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Niles Ron

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Niles Ron

Branch Chief | FDA

Silver Spring, Maryland, United States

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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.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Emerging Technologies

Leadership Development

Innovation

Organisational experience

Corporate Experience

Government Experience

Niles Ron

Work Experience

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Branch Chief at

FDA

December 2018 - Present

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Director, Regulatory Implementation Staff in Office of Dietary Supplement Programs (ODSP)/CFSAN at

FDA

January 2017 - December 2018

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Branch Chief (Acting) - Chemistry Manufacturing and Controls at FDA in CDER at

Food And Drug Administration

January 2011 - January 2017

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Associate Director, CMC at

Teva Pharmaceuticals

February 2009 - January 2011

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Associate Director, Formulation, Fill, and Finish at

Seagen

December 2007 - January 2009

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Assoc. Dir., Pharmaceutical Development at

Stryker

December 2000 - January 2007

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Principal Scientist, Drug Product and Process Development at

Amgen, Inc.

January 2007 - January 2007

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Senior Formulations Engineer at

Abraxis BioScience

April 1998 - December 2000

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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

mail

*********@fda.gov

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