ProPharma Group
Industry: Company
DescriptionFounded: 2001 Subsidiaries: PI Arm, SOLUTIONS in Health Inc., Xendo Holding B.V.
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ProPharma Group Employees
Employee
Years
Job
Industry
Christopher Ford Christopher Ford's ProPharma Group Experience May 2011 - May 2013
Job Medical Devices Regulatory Compliance Consultant
Industry Medical Devices
Experience
Ford & Associates July 2004 - Present
Marion Weinreb & Associates, Inc. June 2009 - Present
Auk Technical Services, LTD October 2014 - Present
Stitches 'n Dishes August 2011 - Present
Food Network February 2012 - Present
fotoMOJO, LLC July 2004 - Present
ProPharma Group May 2011 - May 2013
Foods4Thought April 2012 - April 2013
Game Ready October 2006 - September 2007
Abbott Diabetes Care 2003 - 2004
Skills
Training, CMDCAS, Combination Products, PAI, Gap Analysis, FDA, ISO 13485, Quality System, Medical Devices, CAPA, Quality Assurance, Cross-functional Team..., Design Control, Validation, Product Development, Quality Auditing, Manufacturing, Regulatory Affairs, Project Management, V&V, Market Development, Commercialization, Pharmaceutical Industry, Strategic Planning, Quality Management, Technology Transfer, Start-ups, Product Management, Fashion Photography, Software Documentation, New Business Development, Program Management, R&D, Change Control, Lifesciences, Sop, Product Launch, Process Improvement, Business Development, Healthcare, Team Building, GMP, Management, Biotechnology, Regulatory Submissions, Medical Device Directive, Six Sigma, 21 CFR Part 11, Team Leadership, Regulatory Requirements
Education
University of Phoenix 2002 — 2005
Business Management / Marketing, Business, Marketing
California State University-Dominguez Hills 2003 — 2004
Strategic Planning
American Society for Quality 2000 — 2003
Quality Tools, Customer Satisfaction, ISO Standards
San Jose State University 2001 — 2002
Journalism, Mass Communications
Keesler Technical Training School 1988 — 1988
Certificate, Network Communications
Ford & Associates July 2004 - Present
Marion Weinreb & Associates, Inc. June 2009 - Present
Auk Technical Services, LTD October 2014 - Present
Stitches 'n Dishes August 2011 - Present
Food Network February 2012 - Present
fotoMOJO, LLC July 2004 - Present
ProPharma Group May 2011 - May 2013
Foods4Thought April 2012 - April 2013
Game Ready October 2006 - September 2007
Abbott Diabetes Care 2003 - 2004
Skills
Training, CMDCAS, Combination Products, PAI, Gap Analysis, FDA, ISO 13485, Quality System, Medical Devices, CAPA, Quality Assurance, Cross-functional Team..., Design Control, Validation, Product Development, Quality Auditing, Manufacturing, Regulatory Affairs, Project Management, V&V, Market Development, Commercialization, Pharmaceutical Industry, Strategic Planning, Quality Management, Technology Transfer, Start-ups, Product Management, Fashion Photography, Software Documentation, New Business Development, Program Management, R&D, Change Control, Lifesciences, Sop, Product Launch, Process Improvement, Business Development, Healthcare, Team Building, GMP, Management, Biotechnology, Regulatory Submissions, Medical Device Directive, Six Sigma, 21 CFR Part 11, Team Leadership, Regulatory Requirements
Education
University of Phoenix 2002 — 2005
Business Management / Marketing, Business, Marketing
California State University-Dominguez Hills 2003 — 2004
Strategic Planning
American Society for Quality 2000 — 2003
Quality Tools, Customer Satisfaction, ISO Standards
San Jose State University 2001 — 2002
Journalism, Mass Communications
Keesler Technical Training School 1988 — 1988
Certificate, Network Communications
Carlos L. Pereira Carlos L. Pereira's ProPharma Group Experience 2012 - 2012
Job Computer Validation Specialist at Validation Technologies, Inc. Canada and US
Industry Pharmaceuticals
Experience
Validation Technologies, Inc. May 2012 - Present
Cangene Corporation February 2002 - February 2012
ProPharma Group 2012 - 2012
IBM Global Services February 1998 - August 2000
Rescom Ventures June 1996 - December 1997
Skills
Change Control, GMP, Quality Assurance, Validation, Software Installation, Programming, Quality Systems, Hardware, SQL, Operating Systems, Administration, SQL Server, Documentation, Word, Problem Solving, Customer Relations, GxP, Computer System..., GLP, 21 CFR Part 11, cGMP, SOP, Software Validation, ERP, Risk Management, User Acceptance Testing, GAMP, FDA, LIMS, GCP, SDLC, Change Management, Testing, Process Development, Troubleshooting, Requirements Analysis, Visio, Software Quality..., Trackwise, Technology Transfer, Quality System, Customer Service, Pharmaceutical Industry, Aseptic Processing, Microsoft Word, V&V, Process Simulation, Quality Management, Biotechnology, ISO 13485
Education
University of Winnipeg / Midwestern School of Business and Technology 2000 — 2002
Certificate in Management / Diploma in Database Administrator, Database Administrator
Red River College 1994 — 1996
Computer Analysts Programer, Computer Programing
Red River College 1985 — 1987
Business Administration, Adminsitration and Marketing
Validation Technologies, Inc. May 2012 - Present
Cangene Corporation February 2002 - February 2012
ProPharma Group 2012 - 2012
IBM Global Services February 1998 - August 2000
Rescom Ventures June 1996 - December 1997
Skills
Change Control, GMP, Quality Assurance, Validation, Software Installation, Programming, Quality Systems, Hardware, SQL, Operating Systems, Administration, SQL Server, Documentation, Word, Problem Solving, Customer Relations, GxP, Computer System..., GLP, 21 CFR Part 11, cGMP, SOP, Software Validation, ERP, Risk Management, User Acceptance Testing, GAMP, FDA, LIMS, GCP, SDLC, Change Management, Testing, Process Development, Troubleshooting, Requirements Analysis, Visio, Software Quality..., Trackwise, Technology Transfer, Quality System, Customer Service, Pharmaceutical Industry, Aseptic Processing, Microsoft Word, V&V, Process Simulation, Quality Management, Biotechnology, ISO 13485
Education
University of Winnipeg / Midwestern School of Business and Technology 2000 — 2002
Certificate in Management / Diploma in Database Administrator, Database Administrator
Red River College 1994 — 1996
Computer Analysts Programer, Computer Programing
Red River College 1985 — 1987
Business Administration, Adminsitration and Marketing
Terry Frederick Terry Frederick's ProPharma Group Experience 2009 - 2009
Job Retired
Industry Pharmaceuticals
Experience
Retired December 2014 - Present
Semi-Retired November 2013 - Present
Confidential Client May 2013 - November 2013
21st Century Healthcare 2011 - 2012
Naturally Vitamins, Marlyn Nutraceuticals 2009 - 2010
ProPharma Group 2009 - 2009
Maetrics, LLC 2006 - 2008
Life Sciences International 2005 - 2006
Watson Pharmaceuticals 2002 - 2005
Day & Zimmermann September 1990 - June 2002
Skills
CAPA, GMP, FDA, Validation, Quality Assurance, Quality Control, Compliance, Change Control, Cleaning Validation, ISO 13485, Quality System, Biotechnology, Sterilization, 21 CFR Part 11, GxP, V&V, Sop, Pharmaceutical Industry, Pharmaceutics, Laboratory, Analytical Chemistry, Biopharmaceuticals, GLP, Quality Auditing, Regulatory Submissions, Technology Transfer, LIMS, HPLC, Chemistry, GAMP, Regulatory Affairs, Regulatory Requirements, Chromatography, Lifesciences, R&D, GCP, Formulation, Aseptic Processing, SOP development, Process Simulation, Computer System..., Vaccines, CRO, Clinical Trials, Microbiology, Pharmacovigilance, Quality Management, Contract Manufacturing, Commercialization, Clinical Development
Education
Drexel University 1966 — 1971
BS, Chemistry
Temple University
M.S Pharmaceutical Quality Assurance
Retired December 2014 - Present
Semi-Retired November 2013 - Present
Confidential Client May 2013 - November 2013
21st Century Healthcare 2011 - 2012
Naturally Vitamins, Marlyn Nutraceuticals 2009 - 2010
ProPharma Group 2009 - 2009
Maetrics, LLC 2006 - 2008
Life Sciences International 2005 - 2006
Watson Pharmaceuticals 2002 - 2005
Day & Zimmermann September 1990 - June 2002
Skills
CAPA, GMP, FDA, Validation, Quality Assurance, Quality Control, Compliance, Change Control, Cleaning Validation, ISO 13485, Quality System, Biotechnology, Sterilization, 21 CFR Part 11, GxP, V&V, Sop, Pharmaceutical Industry, Pharmaceutics, Laboratory, Analytical Chemistry, Biopharmaceuticals, GLP, Quality Auditing, Regulatory Submissions, Technology Transfer, LIMS, HPLC, Chemistry, GAMP, Regulatory Affairs, Regulatory Requirements, Chromatography, Lifesciences, R&D, GCP, Formulation, Aseptic Processing, SOP development, Process Simulation, Computer System..., Vaccines, CRO, Clinical Trials, Microbiology, Pharmacovigilance, Quality Management, Contract Manufacturing, Commercialization, Clinical Development
Education
Drexel University 1966 — 1971
BS, Chemistry
Temple University
M.S Pharmaceutical Quality Assurance
Lorissa Maddox Lorissa Maddox's ProPharma Group Experience October 2014 - January 2015
Job Senior Specialist, Supplier & CMO Quality Oversight at Boehringer Ingelheim
Industry Pharmaceuticals
Experience
Boehringer Ingelheim January 2015 - Present
ProPharma Group October 2014 - January 2015
Nephron Pharmaceuticals June 2013 - September 2014
Nephron Pharmaceuticals July 2012 - June 2013
Maxim Healthcare Services May 2012 - July 2012
Maxim Healthcare Services February 2012 - May 2012
TEAM Enterprises May 2010 - January 2012
Rollins College, Department of Chemistry January 2009 - January 2010
Dr. Michael Morgan, DDS Family Practice May 2008 - September 2008
Skills
Quality Assurance, Microbiology, Quality Control, Quality Auditing, Cell Culture, Microsoft Office, Change Control, CAPA, Molecular Biology, Product Marketing, Outlook Express, SharePoint, Trackwise, Leadership, cGMP practices, Quality System, Manufacturing Operations, Technical Writing, Sop, Root Cause Analysis, cGMP manufacturing, Quality Systems Design, Process Quality..., Medical Devices, Prescription Drugs, Quality Operations, NMR spectroscopy, Quality Management, Stability Studies, Field Studies, Western Blot Analysis, Cell Based Assays, Molecular Genetics, FDA, Deviations, Visio, Technical Documentation, Document Drafting, Document Review, SOP, Pharmaceutical Industry, GMP, Regulatory Requirements, TrackWise, Process Improvement, PowerPoint, Regulatory Affairs
Education
Rollins College 2007 — 2011
Bachelor of Arts, Biology
Boehringer Ingelheim January 2015 - Present
ProPharma Group October 2014 - January 2015
Nephron Pharmaceuticals June 2013 - September 2014
Nephron Pharmaceuticals July 2012 - June 2013
Maxim Healthcare Services May 2012 - July 2012
Maxim Healthcare Services February 2012 - May 2012
TEAM Enterprises May 2010 - January 2012
Rollins College, Department of Chemistry January 2009 - January 2010
Dr. Michael Morgan, DDS Family Practice May 2008 - September 2008
Skills
Quality Assurance, Microbiology, Quality Control, Quality Auditing, Cell Culture, Microsoft Office, Change Control, CAPA, Molecular Biology, Product Marketing, Outlook Express, SharePoint, Trackwise, Leadership, cGMP practices, Quality System, Manufacturing Operations, Technical Writing, Sop, Root Cause Analysis, cGMP manufacturing, Quality Systems Design, Process Quality..., Medical Devices, Prescription Drugs, Quality Operations, NMR spectroscopy, Quality Management, Stability Studies, Field Studies, Western Blot Analysis, Cell Based Assays, Molecular Genetics, FDA, Deviations, Visio, Technical Documentation, Document Drafting, Document Review, SOP, Pharmaceutical Industry, GMP, Regulatory Requirements, TrackWise, Process Improvement, PowerPoint, Regulatory Affairs
Education
Rollins College 2007 — 2011
Bachelor of Arts, Biology
Graafin Ginger Leeuwenburg Graafin Ginger Leeuwenburg's ProPharma Group Experience November 2014 - Present
Job Quality Assurance Medical Devices/ Pharma. Mfg. Professional seeks new challenge!
Industry Medical Devices
Experience
ProPharma Group November 2014 - Present
Rescop 2015 - 2015
Rescop 2015 - 2015
ALKU Technologies November 2013 - January 2014
Oxford Global Resources May 2013 - July 2013
Boston Scientific September 2010 - November 2012
Independent Contractor 2007 - 2008
Manpower Professional 2006 - 2007
Amgen 2003 - 2005
Graafin Enterprises 1999 - 2003
Skills
Analytics, Commissioning, NCE/CAPA, Quality System, Medical Devices, Pharmaceutical Industry, GMP, CAPA, Change Control, Sop, Quality Assurance, GLP, Technical Writing, Quality Auditing, Document Review, Document Management, Data Analysis, Software Documentation, GxP, V&V, 21 CFR Part 11, Validation, Microbiology, FDA, ISO 13485, ISO, Management Review, Quality Control, LIMS, Process Simulation, Testing, FMEA, Aseptic Processing, Manufacturing, Technology Transfer, Biotechnology, R&D, eCAPA, Trackwise, MS Office Suite, Executive Presentations, PDMS, Chromatography, Biopharmaceuticals, Quality Management, Lifesciences, Microsoft Office, SOP, Life Sciences
Education
University of New Hampshire 1993 — 1997
Bachelor of Science (BSc), Biochemistry (concentration in Genetics)
El Camino College 1975 — 1978
ProPharma Group November 2014 - Present
Rescop 2015 - 2015
Rescop 2015 - 2015
ALKU Technologies November 2013 - January 2014
Oxford Global Resources May 2013 - July 2013
Boston Scientific September 2010 - November 2012
Independent Contractor 2007 - 2008
Manpower Professional 2006 - 2007
Amgen 2003 - 2005
Graafin Enterprises 1999 - 2003
Skills
Analytics, Commissioning, NCE/CAPA, Quality System, Medical Devices, Pharmaceutical Industry, GMP, CAPA, Change Control, Sop, Quality Assurance, GLP, Technical Writing, Quality Auditing, Document Review, Document Management, Data Analysis, Software Documentation, GxP, V&V, 21 CFR Part 11, Validation, Microbiology, FDA, ISO 13485, ISO, Management Review, Quality Control, LIMS, Process Simulation, Testing, FMEA, Aseptic Processing, Manufacturing, Technology Transfer, Biotechnology, R&D, eCAPA, Trackwise, MS Office Suite, Executive Presentations, PDMS, Chromatography, Biopharmaceuticals, Quality Management, Lifesciences, Microsoft Office, SOP, Life Sciences
Education
University of New Hampshire 1993 — 1997
Bachelor of Science (BSc), Biochemistry (concentration in Genetics)
El Camino College 1975 — 1978
Marshall R. Martin Marshall R. Martin's ProPharma Group Experience June 2013 - February 2014
Job Quality Systems Subject Matter Expert
Industry Pharmaceuticals
Experience
Validant April 2014 - May 2015
ProPharma Group June 2013 - February 2014
Tolmar Inc. September 2011 - March 2013
Oso BioPharmaceuticals Manufacturing, LLC January 2009 - December 2010
Talecris Biotherapeutics, Inc. August 2000 - May 2007
Skills
Project Management, Statistical Data..., Technical Writing, Compliance management, Training program design, Operational..., Regulatory Agency Audits, Hiring top talent, Agilent Chemstation..., ROI analyses, Smartsolve and..., SQL based LIMS systems, Supervising and..., cGMP in Analytical..., Managing laboratory..., Operational SOP..., Team-building, HPLC methods, CAPA design, QC and MFG Partnerships, Microsoft Office and..., Equipment qualification..., Root Cause Analysis, Deviation report writing, Quality Systems, Parenteral, Solid-Dose,..., Quality System, Talent Management, Training, GMP, LIMS, Quality Control, HPLC, Pharmaceutical Industry, Chemistry, Software Documentation, Team Building, Quality Assurance, Laboratory, FDA, CAPA, Validation, SOP
Education
North Carolina State University - College of Management 2006 — 2012
MBA, Management and Finance
Wofford College 1981 — 1985
B.S., Chemistry
Validant April 2014 - May 2015
ProPharma Group June 2013 - February 2014
Tolmar Inc. September 2011 - March 2013
Oso BioPharmaceuticals Manufacturing, LLC January 2009 - December 2010
Talecris Biotherapeutics, Inc. August 2000 - May 2007
Skills
Project Management, Statistical Data..., Technical Writing, Compliance management, Training program design, Operational..., Regulatory Agency Audits, Hiring top talent, Agilent Chemstation..., ROI analyses, Smartsolve and..., SQL based LIMS systems, Supervising and..., cGMP in Analytical..., Managing laboratory..., Operational SOP..., Team-building, HPLC methods, CAPA design, QC and MFG Partnerships, Microsoft Office and..., Equipment qualification..., Root Cause Analysis, Deviation report writing, Quality Systems, Parenteral, Solid-Dose,..., Quality System, Talent Management, Training, GMP, LIMS, Quality Control, HPLC, Pharmaceutical Industry, Chemistry, Software Documentation, Team Building, Quality Assurance, Laboratory, FDA, CAPA, Validation, SOP
Education
North Carolina State University - College of Management 2006 — 2012
MBA, Management and Finance
Wofford College 1981 — 1985
B.S., Chemistry
Eric O'Dell's ProPharma Group Experience October 2012 - Present
Job IT Technician II \ Validation Equipment Administrator at ProPharma Group
Industry Information Technology and Services
Experience
ProPharma Group October 2012 - Present
EMC June 1999 - November 2006
Skills
Microsoft Word, Microsoft Excel, PowerPoint, Microsoft Office, Customer Service, Troubleshooting, Software Documentation, Pharmaceutical Industry, Quality Assurance, Quality System, GMP, FDA, 21 CFR Part 11, Change Control, SOP, Biotechnology, CAPA, Project Management, V&V, Manufacturing, Medical Devices
Education
State University of New York at Albany 1992 — 2006
Bachelor's degree, Communications Technology
ProPharma Group October 2012 - Present
EMC June 1999 - November 2006
Skills
Microsoft Word, Microsoft Excel, PowerPoint, Microsoft Office, Customer Service, Troubleshooting, Software Documentation, Pharmaceutical Industry, Quality Assurance, Quality System, GMP, FDA, 21 CFR Part 11, Change Control, SOP, Biotechnology, CAPA, Project Management, V&V, Manufacturing, Medical Devices
Education
State University of New York at Albany 1992 — 2006
Bachelor's degree, Communications Technology
Michael Chavez Michael Chavez's ProPharma Group Experience 2014 - Present
Job Senior Recruiter at ProPharma Group
Industry Staffing and Recruiting
Experience
ProPharma Group 2014 - Present
Skills
Sales Recruitment, Direct Recruiting, Job Fairs, Compensation Negotiation, Sales Management, Outplacement, Resume Writing, Thought Leadership, Talent Management, Entrepreneurship, Social Networking, Social Media Marketing, Full-cycle Recruiting, Applicant Tracking..., Workforce Planning, Executive Search, Strategic Planning, New Business Development, Staff Augmentation, Veterans, Permanent Placement, Business Development, Team Building, Building Relationships, College Recruiting, Talent Acquisition, Recruiting, SDLC, Employer Branding, Negotiation, Strategy, Leadership, Management, Sales, Sales Process, Contract Recruitment, Selling, Business Strategy, Human Resources, Hiring, Temporary Placement, B2B, Marketing, Staffing Services, Cold Calling, Internet Recruiting, Technical Recruiting, Temporary Staffing, Time Management, Interviews
Education
Missouri State University 1984 — 1989
Bachelor of Science, Business/Organizational Communications
Central
ProPharma Group 2014 - Present
Skills
Sales Recruitment, Direct Recruiting, Job Fairs, Compensation Negotiation, Sales Management, Outplacement, Resume Writing, Thought Leadership, Talent Management, Entrepreneurship, Social Networking, Social Media Marketing, Full-cycle Recruiting, Applicant Tracking..., Workforce Planning, Executive Search, Strategic Planning, New Business Development, Staff Augmentation, Veterans, Permanent Placement, Business Development, Team Building, Building Relationships, College Recruiting, Talent Acquisition, Recruiting, SDLC, Employer Branding, Negotiation, Strategy, Leadership, Management, Sales, Sales Process, Contract Recruitment, Selling, Business Strategy, Human Resources, Hiring, Temporary Placement, B2B, Marketing, Staffing Services, Cold Calling, Internet Recruiting, Technical Recruiting, Temporary Staffing, Time Management, Interviews
Education
Missouri State University 1984 — 1989
Bachelor of Science, Business/Organizational Communications
Central
Eric Midtlyng Eric Midtlyng's ProPharma Group Experience May 2007 - October 2008
Job Product Marketing Specialist at Blackfoot Communications
Industry Telecommunications
Experience
Blackfoot Communications October 2011 - Present
First Security Bank October 2008 - October 2011
ProPharma Group May 2007 - October 2008
Skills
Marketing Strategy, Advertising, Product Marketing, Marketing, Copywriting, Business Development, Marketing Research, Social Media, Social Media Marketing, Market Research, Strategic Planning, Sales, Public Relations, Market Planning, CRM, Newsletters
Education
The University of Montana - School of Business Administration 2009 — 2011
MBA, Entreprenuership & Marketing Emphasis
Montana State University-Bozeman 2003 — 2007
Marketing, Marketing, Management, Statistics, Consumer Behavior, Economics
Blackfoot Communications October 2011 - Present
First Security Bank October 2008 - October 2011
ProPharma Group May 2007 - October 2008
Skills
Marketing Strategy, Advertising, Product Marketing, Marketing, Copywriting, Business Development, Marketing Research, Social Media, Social Media Marketing, Market Research, Strategic Planning, Sales, Public Relations, Market Planning, CRM, Newsletters
Education
The University of Montana - School of Business Administration 2009 — 2011
MBA, Entreprenuership & Marketing Emphasis
Montana State University-Bozeman 2003 — 2007
Marketing, Marketing, Management, Statistics, Consumer Behavior, Economics
Ian Kent Ian Kent's ProPharma Group Experience February 2013 - April 2014
Job Sales/ Business Development/ Marketing Executive, Life Sciences practice/ IT Consulting
Industry Information Technology and Services
Experience
Edgewater Consulting February 2015 - Present
HyperTeam USA Business and IT Consulting, Inc. October 2014 - February 2015
ProPharma Group February 2013 - April 2014
Logixx Corp December 2008 - February 2013
QPharma, Inc February 2009 - December 2009
QAD 2008 - 2009
Stelex February 2004 - February 2008
Magnum 2000 - 2004
Purolator USA 1996 - 2000
Skills
Sales Leader, Sales Management, Operations Management, Management, Strategy, Partnerships, SaaS, Business Development, Medical Devices, Cross-functional Team..., Account Management, Start-ups, Pharmaceutical Industry, Solution Selling, Leadership, Sales Operations, New Business Development, Teamwork, Salesforce.com, Team Building, CRM, Consulting, Sales
Education
Stelex University 2005 — 2006
Risk Assessment and Remediation
Northeastern University 1987 — 1990
BS, Finance
Edgewater Consulting February 2015 - Present
HyperTeam USA Business and IT Consulting, Inc. October 2014 - February 2015
ProPharma Group February 2013 - April 2014
Logixx Corp December 2008 - February 2013
QPharma, Inc February 2009 - December 2009
QAD 2008 - 2009
Stelex February 2004 - February 2008
Magnum 2000 - 2004
Purolator USA 1996 - 2000
Skills
Sales Leader, Sales Management, Operations Management, Management, Strategy, Partnerships, SaaS, Business Development, Medical Devices, Cross-functional Team..., Account Management, Start-ups, Pharmaceutical Industry, Solution Selling, Leadership, Sales Operations, New Business Development, Teamwork, Salesforce.com, Team Building, CRM, Consulting, Sales
Education
Stelex University 2005 — 2006
Risk Assessment and Remediation
Northeastern University 1987 — 1990
BS, Finance
Dr. Eric Good Dr. Eric Good's ProPharma Group Experience September 2014 - Present
Job Director of Compliance at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group September 2014 - Present
KV Pharmaceutical May 2010 - September 2014
KV Pharmaceutical July 2009 - September 2010
Wyeth February 2007 - July 2009
Mallinckrodt 2006 - 2007
Wyeth BioPharma 2002 - 2006
Centocor Biologics LLC 2002 - 2006
Ben Venue Laboratories 2001 - 2002
Aventis Behring 1998 - 2001
SAFC Biosciences 1993 - 1997
Skills
FDA, Validation, Quality Assurance, Quality Control, Manufacturing, Leadership, GMP, Sop, Technology Transfer, Pharmaceutical Industry, Change Control, 21 CFR Part 11, CAPA, Computer System..., Biopharmaceuticals, Aseptic Processing, Quality System, Biotechnology, Analytical Chemistry, Aseptic Technique, CRO, Chromatography, Cleaning Validation, Clinical Trials, Consent Decree, Contract Manufacturing, FDA GMP, GCP, GLP, GxP, HPLC, Lifesciences, Medical Devices, Microbiology, Process Simulation, Quality Auditing, Quality Management, Quality by Design, R, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Root Cause Analysis, Six Sigma, Sterilization, Trackwise, USP, Vaccines, Life Sciences, SOP
Education
University of Phoenix 2003 — 2008
Doctorate, Management-Leadership
Olivet Nazarene University 1999 — 2001
MBA
Central College 1986 — 1990
Bachelor of Arts (B.A.)
Wray HS
ProPharma Group September 2014 - Present
KV Pharmaceutical May 2010 - September 2014
KV Pharmaceutical July 2009 - September 2010
Wyeth February 2007 - July 2009
Mallinckrodt 2006 - 2007
Wyeth BioPharma 2002 - 2006
Centocor Biologics LLC 2002 - 2006
Ben Venue Laboratories 2001 - 2002
Aventis Behring 1998 - 2001
SAFC Biosciences 1993 - 1997
Skills
FDA, Validation, Quality Assurance, Quality Control, Manufacturing, Leadership, GMP, Sop, Technology Transfer, Pharmaceutical Industry, Change Control, 21 CFR Part 11, CAPA, Computer System..., Biopharmaceuticals, Aseptic Processing, Quality System, Biotechnology, Analytical Chemistry, Aseptic Technique, CRO, Chromatography, Cleaning Validation, Clinical Trials, Consent Decree, Contract Manufacturing, FDA GMP, GCP, GLP, GxP, HPLC, Lifesciences, Medical Devices, Microbiology, Process Simulation, Quality Auditing, Quality Management, Quality by Design, R, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Root Cause Analysis, Six Sigma, Sterilization, Trackwise, USP, Vaccines, Life Sciences, SOP
Education
University of Phoenix 2003 — 2008
Doctorate, Management-Leadership
Olivet Nazarene University 1999 — 2001
MBA
Central College 1986 — 1990
Bachelor of Arts (B.A.)
Wray HS
John Wichelt John Wichelt's ProPharma Group Experience December 2004 - April 2010
Job Vice President of Client Pharmaceutical Services at Grand River Aseptic Manufacturing
Industry Pharmaceuticals
Experience
Grand River Aseptic Manufacturing September 2014 - Present
Grand River Aseptic Manufacturing June 2010 - September 2014
ProPharma Group December 2004 - April 2010
Paladiem Technologies 2004 - 2004
PharmTech, Inc. 2002 - 2003
Abbott Laboratories 2000 - 2001
CTG 2000 - 2001
UIC - Joliet, IL 1995 - 1995
Skills
Quality Management, Quality Systems, Quality Assurance, Medical Devices, Validation, Start-ups, Management Development, ISO, Quality Auditing, ISO 13485, Supplier Quality, CAPA, Continuous Improvement, Turnarounds, Operations Management, Quality System, V&V, Change Control, R&D, 21 CFR Part 11, Pharmaceutical Industry, Document Management, Six Sigma, Project Management, Design Control, FDA, Regulatory Affairs, Aseptic Processing, LIMS, Software Documentation, FDA GMP, Biotechnology, GLP, Technology Transfer, Pharmaceutics, Analytical Chemistry, Lifesciences, Regulatory Requirements, GAMP, GxP, Regulatory Submissions, Clinical Trials, Cleaning Validation, Quality Control, GCP, Root Cause Analysis, Biopharmaceuticals, Computer System..., Process Simulation, GMP
Education
Colorado Technical University 2008 — 2009
Bachelor of Business Administration (B.B.A.), Science Project Management, 3.75
Colorado Technical University 2007 — 2008
Associates, Science
Western Illinois University 1990 — 1991
Grand River Aseptic Manufacturing September 2014 - Present
Grand River Aseptic Manufacturing June 2010 - September 2014
ProPharma Group December 2004 - April 2010
Paladiem Technologies 2004 - 2004
PharmTech, Inc. 2002 - 2003
Abbott Laboratories 2000 - 2001
CTG 2000 - 2001
UIC - Joliet, IL 1995 - 1995
Skills
Quality Management, Quality Systems, Quality Assurance, Medical Devices, Validation, Start-ups, Management Development, ISO, Quality Auditing, ISO 13485, Supplier Quality, CAPA, Continuous Improvement, Turnarounds, Operations Management, Quality System, V&V, Change Control, R&D, 21 CFR Part 11, Pharmaceutical Industry, Document Management, Six Sigma, Project Management, Design Control, FDA, Regulatory Affairs, Aseptic Processing, LIMS, Software Documentation, FDA GMP, Biotechnology, GLP, Technology Transfer, Pharmaceutics, Analytical Chemistry, Lifesciences, Regulatory Requirements, GAMP, GxP, Regulatory Submissions, Clinical Trials, Cleaning Validation, Quality Control, GCP, Root Cause Analysis, Biopharmaceuticals, Computer System..., Process Simulation, GMP
Education
Colorado Technical University 2008 — 2009
Bachelor of Business Administration (B.B.A.), Science Project Management, 3.75
Colorado Technical University 2007 — 2008
Associates, Science
Western Illinois University 1990 — 1991
Rachel Bias Rachel Bias's ProPharma Group Experience 2006 - Present
Job Vice President Human Resources | Recruiting | Employee Relations | Benefits Administration
Industry Pharmaceuticals
Experience
ProPharma Group 2006 - Present
Gould Evans Goodman 1998 - 2006
Education
Campbell University
BA, Business Administration
ProPharma Group 2006 - Present
Gould Evans Goodman 1998 - 2006
Education
Campbell University
BA, Business Administration
Brad Nichols Brad Nichols's ProPharma Group Experience 2004 - 2007
Job Owner/Operator at The Validation Engineering and Technology Source, LLC
Industry Biotechnology
Experience
The Validation Engineering and Technology Source, LLC January 2007 - Present
ProPharma Group 2004 - 2007
Skills
Microbiology, Pharmaceutical Industry, Validation, Biotechnology, Sop, Change Control, V&V, Software Documentation, SOP, Management, FDA, GMP, 21 CFR Part 11, CAPA, Quality System, Quality Assurance, Pharmaceutics, GLP, Life Sciences, Medical Devices, Biopharmaceuticals, GxP
Education
The University of New Mexico
The Validation Engineering and Technology Source, LLC January 2007 - Present
ProPharma Group 2004 - 2007
Skills
Microbiology, Pharmaceutical Industry, Validation, Biotechnology, Sop, Change Control, V&V, Software Documentation, SOP, Management, FDA, GMP, 21 CFR Part 11, CAPA, Quality System, Quality Assurance, Pharmaceutics, GLP, Life Sciences, Medical Devices, Biopharmaceuticals, GxP
Education
The University of New Mexico
Amsal Zeleke Amsal Zeleke's ProPharma Group Experience April 2013 - December 2013
Job Associate Staff Quality Engineer
Industry Biotechnology
Experience
bioMerieux January 2014 - Present
ProPharma Group April 2013 - December 2013
Grifols/Talecris Plasma/International BioResources April 2008 - April 2013
Leiner Health Products June 2006 - July 2008
Skills
Quality Systems, Quality Assurance, FDA, cGMP, SOP, Sop, Quality System, 21 CFR Part 11, Biotechnology, Quality Auditing, CAPA, Medical Devices, Validation, GMP, Change Control, GxP, Regulatory Affairs, GLP, Pharmaceutical Industry, FDA GMP, Regulatory Requirements, Trackwise, Root Cause Analysis, TrackWise
Education
Strayer University-North Carolina 2007 — 2009
Master of Business Administration (M.B.A.), Business Administration and Management, General
Winthrop University 2002 — 2006
Bachelor's degree, Biology, General
bioMerieux January 2014 - Present
ProPharma Group April 2013 - December 2013
Grifols/Talecris Plasma/International BioResources April 2008 - April 2013
Leiner Health Products June 2006 - July 2008
Skills
Quality Systems, Quality Assurance, FDA, cGMP, SOP, Sop, Quality System, 21 CFR Part 11, Biotechnology, Quality Auditing, CAPA, Medical Devices, Validation, GMP, Change Control, GxP, Regulatory Affairs, GLP, Pharmaceutical Industry, FDA GMP, Regulatory Requirements, Trackwise, Root Cause Analysis, TrackWise
Education
Strayer University-North Carolina 2007 — 2009
Master of Business Administration (M.B.A.), Business Administration and Management, General
Winthrop University 2002 — 2006
Bachelor's degree, Biology, General
Tiffany Coniglio's ProPharma Group Experience May 2013 - July 2013
Job Public Relations Coordinator at MacFarlane Group
Industry Public Relations and Communications
Experience
MacFarlane Group August 2014 - Present
MRY September 2013 - May 2014
Northwestern Mutual August 2013 - December 2013
ProPharma Group May 2013 - July 2013
G Wear, LLC August 2012 - May 2013
Skills
Marketing, Strategic Planning, Leadership, Sales, Marketing Strategy, Time Management, Lead Generation, Outlook, Photoshop, Teamwork, Team Leadership, Google Analytics, Corporate Communications, SEO, Creative Writing, Press Releases, Blogging
Education
University of Kansas 2010 — 2014
Bachelor of Science (B.S.), Journalism
MacFarlane Group August 2014 - Present
MRY September 2013 - May 2014
Northwestern Mutual August 2013 - December 2013
ProPharma Group May 2013 - July 2013
G Wear, LLC August 2012 - May 2013
Skills
Marketing, Strategic Planning, Leadership, Sales, Marketing Strategy, Time Management, Lead Generation, Outlook, Photoshop, Teamwork, Team Leadership, Google Analytics, Corporate Communications, SEO, Creative Writing, Press Releases, Blogging
Education
University of Kansas 2010 — 2014
Bachelor of Science (B.S.), Journalism
Debbie Sextro, SPHR's ProPharma Group Experience October 2008 - Present
Job Human Resources | Recruiting | Talent Acquisition | Sourcing | Salary Negotiation
Industry Biotechnology
Experience
ProPharma Group October 2008 - Present
Celgene Corporation (formerly Pharmion Corporation) 2007 - 2008
Black & Veatch 2005 - 2007
Lincare 2004 - 2005
sanofi-aventis 1997 - 2004
Sanofi-Aventis Pharmaceuticals 1995 - 2001
Mast Advertising & Publishing 1984 - 1989
Skills
Change Management, Recruiting, Talent Acquisition, Technical Recruiting, Applicant Tracking..., Sourcing, Human Resources, Talent Management, Process Improvement, Performance Management
Education
MidAmerica Nazarene University
Bachelors, management and human relations
ProPharma Group October 2008 - Present
Celgene Corporation (formerly Pharmion Corporation) 2007 - 2008
Black & Veatch 2005 - 2007
Lincare 2004 - 2005
sanofi-aventis 1997 - 2004
Sanofi-Aventis Pharmaceuticals 1995 - 2001
Mast Advertising & Publishing 1984 - 1989
Skills
Change Management, Recruiting, Talent Acquisition, Technical Recruiting, Applicant Tracking..., Sourcing, Human Resources, Talent Management, Process Improvement, Performance Management
Education
MidAmerica Nazarene University
Bachelors, management and human relations
Jessica Pagan (Miller) Jessica Pagan (Miller)'s ProPharma Group Experience April 2011 - Present
Job Senior Validation Engineer
Industry Pharmaceuticals
Experience
ProPharma Group April 2011 - Present
Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC) - CSU January 2008 - April 2011
Skills
Validation, CAPA, 21 CFR Part 11, Change Control, FDA, GxP, V&V, Aseptic Processing, Quality Management, GMP, Quality Assurance, 21 CFR, Trackwise, Quality System, Sop, Cleaning Validation, Computer System..., GLP, SOP
Education
Colorado State University 2004 — 2008
B.S., Microbiology
ProPharma Group April 2011 - Present
Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC) - CSU January 2008 - April 2011
Skills
Validation, CAPA, 21 CFR Part 11, Change Control, FDA, GxP, V&V, Aseptic Processing, Quality Management, GMP, Quality Assurance, 21 CFR, Trackwise, Quality System, Sop, Cleaning Validation, Computer System..., GLP, SOP
Education
Colorado State University 2004 — 2008
B.S., Microbiology
Debra Bahr Debra Bahr's ProPharma Group Experience March 2014 - Present
Job ProPharma Group
Industry Biotechnology
Experience
ProPharma Group March 2014 - Present
Skills
Strategic Planning, Team Building, New Business Development, Proposal Writing, Customer Relations, Marketing Strategy, Business Strategy, Healthcare, Business Planning, Start-ups, Construction, Sales Management, Sustainability, Engineering, Account Management, Business Development, Medical Devices, Strategy, CRM, Marketing, Leadership, Contract Management, Budgets, Contract Negotiation, Sales, Project Planning, Project Management, Competitive Analysis, Customer Service, Pharmaceutical Industry
Education
Hope College
New York Institute of Finance
Institutional Mutual Funds
ProPharma Group March 2014 - Present
Skills
Strategic Planning, Team Building, New Business Development, Proposal Writing, Customer Relations, Marketing Strategy, Business Strategy, Healthcare, Business Planning, Start-ups, Construction, Sales Management, Sustainability, Engineering, Account Management, Business Development, Medical Devices, Strategy, CRM, Marketing, Leadership, Contract Management, Budgets, Contract Negotiation, Sales, Project Planning, Project Management, Competitive Analysis, Customer Service, Pharmaceutical Industry
Education
Hope College
New York Institute of Finance
Institutional Mutual Funds
Ciona Forsythe Ciona Forsythe's ProPharma Group Experience February 2014 - Present
Job Validation Engineer; Consultant at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group February 2014 - Present
PharmEng Technology January 2012 - Present
Black Diamond Networks 2015 - 2015
Black Diamond Networks 2015 - 2015
Black Diamond Networks 2015 - 2015
LifeCell Corporation October 2009 - July 2010
Skills
Validation, Computer System..., 21 CFR Part 11, GMP, Change Control, Cleaning Validation, Aseptic Processing, Protocol
Education
Temple University 2003 — 2007
Bachelor of Science (BS), Anthropological Human Biology and Criminal Justice
ProPharma Group February 2014 - Present
PharmEng Technology January 2012 - Present
Black Diamond Networks 2015 - 2015
Black Diamond Networks 2015 - 2015
Black Diamond Networks 2015 - 2015
LifeCell Corporation October 2009 - July 2010
Skills
Validation, Computer System..., 21 CFR Part 11, GMP, Change Control, Cleaning Validation, Aseptic Processing, Protocol
Education
Temple University 2003 — 2007
Bachelor of Science (BS), Anthropological Human Biology and Criminal Justice
Amanda Knight's ProPharma Group Experience February 2012 - May 2013
Job Marketing I Social Media I Professional Organizer
Industry Civil Engineering
Experience
Olsson Associates November 2014 - Present
Executive Travel Inc. December 2013 - November 2014
ProPharma Group February 2012 - May 2013
ProPharma Group August 2010 - February 2012
Skills
Social Media Marketing, Event Planning, PowerPoint, Marketing Strategy, Email Marketing, Digital Marketing, Press Releases, Customer Service, Project Management, Marketing, Microsoft Office, Constant Contact, Meeting Planning, Strategy, Microsoft CRM, Microsoft Publisher, Microsoft Office..., Office Coordination, Twitter, LinkedIn, Team Building, Proposal Writing, Leadership, Social Networking
Education
University of Kansas 2005 — 2010
Bachelor of Science, Education
Lee's Summit High School
Olsson Associates November 2014 - Present
Executive Travel Inc. December 2013 - November 2014
ProPharma Group February 2012 - May 2013
ProPharma Group August 2010 - February 2012
Skills
Social Media Marketing, Event Planning, PowerPoint, Marketing Strategy, Email Marketing, Digital Marketing, Press Releases, Customer Service, Project Management, Marketing, Microsoft Office, Constant Contact, Meeting Planning, Strategy, Microsoft CRM, Microsoft Publisher, Microsoft Office..., Office Coordination, Twitter, LinkedIn, Team Building, Proposal Writing, Leadership, Social Networking
Education
University of Kansas 2005 — 2010
Bachelor of Science, Education
Lee's Summit High School
Doug Bullard's ProPharma Group Experience October 2013 - Present
Job Senior Consultant of Compliance at ProPharma Group | Experience in Quality, Validation and GMP training | Author
Industry Biotechnology
Experience
ProPharma Group October 2013 - Present
Quality Core Consulting, LLC June 2013 - Present
Sprout Pharmaceuticals June 2013 - October 2013
Regulatory Compliance Associates, Inc. February 2013 - April 2013
Quintiles November 2011 - September 2012
Pfizer Pharmaceuticals October 2008 - November 2010
Wyeth Biotech 2007 - 2008
Wyeth Vaccines 2005 - 2007
Bayer July 1994 - January 2005
Skills
Quality Assurance, Quality Management, Quality Operations, Quality Systems, Quality Auditing, cGMP, Batch Release, Documentation Practices, Document Control, Annual Reports, Change Control, LIMS, SAP, Livelink, Lean Manufacturing, Root Cause Analysis, Validation, Process Validation, Cleaning Validation, Pharmaceuticals, Biotechnology, Vaccines, Aseptic Processing, Trending, Collaboration, Strategic Communications, Pharmaceutical Industry, V&V, GMP, Quality System, FDA, Software Documentation, Document Management, Manufacturing, CAPA, Cross-functional Team..., Technology Transfer, Process Simulation, 21 CFR Part 11, GLP, Computer System..., Sop, Biopharmaceuticals, Continuous Improvement, Pharmaceutics, Regulatory Submissions, Trackwise, Regulatory Requirements, ISO 13485, Deviations
Education
North Carolina State University - College of Management 1990 — 1993
BA, Business Administration, concentration in Marketing
Wayne Community College 1988 — 1990
ProPharma Group October 2013 - Present
Quality Core Consulting, LLC June 2013 - Present
Sprout Pharmaceuticals June 2013 - October 2013
Regulatory Compliance Associates, Inc. February 2013 - April 2013
Quintiles November 2011 - September 2012
Pfizer Pharmaceuticals October 2008 - November 2010
Wyeth Biotech 2007 - 2008
Wyeth Vaccines 2005 - 2007
Bayer July 1994 - January 2005
Skills
Quality Assurance, Quality Management, Quality Operations, Quality Systems, Quality Auditing, cGMP, Batch Release, Documentation Practices, Document Control, Annual Reports, Change Control, LIMS, SAP, Livelink, Lean Manufacturing, Root Cause Analysis, Validation, Process Validation, Cleaning Validation, Pharmaceuticals, Biotechnology, Vaccines, Aseptic Processing, Trending, Collaboration, Strategic Communications, Pharmaceutical Industry, V&V, GMP, Quality System, FDA, Software Documentation, Document Management, Manufacturing, CAPA, Cross-functional Team..., Technology Transfer, Process Simulation, 21 CFR Part 11, GLP, Computer System..., Sop, Biopharmaceuticals, Continuous Improvement, Pharmaceutics, Regulatory Submissions, Trackwise, Regulatory Requirements, ISO 13485, Deviations
Education
North Carolina State University - College of Management 1990 — 1993
BA, Business Administration, concentration in Marketing
Wayne Community College 1988 — 1990
Hanks Kurtis L Hanks Kurtis L's ProPharma Group Experience January 2013 - Present
Job Technical Operations Manager at American Toxicology Institute
Industry Biotechnology
Experience
American Toxicology Institute May 2013 - Present
ProPharma Group January 2013 - Present
Community Health Systems August 2012 - Present
SSM Health Care May 2011 - June 2012
Advanced Pain Centers August 2009 - September 2011
Mid America Transplant Services September 2008 - November 2010
Saint Lukes Hospital, Chesterfield, Missouri April 2004 - August 2009
Mid America Transplant Services February 2002 - June 2005
Skills
Analytical Chemistry, Blood Bank, Hematology, Quality Management, Project Management, Commercial Photography, Medical Microbiology, Mass Spectrometry, Toxicology, Laboratory, Medical Devices, Clinical Chemistry, Clinical Research, Pharmacovigilance, Laboratory Medicine, Hospitals, Quality Assurance
Education
Illinois Central College 1998 — 2000
Certification Eligibility, Clinical Laboratory Science/Medical Technology/Technologist
Spoon River College 1995 — 2000
Associate of Science (AS), Biological and Physical Sciences
American Toxicology Institute May 2013 - Present
ProPharma Group January 2013 - Present
Community Health Systems August 2012 - Present
SSM Health Care May 2011 - June 2012
Advanced Pain Centers August 2009 - September 2011
Mid America Transplant Services September 2008 - November 2010
Saint Lukes Hospital, Chesterfield, Missouri April 2004 - August 2009
Mid America Transplant Services February 2002 - June 2005
Skills
Analytical Chemistry, Blood Bank, Hematology, Quality Management, Project Management, Commercial Photography, Medical Microbiology, Mass Spectrometry, Toxicology, Laboratory, Medical Devices, Clinical Chemistry, Clinical Research, Pharmacovigilance, Laboratory Medicine, Hospitals, Quality Assurance
Education
Illinois Central College 1998 — 2000
Certification Eligibility, Clinical Laboratory Science/Medical Technology/Technologist
Spoon River College 1995 — 2000
Associate of Science (AS), Biological and Physical Sciences
Laura Valdes-Mora Laura Valdes-Mora's ProPharma Group Experience July 2010 - April 2014
Job Quality Control Microbiology Manager at Summit Biosciences, Inc.
Industry Pharmaceuticals
Experience
Summit Biosciences Inc. May 2014 - Present
ProPharma Group July 2010 - April 2014
Contractor June 2008 - July 2010
PharmaDirections, Inc October 2006 - May 2008
Wyeth Vaccines February 2005 - February 2006
Elite MicroSource Corporation August 1998 - December 2004
Gulf Coast Community College January 2000 - May 2004
Applied Analytical Industries (AAIPharma) November 1991 - January 1998
AMSCO Scientific September 1988 - November 1991
Skills
Quality Assurance, SOP, Validation, GMP, Auditing, Investigations, Technical Training, Technical Writing, Technical Documentation, Microbiology, Environmental..., Research, CAPA, Risk Assessment, Sop, GLP, GAMP, V&V, FDA, Private Investigations, Quality Auditing, Quality System, Change Control, Pharmaceutical Industry, Biotechnology, Trackwise, ISO 13485, Regulatory Requirements, Laboratory, 21 CFR Part 11, GxP, Vaccines, Deviations, Sterilization, Medical Devices, Pharmaceutics, Clinical Trials, Aseptic Processing, Quality Control, Environmental Monitoring, TrackWise
Education
North Carolina State University 1983 — 1986
MS, Microbiology
University of Puerto Rico 1978 — 1982
BS, Biology
Summit Biosciences Inc. May 2014 - Present
ProPharma Group July 2010 - April 2014
Contractor June 2008 - July 2010
PharmaDirections, Inc October 2006 - May 2008
Wyeth Vaccines February 2005 - February 2006
Elite MicroSource Corporation August 1998 - December 2004
Gulf Coast Community College January 2000 - May 2004
Applied Analytical Industries (AAIPharma) November 1991 - January 1998
AMSCO Scientific September 1988 - November 1991
Skills
Quality Assurance, SOP, Validation, GMP, Auditing, Investigations, Technical Training, Technical Writing, Technical Documentation, Microbiology, Environmental..., Research, CAPA, Risk Assessment, Sop, GLP, GAMP, V&V, FDA, Private Investigations, Quality Auditing, Quality System, Change Control, Pharmaceutical Industry, Biotechnology, Trackwise, ISO 13485, Regulatory Requirements, Laboratory, 21 CFR Part 11, GxP, Vaccines, Deviations, Sterilization, Medical Devices, Pharmaceutics, Clinical Trials, Aseptic Processing, Quality Control, Environmental Monitoring, TrackWise
Education
North Carolina State University 1983 — 1986
MS, Microbiology
University of Puerto Rico 1978 — 1982
BS, Biology
Joe Biehl Joe Biehl's ProPharma Group Experience August 2012 - Present
Job
Industry Pharmaceuticals
Experience
ProPharma Group August 2012 - Present
ProPharma Group May 2011 - September 2012
SNC-Lavalin Project Services, Inc. September 2007 - January 2011
Gannett Fleming 2006 - 2007
Advanced Automation Associates 2003 - 2005
ValiCor Associates, Inc. 1994 - 2002
Jacobs Engineering 1993 - 1994
Fluor Daniel 1990 - 1993
Skills
Budgeting, Validation, Pharmaceuticals, Compliance, Quality Management, Biotechnology, cGMP, 21 CFR Part 11, CAPA, Risk Management, Quality Auditing, Continuous Improvement, Strategic Planning, Team Building, Cross-functional Team..., Due Diligence, Program Management, GMP, Pharmaceutical Industry, Sop, Commissioning, Quality System, FDA, Strategy, Budgets, Software Documentation, Start-ups, Management, Technology Transfer, Leadership, Quality Assurance, Project Management
Education
Seton Hall University School of Law 2012 — 2012
Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance, Health Care Compliance
Drexel University 1984 — 1989
BSME, Engineering
MN
ProPharma Group August 2012 - Present
ProPharma Group May 2011 - September 2012
SNC-Lavalin Project Services, Inc. September 2007 - January 2011
Gannett Fleming 2006 - 2007
Advanced Automation Associates 2003 - 2005
ValiCor Associates, Inc. 1994 - 2002
Jacobs Engineering 1993 - 1994
Fluor Daniel 1990 - 1993
Skills
Budgeting, Validation, Pharmaceuticals, Compliance, Quality Management, Biotechnology, cGMP, 21 CFR Part 11, CAPA, Risk Management, Quality Auditing, Continuous Improvement, Strategic Planning, Team Building, Cross-functional Team..., Due Diligence, Program Management, GMP, Pharmaceutical Industry, Sop, Commissioning, Quality System, FDA, Strategy, Budgets, Software Documentation, Start-ups, Management, Technology Transfer, Leadership, Quality Assurance, Project Management
Education
Seton Hall University School of Law 2012 — 2012
Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance, Health Care Compliance
Drexel University 1984 — 1989
BSME, Engineering
MN
Janet McComas Janet McComas's ProPharma Group Experience October 2008 - Present
Job Aseptic Process Engineer
Industry Pharmaceuticals
Experience
Merck Sharp & Dohme October 2010 - Present
BMS 2009 - Present
ProPharma Group October 2008 - Present
Amylin Pharmaceuticals 2007 - 2008
Education
Marshall University 1990 — 1995
Merck Sharp & Dohme October 2010 - Present
BMS 2009 - Present
ProPharma Group October 2008 - Present
Amylin Pharmaceuticals 2007 - 2008
Education
Marshall University 1990 — 1995
Muhannad Zainy Muhannad Zainy's ProPharma Group Experience March 2015 - Present
Job Validation/Quality Consultant at Self Employed
Industry Biotechnology
Experience
ProPharma Group March 2015 - Present
Self Employed October 2014 - March 2015
Bio-Rad Laboratories March 2011 - September 2014
Self-Employed July 2010 - March 2011
Foster Wheeler Biokinetics March 2010 - June 2010
Invensys Validation Technologies December 2006 - February 2010
2006Barry Wehmiller Design Group April 2006 - December 2006
AVI BioPharma January 2004 - April 2006
AVI BioPharma July 2002 - December 2003
Gilead Sciences May 2002 - July 2002
Skills
Validation, GMP, Cleaning Validation, SOP, Calibration, Process Validation, FDA, V&V, Sop, Quality Control, Quality Assurance, Pharmaceutical Industry, Change Control, Aseptic Processing, Medical Devices, HPLC, Biotechnology, GxP, 21 CFR Part 11, GLP, CAPA, Quality System, Biopharmaceuticals, Manufacturing
Education
University of Colorado Boulder 1988 — 1992
BA, Economics
Colorado School of Mines 1987 — 1987
ProPharma Group March 2015 - Present
Self Employed October 2014 - March 2015
Bio-Rad Laboratories March 2011 - September 2014
Self-Employed July 2010 - March 2011
Foster Wheeler Biokinetics March 2010 - June 2010
Invensys Validation Technologies December 2006 - February 2010
2006Barry Wehmiller Design Group April 2006 - December 2006
AVI BioPharma January 2004 - April 2006
AVI BioPharma July 2002 - December 2003
Gilead Sciences May 2002 - July 2002
Skills
Validation, GMP, Cleaning Validation, SOP, Calibration, Process Validation, FDA, V&V, Sop, Quality Control, Quality Assurance, Pharmaceutical Industry, Change Control, Aseptic Processing, Medical Devices, HPLC, Biotechnology, GxP, 21 CFR Part 11, GLP, CAPA, Quality System, Biopharmaceuticals, Manufacturing
Education
University of Colorado Boulder 1988 — 1992
BA, Economics
Colorado School of Mines 1987 — 1987
Tom Jones Jr. Tom Jones Jr.'s ProPharma Group Experience March 2012 - Present
Job Engineering and Construction Project Management Consultant at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group March 2012 - Present
TEVA Animal Health 2010 - April 2012
FaciliTeam Consultants 2009 - April 2010
Bayer HealthCare 2008 - 2009
Bayer HealthCare 2005 - 2008
Bayer HealthCare 1996 - 2005
Perigon Architectural and Engineering Associates June 1988 - November 2003
Skills
Six Sigma, MS Project, Procurement, Word, PowerPoint, Excel, cGMP, Capital Projects, Engineers, Concept Design, Contractors, Continuous Improvement, Cross-functional Team..., Supervisory Skills, Process Improvement, Manufacturing, Budgeting, Problem Solving, Scheduling, Quality Assurance, Strategic Planning, Engineering, Forecasting, AutoCAD, Team Building, Black Belt, Budgets, GMP, Process Scheduler, Project Management, 21 CFR Part 11, Leadership, Validation, Management, Microsoft Word, FDA, Microsoft Excel, Project Planning, Lean Manufacturing, Training, Strategy, Contract Management, Quality Control, Change Control, Analysis, Process Engineering, Technology Transfer, Pharmaceutical Industry, SOP, Quality System
Education
Johnson County Community College 2010 — 2010
Certificate, Lean Six Sigma Black Belt
Johnson County Community College 2009 — 2010
Certificate, Project Management
Construction Specifications Institute-Flint Hills Chapter 2001 — 2001
Certificate, Design/Build Principle and Strategy
Workforce Partnership, Overland Park, KS
Kansas WORKReady! Gold Certificate, Applied Mathematics (Level 5), Locating Information (Level 5), Reading for Information (Level 7)
ProPharma Group March 2012 - Present
TEVA Animal Health 2010 - April 2012
FaciliTeam Consultants 2009 - April 2010
Bayer HealthCare 2008 - 2009
Bayer HealthCare 2005 - 2008
Bayer HealthCare 1996 - 2005
Perigon Architectural and Engineering Associates June 1988 - November 2003
Skills
Six Sigma, MS Project, Procurement, Word, PowerPoint, Excel, cGMP, Capital Projects, Engineers, Concept Design, Contractors, Continuous Improvement, Cross-functional Team..., Supervisory Skills, Process Improvement, Manufacturing, Budgeting, Problem Solving, Scheduling, Quality Assurance, Strategic Planning, Engineering, Forecasting, AutoCAD, Team Building, Black Belt, Budgets, GMP, Process Scheduler, Project Management, 21 CFR Part 11, Leadership, Validation, Management, Microsoft Word, FDA, Microsoft Excel, Project Planning, Lean Manufacturing, Training, Strategy, Contract Management, Quality Control, Change Control, Analysis, Process Engineering, Technology Transfer, Pharmaceutical Industry, SOP, Quality System
Education
Johnson County Community College 2010 — 2010
Certificate, Lean Six Sigma Black Belt
Johnson County Community College 2009 — 2010
Certificate, Project Management
Construction Specifications Institute-Flint Hills Chapter 2001 — 2001
Certificate, Design/Build Principle and Strategy
Workforce Partnership, Overland Park, KS
Kansas WORKReady! Gold Certificate, Applied Mathematics (Level 5), Locating Information (Level 5), Reading for Information (Level 7)
Amy Strainer Amy Strainer's ProPharma Group Experience May 2005 - June 2008
Job Accounting Manager at Stahly Engineering & Associates, Inc
Industry Civil Engineering
Experience
Be The Match operated by National Marrow Donor Program June 2013 - Present
Stahly Engineering & Associates, Inc February 2011 - Present
New West Health Services June 2008 - February 2011
ProPharma Group May 2005 - June 2008
D.A. Davidson & Co. January 1999 - August 2003
Skills
Pay Close Attention to..., Organized Multi-tasker, High Sense Of Urgency, Problem Solving, Highly Ambitious, Communication, Customer Service, Empathy, Proofreading, Public Speaking, Ethics, Accounting, QuickBooks, Sales, Microsoft Office
Education
The University of Montana - School of Business Administration 2007 — 2009
Master's degree, Business Administration and Management, General
Montana State University-Bozeman 2001 — 2005
Bachelor of Science (BS), Business Administration and Management, General
Be The Match operated by National Marrow Donor Program June 2013 - Present
Stahly Engineering & Associates, Inc February 2011 - Present
New West Health Services June 2008 - February 2011
ProPharma Group May 2005 - June 2008
D.A. Davidson & Co. January 1999 - August 2003
Skills
Pay Close Attention to..., Organized Multi-tasker, High Sense Of Urgency, Problem Solving, Highly Ambitious, Communication, Customer Service, Empathy, Proofreading, Public Speaking, Ethics, Accounting, QuickBooks, Sales, Microsoft Office
Education
The University of Montana - School of Business Administration 2007 — 2009
Master's degree, Business Administration and Management, General
Montana State University-Bozeman 2001 — 2005
Bachelor of Science (BS), Business Administration and Management, General
Gary Schoofs Gary Schoofs's ProPharma Group Experience April 2012 - November 2012
Job Clinical Production & Process Development Leader
Industry Biotechnology
Experience
ProPharma Group April 2012 - November 2012
Geron Corporation December 2007 - December 2011
Berlex Labs May 1998 - March 2007
Berlex Labs 1990 - 1998
Codon Corporation 1985 - 1990
Western Regional Research Center (ARS, USDA) 1982 - 1985
Western Regional Research Center (ARS, USDA) 1976 - 1982
Skills
cGMP Manufacturing, Process Development, Biotechnology, Cell Culture, Validation, Fermentation Technology, Stem Cells, Project Management, Aseptic Processing, Bioreactors, Biogas, Technical Writing, SOP, Equipment Selection, Sop, cGMP manufacturing, Process Simulation, Lifesciences, V&V, Biopharmaceuticals, Cell, Protein Purification, Chromatography, Protein Chemistry, Bioreactor, ELISA, Pharmaceutical Industry, GMP, GLP, Purification, Technology Transfer, Tissue Culture, In Vitro, Monoclonal Antibodies, Drug Development, Life Sciences
Education
University of California, Berkeley
BA, Zoology, Mathematics (minor)
ProPharma Group April 2012 - November 2012
Geron Corporation December 2007 - December 2011
Berlex Labs May 1998 - March 2007
Berlex Labs 1990 - 1998
Codon Corporation 1985 - 1990
Western Regional Research Center (ARS, USDA) 1982 - 1985
Western Regional Research Center (ARS, USDA) 1976 - 1982
Skills
cGMP Manufacturing, Process Development, Biotechnology, Cell Culture, Validation, Fermentation Technology, Stem Cells, Project Management, Aseptic Processing, Bioreactors, Biogas, Technical Writing, SOP, Equipment Selection, Sop, cGMP manufacturing, Process Simulation, Lifesciences, V&V, Biopharmaceuticals, Cell, Protein Purification, Chromatography, Protein Chemistry, Bioreactor, ELISA, Pharmaceutical Industry, GMP, GLP, Purification, Technology Transfer, Tissue Culture, In Vitro, Monoclonal Antibodies, Drug Development, Life Sciences
Education
University of California, Berkeley
BA, Zoology, Mathematics (minor)
Sherie Loman's ProPharma Group Experience February 2011 - Present
Job Project Quality Manager at Propharma Group
Industry Pharmaceuticals
Experience
ProPharma Group February 2011 - Present
Astellas Pharma (formerly Yamanouchi Pharma) March 2005 - December 2009
Aptuit (formerly Quintiles) February 2003 - March 2005
Johnson & Johnson Medical, Sherman, TX February 2001 - February 2003
Skills
21 CFR Part 11, Change Control, Computer System..., FDA, GxP, Quality Assurance, Validation, Quality Control, Regulatory Requirements, Quality System
Education
Southern Nazarene University
BS, Professional Studies - Organizational Leadership
ProPharma Group February 2011 - Present
Astellas Pharma (formerly Yamanouchi Pharma) March 2005 - December 2009
Aptuit (formerly Quintiles) February 2003 - March 2005
Johnson & Johnson Medical, Sherman, TX February 2001 - February 2003
Skills
21 CFR Part 11, Change Control, Computer System..., FDA, GxP, Quality Assurance, Validation, Quality Control, Regulatory Requirements, Quality System
Education
Southern Nazarene University
BS, Professional Studies - Organizational Leadership
Jim Kolbet Jim Kolbet's ProPharma Group Experience January 2014 - Present
Job Director, Program Management PMP
Industry Pharmaceuticals
Experience
ProPharma Group January 2014 - Present
ProPharma Group July 2012 - Present
ProPharma Group January 2009 - August 2012
ProPharma Group May 2005 - December 2008
ProPharma Group May 2004 - May 2005
ProPharma Group May 2003 - May 2004
Independent Contractor May 2002 - May 2003
Fort Dodge Animal Health May 1998 - May 2001
Education
Mahler Company 2011 — 2012
Advanced Management Skills Program
Iowa State University 2000 — 2003
MBA
Iowa State University 1993 — 1998
BS, Biology
ProPharma Group January 2014 - Present
ProPharma Group July 2012 - Present
ProPharma Group January 2009 - August 2012
ProPharma Group May 2005 - December 2008
ProPharma Group May 2004 - May 2005
ProPharma Group May 2003 - May 2004
Independent Contractor May 2002 - May 2003
Fort Dodge Animal Health May 1998 - May 2001
Education
Mahler Company 2011 — 2012
Advanced Management Skills Program
Iowa State University 2000 — 2003
MBA
Iowa State University 1993 — 1998
BS, Biology
Rob Chestnut, CMA's ProPharma Group Experience September 2013 - Present
Job Chief Financial Officer at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group September 2013 - Present
Nationwide Learning LLC August 2011 - September 2013
Allen Press, Inc. January 2006 - August 2011
Remel - division of Thermo Fisher Scientific June 2003 - December 2005
API Foils Inc. a company of API Group PLC (LSE March 2001 - June 2003
Sellmeat February 2000 - March 2001
Variform Inc October 1995 - February 2000
Farmland Foods Inc., subsidiary of Farmland Industries, Inc January 1990 - October 1995
Sprint Nextel Corporation January 1987 - January 1990
Butler Manufacturing Inc December 1984 - January 1987
Skills
Strategic Planning, Acquistions, Mergers, Public Finance, Private Equity, Finance
Education
University of Kansas 1979 — 1984
BS amd MBA, Accounting and Bus Admin
ProPharma Group September 2013 - Present
Nationwide Learning LLC August 2011 - September 2013
Allen Press, Inc. January 2006 - August 2011
Remel - division of Thermo Fisher Scientific June 2003 - December 2005
API Foils Inc. a company of API Group PLC (LSE March 2001 - June 2003
Sellmeat February 2000 - March 2001
Variform Inc October 1995 - February 2000
Farmland Foods Inc., subsidiary of Farmland Industries, Inc January 1990 - October 1995
Sprint Nextel Corporation January 1987 - January 1990
Butler Manufacturing Inc December 1984 - January 1987
Skills
Strategic Planning, Acquistions, Mergers, Public Finance, Private Equity, Finance
Education
University of Kansas 1979 — 1984
BS amd MBA, Accounting and Bus Admin
Simona Gherman Simona Gherman's ProPharma Group Experience September 2014 - Present
Job Program Manager at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group September 2014 - Present
Pentair Water Solutions March 2014 - September 2014
Boehringer Ingelheim September 2011 - December 2013
Boehringer Ingelheim September 2009 - September 2011
Boehringer Ingelheim September 2007 - September 2009
Boehringer Ingelheim May 2002 - September 2007
Unilever 2000 - 2000
Skills
CAPA, cGMP, Quality Systems, Process Validation, SOP, Pharmaceuticals, Validation, Aseptic Processing, FDA, GMP, Quality Assurance, Manufacturing, Regulatory Affairs, 21 CFR Part 11, Root Cause Analysis, Technical Writing, Quality Auditing, Computer System..., V&V, Pharmaceutical Industry, Sop, Quality System, Quality Management, Technology Transfer, Cleaning Validation, Change Control, Trackwise, Biopharmaceuticals, Process Simulation, GxP, Quality Control, GAMP, GLP, LIMS, ISO 13485, Biotechnology, HPLC
Education
The Ohio State University 1997 — 2001
B.S., Chemical Engineering
ProPharma Group September 2014 - Present
Pentair Water Solutions March 2014 - September 2014
Boehringer Ingelheim September 2011 - December 2013
Boehringer Ingelheim September 2009 - September 2011
Boehringer Ingelheim September 2007 - September 2009
Boehringer Ingelheim May 2002 - September 2007
Unilever 2000 - 2000
Skills
CAPA, cGMP, Quality Systems, Process Validation, SOP, Pharmaceuticals, Validation, Aseptic Processing, FDA, GMP, Quality Assurance, Manufacturing, Regulatory Affairs, 21 CFR Part 11, Root Cause Analysis, Technical Writing, Quality Auditing, Computer System..., V&V, Pharmaceutical Industry, Sop, Quality System, Quality Management, Technology Transfer, Cleaning Validation, Change Control, Trackwise, Biopharmaceuticals, Process Simulation, GxP, Quality Control, GAMP, GLP, LIMS, ISO 13485, Biotechnology, HPLC
Education
The Ohio State University 1997 — 2001
B.S., Chemical Engineering
Alan Dake Alan Dake's ProPharma Group Experience 2010 - 2010
Job Senior Specialist, Quality Assurance Auditing at Boehringer Ingelheim Vetmedica
Industry Pharmaceuticals
Experience
Boehringer Ingelheim Vetmedica March 2015 - Present
SAFC Biosciences April 2012 - March 2015
Boy Scouts of America March 2007 - March 2015
Aptuit July 2011 - April 2012
Sara Lee 2010 - 2011
Bayer HealthCare January 2003 - July 2010
ProPharma Group 2010 - 2010
Boy Scouts of America May 2008 - May 2009
National Registry of Microbiologists 2008 - 2009
Boy Scouts of America September 2004 - May 2008
Skills
Environmental Monitoring, Gamma, Validation, Microbiology, FDA, GMP, Quality Systems, cGMP, Pharmaceuticals, Regulatory Affairs, Life Sciences, Biotechnology, R&D, SOP, Medical Devices, ELISA, LIMS, SAP, PowerPoint, Excel, Word, Technical Writing, CAPA, Quality Control, Sop, Microsoft Excel, Quality System, Laboratory, V&V, Pharmaceutical Industry, Change Control, Cleaning Validation, GLP, Lifesciences
Education
The University of Texas at Arlington 1985 — 1992
Bachelor of Science, Biology
Boehringer Ingelheim Vetmedica March 2015 - Present
SAFC Biosciences April 2012 - March 2015
Boy Scouts of America March 2007 - March 2015
Aptuit July 2011 - April 2012
Sara Lee 2010 - 2011
Bayer HealthCare January 2003 - July 2010
ProPharma Group 2010 - 2010
Boy Scouts of America May 2008 - May 2009
National Registry of Microbiologists 2008 - 2009
Boy Scouts of America September 2004 - May 2008
Skills
Environmental Monitoring, Gamma, Validation, Microbiology, FDA, GMP, Quality Systems, cGMP, Pharmaceuticals, Regulatory Affairs, Life Sciences, Biotechnology, R&D, SOP, Medical Devices, ELISA, LIMS, SAP, PowerPoint, Excel, Word, Technical Writing, CAPA, Quality Control, Sop, Microsoft Excel, Quality System, Laboratory, V&V, Pharmaceutical Industry, Change Control, Cleaning Validation, GLP, Lifesciences
Education
The University of Texas at Arlington 1985 — 1992
Bachelor of Science, Biology
Chris Santarcangelo Chris Santarcangelo's ProPharma Group Experience April 2012 - May 2013
Job Sr. Manager, Quality Systems Compliance at Fresenius Medical Care
Industry Pharmaceuticals
Experience
Fresenius Medical Care February 2015 - Present
Boy Scouts of America September 2009 - Present
Tower Laboratories Ltd. March 2014 - October 2014
Independent Quality and Compliance Consulting May 2013 - February 2014
ProPharma Group April 2012 - May 2013
Purdue Pharma L.P. August 2006 - July 2011
Purdue Pharma July 2003 - August 2006
Protein Sciences Corp. May 2002 - July 2003
Bayer 1996 - 2002
Watson Foods Company, Inc. June 1994 - July 1996
Skills
GMP, Auditing, Compliance Management, Corporate Governance, Quality Systems, Computer System..., Compliance Audits, Compliance, Investigations, FDA, Biotechnology, SOP, Process Improvement, Risk Assessment, Quality Management, Internal Audit, Quality Assurance, Documentation, Audit, Risk Management, Pharmaceuticals, Policy, Healthcare, Change Management, Cross-functional Team..., Validation, Life Sciences, Team Building, Mentoring, Problem Solving, Program Management, Team Leadership, ISO 13485, Quality Auditing, Sop, Pharmaceutical Industry, Quality System, Training, Leadership, Management, Private Investigations, Project Planning, Regulatory Submissions, 21 CFR Part 11, Change Control, Regulatory Affairs, Manufacturing, Regulatory Requirements, Medical Devices, Testing
Education
Albertus Magnus College 1999 — 2001
MS, Management
Rensselaer Polytechnic Institute 1989 — 1994
BS, Chemistry
Fresenius Medical Care February 2015 - Present
Boy Scouts of America September 2009 - Present
Tower Laboratories Ltd. March 2014 - October 2014
Independent Quality and Compliance Consulting May 2013 - February 2014
ProPharma Group April 2012 - May 2013
Purdue Pharma L.P. August 2006 - July 2011
Purdue Pharma July 2003 - August 2006
Protein Sciences Corp. May 2002 - July 2003
Bayer 1996 - 2002
Watson Foods Company, Inc. June 1994 - July 1996
Skills
GMP, Auditing, Compliance Management, Corporate Governance, Quality Systems, Computer System..., Compliance Audits, Compliance, Investigations, FDA, Biotechnology, SOP, Process Improvement, Risk Assessment, Quality Management, Internal Audit, Quality Assurance, Documentation, Audit, Risk Management, Pharmaceuticals, Policy, Healthcare, Change Management, Cross-functional Team..., Validation, Life Sciences, Team Building, Mentoring, Problem Solving, Program Management, Team Leadership, ISO 13485, Quality Auditing, Sop, Pharmaceutical Industry, Quality System, Training, Leadership, Management, Private Investigations, Project Planning, Regulatory Submissions, 21 CFR Part 11, Change Control, Regulatory Affairs, Manufacturing, Regulatory Requirements, Medical Devices, Testing
Education
Albertus Magnus College 1999 — 2001
MS, Management
Rensselaer Polytechnic Institute 1989 — 1994
BS, Chemistry
Nadia C. Zelaya Nadia C. Zelaya's ProPharma Group Experience May 2012 - December 2012
Job Independent Consultant, QC Microbiology in Pharma, Biotechnology & Medical Devices
Industry Pharmaceuticals
Experience
Corning Life Sciences April 2013 - May 2015
PAREXEL January 2013 - March 2013
Maetrics, LLC December 2012 - January 2013
ProPharma Group May 2012 - December 2012
BD July 2009 - April 2012
Schering-Plough October 2007 - July 2009
Biotest Pharmaceuticals Corporation (formerly Nabi Biopharmaceuticals) July 2006 - October 2007
American Express September 2000 - July 2007
Skills
Microbiology, Validation, FDA, Sop, CAPA, GMP, Quality Assurance, Quality Auditing, Root Cause Analysis, Quality System, Regulatory Affairs, ISO, Pharmaceutical Industry, Change Control, Quality Management, Manufacturing, GLP, ISO 13485, Aseptic Processing, Computer System..., Cleaning Validation, Technology Transfer, Trackwise, Quality Control, Biotechnology, 21 CFR Part 11, Biopharmaceuticals, Deviations, Environmental Monitoring, GxP, Iso 9000, LIMS, Laboratory, Sterilization, USP, Regulatory Requirements, Lifesciences, FDA GMP, Aseptic Technique, 21 CFR, Cell Culture, Equipment Qualification, Pharmaceutics, SOP, Life Sciences
Education
Florida Atlantic University 2002 — 2005
BS, Microbiology, Molecular Genetics, Biotechnology
Le Cordon Bleu College of Culinary Arts-Miami 2008 — 2009
Diploma in Patisserie and Baking, Patisserie and Baking
Corning Life Sciences April 2013 - May 2015
PAREXEL January 2013 - March 2013
Maetrics, LLC December 2012 - January 2013
ProPharma Group May 2012 - December 2012
BD July 2009 - April 2012
Schering-Plough October 2007 - July 2009
Biotest Pharmaceuticals Corporation (formerly Nabi Biopharmaceuticals) July 2006 - October 2007
American Express September 2000 - July 2007
Skills
Microbiology, Validation, FDA, Sop, CAPA, GMP, Quality Assurance, Quality Auditing, Root Cause Analysis, Quality System, Regulatory Affairs, ISO, Pharmaceutical Industry, Change Control, Quality Management, Manufacturing, GLP, ISO 13485, Aseptic Processing, Computer System..., Cleaning Validation, Technology Transfer, Trackwise, Quality Control, Biotechnology, 21 CFR Part 11, Biopharmaceuticals, Deviations, Environmental Monitoring, GxP, Iso 9000, LIMS, Laboratory, Sterilization, USP, Regulatory Requirements, Lifesciences, FDA GMP, Aseptic Technique, 21 CFR, Cell Culture, Equipment Qualification, Pharmaceutics, SOP, Life Sciences
Education
Florida Atlantic University 2002 — 2005
BS, Microbiology, Molecular Genetics, Biotechnology
Le Cordon Bleu College of Culinary Arts-Miami 2008 — 2009
Diploma in Patisserie and Baking, Patisserie and Baking
James Meckstroth James Meckstroth's ProPharma Group Experience September 2014 - Present
Job Sr. Compliance Consultant at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group September 2014 - Present
Aptuit April 2013 - September 2014
Aptuit June 2011 - April 2013
Aptuit February 2007 - June 2011
EaglePicher Pharmaceutical Services October 2005 - February 2007
EaglePicher Pharmaceutical Services March 2003 - October 2005
JRH Bioscience 2001 - 2003
Heinz Pet Products 2000 - 2001
Skills
Quality Assurance..., Cleaning Validation, Team Management, FDA GMP, ICH guidelines, SOP development, Internal Audit, External Audit, Equipment Qualification, Supplier Quality..., CAPA, Change Management, Risk Management, Incident Investigation, Employee Training, 21 CFR Part 11, SOP Development, Validation, Change Control, GMP, ICH Guidelines, FDA, GLP, Pharmaceutical Industry, Quality Assurance, Quality Control, Quality System, SOP, Biotechnology, Technology Transfer
Education
Avila University 2005 — 2009
Master of Business Administration (M.B.A.), Business Administration and Management, General
The University of Kansas 1995 — 2000
Bachelor's degree, Microbiology, General
ProPharma Group September 2014 - Present
Aptuit April 2013 - September 2014
Aptuit June 2011 - April 2013
Aptuit February 2007 - June 2011
EaglePicher Pharmaceutical Services October 2005 - February 2007
EaglePicher Pharmaceutical Services March 2003 - October 2005
JRH Bioscience 2001 - 2003
Heinz Pet Products 2000 - 2001
Skills
Quality Assurance..., Cleaning Validation, Team Management, FDA GMP, ICH guidelines, SOP development, Internal Audit, External Audit, Equipment Qualification, Supplier Quality..., CAPA, Change Management, Risk Management, Incident Investigation, Employee Training, 21 CFR Part 11, SOP Development, Validation, Change Control, GMP, ICH Guidelines, FDA, GLP, Pharmaceutical Industry, Quality Assurance, Quality Control, Quality System, SOP, Biotechnology, Technology Transfer
Education
Avila University 2005 — 2009
Master of Business Administration (M.B.A.), Business Administration and Management, General
The University of Kansas 1995 — 2000
Bachelor's degree, Microbiology, General
Trent Ritchey's ProPharma Group Experience 2013 - May 2014
Job Validation Engineer
Industry Pharmaceuticals
Experience
IPS-Integrated Project Services April 2014 - Present
ProPharma Group 2013 - May 2014
Cook Pharmica October 2010 - August 2013
BioConvergence LLC February 2006 - April 2009
Baxter Pharmaceutical Solutions 2002 - 2006
Crane Naval Base 1999 - 2002
Skills
GMP, Validation, Sop, FDA, Change Control, CAPA, 21 CFR Part 11, Trackwise, Aseptic Processing, Biotechnology, Calibration, GxP, LIMS, Pharmaceutical Industry, Technical Writing, Cleaning Validation, Equipment Qualification, FDA GMP, Troubleshooting, Manufacturing
Education
Penn State University 2011 — 2014
Bachelor of Science (BS), Homeland Security, Law Enforcement, Firefighting and Related Protective Services
Vincennes University 1996 — 2000
Associate's Degree, Electrical, Electronic and Communications Engineering Technology/Technician
IPS-Integrated Project Services April 2014 - Present
ProPharma Group 2013 - May 2014
Cook Pharmica October 2010 - August 2013
BioConvergence LLC February 2006 - April 2009
Baxter Pharmaceutical Solutions 2002 - 2006
Crane Naval Base 1999 - 2002
Skills
GMP, Validation, Sop, FDA, Change Control, CAPA, 21 CFR Part 11, Trackwise, Aseptic Processing, Biotechnology, Calibration, GxP, LIMS, Pharmaceutical Industry, Technical Writing, Cleaning Validation, Equipment Qualification, FDA GMP, Troubleshooting, Manufacturing
Education
Penn State University 2011 — 2014
Bachelor of Science (BS), Homeland Security, Law Enforcement, Firefighting and Related Protective Services
Vincennes University 1996 — 2000
Associate's Degree, Electrical, Electronic and Communications Engineering Technology/Technician
Cara Giller's ProPharma Group Experience May 2015 - Present
Job RN/Medical Information Specialist at ProPharma Group
Industry Hospital & Health Care
Experience
ProPharma Group May 2015 - Present
Teva Pharmaceuticals August 2014 - Present
Centene Corporation October 2013 - August 2014
Brown Mackie College June 2012 - March 2013
Colorado Technical University May 2011 - June 2012
Medtronic August 2009 - September 2010
St Jude Medical June 2002 - August 2009
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Research, Windows, Outlook, Photoshop, Teaching, HTML, Public Speaking, Budgets, Strategic Planning, Negotiation, C++, Editing, C, Java, Nursing, Healthcare, Clinical Research
Education
Purdue University 1991 — 1995
Bachelors of Nursing, Registered Nursing/Registered Nurse
Purdue University 1989 — 1993
Bachelor's of Science, Individual and Family Development
ProPharma Group May 2015 - Present
Teva Pharmaceuticals August 2014 - Present
Centene Corporation October 2013 - August 2014
Brown Mackie College June 2012 - March 2013
Colorado Technical University May 2011 - June 2012
Medtronic August 2009 - September 2010
St Jude Medical June 2002 - August 2009
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Research, Windows, Outlook, Photoshop, Teaching, HTML, Public Speaking, Budgets, Strategic Planning, Negotiation, C++, Editing, C, Java, Nursing, Healthcare, Clinical Research
Education
Purdue University 1991 — 1995
Bachelors of Nursing, Registered Nursing/Registered Nurse
Purdue University 1989 — 1993
Bachelor's of Science, Individual and Family Development
Scott Penderis Scott Penderis's ProPharma Group Experience May 2011 - September 2013
Job Assistant Corporate Controller at Euronet Worldwide
Industry Financial Services
Experience
Euronet Worldwide September 2013 - Present
ProPharma Group May 2011 - September 2013
Seaboard Overseas Limited July 2010 - May 2011
ProPharma Group September 2008 - July 2010
Seaboard Corporation April 2007 - September 2008
Seaboard Overseas Limited March 2005 - April 2007
Skills
Accounting, Auditing, GAAP, Accruals, Process Improvement, Internal Audit, Project Management, Cash Management, Financial Modeling, Budgets, Cross-functional Team..., Business Process..., Due Diligence, Financial Analysis, Sarbanes-Oxley Act, Accounts Receivable, General Ledger, Investor Relations, US GAAP, Internal Controls, Forecasting, Variance Analysis, Managerial Finance, Risk Assessment, Finance, Business Analysis, CPA, Strategic Planning, Microsoft Excel, Account Reconciliation, Cash Flow, Biotechnology, Financial Statements, Cost Accounting, Financial Reporting, Management, Risk Management, Sarbanes-Oxley
Education
Durban Institute of Technology 1997 — 2000
National Diploma in Accounting, Accounting and Auditing
Euronet Worldwide September 2013 - Present
ProPharma Group May 2011 - September 2013
Seaboard Overseas Limited July 2010 - May 2011
ProPharma Group September 2008 - July 2010
Seaboard Corporation April 2007 - September 2008
Seaboard Overseas Limited March 2005 - April 2007
Skills
Accounting, Auditing, GAAP, Accruals, Process Improvement, Internal Audit, Project Management, Cash Management, Financial Modeling, Budgets, Cross-functional Team..., Business Process..., Due Diligence, Financial Analysis, Sarbanes-Oxley Act, Accounts Receivable, General Ledger, Investor Relations, US GAAP, Internal Controls, Forecasting, Variance Analysis, Managerial Finance, Risk Assessment, Finance, Business Analysis, CPA, Strategic Planning, Microsoft Excel, Account Reconciliation, Cash Flow, Biotechnology, Financial Statements, Cost Accounting, Financial Reporting, Management, Risk Management, Sarbanes-Oxley
Education
Durban Institute of Technology 1997 — 2000
National Diploma in Accounting, Accounting and Auditing
Tina John Wray Tina John Wray's ProPharma Group Experience 2008 - 2008
Job Server at Olive Garden and Student
Industry Restaurants
Experience
Olive Garden September 2005 - Present
Applebee's March 2011 - May 2012
Salsarita's Fresh Cantina June 2010 - March 2011
Yia Yia's Euro Bistro July 2007 - July 2008
ProPharma Group 2008 - 2008
Encore Staffing June 2006 - December 2006
Skills
Hiring, Customer Service, Inventory Management, Employee Relations, Retail, Restaurant Management, Restaurant Marketing, Human Relations, Customer Satisfaction, Hospitality, People Skills
Education
National American University-Lee's Summit 2013 — 2017
Bachelor's degree, Health/Health Care Administration/Management
Central Missouri State University 1999 — 2004
BSBA, Management
Olive Garden September 2005 - Present
Applebee's March 2011 - May 2012
Salsarita's Fresh Cantina June 2010 - March 2011
Yia Yia's Euro Bistro July 2007 - July 2008
ProPharma Group 2008 - 2008
Encore Staffing June 2006 - December 2006
Skills
Hiring, Customer Service, Inventory Management, Employee Relations, Retail, Restaurant Management, Restaurant Marketing, Human Relations, Customer Satisfaction, Hospitality, People Skills
Education
National American University-Lee's Summit 2013 — 2017
Bachelor's degree, Health/Health Care Administration/Management
Central Missouri State University 1999 — 2004
BSBA, Management
Laura Cribbins Laura Cribbins's ProPharma Group Experience January 2010 - May 2013
Job Principal at C2 Enterprises, Inc.
Industry Pharmaceuticals
Experience
C2 Enterprises, Inc. May 2013 - Present
ProPharma Group January 2010 - May 2013
NovaBay 2008 - May 2013
C2 Enterprises, Inc. October 1998 - March 2010
Chiron 2002 - 2005
Validation Systems, Inc. 1993 - 1997
The Cooper Companies 1984 - 1989
Skills
Technology Transfer, Program Management, Planning, Biotechnology, Validation, Medical Devices, Manufacturing, Cross-functional Team..., GMP, Pharmaceuticals, Life Sciences, FDA, cGMP, Project Planning, Process Development, Strategic Planning, Biopharmaceuticals, Contract Manufacturing, Team Building, Process Validation, Risk Management, Pharmaceutical Industry, V&V, Computer System..., GxP, Lifesciences, Drug Development, Clinical Development, Regulatory Submissions, Pharmaceutics
Education
Santa Clara University 1987 — 1990
MBA
University of California, Santa Cruz 1979 — 1984
BA, Biology/Biochemistry
C2 Enterprises, Inc. May 2013 - Present
ProPharma Group January 2010 - May 2013
NovaBay 2008 - May 2013
C2 Enterprises, Inc. October 1998 - March 2010
Chiron 2002 - 2005
Validation Systems, Inc. 1993 - 1997
The Cooper Companies 1984 - 1989
Skills
Technology Transfer, Program Management, Planning, Biotechnology, Validation, Medical Devices, Manufacturing, Cross-functional Team..., GMP, Pharmaceuticals, Life Sciences, FDA, cGMP, Project Planning, Process Development, Strategic Planning, Biopharmaceuticals, Contract Manufacturing, Team Building, Process Validation, Risk Management, Pharmaceutical Industry, V&V, Computer System..., GxP, Lifesciences, Drug Development, Clinical Development, Regulatory Submissions, Pharmaceutics
Education
Santa Clara University 1987 — 1990
MBA
University of California, Santa Cruz 1979 — 1984
BA, Biology/Biochemistry
Greg Spanel Greg Spanel's ProPharma Group Experience January 2014 - Present
Job Director Account Management at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group January 2014 - Present
ProPharma Group June 2011 - Present
ProPharma Group January 2011 - June 2011
ProPharma Group May 2010 - January 2011
ProPharma Group April 2006 - August 2010
Serologicals February 2002 - February 2004
Wyeth BioPharma February 2000 - February 2002
Pharmacia February 1999 - February 2001
QVM 1997 - 1999
Skills
Certified Project..., New Business Development, Validation, Commissioning, Project Management, Business Development, V&V, Engineering, Pharmaceutical Industry, Quality Assurance, Manufacturing, Medical Devices, GMP, FDA, Technology Transfer, Program Management, Testing, CAPA, Software Documentation
Education
Mahler 2011 — 2012
Advanced Management Skills Program, Executive Development Program
Webster University 2000 — 2003
MBA, Management
Iowa State University 1992 — 1997
BS, Chemical Engineering
Omaha Northwest
ProPharma Group January 2014 - Present
ProPharma Group June 2011 - Present
ProPharma Group January 2011 - June 2011
ProPharma Group May 2010 - January 2011
ProPharma Group April 2006 - August 2010
Serologicals February 2002 - February 2004
Wyeth BioPharma February 2000 - February 2002
Pharmacia February 1999 - February 2001
QVM 1997 - 1999
Skills
Certified Project..., New Business Development, Validation, Commissioning, Project Management, Business Development, V&V, Engineering, Pharmaceutical Industry, Quality Assurance, Manufacturing, Medical Devices, GMP, FDA, Technology Transfer, Program Management, Testing, CAPA, Software Documentation
Education
Mahler 2011 — 2012
Advanced Management Skills Program, Executive Development Program
Webster University 2000 — 2003
MBA, Management
Iowa State University 1992 — 1997
BS, Chemical Engineering
Omaha Northwest
Benjamin Frey's ProPharma Group Experience February 2014 - Present
Job Principal Compliance Consultant at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group February 2014 - Present
ProPharma Group January 2010 - February 2014
ProPharma Group 2005 - December 2009
Eagle Picher Pharmaceutical Services 2002 - 2005
CGMP Validation, LLC January 2000 - January 2002
Antigen Laboratories January 1998 - January 2000
University of New Mexico January 1997 - January 1998
Mallinckrodt Veterinary (Coopers Animal Health), Assoc January 1993 - January 1997
Johnson County Community College January 1993 - January 1994
University of Kansas Medical Center January 1992 - January 1993
Skills
GMP, Validation, Quality Assurance, cGMP, Quality Systems, CAPA, Quality Management, Quality Auditing, Pharmaceuticals, SOP, Change Control, GxP, Quality System, Pharmaceutical Industry, Sop, Strategic Leadership, Team Management, 21 CFR Part 11, GLP, FDA, V&V, Cleaning Validation, Biotechnology, Medical Devices, Computer System..., Biopharmaceuticals, LIMS, Trackwise, GAMP, TrackWise
Education
Emporia State University 1992 — 1993
Master of Science, Biology
The University of Kansas
Bachelor of Science, Biology
ProPharma Group February 2014 - Present
ProPharma Group January 2010 - February 2014
ProPharma Group 2005 - December 2009
Eagle Picher Pharmaceutical Services 2002 - 2005
CGMP Validation, LLC January 2000 - January 2002
Antigen Laboratories January 1998 - January 2000
University of New Mexico January 1997 - January 1998
Mallinckrodt Veterinary (Coopers Animal Health), Assoc January 1993 - January 1997
Johnson County Community College January 1993 - January 1994
University of Kansas Medical Center January 1992 - January 1993
Skills
GMP, Validation, Quality Assurance, cGMP, Quality Systems, CAPA, Quality Management, Quality Auditing, Pharmaceuticals, SOP, Change Control, GxP, Quality System, Pharmaceutical Industry, Sop, Strategic Leadership, Team Management, 21 CFR Part 11, GLP, FDA, V&V, Cleaning Validation, Biotechnology, Medical Devices, Computer System..., Biopharmaceuticals, LIMS, Trackwise, GAMP, TrackWise
Education
Emporia State University 1992 — 1993
Master of Science, Biology
The University of Kansas
Bachelor of Science, Biology
Robert P. Gurley Robert P. Gurley's ProPharma Group Experience 2013 - 2013
Job Scientist / Chemist
Industry Chemicals
Experience
ProPharma Group 2013 - 2013
Ricerca Biosciences November 2010 - October 2012
Boehringer Ingelheim Pharmaceuticals February 1992 - February 2009
Gould Inc. Foil Division May 1988 - January 1991
The Ohio State University June 1985 - August 1987
The Cleveland Electric Illuminating Company September 1981 - June 1985
Skills
HPLC, Organic Chemistry, Chemistry, GMP, Analytical Chemistry, Validation, Sop, Gas Chromatography, Technology Transfer, FDA, Formulation, Pharmaceutics, Dissolution, Chromatography, Laboratory, V&V, Quality System, Pharmaceutical Industry
Education
Temple University 2002 — 2003
Graduate Certificate Program, Pharmaceutical Regulatory Affairs and Quality Assurance
The Ohio State University 1978 — 2003
Bachelors, Chemistry and Graduate Buisiness
ProPharma Group 2013 - 2013
Ricerca Biosciences November 2010 - October 2012
Boehringer Ingelheim Pharmaceuticals February 1992 - February 2009
Gould Inc. Foil Division May 1988 - January 1991
The Ohio State University June 1985 - August 1987
The Cleveland Electric Illuminating Company September 1981 - June 1985
Skills
HPLC, Organic Chemistry, Chemistry, GMP, Analytical Chemistry, Validation, Sop, Gas Chromatography, Technology Transfer, FDA, Formulation, Pharmaceutics, Dissolution, Chromatography, Laboratory, V&V, Quality System, Pharmaceutical Industry
Education
Temple University 2002 — 2003
Graduate Certificate Program, Pharmaceutical Regulatory Affairs and Quality Assurance
The Ohio State University 1978 — 2003
Bachelors, Chemistry and Graduate Buisiness
Jeff Whitman Jeff Whitman's ProPharma Group Experience 2000 - 2001
Job Dental Sales Consultant at VOCO CANADA INC
Industry Pharmaceuticals
Experience
VOCO Canada Inc. April 2011 - Present
CFIB FCEI December 2010 - May 2011
Abbott May 2008 - June 2009
Bayer HealthCare 2007 - 2008
Novartis 2005 - 2008
Fournier Pharma 2002 - 2005
GSK 2001 - 2002
ProPharma Group 2000 - 2001
Skills
Cardiology, Pharmaceutical Sales, Sales Effectiveness, Rheumatology, Business Planning, Hospital Sales, Neurology, Sales Force Development, Pharmaceutical Industry, Endocrinology, Gastroenterology, Account Management, Medical Devices, Sales Operations, Dermatology, Product Launch, Sales Presentations, Dental Sales, Capital Equipment, Selling, Selling Skills, Nephrology, Pulmonology, OB/GYN, Osteoporosis, Hypertension, Urology, Market Access, Managed Care, Oncology, Infectious Diseases, Sales, Dental Marketing
Education
Saint Mary's University 1986 — 1989
Bachelor's degree, Psychology
Queen Elizabeth High School
VOCO Canada Inc. April 2011 - Present
CFIB FCEI December 2010 - May 2011
Abbott May 2008 - June 2009
Bayer HealthCare 2007 - 2008
Novartis 2005 - 2008
Fournier Pharma 2002 - 2005
GSK 2001 - 2002
ProPharma Group 2000 - 2001
Skills
Cardiology, Pharmaceutical Sales, Sales Effectiveness, Rheumatology, Business Planning, Hospital Sales, Neurology, Sales Force Development, Pharmaceutical Industry, Endocrinology, Gastroenterology, Account Management, Medical Devices, Sales Operations, Dermatology, Product Launch, Sales Presentations, Dental Sales, Capital Equipment, Selling, Selling Skills, Nephrology, Pulmonology, OB/GYN, Osteoporosis, Hypertension, Urology, Market Access, Managed Care, Oncology, Infectious Diseases, Sales, Dental Marketing
Education
Saint Mary's University 1986 — 1989
Bachelor's degree, Psychology
Queen Elizabeth High School
Jodi Apple McLeroy Jodi Apple McLeroy's ProPharma Group Experience January 2012 - November 2013
Job Recruiting Director at CST Industries, Inc.
Industry Human Resources
Experience
CST Industries, Inc. December 2013 - Present
Self Employed January 2009 - Present
ProPharma Group January 2012 - November 2013
H&R Block June 2011 - January 2012
Gentiva Health Services April 2011 - June 2011
Apria Healthcare April 2010 - December 2010
Terracon October 2006 - January 2009
Ferrellgas October 2000 - October 2006
Wade Palmer And Associates 1994 - 2000
Skills
Technical Recruiting, Career Counseling, Contract Recruitment, Sourcing, Interviewing, Resume Writing, Talent Acquisition, Applicant Tracking..., College Recruiting, Employer Branding, Talent Management, Hiring, Benefits Negotiation, Social Networking, Employee Training, Job Coaching, Interview Skills..., Career Development..., Recruiting, SDLC, Interviews, Human Resources, Onboarding, Employee Benefits, Full-cycle Recruiting, Social Media, LinkedIn, Job Search Advice, Job Search Coach, Salary Negotiation, Recruitment/Retention, Website Promotion, Process Improvement, Screening, Leadership, New Hire Orientations, Screening Resumes, Employee Relations, Taleo, Temporary Placement, Job Fairs, HRIS, Management, Internet Recruiting, Job Descriptions, Training, PeopleSoft, Performance Management, Program Management, Staffing Services
Education
Missouri State University 1990 — 1994
BS
Maryville RII High School 1980 — 1994
Northwest Missouri State University 1990 — 1990
CST Industries, Inc. December 2013 - Present
Self Employed January 2009 - Present
ProPharma Group January 2012 - November 2013
H&R Block June 2011 - January 2012
Gentiva Health Services April 2011 - June 2011
Apria Healthcare April 2010 - December 2010
Terracon October 2006 - January 2009
Ferrellgas October 2000 - October 2006
Wade Palmer And Associates 1994 - 2000
Skills
Technical Recruiting, Career Counseling, Contract Recruitment, Sourcing, Interviewing, Resume Writing, Talent Acquisition, Applicant Tracking..., College Recruiting, Employer Branding, Talent Management, Hiring, Benefits Negotiation, Social Networking, Employee Training, Job Coaching, Interview Skills..., Career Development..., Recruiting, SDLC, Interviews, Human Resources, Onboarding, Employee Benefits, Full-cycle Recruiting, Social Media, LinkedIn, Job Search Advice, Job Search Coach, Salary Negotiation, Recruitment/Retention, Website Promotion, Process Improvement, Screening, Leadership, New Hire Orientations, Screening Resumes, Employee Relations, Taleo, Temporary Placement, Job Fairs, HRIS, Management, Internet Recruiting, Job Descriptions, Training, PeopleSoft, Performance Management, Program Management, Staffing Services
Education
Missouri State University 1990 — 1994
BS
Maryville RII High School 1980 — 1994
Northwest Missouri State University 1990 — 1990
Elizabeth Dunn Elizabeth Dunn's ProPharma Group Experience November 2013 - Present
Job Principal Consultant at ProPharma Group
Industry Biotechnology
Experience
ProPharma Group November 2013 - Present
Hospira August 2012 - November 2013
Elizabeth Dunn GxP Technical Consulting November 2011 - October 2012
Boehringer Ingelheim March 2011 - November 2011
Amgen January 2007 - March 2011
Gilead Sciences September 2002 - January 2007
Meridian Medical Technologies January 1999 - March 2002
Aventis Behring 1998 - 1999
Centeon LLC 1998 - 1999
Diamond Animal Health/Heska 1994 - 1997
Skills
Validation, Aseptic Processing, Project Management, Sterility Assurance, Continuous Improvement, Change Control, Biotechnology
Education
Keller Graduate School of Management 2003 — 2009
MBA, Project Management
University of Missouri-Columbia 1979 — 1984
Bachelor of Arts, Biological Sciences
ProPharma Group November 2013 - Present
Hospira August 2012 - November 2013
Elizabeth Dunn GxP Technical Consulting November 2011 - October 2012
Boehringer Ingelheim March 2011 - November 2011
Amgen January 2007 - March 2011
Gilead Sciences September 2002 - January 2007
Meridian Medical Technologies January 1999 - March 2002
Aventis Behring 1998 - 1999
Centeon LLC 1998 - 1999
Diamond Animal Health/Heska 1994 - 1997
Skills
Validation, Aseptic Processing, Project Management, Sterility Assurance, Continuous Improvement, Change Control, Biotechnology
Education
Keller Graduate School of Management 2003 — 2009
MBA, Project Management
University of Missouri-Columbia 1979 — 1984
Bachelor of Arts, Biological Sciences
David Novak David Novak's ProPharma Group Experience November 2012 - April 2015
Job Director of Business Development at OSDV Engineering, Inc.
Industry Biotechnology
Experience
OSDV Engineering, Inc. September 2015 - Present
H2H Advisors - Advanced Technologies April 2015 - August 2015
ProPharma Group November 2012 - April 2015
Novak Associates January 2010 - November 2012
AMEC - PharmBio and Chemical February 2007 - December 2009
AMEC February 2007 - December 2009
Erland Construction - Advanced Tech Division September 1998 - November 2005
Marshall Contractors October 1992 - January 1994
Vanderweil Engineers September 1990 - September 1992
Vanderweil Engineers September 1990 - September 1991
Skills
Strategy Development, Biotechnology, New Business Development, Account Management, Business Strategy, Customer Relations, Engineering, Healthcare, Team Leadership, Program Management, Negotiation, Contract Negotiation, Operations Management, Strategic Planning, Planning, Social Media, Data Center, Medical Devices, Business Planning, Global Business..., Strategy, Project Planning, Validation, Management, Project Management, Business Development, Quality Assurance, Process Improvement, Leadership, CRM, Cross-functional Team..., Budgets, Manufacturing, Pharmaceutical Industry, Integration, Technology Transfer, Management Consulting, Start-ups, Lifesciences, Product Development, GMP, FDA
Education
Eastern Nazarene College
Bachelors of Science, Business Administration
Northeastern University
Certificate of Professional Achievement, Mechanical Systems Engineering
Boston Architectural College
Architecture
Penn State University
Microbiology
OSDV Engineering, Inc. September 2015 - Present
H2H Advisors - Advanced Technologies April 2015 - August 2015
ProPharma Group November 2012 - April 2015
Novak Associates January 2010 - November 2012
AMEC - PharmBio and Chemical February 2007 - December 2009
AMEC February 2007 - December 2009
Erland Construction - Advanced Tech Division September 1998 - November 2005
Marshall Contractors October 1992 - January 1994
Vanderweil Engineers September 1990 - September 1992
Vanderweil Engineers September 1990 - September 1991
Skills
Strategy Development, Biotechnology, New Business Development, Account Management, Business Strategy, Customer Relations, Engineering, Healthcare, Team Leadership, Program Management, Negotiation, Contract Negotiation, Operations Management, Strategic Planning, Planning, Social Media, Data Center, Medical Devices, Business Planning, Global Business..., Strategy, Project Planning, Validation, Management, Project Management, Business Development, Quality Assurance, Process Improvement, Leadership, CRM, Cross-functional Team..., Budgets, Manufacturing, Pharmaceutical Industry, Integration, Technology Transfer, Management Consulting, Start-ups, Lifesciences, Product Development, GMP, FDA
Education
Eastern Nazarene College
Bachelors of Science, Business Administration
Northeastern University
Certificate of Professional Achievement, Mechanical Systems Engineering
Boston Architectural College
Architecture
Penn State University
Microbiology
Kellie Ideson Kellie Ideson's ProPharma Group Experience October 2008 - April 2009
Job Client Services, ERA Landmark Real Estate
Industry Real Estate
Experience
Social Butterfly, LLC April 2013 - Present
ERA Landmark Real Estate May 2010 - Present
Keepsakes by Kellie, Custom Memory Albums October 2003 - August 2010
ERA Landmark May 2009 - May 2010
ProPharma Group October 2008 - April 2009
ERA Landmark Real Estate September 2007 - October 2008
Edward M. Berstein and Associates April 2000 - July 2000
Gordon Biersch March 1996 - October 1999
Gordon Biersch Brewing Company January 1997 - May 1998
Station Casinos 1996 - 1997
Skills
Marketing, Home, Sellers, Social Media, Real Estate, Customer Service, Luxury, Listings, Management, Event Management, Negotiation, Marketing Strategy, Advertising, Residential Homes, Event Planning, Photography, Public Speaking, Single Family Homes, Relocation, Buyers, Social Media Marketing, Microsoft Office, Office Management, Microsoft Excel, Administrative..., Referrals, Social Networking, Human Resources, Fundraising, Online Marketing, Microsoft Word, Real Estate Transactions, PowerPoint, Marketing Communications, Property, Copywriting, Small Business, Buyer Representation, Condos, Time Management, Blogging
Education
College of Southern Nevada 1996 — 1998
Connole Morton 2008 — 2008
Real Estate License, Real Estate
Lansing Community College 1986 — 1988
Grand Ledge High School 1981 — 1985
Social Butterfly, LLC April 2013 - Present
ERA Landmark Real Estate May 2010 - Present
Keepsakes by Kellie, Custom Memory Albums October 2003 - August 2010
ERA Landmark May 2009 - May 2010
ProPharma Group October 2008 - April 2009
ERA Landmark Real Estate September 2007 - October 2008
Edward M. Berstein and Associates April 2000 - July 2000
Gordon Biersch March 1996 - October 1999
Gordon Biersch Brewing Company January 1997 - May 1998
Station Casinos 1996 - 1997
Skills
Marketing, Home, Sellers, Social Media, Real Estate, Customer Service, Luxury, Listings, Management, Event Management, Negotiation, Marketing Strategy, Advertising, Residential Homes, Event Planning, Photography, Public Speaking, Single Family Homes, Relocation, Buyers, Social Media Marketing, Microsoft Office, Office Management, Microsoft Excel, Administrative..., Referrals, Social Networking, Human Resources, Fundraising, Online Marketing, Microsoft Word, Real Estate Transactions, PowerPoint, Marketing Communications, Property, Copywriting, Small Business, Buyer Representation, Condos, Time Management, Blogging
Education
College of Southern Nevada 1996 — 1998
Connole Morton 2008 — 2008
Real Estate License, Real Estate
Lansing Community College 1986 — 1988
Grand Ledge High School 1981 — 1985
Bryan Phillips Bryan Phillips's ProPharma Group Experience September 2013 - Present
Job Project Manager at ProPharma Group | PMP | Validation | Technical Leadership
Industry Pharmaceuticals
Experience
ProPharma Group September 2013 - Present
GMP regulated industries June 1994 - September 2013
Skills
Lean Manufacturing, Validation, GMP, Cross-functional Team..., Continuous Improvement, Project Management, Equipment Qualification, Formulation, Process Engineering, Six Sigma, Team Leadership, Quality Control, Leadership, Regulatory Affairs, Packaging, Pharmaceutical Industry, Process Improvement, Change Control, Supply Chain, Quality Auditing
Education
University of Illinois at Urbana-Champaign 1992 — 1994
Master of Science, Food Science; Specialization in Process Engineering
California Polytechnic State University-San Luis Obispo 1989 — 1992
Bachelor of Science, Food Science
ProPharma Group September 2013 - Present
GMP regulated industries June 1994 - September 2013
Skills
Lean Manufacturing, Validation, GMP, Cross-functional Team..., Continuous Improvement, Project Management, Equipment Qualification, Formulation, Process Engineering, Six Sigma, Team Leadership, Quality Control, Leadership, Regulatory Affairs, Packaging, Pharmaceutical Industry, Process Improvement, Change Control, Supply Chain, Quality Auditing
Education
University of Illinois at Urbana-Champaign 1992 — 1994
Master of Science, Food Science; Specialization in Process Engineering
California Polytechnic State University-San Luis Obispo 1989 — 1992
Bachelor of Science, Food Science
Patricia Cadeau Patricia Cadeau's ProPharma Group Experience 2003 - 2005
Job Marketing Specialist, Power & Industrial
Industry Management Consulting
Experience
AECOM April 2015 - Present
AECOM February 2006 - April 2015
ProPharma Group 2003 - 2005
excerpta Medica BV-Adelphi Group 2002 - 2003
Organon 1994 - 1999
Skills
Internal Communications, Project Management, Proposal Writing, Marketing Communications, Corporate Communications, Marketing Strategy, Microsoft Word, Civil Engineering, Corporate Branding, Marketing, Project Planning, Project Coordination, Construction Management, Engineering, Microsoft Office, Strategic Planning, Leadership, Program Management
Education
Ryerson University
Bachelor of Arts (BA), Business/Corporate Communications
St Joseph's College, Toronto
AECOM April 2015 - Present
AECOM February 2006 - April 2015
ProPharma Group 2003 - 2005
excerpta Medica BV-Adelphi Group 2002 - 2003
Organon 1994 - 1999
Skills
Internal Communications, Project Management, Proposal Writing, Marketing Communications, Corporate Communications, Marketing Strategy, Microsoft Word, Civil Engineering, Corporate Branding, Marketing, Project Planning, Project Coordination, Construction Management, Engineering, Microsoft Office, Strategic Planning, Leadership, Program Management
Education
Ryerson University
Bachelor of Arts (BA), Business/Corporate Communications
St Joseph's College, Toronto
James William Shinkle's ProPharma Group Experience August 2010 - March 2011
Job Business Development Consultant
Industry Computer Software
Experience
Improvised Sales October 2012 - Present
The Occasional Comic January 2006 - Present
ProPharma Group August 2010 - March 2011
acadeus August 2010 - March 2011
Connexa Softools August 2008 - July 2010
Propharma group March 2007 - March 2008
Computer Compliance November 2003 - July 2004
WTC Engineering January 2000 - July 2002
Thermo Environmental Instruments November 1997 - November 1999
Shamrock Enviromental Monitoring Systems March 1996 - October 1997
Skills
SAG, Product Development, Strategic Account, Management, Process Analytical..., Business Development, Marketing, CRM, Configuration Management, Theatre, Film, Team Building, Acting, Entertainment, Networking, Program Management, Project Management, Leadership, Sales
Education
The Second City Conservatory 2006 — 2007
The University of Kansas 1989 — 1995
BGS, Environmental Studies
Improvised Sales October 2012 - Present
The Occasional Comic January 2006 - Present
ProPharma Group August 2010 - March 2011
acadeus August 2010 - March 2011
Connexa Softools August 2008 - July 2010
Propharma group March 2007 - March 2008
Computer Compliance November 2003 - July 2004
WTC Engineering January 2000 - July 2002
Thermo Environmental Instruments November 1997 - November 1999
Shamrock Enviromental Monitoring Systems March 1996 - October 1997
Skills
SAG, Product Development, Strategic Account, Management, Process Analytical..., Business Development, Marketing, CRM, Configuration Management, Theatre, Film, Team Building, Acting, Entertainment, Networking, Program Management, Project Management, Leadership, Sales
Education
The Second City Conservatory 2006 — 2007
The University of Kansas 1989 — 1995
BGS, Environmental Studies
Todd Galles Todd Galles's ProPharma Group Experience June 2012 - Present
Job Director of Business Development at Durbin Global, PharPoint, CMIC , BDC, SwissAmerican Products
Industry Pharmaceuticals
Experience
Durbin PLC January 2014 - Present
CMIC HOLDINGS January 2014 - Present
PharPoint Research, Inc. November 2014 - Present
Swiss-American Products, Inc. January 2015 - Present
Business Development Connections (BDC) 2011 - Present
VxP Pharma - The Pharmaceutical Services Company December 2013 - Present
ProPharma Group June 2012 - Present
Appletree CIG July 2012 - Present
Advanced Response Management June 2012 - Present
Dow Pharmaceutical Sciences May 2011 - March 2013
Skills
Pharmaceutical Industry, Pharmaceutical Sales, Biotechnology, Market Research, Marketing Strategy, Product Launch, Oncology, Business Development, Medical Devices, Product Marketing, Product Management, Marketing, Lifesciences, Leadership, Strategy, Sales, CRO, Cross-functional Team..., Strategic Planning, Management, Pharmaceutics, Clinical Research, FDA, Clinical Trials, Life Sciences
Education
St. Norbert College 1976 — 1980
BA, Business Administration and International Business and Language
Durbin PLC January 2014 - Present
CMIC HOLDINGS January 2014 - Present
PharPoint Research, Inc. November 2014 - Present
Swiss-American Products, Inc. January 2015 - Present
Business Development Connections (BDC) 2011 - Present
VxP Pharma - The Pharmaceutical Services Company December 2013 - Present
ProPharma Group June 2012 - Present
Appletree CIG July 2012 - Present
Advanced Response Management June 2012 - Present
Dow Pharmaceutical Sciences May 2011 - March 2013
Skills
Pharmaceutical Industry, Pharmaceutical Sales, Biotechnology, Market Research, Marketing Strategy, Product Launch, Oncology, Business Development, Medical Devices, Product Marketing, Product Management, Marketing, Lifesciences, Leadership, Strategy, Sales, CRO, Cross-functional Team..., Strategic Planning, Management, Pharmaceutics, Clinical Research, FDA, Clinical Trials, Life Sciences
Education
St. Norbert College 1976 — 1980
BA, Business Administration and International Business and Language
Abbey Whitney's ProPharma Group Experience January 2015 - Present
Job Sr. Marketing Manager at ProPharma Group | Marketing Management | Marketing Strategy & Execution | Analytics & Reporting
Industry Marketing and Advertising
Experience
ProPharma Group January 2015 - Present
ProPharma Group January 2014 - Present
ProPharma Group February 2013 - December 2013
Superior Lexus North September 2011 - July 2012
Biologix Research Company, LLC 2008 - September 2011
Biologix Diagnostics, LLC January 2008 - December 2010
Biologix Research Company, LLC 2007 - 2008
Biologix Research Company, LLC 2005 - 2007
Ferguson Enterprises June 2004 - August 2004
Skills
Social Media, Google Analytics, Online Marketing, Marketing Strategy, Email Marketing, Advertising, Marketing Communications, Social Media Marketing, Microsoft Office, Customer Service, Photoshop, Marketing Management, Market Research, Marketing Reporting, Data Analysis, Event Planning, Website Promotion, Web Analytics, Web Marketing, Blogging, Trade Shows, Graphic Design, SEO, Marketing, Lead Generation, B2B, E-commerce, Facebook, Management, Training, Strategic Planning, Digital Marketing, Integrated Marketing, Direct Marketing
Education
Kansas State University 2001 — 2005
Bachelors of Science in Business Administration, Marketing
Olathe South High School 1998 — 2001
High School Diploma
ProPharma Group January 2015 - Present
ProPharma Group January 2014 - Present
ProPharma Group February 2013 - December 2013
Superior Lexus North September 2011 - July 2012
Biologix Research Company, LLC 2008 - September 2011
Biologix Diagnostics, LLC January 2008 - December 2010
Biologix Research Company, LLC 2007 - 2008
Biologix Research Company, LLC 2005 - 2007
Ferguson Enterprises June 2004 - August 2004
Skills
Social Media, Google Analytics, Online Marketing, Marketing Strategy, Email Marketing, Advertising, Marketing Communications, Social Media Marketing, Microsoft Office, Customer Service, Photoshop, Marketing Management, Market Research, Marketing Reporting, Data Analysis, Event Planning, Website Promotion, Web Analytics, Web Marketing, Blogging, Trade Shows, Graphic Design, SEO, Marketing, Lead Generation, B2B, E-commerce, Facebook, Management, Training, Strategic Planning, Digital Marketing, Integrated Marketing, Direct Marketing
Education
Kansas State University 2001 — 2005
Bachelors of Science in Business Administration, Marketing
Olathe South High School 1998 — 2001
High School Diploma
Andrew Abe Andrew Abe's ProPharma Group Experience January 2014 - Present
Job Clinical Assistant Professor, Drug Information Specialist
Industry Pharmaceuticals
Experience
The University of Kansas October 2013 - Present
The University of Kansas October 2013 - Present
ProPharma Group January 2014 - Present
Journal Club Digest November 2013 - Present
Journal of Evidence-Based Complementary & Alternative Medicine April 2014 - Present
Creighton University July 2011 - June 2013
Creighton University July 2011 - June 2013
CVS Pharmacy August 2009 - May 2010
Longs Drugs December 2007 - April 2008
Pearl City Elementary School June 2007 - August 2007
Skills
Evidence-based Medicine, Microsoft Office, Google Docs, PubMed, Drug Information, Literature Evaluation, Teaching Experience, Clinical Research, Informatics, Medicine, Research, Teacher Training, Medication Therapy..., Pharmacists, Higher Education, Public Speaking, University Teaching, Clinical Pharmacology, Pharmacology, Immunization, Pharmacy, Clinical Pharmacy, Medical Writing, Healthcare
Education
University of the Pacific 2005 — 2011
PharmD, Pharmacy
Creighton University 2011 — 2012
Teaching Certificate, Pharmacy
関西学院大学 / Kwansei Gakuin University
Foreign Languages and Literatures, General
The University of Kansas October 2013 - Present
The University of Kansas October 2013 - Present
ProPharma Group January 2014 - Present
Journal Club Digest November 2013 - Present
Journal of Evidence-Based Complementary & Alternative Medicine April 2014 - Present
Creighton University July 2011 - June 2013
Creighton University July 2011 - June 2013
CVS Pharmacy August 2009 - May 2010
Longs Drugs December 2007 - April 2008
Pearl City Elementary School June 2007 - August 2007
Skills
Evidence-based Medicine, Microsoft Office, Google Docs, PubMed, Drug Information, Literature Evaluation, Teaching Experience, Clinical Research, Informatics, Medicine, Research, Teacher Training, Medication Therapy..., Pharmacists, Higher Education, Public Speaking, University Teaching, Clinical Pharmacology, Pharmacology, Immunization, Pharmacy, Clinical Pharmacy, Medical Writing, Healthcare
Education
University of the Pacific 2005 — 2011
PharmD, Pharmacy
Creighton University 2011 — 2012
Teaching Certificate, Pharmacy
関西学院大学 / Kwansei Gakuin University
Foreign Languages and Literatures, General
Bill Schroeder's ProPharma Group Experience February 2012 - March 2013
Job Cleaning Validation SME/Consultant
Industry Biotechnology
Experience
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 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
Ruth Seeger's ProPharma Group Experience 2011 - 2012
Job Quality Management & Process Improvement
Industry Information Technology and Services
Experience
Bosch February 2015 - Present
Merck Serono June 2014 - December 2014
ZF Lenksysteme GmbH January 2014 - May 2014
ZF Friedrichshafen September 2012 - April 2014
Consultant January 2012 - August 2012
American Airlines November 2011 - June 2012
ProPharma Group 2011 - 2012
Ben Venue Laboratories, Boehringer-Ingelheim August 2009 - June 2011
Ben Venue Laboratories, Boehringer-Ingelheim March 2009 - August 2009
Intel January 2009 - March 2009
Skills
Process Improvement, Process Mapping, Six Sigma, ITIL, CMMI, Business Process..., COBIT, ISO, Modeling, Quality Systems, Quality Management, Risk Assessment, Quality Assurance, Business Analysis, FDA, Process Management, Lean Manufacturing, Process Engineering, Pharmaceuticals, GMP, Change Management, Risk Management, Process Development, Program Management, Excel, Requirements Analysis, Metrics, Business Intelligence, Manufacturing, ARIS, BPMN, Eclipse, XML, CQA, CMQ/OE, CSSGB, Green Belt, Project Implementation, Problem Solving, PowerPoint, Access, Visual Basic, Quality System, Pharmaceutical Industry, Microsoft Excel, Business Process Mapping, ASQ, Quality Auditing, Process Simulation, Analysis
Education
Universität des Saarlandes 1988 — 1997
Master's, Spanish, French, Business Administration, Economics
Gymnasium Lohne
Bosch February 2015 - Present
Merck Serono June 2014 - December 2014
ZF Lenksysteme GmbH January 2014 - May 2014
ZF Friedrichshafen September 2012 - April 2014
Consultant January 2012 - August 2012
American Airlines November 2011 - June 2012
ProPharma Group 2011 - 2012
Ben Venue Laboratories, Boehringer-Ingelheim August 2009 - June 2011
Ben Venue Laboratories, Boehringer-Ingelheim March 2009 - August 2009
Intel January 2009 - March 2009
Skills
Process Improvement, Process Mapping, Six Sigma, ITIL, CMMI, Business Process..., COBIT, ISO, Modeling, Quality Systems, Quality Management, Risk Assessment, Quality Assurance, Business Analysis, FDA, Process Management, Lean Manufacturing, Process Engineering, Pharmaceuticals, GMP, Change Management, Risk Management, Process Development, Program Management, Excel, Requirements Analysis, Metrics, Business Intelligence, Manufacturing, ARIS, BPMN, Eclipse, XML, CQA, CMQ/OE, CSSGB, Green Belt, Project Implementation, Problem Solving, PowerPoint, Access, Visual Basic, Quality System, Pharmaceutical Industry, Microsoft Excel, Business Process Mapping, ASQ, Quality Auditing, Process Simulation, Analysis
Education
Universität des Saarlandes 1988 — 1997
Master's, Spanish, French, Business Administration, Economics
Gymnasium Lohne
Frances Fields's ProPharma Group Experience 2005 - 2007
Job Mortgage Loan Specalist NMLS # 1359374 at Mortgage Lenders of America
Industry Real Estate
Experience
Mortgage Lenders of America May 2015 - Present
Reece & Nichols Real Estate May 2007 - April 2015
Summit Power, Inc. October 2014 - March 2015
ProPharma Group 2005 - 2007
VERISIGN July 2001 - March 2002
Adams-Gabbert 2000 - 2001
Sprint 1995 - 2000
Skills
Account Management, Sales, Marketing, Social Media Marketing, Customer Service, Vendor Management, Project Management, SEO, SEO Audits, Trade Shows, Online Marketing, Product Development, Business Analysis, Change Management, Gap Analysis, Department Budget..., Process Management, Recruiting, New Business Development, Sales Management, Social Media, CRM, Training
Education
Ottawa University 1992 — 1994
Bachelor of Arts, Organizational Behavior
Longview Community College 1989 — 1992
Associate of Arts (A.A.)
Mortgage Lenders of America May 2015 - Present
Reece & Nichols Real Estate May 2007 - April 2015
Summit Power, Inc. October 2014 - March 2015
ProPharma Group 2005 - 2007
VERISIGN July 2001 - March 2002
Adams-Gabbert 2000 - 2001
Sprint 1995 - 2000
Skills
Account Management, Sales, Marketing, Social Media Marketing, Customer Service, Vendor Management, Project Management, SEO, SEO Audits, Trade Shows, Online Marketing, Product Development, Business Analysis, Change Management, Gap Analysis, Department Budget..., Process Management, Recruiting, New Business Development, Sales Management, Social Media, CRM, Training
Education
Ottawa University 1992 — 1994
Bachelor of Arts, Organizational Behavior
Longview Community College 1989 — 1992
Associate of Arts (A.A.)
Collin Freeman Collin Freeman's ProPharma Group Experience June 2005 - Present
Job Medical Information Pharmacist at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group June 2005 - Present
Society of Infectious Diseases Pharmacists 1991 - 2010
VHA, Inc. January 2004 - June 2005
Bayer HealthCare July 1998 - December 2003
University of Missouri-Kansas City May 1995 - June 1998
Butler University August 1993 - April 1995
Hartford Hospital July 1991 - June 1993
The University of Arizona Health Network July 1990 - June 1991
St. Luke's Hospital of Kansas City May 1988 - June 1990
University of Kansas Medical Center 1988 - 1990
Skills
Infectious Diseases, Medical Writing, Clinical Trials, Pharmaceutical Industry, Cardiology, Clinical Research, Neurology, Immunology, Medicine, Clinical Pharmacology, Infection, Teaching, Medical Affairs, Hospitals, Clinical Development, Anti-infectives, Medical copy approval..., Teaching and medical..., Oncology, Pharmacovigilance, Pharmacy, Healthcare, Pharmacokinetics, Pharmacology
Education
Hartford Hospital 1991 — 1993
fellowship, Infectious diseases & antimicrobials
University of Arizona 1990 — 1991
residency, clinical pharmacy
The University of Kansas 1983 — 1990
Pharm.D., Pharmacy
Shawnee Mission West High School 1980 — 1983
ProPharma Group June 2005 - Present
Society of Infectious Diseases Pharmacists 1991 - 2010
VHA, Inc. January 2004 - June 2005
Bayer HealthCare July 1998 - December 2003
University of Missouri-Kansas City May 1995 - June 1998
Butler University August 1993 - April 1995
Hartford Hospital July 1991 - June 1993
The University of Arizona Health Network July 1990 - June 1991
St. Luke's Hospital of Kansas City May 1988 - June 1990
University of Kansas Medical Center 1988 - 1990
Skills
Infectious Diseases, Medical Writing, Clinical Trials, Pharmaceutical Industry, Cardiology, Clinical Research, Neurology, Immunology, Medicine, Clinical Pharmacology, Infection, Teaching, Medical Affairs, Hospitals, Clinical Development, Anti-infectives, Medical copy approval..., Teaching and medical..., Oncology, Pharmacovigilance, Pharmacy, Healthcare, Pharmacokinetics, Pharmacology
Education
Hartford Hospital 1991 — 1993
fellowship, Infectious diseases & antimicrobials
University of Arizona 1990 — 1991
residency, clinical pharmacy
The University of Kansas 1983 — 1990
Pharm.D., Pharmacy
Shawnee Mission West High School 1980 — 1983
Jannik Grodt Schmidt Jannik Grodt Schmidt's ProPharma Group Experience March 2010 - May 2010
Job Investment Manager at Invest in Denmark
Industry Government Relations
Experience
Invest in Denmark June 2013 - Present
Aarhus Universitet, Technology Transfer Office September 2010 - May 2013
EpiLabs March 2009 - January 2013
Aarhus University (Denmark) January 2012 - January 2012
Kauffman Foundation January 2010 - June 2010
ProPharma Group March 2010 - May 2010
One Motion November 2009 - January 2010
University of Aarhus January 2008 - January 2010
Technology Transfer Office (AU) September 2008 - May 2009
Ennova September 2007 - February 2008
Skills
Business Statistics, Market Research, IP-management, Innovation Management, Licensing, Entrepreneurship, Market Analysis, Start-ups, Technology Transfer, Patents, Business Strategy, SPSS, Negotiation, Pharmaceutical Industry, Pharmaceutical process..., NPV, rNPV, Risk Management, Project Planning, Project Portfolio..., Stage-Gate Models, Stage-Gate, Business Planning, Product Development, Biotechnology, Business Development, Commercialization, Competitive Analysis, Data Analysis, Intellectual Property, Lifesciences, Management, Marketing, Marketing Management, Marketing Strategy, Project Management, Strategy, Venture Capital, Management Consulting, Mergers & Acquisitions, Analysis, Marketing Research, Investor Relations, International Business, New Business Development, Strategic Planning, Research
Education
LIF 2012 — 2012
Pharmaceutical Consultant (3/4 modules passed), Pharmaceutical Consultant
Kauffman Global Scholars Program 2010 — 2010
Scholarship, Entrepreneurship
Aarhus Universitet 2007 — 2009
MSc, Marketing
Handelshøjskolen i Århus / Aarhus School of Business 2008 — 2008
Elite Program - Applied Business Development, Business Development & Entreprenurship
Syddansk Universitet 2004 — 2007
Bachelor, BA. Negot (Bsc in International Business & Modern Languages
Aabenraa Gymnasium & HF 1999 — 2002
Student, Language
Hessel Gods
Invest in Denmark June 2013 - Present
Aarhus Universitet, Technology Transfer Office September 2010 - May 2013
EpiLabs March 2009 - January 2013
Aarhus University (Denmark) January 2012 - January 2012
Kauffman Foundation January 2010 - June 2010
ProPharma Group March 2010 - May 2010
One Motion November 2009 - January 2010
University of Aarhus January 2008 - January 2010
Technology Transfer Office (AU) September 2008 - May 2009
Ennova September 2007 - February 2008
Skills
Business Statistics, Market Research, IP-management, Innovation Management, Licensing, Entrepreneurship, Market Analysis, Start-ups, Technology Transfer, Patents, Business Strategy, SPSS, Negotiation, Pharmaceutical Industry, Pharmaceutical process..., NPV, rNPV, Risk Management, Project Planning, Project Portfolio..., Stage-Gate Models, Stage-Gate, Business Planning, Product Development, Biotechnology, Business Development, Commercialization, Competitive Analysis, Data Analysis, Intellectual Property, Lifesciences, Management, Marketing, Marketing Management, Marketing Strategy, Project Management, Strategy, Venture Capital, Management Consulting, Mergers & Acquisitions, Analysis, Marketing Research, Investor Relations, International Business, New Business Development, Strategic Planning, Research
Education
LIF 2012 — 2012
Pharmaceutical Consultant (3/4 modules passed), Pharmaceutical Consultant
Kauffman Global Scholars Program 2010 — 2010
Scholarship, Entrepreneurship
Aarhus Universitet 2007 — 2009
MSc, Marketing
Handelshøjskolen i Århus / Aarhus School of Business 2008 — 2008
Elite Program - Applied Business Development, Business Development & Entreprenurship
Syddansk Universitet 2004 — 2007
Bachelor, BA. Negot (Bsc in International Business & Modern Languages
Aabenraa Gymnasium & HF 1999 — 2002
Student, Language
Hessel Gods
Russ Hacker Russ Hacker's ProPharma Group Experience August 2014 - Present
Job Senior Project Fulfillment Specialist at ProPharma Group
Industry Information Technology and Services
Experience
ProPharma Group August 2014 - Present
HackerTalents January 2014 - August 2014
Icon Enterprises / CivicPlus / Networks Plus June 2012 - January 2014
RHAssociates, Inc. January 1996 - June 2012
Boeing 1985 - 1993
Boeing 1985 - 1993
United States Marine Corps November 1976 - October 1979
Skills
Project Management, Technical Recruiting, Temporary Staffing, Hiring, Customer Relations, Negotiation, HR Consulting, Quality Assurance, Recruiting, Applicant Tracking..., Executive Search, Temporary Placement, Talent Acquisition, Human Resources, Leadership, Integrity, Customer Service, Sourcing, Committed to..., Performance-Based Hiring, Management, Vendor Management, Talent Management, Contract Recruitment, Information Technology, SDLC, Business Development, Consulting, Screening, Onboarding, Business Process..., Training, Staff Augmentation, Management Consulting, Team Building, Internet Recruiting, Time Management, Payroll, College Recruiting, CRM, SharePoint, Analysis, Business Networking, E-Verify, iCIMS
Education
Wichita State University
BS, Computer Science
Garden City Community College
Associate of Arts (AA)
ProPharma Group August 2014 - Present
HackerTalents January 2014 - August 2014
Icon Enterprises / CivicPlus / Networks Plus June 2012 - January 2014
RHAssociates, Inc. January 1996 - June 2012
Boeing 1985 - 1993
Boeing 1985 - 1993
United States Marine Corps November 1976 - October 1979
Skills
Project Management, Technical Recruiting, Temporary Staffing, Hiring, Customer Relations, Negotiation, HR Consulting, Quality Assurance, Recruiting, Applicant Tracking..., Executive Search, Temporary Placement, Talent Acquisition, Human Resources, Leadership, Integrity, Customer Service, Sourcing, Committed to..., Performance-Based Hiring, Management, Vendor Management, Talent Management, Contract Recruitment, Information Technology, SDLC, Business Development, Consulting, Screening, Onboarding, Business Process..., Training, Staff Augmentation, Management Consulting, Team Building, Internet Recruiting, Time Management, Payroll, College Recruiting, CRM, SharePoint, Analysis, Business Networking, E-Verify, iCIMS
Education
Wichita State University
BS, Computer Science
Garden City Community College
Associate of Arts (AA)
Erik Georges Erik Georges's ProPharma Group Experience July 2014 - Present
Job Business Development Manager at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group July 2014 - Present
Validant 2012 - 2014
Lab Support, a division of On Assignment August 2010 - November 2012
Opus Regulatory August 2005 - April 2010
Cambridge Search 2001 - 2005
Modis 1999 - 2001
Skills
Biotechnology, Packaging, Diagnostic, Chemical, Contract Testing Lab, Environmental, Industrial Manufacturing, Medical Device, Medical Research Labs, Pharmaceutical, Computer System..., Validation, Cleaning Validation, Process Improvement, Quality Assurance, Regulatory Affairs, Global Regulatory..., Medical Information..., Complaint Management, Commissioning, Technology Transfer, Compliance, Manufacturing Operations, Process Engineering, Program Management, Project Management, Business Development
Education
Colby College 1990 — 1994
BA
ProPharma Group July 2014 - Present
Validant 2012 - 2014
Lab Support, a division of On Assignment August 2010 - November 2012
Opus Regulatory August 2005 - April 2010
Cambridge Search 2001 - 2005
Modis 1999 - 2001
Skills
Biotechnology, Packaging, Diagnostic, Chemical, Contract Testing Lab, Environmental, Industrial Manufacturing, Medical Device, Medical Research Labs, Pharmaceutical, Computer System..., Validation, Cleaning Validation, Process Improvement, Quality Assurance, Regulatory Affairs, Global Regulatory..., Medical Information..., Complaint Management, Commissioning, Technology Transfer, Compliance, Manufacturing Operations, Process Engineering, Program Management, Project Management, Business Development
Education
Colby College 1990 — 1994
BA
Marco Laos Marco Laos's ProPharma Group Experience November 2014 - Present
Job US/OUS Medical Device Quality System Consulting
Industry Medical Devices
Experience
ProPharma Group November 2014 - Present
QualityHub, Inc. June 2013 - Present
QSCS, Inc. 2012 - Present
MARTEC Resources, Inc. Mfg & QA Resources June 2000 - Present
St. Jude Medical - Neuromodulation Divsion 2010 - 2012
St. Jude Medical - Neuromodulation Divsion 2010 - 2010
OM Group - EP Medical Device Battery Power Division 2009 - 2010
MARTEC Electronics - Medical Device, Avionics, Military & Telecom Mfg. 1996 - 2009
Elexsys International - Medical Device & Telecom Mfg. (Aquired by Sanmina-SCI) 1994 - 1996
Abbott Laboratories - Medical Device Diagnostics Division 1992 - 1994
Skills
Quality System, Six Sigma, ISO 13485, FDA, Quality Assurance, CAPA, Medical Devices, Quality Management, Process Improvement, Supplier Quality, Validation, Strategic Planning, Supply Chain Management, Cross-functional Team..., ISO 14971, Risk Management, Design Control, Quality Auditing, Change Management, Design of Experiments, DMAIC, Root Cause Analysis, Product Development, Minitab, Quality Engineering, Quality Systems, FMECA, Statistics, Complaint Management, cGMP, 21 CFR Part 11, ISO standards, Executive Management, P&L, Start-ups, Capital Budgeting, Operations Management, ERP, Manufacturing Management, Contract Manufacturing, Supplier Management, Consensus Building, Team Building, Continuous Improvement, Lean Initiatives, Remediation, Theory of Constraints, FAA, 14 CFR Part 21, Lean Manufacturing
Education
University of Arizona
Bachelor of Science (BS), Mechanical Engineering
ProPharma Group November 2014 - Present
QualityHub, Inc. June 2013 - Present
QSCS, Inc. 2012 - Present
MARTEC Resources, Inc. Mfg & QA Resources June 2000 - Present
St. Jude Medical - Neuromodulation Divsion 2010 - 2012
St. Jude Medical - Neuromodulation Divsion 2010 - 2010
OM Group - EP Medical Device Battery Power Division 2009 - 2010
MARTEC Electronics - Medical Device, Avionics, Military & Telecom Mfg. 1996 - 2009
Elexsys International - Medical Device & Telecom Mfg. (Aquired by Sanmina-SCI) 1994 - 1996
Abbott Laboratories - Medical Device Diagnostics Division 1992 - 1994
Skills
Quality System, Six Sigma, ISO 13485, FDA, Quality Assurance, CAPA, Medical Devices, Quality Management, Process Improvement, Supplier Quality, Validation, Strategic Planning, Supply Chain Management, Cross-functional Team..., ISO 14971, Risk Management, Design Control, Quality Auditing, Change Management, Design of Experiments, DMAIC, Root Cause Analysis, Product Development, Minitab, Quality Engineering, Quality Systems, FMECA, Statistics, Complaint Management, cGMP, 21 CFR Part 11, ISO standards, Executive Management, P&L, Start-ups, Capital Budgeting, Operations Management, ERP, Manufacturing Management, Contract Manufacturing, Supplier Management, Consensus Building, Team Building, Continuous Improvement, Lean Initiatives, Remediation, Theory of Constraints, FAA, 14 CFR Part 21, Lean Manufacturing
Education
University of Arizona
Bachelor of Science (BS), Mechanical Engineering
Chris Steinberg's ProPharma Group Experience December 2013 - April 2014
Job
Industry Pharmaceuticals
Experience
Pharmaceutical Validation Solutions, Inc. July 2014 - December 2014
ProPharma Group December 2013 - April 2014
Integrated Project Services October 2012 - September 2013
Integrated Project Services April 2012 - September 2012
Quality Compliance Partners September 2011 - March 2012
Integrated Project Services April 2011 - September 2011
RCM Technologies, Inc November 2010 - February 2011
Quality Compliance Partners June 2009 - July 2010
Integrated Project Services January 2003 - September 2008
TechSource, Inc September 2003 - January 2004
Skills
Validation, Computer System..., Commissioning, 21 CFR Part 11, Validation Master Plans, Change Control, GMP, V&V, GxP, Sop, FDA, GAMP, CAPA, Quality System, Pharmaceutical Industry, Biopharmaceuticals, GLP, Aseptic Processing, Technology Transfer, Software Documentation, Quality Auditing, Quality Control, Testing, Lifesciences, R&D, LIMS, Quality Assurance, SOP
Education
Temple University
Degree: Bachelor Degree
Williamsport Area Community College
Degree: Associate of Applied
Pharmaceutical Validation Solutions, Inc. July 2014 - December 2014
ProPharma Group December 2013 - April 2014
Integrated Project Services October 2012 - September 2013
Integrated Project Services April 2012 - September 2012
Quality Compliance Partners September 2011 - March 2012
Integrated Project Services April 2011 - September 2011
RCM Technologies, Inc November 2010 - February 2011
Quality Compliance Partners June 2009 - July 2010
Integrated Project Services January 2003 - September 2008
TechSource, Inc September 2003 - January 2004
Skills
Validation, Computer System..., Commissioning, 21 CFR Part 11, Validation Master Plans, Change Control, GMP, V&V, GxP, Sop, FDA, GAMP, CAPA, Quality System, Pharmaceutical Industry, Biopharmaceuticals, GLP, Aseptic Processing, Technology Transfer, Software Documentation, Quality Auditing, Quality Control, Testing, Lifesciences, R&D, LIMS, Quality Assurance, SOP
Education
Temple University
Degree: Bachelor Degree
Williamsport Area Community College
Degree: Associate of Applied
Alex Tramontana Alex Tramontana's ProPharma Group Experience October 2014 - Present
Job Remediation Consultant at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group October 2014 - Present
Sandoz June 2012 - April 2013
GMT June 2008 - June 2012
Abbott Nutrition July 2006 - July 2008
Abbott July 2003 - July 2006
Skills
FDA, GMP, Validation, Pharmaceutical Industry, Change Control, Sop, CAPA, 21 CFR Part 11, Biotechnology, Regulatory Affairs, Quality System, Cross-functional Team..., Quality Assurance, GLP, Medical Devices, Quality Auditing, Technology Transfer, Biopharmaceuticals, Aseptic Processing, Manufacturing, Quality Management, Quality Control, Computer System..., GxP, V&V, Regulatory Submissions, Process Simulation, Lifesciences, Microbiology, Commercialization, Root Cause Analysis, Regulatory Requirements, LIMS, GCP, Leadership, ISO 13485, Trackwise, Formulation
Education
Purdue University 2012 — 2012
Six Sigma Certification Green Belt
The Ohio State University 1995 — 2000
Bachelor's degree, Biology, General
ProPharma Group October 2014 - Present
Sandoz June 2012 - April 2013
GMT June 2008 - June 2012
Abbott Nutrition July 2006 - July 2008
Abbott July 2003 - July 2006
Skills
FDA, GMP, Validation, Pharmaceutical Industry, Change Control, Sop, CAPA, 21 CFR Part 11, Biotechnology, Regulatory Affairs, Quality System, Cross-functional Team..., Quality Assurance, GLP, Medical Devices, Quality Auditing, Technology Transfer, Biopharmaceuticals, Aseptic Processing, Manufacturing, Quality Management, Quality Control, Computer System..., GxP, V&V, Regulatory Submissions, Process Simulation, Lifesciences, Microbiology, Commercialization, Root Cause Analysis, Regulatory Requirements, LIMS, GCP, Leadership, ISO 13485, Trackwise, Formulation
Education
Purdue University 2012 — 2012
Six Sigma Certification Green Belt
The Ohio State University 1995 — 2000
Bachelor's degree, Biology, General
Joseph Cassella's ProPharma Group Experience March 2015 - Present
Job Associate Director, ProPharma Group. Business Development, process/computer validations, project management, staffing
Industry Biotechnology
Experience
ProPharma Group March 2015 - Present
LabAnswer July 2014 - January 2015
iTrend November 2012 - November 2014
QPharma, Inc. November 2013 - February 2014
Prime Technologies June 2013 - October 2013
Regeneron Pharmaceuticals August 2011 - May 2013
Mannkind Corporation June 2006 - April 2011
Breachway Solutions 2004 - 2006
Purdue Pharma 1999 - 2004
Copley Pharmaceutical January 1994 - November 1999
Skills
Validation, 21 CFR Part 11, Pharmaceutical Industry, Computer System..., FDA, Change Control, Sop, GMP, Quality Assurance, GxP, LIMS, Process Improvement, Cross-functional Team..., GLP, CAPA, Business Analysis, MS Project, V&V, Project Management, R&D, Clinical Trials, Quality System, Biopharmaceuticals, Biotechnology, CRO, Software Documentation, Start-ups, Quality Control, Drug Discovery, Regulatory Submissions, Drug Development, Pharmaceutics, Technology Transfer, Lifesciences, Regulatory Affairs, EDC, CTMS, Clinical Development, GCP, Process Simulation, Regulatory Requirements, Data Management, Medical Devices, Clinical Data Management, Pharmacovigilance, Oncology, SOP
Education
Syracuse University
Bachelor's degree
Villanova University 2010 — 2010
Certificate, Six Sigma Certified
ProPharma Group March 2015 - Present
LabAnswer July 2014 - January 2015
iTrend November 2012 - November 2014
QPharma, Inc. November 2013 - February 2014
Prime Technologies June 2013 - October 2013
Regeneron Pharmaceuticals August 2011 - May 2013
Mannkind Corporation June 2006 - April 2011
Breachway Solutions 2004 - 2006
Purdue Pharma 1999 - 2004
Copley Pharmaceutical January 1994 - November 1999
Skills
Validation, 21 CFR Part 11, Pharmaceutical Industry, Computer System..., FDA, Change Control, Sop, GMP, Quality Assurance, GxP, LIMS, Process Improvement, Cross-functional Team..., GLP, CAPA, Business Analysis, MS Project, V&V, Project Management, R&D, Clinical Trials, Quality System, Biopharmaceuticals, Biotechnology, CRO, Software Documentation, Start-ups, Quality Control, Drug Discovery, Regulatory Submissions, Drug Development, Pharmaceutics, Technology Transfer, Lifesciences, Regulatory Affairs, EDC, CTMS, Clinical Development, GCP, Process Simulation, Regulatory Requirements, Data Management, Medical Devices, Clinical Data Management, Pharmacovigilance, Oncology, SOP
Education
Syracuse University
Bachelor's degree
Villanova University 2010 — 2010
Certificate, Six Sigma Certified
Ashley Lang Ashley Lang's ProPharma Group Experience July 2003 - April 2004
Job National Recruiting Manager
Industry Staffing and Recruiting
Experience
SmartHire Inc. 2010 - 2012
Ethan Allen May 2004 - June 2005
ProPharma Group July 2003 - April 2004
Inside Outlet August 2001 - July 2003
NorthStar Marketing May 2001 - March 2002
Skills
Account Management, Advertising, Interior Design, Marketing, Customer Service, Internet Recruiting, Sales, Manage Client..., Project Management, Graphic Design, Recruiting, Talent Acquisition, Technical Recruiting, Temporary Staffing, Budgets, Cold Calling
Education
Harrington College of Design 2006 — 2008
Bachelor of Arts, Interior Design
William Woods University 1993 — 1997
Bachelor of Science, Business Administration - Marketing
Shawnee mission south 1989 — 1993
General Studies
Westminster College (MO)
SmartHire Inc. 2010 - 2012
Ethan Allen May 2004 - June 2005
ProPharma Group July 2003 - April 2004
Inside Outlet August 2001 - July 2003
NorthStar Marketing May 2001 - March 2002
Skills
Account Management, Advertising, Interior Design, Marketing, Customer Service, Internet Recruiting, Sales, Manage Client..., Project Management, Graphic Design, Recruiting, Talent Acquisition, Technical Recruiting, Temporary Staffing, Budgets, Cold Calling
Education
Harrington College of Design 2006 — 2008
Bachelor of Arts, Interior Design
William Woods University 1993 — 1997
Bachelor of Science, Business Administration - Marketing
Shawnee mission south 1989 — 1993
General Studies
Westminster College (MO)
Mark S. Williams's ProPharma Group Experience June 2011 - Present
Job Principal Partner at Comprehensive CMC Outsourcing, Consultant / Contractor: Senior Project Manager
Industry Pharmaceuticals
Experience
Comprehensive CMC Outsourcing April 2012 - Present
ProPharma Group June 2011 - Present
self employed June 2010 - April 2012
MYRIAD PHARMACEUTICALS, INC. (currently Myrexis) November 2006 - June 2010
APTUIT, LLC January 2005 - November 2006
QUINTILES, INC October 2002 - January 2005
GENEVA PHARMACEUTICALS, INC June 1997 - August 2002
HOECHST MARION ROUSSEL, INC January 1995 - June 1997
MARION MERRELL DOW, INC June 1989 - January 1995
MARION LABORATORIES, INC June 1976 - June 1989
Skills
Process Optimization, Formulation Development, Pharmaceutical..., Technology Transfer, Manufacturing Management, Manufacturing Operations, Project Management, Troubleshooting, Product Development, Formulation, GMP, Pharmaceutics, Validation, CRO, CMC, Pharmaceutical Industry, Quality Assurance, Oncology, Sterilization, Change Control, Sop, Cleaning Validation, Quality Auditing, GxP, Quality by Design, Contract Manufacturing, Aseptic Processing, Clinical Development, Regulatory Requirements, IND, NDA, Drug Development, CAPA, FDA, R&D, GLP, Process Simulation, Analytical Chemistry, V&V, Regulatory Affairs, 21 CFR Part 11, Regulatory Submissions, Trackwise, Drug Delivery, Pharmaceutical..., eCTD, ICH guidelines, Cross-functional Team..., ANDA, Manufacturing...
Education
Ottawa University 1992 — 1995
BS, Bus. Admin.
York College 1974 — 1976
Associates
Comprehensive CMC Outsourcing April 2012 - Present
ProPharma Group June 2011 - Present
self employed June 2010 - April 2012
MYRIAD PHARMACEUTICALS, INC. (currently Myrexis) November 2006 - June 2010
APTUIT, LLC January 2005 - November 2006
QUINTILES, INC October 2002 - January 2005
GENEVA PHARMACEUTICALS, INC June 1997 - August 2002
HOECHST MARION ROUSSEL, INC January 1995 - June 1997
MARION MERRELL DOW, INC June 1989 - January 1995
MARION LABORATORIES, INC June 1976 - June 1989
Skills
Process Optimization, Formulation Development, Pharmaceutical..., Technology Transfer, Manufacturing Management, Manufacturing Operations, Project Management, Troubleshooting, Product Development, Formulation, GMP, Pharmaceutics, Validation, CRO, CMC, Pharmaceutical Industry, Quality Assurance, Oncology, Sterilization, Change Control, Sop, Cleaning Validation, Quality Auditing, GxP, Quality by Design, Contract Manufacturing, Aseptic Processing, Clinical Development, Regulatory Requirements, IND, NDA, Drug Development, CAPA, FDA, R&D, GLP, Process Simulation, Analytical Chemistry, V&V, Regulatory Affairs, 21 CFR Part 11, Regulatory Submissions, Trackwise, Drug Delivery, Pharmaceutical..., eCTD, ICH guidelines, Cross-functional Team..., ANDA, Manufacturing...
Education
Ottawa University 1992 — 1995
BS, Bus. Admin.
York College 1974 — 1976
Associates
Jean Bordner's ProPharma Group Experience May 2015 - July 2015
Job Experienced Quality Professional
Industry Pharmaceuticals
Experience
ProPharma Group May 2015 - July 2015
ProPharma Group December 2011 - December 2014
Medical Device, Pharmaceutical, Biotechnology, Clinical 2011 - 2012
Hospira 2011 - 2012
CIBA Vision 2011 - 2011
Lonza 2011 - 2011
Stryker 2010 - 2010
Boston Scientific 2009 - 2010
Talecris Plasma Resources May 2007 - May 2009
Bayer Diagnostics 1973 - 2005
Skills
FDA, CAPA, Validation, Quality Assurance, 21 CFR Part 11, Medical Devices, Biotechnology, V&V, Quality System, GMP, GLP, Pharmaceutical Industry, Clinical Trials, Auditing, GxP, Change Control, Manufacturing, Computer System..., Regulatory Affairs, Quality Auditing, Pharmaceutics, ISO 13485, Technology Transfer, Biopharmaceuticals, SOP, GCP, Regulatory Submissions, Quality Control, Quality Management, Cross-functional Team..., Laboratory, Process Improvement
Education
Bethel College
Bachelors, Science, Business Management
ProPharma Group May 2015 - July 2015
ProPharma Group December 2011 - December 2014
Medical Device, Pharmaceutical, Biotechnology, Clinical 2011 - 2012
Hospira 2011 - 2012
CIBA Vision 2011 - 2011
Lonza 2011 - 2011
Stryker 2010 - 2010
Boston Scientific 2009 - 2010
Talecris Plasma Resources May 2007 - May 2009
Bayer Diagnostics 1973 - 2005
Skills
FDA, CAPA, Validation, Quality Assurance, 21 CFR Part 11, Medical Devices, Biotechnology, V&V, Quality System, GMP, GLP, Pharmaceutical Industry, Clinical Trials, Auditing, GxP, Change Control, Manufacturing, Computer System..., Regulatory Affairs, Quality Auditing, Pharmaceutics, ISO 13485, Technology Transfer, Biopharmaceuticals, SOP, GCP, Regulatory Submissions, Quality Control, Quality Management, Cross-functional Team..., Laboratory, Process Improvement
Education
Bethel College
Bachelors, Science, Business Management
Joseph Mulvey, PMP Joseph Mulvey, PMP's ProPharma Group Experience March 2014 - Present
Job Midwest Regional Manager
Industry Biotechnology
Experience
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
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
Debbie Sydlo's ProPharma Group Experience November 2006 - December 2008
Job Principal Consultant (Independent); Quality and Compliance Partner
Industry Pharmaceuticals
Experience
Bold Design, LLC 2006 - Present
Aptuit, LLC 2008 - July 2012
Wind Ridge Energy Systems, LLC November 2005 - 2012
ProPharma Group November 2006 - December 2008
sanofi-aventis September 2000 - December 2005
sanofi-aventis January 1992 - September 2000
Schering Plough 1991 - 1992
Ivax Pharmaceuticals 1988 - 1991
O'Dell Restaurant and Lounge 1984 - 1988
Glaxo Smith Kline 1974 - 1984
Skills
Quality Assurance, Quality Systems, Business Process..., Compliance, Auditing, Process Improvement, Quality Auditing, GMP, Quality Management, Business Analysis, Testing, CAPA, Validation, SOX, FDA, Risk Management, Supplier Quality, Policy, Test Planning, Quality System, Sarbanes-Oxley Act, V&V, 21 CFR Part 11, Quality Control, Pharmaceutical Industry, Computer System...
Education
Rutgers, The State University of New Jersey-New Brunswick 1976 — 1982
Bachelor of Science
Princeton University
Master of Science (21 credit hr)
Bold Design, LLC 2006 - Present
Aptuit, LLC 2008 - July 2012
Wind Ridge Energy Systems, LLC November 2005 - 2012
ProPharma Group November 2006 - December 2008
sanofi-aventis September 2000 - December 2005
sanofi-aventis January 1992 - September 2000
Schering Plough 1991 - 1992
Ivax Pharmaceuticals 1988 - 1991
O'Dell Restaurant and Lounge 1984 - 1988
Glaxo Smith Kline 1974 - 1984
Skills
Quality Assurance, Quality Systems, Business Process..., Compliance, Auditing, Process Improvement, Quality Auditing, GMP, Quality Management, Business Analysis, Testing, CAPA, Validation, SOX, FDA, Risk Management, Supplier Quality, Policy, Test Planning, Quality System, Sarbanes-Oxley Act, V&V, 21 CFR Part 11, Quality Control, Pharmaceutical Industry, Computer System...
Education
Rutgers, The State University of New Jersey-New Brunswick 1976 — 1982
Bachelor of Science
Princeton University
Master of Science (21 credit hr)
Mike Byrd's ProPharma Group Experience September 2007 - Present
Job
Industry Information Technology and Services
Experience
ProPharma Group September 2007 - Present
ISPE 2014 - 2014
ProPharma Group September 2007 - August 2009
sanofi-aventis August 2001 - July 2007
Hoechst Marion Roussell 1995 - 2001
Marion Merrell Dow 1990 - 1995
Perkin Elmer 1983 - 1985
Skills
Process Improvement, Computer System..., Cross-functional Team..., Quality System, GxP, ITIL, Integration, Project Management, Quality Management, Quality Auditing, Medical Devices, 21 CFR Part 11, Validation, Business Process, Change Control, GMP, FDA, Quality Control, CAPA, Pharmaceutical Industry
Education
Northwest Missouri State University
BS
The University of Kansas
MBA
ProPharma Group September 2007 - Present
ISPE 2014 - 2014
ProPharma Group September 2007 - August 2009
sanofi-aventis August 2001 - July 2007
Hoechst Marion Roussell 1995 - 2001
Marion Merrell Dow 1990 - 1995
Perkin Elmer 1983 - 1985
Skills
Process Improvement, Computer System..., Cross-functional Team..., Quality System, GxP, ITIL, Integration, Project Management, Quality Management, Quality Auditing, Medical Devices, 21 CFR Part 11, Validation, Business Process, Change Control, GMP, FDA, Quality Control, CAPA, Pharmaceutical Industry
Education
Northwest Missouri State University
BS
The University of Kansas
MBA
Jake Cook's ProPharma Group Experience 2006 - 2007
Job Director of Digital Strategy
Industry Internet
Experience
Tadpull May 2013 - Present
Montana State University 2007 - Present
Minneapolis College of Art and Design August 2013 - August 2014
Digital Wax Works 2009 - 2013
Sweet Onion Creations January 2007 - 2010
Microsoft Corporation 2007 - 2008
ProPharma Group 2006 - 2007
Simms Fishing Products 2004 - 2006
Applied Time Compression Technologies 2002 - 2004
Skills
Online Marketing, Web Analytics, Digital Marketing, Social Media, Email Marketing, Social Media Marketing, Entrepreneurship, Web Development, Web Design, SEM, Blogging, University Teaching, Copywriting, Usability Testing
Education
Drury University 1998 — 2004
MA, BA with Honors, Marketing, Physics, Minor in Mathematics and Global Studies
Washington University in St. Louis 2001 — 2001
Mechanical Engineering
Tadpull May 2013 - Present
Montana State University 2007 - Present
Minneapolis College of Art and Design August 2013 - August 2014
Digital Wax Works 2009 - 2013
Sweet Onion Creations January 2007 - 2010
Microsoft Corporation 2007 - 2008
ProPharma Group 2006 - 2007
Simms Fishing Products 2004 - 2006
Applied Time Compression Technologies 2002 - 2004
Skills
Online Marketing, Web Analytics, Digital Marketing, Social Media, Email Marketing, Social Media Marketing, Entrepreneurship, Web Development, Web Design, SEM, Blogging, University Teaching, Copywriting, Usability Testing
Education
Drury University 1998 — 2004
MA, BA with Honors, Marketing, Physics, Minor in Mathematics and Global Studies
Washington University in St. Louis 2001 — 2001
Mechanical Engineering
Lenny Zacks's ProPharma Group Experience August 2003 - May 2009
Job Consultant at The Quantic Group, Ltd
Industry Biotechnology
Experience
The Quantic Group, Ltd July 2010 - Present
LCZ Validation & Consulting Services July 2010 - October 2010
ProPharma Group August 2003 - May 2009
SAIC-Frederick, Inc. 2004 - 2008
Day & Zimmermann Validation Services 1998 - 2003
Raytheon Engineers and Constructors (RE&C) 1990 - 1996
Skills
Validation, V&V, Biotechnology, Medical Devices, Project Management, Management, FDA, Pharmaceutical Industry, Change Control, 21 CFR Part 11, GMP, CAPA, Quality System, SOP, Technology Transfer, Biopharmaceuticals
Education
Ocean County College 1980 — 1984
The Quantic Group, Ltd July 2010 - Present
LCZ Validation & Consulting Services July 2010 - October 2010
ProPharma Group August 2003 - May 2009
SAIC-Frederick, Inc. 2004 - 2008
Day & Zimmermann Validation Services 1998 - 2003
Raytheon Engineers and Constructors (RE&C) 1990 - 1996
Skills
Validation, V&V, Biotechnology, Medical Devices, Project Management, Management, FDA, Pharmaceutical Industry, Change Control, 21 CFR Part 11, GMP, CAPA, Quality System, SOP, Technology Transfer, Biopharmaceuticals
Education
Ocean County College 1980 — 1984
James Stupka's ProPharma Group Experience August 2010 - March 2014
Job Computer System Validation Project Manager at Independent
Industry Biotechnology
Experience
Independent March 2014 - Present
ProPharma Group August 2010 - March 2014
ProPharma Group June 2010 - December 2010
ProPharma Group June 2007 - November 2009
Skills
Computer System..., LIMS, Trackwise, 21 CFR Part 11, Change Control, CAPA, GAMP, Validation, GxP, FDA, GMP, Sop, Pharmaceutical Industry, V&V, Quality System, SOP, Project Management, Quality Assurance
Education
American InterContinental University 2006 — 2007
MBA, Project Management, 4.0
Iowa State University 1965 — 1969
BS, Chemical Engineering
Independent March 2014 - Present
ProPharma Group August 2010 - March 2014
ProPharma Group June 2010 - December 2010
ProPharma Group June 2007 - November 2009
Skills
Computer System..., LIMS, Trackwise, 21 CFR Part 11, Change Control, CAPA, GAMP, Validation, GxP, FDA, GMP, Sop, Pharmaceutical Industry, V&V, Quality System, SOP, Project Management, Quality Assurance
Education
American InterContinental University 2006 — 2007
MBA, Project Management, 4.0
Iowa State University 1965 — 1969
BS, Chemical Engineering
Arsham Shahlari's ProPharma Group Experience December 2008 - October 2009
Job PhD Candidate & Research Assistant at University of WisconsinMadison
Industry Mechanical or Industrial Engineering
Experience
University of Wisconsin-Madison August 2013 - Present
UW Madison Engine Research Center July 2010 - Present
Ford Motor Company May 2013 - August 2013
ProPharma Group December 2008 - October 2009
Trinity Consultants May 2008 - November 2008
Caterpillar, Inc. January 2007 - August 2007
University of Missouri-Rolla August 2006 - December 2006
Skills
Engineering, Validation, Testing, Thermal, Heat Transfer, Fuel, Thermodynamics, Vibration, Calibration, Matlab, Chemkin, Experimentation, Diesel Engine, Six Sigma, Finite Element Analysis, Simulations, LabVIEW, Research, SolidWorks, Microsoft Office, Mechanical Engineering, Data Analysis, Simulink, Teaching, Microsoft Excel
Education
University of Wisconsin-Madison 2012 — 2015
Doctor of Philosophy (PhD), Mechanical Engineering
University of Wisconsin-Madison 2010 — 2012
Master of Science (MS), Mechanical Engineering
Missouri University of Science and Technology 2006 — 2008
BS, Mechanical Engineering
University of Wisconsin-Madison August 2013 - Present
UW Madison Engine Research Center July 2010 - Present
Ford Motor Company May 2013 - August 2013
ProPharma Group December 2008 - October 2009
Trinity Consultants May 2008 - November 2008
Caterpillar, Inc. January 2007 - August 2007
University of Missouri-Rolla August 2006 - December 2006
Skills
Engineering, Validation, Testing, Thermal, Heat Transfer, Fuel, Thermodynamics, Vibration, Calibration, Matlab, Chemkin, Experimentation, Diesel Engine, Six Sigma, Finite Element Analysis, Simulations, LabVIEW, Research, SolidWorks, Microsoft Office, Mechanical Engineering, Data Analysis, Simulink, Teaching, Microsoft Excel
Education
University of Wisconsin-Madison 2012 — 2015
Doctor of Philosophy (PhD), Mechanical Engineering
University of Wisconsin-Madison 2010 — 2012
Master of Science (MS), Mechanical Engineering
Missouri University of Science and Technology 2006 — 2008
BS, Mechanical Engineering
Pierrel Foxworth's ProPharma Group Experience June 2013 - November 2014
Job GMP and Compliance Consultant
Industry Pharmaceuticals
Experience
Belcan TechServices, NNEPharmaplan March 2015 - Present
ProPharma Group June 2013 - November 2014
Oxford Global Resources February 2013 - April 2013
Kellogg, Brown, and Root 2009 - 2011
Covance CLS 2006 - 2008
United States Air Force Reserve (Active/Inactive Reservist) 2001 - 2007
Eli Lilly and Company 2001 - 2005
Cargill 1999 - 2000
U.S. Coast Guard 1993 - 1997
Education
Jackson State University
B.S., Biology (Pre-Med)
Morehouse College
N/A, Pre-Medicine, Biology
Belcan TechServices, NNEPharmaplan March 2015 - Present
ProPharma Group June 2013 - November 2014
Oxford Global Resources February 2013 - April 2013
Kellogg, Brown, and Root 2009 - 2011
Covance CLS 2006 - 2008
United States Air Force Reserve (Active/Inactive Reservist) 2001 - 2007
Eli Lilly and Company 2001 - 2005
Cargill 1999 - 2000
U.S. Coast Guard 1993 - 1997
Education
Jackson State University
B.S., Biology (Pre-Med)
Morehouse College
N/A, Pre-Medicine, Biology
Rik Atkinson's ProPharma Group Experience 2012 - Present
Job Technical / Compliance Consultant
Industry Pharmaceuticals
Experience
ProPharma Group 2012 - Present
EAS Consulting Group June 2009 - March 2013
AAC Consulting Group March 2002 - February 2008
Kendle International March 2002 - February 2007
AAC Consulting 2002 - 2007
Hoffmann-La Roche 1983 - 2000
Roche Vitamins Inc. North America 1973 - 2000
Skills
Compliance, Process Validation, Quality Systems, Change Management, GMP, Validation, Troubleshooting, Pharmaceuticals, Quality Assurance, FDA, Technical Writing, Team Leadership, Biotechnology, Manufacturing, Auditing, 21 CFR Part 11, Document Management, Microsoft Office, Documentation, ERP, New Business Development, Process Improvement, Testing, Process Engineering, Sop, Pharmaceutical Industry, Quality System, V&V, CAPA, Equipment Qualification, Regulatory Requirements, Change Control, Software Documentation, Computer System..., Technology Transfer, GAMP, Quality Auditing, LIMS, Aseptic Processing, GLP, SOP
Education
Bowling Green State University 1967 — 1971
Bachelor of Science (BS), Biochemistry
Pleasantville High School 1963 — 1967
Diploma, College Prep
ProPharma Group 2012 - Present
EAS Consulting Group June 2009 - March 2013
AAC Consulting Group March 2002 - February 2008
Kendle International March 2002 - February 2007
AAC Consulting 2002 - 2007
Hoffmann-La Roche 1983 - 2000
Roche Vitamins Inc. North America 1973 - 2000
Skills
Compliance, Process Validation, Quality Systems, Change Management, GMP, Validation, Troubleshooting, Pharmaceuticals, Quality Assurance, FDA, Technical Writing, Team Leadership, Biotechnology, Manufacturing, Auditing, 21 CFR Part 11, Document Management, Microsoft Office, Documentation, ERP, New Business Development, Process Improvement, Testing, Process Engineering, Sop, Pharmaceutical Industry, Quality System, V&V, CAPA, Equipment Qualification, Regulatory Requirements, Change Control, Software Documentation, Computer System..., Technology Transfer, GAMP, Quality Auditing, LIMS, Aseptic Processing, GLP, SOP
Education
Bowling Green State University 1967 — 1971
Bachelor of Science (BS), Biochemistry
Pleasantville High School 1963 — 1967
Diploma, College Prep
David Kugler, MBA's ProPharma Group Experience September 2006 - December 2006
Job Global Quality Compliance Systems Director at GOJO Industries
Industry Consumer Goods
Experience
GOJO Industries February 2015 - Present
GOJO Industries April 2012 - January 2015
GOJO Industries July 2011 - March 2012
GOJO Industries March 2010 - June 2011
Rx GLOBAL Consulting Solutions Inc. September 2009 - February 2010
Kelley School of Business January 2009 - December 2009
Adecco Technical January 2007 - December 2008
ProPharma Group September 2006 - December 2006
Performance Validation 2003 - 2006
Skills
Validation, Process Improvement, Engineering, Quality Assurance, Root Cause Analysis, Change Control, Cross-functional Team..., Quality System, CAPA, Six Sigma, Manufacturing, Continuous Improvement, V&V, Quality Control, Lean Manufacturing, Deviation Management, Quality Auditing, Supply Chain, Computer System...
Education
Indiana University - Kelley School of Business 2007 — 2010
MBA, Supply Chain Management
Rose-Hulman Institute of Technology 1998 — 2003
BS, Mechanical Engineering
University of Stuttgart 2000 — 2001
Mechanical Engineering
GOJO Industries February 2015 - Present
GOJO Industries April 2012 - January 2015
GOJO Industries July 2011 - March 2012
GOJO Industries March 2010 - June 2011
Rx GLOBAL Consulting Solutions Inc. September 2009 - February 2010
Kelley School of Business January 2009 - December 2009
Adecco Technical January 2007 - December 2008
ProPharma Group September 2006 - December 2006
Performance Validation 2003 - 2006
Skills
Validation, Process Improvement, Engineering, Quality Assurance, Root Cause Analysis, Change Control, Cross-functional Team..., Quality System, CAPA, Six Sigma, Manufacturing, Continuous Improvement, V&V, Quality Control, Lean Manufacturing, Deviation Management, Quality Auditing, Supply Chain, Computer System...
Education
Indiana University - Kelley School of Business 2007 — 2010
MBA, Supply Chain Management
Rose-Hulman Institute of Technology 1998 — 2003
BS, Mechanical Engineering
University of Stuttgart 2000 — 2001
Mechanical Engineering
Kurt Liebrecht's ProPharma Group Experience February 2011 - May 2011
Job Site Director, Quality Assurance, Enigma Diagnostics San Diego
Industry Medical Devices
Experience
Enigma Diagnostics August 2013 - Present
Enigma Diagnostics September 2011 - July 2013
Bio-Medical Products Support, LLC May 2010 - September 2011
ProPharma Group February 2011 - May 2011
Accumetrics May 2008 - April 2010
Biosite 1999 - 2007
Medtronic Vascular 1991 - 1999
Baxter/Edwards Div. 1988 - 1991
BD 1984 - 1988
Education
University of Utah 1984 — 1987
Masters, Engineering
Northeastern Illinois University 1976 — 1979
Bachelor of Science, Physics
Enigma Diagnostics August 2013 - Present
Enigma Diagnostics September 2011 - July 2013
Bio-Medical Products Support, LLC May 2010 - September 2011
ProPharma Group February 2011 - May 2011
Accumetrics May 2008 - April 2010
Biosite 1999 - 2007
Medtronic Vascular 1991 - 1999
Baxter/Edwards Div. 1988 - 1991
BD 1984 - 1988
Education
University of Utah 1984 — 1987
Masters, Engineering
Northeastern Illinois University 1976 — 1979
Bachelor of Science, Physics
David Hyde, CPIP's ProPharma Group Experience November 2009 - April 2010
Job GMP Compliance Manager at Lantheus Medical Imaging, Inc.
Industry Pharmaceuticals
Experience
Lantheus Medical Imaging, Inc. April 2011 - Present
Mount Wachusett Community College - Biotech Programs September 2010 - April 2011
ProPharma Group November 2009 - April 2010
Foster-Miller, Inc. August 2007 - November 2009
LearnWright, Inc. October 2005 - April 2007
Thermo Electron Corporation October 2004 - October 2005
PAREXEL Consulting September 1991 - September 2004
Millipore Corporation 1989 - 1990
Polymer Technology Corporation / Bausch & Lomb 1985 - 1990
Polymer Technology Corporation / Bausch & Lomb 1985 - 1990
Skills
Validation, Pharmaceutical Industry, Quality Assurance, FDA, GMP, Process Improvement, V&V, Biotechnology, Management, Software Documentation, CAPA, Quality Auditing, Medical Devices, Manufacturing, Sop, Quality System, Business Development, Project Management, Program Management
Education
Colby College 1979 — 1983
BA, Biology
Lantheus Medical Imaging, Inc. April 2011 - Present
Mount Wachusett Community College - Biotech Programs September 2010 - April 2011
ProPharma Group November 2009 - April 2010
Foster-Miller, Inc. August 2007 - November 2009
LearnWright, Inc. October 2005 - April 2007
Thermo Electron Corporation October 2004 - October 2005
PAREXEL Consulting September 1991 - September 2004
Millipore Corporation 1989 - 1990
Polymer Technology Corporation / Bausch & Lomb 1985 - 1990
Polymer Technology Corporation / Bausch & Lomb 1985 - 1990
Skills
Validation, Pharmaceutical Industry, Quality Assurance, FDA, GMP, Process Improvement, V&V, Biotechnology, Management, Software Documentation, CAPA, Quality Auditing, Medical Devices, Manufacturing, Sop, Quality System, Business Development, Project Management, Program Management
Education
Colby College 1979 — 1983
BA, Biology
Kyle Nordstrom's ProPharma Group Experience September 2004 - Present
Job Area Manager | Pharmaceutical Consulting | Validation | Compliance | Project Management
Industry Biotechnology
Experience
ProPharma Group September 2004 - Present
Skills
Quality Assurance, Pharmaceutical Industry, Biotechnology, FDA, Computer System..., GMP, Strategic Planning, Validation, Team Building, Project Management, Team Leadership, Process Improvement, Medical Devices, Leadership, Management, Six Sigma, Change Control, Cross-functional Team..., 21 CFR Part 11, Quality Management, Software Documentation
Education
Arizona State University 1996 — 2000
ProPharma Group September 2004 - Present
Skills
Quality Assurance, Pharmaceutical Industry, Biotechnology, FDA, Computer System..., GMP, Strategic Planning, Validation, Team Building, Project Management, Team Leadership, Process Improvement, Medical Devices, Leadership, Management, Six Sigma, Change Control, Cross-functional Team..., 21 CFR Part 11, Quality Management, Software Documentation
Education
Arizona State University 1996 — 2000
Miguel Pagan's ProPharma Group Experience June 2014 - Present
Job Technical Solutions Consultant at ProPharma Group
Industry Biotechnology
Experience
ProPharma Group June 2014 - Present
Eliassen Group for Genzyme Corporation May 2013 - June 2014
Eliassen Group for Shire HGT July 2012 - January 2013
Quintiles Consulting December 2011 - April 2012
Apotex Inc. July 2011 - December 2011
Vectech Pharmaceutical Consultants March 2011 - May 2011
SQA Services June 2010 - October 2010
Accucaps Industries Ltd. June 2007 - September 2008
Catalent Pharma Solutions September 2004 - November 2006
Purdue Pharma October 2003 - May 2004
Skills
Validation, FDA, CAPA, SOP, Technology Transfer, Change Control, Analytical Chemistry, Cleaning Validation, cGMP, Process Validation, Quality Assurance, LIMS, GLP, Auditing, Compliance, R&D, Chemistry, Manufacturing, Quality Auditing, Process Improvement, Process Development, Chromatography, Organic Chemistry, GMP Investigations, Stability, Sop, V&V, GMP, Quality System, ISO, ISO 13485, Pharmaceutical Industry, Aseptic Processing, 21 CFR Part 11, GxP, Quality Management, Purification, Regulatory Affairs, Gas Chromatography, Biopharmaceuticals, Root Cause Analysis, Computer System..., Regulatory Submissions, Biotechnology, Pharmaceutics, Laboratory, Formulation, UV, Regulatory Requirements, Lifesciences
Education
Bloomfield College 1990 — 1994
B.S, Chemistry
JHS 17
ProPharma Group June 2014 - Present
Eliassen Group for Genzyme Corporation May 2013 - June 2014
Eliassen Group for Shire HGT July 2012 - January 2013
Quintiles Consulting December 2011 - April 2012
Apotex Inc. July 2011 - December 2011
Vectech Pharmaceutical Consultants March 2011 - May 2011
SQA Services June 2010 - October 2010
Accucaps Industries Ltd. June 2007 - September 2008
Catalent Pharma Solutions September 2004 - November 2006
Purdue Pharma October 2003 - May 2004
Skills
Validation, FDA, CAPA, SOP, Technology Transfer, Change Control, Analytical Chemistry, Cleaning Validation, cGMP, Process Validation, Quality Assurance, LIMS, GLP, Auditing, Compliance, R&D, Chemistry, Manufacturing, Quality Auditing, Process Improvement, Process Development, Chromatography, Organic Chemistry, GMP Investigations, Stability, Sop, V&V, GMP, Quality System, ISO, ISO 13485, Pharmaceutical Industry, Aseptic Processing, 21 CFR Part 11, GxP, Quality Management, Purification, Regulatory Affairs, Gas Chromatography, Biopharmaceuticals, Root Cause Analysis, Computer System..., Regulatory Submissions, Biotechnology, Pharmaceutics, Laboratory, Formulation, UV, Regulatory Requirements, Lifesciences
Education
Bloomfield College 1990 — 1994
B.S, Chemistry
JHS 17
Chris Redford's ProPharma Group Experience 2005 - 2006
Job Lead Process Improvement Engineer at BJC HealthCare
Industry Hospital & Health Care
Experience
BJC HealthCare Lead Performance Improvement EngineerMissouri Baptist Medical Center2006 - 2007
ProPharma Group 2005 - 2006
Monsanto 1997 - 2005
Skills
Six Sigma, Continuous Improvement, Lean Manufacturing, DMAIC, Process Improvement, Kaizen, 5S, Engineering, Operations Management, Business Process..., Excel, Manufacturing, Medical Devices, Supply Chain, Visio, Healthcare, Inventory Management, Word, PowerPoint, Value Stream Mapping, Root Cause Analysis, SPC, Leadership, Quality Management, Operational Excellence, Quality Assurance, Process Engineering, Program Management, Software Documentation, Minitab, Cross-functional Team..., Microsoft Excel, Kanban, Project Management, Microsoft Word, Change Management, Black Belt, MS Project, EHR
Education
Purdue University 1968 — 1972
BJC HealthCare Lead Performance Improvement EngineerMissouri Baptist Medical Center2006 - 2007
ProPharma Group 2005 - 2006
Monsanto 1997 - 2005
Skills
Six Sigma, Continuous Improvement, Lean Manufacturing, DMAIC, Process Improvement, Kaizen, 5S, Engineering, Operations Management, Business Process..., Excel, Manufacturing, Medical Devices, Supply Chain, Visio, Healthcare, Inventory Management, Word, PowerPoint, Value Stream Mapping, Root Cause Analysis, SPC, Leadership, Quality Management, Operational Excellence, Quality Assurance, Process Engineering, Program Management, Software Documentation, Minitab, Cross-functional Team..., Microsoft Excel, Kanban, Project Management, Microsoft Word, Change Management, Black Belt, MS Project, EHR
Education
Purdue University 1968 — 1972
Marti Hlafka, M.D.'s ProPharma Group Experience May 2005 - August 2006
Job at
Industry Medical Practice
Experience
SIU School of Medicine July 2013 - Present
The University of Iowa Hospitals and Clinics July 2012 - June 2013
University of Iowa Hospitals and Clinics June 2009 - June 2012
ProPharma Group May 2005 - August 2006
Washington University School of Medicine March 2004 - May 2005
Mallinckrodt July 2001 - March 2004
Mallinckrodt September 1997 - July 2001
Mallinckrodt January 1995 - August 1997
Mallinckrodt September 1993 - January 1995
Skills
Validation, Hospitals, Manufacturing, Documentation, Medical Devices, Purification, Software Documentation, Medicine, Internal Medicine, Clinical Trials, Pharmaceutical Industry, Clinical Research, Healthcare, FDA, GMP, Quality System, SOP
Education
Southern Illinois University School of Medicine 2005 — 2009
M.D.
Illinois State University 1988 — 1992
B.S., Chemistry, Biology
SIU School of Medicine July 2013 - Present
The University of Iowa Hospitals and Clinics July 2012 - June 2013
University of Iowa Hospitals and Clinics June 2009 - June 2012
ProPharma Group May 2005 - August 2006
Washington University School of Medicine March 2004 - May 2005
Mallinckrodt July 2001 - March 2004
Mallinckrodt September 1997 - July 2001
Mallinckrodt January 1995 - August 1997
Mallinckrodt September 1993 - January 1995
Skills
Validation, Hospitals, Manufacturing, Documentation, Medical Devices, Purification, Software Documentation, Medicine, Internal Medicine, Clinical Trials, Pharmaceutical Industry, Clinical Research, Healthcare, FDA, GMP, Quality System, SOP
Education
Southern Illinois University School of Medicine 2005 — 2009
M.D.
Illinois State University 1988 — 1992
B.S., Chemistry, Biology
Jeremy Griffin's ProPharma Group Experience July 2006 - December 2010
Job Sr. Manager of Manufacturing at AAIPharma Services
Industry Pharmaceuticals
Experience
AAIPharma Services Corp. January 2015 - Present
Grand River Aseptic Manufacturing December 2012 - December 2014
Grand River Aseptic Manufacturing December 2010 - December 2012
ProPharma Group July 2006 - December 2010
CSL Behring January 2005 - July 2006
Skills
Validation, Biotechnology, Commissioning, GMP, Quality Assurance, Chemistry, Process Validation, Documentation, cGMP, Software Documentation, V&V, 21 CFR Part 11, Computer System..., Quality System, FDA, GxP, Testing, CAPA, Quality Auditing, Change Control, Quality Control, Medical Devices, Manufacturing, GLP, Aseptic Processing, HPLC, Sop, Cleaning Validation, ISO 13485, LIMS, SOP
Education
Colorado Technical University 2007 — 2010
BS, Business (Project Management)
Colorado Technical University 2007 — 2010
Associate of Science, General Studies
AAIPharma Services Corp. January 2015 - Present
Grand River Aseptic Manufacturing December 2012 - December 2014
Grand River Aseptic Manufacturing December 2010 - December 2012
ProPharma Group July 2006 - December 2010
CSL Behring January 2005 - July 2006
Skills
Validation, Biotechnology, Commissioning, GMP, Quality Assurance, Chemistry, Process Validation, Documentation, cGMP, Software Documentation, V&V, 21 CFR Part 11, Computer System..., Quality System, FDA, GxP, Testing, CAPA, Quality Auditing, Change Control, Quality Control, Medical Devices, Manufacturing, GLP, Aseptic Processing, HPLC, Sop, Cleaning Validation, ISO 13485, LIMS, SOP
Education
Colorado Technical University 2007 — 2010
BS, Business (Project Management)
Colorado Technical University 2007 — 2010
Associate of Science, General Studies
Andrea Hiser Oldham's ProPharma Group Experience April 2012 - Present
Job Operations Planner at ProPharma Group | Recruiting | Staffing | Validation | Quality Assurance | Pharmaceutical
Industry Biotechnology
Experience
ProPharma Group April 2012 - Present
Aptuit April 2008 - April 2012
ProPharma Group September 2004 - March 2008
Remel 2000 - 2004
Skills
Validation, Computer System..., GMP, FDA, 21 CFR Part 11, V&V, Pharmaceutical Industry, Sop, CAPA, Change Control, GxP, Biotechnology, Quality Assurance, Quality System, LIMS, Regulatory Affairs, Quality Auditing, Medical Devices, Lifesciences, GLP, Pharmaceutics, GAMP, Regulatory Requirements, Cleaning Validation, Technical Recruiting, Talent Management, Resource Management, Biopharmaceuticals, Chromatography, Aseptic Processing, Trackwise, Software Documentation
Education
Fort Hays State University 1994 — 1999
Bachelor's degree, Biology, General
ProPharma Group April 2012 - Present
Aptuit April 2008 - April 2012
ProPharma Group September 2004 - March 2008
Remel 2000 - 2004
Skills
Validation, Computer System..., GMP, FDA, 21 CFR Part 11, V&V, Pharmaceutical Industry, Sop, CAPA, Change Control, GxP, Biotechnology, Quality Assurance, Quality System, LIMS, Regulatory Affairs, Quality Auditing, Medical Devices, Lifesciences, GLP, Pharmaceutics, GAMP, Regulatory Requirements, Cleaning Validation, Technical Recruiting, Talent Management, Resource Management, Biopharmaceuticals, Chromatography, Aseptic Processing, Trackwise, Software Documentation
Education
Fort Hays State University 1994 — 1999
Bachelor's degree, Biology, General
Enow Nsemanyu, MBA, MS's ProPharma Group Experience January 2015 - Present
Job Computer Systems Validation at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group January 2015 - Present
IPS-Integrated Project Services, Inc. July 2014 - December 2014
ProPharma Group July 2013 - April 2014
Kelly Services @ Hospira Inc in NC September 2012 - August 2013
Sanofi Pasteur April 2007 - September 2012
Advanced Bioscience Laboratories April 2005 - April 2006
Skills
Investigation, CAPA, GMP, Change Control, FDA, 21 CFR Part 11, SOP, Validation, Quality Assurance, GxP, Computer System..., Calibration, Root Cause Analysis, SAP, Software Documentation
Education
The Johns Hopkins University 2009 — 2011
MS, BIOTECHNOLOGY REGULATORY AFFAIRS
University of Maryland University College 2006 — 2008
MBA, MASTERS OF BUSINESS ADMINISTRATION
University of Maryland College Park 2000 — 2003
Bachelor's degree, Biochemistry
Baptist High School--Buea, Cameroon 1997 — 1999
A'Level, science, pass
ProPharma Group January 2015 - Present
IPS-Integrated Project Services, Inc. July 2014 - December 2014
ProPharma Group July 2013 - April 2014
Kelly Services @ Hospira Inc in NC September 2012 - August 2013
Sanofi Pasteur April 2007 - September 2012
Advanced Bioscience Laboratories April 2005 - April 2006
Skills
Investigation, CAPA, GMP, Change Control, FDA, 21 CFR Part 11, SOP, Validation, Quality Assurance, GxP, Computer System..., Calibration, Root Cause Analysis, SAP, Software Documentation
Education
The Johns Hopkins University 2009 — 2011
MS, BIOTECHNOLOGY REGULATORY AFFAIRS
University of Maryland University College 2006 — 2008
MBA, MASTERS OF BUSINESS ADMINISTRATION
University of Maryland College Park 2000 — 2003
Bachelor's degree, Biochemistry
Baptist High School--Buea, Cameroon 1997 — 1999
A'Level, science, pass
Angelina Castro's ProPharma Group Experience October 2013 - September 2014
Job Recruiting Professional, NonProfit Executive, Travel Ambassador
Industry Human Resources
Experience
Travel Basque Country August 2013 - Present
Philippine Development Foundation (PhilDev) July 2013 - Present
ProPharma Group October 2013 - September 2014
Hyde Engineering + Consulting / Hyde Technical Services October 2010 - April 2013
Hyde Engineering + Consulting August 2005 - May 2010
Thomson Learning 2002 - 2004
Tallwood Venture Capital 2001 - 2002
Skills
Recruiting, Event Planning, Trade Shows, Client/Hiring Manager..., Talent Acquisition, Onboarding, New Hire Orientations, Employee Relations, LinkedIn Recruiter, Vendor Relationships, Business Development, Manufacturing, Management, Interviews, Marketing, Budgets, CRM, Project Management, Team Building, Pharmaceutical Industry, Biotechnology, Proposal Writing, Validation, Human Resources, Fundraising, Nonprofits, Travel Planning
Education
University of California, Berkeley 1996 — 2000
BA, Architecture
NDB
Travel Basque Country August 2013 - Present
Philippine Development Foundation (PhilDev) July 2013 - Present
ProPharma Group October 2013 - September 2014
Hyde Engineering + Consulting / Hyde Technical Services October 2010 - April 2013
Hyde Engineering + Consulting August 2005 - May 2010
Thomson Learning 2002 - 2004
Tallwood Venture Capital 2001 - 2002
Skills
Recruiting, Event Planning, Trade Shows, Client/Hiring Manager..., Talent Acquisition, Onboarding, New Hire Orientations, Employee Relations, LinkedIn Recruiter, Vendor Relationships, Business Development, Manufacturing, Management, Interviews, Marketing, Budgets, CRM, Project Management, Team Building, Pharmaceutical Industry, Biotechnology, Proposal Writing, Validation, Human Resources, Fundraising, Nonprofits, Travel Planning
Education
University of California, Berkeley 1996 — 2000
BA, Architecture
NDB
Clint Murphy's ProPharma Group Experience August 2015 - Present
Job Validation Engineer
Industry Medical Devices
Experience
ProPharma Group August 2015 - Present
Fresenius Medical Care October 2012 - February 2015
Compliance Team, Inc. April 2015 - 2015
Brady Medical October 2011 - August 2012
EaglePicher Medical Power March 2010 - October 2011
Aerostar International August 2009 - January 2010
Neos Therapeutics February 2008 - February 2009
Adams Respiratory Therapeutics April 2006 - January 2008
Monitor Inc June 2004 - June 2005
Covidien September 1999 - May 2004
Skills
Validation, FDA GMP, Medical Devices, Pharmaceutical Industry, Sop, Quality Control, Manufacturing, Lean Manufacturing, Root Cause Analysis, FDA, GMP, Computer System..., V&V, R&D, Testing, ISO 13485, ISO, Software Documentation, Minitab, Quality System
Education
Texas A&M University-Commerce 1993 — 1997
Bachelor of Science, Industrial Technology
Texas A&M University-Commerce 1993 — 1997
Bachelor of Science (B.S.), Industrial Technology
ProPharma Group August 2015 - Present
Fresenius Medical Care October 2012 - February 2015
Compliance Team, Inc. April 2015 - 2015
Brady Medical October 2011 - August 2012
EaglePicher Medical Power March 2010 - October 2011
Aerostar International August 2009 - January 2010
Neos Therapeutics February 2008 - February 2009
Adams Respiratory Therapeutics April 2006 - January 2008
Monitor Inc June 2004 - June 2005
Covidien September 1999 - May 2004
Skills
Validation, FDA GMP, Medical Devices, Pharmaceutical Industry, Sop, Quality Control, Manufacturing, Lean Manufacturing, Root Cause Analysis, FDA, GMP, Computer System..., V&V, R&D, Testing, ISO 13485, ISO, Software Documentation, Minitab, Quality System
Education
Texas A&M University-Commerce 1993 — 1997
Bachelor of Science, Industrial Technology
Texas A&M University-Commerce 1993 — 1997
Bachelor of Science (B.S.), Industrial Technology
Rajesh Parekh's ProPharma Group Experience 2013 - 2013
Job Consultant at Gilead Sciences
Industry Information Services
Experience
West-Ward Pharmaceuticals February 2014 - Present
Gilead Sciences September 2012 - January 2013
ProPharma Group 2013 - 2013
CB Fleet Co, Inc September 2008 - July 2012
CB Fleet Laboratories September 2008 - July 2012
Chrysalis (Division of Philip Morris, USA) March 2006 - July 2008
Wyeth Consumer Healthcare October 2005 - February 2006
Frontage Laboratories February 2002 - July 2005
Skills
HPLC, Sop, Quality Control, Validation, 21 CFR Part 11, Chemistry, V&V, Pharmaceutical Industry, Computer System..., FDA, Analytical Chemistry, GMP, UV/Vis, SOP, Cleaning Validation, GxP
Education
South Gujarat University 1979 — 1982
West-Ward Pharmaceuticals February 2014 - Present
Gilead Sciences September 2012 - January 2013
ProPharma Group 2013 - 2013
CB Fleet Co, Inc September 2008 - July 2012
CB Fleet Laboratories September 2008 - July 2012
Chrysalis (Division of Philip Morris, USA) March 2006 - July 2008
Wyeth Consumer Healthcare October 2005 - February 2006
Frontage Laboratories February 2002 - July 2005
Skills
HPLC, Sop, Quality Control, Validation, 21 CFR Part 11, Chemistry, V&V, Pharmaceutical Industry, Computer System..., FDA, Analytical Chemistry, GMP, UV/Vis, SOP, Cleaning Validation, GxP
Education
South Gujarat University 1979 — 1982
Jimi Dyson's ProPharma Group Experience May 2013 - March 2014
Job Sr. Quality Engineer
Industry Pharmaceuticals
Experience
Roche Diagnostics July 2014 - Present
ProPharma Group May 2013 - March 2014
ProPharma Group February 2012 - March 2013
Indiana Blood Center October 2010 - February 2012
Eli Lilly and Company September 2004 - March 2010
Eli Lilly and Company June 2008 - January 2009
Eli Lilly and Company July 2001 - September 2004
Roche Diagnostics Corporation March 2000 - July 2001
Roche Diagnostics Corporation January 1998 - March 2000
Skills
Pharmaceutical Industry, Pharmaceutical Sales, Clinical Trials, cGMP, Investigative Reporting, Investigative Research, Quality Assurance, Data Quality, Quality, Six Sigma, Analytical Chemistry, Analytical Writing, Analytical Techniques, Laboratory Automation, Laboratory Research, Laboratory Techniques, Laboratory Analysis, Laboratory Experience, HPLC, GC/MS, Wet Chemistry, Leading People, Leading Projects, Leading By Example, Business Strategy, International Business, Market Analysis, 21 CFR Part 11, Regulatory Requirements, Technical Writing, Writing Skills, Flexible Working, Listening Skills, Customer Feedback, Laboratory, Validation, GMP, Biotechnology, Quality Control, Leadership
Education
Walden University 2010 — 2012
Masters of Business, Marketing and Sales Management, 3.97
Jackson State University 1993 — 1997
Bachelor, Science and Technology; Biology
Clarksdale High School 1991 — 1993
High School Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
Roche Diagnostics July 2014 - Present
ProPharma Group May 2013 - March 2014
ProPharma Group February 2012 - March 2013
Indiana Blood Center October 2010 - February 2012
Eli Lilly and Company September 2004 - March 2010
Eli Lilly and Company June 2008 - January 2009
Eli Lilly and Company July 2001 - September 2004
Roche Diagnostics Corporation March 2000 - July 2001
Roche Diagnostics Corporation January 1998 - March 2000
Skills
Pharmaceutical Industry, Pharmaceutical Sales, Clinical Trials, cGMP, Investigative Reporting, Investigative Research, Quality Assurance, Data Quality, Quality, Six Sigma, Analytical Chemistry, Analytical Writing, Analytical Techniques, Laboratory Automation, Laboratory Research, Laboratory Techniques, Laboratory Analysis, Laboratory Experience, HPLC, GC/MS, Wet Chemistry, Leading People, Leading Projects, Leading By Example, Business Strategy, International Business, Market Analysis, 21 CFR Part 11, Regulatory Requirements, Technical Writing, Writing Skills, Flexible Working, Listening Skills, Customer Feedback, Laboratory, Validation, GMP, Biotechnology, Quality Control, Leadership
Education
Walden University 2010 — 2012
Masters of Business, Marketing and Sales Management, 3.97
Jackson State University 1993 — 1997
Bachelor, Science and Technology; Biology
Clarksdale High School 1991 — 1993
High School Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
Tina Grybus's ProPharma Group Experience October 2009 - February 2010
Job Production Engineer at Perrigo
Industry Pharmaceuticals
Experience
Perrigo January 2012 - Present
CRB Consulting Engineers January 2011 - January 2012
ProPharma September 2010 - March 2011
ProPharma Group October 2009 - February 2010
Pfizer September 2000 - June 2009
Prima Communications, Inc. March 1995 - September 2000
Skills
Quality Assurance, Internal Audit, GMP, Change Control, Validation, FDA, CAPA, 21 CFR Part 11, Computer System..., Pharmaceutical Industry, Sop, Quality System, Manufacturing, Medical Devices, Process Improvement, Cross-functional Team..., V&V, Pharmaceutics, GLP, Six Sigma, Software Documentation, Aseptic Processing, Process Simulation, Quality Control, Cleaning Validation, GAMP, Technology Transfer, GxP
Education
Michigan Technological University 1988 — 1994
BS, Chemical Engineering
Michigan Technological University 1988 — 1994
BS, Scientific and Technical Communications
Perrigo January 2012 - Present
CRB Consulting Engineers January 2011 - January 2012
ProPharma September 2010 - March 2011
ProPharma Group October 2009 - February 2010
Pfizer September 2000 - June 2009
Prima Communications, Inc. March 1995 - September 2000
Skills
Quality Assurance, Internal Audit, GMP, Change Control, Validation, FDA, CAPA, 21 CFR Part 11, Computer System..., Pharmaceutical Industry, Sop, Quality System, Manufacturing, Medical Devices, Process Improvement, Cross-functional Team..., V&V, Pharmaceutics, GLP, Six Sigma, Software Documentation, Aseptic Processing, Process Simulation, Quality Control, Cleaning Validation, GAMP, Technology Transfer, GxP
Education
Michigan Technological University 1988 — 1994
BS, Chemical Engineering
Michigan Technological University 1988 — 1994
BS, Scientific and Technical Communications
Tony Wilson's ProPharma Group Experience August 2008 - March 2009
Job Consumer Safety Officer at FDA
Industry Biotechnology
Experience
FDA November 2013 - Present
NIAID/NIH [C], Office of Regulatory Affairs February 2011 - November 2013
Thermo Fisher Scientific October 2009 - February 2011
ProPharma Group August 2008 - March 2009
Osiris Therapeutics August 2007 - August 2008
Osiris Therapeutics April 2006 - July 2007
MedImmune June 2005 - February 2006
Baxter BioScience November 2001 - June 2005
Skills
FDA, GMP, Quality Assurance, Validation, GLP, Sop, CAPA, 21 CFR Part 11, Change Control, Regulatory Affairs, Quality Control, Clinical Development, Quality System, Laboratory, SOP development, Medical Devices, Aseptic Processing, Biotechnology, Regulatory Submissions, Purification, Technology Transfer, Lifesciences, Aseptic Technique, Biopharmaceuticals, Vaccines, Clinical Trials, Chromatography, Cleaning Validation, GCP, CRO, V&V, LIMS, IND, Microbiology, HPLC, GxP, Protocol, Regulatory Requirements, Pharmaceutical Industry, Analytical Chemistry, Software Documentation, Assay Development, Computer System..., Cell Biology, Cell Culture, Drug Development, ELISA, ISO 13485, Clinical Research, Immunology
Education
The Johns Hopkins University 2009 — 2011
Master of Science, Regulatory Science (Bioscience Regulatory Affairs)
Xavier University of Louisiana 1998 — 2001
Bachelors of Science, Biology
FDA November 2013 - Present
NIAID/NIH [C], Office of Regulatory Affairs February 2011 - November 2013
Thermo Fisher Scientific October 2009 - February 2011
ProPharma Group August 2008 - March 2009
Osiris Therapeutics August 2007 - August 2008
Osiris Therapeutics April 2006 - July 2007
MedImmune June 2005 - February 2006
Baxter BioScience November 2001 - June 2005
Skills
FDA, GMP, Quality Assurance, Validation, GLP, Sop, CAPA, 21 CFR Part 11, Change Control, Regulatory Affairs, Quality Control, Clinical Development, Quality System, Laboratory, SOP development, Medical Devices, Aseptic Processing, Biotechnology, Regulatory Submissions, Purification, Technology Transfer, Lifesciences, Aseptic Technique, Biopharmaceuticals, Vaccines, Clinical Trials, Chromatography, Cleaning Validation, GCP, CRO, V&V, LIMS, IND, Microbiology, HPLC, GxP, Protocol, Regulatory Requirements, Pharmaceutical Industry, Analytical Chemistry, Software Documentation, Assay Development, Computer System..., Cell Biology, Cell Culture, Drug Development, ELISA, ISO 13485, Clinical Research, Immunology
Education
The Johns Hopkins University 2009 — 2011
Master of Science, Regulatory Science (Bioscience Regulatory Affairs)
Xavier University of Louisiana 1998 — 2001
Bachelors of Science, Biology
Maja Freeman's ProPharma Group Experience May 2011 - December 2012
Job Quality Assurance Manager at Bayer
Industry Pharmaceuticals
Experience
Bayer HealthCare December 2012 - Present
ProPharma Group May 2011 - December 2012
Aptuit / EaglePicher Pharmaceutical Services November 2005 - May 2011
EaglePicher Pharmaceutical Services 2005 - 2007
PharmaForm 2005 - 2005
sanofi-aventis 2001 - 2004
Skills
Validation, GMP, cGMP, Pharmaceuticals, SOP, Change Control, Regulatory Affairs, Quality Auditing, Cleaning Validation, 21 CFR Part 11, Document Management, Analytical Chemistry, Process Validation, Change Management, Computer System..., Documentation, Quality Assurance, Quality Systems, FDA, Compliance, CAPA, GxP, LIMS, GLP, Software Documentation, Technology Transfer, V&V, Pharmaceutical Industry, Quality Control, Biopharmaceuticals, Quality System, GAMP, Regulatory Requirements, Regulatory Submissions, CRO, GCP, ISO 13485, HPLC, Sop
Education
Baker University 1997 — 2001
Bachelor of Science, Chemistry, Mathematics, Computer Science
· Chromatography Institute of America Design
Bayer HealthCare December 2012 - Present
ProPharma Group May 2011 - December 2012
Aptuit / EaglePicher Pharmaceutical Services November 2005 - May 2011
EaglePicher Pharmaceutical Services 2005 - 2007
PharmaForm 2005 - 2005
sanofi-aventis 2001 - 2004
Skills
Validation, GMP, cGMP, Pharmaceuticals, SOP, Change Control, Regulatory Affairs, Quality Auditing, Cleaning Validation, 21 CFR Part 11, Document Management, Analytical Chemistry, Process Validation, Change Management, Computer System..., Documentation, Quality Assurance, Quality Systems, FDA, Compliance, CAPA, GxP, LIMS, GLP, Software Documentation, Technology Transfer, V&V, Pharmaceutical Industry, Quality Control, Biopharmaceuticals, Quality System, GAMP, Regulatory Requirements, Regulatory Submissions, CRO, GCP, ISO 13485, HPLC, Sop
Education
Baker University 1997 — 2001
Bachelor of Science, Chemistry, Mathematics, Computer Science
· Chromatography Institute of America Design
Annette Kenser's ProPharma Group Experience 2012 - 2012
Job Quality Assurance Specialist at Bayer
Industry Pharmaceuticals
Experience
Bayer HealthCare January 2013 - Present
QA Compliant January 2008 - Present
ProPharma Group 2012 - 2012
XenoTech, LLC October 2005 - January 2008
Quintiles 2002 - 2005
Skills
GLP, Sop, Validation, Pharmaceutical Industry, FDA, GMP, CRO, 21 CFR Part 11, Regulatory Affairs, CAPA, Quality Auditing, Lifesciences, Biotechnology, Change Control, LIMS, Quality Assurance, Quality System, V&V, HPLC, Regulatory Requirements, Bioanalysis
Education
Rockhurst University 1995 — 1999
BS, Biology
University of Missouri-Columbia
Bayer HealthCare January 2013 - Present
QA Compliant January 2008 - Present
ProPharma Group 2012 - 2012
XenoTech, LLC October 2005 - January 2008
Quintiles 2002 - 2005
Skills
GLP, Sop, Validation, Pharmaceutical Industry, FDA, GMP, CRO, 21 CFR Part 11, Regulatory Affairs, CAPA, Quality Auditing, Lifesciences, Biotechnology, Change Control, LIMS, Quality Assurance, Quality System, V&V, HPLC, Regulatory Requirements, Bioanalysis
Education
Rockhurst University 1995 — 1999
BS, Biology
University of Missouri-Columbia
Richalle Ritts's ProPharma Group Experience Senior Process EngineerNalcoMarch 2012 - March 2013
Job Independent Technical Professional
Industry Pharmaceuticals
Experience
ProPharma Group Senior Process EngineerNalcoMarch 2012 - March 2013
Boehringer Ingelheim November 2008 - January 2012
Paul Mueller Company November 2006 - October 2008
ProPharma Group November 2005 - October 2006
Paul Mueller Company May 2003 - October 2005
Skills
Process Engineering, Process Optimization, Troubleshooting, Validation, Chemical Engineering, Commissioning, Biotechnology, Change Control, Manufacturing, Continuous Improvement, Project Engineering, GMP, Process Improvement, Quality System, Lean Manufacturing, Quality Assurance, Sop, Automation, CAPA, Engineering, FDA, ISO, Inspection, Process Control, Process Simulation, Quality Management, Root Cause Analysis, Six Sigma, Technology Transfer, Testing, SOP
Education
Missouri University of Science and Technology 1999 — 2003
Bachelor of Science (B.S.), Chemical Engineering
University of Missouri-Rolla 1999 — 2003
Dual BS, Chemical Engineering and Biological Sciences
ProPharma Group Senior Process EngineerNalcoMarch 2012 - March 2013
Boehringer Ingelheim November 2008 - January 2012
Paul Mueller Company November 2006 - October 2008
ProPharma Group November 2005 - October 2006
Paul Mueller Company May 2003 - October 2005
Skills
Process Engineering, Process Optimization, Troubleshooting, Validation, Chemical Engineering, Commissioning, Biotechnology, Change Control, Manufacturing, Continuous Improvement, Project Engineering, GMP, Process Improvement, Quality System, Lean Manufacturing, Quality Assurance, Sop, Automation, CAPA, Engineering, FDA, ISO, Inspection, Process Control, Process Simulation, Quality Management, Root Cause Analysis, Six Sigma, Technology Transfer, Testing, SOP
Education
Missouri University of Science and Technology 1999 — 2003
Bachelor of Science (B.S.), Chemical Engineering
University of Missouri-Rolla 1999 — 2003
Dual BS, Chemical Engineering and Biological Sciences
Samuel J-Joseph's ProPharma Group Experience July 2007 - October 2008
Job System/Application Analyst
Industry Information Technology and Services
Experience
BMO May 2014 - Present
Toyota November 2012 - Present
BMO May 2011 - Present
Shoppers Drug Mart September 2010 - September 2011
GlaxoSmithKline October 2009 - August 2010
Complete Innovations Inc. October 2008 - October 2009
ProPharma Group July 2007 - October 2008
Propharm Ltd July 2007 - October 2008
Kraft Canada November 2005 - July 2007
VCS timeless November 2004 - November 2005
Skills
Troubleshooting, Active Directory, Lotus Notes, XP, SharePoint, Business Analysis, SDLC, Crystal Reports, Testing, Software Documentation, Technical Support, Requirements Analysis, Windows, SQL, IIS
Education
Delta College 1996 — 1998
AEC, Computer Science / Programmer Analyst
AECDelta College
BMO May 2014 - Present
Toyota November 2012 - Present
BMO May 2011 - Present
Shoppers Drug Mart September 2010 - September 2011
GlaxoSmithKline October 2009 - August 2010
Complete Innovations Inc. October 2008 - October 2009
ProPharma Group July 2007 - October 2008
Propharm Ltd July 2007 - October 2008
Kraft Canada November 2005 - July 2007
VCS timeless November 2004 - November 2005
Skills
Troubleshooting, Active Directory, Lotus Notes, XP, SharePoint, Business Analysis, SDLC, Crystal Reports, Testing, Software Documentation, Technical Support, Requirements Analysis, Windows, SQL, IIS
Education
Delta College 1996 — 1998
AEC, Computer Science / Programmer Analyst
AECDelta College
Suzanne Auckerman's ProPharma Group Experience 2011 - 2012
Job President at Auckerman Consulting, LLC
Industry Pharmaceuticals
Experience
Auckerman Consulting, LLC September 2010 - Present
Lachman Consultant Services 2012 - 2014
ProPharma Group 2011 - 2012
Auckerman Consulting 2006 - 2012
Boehringer Ingelheim. 2008 - November 2010
Auckerman Consulting, LLC 2006 - 2010
Brandt Research Consulting, Inc May 2006 - July 2008
Working Words, Inc April 2006 - December 2007
Skills Plus 2007 - 2007
Merck 1977 - 2006
Skills
GMP, 21 CFR Part 11, FDA, Change Control, Pharmaceutical Industry, CAPA, Sop, Quality System, Validation, Training, Computer System..., Auditing, GxP, Quality Auditing, Biopharmaceuticals, Trackwise, Technology Transfer, GAMP, GLP, Contract Manufacturing, GCP, Quality Assurance, Regulatory Affairs, R&D, Continuous Improvement, Cleaning Validation, Drug Development, Analytical Chemistry, Vaccines, V&V, Laboratory, Chemistry, Biotechnology, Regulatory Requirements, Lifesciences, Medical Devices, Regulatory Submissions, ISO 13485, Cross-functional Team..., Pharmaceutics, Aseptic Processing, CRO, LIMS, HPLC, Clinical Trials, Quality Management, Chromatography, Quality Control, Process Simulation, Clinical Development
Education
William & Mary 1969 — 1973
BS, Biology
James Madison University
M.A.T, Biology
Auckerman Consulting, LLC September 2010 - Present
Lachman Consultant Services 2012 - 2014
ProPharma Group 2011 - 2012
Auckerman Consulting 2006 - 2012
Boehringer Ingelheim. 2008 - November 2010
Auckerman Consulting, LLC 2006 - 2010
Brandt Research Consulting, Inc May 2006 - July 2008
Working Words, Inc April 2006 - December 2007
Skills Plus 2007 - 2007
Merck 1977 - 2006
Skills
GMP, 21 CFR Part 11, FDA, Change Control, Pharmaceutical Industry, CAPA, Sop, Quality System, Validation, Training, Computer System..., Auditing, GxP, Quality Auditing, Biopharmaceuticals, Trackwise, Technology Transfer, GAMP, GLP, Contract Manufacturing, GCP, Quality Assurance, Regulatory Affairs, R&D, Continuous Improvement, Cleaning Validation, Drug Development, Analytical Chemistry, Vaccines, V&V, Laboratory, Chemistry, Biotechnology, Regulatory Requirements, Lifesciences, Medical Devices, Regulatory Submissions, ISO 13485, Cross-functional Team..., Pharmaceutics, Aseptic Processing, CRO, LIMS, HPLC, Clinical Trials, Quality Management, Chromatography, Quality Control, Process Simulation, Clinical Development
Education
William & Mary 1969 — 1973
BS, Biology
James Madison University
M.A.T, Biology
Debra Damato-Hunter's ProPharma Group Experience June 2009 - October 2009
Job TrackWise System/Business Administrator at Stryker
Industry Information Technology and Services
Experience
Stryker October 2009 - Present
ProPharma Group June 2009 - October 2009
Pfizer, Inc. January 1983 - October 2008
Michigan June 1972 - March 1977
Skills
Validation, Quality Assurance, SharePoint, 21 CFR Part 11, Change Control, CAPA, Medical Devices, Computer System..., Quality System, Pharmaceutical Industry, FDA, V&V, SDLC, Continuous Improvement, Testing, GMP, Information Technology, Document Management, Software Documentation, Program Management, System Administration, Project Management, Sop, Training
Education
University of Phoenix 2004 — 2006
Bachelor's, Management, 3.95 GPA
Kalamazoo Valley Community College 1982 — 1986
AA, Computer Science, 3.54 GPA
Stryker October 2009 - Present
ProPharma Group June 2009 - October 2009
Pfizer, Inc. January 1983 - October 2008
Michigan June 1972 - March 1977
Skills
Validation, Quality Assurance, SharePoint, 21 CFR Part 11, Change Control, CAPA, Medical Devices, Computer System..., Quality System, Pharmaceutical Industry, FDA, V&V, SDLC, Continuous Improvement, Testing, GMP, Information Technology, Document Management, Software Documentation, Program Management, System Administration, Project Management, Sop, Training
Education
University of Phoenix 2004 — 2006
Bachelor's, Management, 3.95 GPA
Kalamazoo Valley Community College 1982 — 1986
AA, Computer Science, 3.54 GPA
Robert Studholme's ProPharma Group Experience August 2014 - Present
Job Director, Quality and Operations at Cagenix, Inc.
Industry Biotechnology
Experience
ProPharma Group August 2014 - Present
Cagenix, Inc. June 2011 - Present
Eveia Medical, Inc. February 2008 - June 2011
RMS Consulting July 2008 - February 2010
Meridian Life Science, Inc. 1994 - 2008
Diatron Corporation 1987 - 1993
Skills
Biotechnology, PCR, Product Development, Lifesciences, Strategic Planning, Medical Devices, GMP, Infectious Diseases, Genomics, Cross-functional Team..., Regulatory Affairs, Project Management, Molecular Biology, Process Improvement, Licensing, ISO, New Business Development, Six Sigma, Pharmaceutical Industry, Customer Service, Life Sciences, Clinical Trials
Education
California State University-Fullerton 1970 — 1974
B.S., Physics
ProPharma Group August 2014 - Present
Cagenix, Inc. June 2011 - Present
Eveia Medical, Inc. February 2008 - June 2011
RMS Consulting July 2008 - February 2010
Meridian Life Science, Inc. 1994 - 2008
Diatron Corporation 1987 - 1993
Skills
Biotechnology, PCR, Product Development, Lifesciences, Strategic Planning, Medical Devices, GMP, Infectious Diseases, Genomics, Cross-functional Team..., Regulatory Affairs, Project Management, Molecular Biology, Process Improvement, Licensing, ISO, New Business Development, Six Sigma, Pharmaceutical Industry, Customer Service, Life Sciences, Clinical Trials
Education
California State University-Fullerton 1970 — 1974
B.S., Physics
Charnisse Kelly MSQA, CQA, CMQ/OE's ProPharma Group Experience October 2011 - April 2014
Job Owner of CL&D Pharma Consulting LLC
Industry Pharmaceuticals
Experience
Charnisse Kelly (Independent Consultant) April 2014 - Present
ProPharma Group October 2011 - April 2014
Talecris Plasma Resources March 2009 - October 2011
Talecris November 2007 - October 2011
Lockheed Martin July 2006 - November 2007
American Red Cross National Testing Laboratory July 2004 - July 2006
American Red Cross National Testing Laboratory October 1998 - July 2004
Skills
Certified Quality..., Certified Quality..., CAPA, Validation, Root Cause Analysis, Auditing, FDA, Quality Systems, GMP, cGMP, Quality Auditing, SOP, Quality System, Sop, Quality Assurance, Document Management, V&V, CQA, FDA GMP, Pharmaceutical Industry, Aseptic Processing, Quality Control
Education
California State University-Dominguez Hills 2008 — 2013
MS, Quality Assurance-Healthcare
Francis Marion University 1992 — 1996
BS, Biology
Charnisse Kelly (Independent Consultant) April 2014 - Present
ProPharma Group October 2011 - April 2014
Talecris Plasma Resources March 2009 - October 2011
Talecris November 2007 - October 2011
Lockheed Martin July 2006 - November 2007
American Red Cross National Testing Laboratory July 2004 - July 2006
American Red Cross National Testing Laboratory October 1998 - July 2004
Skills
Certified Quality..., Certified Quality..., CAPA, Validation, Root Cause Analysis, Auditing, FDA, Quality Systems, GMP, cGMP, Quality Auditing, SOP, Quality System, Sop, Quality Assurance, Document Management, V&V, CQA, FDA GMP, Pharmaceutical Industry, Aseptic Processing, Quality Control
Education
California State University-Dominguez Hills 2008 — 2013
MS, Quality Assurance-Healthcare
Francis Marion University 1992 — 1996
BS, Biology
Angela Dodoo's ProPharma Group Experience November 2011 - April 2012
Job Corporate QAQS&Compliance ASQ CQA at Takeda Pharmaceuticals International Co.
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals International Co. February 2014 - Present
Medical Device Company July 2013 - February 2014
Lonza April 2012 - June 2013
ProPharma Group November 2011 - April 2012
Thermo Fisher Scientific 2010 - 2011
Bioanalytical Systems Inc. (BASi), April 2009 - November 2009
Maetrics November 2008 - April 2009
Eli Lilly 2008 - November 2008
Baxter 2006 - 2008
Skills
CAPA, GMP, Quality Assurance, Validation, Sop, Biotechnology, Pharmaceutical Industry, Quality System, Change Control, Analytical Chemistry, Quality Control, V&V, GxP, Cleaning Validation, 21 CFR Part 11, Regulatory Affairs, LIMS, Aseptic Processing, Biopharmaceuticals, FDA, Trackwise, Aseptic Technique, Technology Transfer, ISO 13485, Purification, Regulatory Requirements, Lifesciences, UV/Vis, GCP, Regulatory Submissions, Vaccines, ELISA, Microbiology, Chromatography, Deviations, CRO, Computer System..., cGMP practices, Cell Culture, Fermentation, Medical Devices, Document Management, GAMP, HPLC, Drug Development, SOP development, GLP, Protein Chemistry, Sterilization, Quality Auditing
Education
Purdue University 1999 — 2004
Bachelor's of Science, Pharmaceutical Sciences
Hightstown High School
Takeda Pharmaceuticals International Co. February 2014 - Present
Medical Device Company July 2013 - February 2014
Lonza April 2012 - June 2013
ProPharma Group November 2011 - April 2012
Thermo Fisher Scientific 2010 - 2011
Bioanalytical Systems Inc. (BASi), April 2009 - November 2009
Maetrics November 2008 - April 2009
Eli Lilly 2008 - November 2008
Baxter 2006 - 2008
Skills
CAPA, GMP, Quality Assurance, Validation, Sop, Biotechnology, Pharmaceutical Industry, Quality System, Change Control, Analytical Chemistry, Quality Control, V&V, GxP, Cleaning Validation, 21 CFR Part 11, Regulatory Affairs, LIMS, Aseptic Processing, Biopharmaceuticals, FDA, Trackwise, Aseptic Technique, Technology Transfer, ISO 13485, Purification, Regulatory Requirements, Lifesciences, UV/Vis, GCP, Regulatory Submissions, Vaccines, ELISA, Microbiology, Chromatography, Deviations, CRO, Computer System..., cGMP practices, Cell Culture, Fermentation, Medical Devices, Document Management, GAMP, HPLC, Drug Development, SOP development, GLP, Protein Chemistry, Sterilization, Quality Auditing
Education
Purdue University 1999 — 2004
Bachelor's of Science, Pharmaceutical Sciences
Hightstown High School
Tom Paino's ProPharma Group Experience November 2006 - June 2009
Job Review Chemist at U.S. Food & Drug Administration
Industry Pharmaceuticals
Experience
U.S. Food & Drug Administration July 2009 - Present
ProPharma Group November 2006 - June 2009
Monsanto August 2005 - October 2006
Tyco Healthcare/Mallinckrodt January 1994 - August 2005
Bausch & Lomb September 1990 - December 1993
Petrolite December 1986 - September 1990
Sigma Aldrich Chemcal Company August 1983 - December 1986
Missouri Baptist College August 1982 - August 1983
Skills
Quality Assurance, Quality Auditing, Quality Management, FDA, R&D, Root Cause Analysis, Lifesciences, Validation, CAPA, GMP, Six Sigma, Process Improvement, Quality Control, Manufacturing, Continuous Improvement
Education
Webster University 1987 — 1994
Master’s Degree, Management
University of Notre Dame 1978 — 1981
M.S., Chemistry
Saint Louis University 1974 — 1978
B.A., Chemistry
St. Louis U. High
St. Louis U. High
St. Louis U. High
St. Louis U. High
St. Louis U. High
U.S. Food & Drug Administration July 2009 - Present
ProPharma Group November 2006 - June 2009
Monsanto August 2005 - October 2006
Tyco Healthcare/Mallinckrodt January 1994 - August 2005
Bausch & Lomb September 1990 - December 1993
Petrolite December 1986 - September 1990
Sigma Aldrich Chemcal Company August 1983 - December 1986
Missouri Baptist College August 1982 - August 1983
Skills
Quality Assurance, Quality Auditing, Quality Management, FDA, R&D, Root Cause Analysis, Lifesciences, Validation, CAPA, GMP, Six Sigma, Process Improvement, Quality Control, Manufacturing, Continuous Improvement
Education
Webster University 1987 — 1994
Master’s Degree, Management
University of Notre Dame 1978 — 1981
M.S., Chemistry
Saint Louis University 1974 — 1978
B.A., Chemistry
St. Louis U. High
St. Louis U. High
St. Louis U. High
St. Louis U. High
St. Louis U. High
Honey Robinson's ProPharma Group Experience October 2013 - Present
Job Area Manager of Operations, West Region at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group October 2013 - Present
Pacira Pharmaceuticals, Inc. April 2013 - October 2013
Validation Technologies, Inc. August 2005 - April 2013
Validation Technologies, Inc. August 2005 - April 2013
Skills
Validation, GMP, FDA, Quality System, Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, Medical Devices, Sop, Quality Assurance, Technology Transfer, V&V, Change Control, CAPA, Project Management, Manufacturing, Lifesciences, Customer Service, Sales, Troubleshooting, Microsoft Word, Engineering, Microsoft Office, PowerPoint, Microsoft Excel
Education
California State University-San Marcos - College of Business Administration 2006 — 2008
B.A. Business Marketing, Management, Global Marketing
ProPharma Group October 2013 - Present
Pacira Pharmaceuticals, Inc. April 2013 - October 2013
Validation Technologies, Inc. August 2005 - April 2013
Validation Technologies, Inc. August 2005 - April 2013
Skills
Validation, GMP, FDA, Quality System, Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, Medical Devices, Sop, Quality Assurance, Technology Transfer, V&V, Change Control, CAPA, Project Management, Manufacturing, Lifesciences, Customer Service, Sales, Troubleshooting, Microsoft Word, Engineering, Microsoft Office, PowerPoint, Microsoft Excel
Education
California State University-San Marcos - College of Business Administration 2006 — 2008
B.A. Business Marketing, Management, Global Marketing
Nicole Kramer's ProPharma Group Experience September 2009 - April 2010
Job Compliance Team Lead
Industry Computer & Network Security
Experience
ECFIRST March 2012 - Present
Health Technology Services April 2010 - March 2012
Bacterin International, Inc. April 2010 - March 2011
ProPharma Group September 2009 - April 2010
Bozeman Deaconess Health Services June 2007 - September 2008
Right Now Technologies 2005 - 2007
Skills
System Administration, DNS, Active Directory, Cloud Computing, Network Administration, HIPAA, Compliance Management, Business Continuity, Servers, Windows Server, Disaster Recovery, Security, Help Desk Support
Education
Montana Tech-College of Technology 2011 — 2013
Certificate in Informatics, Health Information Technology
Tulane University - A.B. Freeman School of Business 1995 — 1999
bsm, management
ECFIRST March 2012 - Present
Health Technology Services April 2010 - March 2012
Bacterin International, Inc. April 2010 - March 2011
ProPharma Group September 2009 - April 2010
Bozeman Deaconess Health Services June 2007 - September 2008
Right Now Technologies 2005 - 2007
Skills
System Administration, DNS, Active Directory, Cloud Computing, Network Administration, HIPAA, Compliance Management, Business Continuity, Servers, Windows Server, Disaster Recovery, Security, Help Desk Support
Education
Montana Tech-College of Technology 2011 — 2013
Certificate in Informatics, Health Information Technology
Tulane University - A.B. Freeman School of Business 1995 — 1999
bsm, management
Tolejala Keel's ProPharma Group Experience December 2011 - March 2014
Job Sr. Compliance Associate at ProPharma Group
Industry Biotechnology
Experience
Consultant July 2014 - Present
ProPharma Group December 2011 - March 2014
International BioResources March 2008 - June 2010
Life Sera Plasma Center March 2007 - March 2008
American Red Cross October 1999 - February 2005
Skills
Quality Assurance, Root Cause Analysis, Auditing, Process Improvement, Inspection, Internal Audit, 21 CFR Part 11, Biotechnology, CAPA, Change Control, FDA, Deviations, GMP, Quality Auditing, Quality Management, Quality System, Regulatory Affairs, Risk Assessment, Software Documentation, Sop, V&V, Validation, Computer System..., GLP, GxP, SOP
Education
Keller Graduate School of Management of DeVry University 2011 — 2012
Master of Public Administration (MPA), 3.8
Keller Graduate School 2004 — 2006
MBA, Healthcare Administration
Savannah State University 1997 — 1998
Bachelors, Business Management
Consultant July 2014 - Present
ProPharma Group December 2011 - March 2014
International BioResources March 2008 - June 2010
Life Sera Plasma Center March 2007 - March 2008
American Red Cross October 1999 - February 2005
Skills
Quality Assurance, Root Cause Analysis, Auditing, Process Improvement, Inspection, Internal Audit, 21 CFR Part 11, Biotechnology, CAPA, Change Control, FDA, Deviations, GMP, Quality Auditing, Quality Management, Quality System, Regulatory Affairs, Risk Assessment, Software Documentation, Sop, V&V, Validation, Computer System..., GLP, GxP, SOP
Education
Keller Graduate School of Management of DeVry University 2011 — 2012
Master of Public Administration (MPA), 3.8
Keller Graduate School 2004 — 2006
MBA, Healthcare Administration
Savannah State University 1997 — 1998
Bachelors, Business Management
John McLemore's ProPharma Group Experience January 2011 - February 2012
Job Manager, QA Validation at Kremers Urban Pharmaceuticals
Industry Pharmaceuticals
Experience
Kremers Urban Pharmaceuticals March 2014 - Present
Validation Technologies, Inc. August 2013 - March 2014
Cook Pharmica February 2012 - August 2013
ProPharma Group January 2011 - February 2012
Commissioning Agents, Inc October 2007 - January 2011
GKM-Global Knowledge Management April 2006 - September 2007
US Navy November 1985 - November 2005
Skills
Validation, GMP, FDA, Change Control, CAPA, V&V, GAMP, Sop, Biopharmaceuticals, 21 CFR Part 11, GxP, Quality System, Computer System..., Aseptic Processing, Quality Assurance, SOP
Education
Thomas Edison State College 2001 — 2005
Bachelor of Science (BS) Applied Science and Technology, Nuclear Engineering
Kremers Urban Pharmaceuticals March 2014 - Present
Validation Technologies, Inc. August 2013 - March 2014
Cook Pharmica February 2012 - August 2013
ProPharma Group January 2011 - February 2012
Commissioning Agents, Inc October 2007 - January 2011
GKM-Global Knowledge Management April 2006 - September 2007
US Navy November 1985 - November 2005
Skills
Validation, GMP, FDA, Change Control, CAPA, V&V, GAMP, Sop, Biopharmaceuticals, 21 CFR Part 11, GxP, Quality System, Computer System..., Aseptic Processing, Quality Assurance, SOP
Education
Thomas Edison State College 2001 — 2005
Bachelor of Science (BS) Applied Science and Technology, Nuclear Engineering
Debra Walton's ProPharma Group Experience January 2014 - Present
Job Quality Assurance/Regulatory Affairs Professional
Industry Pharmaceuticals
Experience
ProPharma Group January 2014 - Present
CareFusion January 2011 - November 2013
ProPharma Group 2008 - 2010
Aptuit 2007 - 2008
Pfizer 2000 - 2007
Skills
cGMP, Change Control, SOP, GMP, Quality Auditing, Regulatory Reporting, Regulatory Affairs, CAPA, FDA, Validation, 21 CFR Part 11, Sop, GxP, Quality Assurance, Computer System..., V&V, Quality System, Regulatory Requirements
Education
Missouri State University
Bachelor's degree, Mathematics
ProPharma Group January 2014 - Present
CareFusion January 2011 - November 2013
ProPharma Group 2008 - 2010
Aptuit 2007 - 2008
Pfizer 2000 - 2007
Skills
cGMP, Change Control, SOP, GMP, Quality Auditing, Regulatory Reporting, Regulatory Affairs, CAPA, FDA, Validation, 21 CFR Part 11, Sop, GxP, Quality Assurance, Computer System..., V&V, Quality System, Regulatory Requirements
Education
Missouri State University
Bachelor's degree, Mathematics
Andrae Lopez, MBA's ProPharma Group Experience February 2015 - Present
Job Business Development at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group February 2015 - Present
Inside Academics September 2014 - February 2015
WildPackets August 2013 - September 2014
Enterprise and B2B sales April 2013 - August 2013
Syniverse Technologies July 2012 - March 2013
VSS Monitoring June 2011 - July 2012
nAppliance Networks Inc. (Subsidiary of parent company Iron Systems) March 2010 - June 2011
Everest College October 2009 - February 2010
Ricoh Business Solutions January 2009 - July 2009
Blue Coat Systems December 2006 - December 2008
Skills
Lead Generation, Account Management, Sales Force..., Salesforce.com, Sales Process, Direct Sales, New Business Development, Sales Management, Sales Effectiveness, Sales Operations, Selling, Channel Partners, Solution Selling, Enterprise Software, Data Center, Security, Sales, Demand Generation, Cold Calling, Process Improvement, Management, Professional Services, CRM, Marketing, Unified Communications, Youth Mentoring, Networking, Customer Service, Training, Telecommunications, Email Marketing, B2B, Team Building, Marketing Strategy, Cloud Computing, SaaS, Forecasting, Strategic Partnerships, Business Development, Go-to-market Strategy, Managed Services, Product Marketing, Start-ups, Analytics, Business Alliances
Education
Lindenwood University 2004 — 2006
MBA, Business
Missouri Valley College 2001 — 2004
BA, Interdisciplinary Studies
ProPharma Group February 2015 - Present
Inside Academics September 2014 - February 2015
WildPackets August 2013 - September 2014
Enterprise and B2B sales April 2013 - August 2013
Syniverse Technologies July 2012 - March 2013
VSS Monitoring June 2011 - July 2012
nAppliance Networks Inc. (Subsidiary of parent company Iron Systems) March 2010 - June 2011
Everest College October 2009 - February 2010
Ricoh Business Solutions January 2009 - July 2009
Blue Coat Systems December 2006 - December 2008
Skills
Lead Generation, Account Management, Sales Force..., Salesforce.com, Sales Process, Direct Sales, New Business Development, Sales Management, Sales Effectiveness, Sales Operations, Selling, Channel Partners, Solution Selling, Enterprise Software, Data Center, Security, Sales, Demand Generation, Cold Calling, Process Improvement, Management, Professional Services, CRM, Marketing, Unified Communications, Youth Mentoring, Networking, Customer Service, Training, Telecommunications, Email Marketing, B2B, Team Building, Marketing Strategy, Cloud Computing, SaaS, Forecasting, Strategic Partnerships, Business Development, Go-to-market Strategy, Managed Services, Product Marketing, Start-ups, Analytics, Business Alliances
Education
Lindenwood University 2004 — 2006
MBA, Business
Missouri Valley College 2001 — 2004
BA, Interdisciplinary Studies
Tara Bender's ProPharma Group Experience March 2013 - May 2014
Job Manager Quality Control at Sanofi Pasteur Biologics, LLC
Industry Pharmaceuticals
Experience
Sanofi Pasteur Biologics, LLC June 2015 - Present
Sanofi Pasteur May 2014 - June 2015
ProPharma Group March 2013 - May 2014
Desert Rose Manufacturing Inc September 2011 - June 2013
BASF Plant Science April 2010 - December 2010
Northeastern University February 2009 - March 2010
Medical University of South Carolina November 2007 - November 2008
East Carolina University June 2007 - October 2007
Magellan Laboratories Inc April 2000 - July 2002
Eaton Johnson Middle School August 1999 - December 1999
Skills
Cell Culture, ELISA, Western Blotting, Immunohistochemistry, Neuroscience, Physiology, PCR, Molecular Biology, Microscopy, In Vivo, HPLC, Fluorescence Microscopy, Teamwork, Pharmacology, Investigation, Quality System
Education
East Carolina University 2002 — 2007
Ph.D., Pharmacology
Duke University 2001 — 2001
N/A, Neuroscience
Cornell University 1995 — 1999
B.A., Biological Sciences/Neurobiology & Behavior
Towson High School 1991 — 1995
HS diploma, N/A
Sanofi Pasteur Biologics, LLC June 2015 - Present
Sanofi Pasteur May 2014 - June 2015
ProPharma Group March 2013 - May 2014
Desert Rose Manufacturing Inc September 2011 - June 2013
BASF Plant Science April 2010 - December 2010
Northeastern University February 2009 - March 2010
Medical University of South Carolina November 2007 - November 2008
East Carolina University June 2007 - October 2007
Magellan Laboratories Inc April 2000 - July 2002
Eaton Johnson Middle School August 1999 - December 1999
Skills
Cell Culture, ELISA, Western Blotting, Immunohistochemistry, Neuroscience, Physiology, PCR, Molecular Biology, Microscopy, In Vivo, HPLC, Fluorescence Microscopy, Teamwork, Pharmacology, Investigation, Quality System
Education
East Carolina University 2002 — 2007
Ph.D., Pharmacology
Duke University 2001 — 2001
N/A, Neuroscience
Cornell University 1995 — 1999
B.A., Biological Sciences/Neurobiology & Behavior
Towson High School 1991 — 1995
HS diploma, N/A
Sheryl Nichols's ProPharma Group Experience March 1999 - January 2012
Job Programmer Analyst at Murdoch's Ranch & Home Supply
Industry Retail
Experience
Murdoch's Ranch & Home Supply August 2014 - Present
Murdoch's Ranch & Home Supply January 2012 - Present
ProPharma Group March 1999 - January 2012
Skills
Software Documentation, Manufacturing, Management, Cross-functional Team..., Troubleshooting, Project Planning, Leadership, Change Management, Microsoft Excel, Six Sigma, Program Management, Customer Service, Business Process..., Budgets, Continuous Improvement, Microsoft Word, Inventory Management, Engineering
Education
Montana State University-Bozeman 1981 — 1986
BS, Electrical Engineering
Murdoch's Ranch & Home Supply August 2014 - Present
Murdoch's Ranch & Home Supply January 2012 - Present
ProPharma Group March 1999 - January 2012
Skills
Software Documentation, Manufacturing, Management, Cross-functional Team..., Troubleshooting, Project Planning, Leadership, Change Management, Microsoft Excel, Six Sigma, Program Management, Customer Service, Business Process..., Budgets, Continuous Improvement, Microsoft Word, Inventory Management, Engineering
Education
Montana State University-Bozeman 1981 — 1986
BS, Electrical Engineering
Vincent Avila's ProPharma Group Experience 2010 - 2011
Job Lab Systems Specialist at XenoTech, LLC
Industry Pharmaceuticals
Experience
XenoTech, LLC May 2011 - Present
ProPharma Group 2010 - 2011
Aptuit May 1999 - August 2009
Skills
FDA, Validation, GLP, GMP, 21 CFR Part 11, HPLC, Sop, Pharmaceutical Industry, Biotechnology, CRO, Analytical Chemistry, Drug Development, Lifesciences, Regulatory Affairs, LIMS, SOP, Life Sciences
Education
Baker University
MBA, Business Administration
University of Missouri-Kansas City
BS, Chemistry
XenoTech, LLC May 2011 - Present
ProPharma Group 2010 - 2011
Aptuit May 1999 - August 2009
Skills
FDA, Validation, GLP, GMP, 21 CFR Part 11, HPLC, Sop, Pharmaceutical Industry, Biotechnology, CRO, Analytical Chemistry, Drug Development, Lifesciences, Regulatory Affairs, LIMS, SOP, Life Sciences
Education
Baker University
MBA, Business Administration
University of Missouri-Kansas City
BS, Chemistry
Josef Brown's ProPharma Group Experience May 2015 - Present
Job Technical Service Consultant at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group May 2015 - Present
P March 2013 - Present
Independant Consultant January 2013 - Present
Pharmeng April 2012 - Present
Genzyme March 2011 - April 2012
Acusphere, Inc. November 2005 - March 2009
PFI - Parsons March 1996 - February 2002
Skills
Validation, GMP, FDA, V&V, Sop, Quality Assurance, Medical Devices, Process Engineering, Process Simulation, Testing, Manufacturing, Automation, 21 CFR Part 11, Computer System..., CAPA, Cleaning Validation, Change Control, Biotechnology, Pharmaceutical Industry, Biopharmaceuticals, Technology Transfer, SOP
Education
Southern New Hampshire University 2013 — 2016
Master's Degree, Accounting and Finance, MS
Southern NH University 2013 — 2015
Bachelor's Degree, Accounting and Finance, BSc
College of San Mateo 1979 — 1983
Associate of Science (A.S.), Chemistry
ProPharma Group May 2015 - Present
P March 2013 - Present
Independant Consultant January 2013 - Present
Pharmeng April 2012 - Present
Genzyme March 2011 - April 2012
Acusphere, Inc. November 2005 - March 2009
PFI - Parsons March 1996 - February 2002
Skills
Validation, GMP, FDA, V&V, Sop, Quality Assurance, Medical Devices, Process Engineering, Process Simulation, Testing, Manufacturing, Automation, 21 CFR Part 11, Computer System..., CAPA, Cleaning Validation, Change Control, Biotechnology, Pharmaceutical Industry, Biopharmaceuticals, Technology Transfer, SOP
Education
Southern New Hampshire University 2013 — 2016
Master's Degree, Accounting and Finance, MS
Southern NH University 2013 — 2015
Bachelor's Degree, Accounting and Finance, BSc
College of San Mateo 1979 — 1983
Associate of Science (A.S.), Chemistry
Deepthi R's ProPharma Group Experience 2013 - 2015
Job Validation Engineer
Industry
Experience
Depuy synthes (Johnson & Johnson) June 2015 - Present
Propharma group, Biomedical Systems June 2014 - June 2015
ProPharma Group 2013 - 2015
Genzyme January 2013 - April 2014
Skills
Validation, 21 CFR Part 11, Computer System..., Change Control, CAPA, GAMP, V&V, GMP, FDA, GxP, Aseptic Processing, Cleaning Validation
Education
Governors State University
Depuy synthes (Johnson & Johnson) June 2015 - Present
Propharma group, Biomedical Systems June 2014 - June 2015
ProPharma Group 2013 - 2015
Genzyme January 2013 - April 2014
Skills
Validation, 21 CFR Part 11, Computer System..., Change Control, CAPA, GAMP, V&V, GMP, FDA, GxP, Aseptic Processing, Cleaning Validation
Education
Governors State University
Chip Bailey's ProPharma Group Experience December 2012 - July 2013
Job Experienced Professional Qualifying cGMP Quality Control Laboratory Instruments, CVS, and Part 11 for Biotech / Pharma
Industry Biotechnology
Experience
ProPharma Group December 2012 - July 2013
Pfizer Consumer Healthcare November 2001 - July 2012
Wyeth Pharmaceutical August 2001 - October 2001
Merck Group May 2000 - May 2001
Ethicon June 1999 - March 2000
Skills
Computer System..., HPLC, Pharmaceutical Industry, Quality Assurance, Change Control, cGMP practices, Laboratory Equipment, Laboratory Skills, GC, Spectroscopy, 21 CFR Part 11, GAMP, USP 1058, USP 1225, Biotechnology, Dietary Supplements..., Consumer Healthcare, System Administration, Quality Control, Technical Writing, IQ/OQ/PQ, DMAIC, Risk Assessment, Empower, Trackwise, Gas Chromatography, CAPA
Education
Southern Polytechnic State University 1997 — 2000
Master of Science (MSc), Quality Assurance, 3.5
The University of Georgia
Bachelor of Science (BSc), Analytical Chemistry
ProPharma Group December 2012 - July 2013
Pfizer Consumer Healthcare November 2001 - July 2012
Wyeth Pharmaceutical August 2001 - October 2001
Merck Group May 2000 - May 2001
Ethicon June 1999 - March 2000
Skills
Computer System..., HPLC, Pharmaceutical Industry, Quality Assurance, Change Control, cGMP practices, Laboratory Equipment, Laboratory Skills, GC, Spectroscopy, 21 CFR Part 11, GAMP, USP 1058, USP 1225, Biotechnology, Dietary Supplements..., Consumer Healthcare, System Administration, Quality Control, Technical Writing, IQ/OQ/PQ, DMAIC, Risk Assessment, Empower, Trackwise, Gas Chromatography, CAPA
Education
Southern Polytechnic State University 1997 — 2000
Master of Science (MSc), Quality Assurance, 3.5
The University of Georgia
Bachelor of Science (BSc), Analytical Chemistry
Stephen Anisko's ProPharma Group Experience April 2006 - December 2007
Job Validation Engineer at Eisai Pharmaceuticals
Industry Pharmaceuticals
Experience
Eisai Pharmaceuticals December 2007 - Present
ProPharma Group April 2006 - December 2007
hgsi (contract) 2004 - 2005
BioReliance 2002 - 2004
aac consulting 2000 - 2002
Education
The Johns Hopkins University 2005 — 2008
MS, Biotechnology
University of Maryland College Park 1995 — 2000
BS, Chemical Engineering
Eisai Pharmaceuticals December 2007 - Present
ProPharma Group April 2006 - December 2007
hgsi (contract) 2004 - 2005
BioReliance 2002 - 2004
aac consulting 2000 - 2002
Education
The Johns Hopkins University 2005 — 2008
MS, Biotechnology
University of Maryland College Park 1995 — 2000
BS, Chemical Engineering
Scott Dandy's ProPharma Group Experience July 2010 - May 2011
Job Contract Specialist at US Environmental Protection Agency (EPA)
Industry Military
Experience
US Environmental Protection Agency (EPA) April 2015 - Present
Kansas National Guard September 2009 - Present
US Army Corps of Engineers October 2011 - April 2015
US Army December 2012 - August 2013
ProPharma Group July 2010 - May 2011
ThyssenKrupp Access October 2009 - July 2010
Ernst & Young, Mid-Atlantic Region October 1998 - May 2009
Aerzen USA May 2007 - April 2009
Teleflex December 2005 - May 2007
Verizon Enterprise Solutions Group, Philadelphia Metro Area February 2004 - December 2005
Skills
Forecasting, Management, Process Improvement, Microsoft Excel, Accounting, Budgets, Customer Service, Financial Analysis, Analysis, Procurement, Program Management, Finance, Leadership, Accounts Receivable, Project Planning, Strategic Planning
Education
La Salle University 1994 — 1998
BS, Accounting
US Environmental Protection Agency (EPA) April 2015 - Present
Kansas National Guard September 2009 - Present
US Army Corps of Engineers October 2011 - April 2015
US Army December 2012 - August 2013
ProPharma Group July 2010 - May 2011
ThyssenKrupp Access October 2009 - July 2010
Ernst & Young, Mid-Atlantic Region October 1998 - May 2009
Aerzen USA May 2007 - April 2009
Teleflex December 2005 - May 2007
Verizon Enterprise Solutions Group, Philadelphia Metro Area February 2004 - December 2005
Skills
Forecasting, Management, Process Improvement, Microsoft Excel, Accounting, Budgets, Customer Service, Financial Analysis, Analysis, Procurement, Program Management, Finance, Leadership, Accounts Receivable, Project Planning, Strategic Planning
Education
La Salle University 1994 — 1998
BS, Accounting
John Vuong's ProPharma Group Experience 2013 - 2014
Job Director of Quality Compliance at RS Calibration
Industry Pharmaceuticals
Experience
RS Calibration September 2014 - Present
Campolindo High School 2012 - Present
Genentech 2014 - September 2014
J2 Validation Services, LLC May 2011 - September 2014
ProPharma Group 2013 - 2014
Vitapath genetics August 2011 - February 2013
Novartis Vaccines and Diagnostics April 2003 - May 2011
Celera Corporation August 1999 - April 2003
Chiron Corporation May 1994 - August 1999
Skills
Validation, Cleaning Validation, Quality Systems, Commissioning, Process Optimization, Process Validation, GMP, CAPA, cGMP, FDA, ISO 13485, ISO, SOP, GxP, Change Control, Quality Auditing, Quality Assurance, Design Control, Inspection, Supplier Quality, ISO 14971, GLP, Quality Management, Auditing, FMEA, Continuous Improvement, Medical Devices, Quality Control, Quality System
Education
Notre Dame de Namur University 1989 — 1993
Bs, Biochem
RS Calibration September 2014 - Present
Campolindo High School 2012 - Present
Genentech 2014 - September 2014
J2 Validation Services, LLC May 2011 - September 2014
ProPharma Group 2013 - 2014
Vitapath genetics August 2011 - February 2013
Novartis Vaccines and Diagnostics April 2003 - May 2011
Celera Corporation August 1999 - April 2003
Chiron Corporation May 1994 - August 1999
Skills
Validation, Cleaning Validation, Quality Systems, Commissioning, Process Optimization, Process Validation, GMP, CAPA, cGMP, FDA, ISO 13485, ISO, SOP, GxP, Change Control, Quality Auditing, Quality Assurance, Design Control, Inspection, Supplier Quality, ISO 14971, GLP, Quality Management, Auditing, FMEA, Continuous Improvement, Medical Devices, Quality Control, Quality System
Education
Notre Dame de Namur University 1989 — 1993
Bs, Biochem
Gary Zeller's ProPharma Group Experience March 2012 - October 2012
Job Manager Validation at Recro
Industry Pharmaceuticals
Experience
Alkermes May 2013 - Present
Propharma Group March 2012 - October 2012
King Pharmaceuticals July 2003 - July 2011
Medeva/Celltech Pharmaceuticals May 1993 - July 2003
Glaxo/GSK September 1986 - May 1993
Skills
Change Control, Validation, Computer System..., Manufacturing, V&V, LIMS, 21 CFR Part 11, Cleaning Validation, Sop, Testing, FDA, GLP, Quality System, GxP, GMP, CAPA, Aseptic Processing, GAMP, Pharmaceutical Industry, Root Cause Analysis, Biopharmaceuticals, Regulatory Affairs, Technology Transfer, FDA GMP
Education
Catawba College 1980 — 1983
BA, Chemistry
Alkermes May 2013 - Present
Propharma Group March 2012 - October 2012
King Pharmaceuticals July 2003 - July 2011
Medeva/Celltech Pharmaceuticals May 1993 - July 2003
Glaxo/GSK September 1986 - May 1993
Skills
Change Control, Validation, Computer System..., Manufacturing, V&V, LIMS, 21 CFR Part 11, Cleaning Validation, Sop, Testing, FDA, GLP, Quality System, GxP, GMP, CAPA, Aseptic Processing, GAMP, Pharmaceutical Industry, Root Cause Analysis, Biopharmaceuticals, Regulatory Affairs, Technology Transfer, FDA GMP
Education
Catawba College 1980 — 1983
BA, Chemistry
Chuck Luce's ProPharma Group Experience October 2011 - Present
Job Consultant at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group October 2011 - Present
Lonza Hopkinton 2011 - 2012
Diosynth October 2001 - May 2010
Skills
Contract Manufacturing, Biotechnology, GMP, cGMP, Validation, Technology Transfer, 21 CFR Part 11, Biochemistry, Biopharmaceuticals, CAPA, CRO, Cell Culture, Change Control, Chromatography, Drug Development, FDA, GLP, GxP, LIMS, Lifesciences, Manufacturing, Pharmaceutical Industry, Pharmaceutics, Purification, Quality Management, R, Regulatory Requirements, SOP, Sop, V, Vaccines
Education
North Carolina State University 1998 — 2001
Bachelor of Science, Biochemistry
North Carolina State University 1998 — 2001
Bachelor of Arts, Chemistry
ProPharma Group October 2011 - Present
Lonza Hopkinton 2011 - 2012
Diosynth October 2001 - May 2010
Skills
Contract Manufacturing, Biotechnology, GMP, cGMP, Validation, Technology Transfer, 21 CFR Part 11, Biochemistry, Biopharmaceuticals, CAPA, CRO, Cell Culture, Change Control, Chromatography, Drug Development, FDA, GLP, GxP, LIMS, Lifesciences, Manufacturing, Pharmaceutical Industry, Pharmaceutics, Purification, Quality Management, R, Regulatory Requirements, SOP, Sop, V, Vaccines
Education
North Carolina State University 1998 — 2001
Bachelor of Science, Biochemistry
North Carolina State University 1998 — 2001
Bachelor of Arts, Chemistry
Colin Cai's ProPharma Group Experience January 2009 - September 2011
Job Scientist at Pharmaceutical Product Development Inc.
Industry Pharmaceuticals
Experience
Pharmaceutical Product Development Inc. June 2013 - Present
Genentech June 2013 - March 2014
ProPharma Group January 2009 - September 2011
Skills
SUMMARY OF QUALIFICATION, •Combining over 15..., •Experience in GMP..., •Analytical,..., •Experience in..., •Branch-DNA diagnostic..., •Strong on-site...
Education
M.S. San Francisco State University 1995 — 1999
Master of Science (M.S.), Biomedical Sciences/Clinical Sciences
East China University of Science and Technology 1983 — 1987
Bachelor of Science (B.S.), Applied Organic Chemistry/medicinal Chemistry
Pharmaceutical Product Development Inc. June 2013 - Present
Genentech June 2013 - March 2014
ProPharma Group January 2009 - September 2011
Skills
SUMMARY OF QUALIFICATION, •Combining over 15..., •Experience in GMP..., •Analytical,..., •Experience in..., •Branch-DNA diagnostic..., •Strong on-site...
Education
M.S. San Francisco State University 1995 — 1999
Master of Science (M.S.), Biomedical Sciences/Clinical Sciences
East China University of Science and Technology 1983 — 1987
Bachelor of Science (B.S.), Applied Organic Chemistry/medicinal Chemistry
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY