Bio
Credentials
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PMP
Project Management Institute
Experience
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United States
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Biotechnology Research
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1 - 100 Employee
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Associate Director Clinical Operations
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Jan 2024 - Present
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Clinical Trial Manager
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Jul 2020 - Jan 2024
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Germany
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Pharmaceutical Manufacturing
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700 & Above Employee
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Scientist IV Biological Clinical Development
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Mar 2019 - Jul 2020
-Clinical lead for global vaccine projects
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Group Leader Biological Clinical Development
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Aug 2015 - Mar 2019
Scientist III responsibilities plus manage Scientist II-III
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Scientist III - Biological Clinical Development
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Mar 2012 - Aug 2015
Safety and Efficacy (S&E)-Plan and execute non-clinical and clinical studies required for global licensing of vaccines for livestock and companion animals.-Execute life cycle management studies requiring collaboration with Technical Services Veterinarians, Marketing, and Regulatory Affairs to determine objectives that would provide value to the end user and collaborate to mitigate potential risk.-Write protocols, interim and final reports and audit data.-Independently monitor study events to ensure protocol and regulatory compliance.-Train Study Investigators and routinely monitor progression of study activities at the study site.-Assist in outsourcing activities when appropriate, and liaise with Finance to monitor study budget and payables.-Train/mentor new employees and interns as needed.
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United States
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Research Services
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700 & Above Employee
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Supervisor CMC-Pharmaceutical Development Services
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Oct 2011 - Mar 2012
GMP Analytical Services-Manager of Study Coordination-Stability testing, method transfer, method validaiton
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Associate Staff Scientist - Drug Metabolism
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Jul 2009 - Oct 2011
Pre-Clinical, Drug Metabolism and Pharmacokinetics (DMPK)-Study Director, GLP-Principle Investigator, GCP
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Study Coordinator - CMC Pharmaceutical Development Services
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Sep 2006 - Jul 2009
GMP Analytical Services-Project management-Stability testing, method transfer, method validation
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Study Techinician - Drug Metabolism
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Aug 2004 - Oct 2006
Pre-Clinical, Drug Metabolism and Pharmacokinetics (DMPK)-In-Vivo Research Associate-GLP, SOP, ADME, Toxicology
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Education
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2008 - 2010University of Wisconsin-Madison
MS, Biotechnology -
2002 - 2004University of Illinois Urbana-Champaign
BS, Animal Science -
2000 - 2002Parkland College
Cert., Equine Management
Suggested Services
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Industry Focus. “Pharmaceuticals and Healthcare”
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