Tunnell Consulting, Inc.
Industry: Company
DescriptionHeadquarters: Pennsylvania Founded: 1962
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Tunnell Consulting, Inc. Employees
Biomedical Advanced Research and Development Authority (BARDA) January 2007 - Present
Department of Health and Human Services 2007 - Present
AAPS Pharmco-Imaging FG November 2011 - November 2013
Tunnell Consulting, Inc. 2007 - 2009
Certus International, Inc. September 2004 - January 2007
EPIX Pharmaceuticals 2001 - 2004
Diatide Research Laboratories, Inc., a Division of Berlex Laboratories 1999 - 2001
Diatide Research Laboratories, Inc 1992 - 2001
Diatide, Inc. 1992 - 2001
Salutar Imaging, Inc. (subsidiary of Nycomed) January 1992 - October 1992
Skills
Biotechnology, Oncology, Lifesciences, Pharmaceutical Industry, Clinical Trials, CRO, Drug Development, Regulatory Affairs, FDA, Clinical Development
Education
University of California, San Francisco 1981 — 1986
M.S., Pharmacology
University of San Francisco 1980 — 1982
M.S., Toxicology
Tunnell Consulting, Inc. June 2013 - Present
SGS Life Science Services October 2011 - May 2013
Synomics Pharma June 2007 - December 2010
MDS Pharma Services May 2006 - June 2007
MDS 2006 - 2007
Charles River Laboratories May 2000 - May 2006
Bayer Corporation Pharmaceutical Division 1994 - 2000
Bristol-Myers Squibb 1990 - 1994
Columbia University 1984 - 1990
Skills
CRO, GLP, Biotechnology, Pharmaceutical Industry, Clinical Development, Drug Discovery, Lifesciences, Sop, Bioanalysis, FDA, Clinical Trials, Regulatory Affairs, GMP, Biopharmaceuticals, Validation, Oncology, Toxicology, HPLC, Technology Transfer, Pharmacokinetics, R&D, Quality Assurance, Regulatory Submissions, LIMS, Medical Devices, Laboratory, Clinical Research, GCP, Quality Management, Chemistry, CAPA, Quality System, Mass Spectrometry, Pharmaceutics, Proteomics, Quality Control, Tissue Culture, Sales Operations, Drug Development, Cell, LC-MS, Pharmacology, Cell Culture, Chromatography, In Vitro, Protein Chemistry, Analytical Chemistry, Protocol, Vaccines, Organizational...
Education
University of Iowa 1978 — 1981
BS, Cell Biology
Neolpharma May 2013 - Present
Tunnell Consulting, Inc. October 2011 - March 2013
MENTOR Technical Group Corporation July 2010 - October 2011
Mi Esperanza PR November 2009 - July 2010
Skills
Product Development, Technical Services, Technical Leadership, Validation, Product Transfer, cGMP practices, Project Management, DMAIC, 21 CFR Part 11, Technology Transfer, CAPA, Technical Writing, Cleaning Validation, Equipment Qualification, Change Control, Cross-functional Team...
Education
University of Puerto Rico-Rio Piedras
The Quantic Group, Ltd September 2010 - Present
Baxter International Inc. February 2014 - December 2014
Tunnell Consulting, Inc. 2012 - 2013
Lachman Consultant Services 2009 - 2010
Sanofi Aventis, Sanofi Pasteur May 2007 - July 2009
University of Phoenix 2002 - 2009
Merck Schering-Plough Pharmaceuticals 2002 - 2006
Schlumberger 1995 - 2001
Reckitt Benckiser January 1990 - 1993
Skills
Quality System, Medical Devices, ISO13485, Project Management, Program Management, Manufacturing, Validation, Post Market Surveillance, Management Consulting, Complaint Investigations, Deviation Management, Biotechnology, Stability Studies, Analytical Biochemistry, Lifesciences, Sterility Assurance, Management, Sop, Business Process, GMP, Quality Management, Leadership, FDA, CAPA, Quality Assurance, Change Control, Life Sciences, SOP
Education
University of Phoenix 2004 — 2009
Doctor of Management in Organizational Leadership, Leadership and Organizational Effectivess
Drexel University - College of Business and Administration 1993 — 1995
MBA, Marketing and International Business
Institute of Business Administration 1989 — 1991
Post Graduate Diploma, Business Administration, 3.65
NED University of Engineering and Technology 1981 — 1985
BSME, Mechanical & Process Engineering
Tunnell Consulting, Inc. May 2014 - Present
Consulting FM April 2014 - May 2014
Confab Laboratories May 2011 - April 2014
Sandoz Canada inc September 2004 - May 2011
Schering Plough Canada (now Merck Canada) June 2001 - August 2004
Galderma 1998 - 2001
Galderma 1998 - 2001
Skills
Quality Assurance, Pharmaceutics, Quality Control, Sterilization, Manufacturing, Contract Manufacturing, Leadership, Laboratory, Business Development, GMP
Education
Université de Montréal / University of Montreal 1980 — 1985
Master in Sciences, Organic Chemistry
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
Tunnell Consulting, Inc. May 2015 - Present
M+W Group January 2012 - May 2015
Structure Tone January 2008 - February 2012
Skanska USA Building 1998 - 2007
EI Associates October 1989 - October 1998
Skills
Program Management, Construction Management, CRM, Construction, Contract Management, Leadership, Business Planning, Business Development, Team Leadership, Management, Contract Negotiation, Strategic Planning, Strategy, Team Building, Sales, Project Management, Business Strategy, New Business Development, Pharmaceutical Industry, Pre-construction, Account Management, P&L Management, Project Planning, Procurement, Budgets, Negotiation, Proposal Writing, Change Management, Cross-functional Team..., Operations Management
Education
Rider University 1974 — 1976
BS Commerce, Marketing, Finance
West Chester University of Pennsylvania 1972 — 1974
BS, Marketing
Tunnell Consulting, Inc. October 2013 - January 2015
FDA November 1990 - September 2013
US FDA November 1988 - September 2013
Skills
FDA, Regulatory Affairs, Public Health, Regulatory Requirements, Federal Government, Regulations, Policy, Microbiology, Epidemiology, Environmental Health, Infectious Diseases, Health Communication, Government, Policy Analysis, Emergency Management, FDA GMP, SOP, CAPA, Change Control, Technology Transfer, GMP, Pharmaceutical Industry, GLP, Public Policy, Biotechnology
Education
Cheyney University of Pennsylvania 1974 — 1979
Bachelor's Degree, Chemistry
Tunnell Consulting, Inc. March 2015 - Present
Turesol Staffing Solutions May 2014 - March 2015
Aflac January 2014 - May 2014
Pathmark June 2007 - January 2014
Skills
Microsoft Office, PowerPoint, Teamwork, Microsoft Excel, Microsoft Word, Time Management, Public Speaking, Organization, Leadership, Customer Service, Training, Human Resources, Recruiting, Critical Thinking, Strategy, Management, Sourcing
Education
Penn State University 2009 — 2014
Bachelor of Science (B.S.), Communications Arts and Sciences
Concord 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
Tenax Therapeutics, Inc. (formerly Oxygen Biotherapeutics, Inc.) June 2012 - Present
Clinical Research Management June 2011 - February 2012
SAIC January 2009 - June 2011
BWA Consulting, LLC December 2008 - December 2009
Tunnell Consulting, Inc. May 2008 - December 2008
Lonza Walkersville, Inc. August 2004 - January 2008
USP Chapter <1046> ad hock Advisory Panel 2007 - 2008
Argos Therapeutics March 2001 - July 2004
Diosynth January 1996 - June 2001
Wyeth Biotech June 1991 - January 1996
Skills
FDA, GMP, GLP, GCP, Clinical Trials, Validation, Technology Transfer, Biotechnology, Quality Control, Quality Assurance, CAPA, Sop, Purification, Protein Chemistry, Lifesciences, Microbiology, Vaccines, Life Sciences, Regulatory Submissions, Biopharmaceuticals, Pharmaceutical Industry, Cell, R&D, Quality System, V&V, Computer System..., CMC, Regulatory Complicane, Fermentation Process..., Project Management, IND & CTD
Education
Hood College 1978 — 1980
BA, Biology
Teva Pharmaceuticals June 2014 - Present
Operations & Quality Systems Improvement Experts (OQSIE) December 2013 - June 2014
Osman Inc. July 2007 - June 2014
Tunnell Consulting, Inc. October 2001 - July 2007
Answerthink, Inc. August 2000 - July 2001
Skills
Project Management, Strategy, Consulting, Production Planning, Risk Management, Demand Planning, Management, Strategic Sourcing, Budgets, Risk Assessment, CRM, Capacity Planning, Sales, Business Continuity, Process Scheduler, Change Control, Process Improvement, Manufacturing, Pharmaceutical Industry, Process Engineering, Operational Excellence, Cross-functional Team..., Business Process..., Supply Chain Management, Supply Chain, Outsourcing, Management Consulting, Logistics, GMP, Quality Assurance, Change Management, Contract Manufacturing, Business Transformation, Biopharmaceuticals, Operations Management, Sop, Business Process, Quality System, Procurement, Project Portfolio..., Leadership, Lean Manufacturing
Education
University of Tennessee-Health Science Center
College of Pharmacy, Postgraduate Pharmaceutical Tablet Technology
Drexel University 1989 — 1995
BSME, Mechanical Engineering
Chesapeake Current February 2010 - Present
Bayside Partners, LLC October 2006 - Present
Chesapeake Bay Tripper January 2011 - Present
Tunnell Consulting, Inc. 2008 - 2008
Mercer 1997 - 2006
Mercer 1997 - 2006
United Press International 1996 - 1998
Associated Press 1991 - 1996
ABC Radio Network 1991 - 1991
CBS Radio Network News 1990 - 1991
Skills
Advertising, Coaching, Leadership Development, Strategic Planning, Management, Organizational..., Public Speaking, Public Relations, Marketing, Talent Management, Human Resources, Business Development, Project Management, Event Management, Sales Management, Social Networking, Broadcast, Customer Service, Recruiting, Leadership, Photography, Storytelling, New Media, Publications, Magazines, Newspapers, Radio, Strategy, Radio Broadcasting, Social Media Marketing, Marketing Communications, Online Marketing, Strategic Communications, Email Marketing, Online Advertising, Newsletters, Corporate Communications, Digital Media, Blogging
Education
University of Maryland (University College) 2001 — 2002
Bachelor Of Science, Psychology
University of Maryland University College 2000 — 2001
Master's, Management
University of Maryland (University College) 1998 — 1999
Bachelor of Science, Management
ALLIANCE, HIGH SCHOOL 1977 — 1979
Telecom, Telecommunications
Marlington High School
High School Diploma
Britt Pharma Consulting, LLC May 2013 - Present
Tunnell Consulting, Inc. May 2013 - Present
MicroDose Therapeutx April 2009 - September 2012
MicroDose Technologies, Inc. September 2004 - April 2009
Consulting March 2004 - August 2004
Novartis Pharmaceuticals January 1997 - November 2003
CIBA Pharmaceuticals June 1995 - January 1997
CIBA Pharmaceuticals November 1992 - June 1995
Ciba-Geigy Pharmaceuticals Divison January 1990 - November 1992
Skills
ISO 13485, GMP, Pharmaceutical Industry, FDA, CAPA, Quality Management, Quality Systems, Change Control, SOP development, CMC development, Validation, Quality Assurance, Quality Control, Quality Operations, Medical Devices, Pharmaceutics, GxP, R&D, V&V, Quality System, Clinical Development, Sop, GLP, CRO, Computer System..., Clinical Trials, Cleaning Validation, Regulatory Affairs, Technology Transfer, Biotechnology, Biopharmaceuticals, GCP, Aseptic Processing, IND, Lifesciences, LIMS, Regulatory Submissions, Regulatory Requirements, HPLC, Trackwise, Drug Delivery, Analytical Chemistry, Quality by Design, Design Control, CMC, ISO 14971, Deviation Management, Chemistry, Laboratory, Quality Auditing
Education
Fordham University
Ph.D., Organic Chemistry
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
Tunnell Consulting, Inc. August 2014 - Present
Breakthrough Business Performance LLC January 2014 - August 2014
Merck Research Labs July 2012 - December 2013
Merck November 2010 - June 2012
Merck January 2007 - October 2010
Skills
Six Sigma, Cross-functional Team..., Change Management, Process Improvement, Operational Excellence, Continuous Improvement, Pharmaceutical Industry, Process Engineering, Lean Manufacturing, Process Optimization, Business Process..., Project Management, Program Management, Business Process Mapping, Management Consulting, DMAIC, Training, FDA, Leadership, SAP, Strategy, Supply Chain Management, CAPA, Quality Assurance, Quality Management, Business Process, Quality System, Process Simulation, Process Management, Strategic Planning, Validation, GMP, Manufacturing, Vendor Management, Supply Chain, Project Portfolio..., Business Transformation, Root Cause Analysis, Operations Management, Strategic Sourcing, Kaizen, Value Stream Mapping
Education
James Madison University 1983 — 1986
MBA, Business
Virginia Polytechnic Institute and State University 1979 — 1982
BS, Industrial Engineer
Yoh, A Day & Zimmermann Company July 2014 - June 2015
Validant November 2013 - March 2014
Tunnell Consulting, Inc. February 2013 - September 2013
a-connect February 2012 - November 2012
Oriel STAT A MATRIX June 2011 - 2012
ImClone Systems, wholly-owned subsidiary of Eli Lilly & Co. August 2004 - October 2009
Wyeth October 2001 - November 2003
Wyeth January 1996 - October 2001
Teva Pharmaceuticals (formerly Biocraft Labs) September 1989 - January 1996
Baxter Healthcare, Microscan Division 1988 - 1989
Skills
GMP, cGMP practices, cGMP manufacturing, Training Delivery, Training Facilitation, SOP development, ICH guidelines, 21 cfr 211, CAPA, Quality Assurance, Environmental Monitoring, Environmental..., Training Effectiveness, Quality System..., Curriculum Development, Curriculum Assessment, Problem Solving, Presentation Coaching, Train the Trainer..., Project Management, Continuous Improvement, Training, FDA, Instructional Design, Auditing, Technology Transfer, Change Control, GLP, Pharmaceutical Industry, Lifesciences, 21 CFR Part 11, Validation, Quality System, Computer System..., Biotechnology, Biopharmaceuticals, Sop, Program Management, Quality Control, Laboratory, GxP, Regulatory Requirements, Microbiology, Cross-functional Team..., Quality Auditing, Quality Management, Operational Excellence
Education
William Paterson University of New Jersey 1990 — 1994
M.B.A., Management
Rutgers, The State University of New Jersey-Newark
B.A., Biology
North Bergen High School
UGI Corporation September 2015 - Present
CSL Behring March 2013 - May 2015
CSL Behring January 2013 - March 2013
Octagon Research Solutions June 2012 - September 2012
Venio, LLC D/B/A Keane March 2010 - February 2012
Tunnell Consulting, Inc. March 2003 - June 2009
Skills
HRIS, Applicant Tracking..., Training, Leadership, Management, Microsoft Excel, Benefits Administration, Onboarding, Recruiting, Human Resources, PowerPoint, Employee Benefits, Business Process Mapping, Employee Training, Employee Recognition, Talent Acquisition, Deferred Compensation, Sourcing, HR Policies, Microsoft Word, SAP, Benchmarking, Compensation, HR Project Management, Notary Public, Performance Management, Employee Surveys, Event Planning, Microsoft Outlook 2010, Salesforce Administrator, Microsoft Office 2007, Microsoft Excel 2010, Microsoft PowerPoint..., Smart Draw, Payroll Processing, Marketing Communications, Email Marketing, Office Relocation, Relocations, Proposal Writing, FMLA, ADP Payroll, Ad-Hoc Reporting, Paychex, Employee Handbooks, Employee Wellness, Purchase Orders, Project Management, Software Documentation, Employee Relations
Education
Albright College 2013 — 2015
Bachelor of Science (BS), Business Administration and Management, 3.5
Montgomery County Community College 2009 — 2012
Associate of Science (AS), Business Administration, 3.5
Immaculata University 2008 — 2009
B.A., Human Performance Management/Organizational Dynamics, Human Resources, 3.8
AstraZeneca August 2015 - Present
Tunnell Consulting, Inc. December 2013 - August 2015
AstraZeneca 2015 - 2015
Laureate Biopharmaceutical Services March 2012 - June 2013
Human Genome Sciences January 2003 - January 2012
HGS 2007 - March 2010
Lonza December 1994 - June 2003
Lonza Biologics 1995 - 2003
Genetics Institute August 1987 - December 1994
Genetics Institute (now Wyeth) 1987 - 1994
Skills
Biopharmaceuticals, Technology Transfer, Biotechnology, FDA, Pharmaceutical Industry, Manufacturing, Contract Manufacturing, GMP, Validation, Purification, Cell Culture, Lifesciences, Lean Manufacturing, Vaccines, Clinical Development, GLP, Life Sciences, Marketing Strategy, Contract Negotiation, Drug Discovery, SOP, Change Control, Salesforce.com, CAPA, Protein Chemistry, Change Management, Sales Management, Laboratory Medicine, Trade Shows, Regulatory Affairs, Medical Devices, Commercialization, Regulatory Submissions, Aseptic Processing, Cell, Manufacturing..., Strategic Alliances, Business Relationship..., Contract Negotiations, Great People Skills, USCG Captain
Education
Charter Captains Course 2015 — 2015
USCG Master Captain
Northeastern University - Graduate School of Business Administration 1994 — 1997
Master of Business Administration (MBA), Management
University of Massachusetts at Lowell 1980 — 1984
BS, Medical Technology
Tunnell Consulting, Inc. June 2013 - Present
Johnson Controls July 2012 - December 2012
Oxfam GB September 2010 - May 2012
FedEx Office September 2006 - September 2010
ACS (Affiliated Computer Services) January 2004 - August 2006
Skills
Employee Relations, Performance Management, HRIS, HR Policies, Deferred Compensation, Benefits Administration, Organizational..., Talent Management, Recruiting, Succession Planning, Human Resources, Employee Engagement, Labor Relations, Training, Personnel Management, Employee Benefits
Education
Cairn University 2008 — 2010
Master's degree, Organizational Leadership
Rider University 1997 — 2000
Bachelor of Arts (BA), Liberal Arts and Sciences, General Studies and Humanities
Tunnell Consulting, Inc. June 2015 - Present
Validant February 2010 - May 2015
PII March 2009 - November 2009
Tobira Therapeutics June 2008 - February 2009
Bristol-Myers Squibb June 1982 - February 2008
Bristol-Myers Squibb 1982 - 2008
Skills
Quality Assurance, Quality Systems, Quality Management, Document Management, Information Management, Investigations, CAPA, Business Process..., Change Management, Private Investigations, Quality System, FDA, GMP, V&V, Quality Control, Validation, Testing, Change Control, Trackwise, Pharmaceutics, GLP, Drug Development, Quality Auditing, Sop, Software Documentation, LIMS, 21 CFR Part 11, R&D, Computer System..., GCP, IND, Formulation, Cleaning Validation, GxP, Technology Transfer, Regulatory Affairs, GAMP, Biopharmaceuticals, SOP, Pharmaceutical Industry, TrackWise
Education
Fairleigh Dickinson University 1983 — 1987
MBA, Pharmaceutical/Chemical Studies
Binghamton University 1978 — 1982
B.S., Chemistry
Ramapo Senior High School
Global GxP Solutions 2015 - Present
Tunnell Consulting, Inc. August 2014 - June 2015
MyCI Solutions LLC January 2014 - June 2015
Kellogg Company June 2009 - December 2013
GlaxoSmithKline 2008 - June 2009
GlaxoSmithKline 2004 - 2008
GSK 2000 - 2004
U.S. Department of Agriculture June 1992 - May 2000
Skills
Lean Manufacturing, Six Sigma, Program Management, Product Development, Process Improvement, Pharmaceutical Industry, Continuous Improvement, Packaging, Cross-functional Team..., Manufacturing, Operational Excellence, Procurement, Supply Chain, Strategy, GMP, Change Management, Value Stream Mapping, Supply Chain Management, Management, Leadership, Strategic Planning, Project Management, FDA
Education
Michigan State University
Bachelor of Science (BS), Packaging
Tunnell Consulting, Inc. March 2015 - July 2015
ALKU Technologies November 2014 - January 2015
Validation Technologies, Inc. March 2014 - September 2014
Validant April 2013 - January 2014
ProPharma Group February 2012 - March 2013
Pharmceutical Validation Solutions December 2007 - April 2012
Amgen January 2006 - October 2007
VaxGen June 2005 - November 2005
Boston Scientific, MN November 2004 - June 2005
various Ambulance Services June 1993 - August 2004
Skills
Cleaning Validation, Validation, Commissioning, Project Management, Technical Writing, Quality Assurance, Consent Decree..., Consent Decree, FDA, Change Control, V&V, Sop, GAMP, GLP, Aseptic Processing, Trackwise, GMP, CAPA, Computer System..., GxP, 21 CFR Part 11, Medical Devices, Biotechnology, Quality System
Education
Three Rivers Community College 1995 — 1996
Englewood Sr High School 1983 — 1986
HS Diploma
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
Tunnell Consulting, Inc. June 2015 - Present
Skills
Applicant Tracking..., Contract Recruitment, Temporary Placement, Training, Internet Recruiting, Talent Acquisition, Technical Recruiting, Customer Service, Temporary Staffing, Recruiting, Social Networking, Policy, Administrative Work, Meeting Scheduling, Organization, Microsoft Office, Liaison, Software Documentation, Leadership, Onboarding, Organizational..., Interviews, Human Resources, Staffing Services
Education
Kutztown University of Pennsylvania 2002 — 2005
BS
National Academy of Sports Medicine
Clarkston Consulting July 2015 - Present
NDA Life Sciences November 2014 - June 2015
NDA Life Sciences LLC - Senior Consultant November 2014 - June 2015
SC Acclimation Consulting, LLC May 2012 - June 2015
Tunnell Consulting, Inc. November 2013 - November 2014
NDA Consultants May 2012 - February 2014
GSK Inc. November 2008 - October 2011
GSK Inc. April 2007 - November 2008
GSK Inc. January 2006 - April 2007
GlaxoSmithKline Inc. March 2001 - December 2005
Skills
Supply Chain Process..., Import/Export..., Process Optimization &..., Outsourcing/Off-shoring..., Global Project..., Business KPI Improvement, Class A MRP II..., Training Program..., Shared Services Start-up, Staff/Budget Management, Production/Capacity..., Sales/Operations..., Leadership Mentoring, Staff Mentoring, Build and develop high..., Compliance, Supply Chain, Business, Management, MRPII, Key Performance..., Training, Project Management, Pharma Trade Dress..., Continuous Improvement, Pharmaceutical Industry, Logistics Service..., Pharma Trade Dress..., Logistics, Outsourcing, Forecasting, Process Improvement, Six Sigma, Cross-functional Team..., Manufacturing, Business Process, Business Process..., Supply Chain Management, Integration, Product Development, Business Analysis, Operational Excellence, Contractor Management, Contractual Agreements, Demand Planning, Supply Management, Software Documentation, Operations Management, Change Management, Leadership
Education
Conestoga College 1980 — 1983
3 year degree in Supply Chain Management, SC Management
Client Alignment LLC 2013 - Present
AmerisourceBergen 2009 - 2012
Tunnell Consulting, Inc. 2007 - 2008
PRA International 2006 - 2007
IMS Health 1985 - 2005
Skills
Market Research, Strategic Planning, Sales, Business Strategy, Business Development, Marketing, Strategy, New Business Development, Management, Strategic Partnerships, Leadership, Account Management, Consulting, Lead Generation, Healthcare, Pharmaceutical Industry, Cross-functional Team..., Competitive Analysis, Competitive Intelligence, Analytics, Biotechnology, Key Account Management, Market Analysis, Coaching
Education
Boston University
MBA
Villanova University
BS, Science
PD International Holdings, LLC January 2014 - Present
Randstad Engineering US November 2013 - December 2013
Tunnell Consulting, Inc. July 2013 - October 2013
KIK Custom Products December 2011 - August 2012
KV Pharmaceutical April 2009 - November 2011
KV Pharmaceutical September 2008 - April 2009
Pfizer September 2001 - August 2008
Kane Reeves International September 1997 - September 2000
John Hill Associates and Kilowen Ltd October 1996 - September 1997
Hotel Properties Limited October 1995 - September 1996
Skills
Pharmaceutical Industry, GMP, Technology Transfer, CAPA, FDA, Validation, V&V, Sop, Change Control, Continuous Improvement, Manufacturing, 21 CFR Part 11, Project Management, Quality System, Regulatory Affairs, R&D, Aseptic Processing, Drug Delivery, Product Development, GxP, Biotechnology, Quality Assurance, Generic Programming, Protocol, Biopharmaceuticals, Strategic Planning, GLP, Program Management, Contract Manufacturing, Team Building, MS Project, Product Lifecycle..., Regulatory Requirements, Leadership, Formulation, Pharmaceutics, Quality by Design, Cross-functional Team..., Change Management, Process Improvement, Lean Manufacturing, Process Engineering, Process Simulation, Quality Auditing, Procurement, Quality Control, Project Planning, Engineering, Six Sigma, Root Cause Analysis
Education
Queensland University of Technology 1982 — 1987
Bachelor of Applied Science (BASc), Quantity Surveying
Queensland University of Technology 1977 — 1981
Certificate, Cartography
Tunnell Consulting, Inc. October 2013 - Present
WorleyParsons September 2010 - August 2013
Howson and Howson LLP October 2005 - August 2010
Merrill Lynch 1985 - 2001
Skills
Billing Systems, Project Management, SharePoint, Management, Microsoft Excel, Analysis, Databases, Process Improvement, Project Planning, Oracle, Accounts Receivable, Accounting, Customer Service
Education
Montgomery County Community College 1984 — 1987
Associate's degree, Computer Science
Tunnell Consulting, Inc. 2005 - Present
LifeBridge Health 2001 - 2004
Catholic Health East 1997 - 1999
PSEG 1988 - 1997
Skills
Talent Management, Talent Acquisition, Organizational Design, Organizational..., Employee Relations, Applicant Tracking..., Human Resources, Change Management, Strategy, HR Strategic Planning, Executive Development..., Management Consulting
Education
Central Michigan University
Master's Degree, Personnel Management
Southern Illinois University
Bachelor's Degree, Occupational Education
Cell Culture Expert January 2011 - Present
Tunnell Consulting, Inc. March 2011 - June 2011
Xcellerex, Inc. May 2008 - May 2009
Organogenesis, Inc. January 2007 - November 2007
Regeneron Pharmaceuticals 1999 - October 2005
Epic Therapeutice, Inc. 1997 - 1999
Damon Biotech 1983 - 1987
Cappell Labs, Inc. 1981 - 1983
Skills
cGMP Cell Banking, Upstream Process..., cell culture lab and..., Cell Culture, GMP, Process Development, Technology Transfer, cGMP, Manufacturing, Cell
Education
Geisel School of Medicine at Dartmouth 1980 — 1981
NIH Research Fellow
National Jewish Hospital & Research Center 1978 — 1979
Post Doc
University of New Hampshire 1975 — 1978
Ph.D.
Wayne State University 1973 — 1975
MS
Suffolk University 1970 — 1973
BS
Clorox September 2013 - Present
CSA-Soliance July 2011 - August 2013
Tunnell Consulting, Inc. August 2008 - June 2011
Human Genome Sciences May 2003 - October 2007
Diosynth April 2001 - April 2003
GlaxoSmithKline July 1992 - March 2001
GlaxoWellcome 1992 - 2001
Abbott Laboratories July 1985 - June 1992
Skills
Biopharmaceuticals, GMP, Process Validation, Process Management, Protein Chemistry, Method Validation, Technology Transfer, Project Management, Process Characterization, Compliance, HPLC, Validation, Biotechnology, Operational Excellence, Process Simulation, FDA, GLP, Sop, Pharmaceutical..., Quality Management, 21 CFR Part 11, Pharmaceutical Industry, Drug Development, Change Control, Regulatory Submissions, V&V, IND, Quality Assurance, CAPA, Quality System, GxP, SOP
Education
University of Wisconsin-Madison
BS, Bacteriology
The University of Texas at Austin
Certificate, Process Management
Mind Source LLC January 2015 - Present
Tunnell Consulting, Inc. March 2000 - December 2014
Skills
Pharmaceutical Industry, Technology Transfer, Validation, FDA, Lifesciences, Quality System, Cross-functional Team..., Regulatory Affairs, Quality Management, GxP, Pharmaceutics, Biotechnology, Medical Devices, Project Management, FDA GMP, Six Sigma, Management, GMP, CAPA, Change Control, 21 CFR Part 11, V&V, Process Improvement, Sop, Regulatory Submissions, Biopharmaceuticals, Computer System..., Drug Development, Vaccines, Regulatory Requirements, Clinical Development, Quality Assurance, Quality Auditing, Process Simulation, SOP, Life Sciences
Education
University of Rochester 1971 — 1975
PhD, Microbiology / Molecular Biology
State University of New York at Buffalo - Roswell Park Memorial Institute / School of Medicine 1968 — 1971
MS, Cell & Molecular Biology / Immunology
Tunnell Consulting, Inc. September 2007 - March 2008
Alcan Packaging, Inc. June 2005 - August 2007
Sanofi Pasteur June 2004 - May 2005
Education
Penn State Lehigh Valley 2003 — 2005
Certificate, Paralegal
Caldwell University 1980 — 1982
B.S., Business Administration
Katharine Gibbs School 1978 — 1980
AA, Liberal Arts/Secretarial Science
Longstreth Sporting Goods, LLC. October 2013 - Present
Lab Support, a division of On Assignment March 2013 - October 2013
Pottstown School District February 2010 - July 2012
TFI Resources August 2008 - January 2009
PrimePay, LLC January 2006 - March 2008
Tunnell Consulting, Inc. March 2001 - October 2005
PQ Corporation February 1986 - January 2001
Skills
Program & Policy..., Staffing, Employee Benefits, Compliance, HRIS, ATS, Employee Relations, Compensation, Employee Training, Employee Handbooks, Employee Relocation, HR Metrics, Policy, Applicant Tracking..., HR Consulting, Temporary Staffing, Human Resources, Talent Management, Onboarding, Training, Temporary Placement, Leadership, Management, Benefits Administration, New Hire Orientations, Talent Acquisition, Technical Recruiting, Recruiting, Interviews, Payroll
Education
Penn State University 1996 — 1999
MBA, Business Administration
Ursinus College 1995 — 1996
Certificate of Professional Studies, Human Resources
Ursinus College 1985 — 1994
BBA, Management
HHS/ASPR/BARDA August 2015 - Present
Tunnell Consulting, Inc. March 2014 - Present
University of Phoenix April 2005 - Present
KP MEX,LLC October 2011 - March 2014
Quintiles Consulting 2012 - 2012
Novavax October 2005 - September 2011
Bowie State University 2006 - 2009
Alpharma 2003 - 2005
Baxter 1990 - 2003
North American Vaccine 1990 - 2001
Skills
Sop, Validation, Quality System, FDA, GMP, Quality Control, Change Control, Medical Devices, GLP, ISO 13485, GCP, Technology Transfer, Auditing, Product Development, Internal Audit, Quality Assurance, Pharmaceutical Industry, Biotechnology, Vaccines, Quality Auditing, Regulatory Affairs, Manufacturing, Laboratory, Program Management, Clinical Research, Training, Management, Biopharmaceuticals, 21 CFR Part 11, Lifesciences, V&V, CAPA, Aseptic Processing, Leadership
Education
Capella University 2003 — 2005
Doctor of Philosophy (Ph.D.), Organizational Leadership and Human Resources Management, GPA 4.0
University of Maryland University College 1998 — 2002
MBA, Business
North Carolina Central University 1972 — 1976
BS, Biology
Tunnell Consulting, Inc. August 2015 - Present
Tunnell Consulting, Inc. September 2014 - August 2015
MedImmune April 2011 - October 2013
MedImmune November 2007 - April 2011
PFIZER CORPORATION February 2005 - November 2007
URL Mutual Pharmaceuticals June 2003 - February 2005
Delaware Engineering and Design Corp. 2000 - 2003
Wick Fisher White 1997 - 2000
Skills
Biotechnology, CAPA, GMP, Root Cause Analysis, Six Sigma, FDA, Validation, Continuous Improvement, Sop, Quality System, Manufacturing, Quality Assurance, Operational Excellence, Pharmaceutical Industry, Cross-functional Team..., Clinical Development, Change Control, V&V, Vaccines, Quality Control, Process Simulation, ISO 13485, Technology Transfer, Aseptic Processing, Biopharmaceuticals, Process Improvement, Strategy, 21 CFR Part 11, R&D, SOP, Quality Auditing
Education
University of Maryland - Robert H. Smith School of Business 2013 — 2014
Executive MBA
University of Delaware 1991 — 1995
BME, Mechanical Engineering
Alexis I DuPont high school
KME Leadership, LLC June 2012 - Present
Tunnell Consulting, Inc. April 2014 - January 2015
PCI - Pharmaceutical Calibrations and Instrumentation, LLC 2013 - 2013
MedImmune April 2008 - June 2012
Amgen 2005 - 2008
GSK 1989 - 2003
Genentech 1986 - 1989
DuPont August 1972 - April 1986
Skills
Biotechnology, Healthcare, Cross-functional Team..., Strategic Planning, Strategy Development, Strategy, Pharmaceutical Industry, Management, Leadership Development, Leadership, Team Building, Consulting, Quality System, Workshop Facilitation, Project Planning, Validation, Program Management, Start-ups, Change Management, Medical Devices, Six Sigma, GMP, Project Management, Quality Assurance, Executive Coaching, Process Improvement, Strategic Leadership, Business Development
Education
Georgetown University 2010 — 2011
Certificate, Leadership Coaching
Clemson University 1967 — 1971
BA, Architecture
Drexel University 1971 — 1974
BS, Architecture
Tunnell Consulting, Inc. June 2014 - Present
Quintiles November 2011 - Present
Boehringer Ingelheim Chemicals, Inc. October 2008 - March 2011
Boehringer Ingelheim Chemicals September 2007 - September 2008
Eli Lilly and Company November 2003 - August 2007
MedImmune December 1999 - November 2003
IDEC Pharmaceuticals February 1997 - December 1999
Novum Inc. August 1993 - September 1996
Biogen, Inc. April 1989 - May 1993
Bioran Medical Laboratory September 1986 - April 1989
Skills
Pharmaceutical Industry, Biopharmaceuticals, Medical Devices, API, Quality System, Supplier Quality, Supplier Auditing, Internal Auditing, Deviation Management, Change Management, Document Management, CAPA, Annual Product Reviews, Batch Release, Internal Audit, Reviews, Sop, Quality Assurance, V&V, Cleaning Validation, FDA, GMP, Validation, Trackwise, Quality Auditing, Change Control, Quality Control, Auditing, APIs, GxP, LIMS, Computer System..., 21 CFR Part 11, Biotechnology, GLP, Software Documentation, HPLC, Regulatory Requirements, Regulatory Affairs, Technology Transfer, Regulatory Submissions, GAMP, Laboratory, Deviations, Drug Development, Pharmacovigilance, Pharmaceutics, Aseptic Processing, Vaccines, Clinical Development
Education
Bethany College 1981 — 1985
B.S., Biology
ONMedical August 2015 - Present
QCS North America June 2013 - June 2015
Validant January 2013 - May 2013
Tunnell Consulting, Inc. April 2012 - December 2012
Beckman Coulter September 2006 - December 2011
Schering-Plough Research Institute September 2001 - September 2006
The University of Iowa August 1998 - September 2002
Schering-Plough Research Institute August 1996 - August 1998
Skills
Lean Manufacturing..., Problem Solving, Manufacturing Operations, Quality Systems, cGMP Change Control..., 5S, Facility Operations, GMP, Process Improvement, Lean Manufacturing, Six Sigma, Change Control, Value Stream Mapping, Manufacturing, Kaizen, Industrial Engineering, Medical Devices, Toyota Production System, Continuous Improvement, Kanban, Validation, ISO, Quality System, Sop, Quality Control, FDA, Technology Transfer, V&V, ISO 13485, Root Cause Analysis, Software Documentation, DMAIC, Quality Auditing, Pharmaceutical Industry, Minitab, Testing, Design Control, SOP
Education
New Jersey Institute of Technology 1986 — 1992
IE, Production and Manufacturing
Teterboro School of Aeronautics 1988 — 1990
Aviation Technology A&P FAA, Aircraft Airframe and Power Plant Certification
Tunnell Consulting, Inc. March 1992 - December 2011
Drexel University 1989 - 1991
Education
Drexel University 1976 — 1978
MBA, Marketing
Drexel University
BS, Accounting
UniTao Pharmaceuticals, LLC January 2015 - Present
Hessiq, LLC June 2012 - Present
Tunnell Consulting, Inc. November 2013 - January 2015
Sanofi Pasteur July 2012 - November 2013
Ben Venue Laboratories January 2011 - June 2012
Boehringer Ingelheim Chemicals April 2009 - January 2011
boehringer ingelheim roxane, inc 2006 - 2009
Boehringer Ingelheim Chemicals 2002 - 2006
Eli Lilly and Company 1991 - 1995
Skills
Aseptic Processing, GMP, FDA, Pharmaceutical Industry, Cross-functional Team..., Continuous Improvement, Chemical Engineering, Manufacturing, Lean Manufacturing, Process Engineering, FDA GMP, Process Improvement, Operational Excellence, Manufacturing Operations, Engineering, Project Management, Change Management, Technology Transfer, Quality System, Validation, Quality Control, Business Process, CAPA, Change Control, Computer System..., Chemistry, Leadership, V&V, Six Sigma, Sop, Quality Assurance, Biotechnology, Process Simulation, Pharmaceutics, Biopharmaceuticals, R&D, 21 CFR Part 11, Regulatory Affairs, Contract Manufacturing, Vaccines, Cleaning Validation, GxP, Quality Auditing, Regulatory Submissions, Medical Devices, Drug Development, Regulatory Requirements, Analytical Chemistry, LIMS, GAMP
Education
Penn State University 1987 — 1991
BS, Chemical Engineering
PAREXEL April 2015 - Present
Tunnell Consulting, Inc. April 2014 - March 2015
PAREXEL March 2012 - October 2013
UPS November 2011 - January 2012
MedImmune January 1999 - August 2011
Yarnell Securtiy Systems March 1998 - December 1999
SecurityLink from Ameritech January 1995 - January 1998
Connaught Laboratory January 1991 - January 1994
Skills
Validation, GMP, Sop, GLP, CAPA, FDA, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, Biopharmaceuticals, Change Control, Aseptic Processing, Quality Control, Vaccines, Quality Assurance, SOP
Education
Strayer University-Pennsylvania
Business Administration and Management, General
Tunnell Consulting, Inc. June 2015 - Present
IPS-Integrated Project Services, Inc. October 2014 - December 2014
McNeil Consumer Healthcare September 2012 - September 2014
The Greer Group August 2011 - February 2012
Eisai Pharmaceuticals 2008 - 2011
Eisai Pharmaceuticals 2005 - 2008
Eisai Pharmaceuticals 2002 - 2005
Skills
Change Control, Sop, CAPA, GMP, Quality System, 21 CFR Part 11, Six Sigma, V&V, Quality Assurance, FDA, Quality Control, Software Documentation, Pharmaceutical Industry, Continuous Improvement, Project Planning, Validation, Technical Writing, Regulatory Affairs, Quality Management, LIMS, GxP, Process Improvement, Document Management, SOP
Education
East Carolina University 1994 — 1997
M.A., English
East Carolina University 1988 — 1992
B.A., English
Tunnell Consulting, Inc. August 2014 - Present
Sanofi Toronto April 2014 - Present
Merck November 2011 - March 2013
Merck November 2003 - December 2008
Merck October 2001 - November 2003
Merck January 1997 - October 2001
Merck May 1996 - December 1996
Merck January 1996 - May 1996
Skills
Vaccines, Regulatory Submissions, Biopharmaceuticals, Fermentation, Validation, GMP, Purification, CMC, Aseptic Processing, Pharmaceutical Industry, Sterilization, Regulatory Affairs, FDA, Sop, Technology Transfer, 21 CFR Part 11, Change Control, SOP
Education
Gwynedd Mercy University 1997 — 2011
BSHS, microbiology, 3.2 GPA
Montgomery County Community College 1971 — 1975
Associate of Arts and Sciences (A.A.S.), Registered Nursing/Registered Nurse