Jaymeth Maddox Email & Phone Number

I have provided scientific, technical, and regulatory CMC and cGMP compliance support to the pharmaceutical industry for over 14+ years, with experience in all phases of drug, biologic, medical device, and combination product development with demonstrated ability to produce high quality work products under aggressive timelines to meet clients’ goals. While I have broad experience across a range of product classes and dosage forms, my primary area of focus/interest is in sterile/aseptically processed biologics, including cell and gene therapies and advanced therapies. Throughout my career, I have developed, executed, and directed CMC operations and regulatory strategies to support initial investigational-phase or marketing authorization applications as well as changes thereto in the US, EU, and Canada. I have also led cGMP compliance inspections of a variety of establishments (sterile/aseptic, solid oral, small and large molecule active ingredients, analytical laboratories, ancillary support vendors, etc.) for vendor selection/qualification, for-cause, and mock-regulatory authority inspections.

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  Virginia Polytechnic Institute And State University

  Biochemistry