 - February 2012
ilb Enterprises November 2007 - 2012
SQA Services, Inc. 2008 - August 2010
Pfizer December 2006 - February 2008
Bristol-Myers Squibb 2006 - 2008
Tunnell 2005 - 2008
Tunnell Consulting 2006 - 2007
Skills
GCP, Supplements, GMP, Regulatory Affairs, CRO, GLP, eCTD, Pharmaceutical Industry, FDA
Education
University of Alabama School of Medicine 1980 — 1986
PharmOps Group, Inc. April 2007 - Present
Tunnell Consulting 2001 - 2007
Wyeth 1997 - 2001
Wyeth Consumer Health 1997 - 1998
Wyeth International 1992 - 1996
Schering Plough 1983 - 1992
Wyeth Labs 1976 - 1983
Skills
Pharmaceutical Industry, Technology Transfer
Education
Saint Joseph's University
M.S., Chemistry
Temple University
B.A., Biology
INGRAM Consulting Services February 2012 - Present
Tunnell Consulting 2006 - Present
Novartis/QSC 2011 - 2013
PharmaLogika 2009 - 2009
Compliance BioPharm Inc. 2009 - 2009
GlaxoSmithKline 1991 - 2002
Skills
Pharmaceutical Industry, FDA, GMP, Validation, Technology Transfer, Regulatory Affairs, CAPA, Sop, Biotechnology, Clinical Development, Pharmaceutics, Quality System, Medical Devices, Lifesciences, Clinical Trials, V&V, Change Control, 21 CFR Part 11, Cross-functional Team..., Biopharmaceuticals, Computer System..., GLP, GxP, Regulatory Submissions, LIMS, Regulatory Requirements, Vaccines, GAMP, Process Simulation, Drug Development, R&D, Quality Auditing, GCP, ISO 13485, CRO, Aseptic Processing, Quality Management, Quality Assurance, Operational Excellence, Oncology
Education
Campbell University
MB Bengel Consulting, LLC 2004 - Present
Tunnell Consulting 2005 - 2010
MDS 2005 - 2006
PharmaDirections, Inc. September 2004 - December 2005
BioPort Corporation April 2001 - January 2002
BioPort Corporation March 1997 - April 2001
Skills
Change Control, FDA, Validation, Technology Transfer, CAPA, GMP, Biotechnology, Sop, Quality Assurance, Aseptic Processing, Computer System..., Pharmaceutical Industry, Quality System, V&V, Medical Devices, Quality Control, Laboratory, 21 CFR Part 11, Vaccines, SOP
Education
Central Michigan University 1976 — 1982
BS, Biology & Chemistry
Conceptual Mindworks, Inc May 2011 - Present
Tunnell Consulting October 2010 - May 2011
Path Malaria Vaccine Initiative May 2009 - October 2010
VIRxSYS September 2008 - March 2009
Advanced Bioscience Laboratories May 2007 - August 2008
Emergent BioSolutions October 2004 - May 2007
BioReliance January 2003 - October 2004
Entremed February 1999 - December 2002
entremed 1999 - 2002
Skills
Vaccines, Biotechnology, GMP, Technology Transfer, Validation, Lifesciences, Cell Culture, Project Management
Education
The Catholic University of America 1988 — 1991
MS, Microbial and celluylar Biology
Tunnell Consulting February 2012 - Present
QIAGEN Sciences, Inc. June 2007 - June 2011
Digene Corporation January 2004 - June 2007
Message Pharmaceuticals, Inc. October 1998 - November 2003
Skills
Design Control, FDA, GLP, QSR, ISO 13485, Enzyme Assays, Sample Preparation, Immunoassays, Virology, Biotechnology, Validation, R&D, HPLC, Quality System, Molecular Biology, Molecular Diagnostics, ELISA, Protein Chemistry, Clinical Development, Assay Development, Biochemistry, Technology Transfer, Protein Purification, Lifesciences, Infectious Diseases, High Throughput..., Laboratory, Clinical Research, Cell Culture, Sop, DNA, Purification, Genotyping, Clinical Trials, DNA sequencing, Immunology, Medical Diagnostics, Cell, Genomics, Biopharmaceuticals, Laboratory Automation, Microbiology, PCR, qPCR, Cell Biology, Hardware Diagnostics, Chromatography, Commercialization, Cancer, DNA Sequencing
Education
HHMI and University of Pennsylvania School of Medicine 1996 — 1998
Senior Postdoctoral Scientist, Biochemistry
Yale University 1991 — 1996
Postdoctoral Fellow, Biology
University of Iowa 1985 — 1991
Ph.D., Biochemistry
University of Illinois at Urbana-Champaign 1978 — 1982
B.S., Biochemistry
Tunnell Consulting January 2012 - Present
Tunnell Consulting January 2009 - December 2011
Partners Specialty Group December 2001 - July 2008
R&B 2000 - 2001
Skills
Operational Excellence, Process Improvement, Financial Reporting, Financial Accounting, Microsoft Dynamics, Salesforce.com, Consolidated Financial..., Team Leadership, Risk Management, Business Process...
Education
Rosemont College 2010 — 2013
Master of Business Administration (MBA), Business Leadership
Rosemont College 1996 — 2000
BS, Accounting, Business Management
Neshaminy High School 1984 — 1988
Diploma, Business
Tunnell Consulting August 2002 - Present
Smart and Associates September 1997 - September 2002
Barbacane Thornton & Company May 1996 - September 1997
Skills
Auditing, Big 4, Management, Sarbanes-Oxley Act, Accounting, SEC filings, Financial Reporting, Internal Controls, Investments, Finance, Process Improvement, CPA, Internal Audit, Executive Management, Due Diligence, Acquisition Integration, Managerial Finance
Education
Center for Creative Leadership 2010 — 2010
University of Pennsylvania - The Wharton School 2010 — 2010
Executive Education for CFO's
Eastern University 2004 — 2006
MBA
West Chester University of Pennsylvania 1994 — 1996
BS, Accounting
Penn State University 1985 — 1990
BA, Managment Communications
Maynard Consulting April 2014 - Present
AAI Pharma January 2007 - December 2008
Tunnell Consulting 2005 - 2006
Centocor 2003 - 2005
McNeil 1975 - 1988
Skills
GxP, GLP, Quality System, GMP, Quality Control, Quality Assurance, FDA, Sop, cGMP practices, cGMP manufacturing, Pharmaceutical Industry, SOP authoring, Biopharmaceuticals, Change Control, Validation, Cleaning Validation, Microbiology, Employee Training, Technology Transfer, Aseptic Processing, Computer System..., V&V, LIMS, Biotechnology, Drug Development
Education
Temple University 1979 — 1984
Master of Science (MS), Pharmaceutical Quality Assurance
DeSales University 1970 — 1975
BS, Chemistry
Cape Fear Community College 2009 — 2011
pre-ADN, Nursing
Hightower Consulting Services Inc. May 2000 - Present
Quintiles Consultant October 2009 - March 2015
Hospira 2010 - 2010
Tunnell Consulting 2008 - 2009
Solvay Pharmaceuticals September 1997 - May 2000
Marion Labs, Marion Merrell Dow, Hoechst Marion Roussel May 1985 - December 1996
Skills
21 CFR Part 11, Auditing, Biotechnology, FDA, GMP, Medical Devices, Pharmaceutical Industry, Pharmaceutics, Quality Control, Training, Regulatory Affairs, SOP, Technology Transfer, Quality System
Education
University of Missouri-Kansas City 1985 — 1990
MS, Pharmaceutical Sciences - Chemistry
PharmOps Group, Inc. January 2007 - Present
Tunnell Consulting January 2002 - January 2007
Wyeth January 1997 - June 2001
Education
Saint Joseph's University 1977 — 1981
MS, Chemistry
Temple University 1971 — 1975
BA, Biochemistry
Packaging Coordinators Inc. (PCI) June 2012 - Present
Tunnell Consulting July 2009 - June 2012
Catalent 2006 - 2009
Cardinal Health 2004 - 2005
Smurfit-Stone 1978 - 1999
Smurfit 1978 - 1999
Education
Ball State University - College of Business
MBA, Finance Concentration
Colorado State University
Masters, Mathematics
United States Air Force Academy
BS, Mathematics and Aeronautical Engineering
CSC - Computer Sciences Corporation April 2014 - Present
La'Sarah-evette Motley, LLC November 2009 - Present
Baxter International Inc. April 2013 - April 2014
CSC December 2012 - April 2013
Tunnell Consulting June 2009 - April 2012
ReSearch Pharmaceutical Services December 2008 - March 2009
Octagon Research Solutions November 2007 - September 2008
Octagon Research Solutions November 2006 - November 2007
Skills
Publishing, Creative Writing, Pharmaceutical Industry, Adobe Acrobat, Regulatory Submissions, Quality Assurance, Document Management, eCTD, FDA, Microsoft Office, Sop, Clinical Trials, Project Management, Training, Regulatory Affairs, Software Documentation, Medical Devices, Management, Editing, PowerPoint, Team Leadership, Clinical Research, SOP
Education
American InterContinental University 2004 — 2006
Associate of Arts (A.A.), Business Administration, 3.93
Cardinal Health Regulatory Sciences (formerly Beckloff Associates) February 2012 - Present
Tunnell Consulting May 2010 - February 2012
Pfizer 1998 - 2010
PolyChem Corporation 1996 - 1998
Uniroyal Chemical 1993 - 1996
Procter & Gamble 1988 - 1992
Pratt & Whitney 1988 - 1989
Skills
Online Communications, Chemistry, Formulation Development, Manufacturing, Regulatory Submissions, cGMP, Pharmaceuticals, SOP, IND, Regulatory Requirements, Regulatory Strategy, Pharmaceutical Research, Cross-functional Team..., Analytical Chemistry, Microbiology, Formulation, GMP, Sop, Pharmaceutical Industry
Education
Central Connecticut State University
BS, Chemistry, Mathematics
Broome Community College
AAS, Chemical Engineering
PDC 1999 - Present
Tunnell Consulting 1999 - 2009
BioReliance 1998 - 1999
Innovir Laboratories 1995 - 1998
Hybridon (now Idera Pharmaceuticals) 1992 - 1995
Isis Pharmaceuitcals 1991 - 1992
SuperPharm Corporation 1990 - 1991
SmithKline Beecham (now GlaxoSmithKline) 1984 - 1990
Ayerst Laboratories (Wyeth Pharmaceuitcals), now Pfizer 1978 - 1984
Skills
GMP, Validation, CAPA, FDA, Sop, V&V, Pharmaceutics, Drug Development, Pharmaceutical Industry, Quality Assurance, Medical Devices, Biotechnology, Quality Control, Computer System..., Quality System, Vaccines, Drug Discovery, Change Control, IND, HPLC, Biopharmaceuticals, GxP, CRO, GLP, 21 CFR Part 11, Formulation, SOP
Education
State University of New York at Buffalo 1974 — 1978
Ph.D., Analytical Chemistry
State University of New York at Stony Brook 1971 — 1974
Bachelor of Science (BS), Chemistry
Biomimetic Therapeutics May 2015 - Present
Stryker April 2012 - May 2015
Tunnell Consulting February 2010 - April 2012
Pfizer September 1995 - December 2010
Skills
CAPA, FDA, Validation, GMP, 21 CFR Part 11, Regulatory Affairs, Pharmaceutical Industry, Change Control, Medical Devices, GxP, Sop, Quality System, V&V, Regulatory Submissions, Aseptic Processing, Quality Assurance, Cross-functional Team..., Technology Transfer, Regulatory Requirements, SOP, ISO 13485, Process Improvement, Biotechnology, Management, Leadership, Life Sciences, Biopharmaceuticals, Product Launch, Design Control
Education
Andrews University
Master’s Degree, Health/Health Care Administration/Management
Tunnell Consulting February 2012 - Present
WorldVu 2001 - 2013
US Census Bureau 2009 - 2010
MedImmune July 2009 - September 2009
Jacobs Engineering Group January 2005 - March 2007
Cardinal Health July 2005 - November 2005
Skills
Commissioning, Sop, Pharmaceutics, Validation, Software Documentation, Engineering, Biopharmaceuticals, Manufacturing, Troubleshooting, Vaccines
Education
New Jersey Institute of Technology
Bachelor of Science (B.S.), Chemical Engineering
The Quantic Group, Ltd May 2011 - Present
Quality Etc. Consulting, LLC 1999 - Present
Pharmaceutical Company September 2013 - December 2014
Genzyme May 2011 - September 2013
Sandoz Pharmaceuticals January 2009 - August 2009
Tunnell Consulting 1999 - 2009
MDS Pharma Services 2005 - 2007
Watson Pharmaceuticals 2003 - 2005
Watson Pharmaceuticals 2002 - 2003
Abbott Diagnostics 1999 - 2000
Skills
FDA, Consulting, GMP, Management, CAPA, Pharmaceutical Industry, 21 CFR Part 11, Change Control, Quality System, Regulatory Affairs, Sop, Technology Transfer, Validation, Biotechnology, GLP, SOP, V
Education
Rutgers, The State University of New Jersey-Newark 1988 — 1990
MS, Biological Sciences
SG Pharma CMC Consulting, LLC January 2009 - Present
Tunnell Consulting 2009 - Present
HHS/BARDA 2009 - 2015
HHS/BARDA 2009 - 2015
HHS/BARDA 2009 - 2015
PharmaDirections September 2007 - December 2008
Hollis Eden Pharmaceuticals 2004 - 2007
Carter-Wallace Inc. 1979 - 2002
Skills
Pharmaceutical Industry, Technology Transfer, GMP, Validation, FDA, Pharmaceutics, Regulatory Affairs, Drug Development, Sop, CAPA, Analytical Chemistry, Drug Delivery, Change Control, Formulation
Education
University of Connecticut 1970 — 1976
Ph.D., Pharmaceutics
Philadelphia Col. of Pharm. & Sci. 1965 — 1970
BS, Pharmacy
Self Employed June 2014 - Present
DanChem Technologies, Inc. 2010 - June 2014
Tunnell Consulting January 2000 - 2010
Ortho Clinical Diagnostics June 1990 - September 1997
Eastman Kodak 1978 - 1995
Xerox Corporation 1975 - 1978
Skills
Validation, CAPA, GMP, Technology Transfer, FDA, HPLC, Pharmaceutical Industry, Laboratory, Quality Assurance, Quality Control, R&D, Biotechnology, Gas Chromatography, UV/Vis
Education
Rochester Institute of Technology 1987 — 1990
M.S., Clinical Chemistry
State University of New York College at Oswego 1971 — 1974
BA, Chemistry, Biology
Mohawk Valley Community College 1969 — 1971
A.A.S., Biology & Chemistry
Tunnell Consulting January 2011 - Present
Riles Inc. 2009 - 2011
Johnson & Johnson April 2007 - 2009
Johnson & Johnson January 2006 - April 2007
Johnson & Johnson January 2005 - January 2006
Skills
Organizational..., Change Management, Recruiting, Leadership Development, Coaching, Talent Management, Leadership, Employee Relations, Human Resources, Quality Management, Six Sigma, Cross-functional Team..., Team Building, Personnel Management, Strategic Planning, Management, Project Management, Team Leadership, Analysis, Onboarding, Training
Education
Lehigh University
M.A.
University of Portland
B.A., History
Valpharma Inc 2001 - Present
Boehringer Ingelheim December 2012 - August 2013
New Link Genetics May 2013 - July 2013
Novartis 2010 - 2012
Apotex 2010 - 2010
Hospira 2010 - 2010
Sanofi Pasteur 2006 - 2010
Tunnell Consulting 2004 - 2010
Watson Pharmaceuticals (former Andrx site) 2005 - 2006
Watson Pharmaceuticals 2001 - 2004
Skills
Validation, Process Simulation, 21 CFR Part 11, Medical Devices, V&V, Quality Assurance, GxP, Quality System, Change Control, GMP, Quality Management, Regulatory Affairs, R&D, Six Sigma, Aseptic Processing, Pharmaceutics, Quality Auditing, GAMP, Clinical Trials, Regulatory Requirements, ISO, Operational Excellence, FDA, Computer System..., Design of Experiments, Vaccines, Sop, Lifesciences, Analytical Chemistry, LIMS, Technology Transfer, CAPA, Drug Development, Biopharmaceuticals, Root Cause Analysis, Regulatory Submissions, Laboratory, Biotechnology, Cross-functional Team..., Auditing, GLP, ISO 13485, Process Optimization, Testing, Manufacturing, Clinical Development, Quality Control, Commissioning, Process Engineering, Pharmaceutical Industry
Education
Illinois Institute of Technology 1993 — 1995
BS, Chemical Engineering
Bimeda Inc. July 2010 - Present
Tunnell Consulting September 2009 - September 2010
Baxter BioScience August 2007 - July 2009
Gilead Sciences Inc 1999 - 2007
Skills
V&V, Lifesciences, GLP, R&D, Medical Devices, Quality System, FDA, Biopharmaceuticals, Validation, 21 CFR Part 11, LIMS, GxP, ISO 13485, Regulatory Affairs, Cleaning Validation, Manufacturing, Aseptic Processing, Life Sciences
Education
The Ohio State University
Bachelor's of Science, Entomology with concentration in Chemistry and Biology
Saint-Gobain (Life Sciences) October 2013 - Present
Sartorius Stedim Biotech June 2011 - September 2013
Tunnell Consulting 2009 - May 2011
Cook Pharmica, LLC January 2005 - May 2009
Eli Lilly and Company November 2001 - January 2005
Eli Lilly and Company April 1991 - November 2001
Skills
V&V, FDA, 21 CFR Part 11, Pharmaceutical Industry, Aseptic Processing, Lifesciences, Computer System..., Medical Devices, ISO 13485, LIMS, CAPA, Biopharmaceuticals, Validation, Biotechnology, Sop, GMP, Purification, Engineering, Chromatography, Quality Control, Regulatory Requirements, Pharmaceutics, Aseptic Technique, Fermentation, Cell Culture, Filtration, GxP, SOP
Education
Indiana University-Purdue University at Indianapolis
Tunnell Consulting April 2009 - Present
Tunnell consulting April 2009 - May 2012
sanofi-aventis 1998 - 2009
Sanofi Pasteur 1998 - 2009
Wyeth 1989 - 1998
Skills
Biopharmaceuticals, Biotechnology, 21 CFR Part 11, FDA, Change Control, Lifesciences, Sop, CAPA, Medical Devices, Cross-functional Team..., Protein Chemistry, R&D, GMP, Vaccines, Validation, GxP, Technology Transfer, Manufacturing, V&V, Purification, Infectious Diseases, GLP, Assay Development, Microbiology, Regulatory Affairs, ELISA, Clinical Development, LIMS, Computer System..., Life Sciences, SOP
Education
NYU 1983 — 1988
Doctor of Philosophy (PhD), Biochemistry
TayganPoint Consulting - Merck July 2014 - Present
TayganPoint Consulting Groupt - Merck April 2012 - July 2014
Merck 2012 - 2013
Tunnell Consulting July 2010 - April 2012
Tunnell Consulting June 2010 - April 2012
GlaxoSmithKline 2002 - 2009
SmithKline Beecham Pharmaceuticals January 1999 - January 2002
SmithKline Beecham Pharmaceuticals 1999 - 2002
SmithKline Beecham Pharmaceuticals January 1997 - January 1999
Skills
Pharmaceutical Industry, FDA, Regulatory Affairs, SOP, Pharmaceutics, Management, Regulatory Submissions, Strategy, Regulatory Requirements
Education
University of Phoenix 2000 — 2004
BS.B, Business
Eckerd College
University of Phoenix
BS, Business Administration
Ursinus College
Computer Science and Management
Biotech Wave Consultancy - Owner January 2015 - Present
Black Diamond Networks June 2014 - November 2014
CSC Consultant at AstraZeneca November 2013 - May 2014
Oxford Global Resources - PAREXEL Consultant April 2012 - September 2012
Astrix Technology July 2011 - March 2012
Tunnell Consulting June 2010 - June 2011
Delaware Department of Justice December 2009 - April 2010
Wyeth Pharmaceuticals July 2008 - January 2009
MedImmune, Inc. July 2005 - October 2007
SAIC-Frederick, Inc. Federal February 2004 - February 2005
Skills
Regulatory Affairs, Biotechnology, Pharmaceutical Industry, FDA, Validation, Regulatory Submissions, Pharmaceutics, GMP, Clinical Trials, Vaccines, CAPA, Life Sciences, IND, Compliance, Quality Assurance, Medical Devices, Pharmaceuticals, Documentation, eCTD, 21 CFR Part 11, GxP, Biopharmaceuticals, Aseptic Processing, Technology Transfer, GCP, CRO, SOP, GLP, V&V, ICH-GCP, Clinical Development, Regulatory Requirements, Infectious Diseases, Computer System..., Online Communications, Lifesciences, LIMS, Quality System, Regulatory Systems
Education
Center for Professional Innovation and Education 2014 — 2017
Certification as a Chemistry, Manufacturing and Controls Certified Professional
Association of Clinical Research Professionals
Certificate, Clinical Trials
Widener University School of Law
American Bar Association Certified Paralegal, Litigation, 3.88 Magna Cum Laude
NAPRX
CNPR Certificate #: 568932009, Pharmacology/Pharmaceutical Sales Training Program
Keystone College 1973 — 1975
AA, Biology
Franklin Covey
7 Habits of Highly Effective People Workshop
State University of New York at Binghamton
Marine Science, Biology, Computer Science
Tunnell Consulting 2004 - 2009
Lachman Consulting Services 2004 - 2009
Lachmann 2005 - 2008
Quintiles 2003 - 2005
Pharmacia & Upjohn April 1994 - December 2003
Sandoz Inc United States April 1984 - March 1994
Skills
21 CFR Part 11, CAPA, GMP, Pharmaceutical Industry, FDA, Lifesciences, GxP, Quality Auditing, R&D, Six Sigma, Regulatory Submissions, Quality Control, Project Management, LIMS, Medical Devices, Validation, Quality Assurance, Sop, Quality Management, Computer System..., Quality System, V&V, GCP, Regulatory Requirements, Regulatory Affairs, GAMP, Clinical Development, CRO, HPLC, Pharmaceutics, Change Control, ISO 13485, Process Simulation, IND, ISO, Infectious Diseases, Formulation, Pharmacovigilance, Document Management, Drug Development, CTMS, Microbiology, Protocol, Vaccines, Aseptic Processing, Analytical Chemistry, Laboratory, Cleaning Validation
Education
Rutgers University-New Brunswick 1969 — 1972
Ph.D, Pharmaceutics
Tunnell Consulting July 1991 - Present
General Dynamics 1984 - 1991
Skills
Process Improvement, Strategic Planning, Six Sigma, Operational Excellence, Change Management, Project Management, Talent Acquisition, Pharmaceutical Industry, Continuous Improvement, Quality Assurance, Training, Leadership, Business Process..., Cross-functional Team..., Coaching
Education
Montgomery County Community College 1977 — 1979
Associates, Secretarial
MATC Group, Inc February 2012 - Present
Astriva February 2013 - Present
One Source Staffing - At Geisinger Health Systems March 2012 - January 2013
Tech USA March 2011 - July 2011
Tech USA August 2010 - December 2010
Strategic Software Solutions December 2008 - May 2009
Kelly Services August 2008 - January 2009
Tunnell Consulting October 2007 - August 2008
EDS, Inc August 2005 - August 2007
TMG Health December 2004 - July 2005
Skills
Software Documentation, Quality Assurance, Business Analysis, SDLC, Process Improvement, Document Management, Project Management, Technical Writing, Visio, SharePoint, MS Project, Change Management, Access, Requirements Analysis, Adobe Acrobat, Integration, Process Simulation, Training, SQL, Troubleshooting, Proposal Writing, FrameMaker, FDA, Project Planning, Business Process..., Cross-functional Team..., GMP, Analysis, Vendor Management, Program Management, Testing, Pharmaceutical Industry, Databases, Management, Technical Documentation, Requirements Gathering, Business Process, Team Leadership, Data Analysis, Six Sigma, Human Resources
Education
College Misericordia
Bachelor's Degree, Business Administration
Crestwood High School
Luzerne County Community College
Business Administration
Qualitest Pharmaceuticals September 2012 - Present
Quintiles February 2012 - September 2012
Pearl Therapeutics January 2011 - January 2012
Catalent Pharma Solutions January 2009 - January 2011
Tunnell Consulting February 2009 - August 2009
Wyeth Vaccines January 2004 - January 2009
Pfizer January 1995 - January 2004
Skills
CAPA, Validation, GMP, Sop, Change Control, Biotechnology, Biopharmaceuticals, SAP, MES, LIMS, Trackwise, EMCA Regulations, Pharmaceutical process..., Fermentation, cGMP practices, cGMP manufacturing, Internal Audit, Quality Auditing, Batch Records, Lyophilization, Filtration, Quality Assurance, Aseptic Technique, 21 CFR Part 11, FDA, Pharmaceutical Industry, SOP, TrackWise
Education
ECPI College of Technology
AAS, Applied Science
University of Phoenix
Bachelor of Science (B.S.), Industrial Technology
PNC July 2013 - Present
PNC Bank September 2012 - July 2013
PNC August 2011 - August 2012
Kirsten Fedewa & Associates October 2010 - July 2011
Episcopal Church of the April 2010 - June 2010
Dilworthtown Inn June 2008 - June 2009
Tunnell Consulting June 2007 - August 2007
Skills
Media Relations, Management, Marketing, Financial Analysis, Social Networking
Education
Penn State University 2006 — 2010
B.S., Marketing
Tunnell Consulting October 2009 - March 2010
Tunnell Consulting 2009 - 2010
Skills
GMP, CAPA, FDA, Validation, Pharmaceutical Industry, V&V, Change Control
Education
University of Pennsylvania 1969 — 1973
BSEE, Electrical engineer
Zimmer Biomet August 2014 - August 2015
McNeil Consumer Healthcare October 2012 - June 2013
Tunnell Consulting March 2012 - June 2012
Shire Pharmaceuticals, Inc. March 2010 - September 2010
GlaxoSmithKline Biologicals July 2009 - December 2009
Biokinetics Inc. August 2008 - February 2009
Pharma-BioServ Inc. March 2007 - April 2008
GlaxoSmithKline April 2006 - March 2007
Aerotek Scientific October 2005 - February 2006
Washington Group International June 2004 - May 2005
Skills
Pharmaceutical Industry, Validation, Qualification Testing, Change Control, 21 CFR Part 11, GMP, GLP, SOP Writing, Technical Writing, Computer System..., Quality System, CAPA, Biotechnology, Process Simulation, GxP, Manufacturing, Sop, FDA, SOP
Education
The State University of New Jersey at Rutgers 1986 — 1990
B. A., Computer Science
Manhattan College 1974 — 1979
M. Ch. E. ; B. Ch. E., Chemical Engineering
Tunnell Consulting
Skills
Quality Assurance, Process Improvement, Biotechnology, Change Management, FDA, Talent Management, Software Documentation, Cross-functional Team..., Applicant Tracking..., Salesforce.com, Pharmaceutical Industry, Team Building, Professional Travel..., Strategy
Education
Philadelphia University 1975 — 1979
Bachelor of Science, Marketing/Merchandising
ZeroBased Consulting, LLC February 2013 - Present
Tunnell Consulting May 2008 - February 2013
Johnson & Johnson August 1992 - August 2000
McNeil Pharmaceutical August 1988 - August 1992
McNeil Pharmaceutical August 1984 - August 1988
Skills
Operational Excellence, Pharmaceutical Quality..., Quality by Design, Supply Chain, Strategic Sourcing, Process Optimization, Pharmaceutical..., Six Sigma Master Black..., Organizational Design, Quality System, Change Management, Strategy, Six Sigma, Risk Management, Advanced Data Analysis
Education
Villanova University 1981 — 1984
Master of Science (M.S.), Chemistry
Albright College 1973 — 1977
Bachelor of Applied Science (B.A.Sc.), Chemistry
Axcellerate Pharma 2013 - Present
PhuturePharm Associates, LLC 2006 - Present
Enzon Pharmaceuticals 2007 - 2013
Tunnell Consulting 2006 - 2007
Bristol Myers Squibb 1981 - 2006
Skills
Registered Pharmacist,..., Pharmaceuticals and..., Strategic Planning, Outsourcing, Contract Manufacturing, Consulting, Business Development, Supply Chain Management, Materials Management, pharmaceuticals..., Contract Negotiations, Finance, Capital Planning and..., Financial Analysis, Biotechnology, biologics and Chemical..., Technology Transfer, 21 CFR Part 11, Product Launch, Six Sigma, New Product Planning,..., Lean Manufacturing, Process Improvement, Procurement and Sourcing, cGMP, EHS, Cross-functional Team..., Lifesciences, GMP, Life Sciences, Management, Strategy, Validation, FDA, Contract Negotiation
Education
Brooklyn College of Pharmacy
Bachelor of Science, Pharmacy
Rutgers University
Bachelor of Science, Chemistry/Biology
Seton Hall University
Master of Business Administration (M.B.A.), Finance and International Business