SoloPak Pharmaceuticals
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SoloPak Pharmaceuticals Employees
PepsiCo January 1998 - Present
PepsiCo 1998 - 2014
SoloPak Pharmaceuticals 1993 - 1998
Baxter Healthcare 1990 - 1993
Skills
CI (Continuous..., Autonomous MX Certified, Kaizen Leader..., CS (Certified..., MEM (Micro..., Food Safety, Food Processing, Food Industry, Food Science, Food Manufacturing, Food, Quality Management, Packaging, Continuous Improvement, Manufacturing, Operations Management, ISO 22000, Sanitation, SQF, HACCP Certified, HACCP, Food Microbiology, Food Technology, Food Quality
Education
Purdue University 1988 — 1990
Supervisory Management
Citron Pharma October 2013 - Present
Zydus Pharmaceuticals USA January 2005 - September 2013
Sandoz 2003 - 2005
Bedford Laboratories 1996 - 2003
SoloPak Pharmaceuticals 1992 - 1996
Bristol-Myers Squibb, Princeton, New Jersey 1987 - 1992
Skills
Managed Care, Pharmaceutical Industry, Pharmaceutical Sales, Start-ups, Oncology, Sales Effectiveness, Pharmaceutics, Selling, Contract Negotiation, Market Access, Strategic Planning, Product Launch, Account Management, Sales, Sales Operations
Education
Clarion University of Pennsylvania 1973 — 1977
BA, Liberal Arts/Humanities
R.B. Kirsch Consulting September 2000 - Present
Solopak Pharmaceuticals 1997 - 2000
Forest Laboratories September 1994 - August 1997
DuPont Merck Pharmaceutical May 1990 - July 1994
Skills
R&D, Quality Assurance, Software Documentation, Technical Support, GLP, Validation, HPLC, 21 CFR Part 11
Education
New York University 1977 — 1983
Ph.D., Physical Organic Chemistry
University of Maryland College Park 1970 — 1974
BS, Chemistry
General Board of Pension and Health Benefits 2010 - Present
PNC Financial Services Group 2004 - 2009
Cole Taylor Bank 1997 - 2004
SoloPak Pharmaceuticals March 1993 - September 1997
Skills
Employee Engagement, Leadership Development, Performance Management, Organizational..., Labor Relations, Change Management, Sourcing, Employee Relations, Vendor Management, Strategic Planning, Leadership, Recruiting, Human Resources, Coaching, Training, HRIS, Onboarding, Applicant Tracking..., Talent Acquisition, Strategy
Education
Indiana University Bloomington
MS, Education
B&G Partners LLC September 2008 - Present
Baxter International Inc. 2010 - 2014
Baxter International Inc. 2010 - 2014
Northwestern University December 2008 - December 2010
Baxter Healthcare January 2005 - August 2008
Transfusion Therapies at Baxter Healthcare Corporation February 1998 - January 2005
Baxter International Inc. 1998 - 2005
SoloPak Pharmaceuticals March 1993 - February 1998
Baxter Healthcare Corporation July 1983 - March 1993
Skills
Product Development, Medical Devices, ISO 13485, FDA, Regulatory Affairs, CAPA, Regulatory Requirements, Regulatory Submissions, Design Control, Pharmaceutics, Validation, Biotechnology, Strategy, Pharmaceutical Industry, Lifesciences, Life Sciences
Education
Illinois Institute of Technology 1974 — 1976
Masters Work, Inorganic and Biochemistry
Illinois Benedictine College 1970 — 1974
BS, Chemistry, Physics, Biochemistry
Bemis Company, Inc. December 2014 - Present
Weber Packaging Solutions, Inc. 2014 - 2014
Berlin Packaging 2007 - 2013
PartyLite 1998 - 2007
STERIS Isomedix Services 1997 - 1998
Solopak Pharmaceuticals 1996 - 1997
Griffith Micro Science 1990 - 1996
Skills
Manufacturing, Quality Management, Quality System, Packaging, Root Cause Analysis, Product Development, Continuous Improvement, ISO, Cross-functional Team..., Supplier Evaluation, Corrective Actions, Supply Chain, GMP, Quality Auditing, Management, Plastics, Manufacturing..., Product Specifications, Quality Systems..., Employee Training, Product Specification, Six Sigma, Iso 9000, ISO 9000 Management, Sampling Plans, Lean Manufacturing, Kaizen, Injection Molding, Metrology, Employee Development, Food Safety, Food Packaging
Education
University of Illinois at Urbana-Champaign
Bachelor of Science (B.Sc.), Microbiology
Genentech March 2015 - Present
Genentech October 2012 - Present
Genentech November 2009 - October 2012
Denali Biopharmaceutical Consulting October 2008 - November 2009
PDL BioPharma September 2004 - October 2008
XOMA August 1999 - August 2004
Dey L.P. July 1997 - August 1999
Solopak Pharmaceuticals 1993 - 1997
Baxter April 1990 - 1993
US Army 1987 - 1990
Skills
GMP, Procurement, Engineering, Process Engineering, Construction, Management, Continuous Improvement, Lease Negotiations, Cross-functional Team..., Manufacturing, Quality System, ISO, Project Planning, Facilities Management, FDA, CAPA, Sop, Process Improvement, Biotechnology, Strategy, Contract Negotiation, Leadership, Project Management, Start-ups, Outsourcing, Quality Assurance, Six Sigma
Education
Keller Graduate School of Management of DeVry University 2011 — 2012
MBA Finance
Norwich University 1984 — 1987
BSEE, Electrical and Electronics Engineering
Vaisala Oyj February 2010 - Present
Corporate Express, a Staples company October 2006 - February 2010
Andrx Pharmaceuticals, a Watson Pharmaceuticals company 1998 - 2003
Solopak Pharmaceuticals 1996 - 1998
IVAX Pharmaceuticals, a Teva Pharmaceuticals company 1991 - 1996
Education
University of Miami - School of Business 1986 — 1987
MBA, Finance
Tulane University - A.B. Freeman School of Business 1982 — 1986
BSM, Concentration in Accounting
Miami Killian High School 1980 — 1982
McMaster-Carr Supply June 2009 - Present
D.A.B. Trucking January 2009 - Present
McMaster-Carr Supply January 2007 - July 2009
L Trucking January 2005 - November 2006
L Trucking January 2005 - November 2006
Kraft Foods April 1997 - May 2005
Kraft Foods Inc January 1997 - January 2005
Dena Douglas January 1997 - January 2005
Unilever January 1995 - January 1997
SoloPak Pharmaceuticals January 1993 - July 1995
Education
Northern Illinois University
Bachelor of Science, Industrial Engineering Technology
Northern Illinois University
Bachelor of Science, Industrial Engineering Technology
Hollister Incorporated June 2013 - Present
Hollister Incorporated February 2002 - June 2013
Sterigenics 1997 - 2002
SoloPak Pharmaceuticals 1996 - 1997
Wesley-Jensen Corporation 1994 - 1996
Pennex Pharamceuticals 1992 - 1994
Food and Drug Administration 1991 - 1992
Skills
Six Sigma, V&V, ISO 13485, FDA, Quality Assurance, Medical Devices, Testing, Validation, Quality System, ISO, Biotechnology, Calibration, R&D, Design Control, Sterilization, Product Development, CAPA, GMP, Management, 21 CFR Part 11, Change Control, Sop, Quality Auditing, Computer System..., SOP
Education
University of Illinois at Urbana-Champaign 1986 — 1991
Bachelor of Science, Agricultural Sciences
University of Illinois at Urbana-Champaign
Masters of Science, Food science and Human Nutrition
University of Illinois at Urbana-Champaign
Bachelor of Science, Engineering
AT&T Mobility March 2013 - Present
AT&T Mobility February 2011 - March 2013
AT&T Mobility July 2005 - February 2011
Cingular Wireless, Inc January 2001 - January 2005
BellSouth Mobility, Inc January 2000 - January 2001
BellSouth Mobility, Inc January 1997 - January 2000
SoloPak Pharmaceuticals January 1996 - January 1997
Thompson Medical Co January 1992 - January 1996
Corporate Expressions January 1989 - January 1992
Education
University of Phoenix
Bachelor of Science, Business
Northwestern Mutual January 2011 - Present
Abbott Laboratories November 1997 - June 1998
SoloPak Pharmaceuticals May 1993 - October 1997
Lyphomed/Fujisawa February 1990 - May 1993
Pharmaceutical Basics Inc. August 1988 - January 1990
Skills
Customer Service, Microsoft Office, Microsoft Excel, Leadership
Education
University of Illinois at Urbana-Champaign 1984 — 1988
BS
Randstad Pharma 2011 - Present
Pharmaceutical and Device Publishing Operations - Documentation Quality - Regulatory Affairs 2010 - Present
Baxter Healthcare 1999 - 2010
Barbeau Pharma, Inc. 2003 - 2005
SoloPak Pharmaceuticals 1996 - 1998
Skills
Quality Assurance, FDA, Regulatory Affairs, Pharmaceutical Industry, Cross-functional Team..., GMP, 21 CFR Part 11, Strategy, Medical Devices, Sop, Training, Quality Management, Six Sigma, Recruiting, Team Management, Project Management, Group Leadership, Process Improvement, Quality System, Regulatory Submissions, SOP, Validation
Education
Eastern Illinois University 2013 — 2015
Bachelor of Science (B.S), Organizational and Professional Development, 4.0 GPA
Harper College 2011 — 2013
AA, Business Administration
Harper College 2013 — 2014
Advanced Management Certificate, Business Administration and Management, General
Harper College 2013 — 2013
General Management Certificate, Management
Roosevelt University
Certification, Quality Auditing, ASQ
Western Illinois University
Board of Trustees BA Program
Hospira, a Pfizer Company June 2013 - Present
Active BioMaterial March 2010 - April 2013
Catalent Pharma Solutions January 2007 - March 2010
Cardinal Health/Catalent Pharma Solutions May 2005 - January 2007
Cardinal Health 2005 - 2007
ZLB Behring (Aventis Behring) 2000 - 2005
Jordan Pharmaceuticals 1998 - 2000
Wesley Jessen (Ciba) 1997 - 1999
Solopak Pharmaceuticals December 1992 - November 1997
Skills
FDA, Computer System..., 21 CFR Part 11, Validation, CAPA, Sop, Six Sigma, Aseptic Processing, GMP, V&V, Change Control, Biopharmaceuticals, Cleaning Validation, Quality Assurance, Microbiology, Regulatory Affairs, Quality System, Regulatory Requirements, HPLC, Quality Management, Contract Manufacturing, Pharmaceutical Industry, GAMP, Regulatory Submissions, Medical Devices, Quality Auditing, Drug Development, Biotechnology, Technology Transfer, GxP, GLP, Pharmaceutics, Quality Control, LIMS, ISO 13485, Analytical Chemistry, Chromatography, Design Control, Trackwise, Vaccines, R&D, Clinical Development, SOP, CRO, Program Management
Education
Illinois State University 1987 — 1992
Illinois State University
ImmunoGen, Inc. July 2011 - Present
Hyaluron/AMRI June 2009 - August 2010
Xcellerex November 2007 - April 2009
IMMUNETICS, INC October 2006 - November 2007
CHEMGENES CORPORATION November 2005 - October 2006
GLYCOGENESYS, INC August 2002 - October 2005
ALPHAGENE, INC May 2000 - May 2002
SOLOPAK PHARMACEUTICALS January 1997 - June 1998
Abbott Laboratories April 1990 - August 1996
Abbott Laboratories April 1988 - April 1990
Skills
GMP, Quality Systems, SOP, Quality Assurance, Change Control, CAPA, Medical Devices, 21 CFR Part 11, Compliance, cGMP, Document Management, Process Validation, Auditing, Sop, Pharmaceutical Industry, R&D, V&V, Quality System, Technology Transfer, ISO 13485, FDA, Computer System..., Calibration, GxP, Regulatory Affairs, Biopharmaceuticals, GCP, Aseptic Processing, Manufacturing, Software Documentation, Validation, Pharmaceutics, Contract Manufacturing, Clinical Trials, Clinical Development, Analytical Chemistry, Regulatory Submissions, Formulation, GLP, Quality Auditing, LIMS, Lifesciences, Cleaning Validation, Laboratory, Quality Control, Biotechnology, Drug Development, Protein Chemistry, Assay Development, CRO
Education
Lake Forest College 1982 — 1985
Bachelor of Science, Biology
Lake Forest College 1981 — 1985
Bachelor of Science
Therapeutic Proteins International, LLC November 2014 - Present
Horizon Pharma September 2010 - October 2014
Horizon Pharma, Inc. September 2010 - October 2014
Del Global Technologies Corp August 2006 - October 2010
ESSENTIAL GROUP, INC August 2004 - August 2006
KILDEER CONSULTING November 2001 - August 2004
GENEPROT, INC May 2001 - October 2001
ALLSCRIPTS, INC August 1999 - May 2001
VALENCE RESEARCH, LLC January 1997 - August 1999
SOLOPAK PHARMACEUTICALS January 1996 - January 1997
Skills
Mergers, Financial Reporting, Sarbanes-Oxley Act, Budgets, Forecasting, Financial Modeling, Strategy, Start-ups, Finance, Mergers & Acquisitions, Business Planning, Internal Audit, SEC filings, Accounting, Financial Analysis, Auditing, Cost Accounting, Cash Flow, Internal Controls, Accounts Payable
Education
Loyola University of Chicago 1979 — 1983
BBA, Public Accounting
Abbott Logistics 2008 - Present
Abbott GPO 2007 - Present
Hospira, Inc. May 2004 - Present
Abbott Laboratories June 1997 - May 2004
SOLOPAK PHARMACEUTICALS January 1995 - July 1997
ELI LILLY February 1991 - June 1995
Education
University of Illinois at Urbana-Champaign 1971 — 1975
athenahealth August 2014 - Present
MedAssets August 2009 - April 2014
Noblis August 2006 - August 2009
XactiMed August 2004 - August 2006
Cerner Corporation August 2000 - August 2004
Per-Se Technologies November 1997 - August 2000
SoloPak Pharmaceuticals June 1996 - November 1997
Alaris Medical Systems September 1989 - June 1996
Skills
Healthcare Information..., Business Development, Hospitals, Healthcare, CRM, Leadership, Healthcare Industry, SaaS, Healthcare Consulting, Management, Revenue Cycle, Training, EHR, Management Consulting, Contract Negotiation, Managed Care, Program Management, Consulting, Sales Operations, Sales
Education
MBA Our Lady of the Lake University 1990 — 1992
Executive MBA, Management
State University of New York College at Oneonta 1974 — 1977
BA, Communication
Stuyvesant High School 1968 — 1972
Diploma, Magnet School Science & Math - NYC
Fresenius Kabi USA (APP Pharmaceuticals) Work in partnership with site manufacturing operations, research and development, quality control and assurance, engineering, maintenance management and support areas to solve problems and provide expertise on compliance issues and corporate quality policy requirements. Responsible for establishing, deploying and managing an effective supplier quality and internal auditing program. Execute the risk and gap assessment programs to ensure that marketed products and their related systems are received, manufactured, packaged, stored and distributed under an acceptable level of compliance. Identify cGMP inadequacies in facilities that can impact NDA/ANDA approvals, site FDA compliance classification and avoid product recalls, withdrawals and Regulatory actions.Director, QAAPP PharmaceuticalsJanuary 2009 - March 2012
Abraxis Pharmaceutical Products (APP), a Division of Abraxis BioScience, Inc. 2004 - 2008
Abraxis Pharmaceutical Products 2004 - 2007
Abraxis BioScience 2004 - 2007
CSL Behring LLC 2003 - 2004
Aventis Behring 1997 - 2004
ZLB Behring 1997 - 2004
Solopak Pharmaceuticals 1997 - 1997
Luster Products 1994 - 1997
Videojet Systems 1990 - 1993
Skills
Change Control, Validation, Biopharmaceuticals, Pharmaceutics, Chemistry, Aseptic Processing, Cleaning Validation, Quality Control, Quality System, Regulatory Affairs, Quality Assurance, LIMS, CAPA, Sop, GMP, Quality Auditing, Pharmaceutical Industry, Regulatory Requirements, FDA, Computer System..., 21 CFR Part 11, GLP, GxP, V&V, Technology Transfer, Trackwise, FDA GMP, Medical Devices, HPLC, Lyophilization, TrackWise, SOP
Education
Tennessee State University 1985 — 1989
Bachelor of Science (BS), Biology, Chemistry
Abraxis BioScience December 2006 - Present
American Pharmaceutical Partners March 2001 - Present
APP Pharmaceuticals 2001 - Present
Nycomed Amersham October 1999 - March 2001
SoloPak Medical products, Inc. 1986 - 1997
Solopak Pharmaceuticals 1986 - 1997
Education
Triton-College
Fresenius Kabi USA November 2010 - Present
Honeywell Analytics April 2009 - November 2010
Oshkosh Specialty Vehicles June 2004 - November 2008
Dentsply MPL Technologies June 1999 - March 2004
Dentsply Professional West December 1997 - June 1999
SoloPak Pharmaceuticals April 1996 - November 1997
Wesley-Jessen 1989 - 1995
Skills
MRP, Manufacturing, Inventory Control, Purchasing, Logistics, Production Planning, Warehousing, ERP, Cross-functional Team..., Strategic Sourcing, Supply Management, Supply Chain..., Lean Manufacturing, Supply Chain Management, Supply Chain
Education
Michigan State University 1983 — 1987
B.A., Materials and Logistics Management
Partylite Manufacturing August 2006 - February 2009
Partylite Manufacturing January 2000 - August 2006
Aventis Behring October 1998 - December 1999
Aventis Behring September 1997 - October 1998
Solopak Pharmaceuticals April 1995 - September 1997
Wesley-Jessen Corporation July 1987 - March 1995
Skills
Validation, Quality System, MRP, Cross-functional Team..., Continuous Improvement, Manufacturing, Quality Assurance, Root Cause Analysis, Operations Management, Packaging, GMP, FDA
Education
DePaul University 1997 — 1999
Madonna High School 1976 — 1980
Bruker Daltonics December 2009 - Present
Bruker Daltonics January 2004 - 2009
WATERS TECHNOLOGIES January 1998 - January 2004
injectable drug manufacturer January 1997 - January 1998
SoloPak Pharmaceuticals January 1996 - January 1997
SoloPak Pharmaceuticals January 1996 - January 1996
Analytical R&D January 1994 - January 1996
ORGANICS /LAGRANGE, INC January 1992 - January 1994
Skills
Mass Spectrometry, HPLC, UV/Vis, Validation, Analytical Chemistry, Proteomics, Science, Lifesciences, MALDI-TOF, Gas Chromatography, Chromatography, Troubleshooting, Sop, Chemistry, LC-MS, Instrumentation, FDA, Laboratory
Education
Ball State University
B.S, Chemistry
Baxter International Inc. October 2014 - Present
PROTAGON LLC October 2014 - Present
Catalent July 2009 - October 2014
FMC Technologies January 2007 - March 2009
Morton Grove Pharmaceuticals February 2002 - December 2006
Sterigenics December 1997 - January 2002
SoloPak Pharmaceuticals April 1996 - November 1997
ITW Magnaflux March 1991 - April 1996
Skills
GMP, Quality Assurance, R&D, Six Sigma, Quality Systems, Quality System, 21 CFR Part 11, CAPA, Change Control, Validation, FDA, Sop, Product Development, V&V, Software Documentation, Engineering, Technology Transfer, Medical Devices, Pharmaceutical Industry, Manufacturing, Regulatory Affairs, SOP
Education
Keller Graduate School of Management of DeVry University 2011 — 2013
Master's degree, Project Management
Roosevelt University 1987 — 1990
MBA, International Business
University of Illinois at Chicago 1982 — 1984
BSEE, Electrical Engineering
GE Healthcare January 2014 - Present
GE Healthcare April 2010 - December 2013
Amersham Health January 2003 - March 2010
Amersham Health February 1999 - December 2002
Centeon December 1997 - January 1999
Solopak Pharmceuticals November 1995 - December 1997
Solopak Pharmaceuticals July 1992 - November 1995
Skills
Strategic Sourcing, Supplier Risk Management, Direct Materials, Quality Control, GMP, Change Control
Education
University of Illinois at Chicago
Bachelor of Science (B.S.), Biochemistry
Office Depot 1998 - Present
Solopak Pharmaceuticals 1997 - 1998
Skills
Major Accounts, Solution Selling, Management, Cold Calling, Direct Sales, Sales Operations, Account Management, Sales Process, B2B, Salesforce.com, New Business Development, Leadership, Team Building, Customer Service, Sales Management
Education
Polytechnic University of the Philippines
Bachelor’s Degree, Business Administration - Major in Accounting
Catalent Pharma Solutions January 2014 - Present
Catalent Pharma Solutions March 2007 - January 2014
Catalent Pharma Solutions November 2005 - February 2007
CIBA Vision January 2003 - October 2005
Ciba Vision October 2000 - December 2002
Jordan Pharmaceuticals November 1998 - August 2000
Morton Grove Pharmaceuticals April 1998 - November 1998
SoloPak Pharmaceuticals August 1991 - February 1998
Hyatt Hotels & Resorts August 1987 - July 1991
Skills
Change Control, FDA, CAPA, Validation, V&V, GMP, Engineering, Manufacturing, Six Sigma, Continuous Improvement, Operational Excellence, Manufacturing...
Education
Keller Graduate School of Management of DeVry University
Coursework leading to an MBA, with Project Management concentration
Unversity of Wisconsin - Stout 1982 — 1987
Bachelor of Science, Industrial Technology