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Mitchell Gonzales 

Operations

Career Highlights

Mitchell Gonzales is an associate of Cell One Partners and brings over 30 years of biopharmaceutical operations experience that spans biotechnology, biosimilars, vaccines, as well as cell & gene therapies which have endeavored him on three expatriate assignments.

  • Mitchell successfully held positions as Vice President Manufacturing, Process Sciences, and Process Technology including multiple roles in Technical Operations and Commercialization fulfilling roles throughout the lifecycle of regulated drug product. 

  • Key career milestones include multiple supply chain restarts (e.g. H1N1), product launches, ATMP novel facility designs, aseptic equipment designs, and new department start-ups.

  • Half of his career began with the biotechnology Amgen company start-up and is now focused on autologous and allogenic ATMP operational support.

  • Critical to his career achievements have been the collaboration between Development, Quality, Regulatory, Technical Services, Validation, Engineering, Facilities and a vast network of the CDMO industry.

Education

Mitchell earned a bachelor’s degree in mechanical engineering technology from California Polytechnic State University and is certified in Project Management and Six Sigma.  Mitchell holds webinars and authors thought knowledge content in industry publications.  

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