Apptec Company
Industry: Pharmaceutical company
DescriptionWuXi AppTec Group is a global pharmaceutical, biopharmaceutical, and medical device company. The company covers the development cycle through five core operations, including small molecule R&D and ... Headquarters: Shanghai, China Number of employees: >14,000 (2017) Founder: Li Ge Subsidiaries: Abgent, Cycle Solutions, Inc.,
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Apptec Employees
McNeil Consumer Healthcare May 2012 - Present
PMRS October 2005 - October 2010
MedImmune Vaccines, Inc June 2005 - October 2005
AppTec April 2004 - September 2004
Skills
GMP, cGMP, GLP, SOP, Pharmaceuticals, Excel, Word, Microbiology, QC, CAPA, PowerPoint, Aseptic Processing, Microbial Limits, Membrane Filtration, Environmental Monitoring, Antimicrobial..., Sop, Pharmaceutical Industry, Microsoft Excel, FDA, Quality Control, Validation, LIMS, Microsoft Word, Filtration, Laboratory
Education
Drexel University 2001 — 2005
Bachelor of Science, Biological Science
Shire Pharmaceuticals December 2011 - Present
Shire Pharmaceuticals February 2007 - December 2011
AppTec July 2006 - February 2007
Skills
Cell Culture, ELISA, HPLC, Cell Biology, Laboratory Automation, Antibodies, Gel Electrophoresis, Enzyme Activity, Aseptic Technique
Education
St. Joseph's University 2001 — 2005
BS, Biology
Metagenics January 2010 - Present
Metagenics June 2007 - December 2009
AppTec 2006 - 2007
Skills
Environmental Monitoring, Microbiology, GMP, cGMP, Sop, GLP, Biotechnology, Quality Assurance, LIMS, FDA, Validation, ELISA, Regulatory Affairs, Laboratory, Quality Control, Software Documentation, Manufacturing, CAPA, SOP development, SOP
Education
North Dakota State University 2000 — 2005
B.S., Microbiology
WuXi AppTec March 2014 - Present
WuXi AppTec July 2013 - March 2014
WuXi AppTec January 2007 - June 2013
WuXi AppTec 2005 - 2007
WuXi AppTec January 2003 - 2005
Morphochem, Inc January 2001 - June 2002
Emtec, Inc. April 1999 - December 2000
AppTec October 1995 - February 2000
Charming Shoppes May 1992 - October 1995
Education
Holy Family University 1988 — 1992
BA, Computer Management Information Systems
Covance December 2013 - Present
ICON Central Laboratories, Inc. December 2004 - November 2013
AppTec June 2002 - December 2004
Esoterix August 1987 - June 2002
Skills
Clinical Development, Clinical Trials, CRO, Biotechnology, Pharmaceutical Industry, Oncology, CTMS, Lifesciences, EDC, Clinical Data Management, Infectious Diseases, GCP, Drug Development, Central Laboratory, Business Development, Biomarkers, Life Sciences, Validation, GMP, Biopharmaceuticals, Clinical Research, Medical Devices
Education
Dartmouth College 1977 — 1981
Bachelor of Arts (B.A.), History
Roche Molecular Systems June 2011 - Present
Bristol-Myers Squibb November 2007 - June 2011
AppTec November 2006 - November 2007
Skills
Pharmaceutical Industry, GMP, Sop, Customer Support, Creation Of Training..., Mentoring, Laboratory, Testing, Investigation, Material..., Medical Devices, Change Control, FDA, GLP, ISO 13485, Molecular Biology, 21 CFR Part 11, SOP, CAPA, Biotechnology, Technology Transfer, Validation, Cross-functional Team..., Life Sciences, Microsoft Office, Management
Education
NJIT 2008 — 2010
Master's degree, Pharmaceutical Industrial Management
Rutgers University 2002 — 2006
Bachelor's degree, Biology, General
The Janssen Pharmaceutical Companies of Johnson & Johnson August 2005 - Present
The Childrens Hospital of Philadelphia August 2002 - August 2005
AppTec July 2001 - August 2002
Education
Drexel University 1996 — 2001
BS, Biology
Percepticore, LLC July 2012 - August 2013
Merck June 2009 - July 2012
Merck June 2006 - June 2009
Merck February 2006 - June 2006
Percepticore, LLC December 2005 - February 2006
Merck June 2005 - December 2005
AppTec April 2001 - June 2005
Molecular Circuitry Incorporated July 2000 - April 2001
Skills
Assay Development, ELISA, Molecular Biology, GLP, Cell, Cell Biology, Immunology, Validation, GMP, Microbiology, qPCR, Drug Development, Pharmacology, Neuroscience, Biopharmaceuticals, Laboratory
Education
Thomas Jefferson University 2002 — 2004
Lehigh University 1996 — 2000
Bachelor of Science
Fairview Health Services, Ridges Hospital July 2007 - Present
Rasmussen College January 2011 - April 2011
University of Minnesota Medical Center, Fairview April 2003 - April 2007
AppTec July 2002 - March 2003
Zumbrota Area Ambulance September 1998 - April 2000
Skills
Nursing, Post-Partum, Couplet Care, Direct Patient Care, IV, Ambulatory Care, Wound Care, Health Education, Healthcare, EHR, Post Anesthesia Care, Medical Terminology
Education
St. Olaf College 2005 — 2007
Bachelor of Arts (BA), Registered Nursing/Registered Nurse
St. Olaf College 1996 — 2000
Bachelor of Arts (BA), Biology
Chatham Financial April 2015 - Present
GlaxoSmithKline March 2007 - April 2015
AppTec January 2006 - March 2007
American Red Cross March 2005 - January 2006
Skills
Drug Discovery, GLP, Biotechnology, Pharmaceutical Industry, GMP, Assay Development, Lifesciences, Drug Development, Sop, Oracle SQL Developer, Toad, Automation, Compound Management, Critical Thinking, Biopharmaceuticals, SOP
Education
Rowan University 1998 — 2004
Bachelor of Science (B.S.), Biology, General
Des Moines Area Community College July 2013 - Present
Des Moines Area Community College January 2007 - Present
Des Moines Area Community College September 2011 - June 2013
Des Moines Area Community College April 2010 - September 2011
Grimes Library July 2009 - April 2010
Universite de Paris VI : Pierre et Marie Curie February 2008 - May 2008
French Embassy September 2007 - April 2008
AppTec September 2001 - July 2003
Skills
speak French and German..., Training, Leadership, Teaching, Management, SharePoint, Project Management, Research, Process Improvement, Higher Education, Leadership Development, Grant Writing, Public Speaking, Nonprofits, Event Planning, Curriculum Design, Program Development
Education
SUNY Stony Brook 2003 — 2006
MA, Art History and Criticism
Central College 1997 — 2001
BA, Philosophy and French
Research Triangle Park July 2013 - Present
Sanofi Pasteur June 2007 - July 2013
cambrex bio science baltimore February 2002 - January 2007
apptec 2005 - 2006
Alexion Pharmaceuticals May 1999 - February 2002
Skills
Hydrophobic Interaction..., Affinity, Reverse Phase, Vaccines, DNA, Antibodies, Centrifugation, Fermentation, Biopharmaceuticals, Technology Transfer, Purification, Filtration, Processes Development, Deviation Management, CAPA, Downstream Processing, TFF, Viral Clearance, Mammalian Cell Culture, Bacterial Cell Culture, Validation, Process Qualification, Equipment Qualification, Process Improvement, Ion Chromatography, Size Exclusion, Analytical Methods..., UF/DF, Protein Purification, AKTA, Chromatography, Aseptic Processing, GMP, V&V, Trackwise, Commercialization, Monoclonal Antibodies, Process Optimization, Sop, Lyophilization, Biotechnology, SOP
Education
The Johns Hopkins University 2002 — 2005
MS
University of Tampa 2002 — 2005
Bachelor of Science (B.S.)
University of South Florida 1994 — 1997
BS
Merck May 2012 - Present
Merck & Co., Inc. May 2009 - May 2012
Isolagen, Inc. October 2006 - January 2009
AppTec October 2005 - October 2006
Rohm and Haas Company September 2003 - March 2004
Merck and Company Inc. April 2002 - March 2003
Merck and Company Inc. September 2001 - March 2002
Skills
CAPA, GMP, FDA, Quality System, 21 CFR Part 11, Change Management, Lean Tools, Clinical Trials, Project Management
Education
Drexel University 2000 — 2005
Bachelor's of Science
Teva Biopharmaceuticals USA, Inc. January 2015 - Present
Morphotek, Inc. December 2012 - December 2014
Morphotek, Inc. July 2007 - December 2012
Apptec 2006 - 2007
Lampire 2001 - 2006
Skills
CAPA, Technology Transfer, Sop, 21 CFR Part 11, Vaccines, ELISA, Clinical Development, Molecular Biology, Process Development, Chemistry,..., GMP, Regulatory Affairs, Vendor Management, Dossier Preparation, FDA, EMEA, SFDA, Analytical Method..., Process Validation, Cell Culture, Mammalian Cell Culture, Protein Purification, Formulation Chemistry, Stability Studies, Process Control, Report Writing, Trackwise, Technical Project..., IND, Process Simulation, Regulatory Requirements, Project Management, V&V
Education
La Salle University - School of Business Administration 2004 — 2007
MBA, Organizational Management
Delaware Valley College 1998 — 2002
BS, Small Animal Science
University of Pennsylvania - The Wharton School
MS, Biotech Engineering
The Janssen Pharmaceutical Companies of Johnson & Johnson November 2014 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2013 - November 2014
Janssen, Pharmaceutical Companies of Johnson and Johnson January 2007 - September 2012
Centocor, R&D Inc January 2007 - May 2008
AppTec 2003 - 2007
Bristol-Myers Squibb 2001 - 2002
Dupont Pharmaceutical Co 2000 - 2001
Dupont Pharmaceutical Co January 1999 - January 2000
Dupont Pharmaceutical Co January 1992 - January 1999
Cardiovascular group January 1990 - January 1992
Skills
Drug Discovery, Biomarkers, Cell, Immunology, Biotechnology, ELISA, Clinical Development, Molecular Biology, Cancer, Translational Medicine, Oncology, Clinical Trials
Education
University of Delaware 1993 — 1997
Ph.D, Chemistry and Biochemistry
University of Mumbai
B.S, Pharmacy
University of Mumbai
M.S, Pharmacy
AppTec May 2007 - Present
Medical Diagnostic Laboratories July 2005 - May 2007
Education
Thomas Jefferson University 2004 — 2005
Apptec August 2007 - Present
Johnson & Johnson October 2006 - August 2007
Johnson & Johnson 2001 - 2006
Centocor R&D (Johnson & Johnson) 2002 - 2004
GlaxoSmithKline December 2000 - February 2001
Education
Eastern University 1997 — 2008
mba
Cornell University
certificate in finance
Drexel University
MS administion and organizational Management
AstraZeneca March 2013 - Present
Johnson &Johnson August 2008 - March 2013
Centocor Johnson & Johnson 2008 - August 2010
Apptec August 2007 - August 2008
Johnson & Johnson January 2005 - January 2007
Centocor R&D Johnson &Johnson January 2002 - January 2005
GlaxoSmithKline Pharmaceuticals January 2000 - January 2002
Skills
Biotechnology, R&D, Cell Culture, Biopharmaceuticals, Clinical Research, Pharmaceutical Industry, GMP, FDA, Validation, Quality System, Sop, Medical Devices, Cross-functional Team..., Six Sigma, Quality Assurance
Education
Drexel University 2005 — 2007
Master of Science (M.S.), Higher Education Administration and Organizational Management
Cornell University 2004 — 2005
Certificate in Finance, Finance, General
Eastern University 2003 — 2005
Master of Business Administration (MBA), Business Administration and Management, General
Eastern University 1997 — 2001
Bachelor of Science (B.S.), Health & Exercise Science
Lancaster Laboratories (GlaxoSmithKline) December 2009 - Present
WuXi AppTec June 2009 - December 2009
WuXi AppTec September 2007 - February 2009
AppTec October 2006 - November 2007
AppTec August 2005 - December 2006
Skills
GMP, Sop, Cell Culture, Change Control, Aseptic Technique, Aseptic Processing, cGMP manufacturing, Cell Banking, Cell Therapy, Process Transfer, Batch Records, Technology Transfer, Process Flow Charts, Upstream Processing, Technical Transfers, SOP, Biotechnology
Education
La Salle University 2002 — 2005
B.A., Biology
La Salle University 2002 — 2005
A.A., Chemistry and Education
Sartorius Stedim Biotech November 2013 - Present
Sartorius Stedim Biotech March 2009 - October 2013
WuXi Apptec February 2007 - March 2009
AppTec March 2006 - February 2007
Greatbatch, Inc. October 2005 - March 2006
PQ Corporation September 2003 - March 2004
ViroPharma Incorporated September 2002 - May 2003
ViroPharma Incorporated September 2001 - March 2002
US Army Medical Research Institute of Chemical Defense June 1999 - October 1999
US Army Medical Research Institute of Chemical Defense June 1998 - September 1998
Skills
Biotechnology, Biopharmaceuticals, GMP, Cell Culture, Technology Transfer, Pharmaceutical Industry
Education
Drexel University 2006 — 2008
Masters of Science, Biomedical Engineering (Tissue Engineering and Biomaterials)
Drexel University 2000 — 2005
Bachelors of Science, Biomedical Engineering (Biomechanics)
Lancaster Laboratories February 2009 - Present
Therakos (Johnson & Johnson) 2007 - 2009
AppTec 2006 - 2007
Wuxi AppTec 2006 - 2007
Wyeth Biopharma 2001 - 2005
Education
Harvard Medical School 1999 — 2001
Postdoctoral, Cancer Biology
Brandeis University 1994 — 1998
Ph.D, Molecular and Cell Biology
University of Science and Technology of China
Four Corners Management February 2009 - June 2014
Four Corners Management February 2007 - February 2009
AppTec September 2004 - February 2007
Forever Broadcasting 2004 - 2004
Skills
Microsoft Office, Budgets
Education
Penn State University 2000 — 2004
Bachelor of Arts (B.A.), Telecommunications
AppTec ChemistMerckMay 2008 - Present
Education
La Salle University 2002 — 2006
Hemoglobin Oxygen Therapeutics Production ManagerOPK Biotech, LLCJanuary 2010 - December 2013
Merck May 2009 - April 2010
Biopure May 2000 - June 2008
AppTec 2004 - 2005
Pony Express Brewing Co. 1998 - 1999
Skills
GMP, Sop, FDA, Validation, CAPA, Pharmaceutical Industry, Change Control, Biotechnology, Technology Transfer, Aseptic Processing, V&V, Quality System, Industrial Safety, Public Safety, Environmental Health, Brewing, Management, SOP
Education
Saint Joseph's University 2010 — 2013
Masters of Science, Environmental Protection and Safety Management
Saint Peter's University 1989 — 1992
Bachelor of Arts (B.A.), Classical and Ancient Studies
Bucks County Community College
Professional Certification in Fire Fighter 1 and Hazardous Materials Operations
Temple University
Certificate in Quality Assurance/Regulatory Affairs
Medtronic November 2010 - Present
Boston Scientific October 2007 - November 2010
AppTec 2005 - 2007
Kforce Inc. 2005 - 2005
Biovest International 2003 - 2005
Alexon-Trend 2002 - 2002
Skills
Medical Devices, ISO 13485, Biotechnology, CAPA, Quality System, Validation, FDA, Testing, Biocompatibility, Cell Culture, Quality Control, Sterilization, V, GLP, Design Control, GMP
Education
University of Minnesota-Twin Cities
Bachelor of Science, Microbiology
PhaseBio June 2010 - Present
Auxilium Pharmaceuticals October 2007 - May 2010
Biorexis Pharmaceuticals 2005 - 2007
AppTec July 2003 - March 2005
Targeted Genetics March 2000 - February 2003
Education
Thomas Jefferson University 1998 — 1999
BS, Laboratory Science
Noramco, Inc. January 2015 - Present
Janssen, Pharmaceutical Companies of Johnson and Johnson September 2010 - Present
Centocor March 2003 - September 2010
BMS 2001 - 2003
AppTec December 2000 - March 2001
AppTec October 1999 - December 2000
Thomas Jefferson University August 1997 - October 1999
Ortho Clinical Diagnostics March 1996 - August 1997
Ortho Clinical Diagnostics August 1992 - March 1996
Skills
GMP, ELISA, HPLC, GLP, Western Blotting, Assay Development, Sop, Drug Discovery, Molecular Biology, Monoclonal Antibodies, Immunology, Protein Chemistry, Chromatography, Mass Spectrometry, In Vitro, Biotechnology, SOP, Biopharmaceuticals, High Throughput...
Education
The Johns Hopkins University 2011 — 2014
Master's Degree, Regulatory Sciences
Thomas Jefferson University 1997 — 2000
M.S., Biochemistry
The College of New Jersey
Eurofins Lancaster Laboratories January 2009 - Present
Wuxi AppTec February 2007 - December 2008
AppTec October 2005 - March 2007
Lohmann Animal Health International September 2004 - October 2005
Skills
GLP, GMP, Biotechnology, Cell Culture, Sop, Virology, Aseptic Technique, Aseptic Processing, Change Control, Deviations, Vaccines, Technology Transfer, Biopharmaceuticals
Education
Stockton University 1999 — 2003
BS, Biology
Correvio May 2011 - March 2015
Iroko Pharmaceuticals April 2009 - May 2011
CIS 2007 - 2008
Apptec 2003 - 2007
Skills
Manufacturing, Pharmaceutical Industry, GMP, Sop, Biotechnology, Technology Transfer, Validation, FDA, GLP, CAPA, Biopharmaceuticals, Regulatory Affairs, Change Control, Medical Devices, Team Building, SOP
Education
University of Pittsburgh 1992 — 1996
BS, Chemical Engineering, Minor in Bioengineering
Influence Ecology
Influence Ecology
AMRI (Albany Molecular Research Inc.) June 2015 - Present
AMRI (Albany Molecular Research Inc.) April 2014 - February 2015
Merck October 2011 - April 2014
Merck April 2010 - October 2011
Merck May 2007 - April 2010
AppTec May 2004 - May 2007
Henry Troemner LLC February 2002 - November 2004
Thomas Jefferson University December 2002 - May 2004
Skills
Vaccines, GMP, GLP, Sop, Six Sigma, Pharmaceutical Industry, Manufacturing, Aseptic Processing, CAPA, Biotechnology, Formulation
Education
Rowan University
BS, Biology
Thomas Jefferson University
MS Public Health
Grow and Learn Centers, Inc. December 2008 - Present
AppTec November 2006 - November 2008
WuXi AppTec October 2000 - November 2008
Baxter Healthcare 2005 - 2006
Corporate Express 2000 - 2003
CompuCom 1997 - 2000
Skills
Microsoft Excel, Microsoft Word, Access, GMP, GLP, ISO, Databases, Data Analysis, Metrics, Internal Audit, Training, Document Management
Education
Rutgers University – Camden 2004 — 2008
Bachelors, History
WuXi AppTec August 2015 - Present
WuXi AppTec October 2014 - August 2015
WuXi AppTec October 2013 - October 2014
WuXi AppTec January 2012 - October 2013
WuXi AppTec January 2010 - January 2012
WuXi AppTec February 2008 - January 2012
AppTec April 2006 - February 2008
IKEA 2004 - April 2006
Restoration Hardware 1999 - 2004
Skills
Cell Culture, GMP, GLP, R&D, Methods Development, Method Validation, In Vitro..., In Vitro Cytotoxicity..., Phlebotomy, Managing Technical..., Performance Management, Operations Management, FDA, V&V, CAPA, Microbiology, Laboratory, HPLC, Biochemistry, Lifesciences, Biotechnology, ELISA, Technology Transfer, Aseptic Technique, Sop, LIMS, Chromatography, Validation, Analytical Chemistry, Assay Development, Cell, Biopharmaceuticals, Toxicology, UV/Vis, Life Sciences, Medical Devices, Management, Pharmaceutical Industry, SOP
Education
The Johns Hopkins University 2011 — 2015
Master of Science (M.S.), Biotechnology, 3.8 GPA
St. Catherine University 2002 — 2005
B.A., Biology, 3.3 GPA
Aesculap Biologics, LLC January 2009 - Present
WuXi AppTec October 2005 - January 2009
AppTec October 2005 - January 2008
Neose Technologies 2004 - 2005
Merck 2002 - 2003
Thomas Jefferson University 2000 - 2002
Skills
Biotechnology, GMP, Medical Devices, Biopharmaceuticals, 21 CFR Part 11, FDA, Manufacturing, CAPA, Validation, Sop, ISO 13485
Education
Arcadia University 1996 — 2000
BA, Biology
IGI Laboratories, Inc March 2015 - Present
Merck 2013 - 2014
Merck 2009 - 2013
WuXi AppTec 2006 - 2009
AppTec 2005 - 2006
AppTec 2004 - 2005
Merck 2003 - 2003
Wyeth 2001 - 2002
Skills
GMP, Quality Assurance, Sop, Validation, Chromatography, Vaccines, Sterilization, Purification, Manufacturing, Cleaning Validation, Documentation Practices, Marine Biology, Trackwise, Documentum, 21 CFR Part 11, Biotechnology, FDA, LIMS, SOP, Laboratory, TrackWise
Education
East Stroudsburg University of Pennsylvania 1995 — 1999
Bachelor of Science, Biology and Marine Science
American Medical Re June 2009 - Present
Enduracare February 2009 - June 2012
Baxter County June 2008 - December 2008
AppTec October 2006 - February 2008
Moravian Care Ministries February 2001 - February 2008
Skills
Healthcare, Hospitals, Pediatrics, Clinical Research, Public Speaking, Healthcare Management, EMR, Recruiting, Microsoft Office, Leadership Development, Teaching, Surgery, Cpr Certified, Team Building, Coaching, Customer Service, Strategic Planning, Employee Relations, Software Documentation, Research
Education
IHM Health Studies
paramedic, paramedicine
Arkansas State University 2008 — 2008
EMT-B, emergency services
Argosy University Twin Cities 2002 — 2004
Associates of Applied Science, Animal Science
BioMarin September 2010 - September 2012
BioMarin September 2007 - September 2010
AppTec October 2005 - June 2007
Genentech June 2003 - October 2005
Skills
Manufacturing, Aseptic Technique, LIMS, GMP, Cell Culture, Fermentation, Technology Transfer, Biopharmaceuticals, Aseptic Processing, Change Control, Technical Writing, Cell Biology, Quality System, Cell, Protein Purification, Biotechnology, Sop, 21 CFR Part 11, Analytical Chemistry, Filtration, Lean Manufacturing, Microsoft Excel, Microsoft Office, PowerPoint, Purification, R
Education
University of California, Davis 1998 — 2001
B.S., Evolution and Ecology
Santa Rosa Junior College 1996 — 1998
GE, Biology, Chem, Physics, Calculus
PPD April 2013 - Present
PPD October 2011 - April 2013
Charles River Laboratories March 2010 - October 2011
WuXi AppTec February 2008 - March 2010
AppTec May 2006 - February 2008
AppTec August 2004 - April 2006
AppTec August 2003 - August 2004
Siegfried (USA) November 2002 - August 2003
Michigan State University February 1999 - May 2002
Michigan State University July 1999 - December 1999
Skills
Life Sciences, GMP, GLP, SOP, Cell, Laboratory, Biopharmaceuticals, Pharmaceutical Industry, Technology Transfer, CAPA, LIMS, Biotechnology, Lifesciences, Quality Control, Cell Culture, Sop, Microbiology
Education
Michigan State University 1997 — 2002
Bachelor’s Degree, Human Biology
McNeil Consumer Healthcare August 2012 - Present
Auxilium Pharmaceuticals May 2011 - April 2012
Auxilium Pharmaceuticals June 2009 - May 2011
AstraZeneca Pharmaceuticals January 2009 - June 2009
GlaxoSmithKline February 2008 - August 2008
AppTec February 2007 - January 2008
Skills
Multitasker, Self Driven, Quality, Goal Oriented, cGMP, GMP, SOP, GLP, FDA
Education
Goldey-Beacom College 2007 — 2008
Masters, Masters of Business Administation
Goldey-Beacom College 2007 — 2007
Masters, Masters of Management
Delaware State University 2001 — 2006
Bachelor of Science, Biotechnology
American Red Cross May 2014 - Present
American Red Cross October 2009 - May 2014
American Red Cross July 2006 - May 2009
American Red Cross March 2005 - July 2006
Coriell Institute for Medical Research November 2004 - March 2005
AppTec August 2004 - November 2004
Wisconsin Department of Natural Resources May 2003 - August 2003
Skills
GLP, GMP, Data Analysis, Research, ELISA, Microsoft Excel, Microsoft Word, Database Administration, Iso 9000, PowerPoint, FDA, CAPA, Outlook, Microsoft Office, E-Learning, Quality Auditing, Quality Assurance, Stat-A-Matrix, Problem Analysis, Problem Management, Process Review, Procedure Development, Regulatory Affairs, Root Cause Analysis, Validation, Regulatory Requirements, Process Improvement, Training, Laboratory, 21 CFR Part 11, Microbiology, FDA GMP, Technical Writing, Computer System..., Quality Control, Sop, Change Control, Testing, Aseptic Technique, Strategic Planning, Quality Management, Customer Service, Immunology, SOP
Education
Drexel University 2006 — 2008
Masters of Science, Biological Studies
Villanova University 2000 — 2004
Bachelor of Science, Biology
Loyola Academy 1996 — 2000
High School
BryKor, LLC 2012 - Present
WuXi AppTec January 2008 - December 2011
AppTec 2001 - 2008
ViroMed Biosafety Laboratories 1997 - 2001
Skills
Regulatory Affairs, Microbiology, Quality Systems, Technology Transfer, Medical Device..., Sterilization sciences, Biologics and tissues, Laboratory Experience, Test method development, Radiation sterilization, ISO 17025, Sterilization, Science, Test Methodologies, Laboratory, GLP, Quality System, Medical Devices, CAPA, Biologics, Aseptic Processing, V&V, LIMS, Biotechnology, ISO 13485, Sop, Biopharmaceuticals, Change Control, Quality Auditing, 21 CFR Part 11, Design Control, cGMP practices, Cleaning Validation, Sterility Assurance, GxP, Aseptic Technique, Quality Control, ISO 14971, Computer System..., Pharmaceutical Industry, FDA GMP, 21 CFR, Regulatory Requirements, Biocompatibility, Quality Assurance, ISO, SOP
Education
Medical College of Georgia at Augusta University 1977 — 1978
M(ASCP), Medical Microbiology
The University of Georgia 1972 — 1975
B.S., Microbiology
Merck November 2008 - Present
Merck November 2006 - November 2008
AppTec 2005 - 2006
Skills
Vaccines, GMP, Aseptic Processing, LIMS, FDA, Pharmaceutical Industry, Biotechnology, Cell Culture, Six Sigma, SAP, Chromatography, Protein Purification, Lean Manufacturing, Regulatory Inspections, Control Environmental..., Emerson DeltaV, Werum Pas-X, Sop, Biologics, SOP, CAPA, Biopharmaceuticals
Education
University of Pennsylvania 2001 — 2005
BA, Biology
VWR International February 2012 - Present
VWR June 2009 - February 2012
VWR March 2007 - June 2009
VWR September 2004 - March 2007
AppTec May 2004 - September 2004
Skills
Biotechnology, Lifesciences, Molecular Biology, Cross-functional Team..., Product Launch, Medical Devices, Product Marketing, Product Management, Genomics, Product Development, Commercialization, Pharmaceutical Industry, Sales Operations, R&D, Microbiology, Key Account Management, Market Development, Hardware Diagnostics, Biopharmaceuticals, Competitive Analysis, Account Management, Life Sciences
Education
Pennsylvania State University-Great Valley Graduate Center 2008 — 2010
MBA
Lafayette College 2000 — 2004
BS, Biology
WuXi AppTec China 2011 - Present
WuXi AppTec 2008 - 2011
AppTec 2006 - 2008
AppTec 1997 - 2005
Axios 1995 - 1996
Sterilization Services 1993 - 1995
Skills
Pharmaceutical Industry, GMP, Sop, Analytical Chemistry, GLP, Sterilization, Sterilization Residuals, Packaging Testing, Sterilization...
Education
University of South Carolina-Columbia 1983 — 1985
Course work, Occupational Health / Industrial Hygiene
Jacksonville University 1977 — 1982
Bachelor of Arts (B.A.), Biology, General and Marine Biology
Amgen 2006 - Present
AppTec 2004 - 2006
Bayer 1999 - 2004
Skills
Downstream Purification..., Viral Clearance, Process Characterization, Process Validation, Technology Transfer, Process Scale Up, Chromatography, FDA, GMP, Purification, Biopharmaceuticals, Validation
Education
Washington University in St. Louis 1992 — 1997
Doctor of Philosophy (Ph.D.), Molecular Genetics - Virology
The University of New Mexico 1987 — 1992
Bachelor of Science (B.S.), Biology, General
The University of New Mexico 1987 — 1992
Bachelor's Degree, Chemistry