Mitchell Gonzales

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Back to All People

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 of multiple novel life changing products.

I have thoroughly enjoyed contributing my experience and services to the biopharmaceutical industry.  I have had family members use the products that I’ve manufactured and it’s an inspiring feeling knowing the life changing impact of your work.  I was honored to join the AES team and their earned reputation in the clean room design/build industry where I can offer my experience to patients in a whole new way through the application of modern engineering design, installation methods, and materials of construction”.

Mitch has been happily married to his wife Cathy for 32 years and is father of two children, Crystal and John.  Crystal is employed as a nurse in California and John is financial research analyst in New York City.  Cathy is a former personal trainer and it’s safe to say there is no rest for the weary at home as they are constantly on the move hiking, biking, swimming, or running. When he’s not exercising, he is off riding his motorcycle enjoying the Pennsylvania scenery and visiting the many historical sites.

 

IntroducingFaciliflex Express
Faciliflex Express is a pre-designed cleanroom solution that delivers a commissioned cleanroom in as little as 6 months. Pre-designed standard cleanroom layouts are the next generation for snap together installation of modular panel systems. Faciliflex Express has 3 models 5k, 15k, and 30k representing cleanrooms of approximately 5,000, 15,000, and 30,000 square foot.