Ann Nguyen

Utilized aseptic techniques to mammalian cell lines to perform routine bioassay testing, including ELISA, cell-based immunoassays, and flow cytometry assays, on biopharmaceutical product samples in accordance with cGMP requirements, company policies, and procedures.

• Growing and maintaining multiple mammalian cell lines, such as HEK293T, CHO, and Jurkat. Techniques include thawing, conducting harvest procedures and passaging cell culture.
• Conducted cell and non-cell-based assays for GIPR, IFNb, p40/TL1a, PD-1, influenza, and SARS-CoV-2 using techniques of flow cytometry, ELISAs, and cell-based assays.
• Operated a FACScalibur to perform flow cytometry testing on vaccine product, and conducted ELISAs and cell-based assays, utilizing Softmax Pro for data analysis.
• Peer-reviewed data, LIMS and client eLN to ensure accuracy and investigated abnormal results by thoroughly examining results, worksheets, and data logs for precision.

• Performed and review routine wet chemistry testing such as gravimetry and titrimetry per USP, EP, JP, JPE, Chinese Pharmacopeia, FDA regulations, and industry standards.
• Demonstrated competence in various apparatus and instrumentation analysis: FTIR, UV/Vis, TOC, pH meter, conductivity etc.
• Reviewed raw material specifications prior to use in order to ensure they meet required quality standards.
• Investigated causes of contamination or unexpected variations in test results in order to determine root cause of problems.

• Executed assigned assays using UPLC/HPLC on raw material and finished products following standard operating procedures (SOP's), analytical procedure (AP's) while maintaining compliance with FDA, cGMP, GLP regulators and company policies
• Performed routine testing vitamins D3, K1, beta carotene, DHEA, curcuminoid, quercetin ensuring the conformity and quality of finished products as well as the content and purity of raw materials
• Processed data and chromatography integration using software Empower 3.