Catalent Pharma Solutions
Industry: Company
DescriptionCatalent, Inc. is a Somerset, New Jersey company involved in technology and development for drugs, biologics and consumer health products. It claimed production of more than 70 billion doses annually for nearly 7,000 customer products in 2014. Headquarters: Somerset, Ewing Township, New Jersey, United States CEO: John R. Chiminski (17 Mar 2009–) Number of employees: 8,300 (2014) Subsidiaries: Redwood Bioscience, Inc.,
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Catalent Pharma Solutions Employees
Plexxikon Inc. July 2015 - Present
Catalent Pharma Solutions June 2011 - July 2015
The Molecular Foundry, Lawrence Berkeley National Laboratory June 2009 - June 2011
Skills
Materials Science, Spectroscopy, NMR, Organic Synthesis, Organic Chemistry, Chemistry, UV/Vis, Chromatography, Protein Chemistry, Purification, Drug Discovery, Mass Spectrometry, Medicinal Chemistry, LC-MS, HPLC
Education
University of California, Berkeley 2004 — 2009
Doctor of Philosophy (PhD), Chemistry
General Electric Appliances July 2014 - Present
Catalent Pharma Solutions January 2011 - July 2014
Catalent Pharma Solutions August 2008 - January 2011
General Electric Consumer/Industrial June 2006 - August 2008
General Electric Consumer/Industrial October 2004 - June 2006
General Electric Consumer/Industrial August 2002 - October 2004
General Electric Consumer/Industrial September 2001 - August 2002
US Army June 1995 - September 2001
Skills
Six Sigma, Lean Manufacturing, Manufacturing Operations, Continuous Improvement, Operations Management, Supply Chain, Manufacturing, Process Improvement, Kaizen, Cross-functional Team..., Value Stream Mapping, Leadership, Management, Operational Excellence, DMAIC, Quality Assurance
Education
United States Military Academy at West Point 1991 — 1995
Bachelor of Science, Computer Science
TOLMAR Inc. March 2015 - Present
Catalent Pharma Solutions February 2014 - March 2015
Consultant September 2012 - February 2014
APP Pharmaceuticals August 1993 - September 2012
Bristol-Myers Squibb 1977 - 1993
Skills
Medical Devices, Software Documentation, Validation, CAPA, Generic Programming, Calibration, Cleaning Validation, Continuous Improvement, Six Sigma, Regulatory Affairs, Marketing, Regulatory Requirements, Pharmaceutics, 21 CFR Part 11, GLP, Product Development, Quality Auditing, Manufacturing, Engineering, Change Control, Strategic Planning, Biotechnology, GMP, Lifesciences, Computer System..., Packaging, Leadership, Project Management, Clinical Development, Pharmaceutical Industry, Sterilization, Aseptic Processing, Electricians, Biopharmaceuticals, LIMS, Lean Manufacturing, Project Engineering, HPLC, Quality System, Environmental Monitoring, Process Engineering, Facilities Management, Cross-functional Team..., ISO 13485, GxP, Automation, Sop, Security, FDA, PLC
Education
State University of New York at Buffalo 1989 — 1993
BS, Industial Technology
Ei LLC November 2011 - Present
Eurofins AvTech May 2010 - October 2011
Catalent Pharma Solutions June 2007 - May 2010
Cardinal Health January 2004 - June 2007
3M Pharmaceuticals January 1994 - December 2003
3M Company 2000 - 2003
Skills
Six Sigma, Financial Modeling, Key Account Management, Strategy, Pharmaceutical Industry, Cross-functional Team..., FDA, Product Development, Technology Transfer, Biotechnology, GMP, Contract Manufacturing, R&D, Validation, Manufacturing, Commercialization, Sop, Regulatory Affairs, Contract Negotiation, Business Development, Negotiation, Quality System, Pharmaceutics, Outsourcing, Product Launch, Biopharmaceuticals, Management, CAPA, GLP, Strategic Planning, Formulation, Lifesciences, Life Sciences
Education
The University of Chicago Booth School of Business 2001 — 2003
MBA, Finance, Marketing, Strategy
University of Michigan 1990 — 1993
BS, Mechanical Engineering
Catalent Pharma Solutions August 2012 - Present
Novel Laboratories, Inc. December 2010 - September 2011
Coldstream Laboratories, Inc. March 2010 - July 2010
City of Troy Waste water treatment plant January 2009 - May 2009
Elysium Pharmaceutical Ltd January 2005 - December 2006
Choksi Laboratories Inc January 2004 - January 2005
Skills
Dissolution, Wet Chemistry, GLP, HPLC, UV/Vis, GMP, Validation, V&V, Sop, Chromatography, CAPA, Technology Transfer, Pharmaceutical Industry, Chemistry, USP, Cleaning Validation, UV, R&D, 21 CFR Part 11, Analytical Chemistry, Viscosity, TLC, Titration, Method Transfer, ANDA, Stability Studies, Method Development, IR, Karl Fisher, Raw Materials, Change Control, Analytical Method..., FDA, Empower, pH meter, Column Chromatography, TOC, IR spectroscopy, FTIR, Viscometry, Particle Size Analysis, Spectrophotometry, Ion Chromatography, Sample Preparation, Atomic Absorption, Gas Chromatography, ICH guidelines, Quality Control, ICH Guidelines, SOP
Education
Troy University 2007 — 2009
MS, Environmental and Biological Science
M.S.University of Baroda 2001 — 2003
MS, Inorganic and Analytical Chemistry
M.S.University of Baroda 1998 — 2001
BS, Chemistry
Catalent Pharma Solutions October 2013 - Present
Keller Williams Elite Realtors February 2013 - January 2015
Univar April 2011 - November 2012
LeConte Realty May 2010 - 2012
Con Edison September 2010 - April 2011
Con Edison July 2008 - September 2010
Triumvirate Environmental April 2007 - July 2008
Univar August 2002 - August 2006
Skills
Logistics, Hazardous Waste..., Environmental Compliance, Environmental Awareness, Sustainability, HAZWOPER, EHS, Waste Management, Hazardous Materials, Recycling, Waste, Environmental..., Environmental Consulting, Emergency Management, Remediation, Project Planning, Strategic Planning, Negotiation, Account Management, Contract Negotiation, Auditing, Environmental Auditing, Construction, RCRA, Inspection, Program Management, Environmental Impact..., Environmental Science, Energy, Environmental Issues, Environmental..., Leadership, Solid Waste, Environmental Policy, Environmental Services, Asbestos, EPA, Risk Assessment, Indoor Air Quality, Waste Reduction, Industrial Hygiene, Sales, Training, New Business Development
Education
University at Buffalo 1989 — 1995
Bachelor of Science, Environmental Studies
Allergan January 2014 - Present
Catalent Pharma Solutions November 2013 - December 2013
Boehringer Ingelheim February 2012 - August 2013
Boehringer Ingelheim August 2011 - February 2012
Amway March 2011 - July 2011
DuPont March 2006 - December 2008
Abbott Labs July 2002 - March 2006
Skills
Data Analysis, Customer Insight, Market Research, R&D, Project Management, Cross-functional Team..., Product Development, Statistics, Consumer Products, Segmentation, Innovation Management, Analysis, Open Innovation, Research, Process Improvement, Change Control, V, GMP, Validation, ISO, Software Documentation, Commissioning, Engineering, Pharmaceutical Industry
Education
The Ohio State University
Degree in progress, Engineering/Industrial Management
Teva Parenteral Medicines, Inc. January 2004 - Present
Catalent Pharma Solutions May 2000 - November 2003
Skills
Biotechnology, Change Control, Validation, GMP, LIMS, Drug Development, Sop, Analytical Chemistry, HPLC, GLP, 21 CFR Part 11, UV/Vis, Lifesciences, Pharmaceutical Industry, Chromatography, FDA, Technology Transfer, Chemistry, Dissolution, Formulation, CAPA, Quality Assurance, USP
Education
The University of Texas at San Antonio
Bachelor of Science, Chemistry
Wright State University
Master of Science, Chemistry
Catalent Pharma Solutions November 2014 - Present
Creative Cosmetics, Inc August 2013 - November 2014
Janssen-Ortho January 2013 - July 2013
Procter & Gamble September 2005 - October 2012
Skills
Fast Learner, Self-driven, Self-starter, Fully bilingual English, computer knowledge, Sop, Analytical Chemistry, GMP, GLP, HPLC, GC, Analytical Method..., Method Transfer, Water Testing, Gas Chromatography, UV/Vis, Dissolution, Karl Fisher, Raw Materials, pH meter, Wet Chemistry, Method Development, FTIR, Cleaning Validation, Validation, USP, Regulatory Affairs, Chemistry, Laboratory, IR, FDA, Pharmaceutics, SOP, R, Pharmaceutical Industry, Chromatography, Quality System, 21 CFR Part 11
Education
Universidad de Puerto Rico 2000 — 2006
Bachelor, Chemistry, Cum Laude
Universidad de Puerto Rico 2000 — 2006
Chemistry, Chemistry
University of Colorado Hospital, Atrium Pharmacy February 2009 - November 2012
Catalent Pharma Solutions November 2007 - June 2008
Gen-Probe, Inc June 2006 - June 2007
Rite Aid Pharmacy June 2004 - May 2007
Arena Pharmaceuticals, Inc April 2005 - June 2006
Skills
Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Industry, Drug Discovery, Pharmacists, Patient Counseling, GMP, Pharmacy, Medication Therapy..., Pharmacology, HPLC, Immunization, Clinical Pharmacy, Community Pharmacy, Pharmacy Automation, Ambulatory Care, Pharmacy Practice, Compounding, Diabetes
Education
University of Colorado, Skaggs School of Pharmacy and Pharmaceutical Sciences
PharmD, Doctor of Pharmacy
University of California, San Diego
Bachelor of Science (BS), Biochemistry / Chemistry
Terumo Cardiovascular Systems October 2013 - Present
Catalent Pharma Solutions May 2012 - October 2013
BD September 2009 - May 2012
BD April 2008 - August 2009
BD July 2006 - March 2008
BD April 2005 - June 2006
Covidien October 2004 - April 2005
Covidien February 2004 - October 2004
Covidien July 2002 - February 2004
Covidien January 2002 - July 2002
Skills
Lean Manufacturing, Continuous Improvement, Value Stream Mapping, Six Sigma, 5S, Kaizen, Supply Chain, Production Planning, Materials Management, Quality Systems, MRP, Cost Reduction, ISO, Kanban, Manufacturing Operations, Operational Excellence, Cross-functional Team..., Process Improvement, Manufacturing Management, Manufacturing, SAP, Operations Management, Medical Devices, FDA, Injection Molding, GMP, Root Cause Analysis, FMEA, Logistics, CAPA, Quality System, Validation, Quality Control, ISO 13485, V&V, Pharmaceutical Industry, Contract Manufacturing, Quality Management, Design of Experiments, SPC, Change Control, Sop, DMAIC, Process Simulation, Manufacturing..., Manufacturing..., SOP
Education
Webster University 2005 — 2008
MBA
The Citadel 1994 — 1998
BS, Physics
Otsuka Pharmaceutical Companies (U.S.) January 2013 - June 2015
Novo Nordisk A/S June 2010 - December 2012
SER RPO Consulting, LLC June 2006 - December 2010
Bausch & Lomb December 2008 - May 2010
BlueChipSearch Consulting October 2007 - September 2009
Catalent Pharma Solutions October 2007 - November 2008
Unum June 2007 - October 2007
HSBC June 2006 - May 2007
Skills
Executive Search, Strategy, Recruiting, Pharmaceutical Industry, Internet Recruiting, Biotechnology, Strategic Planning, Business Intelligence, Staffing Services, Technical Recruiting, Market Research, Lifesciences, CRO, SharePoint, Social Media Marketing, Corporate Recruiting, Digital Strategy, RPO, Boolean Searching, CRM Integration, SAP ERP, Social Media Strategy, virtual recruiting, OBIEE, talent pipelining, Avature, Quantitative Finance, Client/Hiring Manager..., predictive analytics, Marketing analytics..., Pharma recruiting, Pharmaceutical..., IT Sourcer, life sciences recruiting, pharmaceutical sales..., Semantic Search, recruiting metrics, virtual recruitment, CMO, contract recruiting, Clinical Recruiting, LinkedIn Recruiter, GCP Recruitment, iCIMS, Screening, Life Sciences, CRM, Hiring, Medical Devices
Education
The George Washington University
BA, Psychology
Catalent Pharma Solutions April 2015 - Present
University of Wisconsin-Madison August 2013 - November 2013
UW-Madison August 2008 - August 2013
Silliker 2008 - 2008
Echo Hill Outdoor School 2008 - 2008
Donald Danforth Plant Science Center 2007 - 2007
Fulton Public Schools 2007 - 2007
Montana State University May 2006 - August 2006
Skills
Cell Culture, PCR, Molecular Cloning, Western Blotting, Fluorescence Microscopy, Molecular Biology, Genetics, Transfection, Microscopy, Cell Biology, Protein Chemistry, ELISA, Tissue Culture
Education
University of Wisconsin-Madison 2008 — 2013
Doctor of Philosophy (PhD), Genetics
Truman State University 2003 — 2007
Bachelor of Science (B.S.), Biology, General
Catalent Pharma Solutions January 2015 - Present
Catalent Pharma Solutions July 2012 - December 2014
Catalent Pharma Solutions November 2011 - July 2012
Catalent Pharma Solutions June 2010 - July 2012
Catalent Pharma Solutions March 2011 - November 2011
Catalent Pharma Solutions June 2010 - March 2011
Albuquerque Electric Cycles, LLC August 2008 - June 2010
University of New Mexico August 2002 - August 2008
Sandia National Laboratories May 2001 - August 2002
LosAlamos National Laboratories May 1998 - January 2001
Skills
Lean Manufacturing, Cross-functional Team..., Six Sigma, Process Improvement, Root Cause Analysis, Manufacturing, Engineering, Pharmaceutical Industry, FDA, Process Engineering, Validation, Quality System, Procurement, SPC, Product Development, GMP, Design of Experiments, Continuous Improvement, R&D, Pharmaceuticals, cGMP, V&V, Sop, Supply Chain, Medical Devices, Technology Transfer, Minitab, Biotechnology, Change Management, Negotiation, Strategic Sourcing, Project Management, CAPA, Operational Excellence, Strategy, DMAIC, Statistical Process..., Technical Writing, Contract Negotiation
Education
The University of New Mexico 2002 — 2008
Masters, Chemical Engineering - Nanofluidics and Semiconductor Processing
The University of New Mexico 1998 — 2002
Bachelors, Chemical Engineering
Framingham State University September 2012 - Present
Catalent Pharma Solutions 2011 - 2012
Phyton Biotech 2007 - 2010
Labcon, N.A. 2004 - 2007
Rainin Instrument LLC (Mettler Toledo Division) 2000 - 2004
Thermo Fisher Scientific (Environmental Instruments Division) 1997 - 2000
Leggette, Brashears & Graham, Inc. 1995 - 1997
EG&G Technical Services (now part of URS Corporation) GEOS 1993 - 1994
CDM Smith (formerly Camp Dresser & McKee, Inc.) 1988 - 1991
Skills
Biotechnology, Lifesciences, Pharmaceutical Industry, Technology Transfer, Medical Devices, Start-ups, Product Marketing, Management, Sales, Cross-functional Team..., Business Development, Competitive Analysis, Strategy, Product Development, Market Analysis, Leadership, Life Sciences
Education
Tufts University 1993 — 1998
M.S., Civil and Environmental Engineering
Univ. of Miami, FL
B.S., Geological and Earth Sciences/Geosciences
Catalent Pharma Solutions September 2010 - Present
Education
United States Military Academy at West Point 2006 — 2010
Bachelor of Science, Geography and Environmental Engineering
Hologic Gen-Probe September 2012 - Present
Catalent Pharma Solutions October 2011 - August 2012
Horizon Pharmaceuticals Ltd March 2011 - September 2011
Traversa Therapeutics, Inc February 2010 - February 2011
Amylin Pharmaceuticals March 2007 - May 2009
Genzyme February 2002 - December 2006
AHP/Wyeth-Ayerst Pharmaceuticals August 1999 - July 2001
Skills
Analytical Chemistry, Validation Engineering, Project Management, Troubleshooting, Technical Writing, HPLC, Gas Chromatography, UV/Vis, GMP, LIMS, Testing, Quality Control, Quality Assurance, Sop, Software Documentation
Education
Universidad de Puerto Rico 1995 — 1999
BS, Chemistry
Catalent Pharma Solutions April 2007 - Present
Aptuit November 2000 - March 2007
Skills
Sop, Pharmaceutical Industry, GMP, FDA, Validation, Biotechnology, CRO, Clinical Trials, Regulatory Affairs, 21 CFR Part 11, GCP, Lifesciences, Quality System, Biopharmaceuticals, HPLC, SOP
Education
University of California, Davis 1994 — 1997
Bachelor's degree, Biology/Biological Sciences, General
Catalent Pharma Solutions May 2015 - Present
Seattle Genetics April 2012 - May 2015
Light Sciences Oncology October 2008 - October 2011
Light Sciences Oncology 2006 - 2008
Light Sciences Corp. 2004 - 2006
University of Washington 2001 - 2004
SilkenLynx Inc. 2002 - 2003
Skills
Vendor Management, Drug Process Management, Manufacturing Operations, Clinical Supply Chain..., Project Management, Strategic Sourcing, Sourcing, Supplier Selection, Supplier Negotiations, International Supply..., Contract Manufacturing..., Vendor Relations, cGMP, FDA-GMP, ICH-GMP, Process Development, Process Improvement, Technology Transfer, Scale up, Analytical Development, Technology Development, Process Validation, Supplier Quality, Quality Investigation, International Project..., Research Project..., Invention, Innovation, Idea Generation, Intellectual Property, CMC Operations, Coaching, Supervisory Skills, Staff Mentoring, Pharmaceuticals, Pharmaceutical Industry, Drug Discovery, V&V, Contract Manufacturing, Analytical Chemistry, GMP, Biopharmaceuticals, Process Simulation, Supplier Evaluation
Education
The University of British Columbia
Ph.D., Chemistry
University of Victoria
B.Sc, Chemistry
Catalent Pharma Solutions May 2013 - Present
Coldstream Laboratories, Inc. July 2011 - May 2013
AMRI February 2008 - July 2011
AMRI August 2001 - February 2008
Bristol-Myers Squibb June 1992 - October 1992
Skills
GMP, Technology Transfer, Chemical Processing, Analytical Skills, Validation, Design of Experiments, Procurement, Quality Assurance, Sterile Injectables, API manufacturing, Project Management, FDA, Change Control, Drug Discovery, Chemistry, HPLC, Laboratory, Regulatory Submissions, R&D, Pharmaceutics, Pharmaceutical Industry
Education
University of Illinois at Urbana-Champaign 1998 — 2001
Post Doctoral Research, Organic Chemistry
Trinity College, Dublin 1993 — 1998
PhD, Organic Chemistry
University College Dublin 1989 — 1993
BSc, Chemistry and Math
Numerous LEAN, cGMP, and Continuous Improvement training sessions
“CAP: Change Acceleration Process”
“Chemical Development and Scale-up in the Fine Chemical Industry, Principles and Practices”
“Cornell Project Management Program”
“Leadership Skills Training”
“Practical Process Research and Scale-up”
“Short course on Heterocyclic Chemistry”
Catalent Pharma Solutions November 2012 - Present
Hemispherx BioPharma Inc. March 2010 - November 2012
Lannett Company January 2007 - January 2010
STRIDES, INC July 2005 - October 2006
ABLE LABORATORIES, Inc September 2002 - June 2005
ORTHO-CLINICAL DIAGNOSTICS, INC January 1985 - November 2001
Skills
Microsoft Access, cGMP Training, FDA Regulations, GMP, FDA, Computer System..., Access, Quality System, CAPA, 21 CFR Part 11, Validation, Sop, Quality Assurance, Manufacturing, Medical Devices, Change Control, GLP, Process Improvement, SOP, Pharmaceutics, Pharmaceutical Industry, V&V
Education
Thomas Edison State College
Attenting, Quality Assurance Management
Piscataway High School
Catalent Pharma Solutions February 2012 - Present
Aptuit March 2007 - February 2012
The University of Kansas Cancer Center August 2009 - May 2010
University of Kansas Medical Center November 1998 - March 2007
University of Missouri-Kansas City 1995 - 1998
Universidad Austral de Chile 1988 - 1994
Skills
Biochemistry, Cell Biology, recombinant DNA..., GFP, Immunostaining, FACS, Immunofluorescence, Bacterial Transformation, DNA extraction, Affinity Chromatography, Agarose Gel..., Bacterial Culture, Primer Design, Sequence Analysis, Subcloning, Northern Blotting, Site-directed..., Immunoprecipitation, Transfection, Genetic Engineering, Antibodies, Molecular Cloning, Bioanalysis, RT-PCR, Molecular Biology, Cell Signaling, Immunology, Cancer Research, Drug Development, Biomarkers, Immunoassays, Cell Based Assays, Analytical Techniques, PCR, SDS-PAGE, RNA isolation, Cell Culture, DNA, Protein Expression, Drug Discovery, Cell, Life Sciences, Monoclonal Antibodies, Biopharmaceuticals, Western Blotting, Tissue Culture, Protein Purification, ELISA, Gel Electrophoresis, qPCR
Education
Universidad Austral de Chile 1988 — 1994
MSc, Biochemistry and Molecular Biology
Catalent Pharma Solutions September 2011 - April 2013
Catalent Pharma Solutions January 2009 - September 2011
Catalent Pharma Solutions 2007 - 2009
Catalent Pharma Solutions 2004 - 2007
Metropolitan Life Insurance Company October 2002 - October 2004
FCG November 1999 - October 2002
DMR CONSULTING October 1997 - November 1999
Skills
Program Management, Process Improvement, Change Management, Vendor Management, IT Strategy, Data Warehousing, Project Management, Quality Assurance, ERP, SDLC, SharePoint, CRM, Business Analysis, Validation, Disaster Recovery, 21 CFR Part 11, Business Process..., IT Management, Outsourcing, Pharmaceutical Industry, Team Leadership, Management, Testing, Leadership, Databases, MS Project, Software Development, Strategy, Requirements Analysis, MS Excel Pivot Tables, Visio, VMware, Performance Management, PowerPoint, IT Operations, IT Service Management, IT Audit, IT Outsourcing, Software Documentation, Cross-functional Team..., Business Intelligence, Security, Consulting, Computer System..., Project Portfolio..., Process Engineering, Change Control, GxP, FDA, GMP
Education
State University of New York at Albany
Bachelor of Science (BS)
Novo Nordisk Pharmaceutical Industries Inc. February 2015 - Present
Novo Nordisk Production August 2012 - January 2015
Catalent Pharma Solutions June 2010 - August 2012
Pierre Fabre September 2008 - February 2009
PSA Peugeot Citroën September 2006 - February 2007
PSA Peugeot Citroën April 2005 - June 2005
Skills
Lean Manufacturing, Continuous Improvement, Project Management, 5S, Change Management, Process Optimization, Kaizen Leadership, productivity tracking, production management, Progressive 5S, Operational Excellence, OEE, Production Improvement, SMED, Value Stream Mapping, Flow optimizations, Lean Transformation, Root Cause Analysis, Lean Tools, MS Project, Green Belt, A3, Systematic Problem..., Leadership Development..., KPI implementation, 8D Problem Solving, Lean Management, FMEA, Visual Management, Key Performance..., Amélioration continue, Gestion de projet, Training
Education
Université de Technologie de Compiègne 2005 — 2009
Engineer's degree, Mechanical Engineering / Production Managemen, Diploma obtained
B2 Consultants 2013 — 2014
Coach certification
Sequoïa Consulting and Training 2013 — 2013
Train the trainer
Novo Nordisk Lean Accademy 2012 — 2012
LSS Green Belt, Lean Six Sigma, Certification obtained
Sunseed 2012 — 2012
Leadership Development Program
Université du Québec - Ecole de Technologie supérieure 2007 — 2008
Engineer half year exchange, Production Management, Half year validated
Université Paris Nord - Paris 13 2003 — 2005
DUT (2 years degree), Mechanical and Production Engineering, Valedictorian
Saint Joseph 1999 — 2002
Baccalauréat, Scientific
Clondalkin Group January 1996 - Present
Catalent Pharma Solutions April 2006 - March 2011
Cardinal Health April 2000 - April 2006
Cardinal Health January 1996 - April 2000
Skills
Operational Excellence, Lean Manufacturing, Six Sigma, Continuous Improvement, Manufacturing
Education
Universidad de Puerto Rico 1983 — 1988
BSIE, Engineering
Catalent Pharma Solutions May 2015 - Present
Pfizer November 2011 - May 2015
Veterans Administation August 2010 - December 2011
Life Technologies July 2008 - August 2010
Duplogen Co. LTD January 2000 - January 2001
Boryung Pharmaceutical Co. LTD January 1994 - January 2000
Skills
Molecular Biology, Genetic Engineering, Immunochemistry, recombinant DNA..., Virology, Protein Engineering, High Throughput..., Mutagenesis, Phage Display, Monoclonal Antibodies, B cell biology, Hybridoma generation, recombinant antibody, ScFv library generation, Reformatting of ScFv to..., Phage Panning, Hybridoma, Antibodies, Immunoassays, Cell Biology, Protein Chemistry, Cell, Immunology, Protein Expression, Biotechnology, Biochemistry, Biomarkers, Flow Cytometry, Purification, ELISA, Western Blotting, RT-PCR, Laboratory, Assay Development, Cell Culture, Molecular Cloning, DNA, R&D, Drug Discovery, Vaccines, Genomics, In Vitro, Hardware Diagnostics, Biopharmaceuticals, Lifesciences, Protein Purification, SDS-PAGE, Transfection, RNAi, In Vivo
Education
University of California, Los Angeles 2001 — 2008
Ph.D., Microbiology, Immunology, Molecular Genetics
jennifer mitcham
Catalent Pharma Solutions February 2015 - Present
Catalent Pharma Solutions March 2012 - February 2015
Tradebe Environmental Services, LLC. July 2011 - March 2012
Kansas State University May 2010 - August 2010
Pacific Shipyards International, LLC May 2009 - July 2009
The University of Kansas August 2008 - May 2009
The University of Kansas August 2007 - May 2008
Sherwin-Williams Paints May 2005 - August 2006
Skills
Management, Leadership, Engineering, Training, Project Planning, Customer Service, Project Management, Research, Microsoft Excel, Process Scheduler
Education
The University of Kansas 2006 — 2011
Bachelors of Science, Chemistry
Catalent Pharma Solutions March 2011 - Present
Schering-Plough Research Institute July 2006 - December 2010
Schering-Plough January 1997 - January 2006
Schering-Plough January 1991 - January 1997
Skills
V&V, Process Improvement, Product Development, Leadership, 21 CFR Part 11, GMP, SOP, Cross-functional Team..., Quality System, Pharmaceutics, Regulatory Affairs, Quality Assurance, Computer System..., GxP, Manufacturing
Education
The Culinary Institute of America
Associate of Occupational Studies Degree, Culinary Arts
Catalent Pharma Solutions July 2012 - Present
Catalent Pharma Solutions November 2010 - July 2012
A Global Comparator Drug Sourcing Company December 2008 - October 2010
Skills
Miller Heiman, GMP, Clinical Trials, Sop, Clinical Research, Pharmaceutical Industry, Salesforce.com, Sourcing, Packaging, Cold Calling, Pharmaceutics, Cross-functional Team..., Global Business..., Biopharmaceuticals, Clinical Development, Pharmaceutical Sales, Supply Chain, Supply Chain Management, Quality Assurance, FDA, Medical Devices, Sales Effectiveness, Competitive Intelligence, Contract Manufacturing, Oncology, Biotechnology, Regulatory Affairs, Vaccines, Drug Development, Market Access, CRO, Quality Control, Regulatory Requirements, Lifesciences, Generic Programming, Manufacturing, Product Launch, Selling, Validation, Materials Management, Data Management, Management, New Business Development, Leadership
Education
State University of New York at Albany 1994 — 1998
Bachelor of Science (BS)
Portfolio, Program, Project Mgmt / IT Strategy / Business Relationship Mgmt at 908-510-2289 July 2014 - Present
Catalent Pharma Solutions January 2010 - June 2014
Catalent Pharma Solutions January 2007 - December 2009
CardinalHealth, Inc. June 2004 - December 2006
Hanover Trade, Inc. November 2003 - June 2004
First Consulting Group May 1998 - November 2003
Standard Data Corporation December 1997 - May 1998
Schering Plough Research Institute August 1996 - December 1997
Standard Data Corporation September 1995 - August 1996
First Fidelity Bancorp April 1995 - September 1995
Skills
SDLC, IT Strategy, Vendor Management, Program Management, Project Management, 21 CFR Part 11, Process Improvement, IT Management, Document Management, Pharmaceutical Industry, Business Analysis, Computer System..., Lean Six Sigma, Coaching Staff, Team Leadership, Leadership Development, Profit Center Management, Coaching and Mentoring, Root Cause Problem..., Matrix Management, RFP Generation, Enterprise Content..., HRIS, Contract Negotiation, Business Development, Customer Service, Long-term Customer..., Globalization, Global Management, IT Operations, IT Outsourcing, Communication Skills, Written & Oral..., Compliance, IT Portfolio, Demand Management, Global Resource..., IT Recruitment, Enterprise IT Strategy, Collaborative Leadership, Collaborative Problem..., Project Governance, IT Service Management, IT Service Delivery, Change Management, Risk Management, Relationship Building, Personnel Management, Problem Solving, IT Governance
Education
The College of New Jersey 1981 — 1985
BS, Administrative Management
Catalent Pharma Solutions June 2014 - Present
Catalent Pharma Solutions June 2014 - Present
TAMKO August 2011 - May 2014
US Army April 2011 - August 2011
US Army March 2010 - April 2011
US Army October 2009 - March 2010
US Army July 2008 - May 2009
US Army September 2007 - July 2008
US Army February 2007 - September 2007
Skills
Military, Leadership, National Security, Six Sigma, Military Experience, DoD, Command, Army, Military Operations, Security Clearance, Operational Planning, Program Management, Operations Management, Team Building, Management, Organizational..., Top Secret
Education
The University of Texas at El Paso 2009 — 2009
M.A., Leadership Studies
United States Military Academy at West Point 2002 — 2006
B.S., Economics
Catalent Pharma Solutions February 2014 - Present
Catalent Pharma Solutions May 2012 - Present
University of North Carolina March 2004 - Present
Jubilant Clinsys May 2011 - April 2012
Clinsys Clinical Research March 2008 - May 2011
Clinsys Clinical Research September 2007 - February 2008
Voyager Pharmaceutical Corporation December 2005 - August 2007
Voyager Pharmaceutical Corporation November 2004 - December 2005
Voyager Pharmaceutical Corporation January 2004 - November 2004
University of North Carolina March 2002 - December 2003
Skills
Medicine, Biotechnology, Clinical Trials, Lifesciences, Oncology, Clinical Research, Medical Writing, Drug Discovery, Protocol, Therapeutic Areas, CRO, Cancer, CTMS
Education
The Ohio State University College of Medicine 1988 — 1993
PhD, Anatomy
Concord College 1984 — 1988
BS, Biology
Catalent Pharma Solutions November 2014 - Present
General Electric March 2014 - September 2014
GE Healthcare July 2011 - March 2014
GE Healthcare September 2009 - July 2011
GE Healthcare May 2006 - September 2009
General Electric October 2002 - December 2005
General Electric June 1999 - September 2002
Siemens Limited 1996 - 1997
Skills
Product Development, R&D, Business Strategy, Corporate Finance, Manufacturing, Six Sigma, Cross-functional Team..., Project Finance, Product Management, Economics, Business Valuation, Derivatives, Process Engineering, Integration, Program Management, Project Management, Business Development, Divestitures, Engineering Management, Marketing, Product Requirement..., Strategy, FDA, Analysis, Profit & Loss Management
Education
The University of Chicago - Booth School of Business 2008 — 2011
MBA, Finance, Economics & International Business
University of Florida 1998 — 1999
M.S., Electrical Engineering
University of Madras 1992 — 1996
Bachelor of Engineering, Electrical and Electronics Engineering
Cardinal Health Regulatory Sciences March 2015 - Present
Catalent Pharma Solutions August 1999 - March 2015
Aptuit 2005 - 2012
Quintiles August 1999 - October 2005
Midwest Research Institute May 1995 - August 1999
Skills
GMP, Sop, Validation, GLP, 21 CFR Part 11, FDA, CAPA, HPLC, Drug Development, Analytical Chemistry, Change Control
Education
The University of Kansas 1988 — 1993
BS, Environmental Science
University of Kansas 1988 — 1993
Bachelor of Applied Science (B.A.Sc.), Environmental Science
Catalent Pharma Solutions February 2012 - Present
Aptuit August 2011 - February 2012
Aptuit Ltd July 2008 - August 2011
Skills
GLP, Pharmaceutical Industry, Analytical Chemistry, Biopharmaceuticals, Biotechnology, Clinical Development, Clinical Trials, Drug Development, Drug Discovery, FDA, GMP, HPLC, Pharmaceutics, Sop, Technology Transfer, Validation, CRO, Lifesciences, Regulatory Affairs
Education
The University of Glasgow 2002 — 2008
BSc (Hons), zoology
Catalent Pharma Solutions March 2014 - September 2015
IMS Health June 2013 - March 2014
Novo Nordisk August 2012 - March 2013
Bristol-Myers Squibb, Princeton, New Jersey October 2011 - August 2012
Bristol-Myers Squibb March 2009 - March 2011
Merck February 2009 - April 2009
Novartis September 2008 - February 2009
Bristol-Myers Squibb July 2007 - September 2008
Business Edge Solutions November 2004 - October 2006
Schering Plough 2000 - 2003
Skills
Data Modeling, SDLC, Data Analysis, Integration, Systems Analysis, Data Warehousing, Data Warehouse..., Data Quality, Business Intelligence, Data Management, Business Analysis, ETL, Data Migration, Master Data Management, Consulting
Education
State University of New York at Buffalo
BA, English
Arlington High School Poughkeepsie NY
Catalent Pharma Solutions July 2013 - Present
Bayer HealthCare March 2013 - July 2013
sanofi-aventis December 2000 - December 2012
Community Blood Center of Greater Kansas City September 1995 - December 2000
Skills
HPLC, Chromatography, LIMS, Pharmaceutical Industry, Sop, GMP, Chemistry, Analytical Chemistry, GLP, Gas Chromatography, UV/Vis, UV, Wet Chemistry, Validation, Pharmaceutics, Laboratory, Quality Control, Quality Assurance, Cleaning Validation, Technology Transfer, CAPA, FDA, Change Control, FTIR, 21 CFR Part 11, USP, SOP
Education
University of Missouri-Kansas City 2013 — 2013
Chemistry
MCCKC Penn Valley 2013 — 2013
University of Kansas 1988 — 1993
B.S., Astronomy, Physics
SmartScience Labs. December 2013 - May 2014
Catalent Pharma Solutions January 2011 - December 2013
Bausch & Lomb November 2009 - July 2010
Philosophy August 2009 - September 2009
Amgen December 2005 - May 2009
Eli Lilly and Company March 2004 - December 2005
Skills
FDA, GMP, Sop, HPLC, Dissolution, Dissolution Testing, Filters, Internal Audit, Aseptic Processing, Formulation, Quality Control, Laboratory, Pharmaceutical Industry, Analytical Chemistry, Assay Development, LIMS, Raw Materials, Calibration, Validation, Technology Transfer, Chromatography, Biopharmaceuticals, 21 CFR Part 11, Cleaning Validation, CAPA, SOP
Education
Universidad del Turabo 2007 — 2010
MBA, Management
Inter American University of Puerto Rico- Aguadilla Campus 1999 — 2003
BS, Biology
Bristol-Myers Squibb April 2013 - Present
Advantar Labs January 2011 - February 2013
Advantar Labs December 2010 - January 2011
Catalent Pharma Solutions February 2009 - June 2010
Catalent Pharma Solutions January 2008 - February 2009
Catalent Pharma Solutions January 2005 - January 2008
Cardinal Health March 2004 - September 2004
University of California at San Diego June 1998 - October 2003
Skills
HPLC, Analytical Chemistry, Quality Control, GMP, Validation, Chromatography, Biotechnology, FDA, CAPA, GLP, 21 CFR Part 11, Technology Transfer, Lifesciences, Sop, Quality Assurance, Chemistry, Pharmaceutical Industry, Biopharmaceuticals, CRO, Drug Development, LIMS
Education
University of California, San Diego 1995 — 1999
BS, Biology - Physiology & Nueroscience
Biogen March 2011 - Present
Catalent Pharma Solutions March 2010 - March 2011
Catalent Pharma Solutions 2001 - August 2010
Magellan Laboratories 1998 - 2001
Battelle Memorial Institute 1995 - 1998
Skills
GLP, Microbiology, Laboratory, Biopharmaceuticals, Purification, Vaccines, Aseptic Technique, Chemistry, Virology, Quality Control, DNA, Environmental Monitoring, GMP, Sop, Validation, FDA, Testing, CAPA, 21 CFR Part 11, Biotechnology, SOP
Education
University of Mount Union 1984 — 1988
BS, Biology
The Ohio State University
Ph.D., Medical Microbiology and Immunology
Rhodes Technologies Inc. September 2015 - Present
Catalent Pharma Solutions June 2014 - Present
AMRI (Albany Molecular Research Inc.) October 2008 - May 2014
Skills
HPLC, Analytical Chemistry, LC-MS, GPC, NMR, UV-Vis, IR, TGA, Spectroscopy, Organic Synthesis, Chromatography, Purification, Mass Spectrometry, GC-MS, cGMP, Validation, UV/Vis, Formulation, Gas Chromatography, GMP, Medicinal Chemistry, FTIR
Education
The Ohio State University 2005 — 2008
M.Sc, Chemistry
Western University 2003 — 2005
MS, Materials Chemistry
Zhengzhou University 1998 — 2002
Bachelor of Engineering (BE), Polymer Science and Engineering
Coldstream Laboratories, Inc. August 2011 - Present
Stericycle October 2010 - August 2011
Oso BioPharmaceuticals Manufacturing, LLC March 2008 - August 2009
Oso BioPharmaceuticals Manufacturing, LLC January 2007 - August 2009
Catalent Pharma Solutions July 2005 - January 2007
Cardinal Health , Specialty Pharmaceutical Distribution July 2004 - July 2005
Wyeth Pharmaceuticals September 2003 - July 2005
Caguas Mechanical Contractor, Inc. January 2001 - January 2002
Intel January 1995 - January 2001
Skills
Lean Si, Lean Manufacturing, Six Sigma, FMEA, Validation, Troubleshooting, FDA, GMP, Aseptic Processing, 21 CFR Part 11, CAPA, Calibration, Engineering, Manufacturing, Pharmaceutical Industry, Process Improvement, Quality System, Sterilization, Software Documentation
Education
Universidad Politécnica de Puerto Rico 1995 — 2003
BSME, Mechanical Engineering
Polytechnic University of Puerto Rico
Bachelor of Science, Mechanical Engineering
MISTRAS Group, Inc. June 2015 - Present
HRComputes March 1990 - Present
Novartis October 2014 - June 2015
Collaborate April 2015 - April 2015
CubeSmart January 2014 - August 2014
Novartis March 2012 - December 2013
Catalent Pharma Solutions May 2011 - December 2011
Endo Pharmaceuticals November 2010 - June 2011
Independence Blue Cross March 2010 - September 2010
Comcast May 2010 - August 2010
Skills
International Project..., Corporate Communications, Access, SAP HR, Excel, Work Life Balance, PeopleSoft, Workday, Oracle, Taleo, Kenexa, Authoria, Captivate, HR Consulting, HR Strategy, HR Service Delivery, HR Software, Compensation, Benefits, HRIS, Vendor Management, Vendor Relations, Software Development, Software Implementation, SaaS, Change Management, Program Management, Management Consulting, Human Resources, Personnel Management, Employee Benefits, Outsourcing, Leadership, Performance Management, Deferred Compensation, Talent Management, Team Building, Microsoft Excel, Strategy, Applicant Tracking..., Project Management, Employee Engagement, Management, Organizational..., Training, Business Analysis, Cross-functional Team..., Mergers & Acquisitions, Integration, Sourcing
Education
Six Sigma Green Belt
Honeywell, Six Sigma Process Improvement methodology
New School University
MA, Human Resources Management and Development
University of Massachusetts, Amherst
BA, Human Resources Management and Communication
Moorestown High school
Catalent Pharma Solutions July 2015 - Present
Catalent Pharma Solutions March 2014 - June 2015
Catalent Pharma Solutions November 2006 - March 2014
GlaxoSmithKline February 2002 - November 2006
GlaxoSmithKline April 1998 - January 2002
Stiefel, a GSK company June 1995 - April 1998
Pfizer July 1994 - June 1995
Skills
GMP, Analytical Chemistry, GLP, HPLC, Pharmaceutical Industry, Chromatography, Drug Delivery, Validation, Technology Transfer, FDA, Chemistry, Drug Development, Method Development, Regulatory Submissions, Spectroscopy, SOP
Education
University of Brighton 1990 — 1994
BSc, Chemistry & Biology
IDT Biologika September 2015 - Present
Catalent Pharma Solutions June 2014 - August 2015
Catalent Pharma Solutions July 2008 - July 2014
Catalent Pharma Solutions February 2002 - September 2008
Goodwin Biotechnology, Inc. 2000 - 2002
CropTech Development Corporation 1996 - 2000
U of I 1986 - 1987
Skills
Biotechnology, Oncology, Molecular Biology, Business Development, GMP, Biopharmaceuticals, Cell, Leadership, Manufacturing, Drug Discovery, Biochemistry, Lifesciences, Technology Transfer, Validation, Quality System, Commercialization, Pharmaceutical Industry, FDA, Life Sciences
Education
University of Arizona 1987 — 1995
PhD, Molecular Biology
University of Illinois at Urbana-Champaign 1983 — 1987
Bachelor of Science (BS), Microbiology, General
Aerotek July 2015 - Present
Aerotek June 2012 - July 2015
Aerotek Commercial Staffing September 2011 - June 2012
Catalent Pharma Solutions 2008 - 2009
Skills
Staffing Services, Technical Recruiting, Temporary Placement, Talent Acquisition, Recruiting, Sourcing, Screening, Contract Recruitment, Onboarding, Screening Resumes, Executive Search, Employee Relations, Talent Management, Training, Internet Recruiting
Education
Universidad Metropolitana
Bachelor's degree, Biology, General
Catalent Pharma Solutions May 2015 - Present
Clinical Reference Laboratory June 2014 - May 2015
The University of Kansas August 2013 - May 2014
KU Center for Research, Inc. August 2011 - May 2014
Skills
Healthcare, Critical Thinking, Analytical Skills, Public Speaking, Analytical Chemistry, Cell Biology, HPLC, Leadership, Biochemistry, Research, Laboratory, Microsoft Office
Education
The University of Kansas 2010 — 2014
Bachelor of Science (B.S.), Biochemistry
Mount Sinai Medical Center Miami Beach June 2013 - Present
Kent Hospital June 2012 - June 2013
Catalent Pharma Solutions September 2007 - May 2008
Education
Touro College 2008 — 2012
Doctor of Osteopathic Medicine (DO)
University of Florida 2003 — 2007
Bachelor of Science (BS), Microbiology, Psychology, Theater
Medivators July 2014 - Present
Medivators June 2013 - July 2014
Medivators April 2012 - June 2013
Igloo Products Corp. January 2011 - November 2011
Fluor January 2008 - November 2009
Catalent Pharma Solutions May 2007 - December 2007
Skills
Lean Manufacturing, Continuous Improvement, SPC, Engineering, ISO, Quality Management, Six Sigma, Kaizen, Value Stream Mapping, Quality System, 5S, Manufacturing..., Supplier Quality, Industrial Engineering, AutoCAD, DMAIC, Root Cause Analysis, Process Engineering, FMEA, Manufacturing..., Leadership, Minitab, Quality Assurance, Strategic Sourcing, Problem Solving, Lean Six Sigma
Education
University of Puerto Rico 2001 — 2007
Bachellor of Science, Industrial Engineering
Catalent Pharma Solutions February 2013 - Present
University of Pennsylvania August 2007 - January 2012
Bristol-Myers Squibb Company March 2007 - August 2007
Bristol-Myers Squibb Company November 2006 - March 2007
Skills
Cell Culture, Transfection, Tissue Culture, Highly detail oriented, DNA, International &..., PowerPoint, Excel, Word, Microsoft Office, Management, Molecular Biology, Problem Solving, Life Sciences, Purification, Electrophoresis, SDS-PAGE, Gel Electrophoresis, Iodixanol Purification, CsCl Purification, Protein Purification, Coaching, LIMS, Virology
Education
Thomas Jefferson University 2008 — 2015
Master of Science, Biomedical Sciences focused in Biochemistry and Molecular Biology
Ursinus College 2001 — 2005
Bachelor of Science, Biochemistry and Molecular Biology
Bensalem Township High School 1997 — 2001
Micell Technologies May 2015 - Present
Micell Technologies September 2012 - May 2015
Catalent Pharma Solutions May 2002 - September 2012
LabOne 1999 - 2001
Skills
Analytical Chemistry, HPLC, LC-MS, Chromatography, Mass Spectrometry, GC/MS, cGMP, Spectroscopy, Chemistry, Life Sciences, GLP, UV-Vis, SOP, GMP, Validation, ELISA, Pharmaceuticals, Characterization, R&D, Dissolution, IR, Science, Fluorescence, UV, USP, Gas Chromatography, GC-MS, Chemstation, Wet Chemistry, TLC, UV/Vis, FTIR, LIMS, Sop, Pharmaceutical Industry, Technology Transfer, Method Development, Analytical Method..., Purification, Drug Delivery, Drug Development
Education
University of South Carolina-Columbia 1991 — 1997
Ph.D., Analytical Chemistry
Thiel College 1987 — 1991
B.A., Biology, Chemistry Minor
University of Missouri-Kansas City 1997 — 2002
Post Doctoral Studies, Chemistry
Catalent Pharma Solutions July 2014 - Present
Catalent Pharma Solutions January 2012 - July 2014
Simon & Schuster November 2010 - December 2011
Johnson & Johnson December 2008 - July 2009
Skills
Oracle E-Business Suite, SAP R/3, Business Objects, MS Office Suite, Microsoft Office, Account Reconciliation, Accounting, Data Analysis, Forecasting, General Ledger, Process Improvement, Pharmaceutical Industry, Financial Reporting
Education
The College of New Jersey 2006 — 2010
B.S., Business Administration: Finance
Nexgen Pharma March 2012 - Present
Irvine Pharmaceutical Services October 2010 - May 2011
Catalent Pharma Solutions August 2007 - June 2010
Catalent Pharmaceutical Solutions August 2007 - June 2010
Cancer Research Center University of New Mexico September 2006 - May 2007
University of New Mexico Biochemistry Department January 2005 - February 2006
University of New Mexico Athletic Department August 2002 - May 2004
Skills
Analytical Chemistry, Biochemistry, Biotechnology, Cell Culture, Calibration, FDA, GLP, GMP, HPLC, Laboratory, Mass Spectrometry, Protein Purification, Quality Assurance, Sop, Troubleshooting, Validation, SOP
Education
The University of New Mexico 2001 — 2007
BS, Biochemistry, Spanish
The University of New Mexico
Bachelor of Science, Biochemistry
Catalent Pharma Solutions August 2013 - Present
Q1 Productions January 2013 - July 2013
Schofield Media May 2010 - January 2013
Marcus Evans December 2008 - April 2010
Habitat for Humanity-Greater Columbus June 2005 - August 2007
Education
The Ohio State University Fisher College of Business 2002 — 2006
BS Business Admin., Marketing
Amgen July 2015 - Present
Novartis May 2014 - July 2015
Novartis July 2012 - April 2014
Rutgers University July 2012 - April 2014
UCSD Skaggs School of Pharmacy & Pharmaceutical Sciences 2009 - October 2013
VA San Diego Medical Center 2009 - 2011
Target Pharmacy June 2010 - August 2010
Catalent Pharma Solutions 2003 - 2008
Indiana University June 2002 - August 2002
Skills
Pharmaceutical Industry, Biotechnology, HPLC, GLP, FDA, Pharmacy, Healthcare, Pharmacists, Sop, GMP, Regulatory Affairs, Higher Education, Pharmacy Practice, CRO, Regulatory Submissions, Biopharmaceuticals, Chromatography, Analytical Chemistry, Hospitals, R&D, Data Analysis, Hypertension, Primary Care, IND, NDA, University Teaching, Pharmacology
Education
University of California, San Diego 2008 — 2012
PharmD, Pharmacy
Louisiana Tech University
Bachelor of Science (BSc), Biology/Biological Sciences, General
Intercept Pharmaceuticals March 2014 - Present
Santarus, Inc. August 2013 - March 2014
Prometheus March 2009 - July 2013
Catalent Pharma Solutions November 2002 - March 2009
Covance February 1999 - May 2002
Baxter Healthcare May 1997 - October 1998
Skills
GLP, GMP, HPLC, Validation, Analytical Chemistry, Pharmaceutical Industry, Biotechnology, FDA, Chromatography, LC-MS, Chemistry, CMC, Quality Control, Quality Assurance, CAPA, Change Control, Deviations, Wet Chemistry, Project Management, Quality System, Sop, Clinical Development, Biopharmaceuticals, Technology Transfer, Dissolution, Auditing, 21 CFR Part 11, Lifesciences, UV/Vis, UV, CRO, Aseptic Processing, Regulatory Submissions, Drug Development, Formulation, Regulatory Affairs, Laboratory, LIMS, Medical Devices, SOP Writing, OOS Investigations, Stability, USP/PhEur Compendia, IQ/OQ/PQ, Technical Writing, Subject Matter Expert, IND, Drug Discovery, Assay Development, USP
Education
University of Wisconsin-Madison 1992 — 1997
Bachelor of Science, Chemistry
University of California, San Diego
Certificate Program, Quality Assurance / Quality Control
Catalent Pharma Solutions August 2014 - Present
Catalent Pharma Solutions November 2012 - Present
Alltech March 2009 - November 2012
Withers Enterprises April 2007 - October 2011
Skills
Biotechnology
Education
University of Alabama 1997 — 2011
Bachelor of Science (B.S.), Microbiology, General
Catalent Pharma Solutions January 2012 - Present
Catalent Pharma Solutions July 2007 - January 2012
Pii (Pharmaceutics International, Inc.). September 2005 - July 2007
Skills
New Business Development, Pharmaceuticals, Account Management, Pharmaceutical Industry, Competitive Analysis, Cross-functional Team..., Product Development, Key Account Management, Marketing Management
Education
The Ohio State University 2001 — 2004
MS, Pharmaceutics
The Catholic University of America 1997 — 2001
BS, Biochemistry
Catalent Pharma Solutions April 2012 - Present
Sanofi June 2010 - April 2012
sanofi-aventis August 2002 - June 2010
Sanofi-Synthelabo October 1999 - August 2002
The Mattson Jack Group August 1995 - September 1999
Eli Lilly 1990 - 1993
Skills
Pharmaceutical Industry, Cross-functional Team..., Technology Transfer, Lifesciences
Education
Thunderbird School of Global Management 1993 — 1995
MIHM
University of the Sciences in Philadelphia 1985 — 1990
BS
Catalent Pharma Solutions January 2015 - Present
Andrada Consulting, Inc. January 2002 - Present
Daiichi Sankyo January 2013 - December 2013
Adobe October 2012 - June 2013
Deloitte Consulting contracted at Abbott Laboratories December 2011 - August 2012
Fusion Alliance contracted at Herff Jones January 2010 - June 2011
WellPoint October 2009 - December 2009
TEKsystems contracted at American International Group February 2009 - June 2009
TEKsystems contracted at Eli Lilly Co May 2004 - May 2009
Sapphire Staffing contracted at Liberty Mutual Insurance April 2004 - May 2004
Skills
SDLC, Software Project..., Quality Assurance, Software Quality..., Quality Assurance..., Quality Assurance..., Engagement Management, Solution Delivery..., Project Managers, Quality Center, IBM Rational Tools, Test Automation, Test Planning, Test Management, Agile Methodologies, Agile Testing, Scrum, Agile & Waterfall..., Waterfall, Software Documentation, Integration, SharePoint, Performance Testing, User Acceptance Testing, Project Management, Management, Requirements Gathering, HP Quality Center
Education
Texas A&M University 1982 — 1986
BS, Computer Science & Accounting
Genentech April 2014 - Present
Hospira May 2013 - April 2014
Catalent Pharma Solutions January 2013 - May 2013
Cerilliant Corporation March 2012 - January 2013
Cerilliant Corporation February 2009 - March 2012
Austin Pharma, LLC July 2008 - October 2009
Austin Pharma LLC December 2007 - July 2008
Austin Pharma, LLC September 2007 - December 2007
North American Scientific February 2006 - April 2007
North American Scientific September 2003 - February 2006
Skills
GMP, V&V, Process Improvement, Validation, Quality Assurance, ISO, Manufacturing, Project Management, Medical Devices, Quality Control, ISO 13485, CAPA, Process Optimization, Cleaning Validation, Laboratory, Analytical Chemistry, Team Building &..., SPC (Statistical..., CAPA (Corrective..., Project Management..., Equipment Optimization, Equipment Qualification..., Process Validation, Team Building, FDA
Education
University of California, San Diego 1997 — 2002
BS, Biomedical Engineering
Richardson International October 2013 - Present
Richardson International April 2011 - September 2013
Catalent Pharma Solutions December 2009 - October 2010
Catalent Pharma Solutions June 2007 - December 2009
Cardinal Health 2002 - 2007
Raylo Chemicals January 2001 - September 2002
CV Technologies January 1998 - January 2001
Skills
GMP, CAPA, Quality Assurance, HPLC, Management, Chromatography, Biopharmaceuticals, Quality Control, Chemistry, R&D, FDA, Sop, GLP, Validation, Auditing, Change Control, Analytical Chemistry, Calibration, 21 CFR Part 11, SOP, Quality System, V&V
Education
University of California, San Diego 2008 — 2008
Certificate Program, Leadership and Management Program (LAMP)
The University of Lethbridge 1992 — 1997
Bachelor of Science - Co-op, Biochemistry
Catalent Pharma Solutions September 2015 - Present
BlackRock 2008 - Present
BlackRock Investments December 2006 - January 2008
BlackRock January 2006 - December 2006
Skills
Series 7, Mutual Funds, Asset Allocation, Portfolio Management, Securities, Series 63, Alternative Investments, Asset Management, Investments, Equities, Fixed Income, Wealth Management, Investment Strategies
Education
The College of New Jersey 2001 — 2005
Bachelor of Science (B.S.), Finance, General
Coldwell Banker Residential Brokerage January 2015 - Present
Catalent Pharma Solutions November 2013 - October 2014
Louis Vuitton Moet Hennessy October 2008 - November 2013
Titan Worldwide October 2007 - October 2008
Benjamin Moore & Co. June 2000 - November 2007
Benjamin Moore & Co. 2004 - 2007
Benjamin Moore & Co. 2000 - 2004
JD Edwards 1999 - 2000
Skills
Cross-functional Team..., Project Management, Business Analysis, Business Intelligence, ERP, Process Improvement, Change Management, Management, Retail, CRM, Business Process, Sales Management, IT Management, Supply Chain Management, Product Management, SAP, Supply Chain, Management Consulting, Project Planning, Budgets, Business Strategy
Education
The University of British Columbia 1989 — 1993
Catalent Pharma Solutions February 2012 - Present
Aptuit July 2008 - February 2012
Aptuit July 2006 - July 2008
Quintiles November 2003 - July 2006
Oread Laboratories 1999 - 2001
Skills
Sop, Validation, GMP, Quality System, Microbiology, Quality Assurance, Biopharmaceuticals, GLP, FDA, 21 CFR Part 11, Six Sigma, Computer System..., CAPA, Pharmaceutical Industry, Change Control, GAMP, ICH guidelines, HPLC, Regulatory Requirements, cGMP practices, LIMS, Document Management, Aseptic Processing, Drug Development, GxP, Quality Auditing, Quality Control, Pharmaceutics, Lifesciences, Technology Transfer, Analytical Chemistry
Education
The University of Kansas 1978 — 2001
Ph.D., Microbioloy, Immunoassay
Cardinal Health October 2009 - Present
Catalent Pharma Solutions April 2007 - October 2009
Cardinal Health May 2006 - April 2007
General Electric, Superabrasives 1998 - 2006
GE Superabrasives 1998 - 2004
Education
The Ohio State University Fisher College of Business 2000 — 2003
MBA, Business
University of Wisconsin-Madison 1993 — 1997
Sanofi US, Boston Hub 2012 - Present
sanofi-aventis 2011 - 2012
sanofi-aventis 2008 - 2011
Catalent Pharma Solutions February 2005 - December 2007
Cardinal Health September 2003 - February 2005
Cardinal Health June 2002 - September 2003
Merial Limited December 1998 - June 2002
Merck December 1995 - December 1998
Skills
Drug Development, GMP, HPLC, Analytical Chemistry, Pharmaceutics, Regulatory Submissions, CRO, Regulatory Requirements, IND, Technology Transfer, Pharmaceutical Industry, Validation, GLP, Regulatory Affairs, Formulation, FDA, Drug Discovery, Clinical Development, Biopharmaceuticals, Sop, SOP
Education
The University of Kansas
Ph.D., Pharmaceutical Chemistry
Université de Montréal
B. Pharm., Pharmacy
Catalent Pharma Solutions October 2014 - Present
Redwood Bioscience 2012 - Present
Lawerence Berkeley National Labs October 2009 - February 2012
UC Irvine September 1900 - August 2010
Genomics Institute of the Novartis Research Foundation 2000 - 2002
Combichem Inc 1998 - 1998
Skills
Reaction Discovery, Automated Synthesis, Biopolymers
Education
University of California, Irvine 2002 — 2009
Ph.D., Organic Chemistry
University of California, San Diego 1994 — 1999
BS, Chemistry
Eisai January 2009 - Present
Catalent (Formerly Cardinal Health PTS) July 2006 - January 2009
Catalent July 2003 - January 2009
Catalent Pharma Solutions July 2003 - July 2006
Cell Robotics February 1999 - July 2003
Skills
GMP, CAPA, Quality System, Quality Assurance, Sop, FDA, Change Control, Pharmaceutical Industry, Trackwise, 21 CFR Part 11, Manufacturing, Auditing, Validation, V&V, Internal Audit, Sterilization, ASQ-CQA
Education
The University of New Mexico 1988 — 1989
None, General Studies
Liberal Area Vo-Tech 1986 — 1987
Two Technical Certificate, Electrical and Electronics Engineering, 3.0
Nektar Therapeutics October 2008 - Present
Catalent Pharma Solutions May 2008 - August 2008
Salk Institute for Biological Studies June 2005 - May 2008
Skills
Drug Discovery, Drug Development, Assay Development, HPLC, Biotechnology, Cell Culture, Lifesciences, Oncology, Molecular Biology, In Vitro, In Vivo
Education
The University of New Mexico School of Medicine 2001 — 2005
Ph.D., Neuroscience
University of California, Los Angeles 1996 — 2000
Bachelor's Degree, Physiology
CSS Inc. October 2014 - Present
CSS Inc. September 2012 - October 2014
Catalent Pharma Solutions March 2010 - August 2012
Catalent Pharma Solutions August 2008 - March 2010
Cegedim October 2003 - August 2008
Dendrite October 2000 - October 2003
Bayer March 1997 - October 2000
Skills
Cross-functional Team..., CRM, Strategy, Sales Operations, Business Analysis, Management, Lead Generation, Project Management, Leadership, Six Sigma, Training, Email Marketing, Sales Process, SAP, Pharmaceutical Industry, Sales Effectiveness, SaaS, Salesforce.com
Education
The University of Memphis 1984 — 1991
Bachelor of Arts
Stanley Black & Decker , Inc. September 2011 - Present
Catalent Pharma Solutions March 2011 - September 2011
Baxter December 2009 - January 2011
Baxter October 2007 - December 2009
Johnson & Johnson January 2004 - October 2007
Johnson & Johnson January 2003 - December 2003
Johnson & Johnson August 2001 - December 2002
Johnson & Johnson January 2000 - July 2001
Johnson & Johnson August 1998 - January 2000
Johnson & Johnson January 1997 - August 1998
Skills
Supply Chain Management, Process Improvement, Strategy, Supply Chain, Change Management, Six Sigma, Forecasting, Procurement, Business Process..., Operational Excellence, Teamwork, Management, Logistics, ERP, Strategic Sourcing, Materials Management, Demand Planning, Warehousing, Operations Management, Analysis, Purchasing, Supply Chain..., Leadership, MRP, Outsourcing, Product Development, Project Planning
Education
University of Louisville
MASTER, ENGINEERING MANAGEMENT
Instituto Teconologico Autonomo de Mexico - Mexico
MASTER, BUSINESS ADMINISTRATION
Universidad La Salle, A.C. 1987 — 1991
Bachelor, Industrial Engineer
Catalent Pharma Solutions February 2015 - Present
Binder & Binder November 2013 - January 2015
ISPE January 2006 - July 2013
University of South Florida December 2004 - October 2005
Dow Jones & Co. December 2003 - July 2004
Rutgers University March 2001 - November 2003
Mayor's Office, Hamilton, NJ April 2000 - November 2000
New Jersey Legislature January 2000 - March 2000
The Times of Trenton May 1996 - January 2000
Skills
Editing, Public Relations, Media Relations, Publications, Corporate Communications, Writing, Social Media, Press Releases, Pharmaceuticals, Marketing Communications, Content Management, Blogging, Technical Writing, Strategic Communications, Newsletters, Healthcare, Speech Writing, Public Policy, Policy Analysis, Policy Writing, Pharmaceutical Industry, Strategic Planning, Research, Regulatory Affairs, FDA, Program Management, Content Development, GMP, Validation, GxP, Biotechnology, 21 CFR Part 11, Publicity
Education
University of Florida 2009 — 2011
MS
The College of New Jersey 1995 — 1997
BA, Journalism
Patheon November 2013 - Present
Catalent Pharma Solutions October 2011 - February 2013
Coldstream Laboratories, Inc. August 2010 - October 2011
PharmaForm September 2008 - June 2010
PharmaForm March 2007 - September 2008
PharmaForm February 2006 - March 2007
PharmaForm October 2004 - February 2006
Education
The University of Texas at Austin 2001 — 2004
Bachelor of Science (B.S.), Cell/Cellular and Molecular Biology
Catalent Pharma Solutions November 2013 - Present
Hilex Poly June 2008 - November 2013
Cook Composites and Polymers January 2008 - June 2008
Johns Manville September 2005 - December 2007
Prosoco 2003 - 2005
Johns Manville November 1994 - December 2003
Gard Oil Company January 1993 - April 1994
Skills
Six Sigma, Lean Manufacturing, Plastics, Operational Excellence, Change Management, Packaging, Team Building, Continuous Improvement, Kaizen, Gemba, SPC, Minitab, Design of Experiments, FMEA, 5S, Standard Work, SMED, DMAIC, Root Cause Analysis, Manufacturing, Process Improvement, Extrusion, Toyota Production System, Manufacturing Operations, Value Stream Mapping, TPM, Kanban, Quality Control, ISO, TQM, Product Development, Manufacturing...
Education
University of Kansas 1988 — 1992
BS, Biology, General
RB Consulting September 2012 - Present
Catalent Pharma Solutions January 2014 - July 2015
Ricerca Biosciences March 2010 - September 2012
MDS Pharma Services November 2003 - March 2010
Arkopharma March 2002 - November 2003
Cardinal Health 2000 - 2002
Skills
Pharmaceutical Industry, Biotechnology, Lifesciences, CRO, FDA, Clinical Trials, Clinical Development, Oncology, Regulatory Affairs, GLP, Drug Development, Clinical Research, Cosmetics, Dietary Supplements, GMP, Preclinical, Pharmacology, Toxicology, Supplements, IND, GCP, Drug Discovery, R&D, Technology Transfer, Commercialization, Biopharmaceuticals, Sop, Chemistry, Immunology, Pharmaceutics, Validation, Regulatory Submissions, Infectious Diseases, CTMS, Analytical Chemistry, 21 CFR Part 11, Drug Delivery, Medical Devices, Formulation, Vaccines, Biochemistry, Biomarkers, Pharmacokinetics, Cancer, HPLC, Molecular Biology, Laboratory, CAPA, V&V, Clinical Operations
Education
Université de Montréal 1978 — 1981
Bachelor of Science (B.Sc.), Chemistry
College Jean-de-Brebeuf 1975 — 1977
D.E.C., Health Sciences
Formulated Solutions March 2014 - Present
BayCare Health System April 2013 - March 2014
Catalent Pharma Solutions April 2011 - April 2013
Catalent Pharma Solutions April 2007 - April 2011
Cardinal Health August 2002 - April 2007
Cardinal Health June 1999 - August 2002
Mead January 1998 - June 1999
Stone Container May 1995 - January 1998
Southtrust June 1993 - May 1995
Ernst & Young 1990 - 1991
Skills
Financial Reporting, Accounting, Sarbanes-Oxley Act, Internal Controls, Auditing, Variance Analysis, US GAAP, Managerial Finance, Finance, Strategy, Six Sigma, Cross-functional Team..., Cost Accounting, Process Improvement, Hyperion Enterprise, Financial Analysis, Acquisition Integration, Mergers & Acquisitions, Internal Audit, Forecasting, Business Process..., Consolidation, Business Planning, Strategic Financial..., Due Diligence, Financial Accounting, CPA, Financial Audits, Revenue Recognition, Hyperion, Financial Planning
Education
University of Alabama at Birmingham 1996 — 1997
MBA, MBA
University of Montevallo 1988 — 1992
Bachelor of Business Administration (BBA), Accounting
Ashford Academy 1985 — 1988
Catalent Pharma Solutions February 2012 - Present
Aptuit November 2005 - February 2012
Quintiles December 1998 - November 2005
Hoechst Marion Roussel January 1998 - December 1998
Deloitte & Touche Consulting Group June 1991 - January 1998
United Gas Pipeline July 1985 - June 1991
Skills
Project Management, SDLC, Systems Integration, GMP, Computer System..., 21 CFR Part 11, Scientific Applications, LIMS, Analytical..., Chromatography Data..., Pharmaceutical..., Project Portfolio..., Global Projects, Business Analysis, Building Management..., Oracle SQL, PL/SQL, IT Vendor Auditing, Software Documentation, Vendor Management, Vendor Audit, GAMP, Cross-functional Team..., Integration, Chromatography, Validation, Sop, FDA, Biotechnology, Quality Assurance, GLP, Pharmaceutical Industry, Lifesciences, Regulatory Requirements, Drug Development, HPLC, Change Control, GxP, Software Project..., Requirements Analysis, CRO, Testing, Instrumentation, SOP, Life Sciences, Software Development
Education
Texas State University 1980 — 1985
BBA, Management Information Systems, Psychology
Catalent Pharma Solutions May 2013 - Present
CTG September 2012 - March 2013
Maternity Leave September 2011 - September 2012
Yoh @ Novartis January 2010 - September 2011
Kelly Services June 2009 - January 2010
Invensys Validation Technologies 2007 - 2009
Wyeth Biotech 2003 - 2006
Diosynth 2001 - 2003
Perigon 2000 - 2001
Baxter 1999 - 2000
Skills
CAPA, Computer System..., Validation, Change Control, 21 CFR Part 11, Cleaning Validation, GMP, LIMS, Vaccines, FDA, Regulatory Affairs, Pharmaceutical Industry, Quality Control, Quality System, Technology Transfer, Medical Devices, Sop, GxP, Biotechnology, ISO 13485, Quality Assurance, GAMP, Process Engineering
Education
Tulane University 1996 — 1998
BS, Biomedical Engineering
Xavier University of Louisiana 1993 — 1998
BS, Physics
Catalent Pharma Solutions IT ManagerCatalent Pharma Solutions2004 - 2012
Skills
21 CFR Part 11, GMP, Validation, Pharmaceutical Industry, Process Improvement
Education
The University of Southern Mississippi 1990 — 1992
Catalent Pharma Solutions December 2008 - Present
Gambro January 2008 - August 2008
Johnson & Johnson December 2002 - October 2007
Skills
FDA, Validation, GMP, HPLC, V&V, R&D, CAPA, Medical Devices, Pharmaceutical Industry, ICP-OES, Stability Studies, Lifesciences, Chromatography, Quality Assurance, Quality Control, Life Sciences
Education
Universidad de Puerto Rico 1988 — 1994
Chemistry
Catalent Pharma Solutions June 2008 - Present
Deloitte 1999 - 2004
Education
The Catholic University of America, Columbus School of Law 1996 — 1999
JD
The Catholic University of America 1992 — 1996
BS Accounting
Catalent Pharma Solutions January 2012 - Present
Becton Dickinson April 2010 - December 2011
Baxter January 2007 - April 2010
Water Pik, Inc. October 2004 - November 2006
Bayer September 1999 - December 2002
Skills
Global Marketing, Product Launch, Cross-functional Team..., Pharmaceutical Sales, Sales Effectiveness, Commercialization, Market Development, Medical Devices, Pharmaceutical Industry, Market Access, International Marketing, FDA, Biotechnology, Marketing Strategy, Oncology
Education
Thunderbird School of Global Management 2003 — 2004
Quotient Clinical Ltd September 2014 - Present
Merial, a Sanofi Company June 2013 - September 2014
Catalent Pharma Solutions 2007 - May 2013
Cardinal Health 2003 - 2006
AnorMED 2001 - 2003
Astra 1997 - 1997
Zeneca Pharmaceuticals August 1994 - July 1995
Skills
Drug Delivery, Formulation, Drug Development, Pharmaceutics, Pharmaceutical Industry, GMP, Preformulation, CRO, Technology Transfer, Team Management, Pharmaceutical Research, Quality Assurance, GLP, Dissolution, Quality by Design, HPLC, Generic Programming, Sop, ANDA, R&D, IND, Biopharmaceuticals, Regulatory Submissions, CMC, SOP
Education
University of Wisconsin-Madison 1999 — 2001
University of Bradford 1995 — 1999
PhD, Pharmaceutics
University of London 1991 — 1994
B.Pharm, Pharmacy
AMRI (Albany Molecular Research Inc.) September 2014 - Present
OSO BioPharmaceuticals Manufacturing, LLC 2008 - August 2014
Catalent Pharma Solutions 2006 - 2008
Skills
Contract Manufacturing, Sop, Pharmaceutical Industry, Biotechnology, Validation, GMP, FDA, Sterilization, Biopharmaceuticals, Change Control, Analytical Chemistry, Quality System, Quality Auditing, Manufacturing, Technology Transfer, Pharmaceutics, Quality Control, Regulatory Affairs, Medical Devices, Quality Assurance, GLP, Process Simulation, CAPA, Cross-functional Team...
Education
University of New Mexico 1999 — 2006
Biology/Business
Catalent Pharma Solutions February 2014 - Present
Catalent Pharma Solutions December 2010 - January 2014
Catalent Pharma Solutions July 2008 - December 2010
Catalent Pharma Solutions April 2007 - July 2008
Catalent Pharma Solutions August 2005 - April 2007
Cardinal Health February 2004 - August 2005
Skills
Internal Controls, Leadership, Hyperion Enterprise, Variance Analysis, Sarbanes-Oxley Act, JD Edwards, Financial Reporting, Six Sigma, Process Improvement, Forecasting, Auditing, Financial Analysis, Cross-functional Team..., Internal Audit, Financial Controlling, Financial Audits, Budgets, Accounting, Management, Mergers & Acquisitions, Account Reconciliation, Hyperion
Education
The University of New Mexico - Robert O. Anderson School of Management 1996 — 2002
BBA, Finance
Catalent Pharma Solutions February 2014 - Present
Catalent Pharma Solutions July 2011 - Present
Catalent Pharma Solutions August 2002 - November 2011
Unilever HPC May 1998 - August 2002
unilever 1998 - 2002
Astra-Zeneca July 1996 - August 1998
Merck Sharp & Dohme May 1995 - June 1996
Eli Lilly August 1994 - April 1995
Merck Sharp & Dohme May 1993 - July 1993
Skills
EHS, Safety Management, Occupational Health, Auditing, Environmental, Risk Assessment, Safety Management..., Environmental Awareness, ISO 14001, Root Cause Analysis, Water, Environmental Auditing, Ergonomics, CAPA, Accident Investigation, Six Sigma, Process Safety..., Quality System, Quality Assurance, Hazardous Waste..., PSM, Industrial Hygiene, Quality Auditing
Education
Polytechnic University of Puerto Rico 1999 — 2001
Masters, Engineering Management
University of Puerto Rico 1987 — 1994
BS, Chemical Engineering
Antonio S Pedreira
Genalyte, Inc January 2014 - Present
Allermed Laboratories January 2010 - January 2014
Catalent Pharma Solutions June 2008 - August 2008
Quidel October 2002 - May 2008
Skills
ELISA, GLP, HPLC, Cell Culture, DNA, Protein Chemistry, SDS-PAGE, Validation, FDA GMP, Western Blot, Chromatography, Standard Operating..., Immuno-Assay Development, Radioimmunoassay
Education
University of California, San Diego 1997 — 2001
BS, Biochemistry and Cell Biology
Catalent Pharma Solutions September 2014 - Present
Catalent Pharma Solutions March 2012 - Present
Catalent Pharma Solutions April 2011 - March 2012
MannKind Corporation June 2006 - February 2011
Watson Pharmaceuticals 2005 - 2006
Dur-A-Flex, Inc. May 2002 - February 2005
Skills
Sop, LIMS, R&D, Technology Transfer, Biotechnology, GMP, Drug Development, Cell, GLP, Clinical Development, HPLC, Cross-functional Team..., Pharmaceutical Industry, Validation, V&V, Regulatory Affairs, Analytical Chemistry, Lifesciences, Clinical Trials, FDA, FTIR, Project Management, Drug Discovery, Program Management, CRO, Chromatography, Biopharmaceuticals, Pharmaceutics, Regulatory Submissions
Education
University of New Haven 1999 — 2009
BS, EMBA, Chemistry, Biology, Executive Masters in Business Administration
University of Tennessee-Health Science Center 2008 — 2008
Graduate Certificate, Aseptic Technique and Parenterals Medications for Experimental Pharmacology
Yale University School of Medicine 2000 — 2002
Oncology
Catalent Pharma Solutions August 2010 - Present
GlaxoSmithKline October 2007 - August 2010
GlaxoSmithKline October 2004 - October 2007
GlaxoSmithKline June 2004 - October 2004
Schering Plough June 2003 - August 2003
Education
Texas A&M University-Kingsville 2001 — 2004
M.S, Chemistry
University of Madras 1996 — 2000
B.Tech, Chemical Engineering
LLK Consulting August 2012 - Present
Catalent Pharma Solutions February 2012 - July 2012
Aptuit July 2007 - February 2012
Aptuit June 2007 - December 2008
Pfizer November 2003 - May 2007
Pfizer December 2000 - October 2003
Skills
GLP, Validation, GMP, Sop, Pharmaceutical Industry, Microbiology, Pharmaceutics, CAPA, 21 CFR Part 11, FDA, Computer System..., V&V, Aseptic Processing, Change Control, Drug Development, Biopharmaceuticals, CRO, GAMP, SOP, Regulatory Affairs
Education
The Johns Hopkins University 2013 — 2014
Master of Science (M.S.), Regulatory Science
University of Missouri-Columbia 1995 — 1999
Bachelor of Science (B.S.), Biochemistry
GlaxoSmithKline March 2012 - January 2013
GlaxoSmithKline October 2010 - January 2012
Catalent Pharma Solutions September 2007 - February 2009
Quest Diagnostics January 2004 - July 2007
Cambrex BIoScience November 2001 - January 2004
Skills
GMP, UV/Vis, HPLC, Validation
Education
The George Washington University 2002 — 2004
MS, Forensic Science
Virginia Wesleyan College 1997 — 2001
B.A,, Chemistry
Catalent Pharma Solutions September 2014 - Present
Musser Consulting LLC May 2014 - September 2014
Boehringer Ingelheim September 2012 - January 2014
Boehringer Ingelheim September 2002 - September 2012
Boehringer Ingelheim December 2006 - September 2009
Kroger February 1990 - February 2002
Skills
PMP, Certified Project..., PMI, Pharmaceutical Industry, GMP, FDA, Validation, CAPA, Sop, Change Control, Cross-functional Team..., Regulatory Affairs, Vendor Management, Leadership, Production Managment, Team Leadership, Biotechnology, Quality Assurance, Medical Devices, Budgets, Product Development, Strategic Planning, Team Building, V&V, Change Management, Process Improvement, Operations Management, Project Management, SOP, Production Management
Education
The George Washington University - School of Business 2003 — 2006
MSPM, Project Management
The Ohio State University Fisher College of Business 1999 — 2001
MBA, Operations Mgt and Corporate Finance
University of Cincinnati 1987 — 1992
BS, Pharmacy
Catalent Pharma Solutions January 2015 - Present
Hospira February 2012 - January 2015
AEROTEK, BRISTOL MYERS SQUIBB August 2011 - February 2012
KELLY SCIENTIFIC, AMGEN MANUFACTURING LIMITED June 2010 - August 2011
ADECCO, OLAY LLC June 2009 - June 2010
Wyeth July 2006 - December 2008
RCM Technologies April 2006 - July 2006
Watson Laboratories April 2005 - April 2006
Watson Laboratories May 2003 - April 2005
Watson Laboratories May 2002 - May 2003
Skills
GMP, CAPA, Validation, Quality Assurance, Quality Control, 21 CFR Part 11, SOP
Education
Inter American University Guayama Campus 2009 — 2009
Certificate, Biotechnology
2004 — 2008
MBA, Quality Management
1996 — 2002
BS, Industrial Chemistry
Oso BioPharmaceuticals Manufacturing, LLC January 2014 - Present
OSO BioPharmaceuticals Manufacturing, LLC May 2008 - January 2014
Catalent Pharma Solutions July 2006 - May 2008
Cardinal Health April 2005 - July 2006
Cardinal Health March 2004 - April 2005
Cardinal Health October 2002 - March 2004
Skills
GMP, Root Cause Analysis, Quality Assurance, Technical Writing, CAPA, Pharmaceutical Industry, GxP, Manufacturing, Sterilization, FDA, Sop, Quality System, 21 CFR Part 11, Biopharmaceuticals, Contract Manufacturing, Process Simulation, Validation, Analysis, Management, Lifesciences, Aseptic Processing, Cross-functional Team..., Biotechnology, Pharmaceutics, Technology Transfer, Change Control, Quality Control, LIMS, GLP, Protocol, Microbiology, Quality Auditing, Medical Devices, Internal Audit, Regulatory Requirements, Analytical Chemistry, Accountability, Customer Service, ISO 13485, Responsiveness, Trusted Business Partner, Manufacturing..., Cleaning Validation, Computer System..., Hospitality, Friendly Personality, Eligibility, SOP, Trackwise
Education
The University of New Mexico 1992 — 1997
Bachelors, Biology
Advantar Laboratories, Inc. December 2010 - December 2012
Catalent Pharma Solutions June 2007 - February 2009
Cardinal Health June 2005 - July 2007
Imcor Pharmaceutical Co. June 2004 - June 2005
Imcor Pharmaceutical Co. June 2003 - June 2004
Alliance Pharmaceutical Corp October 1996 - June 2004
Education
University of California, San Diego 1993 — 1995
BS, Chemistry
UTC Aerospace Systems February 2013 - Present
Pfizer January 2011 - February 2013
Catalent Pharma Solutions October 2009 - January 2011
Abbott August 2004 - January 2009
Merck February 1995 - August 2004
ENSR January 1993 - February 1995
Skills
Medical Devices, Compliance, Inspection, Environmental, Safety Management, EHS, ISO, Continuous Improvement, Lean Manufacturing, Manufacturing, Environmental Management, Auditing, Validation, Technology Transfer, Engineering, Process Engineering, Environmental Monitoring, Pharmaceuticals, Chemical Engineering, Environmental Compliance, Biotechnology, Industrial Hygiene, ISO 14001, Environmental..., Environmental Awareness, RCRA, GMP, Process Safety, Pharmaceutical Industry, Waste Management, Ergonomics, Change Control, Safety Management..., Environmental Impact..., Hazardous Waste..., 5S, Recycling
Education
Universidad Politécnica de Puerto Rico 2001 — 2004
MEM, Master Engineering Management
Universidad de Puerto Rico 1986 — 1993
BsChe, Chemical Engineering
Catalent Pharma Solutions November 2000 - February 2009
Hybritech 1986 - 1999
UCSD Psycology Department 1979 - 1980
Skills
Data Analysis, Biochemistry, Biotechnology, Chemistry, Chromatography, Cross-functional Team...
Education
University of California, San Diego 1978 — 1982
EECS
Oso BioPharmaceuticals Manufacturing, LLC 2010 - Present
Catalent Pharma Solutions 2007 - 2010
Cardinal Health 2004 - 2007
Dey, L.P. 1999 - 2004
Pharmacia and Upjohn 1994 - 1997
Skills
Validation, CAPA, Change Control, GMP, FDA, 21 CFR Part 11, V&V, SOP, Quality System, Pharmaceutical Industry, Quality Assurance, Technology Transfer, GAMP, GxP, Quality Auditing, GLP, Regulatory Affairs, Quality Control, Root Cause Analysis, Biotechnology
Education
The University of New Mexico 1983 — 1989
Bachelor of Science (B.S.), Electrical and Electronics Engineering
Kentucky Faith Based Coalition September 2015 - Present
Episcopal Prison Ministry Commission April 2011 - Present
Norton Pharma Consulting July 2010 - Present
Bluegrass Reentry Council 2010 - Present
Bluegrass Families of the Incarcerated 2009 - Present
Pharmatech Associates 2012 - 2012
Catalent Pharma Solutions January 2007 - January 2011
Cardinal Health January 2001 - January 2007
International Processing Company January 1998 - January 2001
Roxane Laboratories January 1993 - January 1998
Skills
Solid Oral Dosage Forms, FDA, Pharmaceutical Industry, GMP, Technology Transfer, Drug Discovery, Quality Control, Process Simulation, Biotechnology, Patents, Manufacturing, Formulation, Cleaning Validation, Biopharmaceuticals, Clinical Development, Validation, Project Management, GLP, Change Control, Analytical Chemistry, Product Development, Process Optimization, Medical Devices, V&V, CAPA, Quality by Design, Coatings, Sop, Oncology, Quality Assurance, Contract Manufacturing, Computer System..., Commercialization, Business Development, Laboratory, Regulatory Affairs, Packaging, Pharmaceutics, Drug Delivery, Clinical Trials, CRO, Chemistry, ISO 13485, Drug Development, Vaccines, Polymers, Quality System, Regulatory Submissions, Lifesciences, Leadership
Education
The Ohio State University 1984 — 1987
MS, Pharmaceutical Administration
Chemical EducationCalvin College
BA
Various
Catalent Pharma Solutions December 2012 - Present
Catalent 2006 - December 2012
Schering Plough 1987 - 2005
Skills
Sop, GMP, FDA, GLP, Pharmaceutical Industry, CAPA, Technology Transfer, Cleaning Validation, 21 CFR Part 11, Change Control, Quality System, V&V, Regulatory Affairs, Validation, GxP, Formulation, Biotechnology, Trackwise, R&D, Aseptic Processing, Biopharmaceuticals, Drug Development, Computer System..., SOP, Quality Assurance, Quality Control, Pharmaceutics
Education
University of Phoenix 2006 — 2008
MBA, Business Administration
Thomas Edison State College
BA, Natural Sciences and Math
Catalent Pharma Solutions August 2002 - Present
Abbott Labs 1992 - 2002
Skills
GMP, FDA, CAPA, Assay Development, Formulation, Validation, Pharmaceutical Industry, Sop, Change Control, Cross-functional Team..., Six Sigma, 21 CFR Part 11, GLP, Quality System
Education
Trinity International University 1987 — 1992
BA, Biblical Studies
Catalent Pharma Solutions September 2011 - Present
Johnson & Johnson November 2002 - September 2011
Johnson and Johnson, PRD 2002 - 2010
Cardinal Health (RP Scherer North America) January 1996 - January 2002
Elizabeth Arden January 1992 - January 1995
Procter & Gamble October 1981 - July 1992
Education
University of Bridgeport
B.S, Biology/Allied Health Technology
Housatonic Community College
A.S, Medical Technology
Catalent Pharma Solutions February 2012 - Present
Aptuit October 2010 - February 2012
Project Management Institute 2012 - 2012
Aptuit May 2001 - September 2010
Oread Laboratories, Inc 1997 - 2001
Skills
Pharmaceutical Industry, GMP, Sop, Analytical Chemistry, HPLC, Project Management, CRO, Change Control, Drug Development, 21 CFR Part 11, Biopharmaceuticals, Technology Transfer
Education
The University of Kansas 1987 — 1991
Biology, Cellular Biology, Analytical Chemistry
Command and General Staff College
Diploma, Combined Arms and Services Staff School
NINIMEL, llc. February 2015 - Present
Amazon June 2014 - February 2015
Amazon.com June 2013 - June 2014
Amazon July 2012 - June 2013
Catalent Pharma Solutions June 2011 - July 2012
United States Marine Corps May 2006 - June 2011
United States Marine Corps April 2010 - September 2010
United States Marine Corps January 2009 - January 2010
United States Marine Corps May 2003 - March 2006
United States Marine Corps October 1995 - June 1999
Skills
Operations Planning, Operations Management, Manufacturing Operations, Lean Initiatives, Leadership Development, Process Optimization, Training & Development, Asset Management, Priority Management, Risk Management, Training, Lean Manufacturing, Operational Planning, Project Management, Project Planning, Leadership, Military, Quality Assurance, Security Clearance, Policy, Navy, Military Operations, Tactics, Aviation, Aircraft, Management
Education
United States Naval Academy 1999 — 2003
BS, Political Science; International Relations; Politics of Low Intensity Conflict; Japanese
Naval Academy Preparatory School 1998 — 1999
BS, Political Science
Catalent Pharma Solutions April 2014 - Present
McNeil Consumer Healthcare (a Johnson & Johnson Company) 2013 - 2013
Novartis Consumer Health 2012 - 2012
Boehringer Ingelheim Roxane Inc. 2002 - 2011
Integrity Pharmaceuticals Corp., Indianapolis, 2000 - 2002
Natco 1992 - 1995
Skills
V&V, Validation, GMP, Pharmaceutical Industry, Change Control, Sop, Cleaning Validation, Pharmaceutics, Contract Manufacturing, Pharmaceutical..., Technology Transfer, CAPA, 21 CFR Part 11, Formulation, Quality System, Regulatory Affairs, Biopharmaceuticals, Regulatory Requirements, Continuous Improvement, GLP, Regulatory Submissions, FDA, Biotechnology, Aseptic Processing, FDA GMP, Equipment Qualification, Quality Control, Trackwise, Quality Assurance, Drug Delivery, Lifesciences, Quality by Design, LIMS, Protocol, Quality Auditing, Product Development, R&D, Drug Development, Quality Management, GAMP, Vaccines, Computer System..., Process Simulation, GxP, GCP, HPLC, ISO 13485, Chromatography, Software Documentation, Analytical Chemistry
Education
Université Paris Sud (Paris XI)
Dr. Sci. Pharm, Pharmaceutics
Mysore University
Bachelor of Pharmacy (B.Pharm.), Pharmacy
Xavier University
Certified Project Manager (CPM), Project Management
Catalent Pharma Solutions October 2011 - Present
MSCI Inc. September 2008 - August 2011
Cardinal Health November 2005 - June 2008
Skills
Sales, Asset Management, Financial Modeling, Negotiation
Education
Texas Tech University 1985 — 1987
Master of Arts, Mass Communication
Catalent Pharma Solutions January 2015 - Present
ROTONDO TECHNOLOGIES LLC January 2008 - Present
Meriter Hospital January 2013 - March 2015
BD September 2011 - March 2012
Novartis Pharmaceutical May 2005 - November 2011
Schering Plough / Merck INC. April 1996 - June 2005
Skills
Marketing Strategy, Business Strategy, Strategic Planning, Product Development, New Business Development, Sales Management, Business Planning, Negotiation, Start-ups, Team Building, Entrepreneurship, Marketing, Management, Business Development, Change Management, Product Management, FMCG, Project Management, Retail, Customer Service
Education
MATC 2014 — 2016
Associate of Arts and Sciences (AAS), HVAC
Union County Vocational Technical School 1990 — 1991
Diploma, Machinist, CAD Drafting, CNC Programing
Catalent Pharma Solutions October 2014 - Present
Bausch + Lomb October 2011 - Present
Skills
Chemical Engineering, R&D, Thin Films, Process Engineering, Process Simulation, Materials Science, Manufacturing, Engineering, HPLC, Product Development, Six Sigma, UV/Vis, Lean Manufacturing, Labview, Research, Characterization, Chemistry, TGA, Design of Experiments, Materials, V&V, Simulations, GMP, Validation, Polymers, Spectroscopy, FDA, Technology Transfer, Scanning Electron..., Minitab, Analytical Chemistry, Project Management, SOP, Laboratory, Process Improvement, Leadership, Cross-functional Team..., Quality System, Pharmaceutical Industry, CAPA
Education
University of South Florida 2007 — 2011
PhD in Chemical Engineering
University of South Florida 2002 — 2007
Master of Chemical Engineering
Universidad Simón Bolívar 1996 — 1999
Master of Science in Chemical Engineering
Universidad Nacional Experimental Politécnica 'Antonio José de Sucre' 1987 — 1994
Bachelor of Science
Catalent Pharma Solutions 1993 - 2010
Education
Tulane University 1973 — 1976
BS, Psychology
Illumina April 2011 - Present
Genentech August 2009 - April 2011
Catalent Pharma Solutions March 2008 - August 2009
FFA Sciences March 2005 - March 2007
Skills
Biotechnology, Protein Purification, Molecular Biology, Assay Development, Purification, Protein Chemistry, SDS-PAGE, Biochemistry
Education
University of California 2004 — 2004
Masters of Science, Chemistry
University of California, Berkeley 1998 — 2003
Bachelor of Science, Biochemistry/Chemistry
Purdue Pharma L.P. August 2015 - Present
ENCO Pharmaceutical Development, Inc. (EPDI) November 2013 - July 2015
Becton, Dickinson and Co. May 2012 - November 2013
Catalent Pharma Solutions October 2006 - May 2012
RTI Laboratories December 2001 - March 2006
Suceava High School September 1998 - May 2001
Skills
HPLC, Gas Chromatography, Chemistry, Mass Spectrometry, Validation, Sop, Organic Chemistry, Dissolution, Laboratory, UV, FDA, Science, Method Development, Ion Chromatography, Assay Development, GMP, R&D, Analytical Chemistry, LC-MS
Education
Bucharest University Romania 1990 — 1996
Master of Science, Chemistry
University of Bucharest 1990 — 1996
Master, Chemistry
Catalent Pharma Solutions August 2011 - Present
Education
Union County College 1983 — 1985
Scafuto Property June 2009 - Present
Catalent Pharma Solutions December 2008 - March 2009
Azure Institute August 2004 - February 2007
Hewlett Packard Inks Research April 2004 - June 2004
Teaching and Traveling October 2003 - March 2004
DuPont Pharmaceuticals May 2001 - November 2002
Combichem/Chirochem May 1998 - April 2001
Biosystematech May 1997 - April 1998
L.A. Water Reclamation Districts January 1997 - April 1997
Skills
Synthesis and Analysis, Organic Synthesis, Purification, Chromatography, Characterization, HAZWOPER, Analytical Instruments, automated synthesis, Inert Environments, Automated Liquid..., Empower, Isis Base, ChemDraw, ChemDraw3D, SciFinder, Reaction Browser, Databases, SAR elucidating, Laboratory Robotics, HPLC, FTIR, LC-MS, English, Spanish, French, Scientists, Iso 9000, cGLP, UV-Vis-NIR
Education
University of California, San Diego 1991 — 1995
Bachelor of Science (BSc), Chemistry
Catalent Pharma Solutions 2012 - Present
Aptuit 2006 - 2012
Quintiles 2004 - 2006
Black & Veatch 1995 - 2004
Skills
Engineering, GMP
Education
University of Kansas
Master of Business Administration (M.B.A.), Finance
University of Kansas
BSME, Mechanical Engineering