Michael Vanderwerf Location
- California, United States
Michael Vanderwerf Work
- 2014 - now Director, Regulatory Affairs @ Organogenesis, Inc
- 2012 - 2014 Director - Regulatory Affairs CMC @ Shire Regenerative Medicine
- 2006 - 2012 Assoc. Director, US Regulatory Affairs - Vaccines @
- 2004 - 2006 Senior Regulatory Affairs Scientist @
- 2001 - 2004 Director, Worldwide Compliance @ AVENTIS BEHRING
- 1998 - 2001 Director, Regulatory Affairs, Establishment Group @ AVENTIS BEHRING (Marburg, GERMANY)
- 1995 - 1998 Associate Director, Drug Regulatory Affairs @ CENTEON, LLC (became Aventis Behring)
- 1991 - 1995 Regulatroy Affairs @ Cambridge Biotech
- 1988 - 1991 Operations Manager @ Endogen
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 on RocketReach.
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