Atul_Dubey

Atul Dubey PhD

Director, Pharmaceutical Continuous Manufacturing, USP Reference Standards Labs

Atul Dubey is the Director of Pharmaceutical Continuous Manufacturing (PCM) at the United States Pharmacopeial Convention (USP). Headquartered in Rockville, MD, USA, USP is committed to global public health and quality of medicines for 200 years. At USP, his group is focused on supporting the ongoing adoption of CM through education programs, public standards and collaborative work for standardization and harmonization. Atul is involved in the development of training curriculum for industry personnel to bring about technological awareness about CM. He is also a part of the expert working group (EWG) for drafting the ICH Q13 guideline for CM. He collaborates with various stakeholders to carry out scientific research in various aspects of CM. After earning his PhD degree in Mechanical Engineering, he carried out research in pharmaceutical manufacturing processes using modeling and simulation to understand and optimize unit operations such as continuous mixing, granulation and pan coating. He has authored several journal articles and book chapters in the domain. After his stint at the C-SOPS (Rutgers University) he moved to India where he worked as a consultant to pharmaceutical companies, as well as a Sr. Scientist in the Aditya Birla Group in India. With a strong motivation to facilitate the access to quality medicines worldwide, he is interested in applied R&D towards development of new standards, training and guidelines for CM.


Appearances

  • Thumbnail for Continuous Manufacturing for Emergency Preparedness and Rapid Response: Accelerating Widespread Adoption
    Date
    June 4, 2020
    Continuous Manufacturing for Emergency Preparedness and Rapid Response: Accelerating Widespread Adoption|The onset of the COVID 19 pandemic has illustrated the importance of the FDA's desired state of a "maximally efficient, agile, flexible pharmaceutical manufacturing sector"…

    Leader/Speaker

    Speaker Image for Christine Moore
    Executive Director, Quality Systems & Compliance, Organon LLC

    Speakers

    Speaker Image for Stelios Tsinontides
    Stelios C. Tsinontides, Ph.D., FAIChE
    Director, Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ, CDER, FDA
    Speaker Image for Atul Dubey
    Director, Pharmaceutical Continuous Manufacturing, USP Reference Standards Labs
    Speaker Image for B. Frank Gupton
    Floyd D. Gotttwald Professor & Chair, Chemical & Life Science Engineering, Virginia Commonwealth University
    Speaker Image for Anne Fischer
    Programs Manager, Defense Science Office, Defense Advanced Research Projects Agency (DARPA)
    Speaker Image for Paul Collins
    Senior Director, Small Molecule Design and Development, Eli Lilly and Company