Mitchell Gonzales

VP, Process Technology at AES Clean Technology

As VP of Process Technology, Mitch is a newer member of the AES leadership team and brings three decades of experience working directly for large and small biopharmaceutical companies including Amgen, Merck, Novartis, and Baxter. He was VP of Manufacturing at Pfenex, a biosimilar company who recently launched a generic (Forteo®) osteoporosis multi use injection pen. Most recently, he comes to AES from Tocagen a gene therapy company in San Diego. He earned degrees in Mechanical Engineering Technology and Mathematics and holds certifications in Six Sigma Green Belt and Project Management.

He originally started his biopharmaceutical career at Amgen as part of the Engineering & Construction department designing, building, and commissioning research and manufacturing facilities at their headquarters site. He then expanded this experience to global operations in Puerto Rico and European finishing sites. Post his facility design and construction experience, he has been leading clinical and commercial biopharma manufacturing functions at numerous companies supplying multiple life-saving products to patients including EPOGEN®, PROCRIT®, Aranesp®, NEUPOGEN®, NEULASTA® INFERGEN®, SYMLIN®, BYETTA® , ADVATE®, Focetria®, OrgalutranTM, Sensipar®, and Mimpara®.

Mitch’s manufacturing experience includes many years of clinical and commercial supply through contract manufacturing organizations. He has lived outside the United States on multiple expatriate work assignments living in Puerto Rico and Liverpool. He considers career highlights to be his leadership roles in the design and construction of over 100Kft2 of regulated biopharma facilities, the supply of H1N1 pandemic flu vaccine, as well as leading the commercial product launches o

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  • VP, Process Technology

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