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Niles Ron
Niles Ron
Branch Chief | FDA
Silver Spring, Maryland, United States
Niles Ron
Summary
Niles Ron is a seasoned professional with extensive experience in Chemistry, Manufacturing, and Controls (CMC) within the pharmaceutical and biopharmaceutical industries. He currently serves as Branch Chief at the FDA, where he oversees pharmaceutical quality assessments across the product lifecycle for generic drugs. With a strong background in formulation development and regulatory affairs, Niles has been instrumental in the successful commercialization of various drug products, including monoclonal antibodies and small molecules. His academic credentials include advanced degrees in Chemical Engineering and an MBA, complementing his technical expertise. Niles has led teams through complex CMC processes, ensuring compliance with FDA regulations while driving innovation in drug development. He is known for his risk-based regulatory approaches and has a proven track record in managing large-scale manufacturing processes. Niles is passionate about advancing pharmaceutical quality and public health through effective regulatory practices.
Niles Ron
Work Experience
Branch Chief at
FDA
December 2018 - Present
Director, Regulatory Implementation Staff in Office of Dietary Supplement Programs (ODSP)/CFSAN at
FDA
January 2017 - December 2018
Branch Chief (Acting) - Chemistry Manufacturing and Controls at FDA in CDER at
Food And Drug Administration
January 2011 - January 2017
Associate Director, CMC at
Teva Pharmaceuticals
February 2009 - January 2011
Associate Director, Formulation, Fill, and Finish at
Seagen
December 2007 - January 2009
Assoc. Dir., Pharmaceutical Development at
Stryker
December 2000 - January 2007
Principal Scientist, Drug Product and Process Development at
Amgen, Inc.
January 2007 - January 2007
Senior Formulations Engineer at
Abraxis BioScience
April 1998 - December 2000
Niles Ron
Education
Clark University, Mba
January 2002 - January 2005
Washington University in St. Louis, Ms, Phd
January 1994 - January 1998
Indian Institute of Technology Bombay, Bachelor's Degree In Chemical Engineering
January 1990 - January 1994
Frequently Asked Questions about Niles Ron
What is Niles Ron email address?
Niles Ron's primary email address is *********@fda.gov. To view the full verified email and additional contact details, sign up for free with Muraena.
What company does Niles Ron work for?
Niles Ron is a Branch Chief at FDA, a company specializing in General government, nec.
Where Niles Ron graduated from?
Niles Ron holds a degree in Management from Clark University.
How can I directly contact Niles Ron?
To contact Niles Ron directly, you can use the email address *********@fda.gov. Complete contact information is available upon registration with Muraena.
Who is Niles Ron?
Niles Ron is a seasoned professional with extensive experience in Chemistry, Manufacturing, and Controls (CMC) within the pharmaceutical and biopharmaceutical industries. He currently serves as Branch Chief at the FDA, where he oversees pharmaceutical quality assessments across the product lifecycle for generic drugs. With a strong background in formulation development and regulatory affairs, Niles has been instrumental in the successful commercialization of various drug products, including monoclonal antibodies and small molecules. His academic credentials include advanced degrees in Chemical Engineering and an MBA, complementing his technical expertise. Niles has led teams through complex CMC processes, ensuring compliance with FDA regulations while driving innovation in drug development. He is known for his risk-based regulatory approaches and has a proven track record in managing large-scale manufacturing processes. Niles is passionate about advancing pharmaceutical quality and public health through effective regulatory practices.
Niles`s contact details
*********@fda.gov
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