Hagay Shmuely
Director of Biotechnology at Amai Proteins- Claim this Profile
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Hebrew Native or bilingual proficiency
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English Professional working proficiency
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Bio
Experience
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Amai Proteins
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Israel
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Biotechnology Research
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1 - 100 Employee
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Director of Biotechnology
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Sep 2021 - Present
Director of Biotechnology at Amai Proteins - Member of management comity reporting directly to the CEO.Amai applies Computational Protein Design, Precision Fermentation and Food Technology to develop great tasting and sustainable proteins for the Food Industry.Developed, optimized and scaled up the precision fermentation and protein purification processes.Built, recruited, trained and managing the biotechnology group that includes 5 teams (Cloning, Precision fermentation, Purification, Pilot and Analytics).Successfully transferred and scaled up (KGs scale) the production process to a CMO. Show less
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Head of Down-Stream process
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Jul 2019 - Sep 2021
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Owner
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Apr 2011 - Present
Working as a free lancer in the field of biomanufacturing. Experties: - Managing several R&D teams with several projects in parallel. - Tech transfer of a protein production process and development of the process from academic level to industry standards production process. - Production process development from the cloning and clone selection to drug substance (API) and drug product. - Cloning and expression in bacterial and yeast cells. - Development of precision fermentation processes for bacteria and yeast up to 5,000L fermenter. - Cloning to mammalian cells, developing working and master cell banks and process development in bioreactors. - More than 20 years of experience with protein purification process development using different chromatography, filtration, precipitation and buffer exchange methods. - Integration of viral inactivation and removal steps. - Working with recombinant and native proteins, including purification from human plasma and serum. - Development of analytical methods for R&D and QC (Biochemical/enzymatic, chromatographic-HPLC, ELISA, gels etc.) to measure protein concentration, purity and activity and detection of contaminants in protein samples. - Working under cGMP. Writing reports, SOPs and MBRs. - RNA and DNA production, purification and processing in large scales . Show less
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Efranat Ltd.
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Rehovot, Israel
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Head of CMC team
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Feb 2011 - Dec 2017
I have developed Efranat's protein production from academic level to industry standards production process, including integration of viral inactivation and removal steps. Performed process optimization and scale up to phase II production level. Managed the members of the CMC team. I led the tech transfer to a CMO and production of material for clinical trials. Working under cGMP. I have developed Efranat's protein production from academic level to industry standards production process, including integration of viral inactivation and removal steps. Performed process optimization and scale up to phase II production level. Managed the members of the CMC team. I led the tech transfer to a CMO and production of material for clinical trials. Working under cGMP.
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Beeologics
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Rehovot, Israel
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Production R&D consultant/contractor
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May 2011 - Dec 2015
An iRNA production company a subsidiary of Monsanto. Scaled up and optimized the production and analytical processes. Worked with different teams all over the world. An iRNA production company a subsidiary of Monsanto. Scaled up and optimized the production and analytical processes. Worked with different teams all over the world.
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PPS
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Rehobot, Israel
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VP R&D
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Jan 2007 - Dec 2010
Protein Production Services (PPS), an Israeli CRO/CMO company that specialized in developing a protein production processes for the industry. I have built the R&D group that included three DSP and two USP teams. Planned, coordinated and supervised the work to meet the budget and costumers needs. Developed the clones, precision fermentation and protein purification processes for 30-50 proteins per year for use in research and different stages of clinical trials. Protein Production Services (PPS), an Israeli CRO/CMO company that specialized in developing a protein production processes for the industry. I have built the R&D group that included three DSP and two USP teams. Planned, coordinated and supervised the work to meet the budget and costumers needs. Developed the clones, precision fermentation and protein purification processes for 30-50 proteins per year for use in research and different stages of clinical trials.
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Education
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Ben Gurion University
Doctor of Philosophy (PhD), Biochemistry, molecular biology and structural biology -
Hareali-Haivri Haifa