Jason Cheng
Senior Quality Control Associate at Tanvex Biopharma USA, Inc- Claim this Profile
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Bio
Experience
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Tanvex Biopharma USA, Inc
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior Quality Control Associate
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Oct 2020 - Present
-Responsible for routine and non-routine product testing using procedural analytical test methods specializing in HPLC and Capillary Electrophoresis. -Complete training on 40+ test methods mainly in physical and bioanalytical tests. Successfully trained other associates on tests methods following a qualified training program to ensure compliance in all testing activities. -Transfer analytical methods from development into the Quality Control laboratory and test method validation. Conduct feasibility studies for seamless test method transfer and recommend test method improvements. -Manage equipment maintenance in the Quality Control laboratory, including tracking and scheduling Preventative Maintenance and routine instrument qualification. Review and approve of service reports and work with outside vendors to ensure that instruments remain in a compliant and qualified state. -Author standard operating procedures to improve Quality systems and fill compliance gaps.-Perform peer review of test results following cGMP and GDP guidelines to ensure data integrity and compliance.
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Quality Control Associate
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Dec 2017 - Oct 2020
-Perform applicable testing on in-process and final product to ensure material quality. -Perform quantitative and purity based HPLC assays in a cGMP environment including Reversed-Phased, Ion Exchange, Size Exclusion chromatography.-Execution of test method validation for method transfer from R&D to Quality Systems. -Initiation and tracking of stability programs.-Perform routine data integrity reviews-Maintain and organize all records, documentation, and forms associated with Quality Control testing.
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Manufacturing Associate
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Oct 2017 - Dec 2017
Execution and review of manufacturing batch records for large-scale cGMP drug substance production. Class A cleanroom operation with gowning for mammalian and microbial operating suites.
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UC San Diego
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United States
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Higher Education
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700 & Above Employee
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Undergraduate Researcher
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Sep 2013 - Jan 2015
Glycocalyx remodeling with proteoglycan mimetics to promote neural specification in embryonic stem cells. Glycocalyx remodeling with proteoglycan mimetics to promote neural specification in embryonic stem cells.
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UC San Diego
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United States
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Higher Education
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700 & Above Employee
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Undergraduate Researcher
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Sep 2012 - Jun 2013
Isolating and culturing microbacteriophage and genetic sequencing of the genome. Isolating and culturing microbacteriophage and genetic sequencing of the genome.
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Education
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University of California San Diego
Bachelor of Science - BS, Pharmacological Chemistry