Łukasz Michurski
Process Biotechnologist - Team Leader at Mabion S.A.- Claim this Profile
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Bio
Credentials
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Certified Project Management Associate IPMA Level D
IPMA PolskaApr, 2019- Nov, 2024
Experience
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Mabion S.A.
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Poland
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Process Biotechnologist - Team Leader
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Sep 2019 - Present
Leading of a team in sterile manufacturing process of mAbs in disposabletechnology.Supervising the upstream stages - culture of mammalian cells in bioreactorand cell harvest in accordance with GMP principlesScaling and validation of the production processPreparation of documentation according to cGMP requirements - batchrecord documentation, instructions for process and device, documentationof qualifications and validation of devices and processesParticipation in preparation User Requirement SpecificationsdocumentationProviding of trainings for subordinate personnel.Conducting affinity chromatography, viruses inactivation, ion exchangechromatographyDesigning methods in accordance with the GMP specificationParticipation in corrective and preventive actions - CAPA
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Process Biotechnologist
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Feb 2019 - Present
Supervising the upstream stages of the production process - Cell culture inbioreactors and cell harvest.Scaling of the production process.Creating technological instructions and system documentation.Participation in qualification of systems and equipment (OQ, PQ).
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Bioprocess Technician
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Oct 2017 - Present
Conducting and analyzing the production process - mammalian cell culturein bioreactors, cell harvest and stages of its purification like affinitychromatography, viruses inactivation, ion exchange chromatography.Verification and control batch record documentationAnalysing trends and raw data from process stages.
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Education
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2010 - 2015
Zachodniopomorski Uniwersytet Technologiczny w Szczecinie
Magister inżynier (Mgr inż.), Biotechnologia
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