Eddie Yang

Experience

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  National Taiwan University

  Sept 2012 - Feb 2014

  Research Assistant

  Over 1 year and half working, we scan gene pool and discover one possible gene which may participate in lung cancer’s migration and causing cancer’s migration and recurrent. In this project, we using variety biological and molecular methods and skills to confirm the role of mine interesting target gene in lung cancer cells, patients’ samples and lung cancer patients’ primary cancer stem cell lines (Including virus prepare and infection, protein extraction and western-blot, invasion/migration assay, animal test…etc). In this project, I am responsible for this full research case and planed and managed the relative examines. For years’ working, we found one potential gene can regulate in lung cancer’s EMT and finally we summary these research data and present to Ministry of Science and Technology in Taiwan. Show less

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  Formosa Laboratories Inc (4746)

  Feb 2014 - May 2016

  Process Engineer

  With 2 years and 4months work in Formosa Lab. Inc., I am participated in improvement of department’s quality manage system and responsible for most Quality relative work cases, like following cases:1. Response process technical transfer from R&D department to productiondepartment (from lab to pilot plant) and/or production process scale-up(scale-up to 500%).2. Building or revising the pharmaceutical production relative SOPs and GMPrelative documents (over 40% in production department) in order to follownational regulation,3. Building 100% production process and /or produced equipment’s risk assessmentin manufacture plant,4. Prepare 80~90% protocol/ plan/ reports of equipment documents (including URS,3Q) and production documents,5. Building and revising process and cleaning validation in complication with GMP,6. Evaluate 100% of new introducing products’ pharmacology, toxicology onproduction area or production risk assessment,7. Monitor quality of process and equipment validation and harvest the data to writerelative reports,8. Identifying validation requirements for proposed changes and correctiveactivities,9. Writing important products’ document for fitting national legislation (like OELdocument) to help company development international market,10. Assist lowing the cost by assessing used solvent/materials’ recycle possibility,11. Manage department’s project cases including deviation, change control, CAPA,customer’s responses and relative quality cases,12. Served as department’s window to keep cross-departments communicationsmooth (including QA/QC/RA/EN) and negotiate with personnel,13. Training for operator about products’ pharmacy and toxicologic,14. Advanced document writing in Chinese/English by MS Office suite,15. Helping internal/external auditor. Show less

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  United Biopharma Inc.

  Sept 2016 - Apr 2018

  Process Engineer/ Microbiological Analyst

  Responsible for following woks:1. New biopharmaceutical plant’s build-up and new equipment qualification works.2. Commercial scale production work.3. GMP build-up.4. Clean room’s microbiological monitor and test (HEPA/WFI).

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  TaiMed Biologics Inc

  Apr 2018 - May 2024

  Associate Manager/ Sr. Production Engineer/Scientist

  Responsible for following works:1. New Biopharmaceutical plant build-up (most in clean room build-up) and relative GMP work preparation.2. Abroad CMO regulated and directly audit.3. Technology transfer for new product or transit to other abroad CMO.4. Commercial scale (200~2000L) purification production for mAB in cleanroom.5. Modularization and Standardization of Production procedures.6. Equipment operation/qualification/maintenance, GMP document/MBR writing.