APP Pharmaceuticals, LLC
Industry: Company
DescriptionFounded: 2007 Parent organizations: Abraxis BioScience, Fresenius Kabi Pharmaceuticals Holding Inc
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APP Pharmaceuticals, LLC Employees
Employee
Years
Job
Industry
Todd Frederick MSHR, SPHR Todd Frederick MSHR, SPHR's APP Pharmaceuticals, LLC Experience May 2006 - May 2008
Job Manager Human Resources at Smiths Group plc
Industry Human Resources
Experience
Smiths Group plc May 2015 - Present
Human Resources Consultant February 2013 - May 2015
Molex May 2008 - April 2013
APP Pharmaceuticals, LLC May 2006 - May 2008
Wrigley Manufacturing, Inc. December 2001 - June 2006
Hendrickson International January 2000 - April 2001
SSI Technologies, Inc September 1997 - January 2000
Commercial Communications, Inc January 1993 - September 1997
Kmart Corporation January 1991 - January 1993
Skills
Employee Relations, Compensation, Performance Management, Leadership Development, Succession Planning, Employee Benefits, Leadership, Team Building, Deferred Compensation, Hiring, Strategy, Human Resources, Temporary Placement, Training, Talent Management, Career Development, Onboarding, Recruiting, HRIS, Policy, Management, Payroll, Personnel Management, Organizational..., Change Management
Education
Marquette University 1993 — 1997
MSHR, Human Resources
Marquette University 1987 — 1990
BSHR, Human Resources
Smiths Group plc May 2015 - Present
Human Resources Consultant February 2013 - May 2015
Molex May 2008 - April 2013
APP Pharmaceuticals, LLC May 2006 - May 2008
Wrigley Manufacturing, Inc. December 2001 - June 2006
Hendrickson International January 2000 - April 2001
SSI Technologies, Inc September 1997 - January 2000
Commercial Communications, Inc January 1993 - September 1997
Kmart Corporation January 1991 - January 1993
Skills
Employee Relations, Compensation, Performance Management, Leadership Development, Succession Planning, Employee Benefits, Leadership, Team Building, Deferred Compensation, Hiring, Strategy, Human Resources, Temporary Placement, Training, Talent Management, Career Development, Onboarding, Recruiting, HRIS, Policy, Management, Payroll, Personnel Management, Organizational..., Change Management
Education
Marquette University 1993 — 1997
MSHR, Human Resources
Marquette University 1987 — 1990
BSHR, Human Resources
Devon rose Devon rose's APP Pharmaceuticals, LLC Experience May 2003 - December 2008
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Confidential March 2013 - Present
Abbott Laboratories, Abbot Park, IL January 2009 - February 2013
APP Pharmaceuticals, LLC May 2003 - December 2008
Skills
Project+, Project Management, Strategic Planning, Vendor Management, Pharmaceutical Industry, Pharmaceutical Sales, Pharmacovigilance, Time Management, Budget Management, Business Planning, Business Analysis
Education
University of Illinois at Chicago 2002 — 2004
Bachelor's degree, Masters in biotechnology, A
Confidential March 2013 - Present
Abbott Laboratories, Abbot Park, IL January 2009 - February 2013
APP Pharmaceuticals, LLC May 2003 - December 2008
Skills
Project+, Project Management, Strategic Planning, Vendor Management, Pharmaceutical Industry, Pharmaceutical Sales, Pharmacovigilance, Time Management, Budget Management, Business Planning, Business Analysis
Education
University of Illinois at Chicago 2002 — 2004
Bachelor's degree, Masters in biotechnology, A
Lisa McChesney-Harris, PhD Lisa McChesney-Harris, PhD's APP Pharmaceuticals, LLC Experience February 2008 - March 2010
Job Founding Member at Prompt Praxis Laboratories LLC
Industry Pharmaceuticals
Experience
Cloaked Therapeutics LLC May 2012 - Present
Prompt Praxis Laboratories LLC May 2011 - Present
Pharma Phriendly LLC April 2010 - Present
APP Pharmaceuticals, LLC February 2008 - March 2010
Protocol Link, Inc. April 2004 - February 2008
Apotex Corp 1996 - 2000
Skills
Pharmaceutical Industry, Start-ups, Lifesciences, Quality System, Validation, HPLC, Regulatory Affairs, Microbiology, GMP, Cross-functional Team..., Clinical Development, Drug Delivery, Leadership, 21 CFR Part 11, FDA, Drug Development, Management, Analytical Chemistry, Drug Discovery, Sop, Medical Devices, Technology Transfer, Clinical Trials, GLP, Chemistry, Formulation, CAPA, Biotechnology, Chromatography, Oncology, CRO, Pharmaceutics, R&D, Regulatory Submissions, Generic Programming, Biopharmaceuticals, Change Control, Regulatory Requirements, V&V, CMC, SOP, Life Sciences
Education
The University of Kansas 1987 — 1992
PhD, Pharmaceutical Chemistry
Cloaked Therapeutics LLC May 2012 - Present
Prompt Praxis Laboratories LLC May 2011 - Present
Pharma Phriendly LLC April 2010 - Present
APP Pharmaceuticals, LLC February 2008 - March 2010
Protocol Link, Inc. April 2004 - February 2008
Apotex Corp 1996 - 2000
Skills
Pharmaceutical Industry, Start-ups, Lifesciences, Quality System, Validation, HPLC, Regulatory Affairs, Microbiology, GMP, Cross-functional Team..., Clinical Development, Drug Delivery, Leadership, 21 CFR Part 11, FDA, Drug Development, Management, Analytical Chemistry, Drug Discovery, Sop, Medical Devices, Technology Transfer, Clinical Trials, GLP, Chemistry, Formulation, CAPA, Biotechnology, Chromatography, Oncology, CRO, Pharmaceutics, R&D, Regulatory Submissions, Generic Programming, Biopharmaceuticals, Change Control, Regulatory Requirements, V&V, CMC, SOP, Life Sciences
Education
The University of Kansas 1987 — 1992
PhD, Pharmaceutical Chemistry
Neil Luciano Neil Luciano's APP Pharmaceuticals, LLC Experience February 2007 - October 2010
Job EHS Department at PPG Industries
Industry Chemicals
Experience
PPG Industries July 2015 - Present
PPG Architectural Coatings April 2013 - June 2015
Akzo Nobel Paints Puerto Rico, LLC October 2010 - March 2013
APP Pharmaceuticals LLC February 2007 - October 2010
Pfizer February 2001 - February 2007
Union Carbide - UCAR Emulsion Systems May 1997 - February 2001
Peerless Oil & Chemicals, Inc. July 1993 - February 1997
Skills
Environmental..., Safety Management..., Fire Safety, Spill Prevention, Title V Permitting, SARA Title III, Quality Assurance, Iso 9000, Recycling, Hazardous Waste..., Solid Waste, Wastewater Treatment, Water Treatment, Process Engineering, Process Safety..., Industrial Hygiene, Ergonomics, Incident Investigation, Root Cause Analysis, Process Simulation, Statistical Data..., Contingency Planning, Project Management, Phase I Environmental..., Behavior Based Safety, Environmental Awareness, Industrial Safety, Water, Process Safety, Inspection, Waste Management, Safety Auditing, Waste, ISO 14001, ISO 9000
Education
University of Phoenix - Puerto Rico 2002 — 2004
Master of Business Administration (MBA), Tecnology Management
University of Puerto Rico - Mayagüez 1987 — 1993
Bachelor of Science (BSc), Chemical Engineering
PPG Industries July 2015 - Present
PPG Architectural Coatings April 2013 - June 2015
Akzo Nobel Paints Puerto Rico, LLC October 2010 - March 2013
APP Pharmaceuticals LLC February 2007 - October 2010
Pfizer February 2001 - February 2007
Union Carbide - UCAR Emulsion Systems May 1997 - February 2001
Peerless Oil & Chemicals, Inc. July 1993 - February 1997
Skills
Environmental..., Safety Management..., Fire Safety, Spill Prevention, Title V Permitting, SARA Title III, Quality Assurance, Iso 9000, Recycling, Hazardous Waste..., Solid Waste, Wastewater Treatment, Water Treatment, Process Engineering, Process Safety..., Industrial Hygiene, Ergonomics, Incident Investigation, Root Cause Analysis, Process Simulation, Statistical Data..., Contingency Planning, Project Management, Phase I Environmental..., Behavior Based Safety, Environmental Awareness, Industrial Safety, Water, Process Safety, Inspection, Waste Management, Safety Auditing, Waste, ISO 14001, ISO 9000
Education
University of Phoenix - Puerto Rico 2002 — 2004
Master of Business Administration (MBA), Tecnology Management
University of Puerto Rico - Mayagüez 1987 — 1993
Bachelor of Science (BSc), Chemical Engineering
Amanda Mbewe Amanda Mbewe's APP Pharmaceuticals, LLC Experience April 2009 - Present
Job QA Manager, Contract Manufacturing at APP Pharmaceuticals, LLC
Industry Pharmaceuticals
Experience
APP Pharmaceuticals, LLC April 2009 - Present
Abraxis BioScience May 2008 - April 2009
Abraxis BioScience October 2004 - April 2008
AVENTIS BEHRING / ZLB BEHRING March 2001 - August 2004
ACCUCAPS INDUSTRIES LIMITED 1999 - 2001
Skills
SOP, Pharmaceuticals, Aseptic Processing, Quality Systems, Biotechnology, cGMP, Process Validation, GMP, CAPA, Quality Assurance, Pharmaceutical Industry, Sop, Validation, GxP, 21 CFR Part 11, FDA, LIMS, GLP, Quality System, Lifesciences, V&V, Cleaning Validation, Trackwise, Change Control, Technology Transfer, Regulatory Affairs, Computer System..., Regulatory Requirements, Regulatory Submissions, FDA GMP, Biopharmaceuticals, GAMP, HPLC
Education
Mount Saint Vincent University 1996 — 1998
Bachelor of Science, Biology, Minor: Math and Computer Science
APP Pharmaceuticals, LLC April 2009 - Present
Abraxis BioScience May 2008 - April 2009
Abraxis BioScience October 2004 - April 2008
AVENTIS BEHRING / ZLB BEHRING March 2001 - August 2004
ACCUCAPS INDUSTRIES LIMITED 1999 - 2001
Skills
SOP, Pharmaceuticals, Aseptic Processing, Quality Systems, Biotechnology, cGMP, Process Validation, GMP, CAPA, Quality Assurance, Pharmaceutical Industry, Sop, Validation, GxP, 21 CFR Part 11, FDA, LIMS, GLP, Quality System, Lifesciences, V&V, Cleaning Validation, Trackwise, Change Control, Technology Transfer, Regulatory Affairs, Computer System..., Regulatory Requirements, Regulatory Submissions, FDA GMP, Biopharmaceuticals, GAMP, HPLC
Education
Mount Saint Vincent University 1996 — 1998
Bachelor of Science, Biology, Minor: Math and Computer Science
Eric Gautier Eric Gautier's APP Pharmaceuticals, LLC Experience June 2005 - July 2007
Job Environmental Consultant at ES&H
Industry Environmental Services
Experience
ES&H July 2007 - Present
APP Pharmaceuticals, LLC June 2005 - July 2007
US Army May 2000 - May 2005
US Army July 1992 - July 1996
Skills
HAZWOPER, Emergency Management, Hazardous Waste..., Environmental Compliance, Remediation, Military Experience
Education
United States Military Academy at West Point 1996 — 2000
BS, Environmental Science
USMA Preparatory School 1995 — 1996
ES&H July 2007 - Present
APP Pharmaceuticals, LLC June 2005 - July 2007
US Army May 2000 - May 2005
US Army July 1992 - July 1996
Skills
HAZWOPER, Emergency Management, Hazardous Waste..., Environmental Compliance, Remediation, Military Experience
Education
United States Military Academy at West Point 1996 — 2000
BS, Environmental Science
USMA Preparatory School 1995 — 1996
Christina McGahan Christina McGahan's APP Pharmaceuticals, LLC Experience March 1999 - March 2009
Job Manager, Global Labeling, Regulatory Affairs at Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals October 2012 - Present
Takeda Pharmaceuticals April 2010 - October 2012
Takeda Pharmaceuticals March 2009 - April 2010
APP Pharmaceuticals, LLC March 1999 - March 2009
Abraxis BioScience March 1999 - March 2009
Abraxis Pharmaceutical Products March 1999 - August 2008
American Pharmaceutical Partners June 1998 - May 2006
Fujisawa August 1996 - March 1999
Skills
Regulatory Affairs, FDA, SOP, Injectables, Distribution LIcensing, Injectable, SOP development, Generic Drugs, regulatory labeling
Education
Roosevelt University 2002 — 2009
Bachelor of Arts, Biology
College of Lake County 1990 — 1994
Associate of Applied Science, Medical Laboratory Technician
Takeda Pharmaceuticals October 2012 - Present
Takeda Pharmaceuticals April 2010 - October 2012
Takeda Pharmaceuticals March 2009 - April 2010
APP Pharmaceuticals, LLC March 1999 - March 2009
Abraxis BioScience March 1999 - March 2009
Abraxis Pharmaceutical Products March 1999 - August 2008
American Pharmaceutical Partners June 1998 - May 2006
Fujisawa August 1996 - March 1999
Skills
Regulatory Affairs, FDA, SOP, Injectables, Distribution LIcensing, Injectable, SOP development, Generic Drugs, regulatory labeling
Education
Roosevelt University 2002 — 2009
Bachelor of Arts, Biology
College of Lake County 1990 — 1994
Associate of Applied Science, Medical Laboratory Technician
Jeff Campaign Jeff Campaign's APP Pharmaceuticals, LLC Experience August 2007 - May 2010
Job Validation Consultant at Sequence Inc. Quality and Compliance Services
Industry Pharmaceuticals
Experience
Sequence Inc. - Quality and Compliance Services January 2015 - Present
Sequence Inc. February 2013 - January 2015
Covidien/Mallinckrodt January 2012 - February 2013
Fresenius Kabi July 2011 - January 2012
APP Pharmaceuticals May 2010 - July 2011
APP Pharmaceuticals, LLC August 2007 - May 2010
APP Pharmaceuticals, LLC August 2006 - August 2007
Skills
Validation experience..., Experience managing >20..., Microsoft office, Validation, Change Control, Aseptic Processing, FDA, Lyophilization, Microsoft Office, Lean Manufacturing, Sterilization, Quality Management, Six Sigma, Manufacturing, Trackwise, TrackWise, GMP, V&V, SOP, CAPA, 21 CFR Part 11, Pharmaceutical Industry
Education
Niagara University
Master of Business Administration
SUNY at Buffalo 2003 — 2007
Bachelor of Science, Chemistry
Sequence Inc. - Quality and Compliance Services January 2015 - Present
Sequence Inc. February 2013 - January 2015
Covidien/Mallinckrodt January 2012 - February 2013
Fresenius Kabi July 2011 - January 2012
APP Pharmaceuticals May 2010 - July 2011
APP Pharmaceuticals, LLC August 2007 - May 2010
APP Pharmaceuticals, LLC August 2006 - August 2007
Skills
Validation experience..., Experience managing >20..., Microsoft office, Validation, Change Control, Aseptic Processing, FDA, Lyophilization, Microsoft Office, Lean Manufacturing, Sterilization, Quality Management, Six Sigma, Manufacturing, Trackwise, TrackWise, GMP, V&V, SOP, CAPA, 21 CFR Part 11, Pharmaceutical Industry
Education
Niagara University
Master of Business Administration
SUNY at Buffalo 2003 — 2007
Bachelor of Science, Chemistry
Georgia Hizon's APP Pharmaceuticals, LLC Experience May 2004 - January 2011
Job Manager, Regulatory Publications at APP Pharmaceuticals
Industry Pharmaceuticals
Experience
APP Pharmaceuticals / Fresenius Kabi USA September 2011 - Present
APP Pharmaceuticals, LLC, a Company of the Fresenius Kabi Group December 2010 - September 2011
APP Pharmaceuticals, LLC May 2004 - January 2011
American Pharmaceutical Partners (currently known as APP Pharmaceuticals, LLC) 2002 - May 2004
American Pharmaceutical Partners (currently known as APP Pharmaceuticals, LLC) 2001 - 2002
American Pharmaceutical Partners (currently known as APP Pharmaceuticals, LLC) 2000 - 2001
Morton Grove Pharmaceuticals 1998 - 2000
Mapua Institute of Technology (Philippines) 1996 - 1998
Skills
Sop, Regulatory Submissions, Regulatory Affairs, Quality Assurance, Change Control, Validation, GLP, IND, 21 CFR Part 11, Formulation, Quality Control, Documentum, eCTD, GMP, Analytical Chemistry, FDA, HPLC, Computer System..., Generic Programming, CMC, Pharmaceutics, Pharmaceutical Industry, Regulatory Requirements, Quality System, Manufacturing, CAPA, Lifesciences, GAMP, UV/Vis, Drug Development, Pharmacovigilance, ANDA, Wet Chemistry, Cleaning Validation, GxP, Regulations, Quality Auditing, Biopharmaceuticals, Method Transfer, Trackwise, Lyophilization, ISO 13485, Gas Chromatography, Aseptic Processing, Chemistry, Chromatography
Education
Mapua Institute of Technology 1992 — 1998
B.S., Chemistry
APP Pharmaceuticals / Fresenius Kabi USA September 2011 - Present
APP Pharmaceuticals, LLC, a Company of the Fresenius Kabi Group December 2010 - September 2011
APP Pharmaceuticals, LLC May 2004 - January 2011
American Pharmaceutical Partners (currently known as APP Pharmaceuticals, LLC) 2002 - May 2004
American Pharmaceutical Partners (currently known as APP Pharmaceuticals, LLC) 2001 - 2002
American Pharmaceutical Partners (currently known as APP Pharmaceuticals, LLC) 2000 - 2001
Morton Grove Pharmaceuticals 1998 - 2000
Mapua Institute of Technology (Philippines) 1996 - 1998
Skills
Sop, Regulatory Submissions, Regulatory Affairs, Quality Assurance, Change Control, Validation, GLP, IND, 21 CFR Part 11, Formulation, Quality Control, Documentum, eCTD, GMP, Analytical Chemistry, FDA, HPLC, Computer System..., Generic Programming, CMC, Pharmaceutics, Pharmaceutical Industry, Regulatory Requirements, Quality System, Manufacturing, CAPA, Lifesciences, GAMP, UV/Vis, Drug Development, Pharmacovigilance, ANDA, Wet Chemistry, Cleaning Validation, GxP, Regulations, Quality Auditing, Biopharmaceuticals, Method Transfer, Trackwise, Lyophilization, ISO 13485, Gas Chromatography, Aseptic Processing, Chemistry, Chromatography
Education
Mapua Institute of Technology 1992 — 1998
B.S., Chemistry
Leena Selvaraj, Ph.D's APP Pharmaceuticals, LLC Experience June 1999 - 2008
Job Director External R&D at Mylan
Industry Pharmaceuticals
Experience
Mylan November 2009 - Present
APP Pharmaceuticals, LLC June 1999 - 2008
Skills
Pharmaceutical Industry, Validation, GMP, FDA, Analytical Chemistry, R&D, Process Simulation, Product Launch, Manufacturing, ANDA, Product Development
Education
Penn State University 1990 — 1995
Doctor of Philosophy (PhD), Materials Science and Engineering
University of Pune 1986 — 1987
Master of Science (MSc), Physical Chemistry
University of Pune 1983 — 1986
Bachelor of Science (BSc), Chemistry
Mylan November 2009 - Present
APP Pharmaceuticals, LLC June 1999 - 2008
Skills
Pharmaceutical Industry, Validation, GMP, FDA, Analytical Chemistry, R&D, Process Simulation, Product Launch, Manufacturing, ANDA, Product Development
Education
Penn State University 1990 — 1995
Doctor of Philosophy (PhD), Materials Science and Engineering
University of Pune 1986 — 1987
Master of Science (MSc), Physical Chemistry
University of Pune 1983 — 1986
Bachelor of Science (BSc), Chemistry
Diane Rader Diane Rader's APP Pharmaceuticals, LLC Experience January 2008 - November 2011
Job Senior Regulatory Affairs Labeling Associate at Fresenius Kabi USA, LLC (APP Pharmaceuticals)
Industry Pharmaceuticals
Experience
Fresenius Kabi USA, LLC (APP Pharmaceuticals) December 2011 - Present
APP Pharmaceuticals, LLC January 2008 - November 2011
APP Pharmaceuticals, LLC January 2005 - January 2008
APP Pharmaceuticals, LLC October 1998 - January 2005
Northwest Community Hospital January 1992 - October 1998
Skills
FDA, GMP, Sop, SPL, Labeling
Education
Northern Illinois University 1977 — 1979
Bachelors of Science Degree, Biology
Harper College 1975 — 1977
Fresenius Kabi USA, LLC (APP Pharmaceuticals) December 2011 - Present
APP Pharmaceuticals, LLC January 2008 - November 2011
APP Pharmaceuticals, LLC January 2005 - January 2008
APP Pharmaceuticals, LLC October 1998 - January 2005
Northwest Community Hospital January 1992 - October 1998
Skills
FDA, GMP, Sop, SPL, Labeling
Education
Northern Illinois University 1977 — 1979
Bachelors of Science Degree, Biology
Harper College 1975 — 1977
Ashley Cooley Ashley Cooley's APP Pharmaceuticals, LLC Experience November 2009 - August 2010
Job Student at Northern Illinois University
Industry Hospital & Health Care
Experience
Johnson Controls July 2012 - Present
Northern Illinois University November 2009 - December 2011
The Wendy's Company May 2007 - August 2011
APP Pharmaceuticals, LLC November 2009 - August 2010
Education
Northern Illinois University 2008 — 2015
Bachelor's Degree, Nursing
Northern Illinois University 2008 — 2015
Bachelor's Degree, Public Health
Northern Illinois University 2008 — 2012
Minor, Gerontology
Bolingbrook Highschool 2004 — 2008
Diploma
Johnson Controls July 2012 - Present
Northern Illinois University November 2009 - December 2011
The Wendy's Company May 2007 - August 2011
APP Pharmaceuticals, LLC November 2009 - August 2010
Education
Northern Illinois University 2008 — 2015
Bachelor's Degree, Nursing
Northern Illinois University 2008 — 2015
Bachelor's Degree, Public Health
Northern Illinois University 2008 — 2012
Minor, Gerontology
Bolingbrook Highschool 2004 — 2008
Diploma
David Kaczmarowski's APP Pharmaceuticals, LLC Experience May 2009 - February 2012
Job Validation Engineer at Athenex, Inc.
Industry Pharmaceuticals
Experience
Athenex, Inc. July 2015 - Present
VWR May 2013 - July 2015
Polymer Conversions, Inc. February 2012 - May 2013
APP Pharmaceuticals LLC May 2009 - February 2012
Astellas Pharma Manufacturing, Inc. November 2001 - April 2009
Emprexe Analytical, LLC September 1995 - November 2001
Skills
Quality Assurance, Quality System, 21 CFR Part 11, GMP, Data Analysis, CAPA, FDA, Root Cause Analysis, Manufacturing, Medical Devices, Lean Manufacturing, Computer System..., Testing, Design Control, Project Management, Change Control, ISO, Quality Auditing, Six Sigma, System Administration, SPC, GxP, LIMS, Supplier Quality, Software Documentation, V&V, Documentum, Process Engineering, Trackwise, ISO 13485, Sop, Process Simulation, FMEA, Network Administration, Technical Documentation, Minitab, Laboratory Automation, Problem Solving, EDRMS, GAMP, Quality Management, DMAIC, GLP, Microsoft Access, SOP
Education
State University of New York at Buffalo 2006 — 2008
M.A., Informatics
State University of New York College at Buffalo 1992 — 1994
B.S., Criminalistics (Forensic Chemistry)
Athenex, Inc. July 2015 - Present
VWR May 2013 - July 2015
Polymer Conversions, Inc. February 2012 - May 2013
APP Pharmaceuticals LLC May 2009 - February 2012
Astellas Pharma Manufacturing, Inc. November 2001 - April 2009
Emprexe Analytical, LLC September 1995 - November 2001
Skills
Quality Assurance, Quality System, 21 CFR Part 11, GMP, Data Analysis, CAPA, FDA, Root Cause Analysis, Manufacturing, Medical Devices, Lean Manufacturing, Computer System..., Testing, Design Control, Project Management, Change Control, ISO, Quality Auditing, Six Sigma, System Administration, SPC, GxP, LIMS, Supplier Quality, Software Documentation, V&V, Documentum, Process Engineering, Trackwise, ISO 13485, Sop, Process Simulation, FMEA, Network Administration, Technical Documentation, Minitab, Laboratory Automation, Problem Solving, EDRMS, GAMP, Quality Management, DMAIC, GLP, Microsoft Access, SOP
Education
State University of New York at Buffalo 2006 — 2008
M.A., Informatics
State University of New York College at Buffalo 1992 — 1994
B.S., Criminalistics (Forensic Chemistry)
Rob Norwick's APP Pharmaceuticals, LLC Experience 1997 - 2012
Job Director, IT Infrastructure at Fresenius Kabi USA
Industry Information Technology and Services
Experience
Fresenius Kabi USA January 2013 - Present
APP Pharmaceuticals, LLC 1997 - 2012
Novopharm 1996 - 1997
Skills
Business Process, VMware, Change Control, Team Leadership, Integration, Sop, Databases, Disaster Recovery, Software Documentation, Manufacturing, Pharmaceutical Industry, Vendor Management, FDA, Project Management, Active Directory, Data Center, Change Management, Networking, GMP, SDLC, 21 CFR Part 11, Lotus Notes, Budgets, Program Management, Troubleshooting, IT Management, Quality System, SQL, SAP Netweaver, PeopleSoft, Continuous Improvement, Servers, Business Analysis, Customer Service, SAP ERP, Database Administration, Data Analysis, ERP, Leadership, Oracle, Process Improvement, Windows, System Administration, SAP, Cross-functional Team..., Windows Server, Citrix, Management, Visio, IT Strategy
Education
Northern Illinois University - College of Business 1985 — 1991
Bachelor of Science (B.S.), Operation Management and Information Systems
Fresenius Kabi USA January 2013 - Present
APP Pharmaceuticals, LLC 1997 - 2012
Novopharm 1996 - 1997
Skills
Business Process, VMware, Change Control, Team Leadership, Integration, Sop, Databases, Disaster Recovery, Software Documentation, Manufacturing, Pharmaceutical Industry, Vendor Management, FDA, Project Management, Active Directory, Data Center, Change Management, Networking, GMP, SDLC, 21 CFR Part 11, Lotus Notes, Budgets, Program Management, Troubleshooting, IT Management, Quality System, SQL, SAP Netweaver, PeopleSoft, Continuous Improvement, Servers, Business Analysis, Customer Service, SAP ERP, Database Administration, Data Analysis, ERP, Leadership, Oracle, Process Improvement, Windows, System Administration, SAP, Cross-functional Team..., Windows Server, Citrix, Management, Visio, IT Strategy
Education
Northern Illinois University - College of Business 1985 — 1991
Bachelor of Science (B.S.), Operation Management and Information Systems
Yellow Schreiber's APP Pharmaceuticals, LLC Experience February 2006 - July 2010
Job Windows/SQL Architect
Industry Information Technology and Services
Experience
Charles Schwab August 2011 - Present
Charles Schwab August 2010 - August 2011
APP Pharmaceuticals, LLC February 2006 - July 2010
APP Pharmaceuticals, LLC April 2005 - February 2006
Skills
Active Directory, Windows Server, VMware, Citrix, Software Documentation
Education
American InterContinental University 2006 — 2007
Bachelor's, Computer Systems
Robert Morris University - Illinois 2002 — 2003
Associates, Computer Science, Networking Concentration
Charles Schwab August 2011 - Present
Charles Schwab August 2010 - August 2011
APP Pharmaceuticals, LLC February 2006 - July 2010
APP Pharmaceuticals, LLC April 2005 - February 2006
Skills
Active Directory, Windows Server, VMware, Citrix, Software Documentation
Education
American InterContinental University 2006 — 2007
Bachelor's, Computer Systems
Robert Morris University - Illinois 2002 — 2003
Associates, Computer Science, Networking Concentration
Camille Kaczmarek's APP Pharmaceuticals, LLC Experience August 2004 - December 2011
Job Previously, Supervisor Plant Regulatory Affairs at FreseniusKabi USA
Industry Pharmaceuticals
Experience
Fresenius-Kabi USA December 2011 - November 2013
APP Pharmaceuticals, LLC August 2004 - December 2011
American Pharmaceutical Partners August 2000 - August 2004
Abraxis BioScience 2000 - 2001
Fujisawa 1993 - 1998
Lyphomed 1979 - 1982
Skills
Pharmaceutical Industry, Sop, FDA, GMP, Regulatory Submissions, Regulatory Affairs, 21 CFR Part 11, Validation, CAPA, Regulatory Requirements, Clinical Development, Quality Management, Quality Auditing, Change Control, ISO 13485, Clinical Trials, Chemistry, Documentum, Laboratory, Lifesciences, Chromatography, Biopharmaceuticals, Medical Devices, Drug Development, Technology Transfer, CTMS, ICH-GCP, Clinical Data Management, Generic Programming, Trackwise, GxP, IND, Biotechnology, Software Documentation, Aseptic Processing, Quality System, Quality Control, Quality Assurance, FDA GMP, ANDA, R&D, Medical Writing, Computer System..., Microbiology, Pharmacovigilance, Pharmaceutics, GCP, EDC, UV/Vis, LIMS
Education
University of Phoenix Online 2008 — 2011
MBA, Health Management
University of Phoenix 2005 — 2008
MHA
Fresenius-Kabi USA December 2011 - November 2013
APP Pharmaceuticals, LLC August 2004 - December 2011
American Pharmaceutical Partners August 2000 - August 2004
Abraxis BioScience 2000 - 2001
Fujisawa 1993 - 1998
Lyphomed 1979 - 1982
Skills
Pharmaceutical Industry, Sop, FDA, GMP, Regulatory Submissions, Regulatory Affairs, 21 CFR Part 11, Validation, CAPA, Regulatory Requirements, Clinical Development, Quality Management, Quality Auditing, Change Control, ISO 13485, Clinical Trials, Chemistry, Documentum, Laboratory, Lifesciences, Chromatography, Biopharmaceuticals, Medical Devices, Drug Development, Technology Transfer, CTMS, ICH-GCP, Clinical Data Management, Generic Programming, Trackwise, GxP, IND, Biotechnology, Software Documentation, Aseptic Processing, Quality System, Quality Control, Quality Assurance, FDA GMP, ANDA, R&D, Medical Writing, Computer System..., Microbiology, Pharmacovigilance, Pharmaceutics, GCP, EDC, UV/Vis, LIMS
Education
University of Phoenix Online 2008 — 2011
MBA, Health Management
University of Phoenix 2005 — 2008
MHA
Margie Becker's APP Pharmaceuticals, LLC Experience May 2010 - Present
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
APP Pharmaceuticals LLC May 2010 - Present
Wockhardt USA/Morton Grove Pharmaceuticals, Inc. February 2002 - March 2009
G.D. Searle 1986 - 2002
Education
Dominican University 1995 — 2000
Bachelors, Organizational Leadership
College of Lake County 1990 — 1993
Associates of Applied Science, Accounting
APP Pharmaceuticals LLC May 2010 - Present
Wockhardt USA/Morton Grove Pharmaceuticals, Inc. February 2002 - March 2009
G.D. Searle 1986 - 2002
Education
Dominican University 1995 — 2000
Bachelors, Organizational Leadership
College of Lake County 1990 — 1993
Associates of Applied Science, Accounting
Sarah Ortiz's APP Pharmaceuticals, LLC Experience March 2009 - December 2011
Job Pipeline Sales Specialist at TAPI Teva Active Pharmaceutical Ingredients
Industry Pharmaceuticals
Experience
TAPI - Teva Active Pharmaceutical Ingredients January 2015 - Present
Mylan Institutional October 2012 - November 2014
Hospira January 2012 - September 2012
APP Pharmaceuticals, LLC March 2009 - December 2011
Abraxis BioScience January 2005 - March 2009
abraxis bioscience 2005 - 2009
Morton Grove Pharmaceuticals May 2004 - January 2005
Cardinal Health September 2001 - May 2004
Skills
FDA, Sop, GMP, GLP, Pharmaceutical Industry, 21 CFR Part 11, Analytical Chemistry, Change Control, Chemistry, Pharmaceutics, Product Development, Quality Auditing, Quality Control, Raw Materials, Technology Transfer, Validation, SOP
Education
California State Polytechnic University-Pomona 1991 — 1999
BS
TAPI - Teva Active Pharmaceutical Ingredients January 2015 - Present
Mylan Institutional October 2012 - November 2014
Hospira January 2012 - September 2012
APP Pharmaceuticals, LLC March 2009 - December 2011
Abraxis BioScience January 2005 - March 2009
abraxis bioscience 2005 - 2009
Morton Grove Pharmaceuticals May 2004 - January 2005
Cardinal Health September 2001 - May 2004
Skills
FDA, Sop, GMP, GLP, Pharmaceutical Industry, 21 CFR Part 11, Analytical Chemistry, Change Control, Chemistry, Pharmaceutics, Product Development, Quality Auditing, Quality Control, Raw Materials, Technology Transfer, Validation, SOP
Education
California State Polytechnic University-Pomona 1991 — 1999
BS
Andres Trujillo's APP Pharmaceuticals, LLC Experience February 2007 - August 2010
Job Validation Consultant
Industry Pharmaceuticals
Experience
Integra LifeSciences March 2012 - September 2014
Procter & Gamble February 2011 - January 2012
Integra LifeSciences 2012 - 2012
VEG 2010 - 2011
Hospira September 2010 - December 2010
APP Pharmaceuticals, LLC February 2007 - August 2010
Mayne Pharma May 2004 - November 2006
Universidad Interamericana de Puerto Rico January 1996 - July 2004
Wyeth-Ayerst Pharmaceuticals Inc. June 1992 - January 1996
Skills
Cleaning Validation, Analytical Chemistry, Statistics, Chemistry, Validation, LIMS, GMP, Product Transfer, CAPA, Technology Transfer, V&V, GLP, 21 CFR Part 11, Quality System, Sop, Pharmaceutical Industry, FDA, HPLC, Change Control, Manufacturing, Process Simulation, Medical Devices, Regulatory Affairs, Laboratory, R&D, Chromatography, Quality Control, Biotechnology, GxP, ISO 13485, Quality Auditing, Quality Assurance, UV/Vis, Lifesciences, Regulatory Submissions, Biopharmaceuticals, Protocol, Design of Experiments, Gas Chromatography, Trackwise, Computer System..., ISO, GAMP, Regulatory Requirements, Aseptic Processing, SOP, TrackWise, Life Sciences
Education
University of Arizona 1984 — 1986
Ph.D., Chemistry-Analytical
University of Arizona 1980 — 1983
MS, Chemistry-Analytical
Universidad Interamericana de Puerto Rico 1975 — 1979
BS, Chemistry
Integra LifeSciences March 2012 - September 2014
Procter & Gamble February 2011 - January 2012
Integra LifeSciences 2012 - 2012
VEG 2010 - 2011
Hospira September 2010 - December 2010
APP Pharmaceuticals, LLC February 2007 - August 2010
Mayne Pharma May 2004 - November 2006
Universidad Interamericana de Puerto Rico January 1996 - July 2004
Wyeth-Ayerst Pharmaceuticals Inc. June 1992 - January 1996
Skills
Cleaning Validation, Analytical Chemistry, Statistics, Chemistry, Validation, LIMS, GMP, Product Transfer, CAPA, Technology Transfer, V&V, GLP, 21 CFR Part 11, Quality System, Sop, Pharmaceutical Industry, FDA, HPLC, Change Control, Manufacturing, Process Simulation, Medical Devices, Regulatory Affairs, Laboratory, R&D, Chromatography, Quality Control, Biotechnology, GxP, ISO 13485, Quality Auditing, Quality Assurance, UV/Vis, Lifesciences, Regulatory Submissions, Biopharmaceuticals, Protocol, Design of Experiments, Gas Chromatography, Trackwise, Computer System..., ISO, GAMP, Regulatory Requirements, Aseptic Processing, SOP, TrackWise, Life Sciences
Education
University of Arizona 1984 — 1986
Ph.D., Chemistry-Analytical
University of Arizona 1980 — 1983
MS, Chemistry-Analytical
Universidad Interamericana de Puerto Rico 1975 — 1979
BS, Chemistry
Scott Straus's APP Pharmaceuticals, LLC Experience 2007 - Present
Job QC Tech 2 at APP Pharmaceuticals LLC
Industry Pharmaceuticals
Experience
Fresenius Kabi 2008 - Present
APP Pharmaceuticals, LLC 2007 - Present
The Home Depot October 2001 - February 2010
M. J. Reider Associates December 2001 - December 2005
MicroWarehouse November 1999 - November 2000
Philip Analytical January 2000 - September 2000
Burns Security June 1997 - August 1999
Niagara Aquarium March 1984 - March 1997
Ecology and Environment, Inc August 1988 - April 1995
Oakdale Christian High School August 1982 - August 1983
Skills
HPLC, SOP, Quality Assurance, Chemistry, Compliance, CAPA, Testing, Pharmaceuticals, GMP, Excel, Word, Microsoft Office, Analysis, Calibration, Customer Service, cGMP, Problem Solving, LIMS, IR, Wet Chemistry
Education
State University of New York College at Plattsburgh 1975 — 1979
B.A., Environmental Science & Economics
Fresenius Kabi 2008 - Present
APP Pharmaceuticals, LLC 2007 - Present
The Home Depot October 2001 - February 2010
M. J. Reider Associates December 2001 - December 2005
MicroWarehouse November 1999 - November 2000
Philip Analytical January 2000 - September 2000
Burns Security June 1997 - August 1999
Niagara Aquarium March 1984 - March 1997
Ecology and Environment, Inc August 1988 - April 1995
Oakdale Christian High School August 1982 - August 1983
Skills
HPLC, SOP, Quality Assurance, Chemistry, Compliance, CAPA, Testing, Pharmaceuticals, GMP, Excel, Word, Microsoft Office, Analysis, Calibration, Customer Service, cGMP, Problem Solving, LIMS, IR, Wet Chemistry
Education
State University of New York College at Plattsburgh 1975 — 1979
B.A., Environmental Science & Economics
Julián Vallés's APP Pharmaceuticals, LLC Experience April 2006 - November 2011
Job Director of Product Development at Neolpharma
Industry Pharmaceuticals
Experience
DMCG March 2015 - Present
Neolpharma July 2013 - Present
Artesia Inc., Puerto Rico January 2012 - November 2012
APP Pharmaceuticals LLC April 2006 - November 2011
Pfizer July 2003 - August 2006
Skills
Manufacturing, Validation, Pharmaceutical Industry, Sop, Process Improvement, GMP, Healthcare, V&V, Cross-functional Team...
Education
Universidad de Puerto Rico 1987 — 1990
Master of Science (MS), Pharmaceutical Sciences
Massachusetts College of Pharmacy and Health Sciences 1977 — 1981
Bachelor of Science (BS), Pharmacy, Pharmacy
Colegio San Ignacio de Loyola 1969 — 1976
DMCG March 2015 - Present
Neolpharma July 2013 - Present
Artesia Inc., Puerto Rico January 2012 - November 2012
APP Pharmaceuticals LLC April 2006 - November 2011
Pfizer July 2003 - August 2006
Skills
Manufacturing, Validation, Pharmaceutical Industry, Sop, Process Improvement, GMP, Healthcare, V&V, Cross-functional Team...
Education
Universidad de Puerto Rico 1987 — 1990
Master of Science (MS), Pharmaceutical Sciences
Massachusetts College of Pharmacy and Health Sciences 1977 — 1981
Bachelor of Science (BS), Pharmacy, Pharmacy
Colegio San Ignacio de Loyola 1969 — 1976
Joe Yassine's APP Pharmaceuticals, LLC Experience October 1992 - Present
Job Product Development Systems Manager at Fresenius Kabi
Industry Pharmaceuticals
Experience
APP Pharmaceuticals, LLC October 1992 - Present
Fresenius Kabi October 1992 - Present
Skills
Pharmaceutical Industry, GMP, Analytical Chemistry, Software Documentation, HPLC, Change Control, Sop, FDA, Validation, SAP, V&V, CAPA, Aseptic Processing, Quality Assurance, Quality System, 21 CFR Part 11, Technology Transfer, Biotechnology, GLP, LIMS, Regulatory Affairs, Computer System..., Trackwise, GxP, Formulation, Regulatory Requirements, Pharmaceutics, Generic Programming, Quality Control, Regulatory Submissions, GAMP, Chromatography, Laboratory, ISO 13485, Gas Chromatography, Calibration, R&D, Quality Auditing, Medical Devices, UV/Vis, Chemistry, LC-MS, IR, FDA GMP, Lifesciences, Cleaning Validation, UV
Education
DeVry University 1990 — 1992
Bachelor of Electronics Engineering (BEE), Electrical and Electronics Engineering, BS Degree
University of South Florida 1982 — 1984
APP Pharmaceuticals, LLC October 1992 - Present
Fresenius Kabi October 1992 - Present
Skills
Pharmaceutical Industry, GMP, Analytical Chemistry, Software Documentation, HPLC, Change Control, Sop, FDA, Validation, SAP, V&V, CAPA, Aseptic Processing, Quality Assurance, Quality System, 21 CFR Part 11, Technology Transfer, Biotechnology, GLP, LIMS, Regulatory Affairs, Computer System..., Trackwise, GxP, Formulation, Regulatory Requirements, Pharmaceutics, Generic Programming, Quality Control, Regulatory Submissions, GAMP, Chromatography, Laboratory, ISO 13485, Gas Chromatography, Calibration, R&D, Quality Auditing, Medical Devices, UV/Vis, Chemistry, LC-MS, IR, FDA GMP, Lifesciences, Cleaning Validation, UV
Education
DeVry University 1990 — 1992
Bachelor of Electronics Engineering (BEE), Electrical and Electronics Engineering, BS Degree
University of South Florida 1982 — 1984
john saad's APP Pharmaceuticals, LLC Experience April 2009 - September 2011
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
APP Pharmaceuticals, LLC April 2009 - September 2011
Astellas Pharma Manufacturing, Inc May 1999 - March 2009
Spinneybeck Enterprises Inc January 1986 - December 1995
Skills
SOP, GMP, Quality Assurance, FDA, 21 CFR Part 11, Pharmaceutical Industry, CAPA, Process Improvement, Quality System, Medical Devices
Education
42
Diploma
APP Pharmaceuticals, LLC April 2009 - September 2011
Astellas Pharma Manufacturing, Inc May 1999 - March 2009
Spinneybeck Enterprises Inc January 1986 - December 1995
Skills
SOP, GMP, Quality Assurance, FDA, 21 CFR Part 11, Pharmaceutical Industry, CAPA, Process Improvement, Quality System, Medical Devices
Education
42
Diploma
Kelia Leach's APP Pharmaceuticals, LLC Experience November 2006 - July 2009
Job Senior Risk Management Specialist at Baxter International Inc.
Industry Pharmaceuticals
Experience
Baxter International Inc. March 2014 - Present
Baxalta 2015 - 2015
Randstad June 2013 - December 2013
Baxter International Inc. June 2009 - June 2013
APP Pharmaceuticals, LLC November 2006 - July 2009
Kelly Scientific Resources January 2006 - November 2006
Skills
Pharmaceutical Industry, Post-marketing Safety..., Research, Clinical Trials, English, Microsoft Office
Education
National Louis University 2001 — 2003
Bachelor of Science (BS), Health/Health Care Administration/Management
Western Kentucky University 1993 — 1995
Associate of Science (A.S.), Registered Nursing/Registered Nurse
Baxter International Inc. March 2014 - Present
Baxalta 2015 - 2015
Randstad June 2013 - December 2013
Baxter International Inc. June 2009 - June 2013
APP Pharmaceuticals, LLC November 2006 - July 2009
Kelly Scientific Resources January 2006 - November 2006
Skills
Pharmaceutical Industry, Post-marketing Safety..., Research, Clinical Trials, English, Microsoft Office
Education
National Louis University 2001 — 2003
Bachelor of Science (BS), Health/Health Care Administration/Management
Western Kentucky University 1993 — 1995
Associate of Science (A.S.), Registered Nursing/Registered Nurse
Cristin Brachmann's APP Pharmaceuticals, LLC Experience May 2007 - August 2008
Job Regulatory Affairs Scientist at Fresenius Kabi
Industry Pharmaceuticals
Experience
Fresenius Kabi August 2008 - Present
APP Pharmaceuticals, LLC May 2007 - August 2008
APP Pharmaceuticals, LLC May 2003 - May 2007
APP Pharmaceuticals, LLC March 2002 - May 2003
APP Pharmaceuticals, LLC August 1998 - March 2002
Skills
Quality Control, Technology Transfer, Chemistry, Regulatory Affairs, GMP, GLP, Manufacturing, CAPA, Change Control, Quality System, 21 CFR Part 11, FDA, Pharmaceutical Industry, SOP, Validation
Education
State University of New York at Buffalo 1996 — 1998
Bachelor of Science in Medical Technology
Niagara County Community College 1994 — 1996
Associate in Science in Liberal Arts, Math and Science
Fresenius Kabi August 2008 - Present
APP Pharmaceuticals, LLC May 2007 - August 2008
APP Pharmaceuticals, LLC May 2003 - May 2007
APP Pharmaceuticals, LLC March 2002 - May 2003
APP Pharmaceuticals, LLC August 1998 - March 2002
Skills
Quality Control, Technology Transfer, Chemistry, Regulatory Affairs, GMP, GLP, Manufacturing, CAPA, Change Control, Quality System, 21 CFR Part 11, FDA, Pharmaceutical Industry, SOP, Validation
Education
State University of New York at Buffalo 1996 — 1998
Bachelor of Science in Medical Technology
Niagara County Community College 1994 — 1996
Associate in Science in Liberal Arts, Math and Science
Mona S. Gupta's APP Pharmaceuticals, LLC Experience 2010 - 2010
Job Toxicologist at Engility Corporation
Industry Biotechnology
Experience
Engility Corporation 2014 - Present
U.S. Consumer Product Safety Commission 2011 - 2011
APP Pharmaceuticals, LLC 2010 - 2010
Afton Chemical 2005 - 2006
Arista Laboratories 2002 - 2004
Medical College of Virginia/Virginia Commonwealth University 2000 - 2002
Texas A&M University 1995 - 1999
Skills
Toxicology, Life Sciences, Risk Assessment, Consumer Product Safety, Proposal Writing, Research, Chemistry, Data Analysis, Environmental Health, Scientific Writing, Grant Writing, Publications, Curriculum Development, University Teaching, College Teaching, Study Protocols, Web-based Teaching, Science
Education
Texas A&M University 1995 — 2000
Doctor of Philosophy (Ph.D.), Toxicology
East Tennessee State University 1993 — 1995
Master's Degree, Environmental Health
Delhi University 1989 — 1992
Bachelor's Degree, Zoology Honors
Engility Corporation 2014 - Present
U.S. Consumer Product Safety Commission 2011 - 2011
APP Pharmaceuticals, LLC 2010 - 2010
Afton Chemical 2005 - 2006
Arista Laboratories 2002 - 2004
Medical College of Virginia/Virginia Commonwealth University 2000 - 2002
Texas A&M University 1995 - 1999
Skills
Toxicology, Life Sciences, Risk Assessment, Consumer Product Safety, Proposal Writing, Research, Chemistry, Data Analysis, Environmental Health, Scientific Writing, Grant Writing, Publications, Curriculum Development, University Teaching, College Teaching, Study Protocols, Web-based Teaching, Science
Education
Texas A&M University 1995 — 2000
Doctor of Philosophy (Ph.D.), Toxicology
East Tennessee State University 1993 — 1995
Master's Degree, Environmental Health
Delhi University 1989 — 1992
Bachelor's Degree, Zoology Honors
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY