Cima Labs
Industry: Biotechnology company
DescriptionHeadquarters: Eden Prairie, MN Founded: 1986 Parent organization: Cephalon, Inc.
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Cima Labs Employees
Employee
Years
Job
Industry
Lou A Cyr Lou A Cyr's Cima Labs Experience 2000 - 2011
Job Machine Operator at Lanz Cabinets
Industry Industrial Automation
Experience
Production / Assembly / Warehouse / Packaging / Machine Operation December 2014 - September 2015
Kelly Services, Labor Ready, Staffing Partners, Personnel Source December 2014 - September 2015
The Right Staff July 2014 - October 2014
CIMA Labs 2000 - 2011
Circuit Check Inc. 1997 - 1999
Temporary Agencies September 1996 - August 1997
Tiro Industries July 1993 - August 1996
Viking Identification Products October 1991 - August 1993
Northern Pipe Products February 1987 - October 1991
Skills
FDA GMP, Pharmaceutical Industry, Change Control, Troubleshooting, Packaging, Process Simulation, Process Improvement, Quality Control, Quality Auditing, SOP development, Chemical Processing, Tablet Compression, Production Support, Blender, Pressure Sensitive..., Mixer, Assembler, 21 CFR Part 11, Trackwise, cGMP manufacturing, R&D, HPLC, Chromatography, SAP, Cross-functional Team..., GLP, 5S, Machine setup, Chemical Compounder, Forklift Operator, Forklift Operation, FDA, GMP
Education
North Dakota State University 1980 — 1991
almost a BA, History & Religious Studies
Grafton Central High School 1973 — 1977
High School, History, Physical Education, Carpentry
Production / Assembly / Warehouse / Packaging / Machine Operation December 2014 - September 2015
Kelly Services, Labor Ready, Staffing Partners, Personnel Source December 2014 - September 2015
The Right Staff July 2014 - October 2014
CIMA Labs 2000 - 2011
Circuit Check Inc. 1997 - 1999
Temporary Agencies September 1996 - August 1997
Tiro Industries July 1993 - August 1996
Viking Identification Products October 1991 - August 1993
Northern Pipe Products February 1987 - October 1991
Skills
FDA GMP, Pharmaceutical Industry, Change Control, Troubleshooting, Packaging, Process Simulation, Process Improvement, Quality Control, Quality Auditing, SOP development, Chemical Processing, Tablet Compression, Production Support, Blender, Pressure Sensitive..., Mixer, Assembler, 21 CFR Part 11, Trackwise, cGMP manufacturing, R&D, HPLC, Chromatography, SAP, Cross-functional Team..., GLP, 5S, Machine setup, Chemical Compounder, Forklift Operator, Forklift Operation, FDA, GMP
Education
North Dakota State University 1980 — 1991
almost a BA, History & Religious Studies
Grafton Central High School 1973 — 1977
High School, History, Physical Education, Carpentry
Adam Dahlke Adam Dahlke's Cima Labs Experience March 2004 - November 2004
Job MEM, CQE, Six Sigma Black Belt
Industry Pharmaceuticals
Experience
Boston Scientific November 2004 - November 2012
CIMA Labs March 2004 - November 2004
Boston Scientific October 2003 - March 2004
Upsher-Smith Laboratories November 1999 - March 2003
Skills
Employee Loyalty, FDA, Validation, GMP, Laboratory Skills, ISO 13485, Quality System, Vendor Relationships, Chromatography, V&V, Technical Reports, Researching New..., Inventory Management, Strongly self-motivated, LIMS, Lean Operations, CAPA, Public Speaking, Technical Writing, High Quality Standards, Chemistry, Dedicated Professional, Team Building, Technical Data Analysis, 21 CFR Part 11, Dedication to..., GLP, Troubleshooting, Technical Leadership, Supervising, Equipment Qualification, CQE, Time Management, HPLC, Lean Tools, Medical Devices, Integrity, ASQ, Hands-on Training, Goal Oriented, Analytical Chemistry, Document Review, Quality Control, Problem Solving, Laboratory Automation, DMAIC, cGMP manufacturing, Sop, Quality Auditing, Design of Experiments
Education
St. Cloud State University 2012 — 2014
Masters Engineering Management (MEM), Engineering/Industrial Management
St. Cloud State University 1994 — 1999
BS, Chemistry
Boston Scientific November 2004 - November 2012
CIMA Labs March 2004 - November 2004
Boston Scientific October 2003 - March 2004
Upsher-Smith Laboratories November 1999 - March 2003
Skills
Employee Loyalty, FDA, Validation, GMP, Laboratory Skills, ISO 13485, Quality System, Vendor Relationships, Chromatography, V&V, Technical Reports, Researching New..., Inventory Management, Strongly self-motivated, LIMS, Lean Operations, CAPA, Public Speaking, Technical Writing, High Quality Standards, Chemistry, Dedicated Professional, Team Building, Technical Data Analysis, 21 CFR Part 11, Dedication to..., GLP, Troubleshooting, Technical Leadership, Supervising, Equipment Qualification, CQE, Time Management, HPLC, Lean Tools, Medical Devices, Integrity, ASQ, Hands-on Training, Goal Oriented, Analytical Chemistry, Document Review, Quality Control, Problem Solving, Laboratory Automation, DMAIC, cGMP manufacturing, Sop, Quality Auditing, Design of Experiments
Education
St. Cloud State University 2012 — 2014
Masters Engineering Management (MEM), Engineering/Industrial Management
St. Cloud State University 1994 — 1999
BS, Chemistry
Bobbi Jo Sellnow Bobbi Jo Sellnow's Cima Labs Experience July 2008 - September 2011
Job Trizact Manufacturing Supervisor at 3M
Industry Pharmaceuticals
Experience
3M September 2013 - Present
3M September 2011 - Present
CIMA Labs July 2008 - September 2011
CIMA Labs June 2006 - July 2008
University of Minnesota September 2002 - May 2004
Skills
Validation, FDA, Formulation, Analytical Chemistry, GMP, Manufacturing, Troubleshooting, CAPA, Drug Delivery
Education
University of Minnesota Duluth 2000 — 2004
Bachelor of Science, Biochemistry/Chemistry
University of Minnesota
Bachelor of Degrees, Biochemistry and Chemistry
3M September 2013 - Present
3M September 2011 - Present
CIMA Labs July 2008 - September 2011
CIMA Labs June 2006 - July 2008
University of Minnesota September 2002 - May 2004
Skills
Validation, FDA, Formulation, Analytical Chemistry, GMP, Manufacturing, Troubleshooting, CAPA, Drug Delivery
Education
University of Minnesota Duluth 2000 — 2004
Bachelor of Science, Biochemistry/Chemistry
University of Minnesota
Bachelor of Degrees, Biochemistry and Chemistry
Erica Mauter Erica Mauter's Cima Labs Experience October 2003 - June 2012
Job Arts Administrator | STEMinist | O.G. Blogger
Industry Nonprofit Organization Management
Experience
Twin Cities Women's Choir July 2014 - Present
swirlspice.com September 2002 - Present
Twin Cities Women's Choir July 2013 - June 2014
CIMA Labs October 2003 - June 2012
Twin Cities Women's Choir September 2006 - May 2012
The Creative Connection Event September 2011 - September 2011
SXSW March 2011 - March 2011
Minnesota Blogger Conference September 2010 - September 2010
Minneapolis Metblog April 2005 - October 2008
New Demographic April 2007 - April 2008
Skills
Technical Writing, Process Validation, Cleaning Validation, Blogging, Social Media, Board Leadership, GMP, Equipment Qualification, Singing, Leadership, Cross-functional Team..., FDA, Wordpress, Quality Assurance, Public Speaking, Pharmaceutical Industry, Content Strategy, Change Control, Newsletters, V&V, WordPress, CAPA, Validation, Sop, Technology Transfer, Quality System, R&D, Manufacturing, Training, Strategy, Management, Nonprofits, Writing
Education
St. Catherine University MAOL Program 2012 — 2014
Master of Arts (MA), Organizational Leadership
University of Minnesota-Twin Cities 2011 — 2011
Certificate, Successful Manager's Leadership Program
University of Michigan 1995 — 1999
BSE, Chemical Engineering
Shrine High School 1991 — 1995
Twin Cities Women's Choir July 2014 - Present
swirlspice.com September 2002 - Present
Twin Cities Women's Choir July 2013 - June 2014
CIMA Labs October 2003 - June 2012
Twin Cities Women's Choir September 2006 - May 2012
The Creative Connection Event September 2011 - September 2011
SXSW March 2011 - March 2011
Minnesota Blogger Conference September 2010 - September 2010
Minneapolis Metblog April 2005 - October 2008
New Demographic April 2007 - April 2008
Skills
Technical Writing, Process Validation, Cleaning Validation, Blogging, Social Media, Board Leadership, GMP, Equipment Qualification, Singing, Leadership, Cross-functional Team..., FDA, Wordpress, Quality Assurance, Public Speaking, Pharmaceutical Industry, Content Strategy, Change Control, Newsletters, V&V, WordPress, CAPA, Validation, Sop, Technology Transfer, Quality System, R&D, Manufacturing, Training, Strategy, Management, Nonprofits, Writing
Education
St. Catherine University MAOL Program 2012 — 2014
Master of Arts (MA), Organizational Leadership
University of Minnesota-Twin Cities 2011 — 2011
Certificate, Successful Manager's Leadership Program
University of Michigan 1995 — 1999
BSE, Chemical Engineering
Shrine High School 1991 — 1995
Mary Heiken (Slinger)'s Cima Labs Experience May 2010 - September 2010
Job Pharmacy Student Intern at Providence Health & Services
Industry Hospital & Health Care
Experience
Providence Health & Services June 2015 - Present
The Minnesota Chemist May 2010 - January 2015
Brief-Lynx Inc. September 2012 - August 2013
Sanctuary Golf Course May 2012 - October 2012
Beckman Coulter September 2010 - December 2011
STMA JO Volleyball December 2010 - May 2011
CIMA Labs May 2010 - September 2010
Concordia University, St. Paul January 2009 - May 2010
Family Tree Clinic June 2008 - August 2009
Skills
Chemistry, Sop, GMP, Science, UV/Vis, Leadership, Validation, Organic Chemistry, Polymer Chemistry, Analytical Chemistry, NMR, Laboratory, Gas Chromatography, Analysis, Lifesciences
Education
Pacific University 2015 — 2016
Master’s Degree, Masters of Healthcare Administration
Pacific University 2013 — 2016
Pharm.D. Candidate, Class of 2016
Concordia University-St. Paul 2006 — 2010
B.A., Chemistry
Providence Health & Services June 2015 - Present
The Minnesota Chemist May 2010 - January 2015
Brief-Lynx Inc. September 2012 - August 2013
Sanctuary Golf Course May 2012 - October 2012
Beckman Coulter September 2010 - December 2011
STMA JO Volleyball December 2010 - May 2011
CIMA Labs May 2010 - September 2010
Concordia University, St. Paul January 2009 - May 2010
Family Tree Clinic June 2008 - August 2009
Skills
Chemistry, Sop, GMP, Science, UV/Vis, Leadership, Validation, Organic Chemistry, Polymer Chemistry, Analytical Chemistry, NMR, Laboratory, Gas Chromatography, Analysis, Lifesciences
Education
Pacific University 2015 — 2016
Master’s Degree, Masters of Healthcare Administration
Pacific University 2013 — 2016
Pharm.D. Candidate, Class of 2016
Concordia University-St. Paul 2006 — 2010
B.A., Chemistry
Olga Johnson Olga Johnson's Cima Labs Experience November 2003 - May 2012
Job Immigration Paralegal at Stinson Leonard Street LLP
Industry Law Practice
Experience
Stinson Leonard Street LLP January 2015 - Present
Edgeline Realty August 2013 - January 2015
Guzior Armbrecht Maher May 2013 - January 2015
U.S. Bank July 2012 - May 2013
ARCH Language Network June 2012 - December 2012
CIMA Labs November 2003 - May 2012
Legal Aid Society of Minneapolis August 2011 - January 2012
Igbanugo Partnerts Int'l Law Firm March 2009 - January 2011
First Class Appraisal August 2006 - January 2009
Skills
FDA, Legal Research, Customer Service, Microsoft Excel, Microsoft Office, Software Documentation, PowerPoint, Real Estate, Quality Assurance, Litigation, Process Improvement, Microsoft Word, Research, Civil Litigation
Education
Hamline University School of Law 2010 — 2011
Master of Laws (LLM), Law
Inver Hills Community College 2007 — 2010
Paralegal Certificate, Law
Kaplan Professional School 2006 — 2006
Real Property Appraiser License, Real Estate License
International University of Social Science 1996 — 2000
Bachelor Degree, Law
Stinson Leonard Street LLP January 2015 - Present
Edgeline Realty August 2013 - January 2015
Guzior Armbrecht Maher May 2013 - January 2015
U.S. Bank July 2012 - May 2013
ARCH Language Network June 2012 - December 2012
CIMA Labs November 2003 - May 2012
Legal Aid Society of Minneapolis August 2011 - January 2012
Igbanugo Partnerts Int'l Law Firm March 2009 - January 2011
First Class Appraisal August 2006 - January 2009
Skills
FDA, Legal Research, Customer Service, Microsoft Excel, Microsoft Office, Software Documentation, PowerPoint, Real Estate, Quality Assurance, Litigation, Process Improvement, Microsoft Word, Research, Civil Litigation
Education
Hamline University School of Law 2010 — 2011
Master of Laws (LLM), Law
Inver Hills Community College 2007 — 2010
Paralegal Certificate, Law
Kaplan Professional School 2006 — 2006
Real Property Appraiser License, Real Estate License
International University of Social Science 1996 — 2000
Bachelor Degree, Law
Lane Gehle's Cima Labs Experience June 2011 - August 2011
Job Registered Client Associate at Merrill Lynch
Industry Financial Services
Experience
Merrill Lynch December 2012 - Present
Integrated Capital Group January 2012 - November 2012
Lab Support, a division of On Assignment April 2012 - September 2012
Maynard's Restaurant September 2011 - May 2012
CIMA Labs June 2011 - August 2011
Medtronic September 2010 - May 2011
Skills
Microsoft Excel, Data Analysis, Customer Service, Microsoft Office, Leadership, PowerPoint, Microsoft Word, Research, Process Improvement, Analysis, Portfolio Management, Public Speaking
Education
Bethel University 2007 — 2011
Chemistry (B.A), Chemistry & Business
Merrill Lynch December 2012 - Present
Integrated Capital Group January 2012 - November 2012
Lab Support, a division of On Assignment April 2012 - September 2012
Maynard's Restaurant September 2011 - May 2012
CIMA Labs June 2011 - August 2011
Medtronic September 2010 - May 2011
Skills
Microsoft Excel, Data Analysis, Customer Service, Microsoft Office, Leadership, PowerPoint, Microsoft Word, Research, Process Improvement, Analysis, Portfolio Management, Public Speaking
Education
Bethel University 2007 — 2011
Chemistry (B.A), Chemistry & Business
Thomas Diezi Thomas Diezi's Cima Labs Experience January 2014 - Present
Job Research Scientist I at CIMA Labs
Industry Pharmaceuticals
Experience
CIMA Labs January 2014 - Present
Perrigo May 2013 - August 2013
Covidien September 2011 - April 2013
University of Wisconsin-Madison School of Pharmacy January 2007 - May 2011
Zeeh Pharmaceutical Experiment Station 2008 - 2009
Skills
Chemistry, HPLC, Drug Delivery, GLP, Pharmaceutics, Formulation, Pharmaceutical Industry, Dissolution, Technology Transfer, Pharmacokinetics, In Vitro, In Vivo, Analytical Chemistry, Biotechnology, Drug Development, UV/Vis, LC-MS, Chromatography, IND
Education
University of Wisconsin-Madison 2006 — 2011
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Drake University 2003 — 2006
B.S., Pharmaceutical Sciences
Fullerton College 2002 — 2003
none, Chemistry
CIMA Labs January 2014 - Present
Perrigo May 2013 - August 2013
Covidien September 2011 - April 2013
University of Wisconsin-Madison School of Pharmacy January 2007 - May 2011
Zeeh Pharmaceutical Experiment Station 2008 - 2009
Skills
Chemistry, HPLC, Drug Delivery, GLP, Pharmaceutics, Formulation, Pharmaceutical Industry, Dissolution, Technology Transfer, Pharmacokinetics, In Vitro, In Vivo, Analytical Chemistry, Biotechnology, Drug Development, UV/Vis, LC-MS, Chromatography, IND
Education
University of Wisconsin-Madison 2006 — 2011
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Drake University 2003 — 2006
B.S., Pharmaceutical Sciences
Fullerton College 2002 — 2003
none, Chemistry
Steven Morfitt Steven Morfitt's Cima Labs Experience March 2014 - Present
Job Research Associate VI at CIMA Labs
Industry Pharmaceuticals
Experience
CIMA Labs March 2014 - Present
Premier Biotech December 2013 - March 2014
PRACS Institute October 2012 - March 2013
CIMA Labs December 2008 - January 2012
WIL Research Laboratories October 2007 - November 2008
Abbott Laboratories October 2001 - September 2007
Procter & Gamble March 1999 - October 2001
Skills
LC-MS, HPLC, Bioanalysis, Drug Metabolism, DMPK, ADME, Bioanalytical Chemistry, Analytical Chemistry, GLP, Method Development, Chemistry, Drug Delivery, Assay Development, In Vitro, UV/Vis, In Vivo, Clinical Development, Chromatography, Drug Development, Drug Discovery
Education
South Dakota State University 1995 — 1999
MS, Biochemistry
South Dakota State University 1992 — 1994
BS, Biochemistry
Worthington Community College 1988 — 1991
AS, Pre-Pharmacy
CIMA Labs March 2014 - Present
Premier Biotech December 2013 - March 2014
PRACS Institute October 2012 - March 2013
CIMA Labs December 2008 - January 2012
WIL Research Laboratories October 2007 - November 2008
Abbott Laboratories October 2001 - September 2007
Procter & Gamble March 1999 - October 2001
Skills
LC-MS, HPLC, Bioanalysis, Drug Metabolism, DMPK, ADME, Bioanalytical Chemistry, Analytical Chemistry, GLP, Method Development, Chemistry, Drug Delivery, Assay Development, In Vitro, UV/Vis, In Vivo, Clinical Development, Chromatography, Drug Development, Drug Discovery
Education
South Dakota State University 1995 — 1999
MS, Biochemistry
South Dakota State University 1992 — 1994
BS, Biochemistry
Worthington Community College 1988 — 1991
AS, Pre-Pharmacy
Jamey Jacobson Jamey Jacobson's Cima Labs Experience January 2002 - March 2005
Job Assistant Compounder/ Plant Chemist at American Pheonix Inc.
Industry Automotive
Experience
American Pheonix Inc. January 2014 - Present
Hutchinson Technology Inc March 2005 - January 2014
CIMA Labs January 2002 - March 2005
Skills
Design of Experiments, Chemistry, Characterization, R&D, Analytical Chemistry, Materials Science, Failure Analysis, Process Simulation, Laboratory, Hazmat Response, DOT Compliance, Scanning Electron..., Quality Control, TGA, Validation
Education
Chippewa Valley Technical College
Hazwoper Certification, Hazardous materials
UW Eau Claire WI 1997 — 2002
BS, Comprehensive Chemistry
American Pheonix Inc. January 2014 - Present
Hutchinson Technology Inc March 2005 - January 2014
CIMA Labs January 2002 - March 2005
Skills
Design of Experiments, Chemistry, Characterization, R&D, Analytical Chemistry, Materials Science, Failure Analysis, Process Simulation, Laboratory, Hazmat Response, DOT Compliance, Scanning Electron..., Quality Control, TGA, Validation
Education
Chippewa Valley Technical College
Hazwoper Certification, Hazardous materials
UW Eau Claire WI 1997 — 2002
BS, Comprehensive Chemistry
Kaelyn E. Wilke's Cima Labs Experience June 2007 - August 2007
Job Product Specialist at SigmaAldrich
Industry Marketing and Advertising
Experience
Sigma-Aldrich June 2015 - Present
Indiana University June 2009 - December 2014
Indiana University August 2009 - December 2010
Intelligent Nutrients October 2008 - April 2009
R&D Systems June 2008 - August 2008
CIMA Labs June 2007 - August 2007
Skills
Protein Purification, Analytical Chemistry, Protein Chemistry, Molecular Cloning, Enzyme Assays, Bacterial Culturing, Activity-Based Protein..., Fluorescence..., High Throughput..., Radioactivity, Protein Aggregation, Unicorn, Antimicrobial..., Chromatography, Circular Dichroism, Biosafety, PCR, HPLC, AKTApurifier FPLC, Bacterial and Mammalian...
Education
Indiana University Bloomington 2009 — 2014
Doctor of Philosophy (PhD), Chemical Biology
University of St. Thomas 2005 — 2009
Bachelor of Science (B.S.), Biochemistry
Sigma-Aldrich June 2015 - Present
Indiana University June 2009 - December 2014
Indiana University August 2009 - December 2010
Intelligent Nutrients October 2008 - April 2009
R&D Systems June 2008 - August 2008
CIMA Labs June 2007 - August 2007
Skills
Protein Purification, Analytical Chemistry, Protein Chemistry, Molecular Cloning, Enzyme Assays, Bacterial Culturing, Activity-Based Protein..., Fluorescence..., High Throughput..., Radioactivity, Protein Aggregation, Unicorn, Antimicrobial..., Chromatography, Circular Dichroism, Biosafety, PCR, HPLC, AKTApurifier FPLC, Bacterial and Mammalian...
Education
Indiana University Bloomington 2009 — 2014
Doctor of Philosophy (PhD), Chemical Biology
University of St. Thomas 2005 — 2009
Bachelor of Science (B.S.), Biochemistry
Pamela Quade Pamela Quade's Cima Labs Experience November 2006 - June 2007
Job Production Trainer at Donatelle
Industry Medical Devices
Experience
Donatelle May 2014 - Present
Kohl's Department Stores November 2012 - May 2014
Anulex Technologies September 2008 - June 2011
Anulex Technologies November 2007 - September 2008
CIMA Labs November 2006 - June 2007
Boston Scientific 2003 - 2006
Boston Scientific 2000 - 2003
Boston Scientific 1997 - 2000
Skills
Accounts Payable, Accounts Receivable, Product Development, Highly detail oriented, Training, Medical Devices, Accurate Record Keeping, Data Entry, Customer Service, Manufacturing, Resourceful..., Involvement with..., In-depth knowledge of..., GMP, ISO, Lean Manufacturing, Team Leadership, Organization &..., Quality System, ISO 13485, Product Launch, FDA
Education
The Medical Institute of Minnesota 1988 — 1990
Certificate, Veterinary Technician Program, Board Certified in Minnesota
North Hennepin Community College 1983 — 1984
Blaine High School 1979 — 1982
Graduated with Honors, B+
Donatelle May 2014 - Present
Kohl's Department Stores November 2012 - May 2014
Anulex Technologies September 2008 - June 2011
Anulex Technologies November 2007 - September 2008
CIMA Labs November 2006 - June 2007
Boston Scientific 2003 - 2006
Boston Scientific 2000 - 2003
Boston Scientific 1997 - 2000
Skills
Accounts Payable, Accounts Receivable, Product Development, Highly detail oriented, Training, Medical Devices, Accurate Record Keeping, Data Entry, Customer Service, Manufacturing, Resourceful..., Involvement with..., In-depth knowledge of..., GMP, ISO, Lean Manufacturing, Team Leadership, Organization &..., Quality System, ISO 13485, Product Launch, FDA
Education
The Medical Institute of Minnesota 1988 — 1990
Certificate, Veterinary Technician Program, Board Certified in Minnesota
North Hennepin Community College 1983 — 1984
Blaine High School 1979 — 1982
Graduated with Honors, B+
Brian Pogainis Brian Pogainis's Cima Labs Experience July 2003 - May 2012
Job Actively seeking new chemist opportunity
Industry Pharmaceuticals
Experience
Cambrex July 2014 - June 2015
Volt (Entegris) May 2013 - February 2014
CIMA Labs July 2003 - May 2012
Kforce March 2003 - July 2003
Kforce October 2001 - March 2003
Part 3 1996 - 1998
Skills
Dissolution, Excel, Calibration, Karl Fisher, Cleaning Validation, Analytical Method..., Gas Chromatography, Material Sampling, Titration, FTIR, Validation, HPLC, UV/Vis, GMP, Microsoft Excel, Method Transfer, Trackwise, FDA, Quality Assurance, GLP, V&V, Quality Control, R&D, LIMS, Sop, Analytical Chemistry, UV, cGMP practices, Chromatography, SOP
Education
University of Minnesota Duluth 1990 — 1996
Bachelor of Science (B.S.), Chemistry
University of Minnesota Duluth 1990 — 1996
Bachelor's Degree, Chemical Engineering
Cambrex July 2014 - June 2015
Volt (Entegris) May 2013 - February 2014
CIMA Labs July 2003 - May 2012
Kforce March 2003 - July 2003
Kforce October 2001 - March 2003
Part 3 1996 - 1998
Skills
Dissolution, Excel, Calibration, Karl Fisher, Cleaning Validation, Analytical Method..., Gas Chromatography, Material Sampling, Titration, FTIR, Validation, HPLC, UV/Vis, GMP, Microsoft Excel, Method Transfer, Trackwise, FDA, Quality Assurance, GLP, V&V, Quality Control, R&D, LIMS, Sop, Analytical Chemistry, UV, cGMP practices, Chromatography, SOP
Education
University of Minnesota Duluth 1990 — 1996
Bachelor of Science (B.S.), Chemistry
University of Minnesota Duluth 1990 — 1996
Bachelor's Degree, Chemical Engineering
Daniel Bruns Daniel Bruns's Cima Labs Experience 2003 - Present
Job Equipment Maintenance, and Metrology
Industry Pharmaceuticals
Experience
CIMA Labs 2003 - Present
J&W Instruments August 2001 - March 2003
PerkinElmer Optoelectronics May 2000 - August 2001
Skills
Pharmaceutical Packaging, Field Service, Electrical Controls, Electronics, Metrology, Equipment Repair, PLC Programming, Equipment Maintenance, Medical Devices, Calibration
Education
Brown College 1981 — 1983
Associate's degree, Industrial Electronics Technology/Technician
Minnesota West Community and Technical College 1977 — 1979
Diploma, Hydraulics and Fluid Power Technology/Technician
CIMA Labs 2003 - Present
J&W Instruments August 2001 - March 2003
PerkinElmer Optoelectronics May 2000 - August 2001
Skills
Pharmaceutical Packaging, Field Service, Electrical Controls, Electronics, Metrology, Equipment Repair, PLC Programming, Equipment Maintenance, Medical Devices, Calibration
Education
Brown College 1981 — 1983
Associate's degree, Industrial Electronics Technology/Technician
Minnesota West Community and Technical College 1977 — 1979
Diploma, Hydraulics and Fluid Power Technology/Technician
Tim Lenz Tim Lenz's Cima Labs Experience June 2005 - March 2008
Job Critical facilities engineer at United Health Group
Industry Information Technology and Services
Experience
United Health Group March 2008 - Present
CIMA Labs June 2005 - March 2008
Tiro Industries January 1994 - June 2005
Skills
Process Improvement, Software Documentation, Project Management, SharePoint, Healthcare Information..., HIPAA, Steam Boilers, Chillers, Building Automation, Building Maintenance, SCADA, Facilities Management, VESDA, Power Generation, Microsoft Word, Microsoft Excel, Cpr Certified, Mission Critical..., Manufacturing, HVAC Controls, PLC Allen Bradley, Troubleshooting, CAPA, Engineering, Cross-functional Team..., GMP, Quality Assurance, Validation, Management, Team Building
Education
Anoka Technical College 1987 — 1989
Building/Property Maintenance
United Health Group March 2008 - Present
CIMA Labs June 2005 - March 2008
Tiro Industries January 1994 - June 2005
Skills
Process Improvement, Software Documentation, Project Management, SharePoint, Healthcare Information..., HIPAA, Steam Boilers, Chillers, Building Automation, Building Maintenance, SCADA, Facilities Management, VESDA, Power Generation, Microsoft Word, Microsoft Excel, Cpr Certified, Mission Critical..., Manufacturing, HVAC Controls, PLC Allen Bradley, Troubleshooting, CAPA, Engineering, Cross-functional Team..., GMP, Quality Assurance, Validation, Management, Team Building
Education
Anoka Technical College 1987 — 1989
Building/Property Maintenance
Joan A. Kivel Joan A. Kivel's Cima Labs Experience June 2003 - May 2012
Job OSD Formulation
Industry Pharmaceuticals
Experience
Perrigo September 2012 - Present
Walser Automotive Group July 2012 - March 2015
CIMA Labs June 2003 - May 2012
Kohl's Department Stores December 2001 - January 2005
Quali Tech, Inc. February 1997 - June 2003
Tsumura Int. Inc August 1995 - February 1997
Skills
GMP, Pharmaceutical Industry, Validation, FDA, Certification 5s..., SOP's, Troubleshooting the..., Food Industry, cGMP, Sop, 5S, Pharmaceutics, Teamwork, 21 CFR Part 11, Team Building, Manufacturing, Packaging, Troubleshooting, CAPA, Quality Control, Quality Auditing, lean sigma, Quality System, Six Sigma, SOP, Quality Assurance
Education
Century College 1983 — 1984
Child Development Assistant Degree, Early Childhood Education and Teaching
North Saint Paul High School, North Saint Paul, MN 1980 — 1983
High School Diploma
Perrigo September 2012 - Present
Walser Automotive Group July 2012 - March 2015
CIMA Labs June 2003 - May 2012
Kohl's Department Stores December 2001 - January 2005
Quali Tech, Inc. February 1997 - June 2003
Tsumura Int. Inc August 1995 - February 1997
Skills
GMP, Pharmaceutical Industry, Validation, FDA, Certification 5s..., SOP's, Troubleshooting the..., Food Industry, cGMP, Sop, 5S, Pharmaceutics, Teamwork, 21 CFR Part 11, Team Building, Manufacturing, Packaging, Troubleshooting, CAPA, Quality Control, Quality Auditing, lean sigma, Quality System, Six Sigma, SOP, Quality Assurance
Education
Century College 1983 — 1984
Child Development Assistant Degree, Early Childhood Education and Teaching
North Saint Paul High School, North Saint Paul, MN 1980 — 1983
High School Diploma
Megan Kearney VALE student Megan Kearney VALE student's Cima Labs Experience October 2011 - December 2011
Job Student at National American UniversityBloomington
Industry Warehousing
Experience
Midwest Staffing October 2011 - Present
CIMA Labs October 2011 - December 2011
Education
National American University-Bloomington 2011 — 2013
bacholor's, criminal justice
vale ed center 2004 — 2008
Midwest Staffing October 2011 - Present
CIMA Labs October 2011 - December 2011
Education
National American University-Bloomington 2011 — 2013
bacholor's, criminal justice
vale ed center 2004 — 2008
Cary Hayner Cary Hayner's Cima Labs Experience May 2007 - August 2007
Job Chief Technology Officer at SiNode Systems
Industry Chemicals
Experience
SiNode Systems April 2012 - Present
Northwestern University January 2009 - Present
Hitchcock Industries / MnTAP May 2008 - August 2008
CIMA Labs May 2007 - August 2007
Army High Performance Computing Research Center (DoD) June 2006 - August 2006
Lubrication Technologies Inc. June 2004 - August 2005
Skills
Chemistry, Chemical Engineering, Nanotechnology, TGA, Characterization, Spectroscopy, Powder X-ray Diffraction, Lithium-ion Batteries, Energy Storage, Research, Engineering, Microscopy, Materials Science, XRD, Heterogeneous Catalysis, Electron Microscopy, Scanning Electron..., Materials, Social Media, Nanomaterials
Education
Northwestern University 2008 — 2013
PhD, Chemical and Biological Engineering
University of Minnesota-Twin Cities 2004 — 2008
BChE, Chemical Engineering
University of Minnesota-Twin Cities 2004 — 2008
BS, Chemistry
SiNode Systems April 2012 - Present
Northwestern University January 2009 - Present
Hitchcock Industries / MnTAP May 2008 - August 2008
CIMA Labs May 2007 - August 2007
Army High Performance Computing Research Center (DoD) June 2006 - August 2006
Lubrication Technologies Inc. June 2004 - August 2005
Skills
Chemistry, Chemical Engineering, Nanotechnology, TGA, Characterization, Spectroscopy, Powder X-ray Diffraction, Lithium-ion Batteries, Energy Storage, Research, Engineering, Microscopy, Materials Science, XRD, Heterogeneous Catalysis, Electron Microscopy, Scanning Electron..., Materials, Social Media, Nanomaterials
Education
Northwestern University 2008 — 2013
PhD, Chemical and Biological Engineering
University of Minnesota-Twin Cities 2004 — 2008
BChE, Chemical Engineering
University of Minnesota-Twin Cities 2004 — 2008
BS, Chemistry
Micah Thomas Micah Thomas's Cima Labs Experience 2002 - 2007
Job New Product Quality Specialist at UpsherSmith Laboratories
Industry Pharmaceuticals
Experience
Upsher-Smith Laboratories September 2012 - Present
Boston Scientific March 2012 - September 2012
Boston Scientific November 2011 - March 2012
WuXi AppTec August 2009 - July 2011
BioTest Laboratories 2007 - 2008
CIMA LABS 2002 - 2007
Quality Compliant Systems 1997 - 2002
Mentor 1994 - 1997
University of Minnesota Dept. of Surgery 1991 - 1994
Skills
Quality System, Validation, Quality Assurance, Medical Devices, FDA, V&V, CAPA, Regulatory Affairs, SOP development, R&D, GCP, ISO, GLP, Laboratory, Drug Development, ISO 13485, GMP, Sop, Biopharmaceuticals, 21 CFR Part 11, Lifesciences, Pharmaceutical Industry, Change Control, Biotechnology, Computer System..., Pharmaceutics, Software Documentation, Product Development, Auditing, Design Control, Quality Management, Quality Auditing, GxP, FDA GMP, Process Simulation, Trackwise, Clinical Trials, LIMS, Aseptic Processing, Regulatory Submissions, Cleaning Validation, HPLC, Quality Control, Technology Transfer, Regulatory Requirements, Analytical Chemistry, ISO 14971, CRO, Clinical Development, Risk Management
Education
Metropolitan State University 2007 — 2009
BS, Business Management
Normandale Community College 2005 — 2007
AA, Chemistry / Biology / Business
University of Minnesota-Twin Cities 1993 — 1994
Genetics
Upsher-Smith Laboratories September 2012 - Present
Boston Scientific March 2012 - September 2012
Boston Scientific November 2011 - March 2012
WuXi AppTec August 2009 - July 2011
BioTest Laboratories 2007 - 2008
CIMA LABS 2002 - 2007
Quality Compliant Systems 1997 - 2002
Mentor 1994 - 1997
University of Minnesota Dept. of Surgery 1991 - 1994
Skills
Quality System, Validation, Quality Assurance, Medical Devices, FDA, V&V, CAPA, Regulatory Affairs, SOP development, R&D, GCP, ISO, GLP, Laboratory, Drug Development, ISO 13485, GMP, Sop, Biopharmaceuticals, 21 CFR Part 11, Lifesciences, Pharmaceutical Industry, Change Control, Biotechnology, Computer System..., Pharmaceutics, Software Documentation, Product Development, Auditing, Design Control, Quality Management, Quality Auditing, GxP, FDA GMP, Process Simulation, Trackwise, Clinical Trials, LIMS, Aseptic Processing, Regulatory Submissions, Cleaning Validation, HPLC, Quality Control, Technology Transfer, Regulatory Requirements, Analytical Chemistry, ISO 14971, CRO, Clinical Development, Risk Management
Education
Metropolitan State University 2007 — 2009
BS, Business Management
Normandale Community College 2005 — 2007
AA, Chemistry / Biology / Business
University of Minnesota-Twin Cities 1993 — 1994
Genetics
Donald Sims Donald Sims's Cima Labs Experience 2000 - 2002
Job President
Industry Pharmaceuticals
Experience
iCeutica April 2015 - Present
jdsims & associates 2002 - Present
PharmaDirections 2004 - Present
QSC 2011 - 2014
DSI 2010 - 2012
MDS Pharma Services 2005 - 2006
cima labs 2000 - 2002
solvay 1996 - 2000
apollon 1993 - 1996
Greenwich Pharmaceuticals 1991 - 1993
Skills
Pharmaceuticals, cGMP, Regulatory Affairs, GMP, Validation, Process Validation, Technology Transfer, Quality Auditing, SOP, Pharmaceutical Industry, FDA, Quality System, Sop, V&V, Regulatory Requirements, Quality Control, 21 CFR Part 11, Pharmaceutics, CAPA, Change Control, GLP, Regulatory Submissions
Education
University of North Carolina at Chapel Hill 1975 — 1979
PhD, Medicinal Chemistry
Rice University 1971 — 1975
BA, biochemistry
iCeutica April 2015 - Present
jdsims & associates 2002 - Present
PharmaDirections 2004 - Present
QSC 2011 - 2014
DSI 2010 - 2012
MDS Pharma Services 2005 - 2006
cima labs 2000 - 2002
solvay 1996 - 2000
apollon 1993 - 1996
Greenwich Pharmaceuticals 1991 - 1993
Skills
Pharmaceuticals, cGMP, Regulatory Affairs, GMP, Validation, Process Validation, Technology Transfer, Quality Auditing, SOP, Pharmaceutical Industry, FDA, Quality System, Sop, V&V, Regulatory Requirements, Quality Control, 21 CFR Part 11, Pharmaceutics, CAPA, Change Control, GLP, Regulatory Submissions
Education
University of North Carolina at Chapel Hill 1975 — 1979
PhD, Medicinal Chemistry
Rice University 1971 — 1975
BA, biochemistry
Jeff Abel CPP's Cima Labs Experience August 2001 - December 2005
Job Process and Packaging Engineer at Michael Foods
Industry Food Production
Experience
Michael Foods, Inc. March 2012 - Present
Abel Professional Services January 2011 - March 2012
Medafor, Inc. June 2009 - September 2010
ConAgra Foods July 2008 - May 2009
Target November 2006 - May 2008
CIMA Labs August 2001 - December 2005
Graphic Packaging International 1997 - 2001
Graphic Packaging Corporation 1994 - 1997
Graphic Packaging Corporation - Golden, CO 1991 - 1994
United States Navy 1990 - 1991
Skills
Packaging Engineering, Manufacturing Operations, Product Development, Process Engineering, Operations Management, Manufacturing, Packaging, Medical Devices, Food, Leadership, Continuous Improvement, Process Improvement, Engineering, FDA, Cross-functional Team..., Validation, Management, Lean Manufacturing, GMP, CAPA, SAP, Quality Control, Quality System, Purchasing, Food Packaging, Food Industry, Quality Assurance, Six Sigma, Production Planning, Quality Management, R&D, Supply Chain, 5S, Root Cause Analysis
Education
University of Cincinnati 1995 — 1997
Material Science - Polymers
United States Naval Academy 1976 — 1980
B.S., Chemistry
Michael Foods, Inc. March 2012 - Present
Abel Professional Services January 2011 - March 2012
Medafor, Inc. June 2009 - September 2010
ConAgra Foods July 2008 - May 2009
Target November 2006 - May 2008
CIMA Labs August 2001 - December 2005
Graphic Packaging International 1997 - 2001
Graphic Packaging Corporation 1994 - 1997
Graphic Packaging Corporation - Golden, CO 1991 - 1994
United States Navy 1990 - 1991
Skills
Packaging Engineering, Manufacturing Operations, Product Development, Process Engineering, Operations Management, Manufacturing, Packaging, Medical Devices, Food, Leadership, Continuous Improvement, Process Improvement, Engineering, FDA, Cross-functional Team..., Validation, Management, Lean Manufacturing, GMP, CAPA, SAP, Quality Control, Quality System, Purchasing, Food Packaging, Food Industry, Quality Assurance, Six Sigma, Production Planning, Quality Management, R&D, Supply Chain, 5S, Root Cause Analysis
Education
University of Cincinnati 1995 — 1997
Material Science - Polymers
United States Naval Academy 1976 — 1980
B.S., Chemistry
Matthew DeRuyter Matthew DeRuyter's Cima Labs Experience October 1999 - June 2007
Job Attorney at Kinney & Lange, P.A.
Industry Legal Services
Experience
Kinney & Lange, P.A. June 2007 - Present
CIMA Labs October 1999 - June 2007
Ecolab September 2006 - May 2007
Allied International Labs October 1997 - October 1999
Skills
Patent Prosecution, Patents, Patent Applications, Trademarks, Intellectual Property, Legal Opinions, Patentability, Registered Patent..., Patent Litigation, Trade Secrets, Patent Drafting, Patent Portfolio..., Prosecution, Patent Analysis, Trademark Prosecution
Education
William Mitchell College of Law 2003 — 2007
J.D.
Lawrence University 1993 — 1997
B.A., Chemistry
Kinney & Lange, P.A. June 2007 - Present
CIMA Labs October 1999 - June 2007
Ecolab September 2006 - May 2007
Allied International Labs October 1997 - October 1999
Skills
Patent Prosecution, Patents, Patent Applications, Trademarks, Intellectual Property, Legal Opinions, Patentability, Registered Patent..., Patent Litigation, Trade Secrets, Patent Drafting, Patent Portfolio..., Prosecution, Patent Analysis, Trademark Prosecution
Education
William Mitchell College of Law 2003 — 2007
J.D.
Lawrence University 1993 — 1997
B.A., Chemistry
Jean Tipton Carr Jean Tipton Carr's Cima Labs Experience May 1997 - September 1997
Job Massage Therapist, Shamanic Practitoner
Industry Hospital & Health Care
Experience
Self-employed August 2000 - Present
LecTec Corporation October 1997 - May 1998
CIMA Labs May 1997 - September 1997
Viromed September 1995 - March 1996
Sanofi Pasteur March 1995 - August 1995
Wright State University April 1991 - March 1993
Skills
Research, Pain Management, Wellness, Treatment, Healthcare, Sports Injuries, Rehabilitation, Holistic Health, Chronic Pain, Relaxation, Headaches, Nutrition, Healing, Stress Management, Body Massage, Reiki, Deep Tissue Massage, Cpr Certified, Therapeutic Massage, Customer Service, Meditation
Education
Dayton School of Medical Massage 1998 — 2000
Licensed Massage Therapist, Massage Therapy/Therapeutic Massage
Penn State University 1986 — 1990
Bachelor of Science (B.S.), Cell Biology and Anatomy
Self-employed August 2000 - Present
LecTec Corporation October 1997 - May 1998
CIMA Labs May 1997 - September 1997
Viromed September 1995 - March 1996
Sanofi Pasteur March 1995 - August 1995
Wright State University April 1991 - March 1993
Skills
Research, Pain Management, Wellness, Treatment, Healthcare, Sports Injuries, Rehabilitation, Holistic Health, Chronic Pain, Relaxation, Headaches, Nutrition, Healing, Stress Management, Body Massage, Reiki, Deep Tissue Massage, Cpr Certified, Therapeutic Massage, Customer Service, Meditation
Education
Dayton School of Medical Massage 1998 — 2000
Licensed Massage Therapist, Massage Therapy/Therapeutic Massage
Penn State University 1986 — 1990
Bachelor of Science (B.S.), Cell Biology and Anatomy
Jared Olson Jared Olson's Cima Labs Experience January 2009 - April 2014
Job Formulation Chemist
Industry Pharmaceuticals
Experience
Aurora Pharmaceutical April 2014 - Present
CIMA Labs January 2009 - April 2014
Nestle April 2008 - December 2008
Pfizer August 2007 - April 2008
Skills
Validation, Pharmaceutical Industry, Quality Assurance, Drug Delivery, Sop, Biotechnology, Chromatography, CAPA, Technology Transfer, FDA, GLP, HPLC, Chemistry, Analytical Chemistry, GMP, UV/Vis, Gas Chromatography, Analytical Method..., LC-MS, UV, Regulatory Affairs, Dissolution, Formulation
Education
University of Florida 2010 — 2013
Master of Pharmacy (M.S.), Pharmaceutical Chemistry
Minnesota State University, Moorhead 2003 — 2007
Bachelor of Arts, Chemistry, Biology
University of the Sunshine Coast
Aurora Pharmaceutical April 2014 - Present
CIMA Labs January 2009 - April 2014
Nestle April 2008 - December 2008
Pfizer August 2007 - April 2008
Skills
Validation, Pharmaceutical Industry, Quality Assurance, Drug Delivery, Sop, Biotechnology, Chromatography, CAPA, Technology Transfer, FDA, GLP, HPLC, Chemistry, Analytical Chemistry, GMP, UV/Vis, Gas Chromatography, Analytical Method..., LC-MS, UV, Regulatory Affairs, Dissolution, Formulation
Education
University of Florida 2010 — 2013
Master of Pharmacy (M.S.), Pharmaceutical Chemistry
Minnesota State University, Moorhead 2003 — 2007
Bachelor of Arts, Chemistry, Biology
University of the Sunshine Coast
Makai Myers-Wilkes Makai Myers-Wilkes's Cima Labs Experience January 2012 - February 2012
Job Tech Consultant with the agility, flexibility, and expereince required to provide creative solutions.
Industry Information Services
Experience
Nsidaria LLC September 2001 - Present
Nsidaria LLC January 1995 - Present
ELCA Board of Pensions February 2012 - April 2012
Roadview Inc September 2006 - March 2012
CIMA Labs January 2012 - February 2012
dsu 2012 - 2012
Decision One December 2003 - June 2005
Dominos February 2002 - September 2004
Dunwoody Bookstore December 2001 - November 2003
Subway August 2000 - August 2001
Skills
Linux, Troubleshooting, Technical Support, Windows 7, JavaScript, Windows, Operating Systems, Management, System Administration, MySQL, XML, Computer Hardware, VPN, Testing, PHP
Education
St Mary's University of Minnesota 2012 — 2014
Information Technology
Dunwoody College of Technology 2001 — 2003
none, Computer Networking
North Branch Senior 1996 — 1999
High School Diploma, General Studies
Nsidaria LLC September 2001 - Present
Nsidaria LLC January 1995 - Present
ELCA Board of Pensions February 2012 - April 2012
Roadview Inc September 2006 - March 2012
CIMA Labs January 2012 - February 2012
dsu 2012 - 2012
Decision One December 2003 - June 2005
Dominos February 2002 - September 2004
Dunwoody Bookstore December 2001 - November 2003
Subway August 2000 - August 2001
Skills
Linux, Troubleshooting, Technical Support, Windows 7, JavaScript, Windows, Operating Systems, Management, System Administration, MySQL, XML, Computer Hardware, VPN, Testing, PHP
Education
St Mary's University of Minnesota 2012 — 2014
Information Technology
Dunwoody College of Technology 2001 — 2003
none, Computer Networking
North Branch Senior 1996 — 1999
High School Diploma, General Studies
Bhaveshkumar H. Kothari Bhaveshkumar H. Kothari's Cima Labs Experience June 2002 - June 2006
Job Pharmaceutical Research and Development
Industry Pharmaceuticals
Experience
Amneal Pharmaceuticals October 2013 - Present
Forest Research Institute June 2006 - August 2010
CIMA Labs June 2002 - June 2006
Emisphere Technologies July 2000 - June 2002
Hoffmann-La Roche January 2000 - June 2000
Bristol-Myers Squibb May 1999 - August 1999
SmithKline Beecham June 1998 - August 1998
Skills
Drug Development, Technology Transfer, Drug Delivery, Pharmaceutical Research, Formulation, Pharmaceutics, Pharmaceutical Industry, Quality by Design, Pharmacokinetics, GMP, GLP, FDA, HPLC, Validation, CMC, Clinical Trials, NDA, Regulatory Submissions, Dissolution, Regulatory Affairs, Sop, IND, ANDA, R&D, Chromatography, Analytical Chemistry, SOP
Education
University of Maryland School of Pharmacy 2010 — 2014
Ph. D., Pharmaceutical Sciences
Registered Pharmacist
R. Ph., New Jersey State
Long Island University, Brooklyn Campus
M.S., Pharmacy Administration and Regulatory Affairs
Long Island University, Brooklyn Campus 1997 — 2000
M.S., Industrial Pharmacy
Welingkar Institute of Management 1992 — 1993
D.M.M., Marketing/Marketing Management, General
University of Pune 1988 — 1992
B.S., Pharmacy
Amneal Pharmaceuticals October 2013 - Present
Forest Research Institute June 2006 - August 2010
CIMA Labs June 2002 - June 2006
Emisphere Technologies July 2000 - June 2002
Hoffmann-La Roche January 2000 - June 2000
Bristol-Myers Squibb May 1999 - August 1999
SmithKline Beecham June 1998 - August 1998
Skills
Drug Development, Technology Transfer, Drug Delivery, Pharmaceutical Research, Formulation, Pharmaceutics, Pharmaceutical Industry, Quality by Design, Pharmacokinetics, GMP, GLP, FDA, HPLC, Validation, CMC, Clinical Trials, NDA, Regulatory Submissions, Dissolution, Regulatory Affairs, Sop, IND, ANDA, R&D, Chromatography, Analytical Chemistry, SOP
Education
University of Maryland School of Pharmacy 2010 — 2014
Ph. D., Pharmaceutical Sciences
Registered Pharmacist
R. Ph., New Jersey State
Long Island University, Brooklyn Campus
M.S., Pharmacy Administration and Regulatory Affairs
Long Island University, Brooklyn Campus 1997 — 2000
M.S., Industrial Pharmacy
Welingkar Institute of Management 1992 — 1993
D.M.M., Marketing/Marketing Management, General
University of Pune 1988 — 1992
B.S., Pharmacy
Jim Klancke Jim Klancke's Cima Labs Experience June 1994 - Present
Job Sr. Director, Analytical Development
Industry Pharmaceuticals
Experience
CIMA Labs June 1994 - Present
Lilly Research Labs August 1989 - July 1994
Skills
GMP, FDA, Validation, Technology Transfer, Analytical Chemistry, Pharmaceutical Industry, V&V, Drug Delivery, HPLC, CAPA, Sop, GLP, Cleaning Validation, Formulation, Regulatory Affairs, FDA GMP, Quality System, Quality Control, Chemistry, Dissolution, Chromatography, Quality by Design, Analytical Method...
Education
The University of South Dakota 1987 — 1989
MS, Analytical Chemistry
St. Cloud State University 1982 — 1986
BS, ACS Chemistry
CIMA Labs June 1994 - Present
Lilly Research Labs August 1989 - July 1994
Skills
GMP, FDA, Validation, Technology Transfer, Analytical Chemistry, Pharmaceutical Industry, V&V, Drug Delivery, HPLC, CAPA, Sop, GLP, Cleaning Validation, Formulation, Regulatory Affairs, FDA GMP, Quality System, Quality Control, Chemistry, Dissolution, Chromatography, Quality by Design, Analytical Method...
Education
The University of South Dakota 1987 — 1989
MS, Analytical Chemistry
St. Cloud State University 1982 — 1986
BS, ACS Chemistry
Forrest Johnson's Cima Labs Experience 2003 - 2005
Job Project Manager for Medical Devices and Pharmaceuticals
Industry Medical Devices
Experience
QiG group April 2011 - Present
SurModics December 2007 - November 2010
PDL BioPharma 2005 - 2007
CIMA Labs 2003 - 2005
Diametrics Medical 1993 - 2002
Education
Indiana University Bloomington 1990 — 1993
QiG group April 2011 - Present
SurModics December 2007 - November 2010
PDL BioPharma 2005 - 2007
CIMA Labs 2003 - 2005
Diametrics Medical 1993 - 2002
Education
Indiana University Bloomington 1990 — 1993
Travis M. Wayne, PMP Travis M. Wayne, PMP's Cima Labs Experience March 1991 - August 1994
Job IT Project Management Office Leader
Industry Hospital & Health Care
Experience
Froedtert Health March 2011 - March 2015
Froedtert Health March 2010 - March 2011
Froedtert and Community Health August 2006 - March 2010
Froedtert Hospital February 2005 - August 2006
Froedtert Hospital February 2000 - February 2005
Froedtert Hospital September 1999 - February 2000
CIMA Labs March 1991 - August 1994
Skills
SharePoint, Healthcare Information..., Project Management, Epic Systems, Information Technology, Strategic Planning, PMP, HIPAA, Informatics, EHR, Program Management, Change Management, Visio, Vendor Management, Healthcare, Software Documentation, Process Improvement, Troubleshooting, System Administration, EMR, Project Portfolio..., PMO, Leadership, ERP, Requirements Analysis, Systems Analysis, Business Analysis, Strategy, Team Building, Business Development, SDLC, Management, Enterprise Software, IT Strategy, Software Project..., Resource Management, Hospitals, Healthcare Management, Business Process, Healthcare Industry, Data Analysis, Integration, Budgets, Analysis, MS Project, Software Implementation
Education
Milwaukee School of Engineering 1998 — 1999
Medical Informatics
UW-Superior 1994 — 1998
Bachelor's Degree, Cell and Molecular Biology, Chemistry
The College of St. Scholastica
Froedtert Health March 2011 - March 2015
Froedtert Health March 2010 - March 2011
Froedtert and Community Health August 2006 - March 2010
Froedtert Hospital February 2005 - August 2006
Froedtert Hospital February 2000 - February 2005
Froedtert Hospital September 1999 - February 2000
CIMA Labs March 1991 - August 1994
Skills
SharePoint, Healthcare Information..., Project Management, Epic Systems, Information Technology, Strategic Planning, PMP, HIPAA, Informatics, EHR, Program Management, Change Management, Visio, Vendor Management, Healthcare, Software Documentation, Process Improvement, Troubleshooting, System Administration, EMR, Project Portfolio..., PMO, Leadership, ERP, Requirements Analysis, Systems Analysis, Business Analysis, Strategy, Team Building, Business Development, SDLC, Management, Enterprise Software, IT Strategy, Software Project..., Resource Management, Hospitals, Healthcare Management, Business Process, Healthcare Industry, Data Analysis, Integration, Budgets, Analysis, MS Project, Software Implementation
Education
Milwaukee School of Engineering 1998 — 1999
Medical Informatics
UW-Superior 1994 — 1998
Bachelor's Degree, Cell and Molecular Biology, Chemistry
The College of St. Scholastica
Kristine Wicken Kristine Wicken's Cima Labs Experience 2010 - Present
Job QC Analyst III at Biothera
Industry Biotechnology
Experience
Biothera February 2013 - Present
CIMA Labs 2010 - Present
CIMA LABS Inc January 2007 - December 2010
CIMA LABS Inc January 2004 - January 2007
CIMA LABS Inc January 2003 - January 2004
College of St. Catherine 2000 - 2003
Skills
First Responder, Trackwise, Cleaning Validation, Chromatography, Quality System, 21 CFR Part 11, FDA GMP, Karl Fisher, UV, Analytical Method..., Quality Auditing, DEA, Laboratory, Aseptic Processing, USP, Deviations, Method Transfer, Regulatory Affairs, Pharmaceutics, Contract Manufacturing, SOP development, Method Development, cGMP practices, Regulatory Submissions, Quality Investigations, FTIR
Education
St.Catherine University 2008 — 2012
Master of Art
Hamline School of Law 2008 — 2011
Certificate
St. Catherine University 1997 — 2003
Bachelor
Minneapolis Community and Technical College 1993 — 1997
Associate
Biothera February 2013 - Present
CIMA Labs 2010 - Present
CIMA LABS Inc January 2007 - December 2010
CIMA LABS Inc January 2004 - January 2007
CIMA LABS Inc January 2003 - January 2004
College of St. Catherine 2000 - 2003
Skills
First Responder, Trackwise, Cleaning Validation, Chromatography, Quality System, 21 CFR Part 11, FDA GMP, Karl Fisher, UV, Analytical Method..., Quality Auditing, DEA, Laboratory, Aseptic Processing, USP, Deviations, Method Transfer, Regulatory Affairs, Pharmaceutics, Contract Manufacturing, SOP development, Method Development, cGMP practices, Regulatory Submissions, Quality Investigations, FTIR
Education
St.Catherine University 2008 — 2012
Master of Art
Hamline School of Law 2008 — 2011
Certificate
St. Catherine University 1997 — 2003
Bachelor
Minneapolis Community and Technical College 1993 — 1997
Associate
Dave Brown, MSc, PMP Dave Brown, MSc, PMP's Cima Labs Experience November 2001 - November 2006
Job Director of New Product Development at Bimeda
Industry Pharmaceuticals
Experience
Bimeda October 2013 - Present
Bimeda December 2012 - September 2013
Amerilab Technologies September 2008 - March 2011
SurModics May 2007 - August 2008
CIMA Labs November 2001 - November 2006
3M Pharmaceuticals August 1986 - November 2001
Skills
GMP, Formulation Development, Coatings, FDA, Drug Delivery, R&D, Validation, Pharmaceuticals, Technology Transfer, Process Improvement, Medical Devices, Project Management, Quality Assurance, CMC Regulatory Affairs, 5S, Pharmaceutical Industry, Formulation, Cross-functional Team..., Lean Manufacturing, Quality System, Sop, CAPA, Manufacturing, Process Simulation, Six Sigma, Pharmaceutics, Product Launch, V&V, Design of Experiments, Commercialization, Regulatory Submissions, Product Development, Analytical Chemistry, ISO 13485, HPLC
Education
The University of Manchester 1993 — 1998
Masters, Industrial Pharmaceutical Sciences
Bimeda October 2013 - Present
Bimeda December 2012 - September 2013
Amerilab Technologies September 2008 - March 2011
SurModics May 2007 - August 2008
CIMA Labs November 2001 - November 2006
3M Pharmaceuticals August 1986 - November 2001
Skills
GMP, Formulation Development, Coatings, FDA, Drug Delivery, R&D, Validation, Pharmaceuticals, Technology Transfer, Process Improvement, Medical Devices, Project Management, Quality Assurance, CMC Regulatory Affairs, 5S, Pharmaceutical Industry, Formulation, Cross-functional Team..., Lean Manufacturing, Quality System, Sop, CAPA, Manufacturing, Process Simulation, Six Sigma, Pharmaceutics, Product Launch, V&V, Design of Experiments, Commercialization, Regulatory Submissions, Product Development, Analytical Chemistry, ISO 13485, HPLC
Education
The University of Manchester 1993 — 1998
Masters, Industrial Pharmaceutical Sciences
Michelle Ngatino's Cima Labs Experience June 2011 - September 2011
Job Quality Engineer at Stryker
Industry Medical Devices
Experience
Stryker August 2015 - Present
Society of Women Engineers - Golden Gate Section June 2013 - Present
Stryker (fka CoAlign Innovations) January 2013 - August 2015
Society of Women Engineers - Minnesota October 2012 - June 2013
Society of Women Engineers July 2012 - June 2013
St. Jude Medical April 2012 - December 2012
Society of Women Engineers - Minnesota July 2012 - September 2012
University of Minnesota October 2010 - April 2012
CIMA Labs June 2011 - September 2011
University of Minnesota December 2010 - May 2011
Skills
Biomedical Engineering, ELISA, R&D, Immunoassays, Medical Devices, C++, Visio, PCR, Laboratory, Matlab, Customer Service, GMP, SolidWorks, Microsoft Office, Cell Culture, LabVIEW, Chinese, Mathlab, CAPA, Manufacturing, Quality System, Quality System..., Change Control, Cross-functional Team..., FDA QSR, ISO 13485
Education
Santa Clara University 2015 — 2017
Master of Science (M.S.), Engineering Management and Leadership
University of Minnesota-Twin Cities 2008 — 2011
Bachelor of Biomedical Engineering, Biomedical Enginering
North Seattle College 2006 — 2008
AA, Engineering and Science
Stryker August 2015 - Present
Society of Women Engineers - Golden Gate Section June 2013 - Present
Stryker (fka CoAlign Innovations) January 2013 - August 2015
Society of Women Engineers - Minnesota October 2012 - June 2013
Society of Women Engineers July 2012 - June 2013
St. Jude Medical April 2012 - December 2012
Society of Women Engineers - Minnesota July 2012 - September 2012
University of Minnesota October 2010 - April 2012
CIMA Labs June 2011 - September 2011
University of Minnesota December 2010 - May 2011
Skills
Biomedical Engineering, ELISA, R&D, Immunoassays, Medical Devices, C++, Visio, PCR, Laboratory, Matlab, Customer Service, GMP, SolidWorks, Microsoft Office, Cell Culture, LabVIEW, Chinese, Mathlab, CAPA, Manufacturing, Quality System, Quality System..., Change Control, Cross-functional Team..., FDA QSR, ISO 13485
Education
Santa Clara University 2015 — 2017
Master of Science (M.S.), Engineering Management and Leadership
University of Minnesota-Twin Cities 2008 — 2011
Bachelor of Biomedical Engineering, Biomedical Enginering
North Seattle College 2006 — 2008
AA, Engineering and Science
Risheng Chen Risheng Chen's Cima Labs Experience 1999 - Present
Job Research Scientist at Teva Pharmaceuticals
Industry Pharmaceuticals
Experience
Teva Pharmaceuticals 2011 - Present
CIMA Labs 1999 - Present
Cephalon 2003 - 2011
Medtronic 1999 - 1999
Celgene 1997 - 1999
LNK International Inc. 1995 - 1997
Education
City University of New York-Queens College 1993 — 1995
MS, Analytical Chemistry
Fudan University
MS, Materials Science
Fudan University
BS, Chemistry
Teva Pharmaceuticals 2011 - Present
CIMA Labs 1999 - Present
Cephalon 2003 - 2011
Medtronic 1999 - 1999
Celgene 1997 - 1999
LNK International Inc. 1995 - 1997
Education
City University of New York-Queens College 1993 — 1995
MS, Analytical Chemistry
Fudan University
MS, Materials Science
Fudan University
BS, Chemistry
Katie Isiminger Katie Isiminger's Cima Labs Experience June 2004 - August 2005
Job Owner Alma Natural Spa, Inc.
Industry Consumer Goods
Experience
Alma Natural Spa, Inc. July 2011 - Present
L'Oreal USA April 2009 - July 2010
Wyeth October 2006 - April 2009
Schering-Plough Pharmaceuticals 2006 - 2006
CIMA Labs June 2004 - August 2005
CIMA Labs June 2002 - June 2004
Fox Enginnering 1998 - 2001
Education
New York University - Leonard N. Stern School of Business 2006 — 2009
MBA, Operations Management
Iowa State University 1997 — 2002
B.S., Chemical Engineering
Alma Natural Spa, Inc. July 2011 - Present
L'Oreal USA April 2009 - July 2010
Wyeth October 2006 - April 2009
Schering-Plough Pharmaceuticals 2006 - 2006
CIMA Labs June 2004 - August 2005
CIMA Labs June 2002 - June 2004
Fox Enginnering 1998 - 2001
Education
New York University - Leonard N. Stern School of Business 2006 — 2009
MBA, Operations Management
Iowa State University 1997 — 2002
B.S., Chemical Engineering
Brian M. Jones Brian M. Jones's Cima Labs Experience January 1994 - February 1998
Job Pharmaceutical and Medical Device Manufacturing
Industry Pharmaceuticals
Experience
U.S. and India Pharma Companies January 2008 - April 2009
Teva 2005 - 2008
Watson Pharmaceuticals June 1998 - September 2005
CIMA Labs January 1994 - February 1998
International Medication Systems, Inc. January 1990 - January 1994
Skills
FDA, V&V, Biotechnology, Regulatory Affairs, Biopharmaceuticals, Cross-functional Team..., GLP, Quality Assurance, Clinical Development, Pharmaceutics, 21 CFR Part 11, ISO 13485, Oncology, CRO, Clinical Trials, IND, Pharmaceutical Industry, HPLC, Aseptic Processing, Process Improvement, Manufacturing, Strategy, Product Launch, Commercialization, GCP, R&D, Leadership, Cleaning Validation, GMP, Validation, cGMP manufacturing, Management, Formulation, Lean Manufacturing, Regulatory Requirements
Education
California State University-Dominguez Hills 1978 — 1980
Graduate Studies
University of California, Irvine 1971 — 1975
BS Biological Science
University of California, Irvine
Bachelor of Applied Science (B.A.Sc.)
U.S. and India Pharma Companies January 2008 - April 2009
Teva 2005 - 2008
Watson Pharmaceuticals June 1998 - September 2005
CIMA Labs January 1994 - February 1998
International Medication Systems, Inc. January 1990 - January 1994
Skills
FDA, V&V, Biotechnology, Regulatory Affairs, Biopharmaceuticals, Cross-functional Team..., GLP, Quality Assurance, Clinical Development, Pharmaceutics, 21 CFR Part 11, ISO 13485, Oncology, CRO, Clinical Trials, IND, Pharmaceutical Industry, HPLC, Aseptic Processing, Process Improvement, Manufacturing, Strategy, Product Launch, Commercialization, GCP, R&D, Leadership, Cleaning Validation, GMP, Validation, cGMP manufacturing, Management, Formulation, Lean Manufacturing, Regulatory Requirements
Education
California State University-Dominguez Hills 1978 — 1980
Graduate Studies
University of California, Irvine 1971 — 1975
BS Biological Science
University of California, Irvine
Bachelor of Applied Science (B.A.Sc.)
Owen W. Hand, Ph.D.'s Cima Labs Experience 2006 - 2008
Job Director of Global Quality & Analytical Sciences at Vertellus
Industry Chemicals
Experience
Vertellus May 2011 - Present
Rapid Diagnostek April 2010 - November 2010
SurModics 2008 - 2010
CIMA Labs 2006 - 2008
BASF 2004 - 2006
ISP Fine Chemicals 1997 - 2004
Griffin LLC 1992 - 1997
Great Lakes Chemical Corporation 1990 - 1992
W.R. Grace 1989 - 1990
Skills
FDA, Iso 9000, APIs, GMP, CAPA, Validation, Analytical Chemistry, V&V, Technology Transfer, Quality System, GLP, HPLC, LIMS, Regulatory Affairs, Pharmaceutical Industry, R&D, Sop, Chemistry, Quality Assurance, Medical Devices, Cleaning Validation, Formulation, Manufacturing, Quality Control, Drug Delivery
Education
Purdue University 1984 — 1989
PhD, Analytical Chemistry
Monmouth University 1979 — 1983
B.S., Chemisry
Vertellus May 2011 - Present
Rapid Diagnostek April 2010 - November 2010
SurModics 2008 - 2010
CIMA Labs 2006 - 2008
BASF 2004 - 2006
ISP Fine Chemicals 1997 - 2004
Griffin LLC 1992 - 1997
Great Lakes Chemical Corporation 1990 - 1992
W.R. Grace 1989 - 1990
Skills
FDA, Iso 9000, APIs, GMP, CAPA, Validation, Analytical Chemistry, V&V, Technology Transfer, Quality System, GLP, HPLC, LIMS, Regulatory Affairs, Pharmaceutical Industry, R&D, Sop, Chemistry, Quality Assurance, Medical Devices, Cleaning Validation, Formulation, Manufacturing, Quality Control, Drug Delivery
Education
Purdue University 1984 — 1989
PhD, Analytical Chemistry
Monmouth University 1979 — 1983
B.S., Chemisry
Ehab Hamed Ehab Hamed's Cima Labs Experience August 2002 - May 2005
Job Pharmaceutical Commercialization Technology at Merck
Industry Pharmaceuticals
Experience
Merck 2015 - Present
Cubist Pharmaceuticals 2012 - Present
Cephalon 2011 - September 2012
Cephalon June 2005 - July 2011
CIMA Labs August 2002 - May 2005
Ain Shams University 2004 - 2004
Skills
Product Development, Drug Delivery, Patents, QbD, Contract Manufacturing, Technology Transfer, FDA, Quality by Design, Validation, Pharmaceutical Industry, GMP, Cross-functional Team..., Oncology, Sop, R&D, Regulatory Affairs, Clinical Trials, Biotechnology, GxP, Pharmaceutics, Biopharmaceuticals, Commercialization, Regulatory Submissions, HPLC, Clinical Development, Drug Development, Drug Discovery, Formulation, GLP, SOP
Education
University of Cincinnati 1998 — 2002
Ph.D., Industrial Pharmacy
Assiut University 1991 — 1996
B.S., Pharmaceutical Sciences
Executive Education/Harvard Business School 2009 — 2009
Strategy Course
Merck 2015 - Present
Cubist Pharmaceuticals 2012 - Present
Cephalon 2011 - September 2012
Cephalon June 2005 - July 2011
CIMA Labs August 2002 - May 2005
Ain Shams University 2004 - 2004
Skills
Product Development, Drug Delivery, Patents, QbD, Contract Manufacturing, Technology Transfer, FDA, Quality by Design, Validation, Pharmaceutical Industry, GMP, Cross-functional Team..., Oncology, Sop, R&D, Regulatory Affairs, Clinical Trials, Biotechnology, GxP, Pharmaceutics, Biopharmaceuticals, Commercialization, Regulatory Submissions, HPLC, Clinical Development, Drug Development, Drug Discovery, Formulation, GLP, SOP
Education
University of Cincinnati 1998 — 2002
Ph.D., Industrial Pharmacy
Assiut University 1991 — 1996
B.S., Pharmaceutical Sciences
Executive Education/Harvard Business School 2009 — 2009
Strategy Course
Stacey Rudolph Stacey Rudolph's Cima Labs Experience May 2014 - August 2014
Job Aspiring product developer for a food company
Industry
Experience
Ardent Mills September 2015 - Present
Lake Wapogasset Lutheran Bible Camp, Inc May 2015 - August 2015
St. Olaf College February 2015 - May 2015
St. Olaf College February 2014 - May 2015
St. Olaf College January 2013 - May 2015
CIMA Labs May 2014 - August 2014
St. Olaf College February 2013 - December 2013
St. Olaf College February 2013 - December 2013
Skills
Organometallic Chemistry, NMR, Research, Chemistry, NMR spectroscopy, GC-MS, Column Chromatography, Glove Box, ChemDraw, Catalysis, Chromatography, Organic Synthesis, Microsoft Excel, PowerPoint, Drug Delivery, Formulation, Microsoft Word
Education
St. Olaf College 2011 — 2015
Bachelor of Arts (BA), Chemistry, Summa Cum Laude
Ardent Mills September 2015 - Present
Lake Wapogasset Lutheran Bible Camp, Inc May 2015 - August 2015
St. Olaf College February 2015 - May 2015
St. Olaf College February 2014 - May 2015
St. Olaf College January 2013 - May 2015
CIMA Labs May 2014 - August 2014
St. Olaf College February 2013 - December 2013
St. Olaf College February 2013 - December 2013
Skills
Organometallic Chemistry, NMR, Research, Chemistry, NMR spectroscopy, GC-MS, Column Chromatography, Glove Box, ChemDraw, Catalysis, Chromatography, Organic Synthesis, Microsoft Excel, PowerPoint, Drug Delivery, Formulation, Microsoft Word
Education
St. Olaf College 2011 — 2015
Bachelor of Arts (BA), Chemistry, Summa Cum Laude
Jackie Torfin's Cima Labs Experience 2001 - 2004
Job Global Vice President at Heraeus Medical Components | Leading Strategic Initiatives and Contract Negotations
Industry Biotechnology
Experience
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
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
Scott Buchheit Scott Buchheit's Cima Labs Experience December 2003 - September 2012
Job Medical Device Regulatory Affairs Specialist seeking new opportunity in Twin Cities area
Industry Medical Devices
Experience
Smiths Medical September 2014 - January 2015
CIMA Labs December 2003 - September 2012
Interplastic Corporation January 1993 - November 2003
3M Corporation August 1990 - March 2003
Technical Ordnance Inc December 1988 - May 1989
Cortex Corporation December 1987 - November 1988
Skills
Validation, GMP, Six Sigma, FDA, Sop, Manufacturing, Medical Devices, Quality Control, Lean Manufacturing, Cross-functional Team..., R&D, Process Engineering, Pharmaceutics, Quality Management, ISO 13485, Pharmaceutical Industry, Regulatory Affairs, Technology Transfer, CAPA, Quality System, V&V, Change Control, SOP, 21 CFR Part 11, Testing, Quality Auditing, Quality Assurance, GLP, Design Control, Process Improvement, Management, Product Development, FDA GMP
Education
St. Cloud State University 2012 — 2014
Masters of Science, Regulatory Affairs & Services for Medical Devices
University of Minnesota 1983 — 1987
Degree: Bachelors Degree, Physics
Billings Senior High School 1980 — 1983
American Society for Quality
Smiths Medical September 2014 - January 2015
CIMA Labs December 2003 - September 2012
Interplastic Corporation January 1993 - November 2003
3M Corporation August 1990 - March 2003
Technical Ordnance Inc December 1988 - May 1989
Cortex Corporation December 1987 - November 1988
Skills
Validation, GMP, Six Sigma, FDA, Sop, Manufacturing, Medical Devices, Quality Control, Lean Manufacturing, Cross-functional Team..., R&D, Process Engineering, Pharmaceutics, Quality Management, ISO 13485, Pharmaceutical Industry, Regulatory Affairs, Technology Transfer, CAPA, Quality System, V&V, Change Control, SOP, 21 CFR Part 11, Testing, Quality Auditing, Quality Assurance, GLP, Design Control, Process Improvement, Management, Product Development, FDA GMP
Education
St. Cloud State University 2012 — 2014
Masters of Science, Regulatory Affairs & Services for Medical Devices
University of Minnesota 1983 — 1987
Degree: Bachelors Degree, Physics
Billings Senior High School 1980 — 1983
American Society for Quality
Erin Schaffer Erin Schaffer's Cima Labs Experience January 2011 - January 2012
Job Supply Chain Integration Engineer at John Deere
Industry Logistics and Supply Chain
Experience
John Deere March 2013 - Present
CIMA Labs January 2011 - January 2012
CIMA Labs January 2008 - December 2010
CIMA Labs October 2006 - December 2007
CIMA Labs August 2005 - September 2006
CIMA Labs April 2004 - July 2005
CIMA Labs January 2003 - March 2004
Skills
Continuous Improvement, Process Improvement, Strategic Planning, Supply Chain Management, Materials Management, Business Relationship..., Customer Service, Cross-functional Team..., Technology Transfer, Process Engineering, ERP, Scheduling, Pharmaceutical Industry, Manufacturing, Contract Manufacturing, Lean Manufacturing, SAP, APICS, FDA, GMP
Education
Iowa State University 1998 — 2002
Bachelor of Science, Chemical Engineering
John Deere March 2013 - Present
CIMA Labs January 2011 - January 2012
CIMA Labs January 2008 - December 2010
CIMA Labs October 2006 - December 2007
CIMA Labs August 2005 - September 2006
CIMA Labs April 2004 - July 2005
CIMA Labs January 2003 - March 2004
Skills
Continuous Improvement, Process Improvement, Strategic Planning, Supply Chain Management, Materials Management, Business Relationship..., Customer Service, Cross-functional Team..., Technology Transfer, Process Engineering, ERP, Scheduling, Pharmaceutical Industry, Manufacturing, Contract Manufacturing, Lean Manufacturing, SAP, APICS, FDA, GMP
Education
Iowa State University 1998 — 2002
Bachelor of Science, Chemical Engineering
Michael Winger Michael Winger's Cima Labs Experience April 2003 - November 2012
Job Manager at Fan HQ
Industry Hospital & Health Care
Experience
UnitedHealth Group September 2013 - May 2015
Prudential Financial November 2012 - May 2013
CIMA Labs April 2003 - November 2012
Pro Motorsports April 2000 - April 2003
Subway April 1995 - September 2001
Skills
Customer Service, Microsoft Office, Excel, Time Management, Troubleshooting, Customer Relations, Inventory Management, Scheduling, Bookkeeping, Team Building, Team Leadership, Teamwork, Packaging, Merchandising, GMP, Leadership, PowerPoint, Microsoft Word, Process Improvement, Pharmaceutical Industry, Training, Sales, Marketing, Management, Budgets, Outlook, FDA, Product Development, Recruiting, Event Management, Cross-functional Team..., Marketing Communications, Strategic Planning, Manufacturing, Operations Management, Social Media, Payroll, Event Planning, Research, Advertising, Facebook, Account Management, Public Speaking, Process Scheduler, Sales Management, Marketing Strategy, Project Management, Quality Assurance, Microsoft Excel
Education
Saint Mary's University of Minnesota 2011 — 2013
Bachelor of Applied Science, Marketing
Hennepin Technical College 2008 — 2011
Associate's degree, Professional Sales
UnitedHealth Group September 2013 - May 2015
Prudential Financial November 2012 - May 2013
CIMA Labs April 2003 - November 2012
Pro Motorsports April 2000 - April 2003
Subway April 1995 - September 2001
Skills
Customer Service, Microsoft Office, Excel, Time Management, Troubleshooting, Customer Relations, Inventory Management, Scheduling, Bookkeeping, Team Building, Team Leadership, Teamwork, Packaging, Merchandising, GMP, Leadership, PowerPoint, Microsoft Word, Process Improvement, Pharmaceutical Industry, Training, Sales, Marketing, Management, Budgets, Outlook, FDA, Product Development, Recruiting, Event Management, Cross-functional Team..., Marketing Communications, Strategic Planning, Manufacturing, Operations Management, Social Media, Payroll, Event Planning, Research, Advertising, Facebook, Account Management, Public Speaking, Process Scheduler, Sales Management, Marketing Strategy, Project Management, Quality Assurance, Microsoft Excel
Education
Saint Mary's University of Minnesota 2011 — 2013
Bachelor of Applied Science, Marketing
Hennepin Technical College 2008 — 2011
Associate's degree, Professional Sales
Jaclyn Wrona Jaclyn Wrona's Cima Labs Experience June 2014 - August 2014
Job Coach at Downers Grove Rebels
Industry Chemicals
Experience
Augustana College March 2014 - Present
Augustana College Concession Stand August 2013 - Present
CIMA Labs June 2014 - August 2014
Downers Grove Rebels November 2011 - August 2013
Augustana College March 2013 - May 2013
Dairy Queen March 2009 - October 2011
Rice Pool Water Park January 2009 - August 2010
Skills
Cpr Certified, Time Management, Critical Thinking, Athletics, First Aid, Student Leadership, Tutoring, Sports Coaching, Research, Microsoft Excel, Goal Oriented, Patience, Communication
Education
Augustana College 2011 — 2015
Chemistry, Chemistry, Junior
Augustana College March 2014 - Present
Augustana College Concession Stand August 2013 - Present
CIMA Labs June 2014 - August 2014
Downers Grove Rebels November 2011 - August 2013
Augustana College March 2013 - May 2013
Dairy Queen March 2009 - October 2011
Rice Pool Water Park January 2009 - August 2010
Skills
Cpr Certified, Time Management, Critical Thinking, Athletics, First Aid, Student Leadership, Tutoring, Sports Coaching, Research, Microsoft Excel, Goal Oriented, Patience, Communication
Education
Augustana College 2011 — 2015
Chemistry, Chemistry, Junior
Josh Plath's Cima Labs Experience August 2001 - October 2004
Job Technical Sales Specialist at AB SCIEX
Industry Medical Devices
Experience
AB SCIEX October 2007 - Present
Applied Biosystems 2007 - 2009
Thermo Fisher Scientific March 2005 - September 2007
3M October 2004 - May 2005
CIMA Labs August 2001 - October 2004
Skills
HPLC, Proteomics, Mass Spectrometry, Chromatography, LC-MS, Lifesciences, Biotechnology, Chemistry, Laboratory Automation, Analytical Chemistry, Metabolomics, Protein Chemistry, Biochemistry, Purification, Drug Discovery, Molecular Biology, Assay Development, GLP, Genomics, GC-MS, UV/Vis, Gas Chromatography, Immunoassays, LIMS, R&D, Sop, Protein Purification, Method Development, Validation, Laboratory, Spectroscopy, ELISA, DNA sequencing, SOP, Life Sciences
Education
St. Cloud State University 1997 — 2001
Bachlors, Chemistry, Biology
Prescott High School
AB SCIEX October 2007 - Present
Applied Biosystems 2007 - 2009
Thermo Fisher Scientific March 2005 - September 2007
3M October 2004 - May 2005
CIMA Labs August 2001 - October 2004
Skills
HPLC, Proteomics, Mass Spectrometry, Chromatography, LC-MS, Lifesciences, Biotechnology, Chemistry, Laboratory Automation, Analytical Chemistry, Metabolomics, Protein Chemistry, Biochemistry, Purification, Drug Discovery, Molecular Biology, Assay Development, GLP, Genomics, GC-MS, UV/Vis, Gas Chromatography, Immunoassays, LIMS, R&D, Sop, Protein Purification, Method Development, Validation, Laboratory, Spectroscopy, ELISA, DNA sequencing, SOP, Life Sciences
Education
St. Cloud State University 1997 — 2001
Bachlors, Chemistry, Biology
Prescott High School
Preeta Maitra's Cima Labs Experience May 2008 - August 2008
Job Project Engineer at Whirlpool Corporation
Industry Consumer Goods
Experience
Whirlpool Corporation July 2013 - Present
Whirlpool Corporation July 2011 - June 2013
General Mills May 2010 - August 2010
General Mills May 2009 - August 2009
CIMA Labs May 2008 - August 2008
Skills
Engineering, Process Improvement, Design of Experiments, Teamwork, Project Management, Manufacturing, Team Leadership, Cross-functional Team..., Leadership, Operational Excellence, Research, Public Speaking, Time Management, Strategy, Six Sigma
Education
The University of Texas at Austin - Red McCombs School of Business 2015 — 2017
MBA
University of Michigan 2007 — 2011
Bachelor of Science (BS), Chemical Engineering
Whirlpool Corporation July 2013 - Present
Whirlpool Corporation July 2011 - June 2013
General Mills May 2010 - August 2010
General Mills May 2009 - August 2009
CIMA Labs May 2008 - August 2008
Skills
Engineering, Process Improvement, Design of Experiments, Teamwork, Project Management, Manufacturing, Team Leadership, Cross-functional Team..., Leadership, Operational Excellence, Research, Public Speaking, Time Management, Strategy, Six Sigma
Education
The University of Texas at Austin - Red McCombs School of Business 2015 — 2017
MBA
University of Michigan 2007 — 2011
Bachelor of Science (BS), Chemical Engineering
Ron Rossmeisl Ron Rossmeisl's Cima Labs Experience June 1988 - August 2013
Job Process/Project Engineer at BayerAnimal Health
Industry Pharmaceuticals
Experience
Bayer Animal Health September 2013 - Present
CIMA Labs June 1988 - August 2013
Skills
Packaging Engineering, GMP, Packaging, Pharmaceuticals, Manufacturing, FDA, Engineering, Process Improvement, Troubleshooting, Pharmaceutical Industry, Product Development, FDA GMP, Cross-functional Team..., Quality System, Technology Transfer, Continuous Improvement, Problem Solving, CAPA, Drug Delivery, Validation, Pharmaceutics, Cleaning Validation, V&V, 5S, Regulatory Affairs, Lean Manufacturing, Sop, 21 CFR Part 11, Change Control, ISO 13485, Medical Devices, R&D, Contract Manufacturing, Quality Assurance, Analytical Chemistry, LIMS, Process Simulation, Leadership, Six Sigma, Quality by Design, GLP, Process Engineering, Biotechnology, Quality Control, Formulation, Regulatory Requirements, Equipment Qualification, Trackwise, Dissolution, Regulatory Submissions
Education
Minnesota State University, Mankato 2007 — 2013
BS in Mechanical Engineering
Normandale Community College 2007 — 2011
Bayer Animal Health September 2013 - Present
CIMA Labs June 1988 - August 2013
Skills
Packaging Engineering, GMP, Packaging, Pharmaceuticals, Manufacturing, FDA, Engineering, Process Improvement, Troubleshooting, Pharmaceutical Industry, Product Development, FDA GMP, Cross-functional Team..., Quality System, Technology Transfer, Continuous Improvement, Problem Solving, CAPA, Drug Delivery, Validation, Pharmaceutics, Cleaning Validation, V&V, 5S, Regulatory Affairs, Lean Manufacturing, Sop, 21 CFR Part 11, Change Control, ISO 13485, Medical Devices, R&D, Contract Manufacturing, Quality Assurance, Analytical Chemistry, LIMS, Process Simulation, Leadership, Six Sigma, Quality by Design, GLP, Process Engineering, Biotechnology, Quality Control, Formulation, Regulatory Requirements, Equipment Qualification, Trackwise, Dissolution, Regulatory Submissions
Education
Minnesota State University, Mankato 2007 — 2013
BS in Mechanical Engineering
Normandale Community College 2007 — 2011
Derek Moe Derek Moe's Cima Labs Experience January 2001 - Present
Job Vice President, Drug Delivery Technologies at CIMA Labs
Industry Pharmaceuticals
Experience
CIMA Labs January 2001 - Present
Agouron Pharmaceuticals Inc. 1995 - 2000
Syntex March 1994 - November 1995
Skills
Drug Delivery, Pharmaceutics, Chemistry, Pharmaceutical Industry, Biotechnology, R&D, GMP, Technology Transfer, Drug Development
Education
University of Minnesota-Twin Cities 1989 — 1994
Ph.D., Pharmaceutics
St. Olaf College 1986 — 1989
B.A., Chemistry and Math
CIMA Labs January 2001 - Present
Agouron Pharmaceuticals Inc. 1995 - 2000
Syntex March 1994 - November 1995
Skills
Drug Delivery, Pharmaceutics, Chemistry, Pharmaceutical Industry, Biotechnology, R&D, GMP, Technology Transfer, Drug Development
Education
University of Minnesota-Twin Cities 1989 — 1994
Ph.D., Pharmaceutics
St. Olaf College 1986 — 1989
B.A., Chemistry and Math
Jessica Koehnen (Struck)'s Cima Labs Experience February 2001 - January 2012
Job Applications Developer at Teva Pharmaceuticals
Industry Pharmaceuticals
Experience
Teva Pharmaceuticals January 2012 - Present
Teva Pharmaceuticals October 2011 - January 2012
Cephalon February 2001 - January 2012
CIMA Labs February 2001 - January 2012
Twin City Catering, Inc. June 2000 - March 2001
McLeod USA October 1998 - June 2000
Skills
FDA, Sop, Validation, CAPA, GMP, Change Control, Pharmaceutical Industry, TrackWise, ComplianceWire, Software Validation, Software Development
Education
KRS 2000 — 2001
Technical, Database Design and Administration
The University of Kansas 1994 — 1995
Japanese/Business
Teva Pharmaceuticals January 2012 - Present
Teva Pharmaceuticals October 2011 - January 2012
Cephalon February 2001 - January 2012
CIMA Labs February 2001 - January 2012
Twin City Catering, Inc. June 2000 - March 2001
McLeod USA October 1998 - June 2000
Skills
FDA, Sop, Validation, CAPA, GMP, Change Control, Pharmaceutical Industry, TrackWise, ComplianceWire, Software Validation, Software Development
Education
KRS 2000 — 2001
Technical, Database Design and Administration
The University of Kansas 1994 — 1995
Japanese/Business
Chad Whiterabbit Chad Whiterabbit's Cima Labs Experience August 2002 - August 2004
Job Sr. Biocompatibility Manager at Medtronic
Industry Medical Devices
Experience
Medtronic May 2015 - Present
Medtronic October 2013 - May 2015
Medtronic October 2011 - October 2013
Medtronic October 2007 - October 2011
Medtronic March 2006 - October 2007
Cephalon/TEVA (CIMA labs) August 2004 - March 2006
CIMA Labs August 2002 - August 2004
CIMA Labs August 2000 - August 2002
CIMA Labs August 1999 - August 2000
CIMA Labs August 1997 - August 1999
Skills
Quality Systems, Medical Devices, Product Development, Quality Assurance, Process Improvement, Engineering, Technology Transfer, Pharmaceuticals, Cross-functional Team..., FDA, Continuous Improvement, Manufacturing, Lean Manufacturing, Scheduling, Supervisory Skills, Inventory Management, GMP, Visio, Product Launch, Supply Chain, Supply Chain Management, Auditing, Strategic Planning, ISO 13485, Operations Management, ERP, Customer Service, Microsoft Office, Excel, Word, Budgeting, Problem Solving, Contract Negotiation, Cost Reduction, Process Validation, Team Building, Engineering Management, Validation, CAPA, Quality Engineering, Process Development, Process Engineering, ISO, Quality Management, Manufacturing..., Value Stream Mapping, Program Management, Operational Excellence, Change Management, Supplier Management
Education
Saint Cloud State University 2009 — 2010
ME, Engineering Management
University of Minnesota Duluth 1989 — 1994
BS, Biology
North Dakota State University 1987 — 1989
Architecture
Medtronic May 2015 - Present
Medtronic October 2013 - May 2015
Medtronic October 2011 - October 2013
Medtronic October 2007 - October 2011
Medtronic March 2006 - October 2007
Cephalon/TEVA (CIMA labs) August 2004 - March 2006
CIMA Labs August 2002 - August 2004
CIMA Labs August 2000 - August 2002
CIMA Labs August 1999 - August 2000
CIMA Labs August 1997 - August 1999
Skills
Quality Systems, Medical Devices, Product Development, Quality Assurance, Process Improvement, Engineering, Technology Transfer, Pharmaceuticals, Cross-functional Team..., FDA, Continuous Improvement, Manufacturing, Lean Manufacturing, Scheduling, Supervisory Skills, Inventory Management, GMP, Visio, Product Launch, Supply Chain, Supply Chain Management, Auditing, Strategic Planning, ISO 13485, Operations Management, ERP, Customer Service, Microsoft Office, Excel, Word, Budgeting, Problem Solving, Contract Negotiation, Cost Reduction, Process Validation, Team Building, Engineering Management, Validation, CAPA, Quality Engineering, Process Development, Process Engineering, ISO, Quality Management, Manufacturing..., Value Stream Mapping, Program Management, Operational Excellence, Change Management, Supplier Management
Education
Saint Cloud State University 2009 — 2010
ME, Engineering Management
University of Minnesota Duluth 1989 — 1994
BS, Biology
North Dakota State University 1987 — 1989
Architecture
Greg Schaffer Greg Schaffer's Cima Labs Experience January 2007 - January 2008
Job Senior Reliability Engineer at John Deere
Industry Machinery
Experience
John Deere May 2015 - Present
John Deere February 2012 - Present
Medtronic December 2009 - February 2012
Medtronic July 2009 - December 2009
Medtronic January 2008 - July 2009
CIMA Labs January 2007 - January 2008
CIMA Labs January 2006 - January 2007
CIMA Labs July 2003 - January 2006
CIMA Labs May 2002 - July 2003
Skills
ASQ Certified...
Education
Iowa State University 1998 — 2002
B.S., Mechanical Engineering
John Deere May 2015 - Present
John Deere February 2012 - Present
Medtronic December 2009 - February 2012
Medtronic July 2009 - December 2009
Medtronic January 2008 - July 2009
CIMA Labs January 2007 - January 2008
CIMA Labs January 2006 - January 2007
CIMA Labs July 2003 - January 2006
CIMA Labs May 2002 - July 2003
Skills
ASQ Certified...
Education
Iowa State University 1998 — 2002
B.S., Mechanical Engineering
Anthony Awuah. PharmD, Rph, MHHSA Anthony Awuah. PharmD, Rph, MHHSA's Cima Labs Experience August 2008 - August 2012
Job Pharmacist at CVS Pharmacy
Industry Pharmaceuticals
Experience
CVS Pharmacy August 2015 - Present
MCPHS University September 2012 - May 2015
CVS Caremark pharmacy September 2013 - November 2013
Fairlawn rehab hospital August 2013 - September 2013
CIMA Labs August 2008 - August 2012
City of Bloomington November 2008 - December 2008
Kemps Milk Plant February 2008 - July 2008
Guinness Ghana Limited June 2005 - August 2007
Skills
FDA, GMP, GLP, Sop, Trackwise, Biotechnology
Education
Massachusetts College of Pharmacy and Health Sciences 2012 — 2015
Doctor of Pharmacy (Pharm.D.), Pharmacy
St. Marys University of Minnesota 2007 — 2009
Master of Arts, Health and Human Services Administration
Kwame Nkrumah' University of Science and Technology, Kumasi 2002 — 2006
Bachelor of Science, Biochemistry
Prempeh College
CVS Pharmacy August 2015 - Present
MCPHS University September 2012 - May 2015
CVS Caremark pharmacy September 2013 - November 2013
Fairlawn rehab hospital August 2013 - September 2013
CIMA Labs August 2008 - August 2012
City of Bloomington November 2008 - December 2008
Kemps Milk Plant February 2008 - July 2008
Guinness Ghana Limited June 2005 - August 2007
Skills
FDA, GMP, GLP, Sop, Trackwise, Biotechnology
Education
Massachusetts College of Pharmacy and Health Sciences 2012 — 2015
Doctor of Pharmacy (Pharm.D.), Pharmacy
St. Marys University of Minnesota 2007 — 2009
Master of Arts, Health and Human Services Administration
Kwame Nkrumah' University of Science and Technology, Kumasi 2002 — 2006
Bachelor of Science, Biochemistry
Prempeh College
Andrew Kraling's Cima Labs Experience June 2001 - August 2004
Job Consultant, Quality Engineering at St. Jude Medical
Industry Real Estate
Experience
St. Jude Medical March 2013 - Present
Initiator Investments, LLC August 2006 - February 2013
St. Jude Medical 2013 - 2013
Boston Scientific July 2004 - July 2006
CIMA LABS June 2001 - August 2004
CIMA Labs February 2003 - January 2004
Skills
Process Development, Statistics, Product Design, Six Sigma, Minitab, Visio, CAD, Gage R&R, MS Project, Process Simulation, Lean Manufacturing, FDA, Validation, Process Improvement, Product Development, Manufacturing, Quality Assurance, Cross-functional Team...
Education
University of Minnesota - Carlson School of Management 2002 — 2004
Master of Business Administration, Entrepreneurship and Operations
Rose-Hulman Institute of Technology 1997 — 2001
BS, Mechanical Engineering
St. Jude Medical March 2013 - Present
Initiator Investments, LLC August 2006 - February 2013
St. Jude Medical 2013 - 2013
Boston Scientific July 2004 - July 2006
CIMA LABS June 2001 - August 2004
CIMA Labs February 2003 - January 2004
Skills
Process Development, Statistics, Product Design, Six Sigma, Minitab, Visio, CAD, Gage R&R, MS Project, Process Simulation, Lean Manufacturing, FDA, Validation, Process Improvement, Product Development, Manufacturing, Quality Assurance, Cross-functional Team...
Education
University of Minnesota - Carlson School of Management 2002 — 2004
Master of Business Administration, Entrepreneurship and Operations
Rose-Hulman Institute of Technology 1997 — 2001
BS, Mechanical Engineering
Deby Notermann's Cima Labs Experience August 2000 - April 2012
Job Senior accountant
Industry Pharmaceuticals
Experience
Patterson Dental November 2014 - Present
Robert Half International June 2013 - October 2013
CIMA Labs August 2000 - April 2012
CIMA Labs 2000 - 2012
Skills
Auditing, Sarbanes-Oxley Act, Validation, Financial Reporting, FDA, Quality Auditing, Sop, Internal Audit, Pharmaceutical Industry, Cost Accounting, Change Control, Process Improvement, Budgets, Forecasting, Payroll, Manufacturing, SEC filings, Software Documentation, Due Diligence, Analysis, CAPA, Accounting, Accounts Payable, GAAP, Financial Accounting, ERP, Internal Controls, Fixed Assets, Account Reconciliation, Journal Entries, US GAAP
Education
University of Minnesota - Carlson School of Management 1990 — 1995
Bachelor of Science, Accounting
Normandale Community College
Associate of Arts and Sciences (AAS), Mathematics
Patterson Dental November 2014 - Present
Robert Half International June 2013 - October 2013
CIMA Labs August 2000 - April 2012
CIMA Labs 2000 - 2012
Skills
Auditing, Sarbanes-Oxley Act, Validation, Financial Reporting, FDA, Quality Auditing, Sop, Internal Audit, Pharmaceutical Industry, Cost Accounting, Change Control, Process Improvement, Budgets, Forecasting, Payroll, Manufacturing, SEC filings, Software Documentation, Due Diligence, Analysis, CAPA, Accounting, Accounts Payable, GAAP, Financial Accounting, ERP, Internal Controls, Fixed Assets, Account Reconciliation, Journal Entries, US GAAP
Education
University of Minnesota - Carlson School of Management 1990 — 1995
Bachelor of Science, Accounting
Normandale Community College
Associate of Arts and Sciences (AAS), Mathematics
Deb Ratte's Cima Labs Experience 2002 - 2006
Job Project Manager at IBM
Industry Information Technology and Services
Experience
IBM September 2010 - Present
Paddock Laboratories 2006 - Present
Paddock Labs 2006 - Present
Paddock Laboratories 2006 - 2009
CIMA Labs 2002 - 2006
CIMA Labs (a Cephalon Company) 2002 - 2006
Education
Illinois Wesleyan University
IBM September 2010 - Present
Paddock Laboratories 2006 - Present
Paddock Labs 2006 - Present
Paddock Laboratories 2006 - 2009
CIMA Labs 2002 - 2006
CIMA Labs (a Cephalon Company) 2002 - 2006
Education
Illinois Wesleyan University
Wroblewski, Kari's Cima Labs Experience 1997 - 2002
Job Quality Assurance Manager at UAS Laboratories, The Probiotic Company
Industry Medical Devices
Experience
UAS Laboratories, The Probiotic Company June 2015 - Present
RR Donnelley Global Turnkey Solutions February 2012 - June 2015
Morris Consulting April 2004 - June 2015
Ortho Molecular Products February 2009 - October 2011
Orphan Medical July 2002 - June 2003
CIMA Labs 1997 - 2002
Skills
Change Control, FDA, Regulatory Affairs, Quality Auditing, Software Documentation, Validation, Pharmaceutical Industry, Quality System, CAPA, GMP, ISO 13485, Medical Devices, Quality Assurance, Sop, Quality Control
Education
Bemidji State University 1993 — 1997
Bachelor of Science, Environmental Studies/Chemistry
UAS Laboratories, The Probiotic Company June 2015 - Present
RR Donnelley Global Turnkey Solutions February 2012 - June 2015
Morris Consulting April 2004 - June 2015
Ortho Molecular Products February 2009 - October 2011
Orphan Medical July 2002 - June 2003
CIMA Labs 1997 - 2002
Skills
Change Control, FDA, Regulatory Affairs, Quality Auditing, Software Documentation, Validation, Pharmaceutical Industry, Quality System, CAPA, GMP, ISO 13485, Medical Devices, Quality Assurance, Sop, Quality Control
Education
Bemidji State University 1993 — 1997
Bachelor of Science, Environmental Studies/Chemistry
Kathryn Angell's Cima Labs Experience June 2003 - March 2006
Job Director, Quality and Regulatory Compliance at Anteco Pharma
Industry Medical Devices
Experience
Anteco Pharma June 2013 - Present
Galil Medical November 2009 - Present
Genmab MN, Inc. March 2008 - September 2009
PDL BioPharma January 2007 - March 2008
PDL Biopharma March 2006 - January 2007
CIMA Labs June 2003 - March 2006
Beckman Coulter & CIMA Labs June 1999 - June 2003
Beckman Coulter June 1989 - April 1999
Skills
Quality System, FDA, Risk Analysis, Process Improvement, CAPA, Compliance, Quality Management, Medical Devices, Quality Assurance, ISO 13485, GMP, 21 CFR Part 11, Change Control, GLP, Regulatory Requirements, GxP, ISO 14971, V&V, Design Control, Validation, LIMS, Quality Auditing, Sop, Computer System..., Regulatory Affairs, Manufacturing, ISO, Cross-functional Team..., Quality Control
Education
St. Cloud State University 1977 — 1981
BA, Biology- Microbiology
Anteco Pharma June 2013 - Present
Galil Medical November 2009 - Present
Genmab MN, Inc. March 2008 - September 2009
PDL BioPharma January 2007 - March 2008
PDL Biopharma March 2006 - January 2007
CIMA Labs June 2003 - March 2006
Beckman Coulter & CIMA Labs June 1999 - June 2003
Beckman Coulter June 1989 - April 1999
Skills
Quality System, FDA, Risk Analysis, Process Improvement, CAPA, Compliance, Quality Management, Medical Devices, Quality Assurance, ISO 13485, GMP, 21 CFR Part 11, Change Control, GLP, Regulatory Requirements, GxP, ISO 14971, V&V, Design Control, Validation, LIMS, Quality Auditing, Sop, Computer System..., Regulatory Affairs, Manufacturing, ISO, Cross-functional Team..., Quality Control
Education
St. Cloud State University 1977 — 1981
BA, Biology- Microbiology
Dick Welter's Cima Labs Experience 2006 - 2010
Job Pharmaceutical Licensing & Business Development Consultant
Industry Pharmaceuticals
Experience
RJWelter BD&L Global, LLC January 2014 - Present
Euthymics Bioscience, Inc. February 2012 - December 2013
CIMA Labs 2006 - 2010
VioQuest June 2005 - June 2006
Vela Pharma July 2003 - June 2005
Pharmacia 1979 - 2003
Education
Iowa State University 1971 — 1976
Ph.D., Genetics
Creighton University 1965 — 1968
B.S., Biology
Wahlert
Wahlert
Wahlert
Wahlert
RJWelter BD&L Global, LLC January 2014 - Present
Euthymics Bioscience, Inc. February 2012 - December 2013
CIMA Labs 2006 - 2010
VioQuest June 2005 - June 2006
Vela Pharma July 2003 - June 2005
Pharmacia 1979 - 2003
Education
Iowa State University 1971 — 1976
Ph.D., Genetics
Creighton University 1965 — 1968
B.S., Biology
Wahlert
Wahlert
Wahlert
Wahlert
Kym Lum, MS, RAC's Cima Labs Experience 2000 - 2003
Job Principal Regulatory Affairs Specialist at Medtronic
Industry Medical Devices
Experience
Medtronic CRHF June 2014 - Present
Medtronic Neuromodulation 2009 - Present
Medtronic Neuromodulation 2004 - August 2010
Boston Scientific 2002 - 2004
CIMA Labs 2000 - 2003
Chiron 1997 - 2000
Millipore Corporation 1995 - 1997
Skills
Medical Devices, Validation, Manufacturing, Quality Assurance, CAPA, Quality Auditing, Quality System, ISO 13485, Six Sigma, Design Control, FDA, GMP, ISO 14971, 21 CFR Part 11
Education
Brandeis University
Bachelor of Arts (B.A.)
Harvard University
Massachusetts Institute of Technology
The Johns Hopkins University
Master of Science (M.S.)
University of St. Thomas - Opus College of Business
Medtronic CRHF June 2014 - Present
Medtronic Neuromodulation 2009 - Present
Medtronic Neuromodulation 2004 - August 2010
Boston Scientific 2002 - 2004
CIMA Labs 2000 - 2003
Chiron 1997 - 2000
Millipore Corporation 1995 - 1997
Skills
Medical Devices, Validation, Manufacturing, Quality Assurance, CAPA, Quality Auditing, Quality System, ISO 13485, Six Sigma, Design Control, FDA, GMP, ISO 14971, 21 CFR Part 11
Education
Brandeis University
Bachelor of Arts (B.A.)
Harvard University
Massachusetts Institute of Technology
The Johns Hopkins University
Master of Science (M.S.)
University of St. Thomas - Opus College of Business
Shelly Neukircher's Cima Labs Experience March 2002 - November 2006
Job Scientist II at Roxane Laboratories
Industry Pharmaceuticals
Experience
Roxane Laboratories December 2007 - Present
CIMA Labs March 2002 - November 2006
Education
Gustavus Adolphus College 1992 — 1996
Roxane Laboratories December 2007 - Present
CIMA Labs March 2002 - November 2006
Education
Gustavus Adolphus College 1992 — 1996
Debbie Holmes's Cima Labs Experience 2003 - 2003
Job Quality Director at Heraeus Medical Components
Industry Pharmaceuticals
Experience
Heraeus Medical Components November 2014 - Present
Apex International Mfg, Inc. August 2014 - October 2014
Biovest International February 2010 - April 2014
WuXi AppTec April 2005 - January 2010
Tapemark 2003 - 2005
CIMA Labs 2003 - 2003
MGI PHARMA 2001 - 2003
Beckman 1992 - 1997
Skills
Cleaning Validation, Clinical Trials, Validation, Management Review, LIMS, Deviations, Batch Release, ISO 13485, Vaccines, Change Control, Regulatory Affairs, GxP, GMP, FDA GMP, Deviation Management, ISO 17025, FDA, Pharmaceutical Industry, Sterilization, Regulatory Submissions, Consent Decree, CAPA, HPLC, Computer System..., Drug Development, Validation Master Plans, Technology Transfer, Clinical Development, Trackwise, Immunology, Sop, Aseptic Processing, Quality Assurance, Pharmaceutics, V&V, Quality Auditing, 21 CFR Part 11, Analytical Chemistry, Biocompatibility, Biotechnology, Lifesciences, USP, Quality System, Medical Devices, CAPAs, Design Control, GCP, Biopharmaceuticals, GLP, MHRA
Education
Rutgers University-New Brunswick 1976 — 1980
Heraeus Medical Components November 2014 - Present
Apex International Mfg, Inc. August 2014 - October 2014
Biovest International February 2010 - April 2014
WuXi AppTec April 2005 - January 2010
Tapemark 2003 - 2005
CIMA Labs 2003 - 2003
MGI PHARMA 2001 - 2003
Beckman 1992 - 1997
Skills
Cleaning Validation, Clinical Trials, Validation, Management Review, LIMS, Deviations, Batch Release, ISO 13485, Vaccines, Change Control, Regulatory Affairs, GxP, GMP, FDA GMP, Deviation Management, ISO 17025, FDA, Pharmaceutical Industry, Sterilization, Regulatory Submissions, Consent Decree, CAPA, HPLC, Computer System..., Drug Development, Validation Master Plans, Technology Transfer, Clinical Development, Trackwise, Immunology, Sop, Aseptic Processing, Quality Assurance, Pharmaceutics, V&V, Quality Auditing, 21 CFR Part 11, Analytical Chemistry, Biocompatibility, Biotechnology, Lifesciences, USP, Quality System, Medical Devices, CAPAs, Design Control, GCP, Biopharmaceuticals, GLP, MHRA
Education
Rutgers University-New Brunswick 1976 — 1980
Dale Hoyd's Cima Labs Experience December 2006 - February 2009
Job Manager Computerized Systems Validation at UpsherSmith Laboratories
Industry Pharmaceuticals
Experience
Upsher-Smith Laboratories February 2009 - Present
CIMA LABS December 2006 - February 2009
CIMA Labs (a Cephalon Company) December 2006 - February 2009
GE Healthcare July 1998 - November 2006
Education
Elmhurst College 1992 — 1996
Upsher-Smith Laboratories February 2009 - Present
CIMA LABS December 2006 - February 2009
CIMA Labs (a Cephalon Company) December 2006 - February 2009
GE Healthcare July 1998 - November 2006
Education
Elmhurst College 1992 — 1996
Melissa Timm's Cima Labs Experience January 2004 - December 2010
Job EHS and Project Engineering Manager at Perrigo
Industry Pharmaceuticals
Experience
Perrigo December 2010 - Present
CIMA Labs January 2004 - December 2010
Siemens Healthcare May 2003 - August 2003
Steensen Varming May 2002 - August 2002
Elgin Sweeper May 2001 - August 2001
Skills
Manufacturing, Engineering, Pharmaceuticals, Safety, Validation, GMP, FDA, Lean Manufacturing, Six Sigma, 5S, Process Engineering, CAPA, Continuous Improvement, Process Improvement, Project Management
Education
University of St. Thomas - Opus College of Business 2008 — 2011
Masters, Business Administration
Iowa State University 1999 — 2003
BS, Mechanical Engineering
Perrigo December 2010 - Present
CIMA Labs January 2004 - December 2010
Siemens Healthcare May 2003 - August 2003
Steensen Varming May 2002 - August 2002
Elgin Sweeper May 2001 - August 2001
Skills
Manufacturing, Engineering, Pharmaceuticals, Safety, Validation, GMP, FDA, Lean Manufacturing, Six Sigma, 5S, Process Engineering, CAPA, Continuous Improvement, Process Improvement, Project Management
Education
University of St. Thomas - Opus College of Business 2008 — 2011
Masters, Business Administration
Iowa State University 1999 — 2003
BS, Mechanical Engineering
Jessica Howden's Cima Labs Experience 2003 - 2003
Job Technology Supervisor 3M Company
Industry Machinery
Experience
3M April 2012 - Present
3M August 2010 - December 2011
3m June 2003 - August 2010
cima labs 2003 - 2003
medtronic 2002 - 2002
ibm 2001 - 2001
dakota electric 1998 - 2000
Skills
Six Sigma, Manufacturing, Automation, Cross-functional Team..., Product Development, Minitab, AutoCAD, Systems Engineering, MS Project, Project Management, Design of Experiments, Pro Engineer, Team Leadership
Education
North Dakota State University 1998 — 2002
Bachelor's degree, Electrical and Electronics Engineering
3M April 2012 - Present
3M August 2010 - December 2011
3m June 2003 - August 2010
cima labs 2003 - 2003
medtronic 2002 - 2002
ibm 2001 - 2001
dakota electric 1998 - 2000
Skills
Six Sigma, Manufacturing, Automation, Cross-functional Team..., Product Development, Minitab, AutoCAD, Systems Engineering, MS Project, Project Management, Design of Experiments, Pro Engineer, Team Leadership
Education
North Dakota State University 1998 — 2002
Bachelor's degree, Electrical and Electronics Engineering
Mary S. Mack's Cima Labs Experience June 2002 - Present
Job Project Manager at CIMA Labs
Industry Pharmaceuticals
Experience
CIMA Labs June 2002 - Present
CIMA Labs June 2002 - January 2011
Lec Tec Corp 1995 - 2002
Education
College of St. Benedict 1991 — 1995
BA, Biology
CIMA Labs June 2002 - Present
CIMA Labs June 2002 - January 2011
Lec Tec Corp 1995 - 2002
Education
College of St. Benedict 1991 — 1995
BA, Biology
Sandy Saunders's Cima Labs Experience April 2003 - February 2008
Job Staff Accountant I at Advanced Solutions International, Inc.
Industry Accounting
Experience
Advanced Solutions International, Inc. June 2012 - Present
Accountemps June 2011 - December 2012
GMAC May 2009 - September 2009
Center for Diagnostic Imaging February 2009 - February 2009
Best Buy April 2008 - January 2009
CIMA Labs April 2003 - February 2008
Uniprise January 2000 - July 2002
S & G Alteration Service August 1991 - January 2000
Skills
Journal Entries, Retail, Auditing, Sarbanes-Oxley Act, Payroll, Financial Reporting, Accounting, Accounts Payable, Budgets, Financial Analysis, GAAP, General Ledger, SAP, Management, Account Reconciliation, Accounts Receivable, Concur, Microsoft Dynamics GP, Microsoft Excel, Process Improvement, Accounts Payable
Education
Minnesota School of Business 2006 — 2008
B S, Accounting
St Cloud Technical High School 1980 — 1984
Advanced Solutions International, Inc. June 2012 - Present
Accountemps June 2011 - December 2012
GMAC May 2009 - September 2009
Center for Diagnostic Imaging February 2009 - February 2009
Best Buy April 2008 - January 2009
CIMA Labs April 2003 - February 2008
Uniprise January 2000 - July 2002
S & G Alteration Service August 1991 - January 2000
Skills
Journal Entries, Retail, Auditing, Sarbanes-Oxley Act, Payroll, Financial Reporting, Accounting, Accounts Payable, Budgets, Financial Analysis, GAAP, General Ledger, SAP, Management, Account Reconciliation, Accounts Receivable, Concur, Microsoft Dynamics GP, Microsoft Excel, Process Improvement, Accounts Payable
Education
Minnesota School of Business 2006 — 2008
B S, Accounting
St Cloud Technical High School 1980 — 1984
Hal Westreich's Cima Labs Experience May 1994 - December 1997
Job Principal at Pharmaceutical Quality Consulting
Industry Pharmaceuticals
Experience
Pharmaceutical Quality Consulting October 2007 - Present
Kimberly-Clark 2008 - December 2014
Poniard Pharmaceuticals May 2006 - October 2007
Chiron Corporation April 2004 - May 2006
Cell Therapeutics, Inc. June 1998 - December 2003
CIMA Labs May 1994 - December 1997
Bayer HealthCare April 1991 - April 1994
Medi-Physics November 1985 - February 1991
E.R. Squibb January 1977 - October 1985
Skills
FDA, Pharmaceutical Industry, GMP, Biotechnology, Validation, GLP, CAPA, Drug Development, Quality System, Quality Assurance, Medical Devices, R&D, Biopharmaceuticals, Analytical Chemistry, SOP, CRO, Life Sciences, Manufacturing, V&V, Quality Control, HPLC
Education
The University of Connecticut 1974 — 1976
MS, Chemistry
Rutgers, The State University of New Jersey-New Brunswick 1970 — 1974
Bachelor of Arts (B.A.), Physical Chemistry
Pharmaceutical Quality Consulting October 2007 - Present
Kimberly-Clark 2008 - December 2014
Poniard Pharmaceuticals May 2006 - October 2007
Chiron Corporation April 2004 - May 2006
Cell Therapeutics, Inc. June 1998 - December 2003
CIMA Labs May 1994 - December 1997
Bayer HealthCare April 1991 - April 1994
Medi-Physics November 1985 - February 1991
E.R. Squibb January 1977 - October 1985
Skills
FDA, Pharmaceutical Industry, GMP, Biotechnology, Validation, GLP, CAPA, Drug Development, Quality System, Quality Assurance, Medical Devices, R&D, Biopharmaceuticals, Analytical Chemistry, SOP, CRO, Life Sciences, Manufacturing, V&V, Quality Control, HPLC
Education
The University of Connecticut 1974 — 1976
MS, Chemistry
Rutgers, The State University of New Jersey-New Brunswick 1970 — 1974
Bachelor of Arts (B.A.), Physical Chemistry
Jason Heidrich's Cima Labs Experience June 2008 - July 2014
Job Principal Scientist at Tapemark
Industry Pharmaceuticals
Experience
Tapemark July 2014 - Present
Cima Labs June 2008 - July 2014
3M October 2007 - June 2008
Cetero Research 2004 - 2007
Skills
GMP, HPLC, Validation, Chromatography, Research, Pharmacueticals, FDA GMP, SOP development, Analytical R&D, Analytical Methods..., Method Transfer, Validation Reports, Analytical Method..., Gas Chromatography, Empower, Regulatory Submissions, Analytical Chemistry, FDA, Pharmaceutical Industry, SOP
Education
University of Minnesota - Carlson School of Management 2012 — 2017
MBA, Business Administration and Management, General
North Dakota State University 2000 — 2004
B.S. Chemistry
Tapemark July 2014 - Present
Cima Labs June 2008 - July 2014
3M October 2007 - June 2008
Cetero Research 2004 - 2007
Skills
GMP, HPLC, Validation, Chromatography, Research, Pharmacueticals, FDA GMP, SOP development, Analytical R&D, Analytical Methods..., Method Transfer, Validation Reports, Analytical Method..., Gas Chromatography, Empower, Regulatory Submissions, Analytical Chemistry, FDA, Pharmaceutical Industry, SOP
Education
University of Minnesota - Carlson School of Management 2012 — 2017
MBA, Business Administration and Management, General
North Dakota State University 2000 — 2004
B.S. Chemistry
Shyeilla Dhuria's Cima Labs Experience July 2001 - August 2003
Job Fellow Clinical Pharmacokinetics at Novartis
Industry Pharmaceuticals
Experience
Novartis April 2015 - Present
Novartis March 2012 - March 2015
Novartis March 2009 - February 2012
Alzheimer's Research Center September 2003 - February 2009
CIMA Labs July 2001 - August 2003
Mylan Bertek Pharmaceuticals July 1999 - July 2001
Bayer August 1998 - July 1999
Covance March 1999 - June 1999
Empi June 1996 - August 1996
Skills
Pharmacokinetics, Drug Metabolism, Drug Development, Pharmaceutical Research, Pharmaceutical Industry, Drug Delivery, Clinical Research, Oncology, Clinical Trials, Clinical Pharmacology, IND, Regulatory Affairs, In Vitro
Education
University of Minnesota-Twin Cities 2003 — 2009
Ph.D., Pharmaceutics - Pharmacokinetics
Carleton College 1994 — 1998
B.A., Chemistry
Novartis April 2015 - Present
Novartis March 2012 - March 2015
Novartis March 2009 - February 2012
Alzheimer's Research Center September 2003 - February 2009
CIMA Labs July 2001 - August 2003
Mylan Bertek Pharmaceuticals July 1999 - July 2001
Bayer August 1998 - July 1999
Covance March 1999 - June 1999
Empi June 1996 - August 1996
Skills
Pharmacokinetics, Drug Metabolism, Drug Development, Pharmaceutical Research, Pharmaceutical Industry, Drug Delivery, Clinical Research, Oncology, Clinical Trials, Clinical Pharmacology, IND, Regulatory Affairs, In Vitro
Education
University of Minnesota-Twin Cities 2003 — 2009
Ph.D., Pharmaceutics - Pharmacokinetics
Carleton College 1994 — 1998
B.A., Chemistry
Lois Rongstad's Cima Labs Experience 2006 - Present
Job Associate Director Project Managment at CIMA Labs
Industry Pharmaceuticals
Experience
CIMA Labs 2006 - Present
CIMA Labs 2003 - 2006
CIMA Labs 2001 - 2003
Novartis Nutrition 1998 - 2001
Novartis 1995 - 1998
Skills
Technology Transfer, Pharmaceutical Industry, FDA, GMP, Validation, Change Control, R&D, Quality System, V&V, 21 CFR Part 11, Pharmaceutics, Clinical Development, Sop, Regulatory Affairs, Regulatory Submissions, Contract Manufacturing, Drug Delivery, CAPA, Drug Development, SOP
Education
South Dakota State University 1984 — 1988
Bachelor of Science Degree, Major Nutrition, Minor in Chemistry
CIMA Labs 2006 - Present
CIMA Labs 2003 - 2006
CIMA Labs 2001 - 2003
Novartis Nutrition 1998 - 2001
Novartis 1995 - 1998
Skills
Technology Transfer, Pharmaceutical Industry, FDA, GMP, Validation, Change Control, R&D, Quality System, V&V, 21 CFR Part 11, Pharmaceutics, Clinical Development, Sop, Regulatory Affairs, Regulatory Submissions, Contract Manufacturing, Drug Delivery, CAPA, Drug Development, SOP
Education
South Dakota State University 1984 — 1988
Bachelor of Science Degree, Major Nutrition, Minor in Chemistry
Bruce Mayland's Cima Labs Experience September 2000 - April 2010
Job Agriculturist at American Crystal Sugar Company
Industry Food Production
Experience
American Crystal Sugar Company January 2014 - Present
Cargill Malt June 2011 - December 2013
Amerilab Technologies April 2010 - May 2011
CIMA Labs September 2000 - April 2010
General Mills 1996 - September 2000
Skills
FDA, Technology Transfer, GMP, Validation, Formulation, Analytical Chemistry, HPLC, Pharmaceutical Industry, Sop, Manufacturing, Quality Assurance, CAPA, Quality System
Education
North Dakota State University
American Crystal Sugar Company January 2014 - Present
Cargill Malt June 2011 - December 2013
Amerilab Technologies April 2010 - May 2011
CIMA Labs September 2000 - April 2010
General Mills 1996 - September 2000
Skills
FDA, Technology Transfer, GMP, Validation, Formulation, Analytical Chemistry, HPLC, Pharmaceutical Industry, Sop, Manufacturing, Quality Assurance, CAPA, Quality System
Education
North Dakota State University
Sarah Rieschl's Cima Labs Experience July 2001 - Present
Job Research Scientist at CIMA Labs
Industry Pharmaceuticals
Experience
CIMA Labs July 2001 - Present
Pace Analytical 1999 - 2001
3M Pharmaceuticals 1999 - 2001
Skills
Formulation, FDA, Technology Transfer, Troubleshooting, Validation, GLP, Trackwise, HPLC, GMP, Drug Delivery, Pharmaceutical Industry, Aseptic Processing, Quality System, Drug Development, Contract Manufacturing, Sop, Laboratory, Analytical Chemistry, R&D, SOP
Education
Concordia College 1994 — 1998
B.A., Chemistry
CIMA Labs July 2001 - Present
Pace Analytical 1999 - 2001
3M Pharmaceuticals 1999 - 2001
Skills
Formulation, FDA, Technology Transfer, Troubleshooting, Validation, GLP, Trackwise, HPLC, GMP, Drug Delivery, Pharmaceutical Industry, Aseptic Processing, Quality System, Drug Development, Contract Manufacturing, Sop, Laboratory, Analytical Chemistry, R&D, SOP
Education
Concordia College 1994 — 1998
B.A., Chemistry
Sara Chastain's Cima Labs Experience February 2011 - Present
Job Product Compliance Manager at CIMA LABS
Industry Pharmaceuticals
Experience
CIMA LABS February 2011 - Present
CIMA LABS June 2008 - February 2011
Education
College of St. Catherine 1985 — 1988
BA, Biology
CIMA LABS February 2011 - Present
CIMA LABS June 2008 - February 2011
Education
College of St. Catherine 1985 — 1988
BA, Biology
Carl Orr's Cima Labs Experience 2000 - 2005
Job Pharmaceutical/Combination Products Site Leader at Medtronic
Industry Medical Devices
Experience
Medtronic May 2009 - Present
Medafor, Inc. 2006 - 2009
CIMA LABS 2000 - 2005
Procter & Gamble 1988 - 2000
Skills
Healthcare, Quality Assurance, Leadership, FDA, Cross-functional Team..., Continuous Improvement, Strategic Planning, Product Development, Strategy, Validation, Supply Chain, Manufacturing, ISO 13485, GMP, Medical Devices, Six Sigma, Management, Process Improvement, R&D, CAPA, Start-ups, Product Launch, Supply Chain Management, Quality System, Lean Manufacturing, Commercialization, Project Management, Pharmaceutical Industry, Market Development, Biotechnology, V&V, Design of Experiments, Manufacturing Operations, Sales, Program Management
Education
Iowa State University
Bachelor's degree, Mechanical/Agricultural Engineering
Iowa State University
Bachelor's degree, Animal Science/Pre-Med
Medtronic May 2009 - Present
Medafor, Inc. 2006 - 2009
CIMA LABS 2000 - 2005
Procter & Gamble 1988 - 2000
Skills
Healthcare, Quality Assurance, Leadership, FDA, Cross-functional Team..., Continuous Improvement, Strategic Planning, Product Development, Strategy, Validation, Supply Chain, Manufacturing, ISO 13485, GMP, Medical Devices, Six Sigma, Management, Process Improvement, R&D, CAPA, Start-ups, Product Launch, Supply Chain Management, Quality System, Lean Manufacturing, Commercialization, Project Management, Pharmaceutical Industry, Market Development, Biotechnology, V&V, Design of Experiments, Manufacturing Operations, Sales, Program Management
Education
Iowa State University
Bachelor's degree, Mechanical/Agricultural Engineering
Iowa State University
Bachelor's degree, Animal Science/Pre-Med
Randy Staffanson's Cima Labs Experience September 2010 - August 2013
Job Senior Metrologist II at UpsherSmith Laboratories
Industry Pharmaceuticals
Experience
Upsher-Smith Laboratories February 2014 - Present
Lifecore Biomedical November 2013 - February 2014
CIMA Labs September 2010 - August 2013
CIMA Labs a Cephalon Company December 2003 - September 2010
Innovatech Labs September 1996 - December 2003
Diametrics Medical April 1992 - June 1996
Education
St. Cloud State University 1987 — 1992
Bachelors degree, Chemistry
Upsher-Smith Laboratories February 2014 - Present
Lifecore Biomedical November 2013 - February 2014
CIMA Labs September 2010 - August 2013
CIMA Labs a Cephalon Company December 2003 - September 2010
Innovatech Labs September 1996 - December 2003
Diametrics Medical April 1992 - June 1996
Education
St. Cloud State University 1987 — 1992
Bachelors degree, Chemistry
Sarah Hansen's Cima Labs Experience June 2003 - March 2004
Job Senior Process Engineer at Amec Foster Wheeler
Industry Mechanical or Industrial Engineering
Experience
Amec Foster Wheeler November 2014 - Present
AMEC January 2012 - November 2014
SSOE Group November 2009 - January 2012
AMEC April 2006 - September 2009
Biorefining, Inc April 2004 - April 2006
CIMA Labs June 2003 - March 2004
Skills
Engineering, Process Engineering, Project Engineering, Process Simulation, Chemical Engineering, Energy, Engineering Management, Process Control, Engineering Design, Continuous Improvement, Instrumentation, Project Planning, Automation, P&ID
Education
Iowa State University 1998 — 2003
Bachelor of Science, Chemical Engineering
Iowa State University 1998 — 2003
Bachelor of Arts, Music
Amec Foster Wheeler November 2014 - Present
AMEC January 2012 - November 2014
SSOE Group November 2009 - January 2012
AMEC April 2006 - September 2009
Biorefining, Inc April 2004 - April 2006
CIMA Labs June 2003 - March 2004
Skills
Engineering, Process Engineering, Project Engineering, Process Simulation, Chemical Engineering, Energy, Engineering Management, Process Control, Engineering Design, Continuous Improvement, Instrumentation, Project Planning, Automation, P&ID
Education
Iowa State University 1998 — 2003
Bachelor of Science, Chemical Engineering
Iowa State University 1998 — 2003
Bachelor of Arts, Music
Deana Baker's Cima Labs Experience 2009 - 2012
Job Assistant Professor (Distant), Biology and Math/Science Division Chair at Thomas University
Industry Biotechnology
Experience
Thomas University September 2014 - Present
Criteria Validation August 2000 - Present
Thomas University 2014 - 2015
Thomas University 2014 - 2015
CIMA Labs 2009 - 2012
Asept Pak, Inc. 2008 - 2009
Catalent Pharma Solutions 2000 - 2009
Cardinal Health 2000 - 2009
Part Three 1999 - 2000
Genentech 1994 - 1998
Education
University of Florida 2012 — 2014
Master's Degree, DNA and Serology, School of Pharmacy, 4.0
California State University-East Bay 1992 — 1994
MS, Science Curriculum
Eastern Mennonite University 1982 — 1986
Thomas University September 2014 - Present
Criteria Validation August 2000 - Present
Thomas University 2014 - 2015
Thomas University 2014 - 2015
CIMA Labs 2009 - 2012
Asept Pak, Inc. 2008 - 2009
Catalent Pharma Solutions 2000 - 2009
Cardinal Health 2000 - 2009
Part Three 1999 - 2000
Genentech 1994 - 1998
Education
University of Florida 2012 — 2014
Master's Degree, DNA and Serology, School of Pharmacy, 4.0
California State University-East Bay 1992 — 1994
MS, Science Curriculum
Eastern Mennonite University 1982 — 1986
Pam Dhaene's Cima Labs Experience 2003 - 2004
Job Document Control Analyst at Apex International Mfg, Inc.
Industry Pharmaceuticals
Experience
Apex International Mfg, Inc. January 2013 - Present
Teva Pharmaceuticals January 2009 - December 2012
Teva Pharmaceuticals January 2005 - December 2008
CIMA Labs 2003 - 2004
ADC Telecommunications 1993 - 2003
Skills
Validation, GMP, Documentum, FDA, Document Management, SAP, Microsoft Excel, Quality System, Sop, Microsoft Word, Trackwise, CAPA, Pharmaceutical Industry, Quality Assurance
Education
Cardinal Stritch University 2011 — 2012
Associate of Sciences (AS), Business, A
Apex International Mfg, Inc. January 2013 - Present
Teva Pharmaceuticals January 2009 - December 2012
Teva Pharmaceuticals January 2005 - December 2008
CIMA Labs 2003 - 2004
ADC Telecommunications 1993 - 2003
Skills
Validation, GMP, Documentum, FDA, Document Management, SAP, Microsoft Excel, Quality System, Sop, Microsoft Word, Trackwise, CAPA, Pharmaceutical Industry, Quality Assurance
Education
Cardinal Stritch University 2011 — 2012
Associate of Sciences (AS), Business, A
Barry Cool's Cima Labs Experience January 1999 - October 2003
Job Managing Partner at Fairplay Asset Management
Industry Investment Management
Experience
Fairplay Asset Management July 2011 - Present
Boston Scientific October 2003 - June 2011
CIMA Labs January 1999 - October 2003
Upsher-Smith Laboratories January 1994 - December 1999
Skills
FDA, CAPA, Validation, GMP, Technology Transfer, Sop, V&V, Medical Devices, R&D, GLP, Pharmaceutical Industry, HPLC, Analytical Chemistry, Quality System, ISO 13485, Biotechnology, 21 CFR Part 11, Regulatory Submissions, Change Control
Education
St. Cloud State University 1985 — 1990
BS, Biotechnology
University of Colorado Denver 1992 — 1993
Analytical Chemistry
Fairplay Asset Management July 2011 - Present
Boston Scientific October 2003 - June 2011
CIMA Labs January 1999 - October 2003
Upsher-Smith Laboratories January 1994 - December 1999
Skills
FDA, CAPA, Validation, GMP, Technology Transfer, Sop, V&V, Medical Devices, R&D, GLP, Pharmaceutical Industry, HPLC, Analytical Chemistry, Quality System, ISO 13485, Biotechnology, 21 CFR Part 11, Regulatory Submissions, Change Control
Education
St. Cloud State University 1985 — 1990
BS, Biotechnology
University of Colorado Denver 1992 — 1993
Analytical Chemistry
Jared Zochert's Cima Labs Experience January 2001 - January 2005
Job QA Manager at Biovest International
Industry Biotechnology
Experience
Biovest International April 2015 - Present
Biovest International August 2014 - March 2015
Perrigo Company plc May 2013 - January 2014
Perrigo Company plc December 2012 - May 2013
CIMA Labs (a Teva Company) January 2005 - November 2012
CIMA Labs January 2001 - January 2005
CIMA Labs September 2000 - January 2001
Skills
FDA, GMP, Quality Assurance, Validation, Cleaning Validation, Technology Transfer, Change Control, CAPA, SAP ERP, QAD MFG Pro, QDocs EDMS, Regulus EDMS, Trackwise, USP/NF, EP (Pharm Eur), JP (Japanese..., 21 CFR Part 11, Batch Release, Quality Investigations, Sop, Document Management, Contract Manufacturing, Deviations, Quality Control, LIMS, Pharmaceutical Industry, Dissolution
Education
University of Minnesota-Twin Cities 1995 — 2000
BS, Astrophysics
Metropolitan State University 2012 — 2013
Law Enforcement Certificate
Biovest International April 2015 - Present
Biovest International August 2014 - March 2015
Perrigo Company plc May 2013 - January 2014
Perrigo Company plc December 2012 - May 2013
CIMA Labs (a Teva Company) January 2005 - November 2012
CIMA Labs January 2001 - January 2005
CIMA Labs September 2000 - January 2001
Skills
FDA, GMP, Quality Assurance, Validation, Cleaning Validation, Technology Transfer, Change Control, CAPA, SAP ERP, QAD MFG Pro, QDocs EDMS, Regulus EDMS, Trackwise, USP/NF, EP (Pharm Eur), JP (Japanese..., 21 CFR Part 11, Batch Release, Quality Investigations, Sop, Document Management, Contract Manufacturing, Deviations, Quality Control, LIMS, Pharmaceutical Industry, Dissolution
Education
University of Minnesota-Twin Cities 1995 — 2000
BS, Astrophysics
Metropolitan State University 2012 — 2013
Law Enforcement Certificate
Len Hatcher's Cima Labs Experience July 2011 - December 2012
Job Operations Manager at Clearfield, Inc.
Industry Telecommunications
Experience
Clearfield November 2013 - Present
Key Surgical July 2013 - November 2013
Cosmetic/OTC Contract Manufacturer March 2013 - June 2013
CIMA Labs July 2011 - December 2012
CIMA Labs May 2006 - July 2011
CIMA Labs September 2003 - May 2006
CIMA Labs October 2002 - September 2003
Cruiser's Southwest Division July 2001 - July 2002
Uniroyal Goodrich/Michelin Tire Inc March 1997 - May 2001
Skills
FDA, GMP, DEA, cGMP manufacturing, MS Word, SOP authoring, 5S, Lean Manufacturing, Quality Assurance, Validation, Process Improvement, CAPA, Manufacturing, Sop, Quality System, Leadership, 21 CFR Part 11, Quality Auditing, Change Control, GLP, Pharmaceutical Industry, Troubleshooting, Contract Manufacturing, Technology Transfer, Continuous Improvement, Quality Control, Regulatory Requirements, Trackwise, ISO 13485, LIMS, Cleaning Validation, V&V, FDA GMP, Aseptic Processing
Education
Concordia University-St. Paul 2008 — 2009
Masters, Organizational Management
University of Oklahoma 1998 — 2002
B.A, International Studies
Clearfield November 2013 - Present
Key Surgical July 2013 - November 2013
Cosmetic/OTC Contract Manufacturer March 2013 - June 2013
CIMA Labs July 2011 - December 2012
CIMA Labs May 2006 - July 2011
CIMA Labs September 2003 - May 2006
CIMA Labs October 2002 - September 2003
Cruiser's Southwest Division July 2001 - July 2002
Uniroyal Goodrich/Michelin Tire Inc March 1997 - May 2001
Skills
FDA, GMP, DEA, cGMP manufacturing, MS Word, SOP authoring, 5S, Lean Manufacturing, Quality Assurance, Validation, Process Improvement, CAPA, Manufacturing, Sop, Quality System, Leadership, 21 CFR Part 11, Quality Auditing, Change Control, GLP, Pharmaceutical Industry, Troubleshooting, Contract Manufacturing, Technology Transfer, Continuous Improvement, Quality Control, Regulatory Requirements, Trackwise, ISO 13485, LIMS, Cleaning Validation, V&V, FDA GMP, Aseptic Processing
Education
Concordia University-St. Paul 2008 — 2009
Masters, Organizational Management
University of Oklahoma 1998 — 2002
B.A, International Studies
Nathanial Heflin's Cima Labs Experience 2009 - 2012
Job Quality Assurance Specialist at Apex International Mfg, Inc.
Industry Pharmaceuticals
Experience
Apex International Mfg, Inc. April 2013 - Present
CIMA Labs 2009 - 2012
CIMA Labs 2006 - 2009
CIMA Labs 2005 - 2006
CIMA Labs 2003 - 2005
CIMA Labs December 2001 - 2003
Lab Support April 2001 - December 2001
Guthrie Theater 1999 - 2001
HSC Scenic Services 2000 - 2000
Pennsylvania Shakespeare Festival May 1999 - August 1999
Skills
GMP, Pharmaceuticals, SAP, Deviations, CAPA, Quality Assurance, FDA, Vendor Audit, Quality System, Trackwise, Technical Writing, Analytical Chemistry, Word, Excel, PowerPoint, Outlook, Carpentry, Forklift Operator, Computer Hardware, Sop, Microsoft Word, Pharmaceutical Industry, Microsoft Excel, cGMP manufacturing, Change Control, Quality Auditing, 21 CFR Part 11, Validation, Technology Transfer, LIMS, GLP, cGMP practices, SOP
Education
Connecticut College 1994 — 1998
BA, Zoology
Apex International Mfg, Inc. April 2013 - Present
CIMA Labs 2009 - 2012
CIMA Labs 2006 - 2009
CIMA Labs 2005 - 2006
CIMA Labs 2003 - 2005
CIMA Labs December 2001 - 2003
Lab Support April 2001 - December 2001
Guthrie Theater 1999 - 2001
HSC Scenic Services 2000 - 2000
Pennsylvania Shakespeare Festival May 1999 - August 1999
Skills
GMP, Pharmaceuticals, SAP, Deviations, CAPA, Quality Assurance, FDA, Vendor Audit, Quality System, Trackwise, Technical Writing, Analytical Chemistry, Word, Excel, PowerPoint, Outlook, Carpentry, Forklift Operator, Computer Hardware, Sop, Microsoft Word, Pharmaceutical Industry, Microsoft Excel, cGMP manufacturing, Change Control, Quality Auditing, 21 CFR Part 11, Validation, Technology Transfer, LIMS, GLP, cGMP practices, SOP
Education
Connecticut College 1994 — 1998
BA, Zoology
Doug Root's Cima Labs Experience 1999 - 2004
Job Senior Scientist at AURI
Industry Biotechnology
Experience
AURI September 2007 - Present
GelStat 2004 - 2007
Boston Scientific 2003 - 2004
CIMA LABS 1999 - 2004
Cygnus Inc. 1997 - 1999
Shaman Pharmaceuticals 1992 - 1995
University of Hawaii September 1984 - June 1990
Skills
R&D, Technology Transfer, FDA, Product Development, Analytical Chemistry, HPLC, Medical Devices, Validation, Chromatography, Chemistry, GLP, Pharmaceutical Industry, Biotechnology, Strategic Planning, Regulatory Affairs, Biofuels, GMP, Laboratory, Commercialization, Science, Lifesciences, Life Sciences
Education
University of Arizona 1979 — 1984
Ph.D., Chemistry
University of Minnesota-Twin Cities 1973 — 1978
B.A., Chemistry
AURI September 2007 - Present
GelStat 2004 - 2007
Boston Scientific 2003 - 2004
CIMA LABS 1999 - 2004
Cygnus Inc. 1997 - 1999
Shaman Pharmaceuticals 1992 - 1995
University of Hawaii September 1984 - June 1990
Skills
R&D, Technology Transfer, FDA, Product Development, Analytical Chemistry, HPLC, Medical Devices, Validation, Chromatography, Chemistry, GLP, Pharmaceutical Industry, Biotechnology, Strategic Planning, Regulatory Affairs, Biofuels, GMP, Laboratory, Commercialization, Science, Lifesciences, Life Sciences
Education
University of Arizona 1979 — 1984
Ph.D., Chemistry
University of Minnesota-Twin Cities 1973 — 1978
B.A., Chemistry
Sharon Blaha's Cima Labs Experience November 1998 - August 2010
Job Stability Manager at Lifecore Biomedical
Industry Pharmaceuticals
Experience
Lifecore Biomedical August 2010 - Present
CIMA LABS November 1998 - August 2010
Glaxo Wellcome 1995 - July 1997
Burroughs Wellcome February 1993 - 1995
Babcock and Wilcox, NESI Environmental Testing Laboratory June 1991 - February 1993
Abbott Laboratories January 1991 - June 1991
Skills
Validation, Medical Devices, Product Development, QC, GMP, HPLC, FDA
Education
The University of New Mexico 1981 — 1985
MS, PhD, Chemistry
University of Wisconsin-Parkside 1976 — 1980
BS, chemistry
Lifecore Biomedical August 2010 - Present
CIMA LABS November 1998 - August 2010
Glaxo Wellcome 1995 - July 1997
Burroughs Wellcome February 1993 - 1995
Babcock and Wilcox, NESI Environmental Testing Laboratory June 1991 - February 1993
Abbott Laboratories January 1991 - June 1991
Skills
Validation, Medical Devices, Product Development, QC, GMP, HPLC, FDA
Education
The University of New Mexico 1981 — 1985
MS, PhD, Chemistry
University of Wisconsin-Parkside 1976 — 1980
BS, chemistry
Todd Alkire's Cima Labs Experience 1991 - 1996
Job Sr. Process Engineer at Boehringer Ingelheim Roxane Inc.
Industry Pharmaceuticals
Experience
Boehringer Ingelheim Roxane Inc. 2009 - Present
Boehringer Ingelheim Roxane Inc. 2007 - 2009
Boehringer Ingelheim Roxane Inc. 2001 - 2007
Boehringer Ingelheim Roxane Inc. 1999 - 2001
Boehringer Ingelheim Roxane Inc. 1997 - 1998
Boehringer Ingelheim Roxane Inc. 1996 - 1997
CIMA Labs 1991 - 1996
Education
St. John's University 1981 — 1985
BS, Biology, Chemistry
Boehringer Ingelheim Roxane Inc. 2009 - Present
Boehringer Ingelheim Roxane Inc. 2007 - 2009
Boehringer Ingelheim Roxane Inc. 2001 - 2007
Boehringer Ingelheim Roxane Inc. 1999 - 2001
Boehringer Ingelheim Roxane Inc. 1997 - 1998
Boehringer Ingelheim Roxane Inc. 1996 - 1997
CIMA Labs 1991 - 1996
Education
St. John's University 1981 — 1985
BS, Biology, Chemistry
Patricia Thul's Cima Labs Experience October 2003 - Present
Job Research Scientist I at CIMA Labs
Industry Pharmaceuticals
Experience
CIMA Labs October 2003 - Present
MedTox Laboratories October 2001 - October 2003
Parker Hughes Institute October 1998 - October 2001
Skills
HPLC, Gas Chromatography, Laboratory, LC-MS, Analytical Chemistry, GMP, Sop, CAPA, Drug Delivery, Chromatography, Dissolution, GLP, LIMS, UV/Vis, Technology Transfer, FDA, Change Control, 21 CFR Part 11, Organic Chemistry, FTIR, UV, cGMP practices, Validation, Analytical Method..., Formulation, NMR, Trackwise, Chemistry, Pharmaceutical Industry, Quality by Design, V&V, Karl Fisher, Method Development
Education
University at Buffalo 1996 — 1998
MS, Medicinal Chemistry
St. Cloud State University 1989 — 1995
BS, Chemistry, Biology, German
St. Cloud State University 1989 — 1994
BA, Biology/German
CIMA Labs October 2003 - Present
MedTox Laboratories October 2001 - October 2003
Parker Hughes Institute October 1998 - October 2001
Skills
HPLC, Gas Chromatography, Laboratory, LC-MS, Analytical Chemistry, GMP, Sop, CAPA, Drug Delivery, Chromatography, Dissolution, GLP, LIMS, UV/Vis, Technology Transfer, FDA, Change Control, 21 CFR Part 11, Organic Chemistry, FTIR, UV, cGMP practices, Validation, Analytical Method..., Formulation, NMR, Trackwise, Chemistry, Pharmaceutical Industry, Quality by Design, V&V, Karl Fisher, Method Development
Education
University at Buffalo 1996 — 1998
MS, Medicinal Chemistry
St. Cloud State University 1989 — 1995
BS, Chemistry, Biology, German
St. Cloud State University 1989 — 1994
BA, Biology/German
Maureen Stolt's Cima Labs Experience May 2001 - August 2008
Job Project Manager at Target
Industry Pharmaceuticals
Experience
Target July 2014 - Present
Target July 2011 - Present
Shot Rock Curling Supplies October 2010 - Present
Paddock Laboratories August 2008 - July 2011
CIMA Labs May 2001 - August 2008
Skills
SAP, GMP, HPLC, Strategic Planning, Pharmaceutics, Process Improvement, Quality Assurance, Business Process..., Quality System, Project Management, V&V, Dissolution, FDA GMP, Cross-functional..., Pharmacy Dispensing..., Pharmaceutical Industry, Customer Service, Business Process, Agile Methodologies, Scrum
Education
The University of South Dakota 1998 — 2001
ACS, Chemistry
Target July 2014 - Present
Target July 2011 - Present
Shot Rock Curling Supplies October 2010 - Present
Paddock Laboratories August 2008 - July 2011
CIMA Labs May 2001 - August 2008
Skills
SAP, GMP, HPLC, Strategic Planning, Pharmaceutics, Process Improvement, Quality Assurance, Business Process..., Quality System, Project Management, V&V, Dissolution, FDA GMP, Cross-functional..., Pharmacy Dispensing..., Pharmaceutical Industry, Customer Service, Business Process, Agile Methodologies, Scrum
Education
The University of South Dakota 1998 — 2001
ACS, Chemistry
Rachel Gartner's Cima Labs Experience May 2003 - August 2003
Job
Industry Medical Devices
Experience
Boston Scientific July 2015 - Present
Frestedt Incorporated March 2014 - June 2015
Minnesota Coaches, Inc. July 2009 - March 2014
Patrick Burns & Associates October 2008 - May 2009
University of Minnesota Tax Clinic September 2006 - August 2008
Boston Scientific July 2004 - August 2005
American Association for the Advancement of Science January 2004 - June 2004
CIMA Labs May 2003 - August 2003
University of California - Riverside June 2002 - August 2002
Skills
Legal Research, Research, Microsoft Office, PowerPoint, Public Speaking, Analysis, Microsoft Excel, Microsoft Word, Employee Benefits, Benefits Administration, Chemistry, Internal Audit, Retirement Benefits, 401k, Compliance, Human Resources, Affordable Care Act
Education
University of Minnesota Law School 2005 — 2008
JD
University of Minnesota-Morris 1999 — 2003
BA
University of Melbourne 2001 — 2002
Boston Scientific July 2015 - Present
Frestedt Incorporated March 2014 - June 2015
Minnesota Coaches, Inc. July 2009 - March 2014
Patrick Burns & Associates October 2008 - May 2009
University of Minnesota Tax Clinic September 2006 - August 2008
Boston Scientific July 2004 - August 2005
American Association for the Advancement of Science January 2004 - June 2004
CIMA Labs May 2003 - August 2003
University of California - Riverside June 2002 - August 2002
Skills
Legal Research, Research, Microsoft Office, PowerPoint, Public Speaking, Analysis, Microsoft Excel, Microsoft Word, Employee Benefits, Benefits Administration, Chemistry, Internal Audit, Retirement Benefits, 401k, Compliance, Human Resources, Affordable Care Act
Education
University of Minnesota Law School 2005 — 2008
JD
University of Minnesota-Morris 1999 — 2003
BA
University of Melbourne 2001 — 2002
Paula DeGrandis's Cima Labs Experience May 2010 - December 2011
Job Director of Intellectual Property at BioAmber Inc.
Industry Pharmaceuticals
Experience
BioAmber Inc. December 2013 - Present
BioAmber Inc. June 2013 - December 2013
Teva Pharmaceutical Industries Ltd. January 2012 - November 2013
CIMA Labs May 2010 - December 2011
Leptos Biomedical May 2009 - June 2010
Klarquist Sparkman, LLP November 2006 - March 2009
Cargill February 2001 - October 2006
Klarquist Sparkman, LLP June 1998 - February 2001
Northern Illinois University August 1995 - September 1997
University of Illinois at Chicago July 1994 - August 1995
Skills
Patentability, Intellectual Property, Patent Prosecution, Licensing, Patents, Trademarks, Trade Secrets, Prosecution, Biotechnology, Litigation, Legal Writing, Joint Ventures, Patent Litigation, Technology Transfer, Start-ups, Patent Applications
Education
University of St. Thomas 2013 — 2013
Northern Illinois University 1993 — 1996
Juris Doctor, Law
Northern Illinois University 1992 — 1993
MS, Molecular Biology
Northern Illinois University 1988 — 1992
BS, Biology
BioAmber Inc. December 2013 - Present
BioAmber Inc. June 2013 - December 2013
Teva Pharmaceutical Industries Ltd. January 2012 - November 2013
CIMA Labs May 2010 - December 2011
Leptos Biomedical May 2009 - June 2010
Klarquist Sparkman, LLP November 2006 - March 2009
Cargill February 2001 - October 2006
Klarquist Sparkman, LLP June 1998 - February 2001
Northern Illinois University August 1995 - September 1997
University of Illinois at Chicago July 1994 - August 1995
Skills
Patentability, Intellectual Property, Patent Prosecution, Licensing, Patents, Trademarks, Trade Secrets, Prosecution, Biotechnology, Litigation, Legal Writing, Joint Ventures, Patent Litigation, Technology Transfer, Start-ups, Patent Applications
Education
University of St. Thomas 2013 — 2013
Northern Illinois University 1993 — 1996
Juris Doctor, Law
Northern Illinois University 1992 — 1993
MS, Molecular Biology
Northern Illinois University 1988 — 1992
BS, Biology
Malai Vang's Cima Labs Experience January 2009 - January 2012
Job Environmental Analyst at MN Dept of Ag
Industry Pharmaceuticals
Experience
MN Dept of Ag July 2012 - Present
CIMA Labs January 2009 - January 2012
Mannatech May 2007 - December 2008
CIMA Labs January 2003 - April 2007
LecTec Corporation May 2001 - November 2002
Great Lakes Analytical May 1994 - November 1999
Skills
Analytical Chemistry, Pharmaceutical Industry, Quality Assurance, Drug Delivery, Analysis, R&D, Validation
Education
UC Davis 1988 — 1991
BS, Chemical Engineering
Fresno City College 1986 — 1988
MN Dept of Ag July 2012 - Present
CIMA Labs January 2009 - January 2012
Mannatech May 2007 - December 2008
CIMA Labs January 2003 - April 2007
LecTec Corporation May 2001 - November 2002
Great Lakes Analytical May 1994 - November 1999
Skills
Analytical Chemistry, Pharmaceutical Industry, Quality Assurance, Drug Delivery, Analysis, R&D, Validation
Education
UC Davis 1988 — 1991
BS, Chemical Engineering
Fresno City College 1986 — 1988
David Allen Weidner's Cima Labs Experience 2000 - 2007
Job Product Analyst II at Covidien
Industry Medical Devices
Experience
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
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
Daniel Brechko's Cima Labs Experience March 2004 - September 2010
Job Environmental, Health, and Safety (EHS) Consultant experienced with EHS programs, combustible dust, and hazardous waste.
Industry Pharmaceuticals
Experience
CIMA Labs March 2004 - September 2010
Lockwood Greene 2002 - 2004
Lockwood Greene Asia Pacific 1999 - 2001
Lockwood Greene 1995 - 1999
Education
University at Buffalo
BS, Chemical Engineering
CIMA Labs March 2004 - September 2010
Lockwood Greene 2002 - 2004
Lockwood Greene Asia Pacific 1999 - 2001
Lockwood Greene 1995 - 1999
Education
University at Buffalo
BS, Chemical Engineering
Jake Bullard's Cima Labs Experience June 2003 - August 2011
Job Sr. Scientist at St. Jude Medical
Industry Pharmaceuticals
Experience
St. Jude Medical August 2011 - Present
CIMA Labs June 2003 - August 2011
Skills
HPLC, Validation, Analytical Chemistry, Chromatography, GMP, FDA, Pharmaceutical Industry, Statistics, Design of Experiments
Education
Texas A&M University 2011 — 2014
Master's degree, Statistics
St. Olaf College 1999 — 2003
BA, Chemistry, Mathematics
St. Jude Medical August 2011 - Present
CIMA Labs June 2003 - August 2011
Skills
HPLC, Validation, Analytical Chemistry, Chromatography, GMP, FDA, Pharmaceutical Industry, Statistics, Design of Experiments
Education
Texas A&M University 2011 — 2014
Master's degree, Statistics
St. Olaf College 1999 — 2003
BA, Chemistry, Mathematics
Jason Jennissen's Cima Labs Experience November 2001 - April 2005
Job Analytical Chemist
Industry Consumer Goods
Experience
3M December 2012 - Present
Hutchinson Technology April 2008 - November 2012
Hutchinson Technology August 2007 - April 2008
Hutchinson Technology April 2006 - August 2007
CIMA Labs November 2001 - April 2005
Skills
Minitab, SPC, Design of Experiments, Quality System, SEM, EDS, IC, FIB, HPLC
Education
University of Minnesota-Twin Cities 1999 — 2002
BA, Chemistry
Saint John's University 1992 — 1996
BA, Natural Science
Sauk Centre High School 1988 — 1992
3M December 2012 - Present
Hutchinson Technology April 2008 - November 2012
Hutchinson Technology August 2007 - April 2008
Hutchinson Technology April 2006 - August 2007
CIMA Labs November 2001 - April 2005
Skills
Minitab, SPC, Design of Experiments, Quality System, SEM, EDS, IC, FIB, HPLC
Education
University of Minnesota-Twin Cities 1999 — 2002
BA, Chemistry
Saint John's University 1992 — 1996
BA, Natural Science
Sauk Centre High School 1988 — 1992
Lucinda Lippert's Cima Labs Experience June 1988 - April 1992
Job Principal Clinical Quality Specialist at Medtronic
Industry Medical Devices
Experience
Medtronic July 2014 - Present
Medtronic January 2013 - Present
Boston Scientific October 2006 - November 2012
3M Pharmaceuticals September 2000 - October 2006
3M Pharmaceuticals May 1992 - September 2000
CIMA Labs June 1988 - April 1992
General Nutrition September 1981 - June 1988
Skills
RQAP-GCP (SQA), CQA (ASQ), CCRP (SOCRA), CQA, CAPA, GLP, FDA, ISO 13485, Quality System, Clinical Trials, Sop, GCP, GMP, Validation, Clinical Research, Protocol, Quality Assurance, Clinical Development, Medical Devices, HPLC, Biotechnology, Regulatory Affairs, 21 CFR Part 11, Software Documentation, Design Control, Chromatography, Computer System..., Regulatory Submissions, Change Control, GxP, Regulatory Requirements, Quality Auditing, ISO 14971, V&V, LIMS, SOP
Education
University of Wisconsin-Platteville 1979 — 1981
BA, Chemistry
Austin Community College, Austin MN 1977 — 1979
AA, Chemistry
Medtronic July 2014 - Present
Medtronic January 2013 - Present
Boston Scientific October 2006 - November 2012
3M Pharmaceuticals September 2000 - October 2006
3M Pharmaceuticals May 1992 - September 2000
CIMA Labs June 1988 - April 1992
General Nutrition September 1981 - June 1988
Skills
RQAP-GCP (SQA), CQA (ASQ), CCRP (SOCRA), CQA, CAPA, GLP, FDA, ISO 13485, Quality System, Clinical Trials, Sop, GCP, GMP, Validation, Clinical Research, Protocol, Quality Assurance, Clinical Development, Medical Devices, HPLC, Biotechnology, Regulatory Affairs, 21 CFR Part 11, Software Documentation, Design Control, Chromatography, Computer System..., Regulatory Submissions, Change Control, GxP, Regulatory Requirements, Quality Auditing, ISO 14971, V&V, LIMS, SOP
Education
University of Wisconsin-Platteville 1979 — 1981
BA, Chemistry
Austin Community College, Austin MN 1977 — 1979
AA, Chemistry
David Vouk's Cima Labs Experience September 1999 - December 2012
Job Director of Purchasing at Smead Manufacturing
Industry Pharmaceuticals
Experience
Smead Manufacturing August 2013 - Present
CIMA Labs September 1999 - December 2012
CIMA Labs January 2004 - January 2007
CIMA Labs January 2001 - January 2004
CIMA Labs September 1999 - January 2001
Medallion Cabinetry September 1996 - September 1999
Dura Supreme September 1993 - September 1996
Skills
FDA, GMP, Pharmaceutical Industry, Validation, Technology Transfer, SOP development, Contract Manufacturing, CAPA, Quality System, Cross-functional Team..., Supply Chain Management, ERP Implementations, SAP ERP, MFG-Pro, cGMP practices, Purchase Management, Warehouse Management, Strategic Sourcing, Global Sourcing, Sourcing, Supplier Negotiation, Negotiation, SAP, Batch Records, Vendor Management, Staff Development, Increase Productivity, SAP Procurement, Procurement, FDA GMP, Customer Service, S&OP, Inventory Management, Inventory Control, Physical Inventory, ERP Software, Cost Management, KPI Reports, APICS, CSCP, CPIM, ASQ Member, Sales Plan, Sop, Manufacturing, Change Control, MRP, Product Development, Materials Management, ISO 13485
Education
Saint Cloud State University - G.R. Herberger College of Business 1984 — 1989
B.S., Business Management
Smead Manufacturing August 2013 - Present
CIMA Labs September 1999 - December 2012
CIMA Labs January 2004 - January 2007
CIMA Labs January 2001 - January 2004
CIMA Labs September 1999 - January 2001
Medallion Cabinetry September 1996 - September 1999
Dura Supreme September 1993 - September 1996
Skills
FDA, GMP, Pharmaceutical Industry, Validation, Technology Transfer, SOP development, Contract Manufacturing, CAPA, Quality System, Cross-functional Team..., Supply Chain Management, ERP Implementations, SAP ERP, MFG-Pro, cGMP practices, Purchase Management, Warehouse Management, Strategic Sourcing, Global Sourcing, Sourcing, Supplier Negotiation, Negotiation, SAP, Batch Records, Vendor Management, Staff Development, Increase Productivity, SAP Procurement, Procurement, FDA GMP, Customer Service, S&OP, Inventory Management, Inventory Control, Physical Inventory, ERP Software, Cost Management, KPI Reports, APICS, CSCP, CPIM, ASQ Member, Sales Plan, Sop, Manufacturing, Change Control, MRP, Product Development, Materials Management, ISO 13485
Education
Saint Cloud State University - G.R. Herberger College of Business 1984 — 1989
B.S., Business Management
Irvin Hosford's Cima Labs Experience June 1999 - August 1999
Job Coatings Chemist at Tennant Company
Industry Chemicals
Experience
Tennant Company June 2010 - Present
EXL Laboratories March 2009 - June 2010
Tennant Company June 2007 - December 2008
Chemstar Products September 1999 - June 2007
CIMA Labs June 1999 - August 1999
Aspen Research Corporation June 1998 - August 1998
Skills
Coatings, Polymers, Product Development, R&D, Polyurethane, Quality Control, Process Engineering, Organic Chemistry, Chemistry, Formulation, Additives, Laboratory, UV/Vis, Raw Materials, Resin, Manufacturing, New Business Development
Education
University of Minnesota Duluth 1995 — 1999
BS, Chemistry
Tennant Company June 2010 - Present
EXL Laboratories March 2009 - June 2010
Tennant Company June 2007 - December 2008
Chemstar Products September 1999 - June 2007
CIMA Labs June 1999 - August 1999
Aspen Research Corporation June 1998 - August 1998
Skills
Coatings, Polymers, Product Development, R&D, Polyurethane, Quality Control, Process Engineering, Organic Chemistry, Chemistry, Formulation, Additives, Laboratory, UV/Vis, Raw Materials, Resin, Manufacturing, New Business Development
Education
University of Minnesota Duluth 1995 — 1999
BS, Chemistry
Andrew Goode's Cima Labs Experience October 2009 - February 2010
Job Analytical Chemist
Industry Pharmaceuticals
Experience
Nanocopoeia September 2010 - August 2015
CIMA Labs October 2009 - February 2010
The Herkimer Pub & Brewery May 2009 - October 2009
Pace Analytical 2008 - April 2009
3M 2008 - 2009
Upsher-Smith Laboratories 2004 - 2008
Upsher-Smith Laboratories 2002 - 2004
Skills
HPLC, cGMP, Methods Development, Drug Delivery, Medical Devices, UV, Troubleshooting, Documentation, GMP, Software Documentation, Laboratory, Analytical Chemistry
Education
University of Illinois at Urbana-Champaign 1998 — 2002
BS, Chemistry
Nanocopoeia September 2010 - August 2015
CIMA Labs October 2009 - February 2010
The Herkimer Pub & Brewery May 2009 - October 2009
Pace Analytical 2008 - April 2009
3M 2008 - 2009
Upsher-Smith Laboratories 2004 - 2008
Upsher-Smith Laboratories 2002 - 2004
Skills
HPLC, cGMP, Methods Development, Drug Delivery, Medical Devices, UV, Troubleshooting, Documentation, GMP, Software Documentation, Laboratory, Analytical Chemistry
Education
University of Illinois at Urbana-Champaign 1998 — 2002
BS, Chemistry
Alex Willey's Cima Labs Experience 2004 - 2006
Job Production Leader, Crawler Dozer Assembly at John Deere
Industry Machinery
Experience
John Deere September 2014 - Present
John Deere November 2010 - Present
John Deere June 2008 - November 2010
Case New Holland August 2006 - June 2008
CIMA Labs 2004 - 2006
Skills
Lean Manufacturing, Continuous Improvement, Manufacturing, 5S, Six Sigma, Value Stream Mapping, Manufacturing..., Engineering, Root Cause Analysis, Process Improvement, Product Development, Cross-functional Team..., Quality System, Pro Engineer, Process Engineering, Kaizen, Quality Management, Engineering Management, Quality Assurance, Supply Chain Management
Education
University of Iowa - Henry B. Tippie College of Business 2008 — 2011
MBA, Business
Iowa State University 1999 — 2004
B.S., Agricultural Engineering
John Deere September 2014 - Present
John Deere November 2010 - Present
John Deere June 2008 - November 2010
Case New Holland August 2006 - June 2008
CIMA Labs 2004 - 2006
Skills
Lean Manufacturing, Continuous Improvement, Manufacturing, 5S, Six Sigma, Value Stream Mapping, Manufacturing..., Engineering, Root Cause Analysis, Process Improvement, Product Development, Cross-functional Team..., Quality System, Pro Engineer, Process Engineering, Kaizen, Quality Management, Engineering Management, Quality Assurance, Supply Chain Management
Education
University of Iowa - Henry B. Tippie College of Business 2008 — 2011
MBA, Business
Iowa State University 1999 — 2004
B.S., Agricultural Engineering
Darrell Hartung's Cima Labs Experience 2005 - December 2012
Job Production Engineering Technician at Perrigo
Industry Pharmaceuticals
Experience
Perrigo January 2013 - Present
CIMA Labs 2005 - December 2012
Tiro 2000 - 2005
Lamaur 1995 - 2000
Dowbrands 1987 - 1995
Skills
GMP, Manufacturing, Engineering, Troubleshooting
Education
Allen Bradley, Nation Tech, Lewelly, ITC, American Trainco 1996 — 2009
Anoka Technical College 1991 — 1999
Hennepin Technical College 1992 — 1998
Perrigo January 2013 - Present
CIMA Labs 2005 - December 2012
Tiro 2000 - 2005
Lamaur 1995 - 2000
Dowbrands 1987 - 1995
Skills
GMP, Manufacturing, Engineering, Troubleshooting
Education
Allen Bradley, Nation Tech, Lewelly, ITC, American Trainco 1996 — 2009
Anoka Technical College 1991 — 1999
Hennepin Technical College 1992 — 1998
Brent Rosenberger's Cima Labs Experience 2002 - 2006
Job CAPA Process Specialist at Medtronic
Industry Medical Devices
Experience
Medtronic September 2014 - Present
Medtronic November 2011 - 2014
Medafor Inc. 2010 - November 2011
Medafor Inc. 2006 - November 2010
CIMA Labs 2002 - 2006
Baxter 1998 - 2000
Skills
CAPA, Cross-functional Team..., Design Control, FDA, GMP, ISO 13485, Inspection, Leadership, Manufacturing, Product Development, Quality Assurance, Quality System, Validation, V&V, ISO 14971
Education
University of Minnesota
Bachelor of Chemical Engineering, Chemical Engineering
University of Minnesota - Carlson School of Management
MBA, Operations Management
University of Minnesota-Twin Cities
Bachelor of Science, Microbiology
Medtronic September 2014 - Present
Medtronic November 2011 - 2014
Medafor Inc. 2010 - November 2011
Medafor Inc. 2006 - November 2010
CIMA Labs 2002 - 2006
Baxter 1998 - 2000
Skills
CAPA, Cross-functional Team..., Design Control, FDA, GMP, ISO 13485, Inspection, Leadership, Manufacturing, Product Development, Quality Assurance, Quality System, Validation, V&V, ISO 14971
Education
University of Minnesota
Bachelor of Chemical Engineering, Chemical Engineering
University of Minnesota - Carlson School of Management
MBA, Operations Management
University of Minnesota-Twin Cities
Bachelor of Science, Microbiology
Simion Samoei's Cima Labs Experience May 2005 - November 2009
Job StudentDoctorate program at Saint Mary's University of Minnesota
Industry Education Management
Experience
Saint Mary's University of Minnesota September 2009 - Present
CIMA Labs May 2005 - November 2009
Education
Saint Mary's University of Minnesota 2009 — 2012
Doctorate, Education Leadership
Saint Mary's University of Minnesota September 2009 - Present
CIMA Labs May 2005 - November 2009
Education
Saint Mary's University of Minnesota 2009 — 2012
Doctorate, Education Leadership
Craig McCarney's Cima Labs Experience September 2002 - November 2012
Job QA Inspector at New Flyer Industries
Industry Pharmaceuticals
Experience
New Flyer Industries July 2014 - Present
PouchTec, LLC June 2013 - June 2014
CIMA Labs September 2002 - November 2012
Skills
GMP, CAPA, Sop, FDA, Quality Assurance, Validation, Pharmaceutical Industry, Change Control, Software Documentation, Quality System, GLP, Manufacturing, 5S, V&V, 21 CFR Part 11, Continuous Improvement, Lean Manufacturing, SSOP, CCP, HACCP, CQP, SQF, DEA, Audits
Education
St. Cloud State University 1997 — 1999
BS, Education
New Flyer Industries July 2014 - Present
PouchTec, LLC June 2013 - June 2014
CIMA Labs September 2002 - November 2012
Skills
GMP, CAPA, Sop, FDA, Quality Assurance, Validation, Pharmaceutical Industry, Change Control, Software Documentation, Quality System, GLP, Manufacturing, 5S, V&V, 21 CFR Part 11, Continuous Improvement, Lean Manufacturing, SSOP, CCP, HACCP, CQP, SQF, DEA, Audits
Education
St. Cloud State University 1997 — 1999
BS, Education
Amanda Ryczek Rogers's Cima Labs Experience February 2014 - Present
Job Research Associate at CIMA Labs
Industry Pharmaceuticals
Experience
CIMA Labs February 2014 - Present
CIMA Labs January 2007 - February 2014
CIMA Labs May 2006 - December 2006
Skills
Analytical Chemistry, GMP, HPLC, FDA, Validation, Testing, Sop, Process Improvement, CAPA, Chromatography, GLP, Trackwise, Chemistry
Education
Institute of Technology, University of Minnesota 2002 — 2006
Bachelor of Science (BS), Chemistry
Justus-Liebig-Universität Giessen 2004 — 2004
Chemistrty, German Language
PHS
CIMA Labs February 2014 - Present
CIMA Labs January 2007 - February 2014
CIMA Labs May 2006 - December 2006
Skills
Analytical Chemistry, GMP, HPLC, FDA, Validation, Testing, Sop, Process Improvement, CAPA, Chromatography, GLP, Trackwise, Chemistry
Education
Institute of Technology, University of Minnesota 2002 — 2006
Bachelor of Science (BS), Chemistry
Justus-Liebig-Universität Giessen 2004 — 2004
Chemistrty, German Language
PHS
Catherine (Catherine Spolar) Gates's Cima Labs Experience March 2002 - December 2003
Job Patent Agent at Entegris, Inc.
Industry Law Practice
Experience
Entegris, Inc. October 2014 - Present
Seager, Tufte & Wickhem March 2011 - October 2014
Faegre & Benson LLP June 2006 - February 2011
Mayo Clinic March 2004 - June 2006
CIMA Labs March 2002 - December 2003
Merchant & Gould P.C. June 2001 - November 2001
Skills
Patents, Intellectual Property, Patent Prosecution, Litigation Support, Patent Searching, Patent Applications, Registered Patent Agent, Patent Portfolio..., Prosecution, Copyright Law, Legal Research
Education
University of Iowa 1997 — 1999
M.S., Chemistry
University of Iowa 1995 — 1997
Bachelor of Arts (B.A.), Chemistry
Entegris, Inc. October 2014 - Present
Seager, Tufte & Wickhem March 2011 - October 2014
Faegre & Benson LLP June 2006 - February 2011
Mayo Clinic March 2004 - June 2006
CIMA Labs March 2002 - December 2003
Merchant & Gould P.C. June 2001 - November 2001
Skills
Patents, Intellectual Property, Patent Prosecution, Litigation Support, Patent Searching, Patent Applications, Registered Patent Agent, Patent Portfolio..., Prosecution, Copyright Law, Legal Research
Education
University of Iowa 1997 — 1999
M.S., Chemistry
University of Iowa 1995 — 1997
Bachelor of Arts (B.A.), Chemistry
Catherine Oslund's Cima Labs Experience June 1987 - May 1990
Job Owner, PharmAssist
Industry Pharmaceuticals
Experience
Pharm-Assist May 1990 - Present
CIMA Labs June 1987 - May 1990
Eli Lilly and Company February 1983 - March 1986
Education
University of Minnesota-Twin Cities 1977 — 1980
B.S., Pharmacy
St. Olaf College 1974 — 1976
Biology
Robbinsdale High School 1971 — 1974
Pharm-Assist May 1990 - Present
CIMA Labs June 1987 - May 1990
Eli Lilly and Company February 1983 - March 1986
Education
University of Minnesota-Twin Cities 1977 — 1980
B.S., Pharmacy
St. Olaf College 1974 — 1976
Biology
Robbinsdale High School 1971 — 1974
Jeff Pearson's Cima Labs Experience 2000 - 2005
Job Quality Assurance Leader | Creating Innovative Solutions | Exceeding Industry Standards for Pharmaceutical Quality
Industry Pharmaceuticals
Experience
Patheon January 2013 - January 2015
CIMA/Cephalon/Teva 2006 - December 2012
CIMA/Cephalon 2005 - 2006
CIMA Labs 2000 - 2005
Universal Laboratories 1997 - 2000
Wendt Professional Labs 1995 - 2000
Envirostaff, Inc 1994 - 1995
Skills
GMP, FDA, Validation, Quality Assurance, Pharmaceutical Industry, Quality System, SAP, CAPA, Quality Control, Cleaning Validation, 21 CFR Part 11, Change Control, Quality Management, LIMS, Trackwise, Process Improvement, Technology Transfer, Quality Auditing
Education
Gustavus Adolphus College 1990 — 1994
Bachelor of Arts (B.A.), ACS Chemistry
Patheon January 2013 - January 2015
CIMA/Cephalon/Teva 2006 - December 2012
CIMA/Cephalon 2005 - 2006
CIMA Labs 2000 - 2005
Universal Laboratories 1997 - 2000
Wendt Professional Labs 1995 - 2000
Envirostaff, Inc 1994 - 1995
Skills
GMP, FDA, Validation, Quality Assurance, Pharmaceutical Industry, Quality System, SAP, CAPA, Quality Control, Cleaning Validation, 21 CFR Part 11, Change Control, Quality Management, LIMS, Trackwise, Process Improvement, Technology Transfer, Quality Auditing
Education
Gustavus Adolphus College 1990 — 1994
Bachelor of Arts (B.A.), ACS Chemistry
Erik Wozniak's Cima Labs Experience March 2006 - December 2012
Job Sr. Product Surveillance Analyst Structural Heart Division St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical December 2012 - Present
CIMA Labs March 2006 - December 2012
CIMA Labs February 2003 - February 2006
CIMA Labs October 1999 - January 2003
Skills
FDA, Trackwise, Validation, GMP, CAPA, Deviations, cGMP practices, Sop, Change Control, Contract Manufacturing, LIMS, Quality Auditing, 21 CFR Part 11, Pharmaceutical Industry, Quality System, V&V, Cleaning Validation, GLP, Quality Assurance, FDA GMP, Technology Transfer, Quality Control, Aseptic Processing, Analytical Chemistry, Regulatory Affairs, SOP
Education
St. Olaf College 1995 — 1999
BA, Biology
ASQ
ASQ - Certified Quality Auditor
St. Jude Medical December 2012 - Present
CIMA Labs March 2006 - December 2012
CIMA Labs February 2003 - February 2006
CIMA Labs October 1999 - January 2003
Skills
FDA, Trackwise, Validation, GMP, CAPA, Deviations, cGMP practices, Sop, Change Control, Contract Manufacturing, LIMS, Quality Auditing, 21 CFR Part 11, Pharmaceutical Industry, Quality System, V&V, Cleaning Validation, GLP, Quality Assurance, FDA GMP, Technology Transfer, Quality Control, Aseptic Processing, Analytical Chemistry, Regulatory Affairs, SOP
Education
St. Olaf College 1995 — 1999
BA, Biology
ASQ
ASQ - Certified Quality Auditor
Shaun Vang's Cima Labs Experience September 2008 - August 2012
Job Quality Technician II at Boston Scientific
Industry Pharmaceuticals
Experience
Boston Scientific July 2013 - Present
CIMA Labs September 2008 - August 2012
UMD September 2004 - August 2008
University of Wisconsin - Superior June 2003 - August 2007
Skills
FDA, GMP, Validation, Pharmaceutical Industry, HPLC, Quality System, CAPA, Trackwise, GLP, Sop, Cleaning Validation, LIMS, SAP, QDocs, 5S, Quality Control, 21 CFR Part 11, Quality Assurance, Change Control, FDA GMP, Regulatory Requirements, Quality Auditing
Education
University of Minnesota Duluth 2003 — 2008
B.S., Biology
Lake Superior College 2003 — 2003
Post Secondary Courses During High School
Boston Scientific July 2013 - Present
CIMA Labs September 2008 - August 2012
UMD September 2004 - August 2008
University of Wisconsin - Superior June 2003 - August 2007
Skills
FDA, GMP, Validation, Pharmaceutical Industry, HPLC, Quality System, CAPA, Trackwise, GLP, Sop, Cleaning Validation, LIMS, SAP, QDocs, 5S, Quality Control, 21 CFR Part 11, Quality Assurance, Change Control, FDA GMP, Regulatory Requirements, Quality Auditing
Education
University of Minnesota Duluth 2003 — 2008
B.S., Biology
Lake Superior College 2003 — 2003
Post Secondary Courses During High School
Sanjay Makwana's Cima Labs Experience July 2000 - September 2006
Job Global Quality Systems Manager Medical Component Division of Heraeus Inc.
Industry Medical Devices
Experience
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
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
John Hontz's Cima Labs Experience January 1997 - September 2004
Job Executive Director Pharmaceutical Sciences at Supernus Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
Supernus Pharmaceuticals, Inc. February 2015 - Present
Biovail November 2004 - April 2011
CIMA Labs January 1997 - September 2004
Education
University of the Sciences in Philadelphia 1974 — 1979
Bachelor's Degree, Pharmacy
Duke University - Fuqua School of Business
MBA
University of Maryland School of Pharmacy
Ph.D., Pharmaceutics
Supernus Pharmaceuticals, Inc. February 2015 - Present
Biovail November 2004 - April 2011
CIMA Labs January 1997 - September 2004
Education
University of the Sciences in Philadelphia 1974 — 1979
Bachelor's Degree, Pharmacy
Duke University - Fuqua School of Business
MBA
University of Maryland School of Pharmacy
Ph.D., Pharmaceutics
karl mills's Cima Labs Experience August 2006 - Present
Job utility operator at CIMA Labs
Industry Pharmaceuticals
Experience
CIMA Labs August 2006 - Present
CIMA Labs December 2001 - Present
Perrigo September 1994 - September 2000
Perrigo September 1991 - September 1994
Skills
dispensing attendant, Forklift Operator, GMP, tablet press..., Construction, Continuous Improvement, Supervisory Skills, FDA, cGMP, Manufacturing, Inventory Management, Process Improvement, Troubleshooting, Customer Service, Lean Manufacturing, 5S, Packaging, Team Building, SOP
Education
Appalachian Bible College 1972 — 1975
ba., christian education
Broome Community College 1970 — 1972
assoc, liberal arts
CIMA Labs August 2006 - Present
CIMA Labs December 2001 - Present
Perrigo September 1994 - September 2000
Perrigo September 1991 - September 1994
Skills
dispensing attendant, Forklift Operator, GMP, tablet press..., Construction, Continuous Improvement, Supervisory Skills, FDA, cGMP, Manufacturing, Inventory Management, Process Improvement, Troubleshooting, Customer Service, Lean Manufacturing, 5S, Packaging, Team Building, SOP
Education
Appalachian Bible College 1972 — 1975
ba., christian education
Broome Community College 1970 — 1972
assoc, liberal arts
Derek Enos's Cima Labs Experience January 2007 - December 2009
Job Student at American University of Antigua (AUA) College of Medicine
Industry Medical Practice
Experience
CIMA Labs January 2007 - December 2009
Luther College May 2004 - August 2004
Education
American University of Antigua (AUA) College of Medicine 2010 — 2014
Luther College 2003 — 2006
Adisadel College 1998 — 2000
Science
Plymouth State University
Master of Business Administration (M.B.A.)
CIMA Labs January 2007 - December 2009
Luther College May 2004 - August 2004
Education
American University of Antigua (AUA) College of Medicine 2010 — 2014
Luther College 2003 — 2006
Adisadel College 1998 — 2000
Science
Plymouth State University
Master of Business Administration (M.B.A.)
Michael Newhouse's Cima Labs Experience October 2000 - July 2012
Job Quality Assurance at Glutenfreeda Foods, Inc
Industry Food Production
Experience
Oak Harbor Marina May 2015 - Present
Glutenfreeda Foods, Inc June 2014 - September 2014
CIMA Labs October 2000 - July 2012
Circuit Research Corporation May 2000 - October 2000
Skills
Validation, Chemistry, Quality Auditing, Calibration, Quality Assurance, USP, OOS, Pharmaceutics, Karl Fisher, Batch Release, Analytical Method..., Deviations, HPLC, FTIR, Dissolution Testing, Leadership, Cleaning Verification, Software Testing and..., 21 CFR, FDA GMP, GLP, SOP development, Specifications, Hardness, Titration, ICP, Viscosity, Hardware technician, Civil Engineering, CBRN, Data Review, Method Transfer
Education
Black Hills State University 1993 — 1997
Bachelor of Science (BS), Chemistry
Maui Community College 1984 — 1984
Classes only, Astronomy
Black Hills State University
BS, Chemistry
Oak Harbor Marina May 2015 - Present
Glutenfreeda Foods, Inc June 2014 - September 2014
CIMA Labs October 2000 - July 2012
Circuit Research Corporation May 2000 - October 2000
Skills
Validation, Chemistry, Quality Auditing, Calibration, Quality Assurance, USP, OOS, Pharmaceutics, Karl Fisher, Batch Release, Analytical Method..., Deviations, HPLC, FTIR, Dissolution Testing, Leadership, Cleaning Verification, Software Testing and..., 21 CFR, FDA GMP, GLP, SOP development, Specifications, Hardness, Titration, ICP, Viscosity, Hardware technician, Civil Engineering, CBRN, Data Review, Method Transfer
Education
Black Hills State University 1993 — 1997
Bachelor of Science (BS), Chemistry
Maui Community College 1984 — 1984
Classes only, Astronomy
Black Hills State University
BS, Chemistry
Ken Peter's Cima Labs Experience October 1997 - September 2001
Job Principal Packaging Engineer at UpsherSmith Laboratories
Industry Pharmaceuticals
Experience
Upsher-Smith Laboratories Sr. Packaging EngineerHoneywellFebruary 2003 - February 2011
CIMA Labs October 1997 - September 2001
JAFRA Cosmetics International 1992 - 1996
Education
Michigan State University 1985 — 1990
Bachelor of Science (BS), Packaging Engineering
Upsher-Smith Laboratories Sr. Packaging EngineerHoneywellFebruary 2003 - February 2011
CIMA Labs October 1997 - September 2001
JAFRA Cosmetics International 1992 - 1996
Education
Michigan State University 1985 — 1990
Bachelor of Science (BS), Packaging Engineering
Amgen
Biogen Idec
Gilead Sciences
Celgene
Biogen
Amgen Inc
bioMerieux
Centocor