Jorge M.

Process Engineer I-iii @Ginkgo Bioworks

Boston, MA, US

Experience designing, planning, developing, evaluating, optimizing, and deploying multiple aerobic fermentation processes (batch, fed-batch and perfusion type fermentations) and their respective downstream processes using a variety of organisms (bacterial, yeast and filamentous fungi) as bioconversion systems for the expression of multiple target products (biological substances (such as proteins, enzymes, capsids, nucleic acids (pDNA), peptides) and APIs) ranging from lab/bench scale (1L – 50L) through non-GMP pilot scale (100L – 500L) to cGMP commercial/production scale manufacturing (500L – and non-GMP commercial scale manufacturing – planning, developing, executing and analyzing scale down fermentation and purification process development and validation studies using a variety of upstream and downstream units of operation such as microbial fermenters, chemical lysis, mechanical lysis, centrifugation, depth filtration, tangential flow filtration (UF/DF), various types of chromatography (IMAC, CIEX, AIEX, MMC, HIC, affinity and/or SEC) and lyophilization-Direct experience troubleshooting and adjusting active fermentation and downstream processes and equipment to ensure key process parameters are maintained throughout the process operation-Lead tech-transfer, process validation, process performance qualification (PPQ) and scale-up activities from lab/bench-scale through non-GMP pilot to cGMP and non-GMP commercial/production scale manufacturing serving as subject matter expert (SME) of developed upstream and downstream processes for various biological products (proteins, enzymes, capsids, pDNA and other biologics) and other APIs from various microbial host organisms-Responsible for setting up and monitoring bioreactor systems through various fermentation processes ensuring all target key process parameters are tracked, maintained and recorded throughout the fermentation processes.

University of California, Santa Cruz

Bachelor of Science - BS, Chemistry