洪乾文(CHIEN-WEN, HUNG)
Senior Project Coordinator at Amaran Biotechnology, Inc.- Claim this Profile
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Bio
Experience
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Amaran Biotechnology, Inc.
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Taiwan
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior Project Coordinator
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Feb 2022 - Present
Organizing drug substance and aseptic drug product technical transfer for the clinical trial. Robotic aseptic filling machine, Vanrx, Comprehensive CDMO customer service management for clinical trial products, including inquiry evaluation, quotation preparation, and coordination Organizing drug substance and aseptic drug product technical transfer for the clinical trial. Robotic aseptic filling machine, Vanrx, Comprehensive CDMO customer service management for clinical trial products, including inquiry evaluation, quotation preparation, and coordination
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旭能醫藥生技股份有限公司 SHINER PHARM CORP.
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Taiwan
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Hospitals and Health Care
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1 - 100 Employee
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Research Development Specialist (Technical Transfer)
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Mar 2021 - Feb 2022
Lead technical transfer and project management from the laboratory to the manufacturing site. Completed orphan drug scale-up and product released in 6 months. Establish and execute GMP technical documents for manufacturing and packaging. Production scale-up for solid/semi-solid dosage, powder, and solution drug products. Packaging configuration covering bottling, sachet, aluminum tube, and PTP. Lead technical transfer and project management from the laboratory to the manufacturing site. Completed orphan drug scale-up and product released in 6 months. Establish and execute GMP technical documents for manufacturing and packaging. Production scale-up for solid/semi-solid dosage, powder, and solution drug products. Packaging configuration covering bottling, sachet, aluminum tube, and PTP.
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Bora Pharmaceuticals
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Taiwan
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Technical Services Engineer
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Dec 2018 - Feb 2021
Manufacture Process Validation and Process Improvement for solid dosage form, e.g., controlled-release tablets, and capsules. Hands-on technical writing skills for GMP documentation. Production related issue investigation and root cause analysis.
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QC Chemist
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Sep 2018 - Nov 2018
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Research Assistant
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Sep 2012 - Aug 2015
With a view to promote the pharmaceutical product quality based on PIC/S in Taiwan, Taiwan's authority Taiwan Food and Drug Administration(TFDA) has been a PIC/S member authority since 2013. Besides, <<西藥藥品優良製造規範(based on PIC/S GMP Part 1)>> was enacted as the manufacturing guideline of pharmaceutical industry in Taiwan in early 2010. Therefore, with my highly interest in Drug manufacturing, I entered TPQRI and started involving in the research and amendment of the Good Manufacture Practice from PIC/S GMP in Taiwan. Also, I was responsible for planing and holding of 9 GMP workshops, 3 Official GMP explanation conferences to Taiwan pharmaceutical industry and 10 Active Pharmaceutical Ingredient GMP training courses since 2012. I'm now continue learning the GMP and dedicate myself in GMP. Show less
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Self-employed
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Taipei city, Taiwan
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Teacher
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Jul 2010 - May 2012
Teaching science curriculum, e.g. Chemistry, Physics, and Biology, and Mathematics among 7-12 grade. Giving useful advice about senior high school/college entrance examination to 7-12 grade students. Teaching science curriculum, e.g. Chemistry, Physics, and Biology, and Mathematics among 7-12 grade. Giving useful advice about senior high school/college entrance examination to 7-12 grade students.
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Army Infantry school, Taiwan (ROC)
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Kaohsiung, Taiwan(ROC)
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Platoon Commander (Secondary lieutenant, 98-1 Compulsory Officer)
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Aug 2009 - Jul 2010
Leading soldiers to accomplished whatever commander ordered. Leading soldiers to accomplished whatever commander ordered.
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Education
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Taipei Medical University
Master of Science (MSc), Department of Pharmaceutical Science -
National Yang Ming University
Bachelor of Science (BS), Medical technology and laboratory science in medicine