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Mitchell Gonzales 

Operations

Career Highlights

Mitchell Gonzales brings over 30 years of biopharmaceutical operations experience to Cell One Partners, with a career that spans biotechnology, biosimilars, vaccines, and cell and gene therapies. His extensive background includes roles as Vice President of Manufacturing, Process Sciences, and Process Technology, where he has successfully managed technical operations and commercialization throughout the lifecycle of regulated drug products. Mitchell's key career milestones include multiple supply chain restarts, product launches, novel facility designs for ATMPs (Advanced Therapy Medicinal Products), aseptic equipment designs, and new department start-ups. His ability to collaborate across Development, Quality, Regulatory, Technical Services, Validation, Engineering, and Facilities has been critical to his success.

Mitchell's career began with the biotechnology start-up Amgen, where he gained valuable experience that now focuses on autologous and allogeneic ATMP operational support.  Mitchell's expertise in streamlining workflows, eliminating bottlenecks, and integrating acquired plants demonstrates his proficiency in enhancing operational efficiency and compliance. His comprehensive operations experience makes him a significant contributor to the success of Cell One Partners.

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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