Genmab Company
Industry: Biotechnology company
DescriptionGenmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund. Genmab is based in Copenhagen. CEO: Jan G. J. van de Winkel (Jun 15, 2010–) Headquarters: Copenhagen, Denmark Number of employees: 157 (2013) Subsidiaries: Genmab US, Inc., Genmab, Inc., Genmab Ltd., Genmab B.V.
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Genmab Employees
Serta Simmons Bedding, LLC March 2014 - Present
Tech Impact January 2005 - Present
WGroup November 2011 - March 2014
Amgen March 2011 - October 2011
Genmab January 2009 - October 2010
NCO Financial Systems February 2003 - January 2009
SAP January 2005 - December 2008
Broadreach Consulting 2000 - 2003
Ernst & Young LLP 1998 - 2000
PriceWaterhouseCoopers 1996 - 1998
Skills
Executive Management, Business Transformation, IT Transformation, IT Strategy, Strategic Sourcing, Acquisition Integration, SAP, Banking, Life Sciences, Management Consulting, Turnarounds, IT Service Management, Operations Management, Shared Services, Big 4, Vendor Management, Enterprise Services, Governance, Outsourcing, Applications, IT Infrastructure..., VMO, Lifesciences, Turn Around Management, Business Process..., IT Management, Strategic Planning, Change Management, PMO, Program Management, Integration, Strategy, Leadership, Business Process, Management, Business Development, Risk Management, Mergers & Acquisitions, Professional Services, Disaster Recovery, Business Strategy, IT Operations, IT Outsourcing, Training, Information Technology, Analytics, Process Improvement, ERP, Organizational Design, Business Analysis
Education
Kutztown University of Pennsylvania 1983 — 1985
Bachelor of Science, Business Administration & Management
Penn State University 1980 — 1982
Business Administration
Central Atlantic Advanced School of Banking 1989 — 1992
Retail and Commercial Banking
Arkema May 2012 - Present
Arkema June 2010 - May 2012
Genmab June 2009 - September 2009
Skills
Chemical Engineering, Process Engineering, Aspen Plus, Process Safety, Process Optimization, SAP, Polymers, Polymer Science, Pilot Plant, Design of Experiments, Microsoft Office, PI Data Historian, Chemistry, Engineering, Distillation
Education
University of Minnesota-Twin Cities 2006 — 2010
Bachelor, Chemical Engineering
University of Minnesota-Twin Cities 2006 — 2010
Bachelor, Chemistry
MedNet Solutions June 2014 - Present
IMI Cornelius December 2009 - June 2014
Genmab April 2008 - November 2009
PDL BioPharma July 2003 - October 2007
R&D Systems January 2001 - July 2003
Parker Hughes Cancer Center August 1999 - October 2000
Skills
Global Project..., Communications, Training, Recruiting, Talent Development, Performance Management, Talent Management, Project Management, Cross-functional Team..., Management, Strategy, Employee Benefits, Team Building, Personnel Management, Coaching, Employee Relations, Benefits Administration, Human Resources, Sales, Data Analysis, Onboarding, Customer Service, Leadership
Education
Colorado Technical University
MBA, Human Resource Management
The University of North Dakota 1994 — 1998
BS, Biology
Century High
Genmab 2007 - Present
Genmab 2005 - 2007
Genmab 2004 - 2005
Genmab 2001 - 2004
Skills
Press Releases, Web Content, Corporate Communications, Intranet, Internal Communications, Public Relations, Strategic Communications, Newsletters, Event Management, Event Planning, Speech Writing, Writing, Editing, Press Kits, Brochures, Communications Planning, Content Management, Intranet Strategy, Research, Communications Strategy, Problem Solving, Team Building, Website Copy, Company Profiles, Website Updating, Investor Relations, Shareholder..., Press Release Creation, Investor Presentations, Corporate Websites, Change Communication, Executive Messaging, Annual Reports, Web Content Management, Project Management, Sitefinity, Communication Skills, Company Presentations, Oral & Written..., Q&A, Talking Points
Education
The College of New Jersey 1996 — 2000
BA, Psychology, marketing
Janssen, Pharmaceutical Companies of Johnson and Johnson July 2011 - Present
Genmab June 2009 - July 2011
Goldman Sachs February 2007 - June 2009
Deloitte September 2004 - February 2007
Deloitte June 2003 - August 2003
New Jersey Manufacturers Insurance June 1998 - August 2002
Skills
Financial Analysis, Accounting, Hedge Funds, Excel, Bloomberg, Auditing, Alternative Investments, Derivatives, Hedge Accounting, Fund Administration, Financial Services, Finance, Financial Reporting
Education
Rider University 1999 — 2004
Master's of Accountancy, Accounting, Computer Information Systems
The Novo Nordisk Foundation Center for Basic Metabolic Research September 2013 - Present
UC Berkeley August 2012 - June 2013
Genmab March 2011 - June 2012
Frederiksberg Gymnasium January 2011 - July 2011
Skills
Science, Molecular Biology, Cell Culture, Bioinformatics, Biochemistry, Microscopy, Statistics, Cell Biology, Protein Chemistry, PCR, Genetics, Western Blotting, Lifesciences, Protein Purification, LaTeX, Confocal Microscopy, Research, Protein Expression, Gel Electrophoresis, Scientific Writing
Education
Copenhagen University 2011 — 2013
Master of Science (MSc), Bioinformatics
Copenhagen University 2007 — 2010
Bachelor of Applied Science (BASc), Nanotechnology
Catalent Pharma Solutions July 2013 - Present
Catalent Pharma Solutions July 2011 - Present
Genmab July 2010 - August 2011
Genmab July 2009 - July 2010
Catalent Pharma Solutions January 2009 - July 2009
Catalent Pharma Solutions January 2008 - January 2009
Catalent Pharma Solutions January 2006 - January 2008
Cardinal Health January 2004 - January 2006
Cardinal Health January 2003 - January 2004
Cardinal Health September 2001 - January 2003
Skills
Business Development, Negotiation, Finance, Turn Around Management, Pharmaceutical Industry, Biotechnology, Acquisition Integration, Technology Transfer, GMP, FDA, Operational Excellence, Six Sigma, Cross-functional Team..., Validation, Process Improvement, Medical Devices, Mergers, Sop, Manufacturing, Strategic Planning, CAPA, 21 CFR Part 11, Change Control, Leadership, Lean Manufacturing, Management, Mergers, Clinical Development, Program Management, Quality Assurance, SOP, Strategy
Education
University of Derby 1985 — 1988
Institute of managment Acountants, Finance
Swindon College 1982 — 1984
HND, Business and Finance
Dako September 2013 - Present
Biothera September 2010 - January 2013
Genmab July 2008 - November 2009
PDL BioPharma January 2006 - July 2008
R&D Systems August 2000 - January 2005
Skills
Chromatography, HPLC, GMP
Education
University of Minnesota-Duluth 1997 — 2000
Bachelor of Science, Biology
Metropolitan State University
Computer Science
Bio-Gist Ventures, LLC 2010 - Present
Genmab 2005 - 2010
Medarex 1999 - 2005
Wildlife Conservation Society 1989 - 1999
Skills
Certified Licensing..., Biotechnology, Licensing, Entrepreneurship, Lifesciences, Immunology, Infectious Diseases, Commercialization, CTMS, Intellectual Property, Vaccines, FDA, Antibodies, Biochemistry, Biomarkers, Business Development, Biopharmaceuticals, Management, Patents, Regulatory Affairs, GCP, Venture Capital, Technology Transfer
Education
Princeton University 1984 — 1990
Ph.D., Biology, Population Biology
Yale University 1979 — 1983
B.S., Biology
GMB Bio:Pharma Development February 2011 - Present
TenX Biopharma February 2010 - January 2011
Aegerion Pharmaceuticals February 2009 - September 2009
Genmab December 2007 - October 2008
AstraZeneca Pharmaceuticals August 2000 - December 2007
AstraZeneca / Atherogenics 2006 - 2007
Sanofi June 1998 - August 2000
GMB Consulting 1995 - 1998
Sterling Winthrop Pharmaceuticals 1990 - 1994
Skills
Regulatory Affairs, Medical Writing, Regulatory Submissions, Pharmaceutics, Quality Assurance, FDA, GMP, Sop, Clinical Trials, Clinical Development, Drug Development, GCP, Biopharmaceuticals, Pharmacovigilance, CRO, Pharmaceutical Industry, Diabetes, Biotechnology, Technology Transfer, CTMS, Biologics, Clinical Research, Oncology, Lifesciences, IND, Regulatory Requirements, Pharmacology, 21 CFR Part 11, Drug Discovery, GLP, Validation
Education
University of Oklahoma Health Sciences Center 1980 — 1986
Ph.D., Pharmacology
Harvard Medical School
reserach fellow Cardiology
The University of Texas at Arlington
BS, Biology Chemistry
Genmab December 2007 - Present
NovaDel Pharma Inc. March 2005 - December 2007
KPMG August 1999 - March 2005
Wyeth 1996 - 1999
Skills
Mergers & Acquisitions, Sarbanes-Oxley Act, Managerial Finance, Auditing, Accounting, Strategy, FX Hedging, Corporate Tax Planning, Corporate Development, Business Development, International Operations, Corporate FP&A, Biotechnology, Senior Executive..., Turn Around Management, Investment Management, Commercial Assessment, Market Research, Contract Negotiation, Divestitures, SEC filings, IFRS, US GAAP, Corporate Governance, Executive Compensation..., Finance, Business Planning, Management, Leadership, Strategic Planning, GAAP, Executive Management, Tax, Project Planning, CPA, Big 4, Negotiation, Financial Reporting, Internal Controls, Financial Analysis, Due Diligence, Financial Accounting, Forecasting, Pharmaceutical Industry, Treasury Management, Process Improvement, Budgets, Cross-functional Team..., Valuation, Sarbanes-Oxley
Education
The College of New Jersey 1996 — 1999
Bachelor of Science (BS), Accounting
Comcast March 2011 - November 2011
Genmab August 2009 - May 2010
Canon Technology Solutions January 2008 - February 2009
Prosodie March 2007 - January 2008
GSI Commerce, Inc. June 2006 - March 2007
GSI Commerce, Inc. September 2005 - June 2006
Everything Garage, LLC 2003 - 2005
PricewaterhouseCoopers 2001 - 2003
Ajunto 2000 - 2001
Ernst & Young 1993 - 1997
Skills
Program Management, Integration, Start-ups, Vendor Management, Project Management, IT Strategy, B2B, E-commerce, Management, SDLC, Consulting, Strategy, Process Improvement, Outsourcing, Risk Management, Analysis, Management Consulting
Education
Drexel University 1984 — 1988
BS, Computerized Informational Systems
SurModics May 2015 - Present
American Medical Systems March 2010 - May 2015
Genmab October 2007 - November 2009
PDL BioPharma November 1994 - October 2007
Allina Hospitals & Clinics June 1992 - November 1994
Skills
GMP, FDA, CAPA, Quality Assurance, Medical Devices, Change Control, Process Improvement, Technology Transfer, Continuous Improvement, Quality Management, Quality Control, Microbiology, ELISA, ISO 13485, Manufacturing, ISO, Cell Culture, Validation, V&V, Quality System
Education
St. Cloud State University 1988 — 1992
B.S., Medical Technology
St. Cloud State University 1987 — 1992
Medical Technology
Baxalta October 2013 - Present
ViTAL, A Toshiba Medical Systems Group Company January 2012 - October 2013
Kroll Ontrack April 2010 - December 2011
Genmab March 2009 - January 2010
Compliance Partners February 2009 - March 2009
Mayo Clinic November 2005 - February 2009
ValSource, LLC July 2003 - July 2005
PAREXEL February 2002 - July 2003
PAREXEL February 2000 - February 2002
PAREXEL February 1998 - February 2000
Skills
Testing, Team Leadership, Test Planning, ETL, SQL, Quality Assurance, Defect Tracking, Quality Center, 21 CFR Part 11, GMP, GAMP, Test Estimation, Test Execution, Audit Support, Risk Assessment, ERP, SAP, Enterprise Architecture, Program Management, Validation, Process Validation, Software Quality..., HIPAA, SOX, Document Management, FDA, ISO standards, ICH-GCP, Change Management, Managerial Experience, Virtual Server, VMware Infrastructure, EMR, Test Strategy, Test Cases, Agile Testing, SDLC, Use Case Analysis, Requirements Analysis, Functional Design, LIMS, Electronic discovery, Agile Methodologies, Computer System..., Quality Control, Integration, V&V, Change Control, SharePoint, HP Quality Center
Education
University of Oklahoma
BS, Chemical Engineering
Mindset Consulting, LLC June 2014 - Present
TSI Incorporated March 2010 - Present
Genmab August 2008 - November 2009
Pure Fishing March 2004 - August 2008
eFunds February 2003 - March 2004
Thomson Reuters April 2002 - February 2003
EMA, Inc December 2000 - April 2002
Skills
SAP, SAP R/3, Security, SAP Basis, Team Leadership, SAP ERP, Troubleshooting
Education
Hamline University 2012 — 2014
Master of Business Administration (M.B.A.), Business
Minnesota State University, Mankato 1996 — 1999
Bachelor's Degree, Management Information Systems, General
Implen 2011 - Present
GNC 2010 - 2011
WorldVentures 2008 - 2011
University of Southern California 2010 - 2010
Genmab 2008 - 2010
University of Minnesota Department of Pharmacology 2005 - 2010
University of Minnesota/University of Saint Thomas 2003 - 2005
Mayo Clinic 2004 - 2004
University of St. Thomas 2002 - 2003
Skills
Molecular Biology, Biochemistry, Life Sciences, Biotechnology, Pharmacology, Cancer Research, Cell Culture, PCR, Western Blotting, Sales Management, Protein Purification, Cell Biology, Customer Service, Fundraising, Direct Sales, Distribution Management, Marketing Management, Business-to-Business..., International Sales, Sales Operations, Sales Presentations, Tumor Immunology, Protein Expression, Protein Characterization, Proteomics, Cancer Genomics, Cancer Proteomics, Travel, Business Travel, Cell, Cancer, Microsoft Office, Management, Clinical Trials, Research, Leadership, Pharmaceutical Industry, Protein Chemistry, Immunology, Science, Public Speaking
Education
University of Minnesota Medical School 2005 — 2010
PhD, Pharmacology, Cum Laude
University of Saint Thomas 2001 — 2005
B.S., Biochemistry, Magna Cum Laude
Heraeus Medical Components September 2010 - Present
St. Cloud State University January 2014 - Present
Quality Leadership Consulting LLC September 2008 - October 2010
Arizant Healthcare June 2009 - September 2010
St. Jude Medical November 2008 - June 2009
Genmab March 2008 - October 2008
PDL BioPharma March 2006 - March 2008
PDL BioPharma November 2004 - February 2006
CIMA Labs 2001 - 2004
Beckman Coulter September 1997 - January 2001
Skills
CAPA, FDA, Quality System, ISO 13485, GMP, Quality Assurance, Change Control, Cross-functional Team..., Medical Devices, Strategic Leadership, Contract Negotiation, Sop, Quality Management, GLP, Management, Validation, Regulatory Requirements, Auditing, V&V, Quality Control, Regulatory Affairs, Pharmaceutical Industry, 21 CFR Part 11, Biopharmaceuticals, Regulations, Design Control, LIMS, Iso 9000, GxP, Quality Auditing, Design of Experiments, 21 CFR, Medical Device Directive, FDA GMP, Leadership, Root Cause Analysis, Contract Management, CMDCAS, Biologics, Computer System..., Technology Transfer, ISO 14971, Manufacturing, Process Improvement, ISO, GCP, IVD, Supplier Quality, Program Management, Biotechnology
Education
Augsburg College
Masters, Leadership
University of Minnesota-Twin Cities
B.S., Medical Technology
North Star Biopharma Consulting May 2015 - Present
Biovest International April 2014 - Present
Biovest International June 2012 - Present
Biovest International January 2010 - June 2012
Genmab 2008 - 2009
PDL BioPharma Inc January 1999 - January 2008
PDL BioPharma Inc January 1996 - January 1999
Skills
Centrifugation, JMP, Ultrafiltration, SAP ERP, Glassware, Chromatography, Protein Purification, Trackwise, Filtration, Document Management, LIMS, GLP, GMP, Biotechnology, Validation, Purification, Technology Transfer, FDA, HPLC, Analytical Chemistry, SDS-PAGE, PCR, Biopharmaceuticals, Change Control, Sop, V&V, Process Simulation, Vaccines, Monoclonal Antibodies, ELISA, Antibodies, Drug Development, Protein Chemistry, CAPA, 21 CFR Part 11, Laboratory, Lifesciences, Quality System, Pharmaceutical Industry, Cell Culture, R&D, Manufacturing
Education
University of Minnesota College of Biological Sciences 1994 — 1996
Plant Biology
Normandale Community College 1992 — 1994
Chemistry/Biology
Pfizer (Execupharm, Inc.) June 2007 - Present
BD June 2006 - June 2007
Merck March 2004 - June 2006
Merck November 2002 - March 2004
Genmab June 2001 - November 2002
Ridgewood Orthopedic Group October 1999 - May 2001
Stryker Howmedica June 1998 - October 1999
Skills
Pharmaceutical Industry, Clinical Trials, Biotechnology, Clinical Research, SOP, Clinical Development, GCP
Education
Fairleigh Dickinson University
Bachelor's degree, Psychology
Barry-Wehmiller Design Group October 2014 - Present
Medtronic May 2014 - September 2014
American Medical Systems March 2011 - December 2013
Medtronic February 2011 - March 2011
Zimmer Spine August 2010 - November 2010
St. Jude Medical December 2009 - July 2010
ev3 June 2009 - September 2009
Genmab January 2009 - April 2009
Boston Scientific June 2008 - September 2008
Illumina March 2007 - March 2008
Skills
Validation, Medical Devices, 21 CFR Part 11, ISO 13485, SDLC, Computer System..., Quality Assurance, CAPA, FDA, Requirements Analysis, Software Quality..., Quality System, IEC 62304, Quality Systems, Change Control, GAMP, Automation, GxP, GMP, GLP, ISO 14971, Design Control, QSR, Software Validation, Life Sciences, Agile, JD Edwards, Agile Methodologies, FMEA, Testing, Process Improvement, Software Documentation, ISO, Cross-functional Team..., Quality Control, V&V, 21 CFR, Manufacturing, Regulatory Requirements, LIMS, Design of Experiments, Process Simulation, Root Cause Analysis, Quality Auditing, SPC, R&D, Quality Management, DMAIC, Biomedical Engineering, Project Management
Education
University of Phoenix 1999 — 2002
B.S.
Campbell University 1997 — 1998
Associates Degree
Excel Engineering June 2012 - Present
Rockwell Automation June 2011 - June 2012
Excel Engineering February 2010 - June 2011
Genmab March 2008 - January 2010
PDL BioPharma INC February 2006 - March 2008
Praxair, INC July 2000 - February 2006
Skills
ControlLogix, Process Control, DeltaV, Control Logic, WebDAV, Automation, PLC, Instrumentation, Process Improvement, Control Systems Design, Manufacturing, Engineering, Commissioning, Project Engineering
Education
Clarkson University 1996 — 2000
BS, Chemical Engineering
Concord High School 1992 — 1996
Urologix April 2013 - Present
Doterra Essential Oils April 2012 - Present
Urologix July 2011 - April 2013
Greatbatch Medical August 2010 - July 2011
Genmab March 2008 - November 2009
PDL BioPharma 1999 - March 2008
Merlin Development July 1999 - August 1999
Hennepin County June 1995 - August 1997
Skills
LIMS, cGMP, ISO, Document Management, SAP, GMP, CAPA, Biotechnology, Change Control, Cell Culture, Cross-functional Team..., Deviations, Environmental Monitoring, FDA, ISO 13485, Laboratory, Quality System, Quality Assurance, Software Documentation, Sop, Troubleshooting, V, USP, Validation, Training, Technical Writing, Quality Control, Quality Auditing, Process Improvement, Pharmaceutical Industry, Microbiology, Gas Chromatography
Education
Minneapolis Community and Technical College 2011 — 2011
Certificate, NA/HHA
St. Cloud State University 1995 — 1999
Bachelor of Science, Biotechnology/Microbiology
Blueprint Medicines January 2014 - Present
sanofi-aventis May 2011 - January 2014
TenX Biopharma Inc April 2010 - December 2010
Genmab October 2008 - March 2010
Genmab July 2008 - October 2008
Novartis - Oncology Group September 2007 - July 2008
GE Healthcare April 2005 - September 2007
GE Healthcare August 2000 - April 2005
Case Western Reserve University October 1993 - July 2000
Skills
Biotechnology, Clinical Development, Clinical Trials, Oncology, Pharmaceutical Industry, Clinical Research, Virology, Regulatory Affairs, Drug Discovery, Infectious Diseases, Drug Development, Cancer, EDC, Molecular Biology, Lifesciences, Cell Biology, Vaccines, Immunology, CTMS, ICH-GCP, CRO, Clinical Operations, Biochemistry, Cell Culture, Regulatory Submissions, GCP, Medical Writing, Technology Transfer, In Vitro, ELISA, Pharmacology, Hematology, Pharmacovigilance, Neurology, Biopharmaceuticals, Monoclonal Antibodies, FDA, Clinical Monitoring, Therapeutic Areas, IND, Biomarkers, Medical Affairs, Hardware Diagnostics, Life Sciences
Education
Harvard Business School 2009 — 2009
Leadership & Strategy Training, Executive Education in Leadership & Strategy in Pharma and Biotech
Weatherhead School of Management at Case Western Reserve University 1997 — 2000
MBA, Finance & Health
University of Surrey 1988 — 1991
Ph.D., Molecular Biology
University of Pune 1980 — 1987
M. Phil., M. Sc. & B. Sc., Molecular Biology, Microbial Genetics, Microbiology
Genmab June 2009 - January 2010
BTM Global Consulting January 2009 - June 2009
Eisai June 2007 - December 2008
MGI PHARMA 2007 - December 2008
Target October 2005 - June 2007
Express Scripts 2002 - 2005
Select Comfort 2001 - 2002
RZ Solutions 1999 - 2002
Education
Gustavus Adolphus College 1990 — 1994
BA, Biology
Woodbury High School 1987 — 1990
Genmab March 2008 - Present
PDL 2004 - 2007
Education
St. Cloud State University 1994 — 1998
Cardiovascular Systems, Inc. February 2015 - Present
Cardiovascular Systems, Inc. October 2013 - February 2015
Cardiovascular Systems Inc. June 2011 - October 2013
3M/Arizant Healthcare December 2009 - June 2011
Genmab October 2007 - November 2009
PDL Biopharma April 2006 - October 2007
PDL Biopharma May 2004 - April 2006
Aventis Behring October 2001 - May 2004
Aventis Behring May 1999 - October 2001
Skills
FDA, CAPA, Validation, GMP, 21 CFR Part 11, Sop, ISO 13485, LIMS, Quality System, V&V, Change Control, Biotechnology, Computer System..., GxP, GLP
Education
Bradley University
Bachelors of Science
Lifecore Biomedical January 2010 - Present
North Hennepin Community College November 2007 - May 2010
Genmab March 2008 - January 2010
PDL BioPharma, Inc July 2002 - March 2008
Amgen July 1999 - July 2002
Skills
GMP, CAPA, Validation, FDA, Quality System, Sop, Aseptic Technique, 21 CFR Part 11, Biotechnology, Microbiology, Regulatory Affairs, Quality Auditing, Purification, Quality Control, Cell Culture, ISO 13485, Product Development, Biopharmaceuticals, Quality Assurance, Regulatory Submissions, Manufacturing, Software Documentation, Medical Devices, Technology Transfer, Training, V&V, HPLC, LIMS, SOP, Design Control, Change Control, GLP, Process Simulation
Education
California Polytechnic State University-San Luis Obispo 1994 — 1999
BS, Major: Microbiology; Concentration in Public Health
Rahr Malting Co May 2015 - Present
SUPERVALU June 2013 - October 2014
CSM BSNA January 2010 - June 2013
Genmab February 1999 - November 2009
PDL BioPharma 1999 - 2008
Land O Lakes March 1998 - January 1999
Stroh Brewery November 1994 - November 1997
Skills
Software Documentation, GMP, Management, LIMS, Sop, HPLC, Quality Control, Quality Assurance, GLP, CAPA, Trackwise, Auditing, FDA, Quality System, Biotechnology, Analysis, V&V, SAP, Validation, Testing, Process Improvement, Quality Auditing, Pharmaceutical Industry, Lifesciences, Change Control, Microbiology, 21 CFR Part 11, GxP, Computer System..., Analytical Chemistry, Biopharmaceuticals, FDA GMP, Aseptic Processing, Chemistry, Technology Transfer, Aseptic Technique, ISO, Chromatography, Quality Management, SOP
Education
Michigan State University 2011 — 2014
MS, Food Safety
University of Wisconsin-Eau Claire 1990 — 1994
Bachelor of Science (BS), Biology
Lifecore Biomedical October 2011 - Present
3M March 2010 - December 2011
Genmab 2009 - 2009
Genmab 2007 - 2009
PDL BioPharma November 2005 - October 2007
American Red Cross St. Paul National Testing Center 2000 - 2005
Skills
SOP, LIMS, Technical Writing, cGMP, Autoclave, Document Management, USP, GMP, CAPA, Microbiology, Validation, Sop, Change Control, V&V, Quality Control, FDA
Education
St. John's University 1996 — 2000
Bachelor of Arts, Biology
Lutonix Inc May 2010 - Present
Lutonix, Inc November 2012 - March 2014
Lutonix, Inc May 2010 - November 2012
Genmab March 2008 - November 2009
PDL Biopharma January 2004 - March 2008
Birch Point Medical (Travanti Pharma) January 2000 - January 2004
3M Drug Delivery Systems June 1997 - January 2000
ALZA Corporation 1991 - 1997
Skills
Validation, 21 CFR, Medical Devices, GMP, CAPA, Sop, Quality System, Quality Control, Supplier Quality, ISO 13485, ISO
Education
University of Minnesota-Twin Cities 1986 — 1988
B.S., Chemistry
UW-River Falls 1984 — 1986
Baxalta July 2015 - Present
Baxter March 2014 - June 2015
Baxter Healthcare April 2013 - March 2014
Genmab January 2009 - March 2013
Genmab March 2008 - December 2008
PDL BioPharma Inc. November 2003 - March 2008
R & D Systems July 1999 - November 2003
Skills
Validation, Analytical Chemistry, Purification, Quality Control, Chemistry, Assay Development, GMP, LIMS, Sop, FDA, CAPA, GLP, Biotechnology, 21 CFR Part 11, HPLC, Biopharmaceuticals, Quality System, Chromatography, Technology Transfer, Pharmaceutical Industry
Education
St. Cloud State University 1995 — 1999
Bachelor of Science, Biotechnology & Ecology
Mesabi Community College 1993 — 1995
Associate of Arts, Science
Genmab March 2008 - Present
Skills
LIMS, cGMP, GLP, ELISA, GMP, Validation, Quality Systems, Western Blotting, Cell Culture, FDA, Aseptic Technique, SAP, SDS-PAGE, HPLC, SOP, Chromatography, Cell Based Assays, Word, Outlook, Biotechnology, Pharmaceuticals, PowerPoint, Excel, PCR, Technology Transfer, Quality Assurance, Microsoft Office, Documentation, Troubleshooting, Process Improvement, Supervisory Skills, Windows, Writing, Research, UV-Vis, Statistics, Compliance
Education
University of Minnesota-Twin Cities 1991 — 1995
Osprey Medical July 2015 - Present
Zimmer Spine August 2014 - July 2015
Target August 2012 - July 2014
Target July 2010 - July 2012
Biotest Laboratories, Inc. November 2009 - July 2010
Genmab February 2005 - November 2009
Wyeth Pharmaceuticals August 2003 - July 2004
Wyeth Pharmaceuticals March 2002 - August 2003
Skills
GMP, Validation, Protocol, Process Engineering, Engineering, Functional Requirements, Data Management, Visio, Batch Processing, Packaging, Shipping, Control Logic, IQ, FDA, CAPA, LIMS, Sop, V&V, Quality System, Biotechnology, Computer System..., Cross-functional Team..., Quality Assurance, SOP, Quality Control, ISO 13485, Change Control, Manufacturing, Software Documentation, 21 CFR Part 11, Trackwise, Quality Auditing, Testing, Process Simulation, ISO, GAMP, PLC, Medical Devices
Education
Drexel University 2002 — 2006
M.B.A
University of Wisconsin-Madison 1997 — 2001
B.S, Chemical Engineering
Takeda Pharmaceuticals September 2014 - Present
Hospira September 2013 - September 2014
Merck Bioventures Boulder January 2011 - September 2012
United Therapeutics November 2009 - February 2011
Genmab September 2008 - November 2009
JM Hyde Consulting October 2006 - August 2008
Protein Design Labs, Inc November 2003 - October 2006
Baxter International/Baxter Hemoglobin Therapeutics 2000 - 2003
Biological Process Development Facilty-Univ. of NE-Lincoln May 1998 - August 2000
NAPA 1990 - 1993
Skills
Biotechnology, Validation, GMP, Sop, CAPA, FDA, Pharmaceutical Industry, Change Control, Quality System, V&V, Technology Transfer, Manufacturing
Education
University of Nebraska-Lincoln 1995 — 1999
Bachelor of Science (B.S.), Chemical Engineering
University of Nebraska at Omaha 1991 — 1994
Pre-Chemical Engineering
Daniel J Gross 1987 — 1991
College Prep
Biovest International March 2011 - Present
DiaSorin February 2010 - March 2011
Genmab January 2009 - November 2009
Genmab March 2008 - January 2009
PDL BioPharma August 2007 - March 2008
PDL BioPharma February 2005 - August 2007
Remel August 2001 - February 2005
Remel December 1999 - August 2001
Remel August 1998 - December 1999
Remel March 1998 - August 1998
Education
St. Cloud State University 1991 — 1995
BS, Biotechnology
Upsher-Smith Laboratories July 2011 - Present
Atterro Human Capital Group February 2010 - July 2011
Genmab October 2004 - November 2009
GeoComm 2003 - October 2004
PrimeVest Financial Services 2000 - 2002
Skills
VMware, Microsoft Exchange, Cisco Technologies, Active Directory, VMware Infrastructure, DHCP, DNS, vSphere, Cluster, Storage Area Networks, TCP/IP, IIS, Troubleshooting, Network Administration
Education
St. Cloud State University 1997 — 2002
Bachelor of Science (BS), Business Computer Information Systems
Perrigo January 2012 - Present
Beckman Coulter December 2009 - June 2011
Genmab March 2008 - January 2010
PDL Biopharma September 2001 - 2008
Quest Diagnostics June 1998 - June 2001
Skills
Pharmaceutical Industry, Biotechnology, FDA, GMP, Deviations, CAPA, Sop, Change Control, Validation, Cell Culture, Chromatography, HPLC, SAP, Trackwise, LIMS, 21 CFR Part 11
Education
College of Saint Benedict 1996 — 2000
BA, Biology, Chemistry
Saint John's University 1996 — 2000
BA, Biology, Chemistry
Phillips Medical November 2009 - Present
Genmab January 2002 - October 2009
Boston Scientific March 2000 - January 2002
ALZA Corporation May 1992 - March 2000
ALZA Corporation, a Johnson & Johnson Company 1992 - 2000
Skills
Validation, Quality System, Change Control, GMP, Biopharmaceuticals, CAPA, HPLC, Medical Devices, Training, FDA, ISO 13485
Education
University of Minnesota-Twin Cities 1993 — 1998
MEd, Science Ed--Curriculum and Instruction
St. Catherine University 1988 — 1992
3M October 2009 - Present
Pace Analytical October 2009 - July 2012
Lifecore Biomedical June 2008 - October 2009
Genmab 2005 - January 2008
Skills
FDA, GMP, Laboratory, Validation, Quality System, CAPA, ISO 13485, Sop, V&V, Medical Devices, Aseptic Processing, Quality Assurance, Quality Control, Biotechnology, Manufacturing, Design Control, HPLC, Chromatography, GLP, Change Control, Analytical Chemistry, 21 CFR Part 11
Education
University of Minnesota-Duluth 1999 — 2005
Bachelor of Science (B.S.), Cellular and Molecular Biology
De La Salle
Cambrex April 2015 - Present
Cambrex September 2012 - April 2015
Cambrex May 2010 - September 2012
Amerilab Technologies February 2010 - April 2010
Genmab March 2008 - January 2010
PDL BioPharma March 2004 - March 2008
Abbott Diagnostics 2000 - 2004
Education
North Central College 1996 — 2000
Bachelor of Arts (BA), Biology, General
Canton High School 1992 — 1996
American College of Radiology Clinical Research Center December 2008 - Present
Nucleonics, Inc. February 2007 - April 2008
Actelion December 2005 - January 2007
PharmaNet May 2005 - December 2005
Genmab September 2002 - January 2005
J&J PRD August 1992 - September 2002
J&J PRD 1992 - 2002
Skills
Oncology, Clinical Trials, Infectious Diseases, Clinical Research, Protocol, Cardiology, CRO, CTMS, Pharmaceutical Industry, Lifesciences, Sop, Biotechnology, Chemistry, GLP, Validation, GCP, Therapeutic Areas, Regulatory Affairs, Technology Transfer, Life Sciences
Education
Rutgers University-New Brunswick 1987 — 1992
BA, Africana Studies/Biology
Cardiovascular Systems Inc October 2011 - Present
Arizant Healthcare April 2010 - February 2011
Aerotek December 2009 - July 2010
Genmab 2007 - March 2010
PDL BioPharma 2006 - 2007
Education
South Dakota State University 1994 — 1999
BS, Microbiology
Genmab July 2012 - Present
Genmab, Inc. July 2011 - July 2012
Genmab, Inc. 2005 - 2011
Genmab, Inc. 2001 - 2005
Gemini Genomics plc 2001 - 2001
Gemini Genomics plc 2000 - 2000
Gemini Genomics plc 1999 - 1999
Gemini Genomics plc 1998 - 1999
Gemini Genomics September 1996 - September 1998
Imperial Cancer Research Fund, UK 1996 - 1996
Skills
SQL, Licensing, Valuation, Negotiation, Biotechnology, Bioinformatics, Deal Structuring, Alliance Management, Strategic Alliances
Education
The Open University 1993 — 2001
PhD, Human Genetics
University of York 1985 — 1986
M.Sc., Biology, Computer Science
Bath Spa University 1981 — 1985
B.Sc. (First Class Honours), Applied Biology
Genmab May 2010 - Present
Genmab January 2008 - April 2010
Genmab June 2006 - January 2008
Genmab August 2005 - June 2006
Manhattan Production Music 2000 - 2005
Skills
System Administration, Clinical Trials, Regulatory Submissions, Clinical Development, Biotechnology, Editing, Management, Pharmaceutical Industry, Microsoft Excel, Press Releases, Leadership, Market Research, Oncology, Team Building
Education
Penn State University 1997 — 2000
BA, Anthropology
Bellerophon Therapeutics April 2015 - Present
Grünenthal January 2012 - January 2013
Grünenthal December 2008 - January 2012
Genmab September 2007 - October 2008
Pharmanet, Inc. 2004 - 2007
Taiho Pharma, Inc. 2002 - 2004
Bracco Diagnostics 1999 - 2003
Skills
Clinical Trials, CTMS, GCP, Clinical Research, Clinical Development, EDC, ICH-GCP, CRO, Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry, Pharmacovigilance, Oncology, Sop, Clinical Data Management, Clinical Monitoring
Education
Thomas Edison State College 2011 — 2012
Bachelors' of Arts, Psychology
Mercer County Community College
Forest Laboratories 2009 - Present
Novo Nordisk 2007 - July 2009
Novo Nordisk 2007 - 2009
Schering Plough Research Institute 2005 - 2007
Nabi Biopharmaceuticals June 2005 - December 2005
Omnicare Clinical Research, Inc. January 1999 - January 2005
Alteon Inc. 2004 - 2005
Elan Pharmaceuticals, Inc. 2004 - 2005
Ortec International, Inc. 2000 - 2003
GenMab June 2002 - December 2002
Education
University of North Carolina at Chapel Hill 1985 — 1989
BSN, Nursing
Genmab April 2008 - Present
MakeMusic July 2002 - February 2008
Education
Minnesota School of Business
ACT Oncology, LLC February 2011 - Present
TenX Biopharma, Inc April 2010 - January 2011
Genmab September 2005 - March 2010
ORION Clinical Services 2004 - 2005
PTC Therapeutics 2001 - 2004
Skills
Clinical Research..., Clinical Development, GCP, CTMS, CRO, Clinical Trials
Education
University of Maryland College Park 1997 — 2001
Bachelor of Science, Biology
Covidien May 2013 - Present
3M Office Supply February 2013 - May 2013
3M Infection Prevention Div. Patient Warming (Arizant) October 2010 - May 2012
Arizant Healthcare September 2009 - October 2010
Genmab 2007 - 2008
PDL BioPharma 2007 - 2008
CIMA Labs 2000 - 2007
Minnesota Valley Testing Laboratories June 1999 - August 1999
Minnesota Valley Testing Laboratories June 1998 - August 1998
Skills
Experienced in hosting..., Experienced in FDA NDA..., Experienced in..., FDA, Pharmaceutical Industry, Chemistry, GMP, Validation, Sop, CAPA, LIMS, GLP, HPLC, Software Documentation, Quality Assurance, V&V, Analytical Chemistry, Gas Chromatography, Quality System, Quality Control, Change Control, Reading X-ray cines, Reading Sonograms, ISO 13485, Regulatory Affairs, Medical Devices
Education
Bemidji State University
Bachelor Science Secondary Education, Mathematics
Bemidji State University
Bachelor of Science, Chemistry
Bemidji State University
Bachelor Science Secondary Education, Physical Science
Novo Nordisk Inc. January 2010 - Present
Teva Pharmaceuticals November 2008 - December 2009
Genmab June 2008 - October 2008
McCarty Clinical Research, LLC May 2007 - May 2008
Education
Saint Joseph's University - Erivan K. Haub School of Business 2003 — 2007
BS in Business Administration, Business Management
Novo Nordisk Inc. September 2013 - Present
Liquent February 2011 - September 2013
Ono Pharma USA April 2010 - January 2011
Genmab November 2007 - April 2010
Skills
Regulatory Submissions, eCTD, Regulatory Operations, IND, Electronic Document..., NDA, BLA, Document Management, Regulatory Requirements, EDRMS, Sop, Validation, Drug Development, Regulatory Affairs, SOP
Education
New York University 1998 — 2000
MA, Food Management
Taipei Medical University 1993 — 1996
BS, Nutrition and Health
Schutz Container Systems, Inc. March 2013 - Present
Alliance Life Sciences Consulting Group, Inc May 2011 - February 2013
Genmab, Inc. July 2007 - October 2010
Genmab May 2005 - July 2007
Skills
Analysis, Analytics, Biotechnology, Business Analysis, Business Development, Pharmaceutical Industry, Sales Operations, Process Improvement, Cross-functional Team..., Vendor Management, Business Intelligence
Education
Kean University
Business Administration and Management, General
Raritan Valley Community College
A.S, Business Administration, Business
Cambrex May 2010 - Present
Genmab November 1999 - January 2010
Genmab MN (Formerly PDL BioPharma Inc.), 2003 - 2008
PDL BioPharma 1999 - 2003
Medtronic 1996 - 1999
Skills
Quality System, GMP, Sop, V&V, 21 CFR Part 11, Validation, Purification, Software Documentation, Computer System..., Manufacturing, ISO 13485, CAPA, Technology Transfer, Protein Purification, Biopharmaceuticals, FDA, Commissioning, Medical Devices, Quality Assurance, Change Control, Protein Chemistry, Cross-functional Team..., Testing, Monoclonal Antibodies, Formulation, Biotechnology
Education
University of Alaska Fairbanks 1992 — 1996
BS, Biological Science
Emergent BioSolutions May 2013 - Present
Perrigo May 2011 - Present
Paddock Laboratories December 2009 - May 2011
Genmab May 2009 - October 2009
Upsher-Smith Laboratories July 2007 - April 2009
Skills
HPLC, LIMS, Chromatography, GLP, Analytical Chemistry, GMP, Sop, Validation, Pharmaceutical Industry, Technology Transfer, FDA, Formulation, UV/Vis, Chemistry, Medicinal Chemistry, Biotechnology, Drug Discovery, UV, 21 CFR Part 11, Research Development, Dissolution, UPLC, Method Development
Education
University of Minnesota-Twin Cities 2003 — 2007
BA, Chemistry
R&D Systems April 2012 - Present
R&D Systems March 2010 - April 2012
Genmab October 2009 - April 2010
R&D Systems, Inc. September 2000 - August 2008
University of Minnesota July 1991 - August 2000
Skills
Cell Culture, PCR, ELISA, Protein Purification, Biotechnology, Lifesciences, Western Blotting, Antibodies, Immunology, Life Sciences, Protein Chemistry
Education
University of Minnesota-Twin Cities 1988 — 1991
Bachelor's of Science, Microbiology
South Dakota State University 1981 — 1983
Microbiology
Dream For a Cure Research Foundation March 2009 - Present
Genmab January 2009 - January 2010
College Nannies & Tutors 2007 - 2008
Education
University of Minnesota Medical School 2005 — 2009
PhD, Pharmacology
University of St. Thomas 2001 — 2005
B.S., Biochemistry
Boston Scientific November 2014 - Present
Boston Scientific February 2011 - November 2014
Beckman Coulter June 2010 - February 2011
DiaSorin February 2010 - June 2010
Genmab 2008 - 2010
PDL BioPharma 2005 - 2008
R&D Systems 2001 - 2005
Alexon-Trend 1999 - 2001
Skills
ELISA, GLP, Biotechnology, Sop, Validation, Chromatography, Cell Culture, Quality Assurance, LIMS, GMP, Outlook, Assay Development, SAP, Microbiology, Cell, Quality System, Immunoassays
Education
St. Cloud State University 1994 — 1998
Bachelor of Science, Bio-Medical Science, Community Health
MD Anderson Cancer Center May 2013 - Present
University of Texas at Arlington August 2010 - December 2012
Genmab June 2008 - August 2008
R&D Systems June 2007 - August 2007
Skills
Research, Microsoft Office, Matlab, HTML, Java, Photoshop
Education
University of Texas at Arlington / UT Southwestern Medical Center at Dallas 2010 — 2012
Master's degree, Biomedical Engineering
Minnesota State University, Mankato 2005 — 2009
Bachelor of Science (B.S.), Biotechnology & Biochemistry
3M Health Care June 2015 - Present
3M Health Care May 2014 - June 2015
3M Health Care February 2010 - May 2014
Genmab March 2008 - March 2010
Protein Design Labs October 2006 - March 2008
Skills
GMP, Manufacturing, Microsoft Office, Word, SAP, Excel, Chromatography, Documentation, Technical Writing, Troubleshooting, Document Management, Change Management, LIMS, cGMP, Writing, Process Improvement, Biotechnology, Computer-Aided Drafting, Equipment Validation, Manufacturing Scale-up, Sop, Purification, Filtration, Formulation, Change Control, Monoclonal Antibodies, Pharmaceutical Industry, GxP, Biopharmaceuticals, Training, Aseptic Technique, Protocol, Protein Purification, Deviations
Education
St. Cloud State University 2000 — 2005
B.A., Creative Writing
J.J. Taylor Companies, Inc. December 2012 - Present
Chisago Lakes Distributing June 2011 - December 2012
Chisago Lakes Distributing November 2010 - July 2011
Lifecore Biomedical January 2010 - January 2011
Genmab 2005 - 2009
PDL BioPharma 2005 - 2007
Skills
Sop, GMP, FDA, Validation, Sales, Technical Writing
Education
Concordia University-St. Paul
BA, AA, History
Perrigo February 2011 - Present
Paddock Laboratories February 2011 - April 2012
Minnesota Air National Guard January 2010 - February 2011
Genmab August 2004 - November 2009
Genmab MN, Inc. 2004 - 2009
PDL BioPharma Inc 2004 - 2008
Unisys June 2001 - August 2004
Education
Hennepin Technical College 2001 — 2003
A.A.S., HVAC
Anoka Technical College 1999 — 2001
Diploma, Building Utilities Technician
MGC Diagnostics October 2014 - Present
Bosch Packaging Technology, Inc. August 2013 - Present
Heraeus Medical Components October 2012 - June 2013
Colder Products Company June 2011 - October 2012
Genmab 2005 - 2010
Syngenta Seeds 2002 - 2005
Coca-Cola Enterprises 1995 - 2002
Skills
Accounting, SAP, Forecasting, Variance Analysis, Cross-functional Team..., Budgets, Finance, Inventory Analysis
Education
University of Minnesota - Carlson School of Management 1983 — 1988
BS, Accounting
Taiho Oncology, Inc. July 2013 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company January 2009 - July 2013
Genmab June 2006 - October 2008
Skills
Clinical Trial..., GCP, Oncology, Clinical Trials, Clinical Research, EDC, Clinical Monitoring, SOP, CRO, ICH-GCP, FDA, Clinical Data Management, Pharmacovigilance, Regulatory Submissions, Clinical, 21 CFR Part 11, Documentation, Line Management, Compliance, CTMS, Sop, Drug Development, Biopharmaceuticals, Clinical Research..., Software Documentation, Therapeutic Areas, Protocol
Education
University of New Hampshire
Bachelor of Arts (B.A.)
Genmab May 2008 - Present
Genmab June 2010 - April 2013
PricewaterhouseCoopers September 2002 - May 2008
Skills
IFRS, Auditing, Financial Reporting, Accounting, Financial Accounting, Sarbanes-Oxley Act, Big 4, SEC filings, Biotechnology, Revenue Recognition, Internal Controls, Financial Analysis, Managerial Finance, US GAAP, Pharmaceutical Industry
Education
Fairleigh Dickinson University
M.S., Accounting & Finance
Cargill May 2010 - Present
Genmab March 2008 - January 2010
Genmab March 2008 - January 2010
PDL BioPharma, Inc September 2003 - March 2008
Skills
SAP, Outlook, Benefits Administration, Employee Benefits, Human Resources, Team Building, Process Improvement, Quality Assurance, Customer Service, Recruiting, HRIS, Onboarding, Payroll, New Hire Orientations, Talent Management, Management, Applicant Tracking..., Interviews, Access, Training, Employee Relations, Performance Management, Change Management, Hiring, Software Documentation, FMLA, Organizational..., Deferred Compensation, Employee Engagement, ADP Payroll, PeopleSoft, Administration, Job Descriptions, SAP HR, Temporary Placement, Employee Training, Talent Acquisition, Succession Planning, Organizational..., Open Enrollment
Education
Hennepin Technical College
North Hennepin Community College
St. Paul Technical College
Genmab ReceptionistGenmabJune 2007 - Present
Education
Middlesex County College
Genmab April 2008 - November 2009
MakeMusic July 2006 - February 2008
MakeMusic July 2002 - July 2006
MakeMusic, Inc July 2002 - July 2003
Education
Minnesota School of Business
Associate, Applied Science; Management Accounting
Medical Component Division of Heraeus November 2010 - Present
Arizant Healthcare December 2009 - January 2011
Genmab May 2008 - December 2009
Boston Scientific October 2006 - May 2008
CIMA Labs July 2000 - September 2006
Skills
Auditing, CAPA, Quality System, Supplier Quality, Quality Management, Management, Risk Management, ISO 13485, FDA, Medical Devices, V&V, GMP, Validation, Regulatory Affairs, LIMS, Six Sigma, Quality Assurance
Education
University of Saint Thomas 2001 — 2002
MIni Master, Quality Management & Auditing
St. Olaf College 1987 — 1992
BA, Biology Minor Chemistry
Baxter Healthcare April 2013 - Present
Genmab November 2006 - Present
Medtronic January 1995 - November 2006
Rosemount Aerospace March 1988 - December 1994
Education
Hutchinson Technical Institute (now Ridgewater College) 1986 — 1988
Diploma, Metrology Technology
University of Minnesota-Twin Cities 1984 — 1986
None, Pre-Engineering General Studies