Michael Vanderwerf Email & Phone Number
Director, Regulatory Affairs
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Michael Vanderwerf Location
- California, United States
Michael Vanderwerf Work
- Director, Regulatory Affairs @ Organogenesis, Inc (April 2014 - Present)
- Director - Regulatory Affairs CMC @ Shire Regenerative Medicine (August 2012 - April 2014)
- Assoc. Director, US Regulatory Affairs - Vaccines @ (January 2006 - August 2012)
- Senior Regulatory Affairs Scientist @ (January 2004 - January 2006)
- Director, Worldwide Compliance @ AVENTIS BEHRING (January 2001 - January 2004)
- Director, Regulatory Affairs, Establishment Group @ AVENTIS BEHRING (Marburg, GERMANY) (January 1998 - January 2001)
- Associate Director, Drug Regulatory Affairs @ CENTEON, LLC (became Aventis Behring) (January 1995 - January 1998)
- Regulatroy Affairs @ Cambridge Biotech (January 1991 - January 1995)
- Operations Manager @ Endogen (January 1988 - January 1991)
Michael Vanderwerf Education
- The Johns Hopkins University
MS (Biotechnology)
2007-2010 - University of Minnesota
BA Biology (Evolutionary Biology/Genetics and Philosophy of Science)
1981-1986
Michael Vanderwerf Skills
- Regulatory strategy
- CMC problem solving
- Regulatory Affairs
- GMP
- Life Sciences
- Biotechnology
- Vaccines
- cGMP
- Process Validation
- Validation
- Quality System
- IND
- FDA
- Biologics
- CAPA
- Biopharmaceuticals
- Regulatory Submissions
- Infectious Diseases
- CMC
- Lifesciences
- Technology Transfer
- Pharmaceutics
- CMC Regulatory Affairs
- GLP
- Sop
- Drug Development
- Medical Devices
- Cell
- eCTD
- Technical Writing
- Social Media
- Global Regulatory Compliance
- Sop Writing
- FDA GMP
- Sales
- Quality Improvement
- Regulatory Requirements
- Clinical Trials
- Molecular and Cellular Biology
- Root Cause Analysis
- Quality Assurance
- Regulatory Compliance
- u.s. Food and Drug Administration Fda
- Microsoft Office
- Customer Service
- Quality Systems Design
- Regulatory Analysis
- Quality System Compliance
- Regulatory
- Pharmaceutical Industry
- Software
- u.s. Food and Drug Administration
Michael Vanderwerf Summary
- Michael Vanderwerf, based in California, United States, is currently a Director, Regulatory Affairs at Organogenesis, Inc. Michael Vanderwerf brings experience from previous roles at Shire Regenerative Medicine, GlaxoSmithKline Biologicals, SAIC and AVENTIS BEHRING. Michael Vanderwerf holds a 2007 - 2010 MS in Biotechnology @ The Johns Hopkins University. With a robust skill set that includes Regulatory strategy, CMC problem solving, Regulatory Affairs, GMP, Life Sciences and more. Michael Vanderwerf has 1 emails and 1 mobile phone numbers on RocketReach.
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