Wonsik Shin

Experience

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  Duc-Yu

  Mar 2006 - Jul 2008

  Alternative Military service

  Military training (4 weeks)Manufacuring plastic box.

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  Celltrion Pharm Inc.

  Aug 2012 - Apr 2014

  Quality Control

  Responsibilities:• Chemical and microbiology analysis for water, air, a product, a raw material(API) and packaging materials according to USP, EP and KP• Identification of microorganism and library of detected pathogen • Manage sterile zone with disinfectant and daily recording in GMP about Temp., Difference Pressure, Humid.• Manage GMP facility about OOS, deviation, validation, CAPA and Risk assessment• Writing and renewing SOPs, Protocol for GLP, device, test method and Clean room condition according to ISO 146441 & 8573, USP, EP, KP• Responsible for consumable reagent, stock solution, devices (chart, calibration) and media (Microbiology lab) • Data analysis with Excel: Set up Alert/action level with data after OQ and PQ.Project:• Set up new plant: Cleaning Validation, Audit, SOPs, EM validation, Test Method (SOP, Protocol, validation), Devices (SOP, Calibration), GLP (Microorganism lab)• Change control for rebuilding plant Show less

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  Leibniz-Institut für Gewässerökologie und Binnenfischerei - Berlin

  Feb 2017 - Oct 2017

  Master Thesis Student

  Project title (Master thesis) ; Influence of low intensity electromagnetic EHF-radiation (30-60GHz) on homeostasis of organisms in aquacultureAnimal test of zebrafish and embryo Evaluation of Radiation therapy and Toxicology and Immune assesmentInfection experimentData management with R

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  Chungbuck Technopark

  Aug 2018 - Dec 2021

  Reseacher

  I am a manager about 4Dbiotechnich project and bioheathcare project in Korea. I am in charge of building up a center which is possible to support growing up start-up companies. I support QC, Bio Process, preclinic part for company.

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  Daesang Corporation

  Dec 2021 - now

  Upstream Process Development Manager

  Upstream process development manager