CIMA Labs Inc.
Industry: Biotechnology company
DescriptionHeadquarters: Eden Prairie, MN Founded: 1986 Parent organization: Cephalon, Inc.
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CIMA Labs Inc. Employees
Employee
Years
Job
Industry
Nancy Monin Nancy Monin's CIMA Labs Inc. Experience May 2014 - Present
Job Senior Document Control Specialist at CIMA LABS, INC
Industry Pharmaceuticals
Experience
CIMA LABS, INC May 2014 - Present
CIMA LABS Inc January 2009 - Present
CIMA LABS Inc November 2004 - January 2009
United States Investigations Services April 2002 - September 2004
Education
Central Texas College
Associates of Applied Science, Office Management
Saint John's University
Bachelors, Business Management
CIMA LABS, INC May 2014 - Present
CIMA LABS Inc January 2009 - Present
CIMA LABS Inc November 2004 - January 2009
United States Investigations Services April 2002 - September 2004
Education
Central Texas College
Associates of Applied Science, Office Management
Saint John's University
Bachelors, Business Management
Douglas Moran Douglas Moran's CIMA Labs Inc. Experience January 1999 - June 2006
Job Account Director at Catalent Pharma Solutions
Industry Hospital & Health Care
Experience
Catalent Pharma Solutions August 2013 - Present
Consultant January 2012 - Present
Perspective Films, Inc. April 2010 - December 2011
PII March 2008 - June 2008
Ethypharm 2006 - 2007
CIMA LABS INC. January 1999 - June 2006
Pharmacy Gold, Inc. 1993 - 1997
Skills
Licensing, Sales Cycle Management, Business Development, New Business Development, Project Management, Negotiation, Cold Calling, Medical Devices, Product Development, Strategic Planning, Pharmaceutical Industry, R&D, Biotechnology, CRM
Education
Carlson School of Management 2000 — 2001
Certificate, Minnesota Management Institute
Saint Mary's University of Minnesota 1991 — 2000
MA, Health & Human Services Admin
Augsburg College 1982 — 1986
BA, Poli Sci
Catalent Pharma Solutions August 2013 - Present
Consultant January 2012 - Present
Perspective Films, Inc. April 2010 - December 2011
PII March 2008 - June 2008
Ethypharm 2006 - 2007
CIMA LABS INC. January 1999 - June 2006
Pharmacy Gold, Inc. 1993 - 1997
Skills
Licensing, Sales Cycle Management, Business Development, New Business Development, Project Management, Negotiation, Cold Calling, Medical Devices, Product Development, Strategic Planning, Pharmaceutical Industry, R&D, Biotechnology, CRM
Education
Carlson School of Management 2000 — 2001
Certificate, Minnesota Management Institute
Saint Mary's University of Minnesota 1991 — 2000
MA, Health & Human Services Admin
Augsburg College 1982 — 1986
BA, Poli Sci
Vickie O'Neill Vickie O'Neill's CIMA Labs Inc. Experience December 2012 - Present
Job Director, Formulation Development at CIMA Labs Inc.
Industry Pharmaceuticals
Experience
CIMA Labs Inc. December 2012 - Present
Orchard Pharma Consulting LLC January 2011 - December 2012
Upsher-Smith Laboratories 2007 - 2010
Upsher-Smith Laboratories 2004 - 2007
Upsher-Smith Laboratories 1995 - 2003
Upsher-Smith Laboratories 1986 - 1995
SmithKline Beecham September 1978 - February 1986
Skills
New Business Development, Product Development, Research Project..., Technology Transfer, Licensing, Acquisition Analysis, Due Diligence, Drug Delivery, Roller Compaction, Spray Drying, Tablet Compression, Encapsulation, Biodegradable Polymers, Business Development, Pharmaceutical Industry, Biotechnology, GMP, Validation, Cross-functional Team..., Contract Manufacturing, Drug Development, Strategic Alliances, Analytical Chemistry, Project Management
Education
University of Nebraska-Lincoln 1979 — 1984
MBA, Marketing
University of Nebraska Medical Center 1974 — 1978
B. S., Pharmacy
CIMA Labs Inc. December 2012 - Present
Orchard Pharma Consulting LLC January 2011 - December 2012
Upsher-Smith Laboratories 2007 - 2010
Upsher-Smith Laboratories 2004 - 2007
Upsher-Smith Laboratories 1995 - 2003
Upsher-Smith Laboratories 1986 - 1995
SmithKline Beecham September 1978 - February 1986
Skills
New Business Development, Product Development, Research Project..., Technology Transfer, Licensing, Acquisition Analysis, Due Diligence, Drug Delivery, Roller Compaction, Spray Drying, Tablet Compression, Encapsulation, Biodegradable Polymers, Business Development, Pharmaceutical Industry, Biotechnology, GMP, Validation, Cross-functional Team..., Contract Manufacturing, Drug Development, Strategic Alliances, Analytical Chemistry, Project Management
Education
University of Nebraska-Lincoln 1979 — 1984
MBA, Marketing
University of Nebraska Medical Center 1974 — 1978
B. S., Pharmacy
Kerry Berken Kerry Berken's CIMA Labs Inc. Experience September 2008 - May 2009
Job Quality Systems Engineer at Fast Forward Medical
Industry Medical Devices
Experience
Fast Forward Medical November 2011 - Present
VASCULAR SOLUTIONS, INC April 2011 - October 2011
MOE'S DOCKS & LIFTS, INC April 2009 - May 2011
CIMA LABS, INC September 2008 - May 2009
CIMA LABS, INC January 1996 - January 2007
Education
St. Cloud State University
Bachelor's Degree of Science (B.S, Biology
Fast Forward Medical November 2011 - Present
VASCULAR SOLUTIONS, INC April 2011 - October 2011
MOE'S DOCKS & LIFTS, INC April 2009 - May 2011
CIMA LABS, INC September 2008 - May 2009
CIMA LABS, INC January 1996 - January 2007
Education
St. Cloud State University
Bachelor's Degree of Science (B.S, Biology
Kristine Wicken Kristine Wicken's CIMA Labs Inc. Experience January 2007 - December 2010
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
Kathleen Brendemuehl Kathleen Brendemuehl's CIMA Labs Inc. Experience April 2001 - Present
Job QC Scientist at CIMA LABS Inc.
Industry Pharmaceuticals
Experience
CIMA LABS Inc. April 2001 - Present
Tiro Industries 1988 - 2001
Lan-OSheen, Inc. 1980 - 1985
Education
University of Minnesota-Twin Cities 1976 — 1980
CIMA LABS Inc. April 2001 - Present
Tiro Industries 1988 - 2001
Lan-OSheen, Inc. 1980 - 1985
Education
University of Minnesota-Twin Cities 1976 — 1980
Michael Wangsness's CIMA Labs Inc. Experience October 2003 - November 2012
Job Lab Ops Supervisor at UpsherSmith
Industry Pharmaceuticals
Experience
Tapemark October 2015 - Present
Upsher-Smith Laboratories January 2013 - October 2015
CIMA Labs, Inc October 2003 - November 2012
Novartis Nutrition March 2003 - September 2003
Micron Technology, Inc February 2001 - January 2003
Skills
CQA, FDA, GMP, Validation, CAPA, Analytical Chemistry, HPLC, Technology Transfer, Pharmaceutical Industry, LIMS, GLP, Quality System, Sop, Chemistry, Regulatory Affairs, UV/Vis, Cleaning Validation, Gas Chromatography, Quality Assurance, Manufacturing
Education
The University of North Dakota 1992 — 1997
B.S., Chemistry
The University of North Dakota 1992 — 1997
Graduate Research, Analytical Chemistry
Woodbury High School 1988 — 1992
Tapemark October 2015 - Present
Upsher-Smith Laboratories January 2013 - October 2015
CIMA Labs, Inc October 2003 - November 2012
Novartis Nutrition March 2003 - September 2003
Micron Technology, Inc February 2001 - January 2003
Skills
CQA, FDA, GMP, Validation, CAPA, Analytical Chemistry, HPLC, Technology Transfer, Pharmaceutical Industry, LIMS, GLP, Quality System, Sop, Chemistry, Regulatory Affairs, UV/Vis, Cleaning Validation, Gas Chromatography, Quality Assurance, Manufacturing
Education
The University of North Dakota 1992 — 1997
B.S., Chemistry
The University of North Dakota 1992 — 1997
Graduate Research, Analytical Chemistry
Woodbury High School 1988 — 1992
Nick Valentine's CIMA Labs Inc. Experience March 2000 - April 2013
Job CFO at Shooting Star Casino
Industry Gambling & Casinos
Experience
Shooting Star Casino February 2015 - Present
Celadon Systems February 2014 - April 2014
CIMA LABS INC March 2000 - April 2013
Minnesota Vikings 1992 - 2000
Tonka Corporation September 1987 - October 1991
Kenner Products January 1980 - August 1987
Skills
Forecasting, Sarbanes-Oxley Act, SAP, Mergers & Acquisitions, Budgets, Cost Accounting, Auditing, Finance, Analysis, Leadership, Revenue Recognition, SEC filings, Internal Audit, Payroll, Fixed Assets, Financial Reporting, Financial Modeling, Sarbanes-Oxley, Mergers, US GAAP, Financial Accounting, Managerial Finance, Accounting, Due Diligence, ERP, Variance Analysis, Consolidation, Internal Controls, Cross-functional Team..., Accounts Payable, Cash Flow, GAAP, Manufacturing, Tax, Financial Audits, Budget
Education
Xavier University
MBA, Finance
University of Cincinnati
BS, Accounting
Shooting Star Casino February 2015 - Present
Celadon Systems February 2014 - April 2014
CIMA LABS INC March 2000 - April 2013
Minnesota Vikings 1992 - 2000
Tonka Corporation September 1987 - October 1991
Kenner Products January 1980 - August 1987
Skills
Forecasting, Sarbanes-Oxley Act, SAP, Mergers & Acquisitions, Budgets, Cost Accounting, Auditing, Finance, Analysis, Leadership, Revenue Recognition, SEC filings, Internal Audit, Payroll, Fixed Assets, Financial Reporting, Financial Modeling, Sarbanes-Oxley, Mergers, US GAAP, Financial Accounting, Managerial Finance, Accounting, Due Diligence, ERP, Variance Analysis, Consolidation, Internal Controls, Cross-functional Team..., Accounts Payable, Cash Flow, GAAP, Manufacturing, Tax, Financial Audits, Budget
Education
Xavier University
MBA, Finance
University of Cincinnati
BS, Accounting
Carol Anding's CIMA Labs Inc. Experience February 2006 - Present
Job Regulatory Affairs Consultant Anding Consulting
Industry Pharmaceuticals
Experience
CIMA LABS INC February 2006 - Present
Anding Consulting, Inc. May 2003 - Present
CNS Therapeutics, Inc. September 2011 - April 2013
MGI PHARMA, INC. April 2003 - September 2005
Paddock Laboratories 1996 - 2001
SUMMARY OF EARLY REGULATORY EXPERIENCE 1987 - 1994
Skills
Technology Transfer, Regulatory Affairs, Pharmaceutical Industry, Biotechnology, GMP, Validation, FDA, Medical Devices, Product Development, Quality Assurance, Pharmaceutics, CAPA
Education
University of Minnesota-Twin Cities
Bachelor's degree, Developmental and Child Psychology
CIMA LABS INC February 2006 - Present
Anding Consulting, Inc. May 2003 - Present
CNS Therapeutics, Inc. September 2011 - April 2013
MGI PHARMA, INC. April 2003 - September 2005
Paddock Laboratories 1996 - 2001
SUMMARY OF EARLY REGULATORY EXPERIENCE 1987 - 1994
Skills
Technology Transfer, Regulatory Affairs, Pharmaceutical Industry, Biotechnology, GMP, Validation, FDA, Medical Devices, Product Development, Quality Assurance, Pharmaceutics, CAPA
Education
University of Minnesota-Twin Cities
Bachelor's degree, Developmental and Child Psychology
Philip Simonson's CIMA Labs Inc. Experience July 2003 - June 2015
Job Director, Head of Specialty Pharma Products, Global Regulatory Affairs at Perrigo Company plc
Industry Pharmaceuticals
Experience
Perrigo Company plc August 2015 - Present
CIMA LABS INC July 2003 - June 2015
Pfizer 2002 - 2003
Pfizer Global Research & Development 2000 - 2002
Warner Lambert/Parke-Davis 1995 - 1999
Warner Lambert 1993 - 1995
Warner Lambert/Parke-Davis 1991 - 1993
Skills
FDA, GMP, Pharmaceutical Industry, Technology Transfer, Regulatory Affairs, V&V, Validation, Drug Development, IND, CAPA, Regulatory Submissions, NDA, Regulatory Requirements, Pharmaceutics, R&D, Biotechnology, Change Control
Education
University of Iowa 1986 — 1991
Ph.D., Analytical Chemistry
University of Wisconsin-Superior 1982 — 1986
B.S., Chemistry
Frankfurt American High School 1979 — 1982
Diploma
Perrigo Company plc August 2015 - Present
CIMA LABS INC July 2003 - June 2015
Pfizer 2002 - 2003
Pfizer Global Research & Development 2000 - 2002
Warner Lambert/Parke-Davis 1995 - 1999
Warner Lambert 1993 - 1995
Warner Lambert/Parke-Davis 1991 - 1993
Skills
FDA, GMP, Pharmaceutical Industry, Technology Transfer, Regulatory Affairs, V&V, Validation, Drug Development, IND, CAPA, Regulatory Submissions, NDA, Regulatory Requirements, Pharmaceutics, R&D, Biotechnology, Change Control
Education
University of Iowa 1986 — 1991
Ph.D., Analytical Chemistry
University of Wisconsin-Superior 1982 — 1986
B.S., Chemistry
Frankfurt American High School 1979 — 1982
Diploma
Amgen
Biogen Idec
Gilead Sciences
Celgene
Biogen
Amgen Inc
bioMerieux
Centocor