Michael K. O'Brien, PhD

NGT BioPharma Consultants
Founder & President
Founder and president of NGT BioPharma Consultants, Dr. O’Brien is recognized as a forward-thinking innovator in the biopharmaceutical industry. As VP Pharmaceutical Sciences Technology & Innovation at Pfizer Pharmaceutical, he conceived and collaborated on the design, fabrication and implementation of a portable, continuous, miniature and modular (PCMM) oral solid dose manufacturing facility that was built off-site and assembled in a warehouse, with capabilities to transfer and reassemble the facility at other sites. The PCMM facility won the 2016 ISPE Facility of The Year Award. Dr. O’Brien previously served as the acting head of a large biopharma chemical development organization, where he oversaw and managed cGMP Kg-laboratories, pilot plants, API external supply groups, environmental, health and safety (EHS) teams, as well as the synthesis R&D groups.

An agent of change who strategically aligns stakeholders to ensure executive support for status quo transformation, Dr. O’Brien’s expertise extends to development of digital, analytical, drug substance and drug product platform technologies, which, when implemented, automate critical CMC processes, operations and oversight. He was named an Industry Influencer on The Medicine Maker 2019 Power List and has more than 55 publications, presentations and patents.

Expertise:
  • Manufacturing technology innovation
  • Technology transfer, digital/data technology development, CMC-focused technology design
  • API and drug product R&D