Linh Tran
Los Angeles,CA
Summary
A well-rounded QC specialist/technician and researcher with over 15 years of laboratory experience. Track record in assay development, instrument validation, regulatory compliance for vector-based and CAR-T immunotherapy approaches, and genomic research and publications with NGS platform.
Overview
12
12
years of professional experience
Work History
Sr. Quality Control Specialist II
GenVivo, Inc.
Pasadena, CA
03.2022 - 12.2025
- Perform, design, validate, and revise cGMP assays to meet regulatory standards for stability and manufacturing practices.
- Draft, execute, and summarize IQ/OQ/PQ reports for instrument and computer system validations per 21 CFR Part 11.
- Supported team to ensure product meets FDA and cGMP standards through assay analysis, data tracking, instrument calibrations/performance maintenance, and provided technical support.
- Draft and execute PRT/VAM studies to ensure QC assays are consistent and reliable.
- Collaborate with Quality Assurance in DR, CAPA, and OOS investigations, drafts, and reports.
- Manage department's training program to ensure analysts meet company standards and FDA standards.
Research Associate
Saint John's Cancer Institute and Cal Poly Pomona
Santa Monica, CA
03.2018 - 03.2022
- Executed library preparation techniques for RNA-Seq, miRNA-Seq, DNA-Seq and other sequencing methods.
- Utilized Nanostring GeoMX and Illumina MiSeq for advanced sequencing projects.
- Assisted in the development and optimization of experimental protocols for cancer research projects.
- Managed sequencing projects for MD Anderson and Cornell University, ensuring alignment with research objectives and timelines.
- Collaborated with fellows and vendors to develop and optimize sequencing assays, contributing to project success.
- Designed and conducted cell-based experiments using siRNA transfection and PCR techniques.
- Presented project findings at labs and conferences, resulting in multiple journal publications.
Laboratory Technician
Los Angeles County Sanitation District
Whittier, CA
10.2013 - 08.2018
- Conducted tests mandated by Environmental Agencies at reclamation plants in LA County to ensure compliance with environmental regulations.
- Executed over 30 assays in wet chemistry and microbiology.
- Utilized instruments including flow injection analyzer, spectrophotometer, automatic titrator, and BOD probe.
- Managed laboratory operations and trained new lab technicians to maintain high standards of quality and safety.
- Performed safety inspections and data reviews to ensure compliance and accuracy.
- Maintained laboratory equipment and troubleshot issues to support uninterrupted lab operations.
- Prepared samples and conducted general laboratory maintenance to support ongoing projects.
Education
B.S. - Biotechnology
California State Polytechnic University-Pomona
Pomona, CA12.2019
Skills
- Project and Lab Management
- Current Good Manufacturing Practices
- 21 CFR Part 11 Compliance
- Instrument and Computer Validation, Calibration, and Maintenance
- Stability testing
- Assay Development
- Research and Publication
- Laboratory management
Training
Molecular Biology Workshop, Professor David Ng, The University of British Columbia, 06/01/17
Timeline
Sr. Quality Control Specialist II
GenVivo, Inc.
03.2022 - 12.2025
Research Associate
Saint John's Cancer Institute and Cal Poly Pomona
03.2018 - 03.2022
Laboratory Technician
Los Angeles County Sanitation District
10.2013 - 08.2018
B.S. - Biotechnology
California State Polytechnic University-Pomona