Ann Nguyen
Westminster,CA
Summary
Scientist I with a Bachelor's degree in Molecular Cell Biology and five years of expertise in cGMP CDMO facilities. Experiences in the routine testing of cell-based and non-cell-based assays within BLS-2 environment. Highly motivated and actively seeking out new challenges.
Overview
5
5
years of professional experience
Work History
Scientist I
Nitto Avecia Pharma Services
Irvine, CA
06.2023 - Current
- Maintained mammalian cell cultures (HEK293T, CHO, Jurkat) using aseptic techniques and supported routine bioanalytical testing through ELISA, complex cell-based assays, and flow cytometry in a cGMP-regulated environment.
- Generated Working Cell Banks from Master Cell Banks using aseptic cell expansion and cryopreservation, with mycoplasma testing for quality assurance.
- Conducted complex cell-based and non-cell-based assays for multiple therapeutic and vaccine programs, including GIPR, IFNβ, p40/TL1a, PD-1, influenza, and SARS-CoV-2, utilizing ELISA, ADCs, potency, and flow cytometry methodologies.
- Performed transient transfection of mammalian cell lines and evaluated in vitro protein expression using flow cytometry, supporting cell-based assay development, cellular characterization, and downstream functional assays.
- Analyzed and reviewed assay data using FACScalibur, SoftMax Pro, LIMS, and eLN systems, ensuring data accuracy, GMP compliance, and timely investigation of deviations and assay trends.
Chemist I
Nitto Avecia Pharma Services
Irvine, CA
06.2022 - 06.2023
- Conducted and evaluated routine wet chemistry testing including gravimetry and titrimetry, ensuring compliance with USP, EP, JP, JPE, Chinese Pharmacopeia, FDA regulations, and industry standards.
- Utilized various analytical instruments such as FTIR, UV/Vis, TOC, pH meter, and conductivity meter to perform precise chemical analyses.
- Reviewed raw material specifications prior to use in order to ensure they meet required quality standards.
- Analyzed causes of contamination or unexpected variations in test results to identify root problems and implement corrective measures.
Laboratory Technician III
Robinson Pharma Inc.
Santa Ana, CA
03.2021 - 06.2022
- Executed assays using UPLC/HPLC on raw materials and finished products per SOPs and APs, ensuring compliance with FDA, cGMP, and GLP regulations.
- Conducted routine testing of vitamins D3, K1, beta carotene, DHEA, curcuminoid, and quercetin to confirm quality and purity of finished products and raw materials.
- Processed data and integrated chromatography results using Empower 3 software to support analytical assessments.
Education
Master of Science - Microbiology And Cell Science
University of Florida
Gainesville, FL12-2027
Bachelor of Science - Molecular Cell Biology and Physiology
California State University
Long Beach, CA12-2020
Skills
- Cell culture processing & aseptic techniques
- ELISA
- Binding Assays
- Peer review
- CAPAs
- Good Manufacturing Practice (GMP)
- Stability Studies
Instrument And Software Experiences
- FACScalibur Flow Cytometer
- NC-200 Cell Count
- SpectraMax Plate Reader
- Plate Washer
- PH meter
- CryoExtra
- Single-channel, multi-channel pipettes
- LIMS
- ELN
- SoftMax Pro 7.2 GxP Software
Timeline
Scientist I
Nitto Avecia Pharma Services
06.2023 - Current
Chemist I
Nitto Avecia Pharma Services
06.2022 - 06.2023
Laboratory Technician III
Robinson Pharma Inc.
03.2021 - 06.2022
Master of Science - Microbiology And Cell Science
University of Florida
Bachelor of Science - Molecular Cell Biology and Physiology
California State University