Therakos, Inc.
Industry: Company
DescriptionHeadquarters: Pennsylvania Founded: 1984 Parent organization: Mallinckrodt
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Therakos, Inc. Employees
Therakos, Inc. March 2015 - Present
BB Solutions, LLC February 2015 - Present
Healthtronics IT Solutions, a division of Endo Pharmaceuticals August 2012 - February 2015
Endo Pharmaceuticals May 2010 - August 2012
Animas Corporation, a Johnson and Johnson Company November 2008 - May 2010
Animas Corporation, a Johnson and Johnson Company November 2006 - November 2008
United BioSource Corporation January 2006 - October 2006
Animas Corporation March 1997 - December 2005
Bryn Mawr College September 1995 - March 1997
Business for Business, Inc. May 1993 - September 1995
Skills
IT Management, Integration, Software Development, Cross-functional Team..., SDLC, Disaster Recovery, Process Improvement, Business Intelligence, Change Management, Sales Operations, Enterprise Software, Strategy, Data Warehousing, Start-ups, System Architecture, IT Infrastructure..., Mergers, Entrepreneurship, Leadership, Data Center, Management, Medical Devices, Project Management, Global IT Operations, Budgets, Quality Assurance, Vendor Management, Analysis, Mergers & Acquisitions, Manufacturing, Product Development, Executive Management, Security, SaaS, Program Management, Project Planning, Innovator, Sales Management, Healthcare, Strategic Planning, Account Management, New Business Development, Business Development, Healthcare Information..., Business Strategy, Due Diligence, Financial Modeling, Valuation, Financial Analysis, Corporate Finance
Education
Bryn Mawr College 1997 — 2005
PhD, Mathematics
Bryn Mawr College 1995 — 1997
MA, Mathematics
Politehnica University of Bucharest 1990 — 1995
MS, Electrical Engineering/Software Engineering
Therakos, Inc. September 2002 - Present
Skills
Medical Devices, FDA, Healthcare, Capital Equipment, Product Launch, Hospitals, CAPA, ISO 13485, TIG Welding, MIG Welding, Arc Welding, Spot Welding, CNC Programming, CNC Manufacturing, CNC Machine, CNC Mill, CNC Turning, SolidWorks, Solid Modeling, Weapons & Tactics..., Weapons Training, Weapons Handling, pistol smithing, Gunsmithing, machinist, Powder Coating, black oxide finishing, diesel Mechanic, Surface Grinding, Polishing, Mechanical Product..., Owner-managed businesses
Education
Bucks County Community College 1994 — 1995
Computer Numerically Controlled (CNC) Machinist Technology/CNC Machinist
laval High Canada 1974 — 1976
Architectural Drafting and Architectural CAD/CADD
Cylinder and Slide Auto matic weapons pistole smithing
Auto matic weapons
Cylinder and Slide Gun Smithing
hand guns
Montreal school of Deisel Motor
Deisel Motor
prism Soild works
Mechanical Drafting and Mechanical Drafting CAD/CADD
Therakos, Inc. October 2012 - Present
Johnson & Johnson (ASP) 2010 - 2012
Johnson & Johnson (ASP) 2005 - 2010
Skills
Surgeons, Operating Room, Capital Equipment, Medical Devices, Disposables, Leadership, New Business Development, Product Launch, Hospitals, Selling, Market Development, Managed Care, Cardiology, Healthcare, Cross-functional Team..., Surgery, Urology, Sales Force Development, Management, Surgical Instruments, Competitive Analysis, Product Development, Sales Operations, Interventional Radiology, Sales Effectiveness, Capital Equipment Sales, ENT, Medical Sales, Pharmaceutical Sales, Hospital Sales, Cath Lab, Healthcare Industry, Orthopedic, Hardware Diagnostics, Medical Imaging, Interventional..., Selling Skills, Commercialization, OB/GYN, Vascular, Gastroenterology, General Surgery, Global Marketing, Spine, FDA, Sales
Education
Central Washington University
Bachelor's Degree, Business Administration and Management, General
Therakos, Inc. December 2013 - Present
Zimmer September 2008 - September 2013
OrthoRx May 2007 - September 2008
The Hockaday School August 2002 - May 2007
Skills
Public Speaking, Radio Broadcasting, Broadcast Television, Ballet, Sports Medicine, Sports Media, Auto Racing, Athletic Training, Durable Medical..., Dance Education, Cheerleading, Sports Nutrition, Sports Injuries, Orthopedic..., Sports Radio, Medical Devices, Management, Orthopedic, Biologics, Sports, Capital Equipment, Neurosurgery, Surgical Device Sales, Medical Sales, Sales Operations, Cartilage, Product Specialists, Market Development, Operating Room Sales, Arthroscopy, Medical Education, Product Launch, joint preservation, Pharmaceutical Sales, General Surgery, Disposables, Neurology, Cardiology, Urology, Orthopedics, Surgeons
Education
California University of Pennsylvania
Master of Science (MS), Health Promotion: Performance Enhancement/Injury Prevention
Texas Woman's University
Bachelor of Science (B.S.), Human Biology
EADD Technologies, LLC 2012 - Present
Therakos, Inc. 2013 - 2014
Water Pik, Inc. 2000 - 2012
GAJE Technologies Inc. 1996 - 2000
Baxter Healthcare Corporation 1986 - 1996
Skills
Product Development, Quality Assurance, Stage-Gate development..., Problem Solving, Root Cause Analysis, New Product Validation, New Product Ideas, Manufacturing, Medical Devices, ISO 13485, Engineering, Systems Engineering, CAD, Regression Analysis, FMEA, Electro-mechanical, Electro-optics, Embedded Systems, FDA, 21 CFR Part 820.30, GMP, Leadership, Program Management, ISO 14971, Business Development, Cross-functional Team..., Management, Quality System, Project Management, Lean Manufacturing, Product Design, Six Sigma, Design for Manufacturing, V&V, Supply Chain, Injection Molding, Product Launch, Quality Management, Continuous Improvement, Design Control, Machine Tools, Operations Management, Process Improvement, Manufacturing..., Process Engineering, SPC, Process Simulation, ISO, Manufacturing..., 5s
Education
The University of Chicago - Booth School of Business
MBA
University of Notre Dame
MSME
Indian Institute of Technology, Delhi
Bachelor's Degree
Therakos March 2013 - Present
US Diabetes Care (LifeScan USA) 2011 - March 2013
Animas Corporation 2008 - 2011
Therakos Inc. 2007 - 2008
Therakos Inc. 2002 - 2007
Therakos Inc. 2000 - 2002
Skills
Embedded Systems, Software Engineering, Medical Devices, ISO 13485, C++, Biomedical Engineering, Software Development, Design Control, C, System Architecture, Testing, FDA, R&D, Matlab, Java, ISO 14971, Product Development, Quality System, Embedded Software, Firmware, CAPA, Product Launch, Agile Project Management, RTOS, Technical Leadership, Software Design, Algorithms, ARM, Visual Basic, Debugging, C#, Multithreading, Cross-functional Team..., Manufacturing, Labview, Simulations, Digital Signal..., FMEA, Process Improvement, Unix, Design for Manufacturing, Linux, Root Cause Analysis, Embedded Linux, V, Engineering Management, Systems Engineering, Project Management, Object Oriented Design, IEC 62304
Education
Penn State University 2006 — 2008
MS in Software Engineering, Software Engineering
Drexel University 1996 — 2000
BS In Computer Engineering, Computer Engineering
Therakos, Inc. September 2014 - Present
Skills
Military Logistics, Operational Planning, Communications Planning, Leadership, Technical Writing, Business, Economics, Microsoft Office, Microsoft Excel, Microsoft Word, Network Administration, Problem Solving, Finance, Program Management, Project Planning, Military Operations, Military, Operations Management, Training, Security Clearance, Team Leadership, Military Experience, Management, DoD
Education
Penn State University 2006 — 2010
Bachelor of Science, Energy, Business and Finance, 3.27
Therakos, Inc. August 2014 - Present
PTV Sciences November 2013 - Present
Seraph LLC 2014 - August 2014
DW Medtech Advisory LLC November 2013 - August 2014
PA Consulting Group August 1997 - November 2013
Moberg Medical 1996 - 1997
PA Consulting Group November 1994 - November 1996
Iolab Corporation 1991 - 1994
Site Microsurgical 1990 - 1994
Air Shields 1989 - 1991
Skills
Class III Medical..., Medical Device Product..., Life Sciences R&D..., Change Management and..., Product Development, Technology Development, Regulatory Strategy, Due Diligence, Pharmaceuticals, Medical Devices, R&D, Life Sciences, Medical Device Product..., Change Management, Technology Transfer, Technology Evaluation, FDA, 21 CFR Part 11, GxP, CAPA, Intellectual Property, Strategy Development, Biomedical Engineering, Cross-functional Team..., Competitive Intelligence, cGMP, Business Strategy, GMP, Quality Systems, Venture Capital, Program Management, ISO 13485, Business Planning, Process Improvement, Lifesciences, Strategy, Pharmaceutical Industry, Start-ups, Quality System, IT Strategy, Commercialization, V&V, Product Launch, Regulatory Affairs, Validation, Process Simulation, Six Sigma, Leadership, Consulting, Management
Education
Drexel University 1985 — 1988
MS, Biomedical Engineering
Drexel University 1977 — 1982
BSEE, Electrical Engineering
Therakos, Inc. 2013 - Present
Endo Pharmaceuticals March 2011 - 2013
Endo Pharmaceuticals 2009 - April 2011
Impax Laboratories 2008 - 2009
AmerisourceBergen 2005 - 2008
AmerisourceBergen 2002 - 2005
AmerisourceBergen 2000 - 2002
CalComp 1997 - 2000
Black & Decker 1995 - 1997
Skills
Forecasting, Budgets, Cross-functional Team..., Financial Analysis, Finance, Process Improvement, Management, Leadership, Pricing, Strategic Planning, Strategy, Sarbanes-Oxley Act, Analysis, Strategic Financial..., Team Leadership, Microsoft Excel, Accounting, SAP, Executive Management, Sales Operations, Change Management, Managerial Finance, P&L Management, Financial Modeling, New Business Development, Program Management, Business Planning, Marketing Strategy, Variance Analysis, Cash Flow, Hyperion Enterprise, Financial Reporting, Mergers & Acquisitions, Project Planning, Business Process..., P&L, Financial Planning, Pharmaceutical Industry, Sales, Sales Management, Business Intelligence, Income Statement, Competitive Analysis, Problem Solving, Prophix
Education
Penn State University 2012 — 2013
Project Risk Management Certificate
Chapman University, The George L. Argyros School of Business and Economics
MBA, Business
Northern Arizona University, College of Business Administration
B.S., Business Administration, Finance
Therakos, Inc. April 2015 - Present
Therakos, Inc. September 2014 - April 2015
Therakos, Inc. October 2013 - September 2014
WuXi AppTec October 2011 - October 2013
Olympus June 2010 - September 2011
Drexel University 2008 - 2008
Skills
Medical Devices, Product Launch, Biomedical Engineering, Healthcare, Biotechnology, FDA, Lifesciences, Validation, GMP, CAPA, Clinical Trials, Commercialization, Regulatory Affairs, Technology Transfer, Quality System, Pharmaceutical Industry, Market Development, Clinical Research, Product Development, Laboratory, Viral Clearance, Cell Therapy, Quality by Design, Biopharmaceuticals, Sop, Drug Development, CRO, Photopheresis, GLP
Education
Lehigh University 2006 — 2010
Bachelors, Bioengineering
University of New South Wales
BioPrecision Group, LLC August 2015 - Present
Theorem Clinical Research January 2014 - July 2015
Oracle 2011 - May 2013
BioClinica May 2010 - December 2010
Bioclinica, Inc. (formerly Phoenix Data Systems) January 2005 - December 2010
Therakos, Inc. 2004 - 2005
Cephalon 2003 - 2004
Discovery Labs 2002 - 2003
Centocor 2000 - 2002
Rhone-Poulenc Rorer (Aventis) 1995 - 2000
Skills
21 CFR Part 11, CTMS, Vendor Management, Clinical Trials, EDC, Sop, Management, Data Management, Databases, Clinical Operations, Clinical Research, Clinical Data Management, Quality Assurance, Oncology, ICH-GCP, Cross-functional Team..., SOP
Education
Harcum College
Sunrise Milk May 2015 - Present
Therakos, Inc. December 2012 - Present
Johnson & Johnson (Threrakos) April 2011 - December 2012
Xcellerex 2007 - 2011
Skills
Validation, Medical Devices, Field Service, R&D, FDA, Design of Experiments, Calibration, Biotechnology, Manufacturing, Bioreactor, Field Service..., Biomedical Engineering, Medical Imaging, Process Engineering, Capital Equipment, Chemical Engineering, GMP, Chromatography, Technology Transfer, V&V, Quality System, Lifesciences, Process Simulation, Fermentation, CAPA, Biopharmaceuticals, Cross-functional Team..., Automation, Hardware Diagnostics, ISO 13485, Process Optimization, Pharmaceutical Industry, Laboratory Automation, Immunoassays, Design Control, Commercialization, Quality Assurance, 21 CFR Part 11, Testing, Engineering, Product Development, Lean Manufacturing, Process Improvement, Root Cause Analysis, Troubleshooting, GLP, SOP, Continuous Improvement, QlikView, QlikView Development
Education
Worcester State University 2009 — 2017
Master of Science (M.S.), Biological and Biomedical Sciences
Lehigh University 2001 — 2005
Bachelor's Degree, Chemical Engineering
Therakos is now a part of Mallinckrodt Pharmaceuticals. May 2014 - Present
Therakos, Inc. June 2013 - Present
Ipsen Biopharmaceuticals, Inc. January 2012 - June 2013
Thorlabs 2011 - 2011
Roche Diagnostics; Roche Molecuar Systems Inc. 2000 - 2011
Roche Diagnostics; Roche Molecuar Systems Inc. 1997 - 2000
Roche Diagnostics; Roche Molecuar Systems Inc. 1994 - 1997
Roche Diagnostics; Roche Molecuar Systems Inc. 1992 - 1994
Roche Diagnostics 1989 - 1992
Van Leer Chocolate 1989 - 1991
Skills
GMP, FDA, Validation, CAPA, Cross-functional Team..., Process Improvement, V&V, Quality Assurance, Change Control, Manufacturing, Pharmaceutical Industry, Supply Chain Management, ISO, Auditing, Medical Devices, Six Sigma, Supply Chain, Technology Transfer, Biotechnology, SAP, GLP, Quality Management, ISO 13485, 21 CFR Part 11, Product Development, Inventory Management, Continuous Improvement, Quality Auditing, Product Launch, Document Management, Regulatory Affairs, GxP, Technical Writing, Production Planning, Lean Manufacturing, HPLC, Operational Excellence, Vendor Management, Forecasting, LIMS, Biopharmaceuticals, Materials Management, Operations Management, SOP, Quality Systems, cGMP, Life Sciences, Pharmaceuticals, Process Validation, Diagnostics
Education
Rutgers, The State University of New Jersey-Newark 2006 — 2006
MBA (mini)
University of Medicine and Dentistry of New Jersey -New Jersey Medical School 1988 — 1989
Rutgers, The State University of New Jersey-Newark 1984 — 1988
BA, Biology, Chemistry, Pre-med, GPA 3.9/4.0; Major 4.0/4.0
Therakos, Inc. October 2014 - Present
Medical Device Company November 2012 - October 2014
Animas Corporation, a Johnson & Johnson Company January 2011 - November 2012
Animas Corporation, a Johnson & Johnson Company January 2009 - December 2010
Animas Corporation, a Johnson & Johnson Company February 2006 - December 2008
Animas Corporation, a Publicly Traded Company December 2004 - February 2006
Animas Corporation, a Privately Funded Company July 2000 - November 2004
Kulicke & Soffa Industries, Inc. 1999 - 2000
Porter Instrument, efector, Ethicon J&J Company, Westinghouse 1985 - 1999
Skills
Medical Devices, Operational Excellence, Lean Manufacturing, Supply Chain, Process Improvement, Cross-functional Team..., Business Planning, Manufacturing, FDA, ISO 13485, Management, Product Development, GMP, Change Management, Continuous Improvement, Quality System, Strategy, ISO, Project Management, Forecasting, Software Documentation, Root Cause Analysis, Design Control, Supply Chain Management, Operations Management, Strategic Planning, Six Sigma, Purchasing, Leadership, Product Launch, ERP, Quality Assurance, Start-ups, Logistics, Project Planning, MRP
Education
La Salle University 1990 — 1994
MBA, Management
Therakos, Inc. February 2015 - Present
Therakos, Johnson & Johnson December 2008 - Present
Insys Therapeutics January 2008 - December 2008
Astellas Pharma 2005 - 2008
Prodentec 2001 - 2003
Skills
Oncology, Apheresis, Dermatology, Capital Equipment, Medical Devices, Contract Management, Cold Calling, Selling Skills
Education
University of Illinois at Urbana-Champaign
Bachelor’s Degree
Microsoft June 2011 - Present
Johnson & Johnson September 2005 - June 2011
Janssen Pharmaceutica January 1997 - September 2005
THERAKOS Inc. July 1994 - January 1997
Johnson & Johnson September 1990 - July 1994
First Fidelity Bank Corporation May 1989 - August 1990
Ohio Student Loan Commission February 1988 - May 1989
Education
Stevens Institute of Technology 2006 — 2008
Masters - With Honors, Computer Science, 3.94 GPA Dean's List
Ohio Institute of Technology 1985 — 1988
Bachelors - with honors, Computer Science, 3.5 - Dean's List
Therakos, Inc. November 2014 - Present
Exelon (via TEKSystems) March 2014 - October 2014
Sam's Club July 2012 - October 2014
Valley Forge Casino Resort April 2013 - October 2013
Calspan Corporation March 2011 - March 2012
The Drainage Solution Company February 2009 - February 2011
Qimonda North America 2007 - 2009
Radio Shack 2001 - 2007
Skills
Customer Service, Troubleshooting, Windows, Microsoft Office, Electronics, Windows 7, Technical Support, Reliability, Data Analysis, Network Administration, Active Directory, Computers, Windows Server, Windows XP, Hardware, Operating Systems, Networking
Education
DeVry University-Pennsylvania 2012 — 2013
Network Systems Administration, Computer Science, 3.06 (3.61 for onsite classes)
Eastern University 2001 — 2002
N/A, General study
Ortho Clinical Diagnostics December 2013 - Present
Therakos, Inc. 2012 - 2013
Johnson & Johnson 2003 - 2012
Xerox 1999 - 2003
United States Postal Service 1991 - 2001
Monroe Community College 1981 - 1991
James E. Sperry High School 1988 - 1988
Skills
Medical Devices, ISO 13485, Design Control, FDA, Design of Experiments, Six Sigma, R&D, V&V, Validation, FMEA, Quality System, Root Cause Analysis, DMAIC, Lean Manufacturing, CAPA, Quality Engineering..., Good Manufacturing..., Biology for Engineering, Anatomy & Physiology, Theories of Software..., ISTQB Certified..., Association for..., Software Quality..., Engineering Excellence, CMM, SPI, Lean Fundamentals, SharePoint, Visio, Serena Business Mashups..., MS Project, Photoshop, Publisher, Java, Beyond Compare, MS Excel Pivot Tables, Minitab
Education
Rochester Institute of Technology
Master of Science Program, Information Technology Project Management, GPA 3.0
SUNY Brockport
Master of Science Program, Secondary Science Education, GPA 3.7
SUNY Oswego
Bachelor of Science Degree, Meteorology and Astronomy, GPA 3.5
Monroe Community College
Associate of Science Degree, Mathematics & Natural Science, GPA 3.8
James E. Sperry High School
New York State Regents Diploma, NYS Regents, Honors and Advanced Placement Curriculum, 85th Percentile
Bristol-Myers Squibb December 2014 - Present
Therakos, Inc. January 2014 - November 2014
Pfizer January 2006 - December 2013
Pfizer January 2005 - November 2005
Roche 2003 - 2004
Pfizer (Formerly Wyeth) 2001 - 2003
Merck 2000 - 2001
Skills
Validation, FDA, CAPA, Sop, V&V, Quality Assurance, Change Control, Pharmaceutical Industry, Computer System..., Quality Control, Biotechnology, Aseptic Processing, Regulatory Affairs, LIMS, 21 CFR Part 11, Chromatography, GAMP, Quality Management, GLP, Cross-functional Team..., GxP, Biopharmaceuticals, HPLC, Quality System, Cleaning Validation, Technology Transfer, Regulatory Requirements, Analytical Chemistry, Regulatory Submissions, Trackwise, 21 CFR Part 210 & 211, Pharmaceutics, Software Documentation, Vaccines, Quality Auditing, UV/Vis, USP, Deviations, SOP, TrackWise
Education
Kean University
B.S., Chemistry
Odessa Technologies, Inc. October 2013 - Present
Therakos, Inc. November 2012 - June 2013
Temple University August 2011 - August 2012
Animas Corporation, a Johnson & Johnson Company November 2009 - August 2011
Animas Corporation - Johnson & Johnson November 2006 - November 2009
Johnson & Johnson June 2005 - June 2007
Skills
Green Belt, SAS, Forecasting, Project Management, Project Planning, MS Project, MS Excel Pivot Tables, Business Process..., Business Analysis, Data Analysis, Medical Devices, Cross-functional Team..., Six Sigma, Process Improvement, FDA, Pharmaceutical Industry, Product Development, Business Intelligence, Change Management, Strategic Planning, Training, Marketing, Team Leadership, Strategy, Program Management, Vendor Management, Leadership, Business Strategy, Strategic Partnerships, E-commerce, IT Management, Quality Assurance
Education
Temple University - Fox School of Business and Management 2011 — 2012
IMBA, International Business
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2005
B.S., Biomedical Engineering
Therakos, Inc. May 2014 - Present
Sanofi (contractor) September 2013 - February 2014
NPS Pharmaceuticals (contractor) March 2013 - August 2013
LifeCell Corporation December 2009 - February 2013
LifeCell Corporation October 2007 - December 2009
Enzon Pharmaceuticals December 2003 - June 2007
Medarex October 2001 - October 2003
Celgene 1998 - 2001
Skills
CAPA, Quality Auditing, FDA, Quality System, Quality Assurance, Sop, ISO 13485, Change Control, 21 CFR Part 11, GLP, V&V, FDA GMP, Regulatory Requirements, GMP, 21 CFR, Cleaning Validation, GDP, Validation, Trackwise, Design Control, ISO 14971, Computer System..., Sterilization, Medical Devices, Biopharmaceuticals, Batch Records, Quality Management, GxP, CQA, HPLC, Document Management, GCP, Regulatory Affairs, Complaint Management, Quality Control, Iso 9000, Aseptic Processing, Complaint Investigations, MDRs, Vigilance, SOP, TrackWise
Education
State University of New York College at Oswego 1986 — 1990
Bachelor's Degree, Biology
Therakos, Inc. July 2014 - Present
Performance Development Group March 2014 - April 2014
Proconex May 2013 - March 2014
GlaxoSmithKline January 2011 - April 2013
Almac Group November 2010 - December 2010
Octagon Research Solutions July 2007 - October 2008
ACE Group June 2004 - July 2007
Aventis Behring January 2002 - June 2004
Skills
Microsoft Excel, Outlook, Customer Service, Software Documentation, Microsoft Word, Microsoft Office 2010, Microsoft Power Point, Administrator of the..., Administrator of the..., Certified Training..., Access for PeopleSoft, Lotus Notes customized..., SharePoint Internet..., Siebel, Adobe Acrobat 8..., Management, Time Management, Training, Project Planning, Adobe Acrobat, Project Management, Team Building, PowerPoint, FLEx, NOMIS, Metastorm BPM (Phoenix), Alliance, Microsoft Office, Office 2010, Flex, Analysis, GMP, Budgets, Validation, Leadership
Education
Villanova University 2014 — 2015
Certified Associate Project Manager, Project Management
Immaculata University 2003 — 2005
BA, Magna Cum Laude, Human Performance Management
The Chubb Institute 1998 — 1999
Data & Networking Certification
Main Line Paralegal 1996 — 1996
Paralegal Certificaiton, Legal Education
Therakos, Inc. March 2014 - Present
Stoltz Management of DE, Inc. January 2008 - March 2014
VWR June 2005 - December 2007
Skills
Active Directory, Budgets, Security, Troubleshooting, Windows, Management, Employee Management, Project Management, Department Budgeting, Telecommunications..., Vendor Management, Vendor Relationships, Contract Negotiation, Contract Management, Desktop Support..., Asset Management, Help Desk Support, Network Administration, LAN-WAN, VMware ESX, Hyper-V, Cloud Computing, Cloud Applications, Terminal Services, Office 365, Firewalls, VPN, Blackberry Enterprise..., Mobile Device Management, Microsoft Office, Windows Server, Sophos, SAN, IIS, SSL Certificates, IP PBX, Fibre, T1s, POTS, Microsoft Exchange, WAN, Account Management, Customer Service
Education
Capella University 2015 — 2019
Bachelor’s Degree, Information Technology Project Management
Cittone Institute 2001 — 2002
Microsoft Certified Engineer/Administrator (W2K)
Coatesville Area Senior High School 1996 — 1999
Diploma
Therakos, Inc. December 2013 - Present
Skills
Insurance, Microsoft Excel, PowerPoint, Microsoft Word, Data Analysis, Risk Management, Outlook
Education
Akademia Medyczna im. Prof. Feliksa Skubiszewskiego w Lublinie
Doctor of Medicine (M.D.)
Temple University - Fox School of Business and Management
Bachelor’s Degree, Healthcare Risk Management and Insurance
Indivior June 2014 - Present
PureStat Consulting Inc. December 2013 - May 2014
Salix Pharmaceuticals January 2013 - November 2013
Aeras Global TB Foundation November 2011 - October 2012
Merck Research Labs July 2006 - November 2011
Therakos, inc June 2004 - June 2006
Novartis Corp February 2002 - May 2004
Fujisawa Healthcare Inc. September 1998 - February 2002
Skills
Statistics
Education
Temple University - Fox School of Business and Management 1987 — 1991
Doctor of Philosophy (Ph.D.), Statistics
GSK March 2015 - Present
Therakos, Inc. September 2014 - December 2014
Olympus April 2014 - September 2014
McNeil Consumer Healthcare July 2011 - March 2014
BD Diagnostics (Becton-Dickinson) April 2004 - July 2011
Johnson & Johnson 2011 - 2011
Wyeth October 1995 - December 2003
Skills
Quality System, Training, FDA, CAPA, Medical Devices, Quality Auditing, Quality Assurance, GMP, 21 CFR Part 11, ISO 13485, Pharmaceutical Industry, V&V, GCP, RCA, 21 CFR Part 210/211, Root Cause Analysis, Six Sigma
Education
Pennsylvania State University-Penn State Mont Alto
none, Human Biology
Shippensburg University of Pennsylvania
BS, Biology
Therakos, Inc. July 2015 - Present
University of Pennsylvania October 2012 - November 2014
Georgia Institute of Technology October 2010 - October 2012
Temple University October 2009 - September 2010
Temple University June 2009 - August 2009
Skills
Microsoft Excel, Regulatory Compliance, ICH-GCP, Research, Data Management, ENOVIA LCA, Oracle Agile PLM, HIPAA, Quality Control, Literature Reviews, Writing, Microsoft Office, Data Analysis, Change Management, ICH Guidelines, cGMP practices, cGMP manufacturing, Proofreading, Project Management, Document Management, Formal Logic, Epic Systems, Fact-checking, Editing, APA Style, Adobe Acrobat, Illustrator, Human Subjects Research, Photoshop, Copy Editing, Research Design, InDesign, Creative Writing, SPSS, E-Prime, Chicago Manual of Style, Social Media, Philosophy Of Science, Critical Thinking, Visual Arts, Research Ethics
Education
University of Pennsylvania 2012 — 2014
Post-Baccalaureate Studies, Writing
Temple University 2006 — 2010
Bachelor’s Degree, Philosophy, Cognitive Neuroscience
University of East Anglia 2006 — 2009
Philosophy
Methacton High School 2002 — 2006
Diploma
University of The Arts 2005 — 2005
Pre-College Program, Creative Writing
Montgomery County Community College 2004 — 2004
Figure Drawing
Vital Therapies, Inc. May 2015 - Present
Therakos, Inc. December 2014 - May 2015
Vital Therapies, Inc. March 2013 - December 2014
University of Colorado Health 2012 - 2013
HealthONE 2010 - 2013
Denver Water 2010 - 2012
Alliance Beverage 2006 - 2007
Skills
Healthcare, Clinical Research, Oncology, Nursing, Clinical Trials, Hospitals, FDA, Training, Biotechnology, Life Sciences, Patient Education, Patient Safety, Health Education, BLS, Medical Devices, Oncology Nursing, Occupational Health, Bone Marrow..., Patient Advocacy, clinical marketing, Product Marketing, Marketing Event Planning, Hepatology, Liver Disease
Education
Regis University 2009 — 2010
Bachelor's Degree, Nursing
University of Arizona 2002 — 2006
Bachelor's Degree, Sociology
Light Age, Inc. June 2015 - Present
Therakos, Inc. October 2013 - May 2015
Sanofi September 2013 - October 2013
Musculoskeletal Transplant Foundation September 2004 - September 2013
East Orange General Hospital July 2000 - August 2004
Skills
FDA, Medical Devices, Validation, Quality Assurance, Process Improvement, ISO 13485, Cross-functional Team..., Root Cause Analysis, Six Sigma, Project Management, Microsoft Office, Orthopedic, CAPA, Lean Manufacturing, Product Development, Healthcare, ASQ-Certified Quality..., Auditor/Lead Auditor..., Certified Tissue Bank..., Change Management, Risk Management, Surgery, ISO 14971, 21 CFR Part 820, 21 CFR Part 1271, SOR/98-282, Risk Assessment, 21 CFR Part 803, Pharmacovigilance, 21 CFR Part 11, Statistical Data..., Minitab, Quality System, Quality Control, GMP, Quality Management, Orthopedics
Education
Centenary College
Master of Business Administration (MBA), Business Administration and Management, General
New Jersey City University
Bachelor of Science (BS), Biology, General
Johnson & Johnson Diabetes Solutions January 2015 - Present
DepuySynthes Trauma October 2013 - January 2015
Animas Corp 2010 - 2013
Animas Corp 2007 - 2010
Ortho Clinical Diagnostics 2006 - 2007
Therakos, Inc. May 2005 - 2007
Skills
Medical Devices, Product Development, Biotechnology, Cross-functional Team..., Design Control, Engineering, Process Improvement, Biomedical Engineering, Data Analysis, CAPA, FDA, Validation, Pharmaceutical Industry, Matlab, R&D, GMP, Design of Experiments, Quality System, Minitab, Six Sigma, Manufacturing, Strategy, Quality Assurance, Leadership, Management, V&V, Lean Manufacturing, Clinical Trials, ISO 13485, Strategic Planning, Lifesciences, Project Management, Technology Transfer, Commercialization, Product Launch, Process Simulation, Sop, Regulatory Affairs, Process Engineering, Regulatory Submissions, 21 CFR Part 11, Drug Delivery, Hardware Diagnostics, FMEA, Oncology, Quality Control, Market Development, Biopharmaceuticals
Education
Villanova University 2008 — 2012
MBA, Marketing
The Johns Hopkins University 2001 — 2005
BS, Chemical and Biomolecular Engineering
Riggs Distler Company October 2015 - Present
Therakos, Inc. July 2014 - October 2015
University of Pittsburgh August 2009 - July 2014
Volvo Construction Equipment August 2012 - August 2013
Skills
Industrial Engineering, Lean Manufacturing, Six Sigma, Continuous Improvement, Value Stream Mapping, Kaizen, 5S, Supply Chain Management, Solidworks, Manufacturing, Minitab, Engineering, FMEA, Supply Chain, Matlab, Root Cause Analysis, Manufacturing..., Microsoft Excel, PowerPoint, Microsoft Word
Education
University of Pittsburgh 2009 — 2014
Bachelor's degree, Industrial Engineering
Johnson & Johnson June 2010 - Present
THERAKOS INC September 2006 - June 2010
Johnson & Johnson November 2005 - September 2006
Johnson & Johnson July 2004 - November 2005
Exton PA July 2001 - July 2004
HCI DIRECT, INC April 2000 - July 2001
Data Center November 1999 - April 2000
Data Center April 1999 - November 1999
Skills
Customer Relations, Process Engineering, Budgeting, Vendor Management, Process Improvement, Management, Budgets, Reviews, Customer Service, Software Documentation, Leadership, Business Process, IT Management, Project Management, Program Management
Education
Eastern University 2006 — 2008
BA, MIS
Delaware Valley University
CHI Institute
Therakos, Inc. August 2015 - Present
Terumo Cardiovascular Systems June 2008 - Present
Skills
Solidworks, Microsoft Office, Injection Molding, Master Molder I, Six Sigma Green Belt, CMM, Process Validation, Machine Design, Design Control, V&V, ISO 13485, Design of Experiments, FDA, Six Sigma, Biomedical Engineering, Minitab, Medical Devices, Validation, Quality System, Design for Manufacturing
Education
University of Maryland College Park 2011 — 2014
Master's Degree, Bioengineering and Biomedical Engineering
University of Delaware 2004 — 2008
BME, Mechanical Engineering, Biomedical Engineering, Mathematical Sciences
Therakos, Inc. September 2013 - Present
ITT Technical Institute September 2006 - September 2014
Medical Components, Inc. September 2008 - September 2013
THERAKOS A Johnson & Johnson Company April 2008 - September 2008
Alcoa - Flexible Packaging Division January 2006 - April 2008
Orthovita Inc August 2003 - July 2005
Unisys June 2001 - March 2003
Unisys May 2000 - June 2001
Skills
Solidworks, Injection Molding, AutoCAD, Six Sigma, Medical Devices, Design of Experiments, Pro Engineer, Manufacturing, Minitab, R&D, CAD, Process Engineering, Product Development, Engineering Management, Finite Element Analysis, Lean Manufacturing, MS Project, Project Engineering, Process Improvement, Process Capability, Engineering, FDA, Design Control, PTC Creo, Quality Control, Mechanical Engineering, Plastics, Testing, Moldflow, Syringe Filling, Plant Engineering, Plastic Part Design, Extrusion, Automation, Programmable Logic, CNC, PLC, Quality Engineering, Hydraulics, GD&T
Education
Penn State University
Master's Degree, Systems Engineering, 3.4/4.0
Temple University
Bachelor of Engineering (BEng), Mechanical Engineering & Technology
Montgomery County Community College
Associate of Science (AS), Computer & Electrical Engineering Technology
Upper Merion High School
High School, General Studies
Therakos, Inc. July 2010 - Present
Janssen-Ortho July 2000 - July 2010
Dana Corporation August 1990 - January 1998
Skills
Managed Care, Pharmaceutical Sales, Gastroenterology, Hospitals, Urology, Pharmaceutical Industry, Medical Devices, Oncology, Account Management, Sales Management, Healthcare, Strategic Planning
Education
The Ohio State University 1985 — 1990
BSBA, Finance
St. John's Jesuit 1981 — 1985
Braeburn Pharmaceuticals September 2015 - Present
HITLAB Healthcare Innovation Lab August 2015 - Present
Trevena, Inc March 2015 - August 2015
Therakos, Inc. October 2013 - March 2015
Shire Pharmaceuticals June 2011 - October 2013
Cephalon, Inc. May 2008 - June 2011
Infusion Pharma Consulting LLC 2004 - 2008
Fairfield Medical Center 2004 - 2008
Education
Columbia University College of Physicians and Surgeons 1995 — 2002
MD,PhD, medicine, neuroscience
University of Pittsburgh 1992 — 1995
BA,BS, neuroscience, math, French
Therakos, Inc. March 2011 - Present
Skills
Management, Microsoft Word, Research, Microsoft Excel, Microsoft Office
Education
Georgian Court University 1995 — 1999
Bachelors in Science
Therakos, Inc. December 2014 - Present
Phase 2 Medical Manufacturing, Inc. 2010 - 2014
Cytonome June 2009 - September 2010
DxTech October 2007 - May 2009
DxTech October 2007 - August 2008
Haemonetics May 2005 - October 2007
Transfusion Technologies 1997 - 2000
Skills
Design Control, Medical Devices, ISO 13485, R&D, FDA, Design for Manufacturing, V&V, Quality System, Manufacturing, Manufacturing..., Product Development, Injection Molding, Engineering, FMEA, Plastics, Validation, Minitab, CAPA, DMAIC, Design of Experiments, Lean Manufacturing, Manufacturing..., Biomedical Engineering, ISO 14971, Product Design, Six Sigma, SPC, Continuous Improvement, Root Cause Analysis, Solidworks, Cross-functional Team..., Machining, Kaizen, ISO, Molding
Education
University of Massachusetts Lowell 2000 — 2004
Plastics Engineering
CooperVision January 2015 - Present
Therakos, Inc. August 2014 - January 2015
Therakos, Inc. June 2013 - August 2014
Johnson and Johnson - Ortho Clinical Diagnostics September 2010 - June 2013
Harris Corporation June 2009 - August 2010
Johnson & Johnson June 2007 - May 2009
Skills
Packaging Engineering, Design of Experiments, Design Control, Packaging, ISO 13485, CAPA, DMAIC, Root Cause Analysis, Validation, Manufacturing
Education
Rochester Institute of Technology 2007 — 2010
MS, Packaging Science
Rochester Institute of Technology 2003 — 2007
BS, Graphic Media Marketing
Therakos, Inc. June 2013 - Present
CSL Behring November 2012 - June 2013
CSL Behring July 2010 - October 2012
CSL Behring 2006 - July 2010
Therakos, Inc. 2004 - 2006
CSL Behring 2001 - 2004
University of Pennsylvania 1998 - 2001
University of Pennsylvania 1998 - 2001
Freie Universität Berlin 1995 - 1998
National Institutes of Health/ NCI 1992 - 1995
Skills
Clinical Trials, Clinical Development, Immunology, Infectious Diseases, Clinical Research, Vaccines, Therapeutic Areas, Medical Affairs, FDA, Medicine, Clinical Operations, Pharmaceutical Industry, Drug Development, Regulatory Affairs, Pharmacovigilance, Lifesciences, Neurology, Regulatory Submissions, IND, Biotechnology, GCP, Protocol, Medical Writing, Oncology, Cancer, Medical Devices, CRO, Biopharmaceuticals, R&D, Healthcare
Education
Freie Universität Berlin 1985 — 1991
MD, PhD, cellular immunology, infectious diseases
Therakos, Inc. May 2015 - Present
Globus Medical December 2011 - April 2015
Biomerix January 2006 - December 2011
FDA 1993 - 1999
Skills
Medical Devices, Design Control, ISO 13485
Education
The Catholic University of America 1988 — 1992
BBE, Biomedical Engineering
Therakos, Inc. October 2014 - Present
Therakos, Inc. March 2013 - October 2014
Therakos, Inc & Veridex, LLC, J&J Family of Companies September 2012 - March 2013
Cellular Technologies (Therakos, Inc and Veridex, LLC), J&J Family of Companies September 2010 - October 2012
Cordis December 2007 - October 2010
DePuy Spine February 2007 - November 2007
Codman April 2004 - January 2007
Skills
Business Planning, Management, Analytics, Financial Modeling, Medical Devices, Sarbanes-Oxley Act, Strategy, Financial Reporting, CRM, Sales Operations, Forecasting, Strategic Planning, Pricing, Finance, Sales, Process Improvement, Competitive Analysis, Cross-functional Team..., Business Analytics, Product Launch, Financial Analysis
Education
Rutgers, The State University of New Jersey-New Brunswick 1993 — 1997
BS, Accounting
Therakos, Inc. October 2014 - Present
Therakos, Inc. August 2012 - October 2014
Therakos Inc, a Johnson & Johnson Company June 2011 - August 2012
Therakos Inc, a Johnson & Johnson Company December 2009 - May 2011
Veridex February 2007 - November 2009
Veridex November 2005 - January 2007
Kelly Services September 2004 - October 2005
Skills
Oncology, FDA, Pharmaceutical Industry, Clinical Research, Medical Devices, Lifesciences, Regulatory Affairs, Healthcare, Clinical Trials, Clinical Monitoring
Education
Oberlin College 2000 — 2004
Bachelor of Arts (B.A.), Biology/Biological Sciences, General
SAFARI Montage 2015 - Present
Therakos, Inc. 2013 - 2015
Urban Engineers, Inc. 2010 - 2013
Urban Engineers, Inc. 2007 - 2010
NELSON 2006 - 2007
EDS (Formerly Towers Perrin) 2001 - 2006
Community Options, Inc. 2000 - 2001
Skills
HRIS, Employee Relations, Performance Management, Benefits Administration, Recruiting, Onboarding, HR Policies, Employee Engagement, Job Descriptions, Human Resources, Interviews, Employee Benefits, Payroll, ADP Payroll, Employment Law, Deferred Compensation
Education
Saint Joseph's University - Erivan K. Haub School of Business 2004 — 2007
MSHR, Human Resources Management
The College of New Jersey 1996 — 2001
Bachelors, Business Management/HR
Intuity Medical July 2015 - Present
Intuity Medical April 2014 - Present
Intuity Medical June 2009 - April 2014
LifeScan Inc August 2007 - June 2009
Johnson & Johnson 2005 - 2009
ALZA Corporation January 2007 - August 2007
Therakos, INC. May 2006 - January 2007
LifeScan June 2005 - May 2006
Guidant May 2004 - August 2004
Education
University of California, Berkeley 2001 — 2005
B.S.
Bayer January 2015 - Present
Therakos, Inc. June 2013 - November 2014
Therakos, Inc. January 2013 - May 2013
Therakos Inc, part Johnson & Johnson Family of Companies June 2010 - December 2012
Johnson & Johnson January 2008 - May 2010
Johnson & Johnson February 2005 - December 2007
Johns Hopkins University, Baltimore, MD August 1999 - February 2005
Central Drug Research Institute, India November 1993 - December 1997
Skills
Oncology, Regulatory Affairs, Medical Devices, Pharmaceutical Industry, Biomarkers, Assay Development, DNA, FDA, Vaccines, Medical Affairs, Cross-functional Team..., Regulatory Submissions, Clinical Development, Validation, Lifesciences, Life Sciences
Education
University of Allahabad 1989 — 1993
PhD, Biochemistry
Therakos, Inc. December 2014 - Present
DSM June 2001 - December 2014
Newport Corporation August 2000 - November 2000
Spectronic Unicam March 2000 - June 2000
Warner Lambert September 1999 - November 1999
York Casket Company June 1998 - November 1998
Silgan Plastics June 1997 - September 1997
Skills
Six Sigma, Injection Molding, Project Management, Extrusion, Medical Devices, Manufacturing, Management, Lean Manufacturing, Biomedical Engineering, Biomaterials, Continuous Improvement, ISO 13485, Engineering, Polymers, Cross-functional Team..., Process Engineering, Design Control, Characterization, Manufacturing..., FDA, Process Improvement, Manufacturing..., Laboratory, Design of Experiments, Automation, Design for Manufacturing
Education
Villanova University 2003 — 2009
Masters, Business Administration
Rochester Institute of Technology 1996 — 2001
BS, Mechanical Engineering
Clinical Trial Consultants, LTD 2002 - Present
Protarga Incorporated October 2001 - April 2002
DuPont Pharmaceuticals 1998 - 2001
IBRD-Rostrum Global, Inc. 1996 - 1998
Sanofi-Winthrop 1990 - 1996
Therakos, Inc. 1980 - 1990
Nursing Positions 1975 - 1980
Skills
CTMS, Clinical Trials, Clinical Research, Infectious Diseases, CRO, Oncology, Clinical Development, Pharmaceutical Industry, Protocol, Neurology, IND, Clinical Operations, Phase I, Cardiology, GCP, Drug Development
Education
Gwynedd Mercy University 1980 — 1988
BSN
Reading Hospital School of Nursing 1972 — 1975
diploma, nursing
Blue Mountain High School 1968 — 1972
Gwynedd Mercy University
BSN, Nursing
Therakos, Inc. May 2013 - Present
Parker Labs May 2012 - May 2013
International Technidyne Corporation October 2011 - May 2012
Johnson & Johnson September 2010 - October 2011
Mindray DS, USA December 2003 - July 2009
Telcordia Technologies April 2000 - December 2002
Warner Lambert Tech Docs Project January 1999 - July 1999
Skills
Quality Assurance, FDA, Computer System..., CAPA, Cross-functional Team..., Quality System, Validation, ISO 13485, V&V, GMP, Software Documentation, Design Control, ISO, Medical Devices, ISO 14971, Process Improvement, Quality Auditing, Quality Control, Quality Management, Sop, Testing
Education
Stevens Institute of Technology 1994 — 2000
Masters, Electrical Engineering; Telecommunications
Stevens Institute of Technology 1994 — 1998
Bachelors, Mathematics
Therakos, Inc. October 2014 - Present
Therakos, Inc. January 2013 - October 2014
Johnson & Johnson February 2008 - December 2012
Johnson & Johnson July 2007 - February 2008
JP Stevens High School September 2004 - June 2007
Johnson & Johnson February 1994 - June 1997
Johnson & Johnson January 1985 - October 1992
Skills
Capital Equipment, Medical Devices, Market Development, Managed Care, Product Launch, Oncology, Pharmaceutical Sales, Cardiology, Sales Effectiveness, Pharmaceutical Industry, Global Marketing, Hospitals, FDA
Education
Kean University 2000 — 2003
Psychology
Rutgers Graduate Business School 1990 — 1993
MBA
Kean College 1982 — 1986
Management Science
Therakos, Inc. October 2014 - Present
Therakos, Inc. July 2013 - September 2014
Therakos, Inc. February 2013 - June 2013
Therakos, Johnson & Johnson June 2008 - January 2013
Advanced Sterilization Products (a Division of Johnson & Johnson) July 2007 - May 2008
Advanced Sterilization Products (a Division of Johnson & Johnson) January 2004 - June 2007
Advanced Sterilization Products (a Division of Johnson & Johnson) January 2002 - December 2003
Advanced Sterilization Products (a Division of Johnson & Johnson) December 2000 - December 2001
Advanced Sterilization Products (a Division of Johnson & Johnson) July 1999 - November 2000
Advanced Sterilization Products (a Division of Johnson & Johnson) March 1998 - June 1999
Skills
Managed Care, Consultative Selling, Capital Equipment, Contract Negotiations, Hospitals, Sales Management, Healthcare, Strategic Planning, Medical Devices, Management, Sales, Pharmaceutical Industry, Account Management, Market Development, Selling, Cross-functional Team..., Sales Effectiveness, Contract Negotiation, Product Launch, Leadership, Surgeons, Sales Operations, Operating Room, Cardiology, Sales Process, Cell, Disposables, Sales Presentations, Cold Calling, Urology, Pharmaceutical Sales, Sales Force Development, Surgical Instruments
Education
The University of Dallas 1990 — 1991
MBA, Management
Colorado State University 1985 — 1989
B.A., Economics
Eastman Kodak Company September 2015 - Present
Harris RF Communications December 2013 - September 2015
Lumetrics September 2013 - November 2013
Therakos, Inc. December 2012 - August 2013
Ortho Clinical Diagnostics December 2007 - December 2012
NexPress 1998 - 2007
Kodak 1991 - 1998
Skills
C++, Embedded Systems, Visual Studio, .NET, C#, Embedded Software, Object Oriented Design, Software Development, Software Engineering, Algorithms, C, System Architecture, Agile Methodologies, Testing, Cross-functional Team...
Education
Michigan State University 1983 — 1988
Bachelor of Science (BS), Systems Science
Therakos, Inc. September 2014 - Present
UCB Pharma February 2009 - September 2014
Premiere Oncology of Arizona November 2007 - February 2009
Skills
Rheumatology, Medical Affairs, Immunology, Clinical Development, Gastroenterology, Clinical Trials, Therapeutic Areas, Neurology, Oncology, Pharmaceutical Industry, Endocrinology, Medical Writing, Infectious Diseases, Nephrology, Diabetes, Cardiology, Rheumatoid Arthritis, Pharmacology, GCP, CTMS, Clinical Research
Education
University of Minnesota-Twin Cities 2001 — 2006
Ph.D., Pharmacology
Iowa State University 1997 — 2000
BS, Nutritional Science
Therakos, Inc. November 2014 - Present
Therakos, Inc. November 2013 - November 2014
Therakos, Inc. December 2012 - November 2013
Ortho Clinical Diagnostics June 2011 - December 2012
Therakos January 2009 - June 2011
Ortho Clinical Diagnostics April 2007 - January 2009
Ortho Clinical Diagnostics June 2006 - April 2007
McNeil Consumer Healthcare 2003 - 2003
Skills
Six Sigma, Medical Devices, Lean Manufacturing, Supply Chain Management, Supply Chain, Project Management, S&OP implementation, Inventory Management, Procurement, ERP Implementations, Cross-functional Team..., MRP, Supply Chain..., Supply Management, Continuous Improvement, DMAIC, Demand Planning, Quality System, Strategic Sourcing, Value Stream Mapping, Kaizen
Education
Lehigh University 2007 — 2010
Master of Business Administration (MBA), Supply Chain Management
Drexel University - College of Business and Administration 1999 — 2004
Bachelor of Science (BS), Commerce and Engineering (Operations Management)
Therakos, Inc. August 2014 - Present
TenCate Enbi September 2010 - August 2014
Bausch & Lomb September 2007 - September 2010
NexPress/Kodak 1998 - 2008
Eastman Kodak 1997 - 2007
Kodak 1997 - 2007
Skills
Imaging Science, Surface, Product Development, Root Cause Analysis, Statistics, Thin Films, Optics, Reliability, Image Processing, Materials Science, Six Sigma, JMP, Inkjet, FMEA, Design of Experiments, Matlab, Labview, Commercialization, Surface Chemistry, Polymer Chemistry, Nanotechnology
Education
Saint John Fisher College 1992 — 1996
Rochester Institute of Technology
Aurora SFC Systems Co. December 2008 - April 2010
TA Instruments Inc February 2006 - October 2008
Seimens Medical Systems December 2004 - February 2006
Therakos, Inc December 2002 - December 2004
Binney & Smith January 2001 - December 2002
Ethicon Endo-Surgery May 1998 - August 1999
Skills
Manufacturing, SolidWorks, Geometric Dimensioning..., Mechanical Engineering, Pro Engineer, Continuous Improvement, Product Development, Solidworks, R&D, Sheet Metal, CAD, NX Unigraphics, Design Engineering, Machine Tools
Education
BSMET, University of Dayton
Franklin University 1976 — 1979
ASME, Mechanical Engineering technology
Flink Learning December 2013 - Present
IMPACT ESC LLC January 1998 - Present
The American Education Corporation January 1993 - January 1998
Birtcher Medical Systems February 1989 - January 1993
Therakos Inc May 1987 - February 1989
Ortho Clinical Diagnostics May 1982 - May 1985
Skills
E-Learning, Educational Technology, Leadership Development, Team Building, Blended Learning, Instructional Design, Coaching, Staff Development, Teaching, Web 2.0, Technical Writing, Teachers, Strategic Planning, Higher Education, Public Speaking, Entrepreneurship, Entrepreneur, Training, Project Management, Sales, Learning Management..., Learning Management, Strategy, Sales Operations, Leadership, Instructional Technology, Start-ups, Sales Process, Distance Learning, Adult Education, Technology Integration, Strategic Partnerships, Marketing, Teacher Training, Publishing, Content Development, Curriculum Development, Educational Leadership, Curriculum Design, K-12
Education
University of Colorado Boulder 1981 — 1984
BS, Molecular Biology
University of Colorado at Boulder 1980 — 1984
BS, Biochemistry and Molecular Biology
Therakos, Inc. August 2014 - Present
Novartis (contractor with Sunrise Systems) July 2014 - August 2014
Ethicon (Acro Staffing) April 2013 - May 2014
sanofi June 2010 - March 2012
sanofi-aventis June 1993 - June 2010
Skills
In Vivo, Animal Models, Pharmacology, Drug Discovery, Psychopharmacology, Drug Development, Neuropharmacology, Assay Development, Life Sciences, Lifesciences, Neuroscience, Biomarkers, Diabetes, DMPK, GPCRs, Laboratory, Medical Devices, Wound Healing, Wound Care, medwatch, Quality Assurance, Product Complaints, Trackwise, Complaint Management, CAPA, MDRs, ADRs
Education
Raritan Valley Community College 2013 — 2013
Virginia Polytechnic Institute and State University 1989 — 1993
Bachelor's degree, Biology, General
Honeywell December 2005 - Present
PHOTOMEDEX, INC./SURGICAL LASER TECHNOLOGIES, INC. 1997 - 2005
THERAKOS, INC. 1992 - 1997
IOLAB SITE MICROSURGICAL SYSTEMS, INC. 1987 - 1992
NATIONAL DESIGNERS, INC. 1980 - 1987
United States Navy 1969 - 1975
Education
Spring Garden College 1987 — 1988
CERTIFICATE OF PROFICIENCY, TECHNICAL WRITING
Université Paris-Sorbonne 1980 — 1980
CERTIFICATE OF PROFICIENCY, French Language
Temple University 1976 — 1980
BA, LANGUAGES, BUSINESS
University of Pennsylvania 1979 — 1979
NA, Critical Languages
Defense Language Institute East Coast 1970 — 1971
CERTIFICATE OF PROFICIENCY, ARABIC LANGUAGE
Penn State University 1965 — 1969
ASME, ENGINEERING, CHEMISTRY, LIFE SCIENCES
Orthoclinical Diagnostics, Johnson and Johnson April 2011 - Present
Therakos, Inc. December 2012 - May 2014
JOHNSON AND JOHNSON CONSUMER PRODUCTS January 2009 - December 2010
CAREMARK PHARMACY April 2007 - January 2008
CORDIS CORPORATION May 2004 - December 2006
NEIGHBORHOOD HEALTH PARTNERSHIP (NHP) January 1999 - January 2004
Skills
Six Sigma, Process Improvement, FDA, Quality System, GMP, Training, Quality Auditing, Medical Devices, Leadership, Program Management, Management, Sop, Quality Control, Risk Management, Manufacturing, Cross-functional Team..., Auditing
Education
Capella University
Bachelor of Science, Management and Leadership
MIAMI DADE COMMUNITY COLLEGE
Associate of Arts, Medical Studies
Therakos, Inc. April 2014 - Present
DePuy Synthes Biomaterials, a Johnson & Johnson company April 2011 - April 2014
Synthes September 2005 - March 2011
ResMed August 2002 - August 2005
U.S. Army DENTAC 1999 - 2002
Brigham and Women's Hospital 1995 - 1996
Skills
R&D, Biomedical Engineering, Product Design, Product Development, Idea Generation, Ideas Development, Medical Devices, CAD/CAM, Orthopedics, Pro/Mechanica, Pro/Engineer, Finite Element Analysis, ANSYS, Injection Molding, FDA, GD&T, Mechanical Testing, Prototyping, Patents, Testing, Materials, Rapid Prototyping, Design Control, Windchill, Automation, Technical Drawing, Electronics, Customer Engagement, Technology Evaluation, ISO 13485, Mechanical simulation, Intellectual Property, Fixture Design, Ergonomics, Design Verification..., Design for Manufacturing, Supervision, Biomaterials, Biomechanics, Orthopedic, Pro Engineer, Manufacturing..., V&V, Machining, Design of Experiments, Spine, FMEA, CE marking, CAPA, Commercialization
Education
Fachhochschule München 1993 — 1997
Dipl-Ing (FH), Biomedical Engineer
Therakos, Inc. October 2013 - Present
ZSL May 2004 - Present
Skills
SSRS, Microsoft SQL Server, Netezza, SSIS, T-SQL, ETL, Business Intelligence, Data Achitech, Data Mining, Data Warehousing, Informatica, Oracle, Master Data Management, Salesforce.com
Education
Bharathidasan University 1996 — 1999
Master of computer Application, Computer Application
Bharathidasan University 1993 — 1996
Bachelor's degree, Computer Science
Therakos, Inc. February 2013 - Present
Ortho Clinical Diagnostics April 2001 - February 2013
Bausch & Lomb December 1995 - April 2001
Education
Rochester Institute of Technology 1995 — 1996
MS, Career & Human Resource Development
State University of New York College at Fredonia 1991 — 1993
BS, Business Administration
Cazenovia College 1989 — 1991
AS, Business Management
Fresenius Medical Care February 2011 - Present
Concert Pharmaceuticals March 2008 - February 2011
Therakos, Inc. March 2002 - March 2008
Sanofi 1990 - 2000
Skills
Regulatory Affairs, Medical Devices
Education
University of South Florida 1974 — 1978
B.S., Clinical Chemistry
Therakos, Inc. November 2014 - Present
AstraZeneca January 2013 - November 2014
Teva Pharmaceuticals March 2012 - January 2013
Covance 2009 - April 2012
Covance September 2009 - October 2010
Sepracor 2008 - 2009
Skills
Clinical Trials, Immunology, Pharmacovigilance, Clinical Research, Clinical Development, CRO, Pharmaceutical Industry, Biotechnology, CTMS, Cardiology, Clinical Monitoring, Clinical Study Design, Drug Development, FDA, GCP, GMP, Medicine, Internal Medicine, Oncology, Protocol, Respiratory Therapy
Education
Duke University School of Medicine 2004 — 2008
Translational Airway Biology
Duke University School of Medicine 2004 — 2007
Pediatric Pulmonology
State University of New York Upstate Medical University 2000 — 2004
MD, Pediatrics
State University of New York Upstate Medical University 1986 — 2000
MD, Medicine
Le Moyne College 1992 — 1996
BS, Biology
Therakos, Inc. September 2013 - Present
Therakos, Inc. February 2011 - September 2013
Johnson & Johnson April 2008 - April 2009
Johnson & Johnson January 2006 - April 2008
Johnson & Johnson March 2001 - January 2006
Education
Wagner College 2004 — 2006
International Business, 4.0 GPA
Stony Brook University 1997 — 2000
BS, Chemistry and Biology, 3.97 GPA
Therakos, Inc. April 2013 - Present
Animas Corporation, a Johnson & Johnson Company July 2011 - April 2013
Animas Corporation November 2006 - July 2011
Skills
Medical Devices, FDA, Product Development, Lean Manufacturing, R&D, Design Control, ISO, ISO 14971, ISO 13485, CAPA, Manufacturing, Quality System, V&V, Team Building, Design of Experiments, Minitab, Process Improvement, Cross-functional Team..., Six Sigma, Root Cause Analysis, Quality Assurance, Product Launch, Continuous Improvement, Engineering, Validation, FMEA, GMP, DMAIC, Biomedical Engineering, Manufacturing..., Design for Manufacturing, Process Engineering, Quality Auditing, Change Control, Quality Control
Education
Drexel University 1990 — 1998
Bachelor of Science, Industrial Engineering
Therakos, Inc. August 2013 - Present
Therakos January 2010 - Present
Therakos, Inc January 2010 - August 2013
Veridex November 2004 - September 2010
Veridex.com April 2009 - January 2010
Veridex, LLC November 2004 - January 2010
Veridex Scientific & Medical Affairs March 2007 - April 2009
Veridex, LLC 2004 - 2009
Veridex Clinical & Medical Affairs November 2004 - March 2007
Centocor, a April 2003 - November 2004
Skills
Biotechnology, Oncology, Pharmaceutical Industry, Validation, Commercialization, Medical Devices, Molecular Biology, Lifesciences, Clinical Trials, FDA, Technology Transfer, CAPA, GMP, Cross-functional Team..., GLP, Clinical Research, PCR, Quality System, Biochemistry, V&V, R&D
Education
University of Medicine and Dentistry of New Jersey 1993 — 2001
PhD, Pathology and Laboratory Medicine
University of Medicine and Dentistry of New JerseyGraduate School of Biomedical Sciences 1993 — 2001
Ph.D, Pathology & Laboratory Medicine; Immunology
University of Vermont 1987 — 1991
BS, Biochemistry
University of Vermont
Bachelor of Science, Biochemistry
Montclair Kimberly Academy 1982 — 1987
High School Diploma
The Children's Hospital of Philadelphia July 2014 - Present
Therakos, Inc. December 2013 - July 2014
Depuy Synthes May 2013 - October 2013
SunGard Availability Services January 2013 - April 2013
TEKSYSTEMS/DELL COMPUTER May 2011 - December 2012
TEKSYSTEMS/IBM March 2010 - November 2010
COMCAST NATIONAL IP September 2005 - April 2009
Broadview Networks 2001 - 2004
Cavalier Telephone 2001 - 2001
Skills
Troubleshooting, Internet Recruiting, Technical Recruiting, Visio, Disaster Recovery, Vendor Management, Management, Customer Service, VoIP, Networking, TCP/IP, Network Administration, SharePoint, Talent Acquisition, System Administration, Testing, Citrix, Remedy Ticketing System, Altris, MS Office 2010, Clarity, Microsoft Dynamics, Microsoft Office 2013, Showcase Query 8.0, Google Docs, Microsoft Office, Project Management, Team Leadership, Training
Education
DeVry University 2013 — 2015
Bachelor's degree, Technical Managment
University of Phoenix 2007 — 2008
n/a, Information Systems
Delaware County Community College
Information Systems
Computer Learning Center 1998 — 1999
Information Technology
West Philadelphia Catholic High School 1990 — 1994
Diploma, General Studies
Unilever October 2011 - January 2014
Johnson & Johnson Health Care Systems Inc. January 2008 - March 2010
Therakos, Inc. May 2009 - January 2010
Skills
Sarbanes-Oxley Act, Auditing, Accounting, Cross-functional Team..., Pharmaceutical Industry, Healthcare, Financial Reporting, General Ledger, Consumer Products, Managed Care, FMCG, Product Development
Education
Rutgers University-New Brunswick 1996 — 2000
Brookdale Community College 2002 — 2007
AAS, Nursing
All-Fill, Inc. April 2011 - Present
Montgomery County Community College January 2010 - November 2013
Angiotech July 2010 - April 2011
Therakos, Inc August 2004 - December 2009
Everest Video Imaging Technology January 2004 - July 2004
Cook Technologies April 2003 - November 2003
Cenix, Inc September 2000 - December 2002
Lucent Technologies April 1999 - September 2000
AMP Incorporated January 1995 - March 1999
Lucent Technologies June 1988 - July 1994
Skills
Solidworks, Medical Devices, Design of Experiments, R&D, Manufacturing, Manufacturing..., Mechanical Engineering, Product Development, AutoCAD, SPC, FDA, Process Engineering, Testing, Design Control, Validation, Design for Manufacturing, GD&T
Education
Lehigh University 1990 — 1994
M.B.A.
Drexel University 1984 — 1988
B.S., Mechanical Engineering
Therakos, Inc. February 2014 - Present
Kelly Engineering Resources April 2013 - February 2014
Sutherland Global Services June 2007 - January 2013
Jason J. Bowman, Esq June 2007 - November 2011
Skills
Customer Service, Leadership, Training, Team Management, Data Entry, Call Center, Outlook, BPO, Psychology, Case Managment, Technical Support, Call Centers, Coaching, Analysis, Software Documentation
Education
Kaplan University 2009 — 2010
Bachelor, Psychology
State University of New York College at Oswego 1997 — 2001
State University of New York College at Oswego
Therakos, Inc. May 2013 - Present
Impax Laboratories October 2012 - May 2013
Impax Laboratories March 2006 - October 2012
Education
Strayer University-Pennsylvania 2011 — 2014
Bachelor of Science (BS), Accounting
Lansdale School of Business 2007 — 2011
Associate, Accounting
Therakos, Inc. September 2014 - Present
Citromax May 2012 - June 2013
China Vitamins, LLC August 2009 - May 2012
D&E Pharmaceuticals, Inc June 2005 - July 2009
LA Weight Loss Centers, Inc December 2001 - June 2005
Skills
PowerPoint, Raw Materials, Excel, Quickbooks, Word, Inventory Control, Spreadsheets, Invoicing, Purchase Orders, Logistics Management, SOP development, Customer Satisfaction, Customer Service, 3PL, Hazmat Trained, Hiring Employees, Employee Training, Import Logistics, International Logistics, Customer Service..., Microsoft Excel, Microsoft Word, Process Improvement, Supply Chain, Microsoft Office, Logistics, Purchasing, Sales
Education
College of Saint Elizabeth 2003 — 2006
BS, Food and Nutrition/Marketing
Execupharm (Pfizer Inc.) August 2007 - Present
Therakos Inc. April 2007 - August 2007
Astrazeneca, LP September 2006 - February 2007
Bristol-Myers Squibb 2003 - 2004
Johnson & Johnson Pharmaceutical Research and Development March 1999 - September 2003
Skills
CRO, GCP, Clinical Trials, Global Operations, CTMS, Clinical Development
Education
Rutgers, The State University of New Jersey-Newark
BA, Biology
Janssen, Pharmaceutical Companies of Johnson and Johnson November 2006 - Present
Therakos, Inc. May 2004 - November 2006
Centocor June 2000 - May 2004
Skills
Pharmacovigilance, Regulatory Submissions, Clinical Development, Pharmaceutical Industry, Regulatory Requirements, eCTD, FDA, Regulatory Affairs, Clinical Trials, GCP, Drug Development, IND, Therapeutic Areas
Education
Temple University 1997 — 2000
Master of Science (M.Sc.), Quality Assurance and Regulatory Affairs
Villanova University 1988 — 1991
Bachelor of Science (B.Sc.), Comprehensive Science
Therakos, Inc. April 2014 - Present
WM Robots LLC March 2014 - April 2014
MEDCOMP/MARTECH/POINT medical June 2010 - January 2013
MEDCOMP/MARTECH/POINT medical November 2002 - June 2010
MEDCOMP/MARTECH/POINT medical January 2002 - November 2002
Medcomp July 1997 - January 2002
Skills
Mastercam, Solidworks, Cnc milling, Injection Molding, CNC manufacturing, Machinery, Molding, Six Sigma, Design Control, ISO 13485, Design for Manufacturing, Manufacturing..., Cross-functional Team...
Education
Pennsylvania College of Technology 1999 — 2002
Associates, Plastics and polymers engineering
North Montco TCC 1996 — 1999
Certificate, Drafting and Design
Therakos, Inc April 2013 - Present
Kelly Engineering Resources January 2009 - March 2013
Therakos, Inc. October 2002 - December 2008
GE 1986 - April 1994
Skills
Quality Assurance, Change Control, Document Management, Engineering Change..., Software Documentation, Software Development..., Quality System, FDA, Testing, Software Development, Pharmaceutical Industry, 21 CFR Part 11, Validation, GMP, Medical Devices, Training, Requirements Analysis, Quality Auditing, Cross-functional Team..., ISO 13485, V&V, CAPA
Education
Penn State University 1994 — 1996
Master of Education (MEd), Instructional Systems
Bucknell University 1982 — 1986
Bachelor of Science (BS), Computer Engineering
Mallinckrodt Pharmaceuticals September 2015 - Present
Therakos, Inc. December 2014 - September 2015
AbbVie January 2013 - November 2014
Abbott October 2008 - December 2012
Abbott 2003 - 2008
Novartis 1997 - 2003
Skills
CAPA, Quality Auditing, OOS, Quality Assurance, Quality Management, Supplier Quality, GMP, Validation, Quality System, Change Control, V&V, GLP, 21 CFR Part 11, FDA, SOP
Education
Temple University
Master's Degree, Quality Assurance/Regulatory Affairs
Rensselaer Polytechnic Institute
Bachelor's Degree, Physics
Therakos, Inc. 2014 - Present
Therakos, Inc. 2013 - 2014
Ortho Clinical Diagnostics 1993 - 2012
Skills
Quality System, ISO 13485, Design Control, FDA, CAPA, Design of Experiments, Medical Devices, ISO 14971, V&V, FMEA, Biomedical Engineering, Change Control
Education
Rochester Institute of Technology
Master’s Degree, Master of Science in Manufacturing Leadership
Rochester Institute of Technology
Graduate Certificate in Systems Engineering
Rochester Institute of Technology
Graduate Certificate in Quality & Applied Statistics
Rochester Institute of Technology
Bachelor’s Degree, BS with Honors ACS Chemistry
Therakos, Inc. August 2015 - Present
Vital Therapies January 2013 - August 2015
Sharps Grossmount Medical Center October 2011 - October 2012
Harborview Medical Center September 2008 - October 2011
Skills
Clinical Research, Clinical Trials, Medical Devices, ICU, Critical Care, Clinical Development, PowerPoint, Procedure Development, CCRN, Standard of Care, Procedure Creation, Liver Disease, Mentoring, GCP, Clinical Education, Nursing Education, Nursing, Medical Writing, Health Education, Brochure Production
Education
Seattle University 2003 — 2008
Bachelor's of Science, Registered Nursing/Registered Nurse
Stahl Junior High School
University of California, San Diego
University of California, San Diego
Specialized Certificate in Clinical Trials Administration - date of completion 26JUL2014
Therakos, Inc. April 2015 - Present
Stryker June 2014 - April 2015
Stryker May 2013 - June 2014
Stryker March 2012 - May 2013
Stryker June 2011 - March 2012
Orthovita November 2008 - June 2011
Groundwater & Environmental Services, Inc. October 2006 - November 2008
Skills
Medical Devices, ISO 13485, Root Cause Analysis
Education
Temple University 2010 — 2013
Master of Science (M.S.), Quality Assurance and Regulatory Affairs
University of New Hampshire 2002 — 2006
Bachelor of Science (B.S.), Mechanical Engineering
United States Department of Veterans Affairs April 2014 - August 2014
United States Department of Defense (Army) March 2014 - April 2014
Advanced Pharmaceutical Consultants, Inc. October 2010 - October 2013
Therakos, Inc. August 2003 - August 2006
Skills
Patient Safety, Hospital Pharmacy, Medication Therapy..., Medication..., Pharmacy Automation, Patient Counseling
Education
University of Maryland School of Pharmacy 2006 — 2010
Doctor of Pharmacy (PharmD)
University of Arizona 1997 — 2001
Bachelor of Science in Microbiology
The University of Texas at El Paso 1991 — 1996
Bachelor of Science in Mechanical Engineering