Michael (Misha) Shamashkin Email and Phone Number
• CMC leader with Drug Substance and Drug Product development experience in viral vectors, mRNA, and recombinant protein therapeutics.• Building new R&D and Pilot laboratory capabilities, hiring and training effective teams in start-up settings.• Driving phase-appropriate strategies for programs via collaboration with Research, Analytical, QA/QC, Regulatory, Supply Chain, Manufacturing, and Clinical teams.• End-to-end process development and analytical integration for early and late-stage clinical manufacturing.• Scale-up and technology transfer of Drug Substance and Drug Product to internal and external GMP facilities.• Leading and mentoring teams in upstream, downstream, formulation, production, and analytical roles.• Coordinating activities of cross-functional teams and managing project timelines across multiple company sites. • Managing suppliers of strategic raw materials, CROs, and CDMOs under constrained timelines.• Authoring regulatory filings, protocols, reports, process descriptions, batch records, and invention disclosures.
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Senior Director, Nucleic Acid Process DevelopmentMirai BioBoston, Ma, Us
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Senior Director, Nucleic Acid Process DevelopmentMirai Bio Nov 2023 - PresentCambridge, Massachusetts, United StatesResponsible for process development and production of therapeutic cargo -
Senior DirectorSana Biotechnology, Inc. Nov 2022 - Nov 2023Cambridge, Massachusetts, United States• Developed an end-to-end Drug Substance process for fusosomes (lentiviral vectors comprising tissue-specific fusogens and transfer genes) and virus-like particles (VLP) for direct in vivo administration.• Managed a team of 7 scientists and engineers in upstream, downstream, and formulation functions and supervised production of Drug Substance and Drug Product batches.• Contributed to defining a phase-appropriate control strategy for in-process testing and release.• Transferred Upstream, Downstream, and Fill/Finish processes to CDMOs.• Technical subject matter expert in a Quality Audit of a CDMO.• Authored sections of the Pharmacy Manual, the GLP Tox study protocol, and the CMC module of an IND. -
DirectorSana Biotechnology, Inc. Jan 2020 - Nov 2022• Built downstream process development lab and hired and trained staff on purifying lentiviral vector (LVV).• Designed a scalable downstream process for broad spectrum of fusosomes and virus-like particles (VLP) for direct in vivo administration. • Developed stable frozen Drug Product formulation and designed an infusion set configuration.• Transferred Fill/Finish process to a CDMO and served as a Person-in-Plant during the execution of GMP batches.
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Associate DirectorModerna Mar 2019 - Jan 2020Cambridge, Ma• Managed a team of 4 scientists and engineers to develop early and late-stage manufacturing processes for mRNA Drug Substance.• Developed and implemented a new custom affinity resin with 2x binding capacity for large mRNA.• Invented and implemented novel mRNA synthesis methods resulting in a specific product profile. -
Principal ScientistModerna Jul 2017 - Mar 2019Cambridge, Massachusetts, United States
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Senior ScientistModerna Jul 2015 - Jul 2017Cambridge, Ma
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Senior ScientistPfizer Dec 2011 - Jul 2015Centers For Therapeutic Innovation--Boston• Technical Lead for translation of recombinant protein candidates from Discovery to Pharmaceutical Sciences.• Performed biophysical screening, selection, and molecular assessment of lead molecules.• Developed prototype purification processes, characterized product-related impurities, performed stability studies, and prepared knowledge transfer packages for the initiation of development activities. -
Research Scientist, Bioprocess DevelopmentRepligen Corporation Jun 2011 - Dec 2011Waltham, Ma• Evaluated novel tools in the company’s disposable chromatography portfolio.• Developed procedures for packing and cleanability testing of large scale chromatography columns. -
Scientist, Process DevelopmentVirdante Pharmaceuticals May 2010 - May 2011Cambridge, Ma• Led a team of three scientists to develop a process for purification of enzymatically glycosylated intravenous immunoglobulin (IVIG).• Developed downstream purification of an E. coli derived recombinant sialyltransferase enzyme and transferred the process to a CMO. -
Research Scientist I/Ii, Process And Product DevelopmentPfizer Feb 2002 - May 2010Andover, Ma• Responsible scientist for development of capture and polishing chromatographic steps for mAbs, fusion proteins, cytokines and blood clotting factors. • Developed liquid and lyophilized drug product formulations of mAbs and Fc-fusion proteins for Phase I clinical trials. Characterized drug product by HPLC, SDS-PAGE, Karl-Fischer titration, spectroscopic and calorimetric methods.
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Assistant ScientistAltus Pharmaceuticals Jul 2000 - Jan 2002Cambridge, Ma• Developed crystallization conditions for a variety of proteins and peptides.• Performed high-throughput screening and optimization of crystallization conditions
Michael (Misha) Shamashkin Education Details
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Chemistry -
Biotechnology Engineering -
Chemical Engineering
Frequently Asked Questions about Michael (Misha) Shamashkin
What company does Michael (Misha) Shamashkin work for?
Michael (Misha) Shamashkin works for Mirai Bio
What is Michael (Misha) Shamashkin's role at the current company?
Michael (Misha) Shamashkin's current role is Senior Director, Nucleic Acid Process Development.
What schools did Michael (Misha) Shamashkin attend?
Michael (Misha) Shamashkin attended Bowling Green State University, Tufts University, Mendeleyev University Of Chemical Technology Of Russia.
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