Overview
Work History
Education
General Skills and Qualifications
Certification
Affiliations
License
Presentations
Timeline
Generic

Victoria Luong

Biomanufacturing Associate II
San Diego,CA

Overview

4
4
years of professional experience
9
9
years of post-secondary education
4
4
Certifications

Work History

Biomanufacturing Associate II

Gallant Therapeutics
San Diego, CA
08.2023 - Current
  • Aseptically process feline and canine uterine tissue sample to isolate uterine-derived mesenchymal stem cells for stem cell banking
  • Bank/ship/culture cells as needed after tissue processing based on individual patient treatment plan
  • Cryopreservation in cryovials using CoolCell and liquid-phase liquid-nitrogen tanks
  • Manufacture canine and feline uterine-derived mesenchymal stem cell drug product for clinical studies
  • Thaw and seed WCB/MCB; expansion up to (24) 10-layer CellSTACK factories; final product formulation; fill finish; and cryopreservation into cryovials and CZ vials
  • Large-batch culture media formulation (up to 20L bag assemblies)
  • Perform screening of canine and feline donors for research and development purposes
  • Monitored cell growth, population doubling, morphology, and possible contamination
  • Execute Aseptic Validation Protocol (APV) as part of the Chemistry, Manufacturing, and Controls (CMC)
  • Assist executives in preparing and submitting the Drug Master File for inclusion in the IND application
  • Update batch records and work instructions via change order process
  • Assist Quality Assurance in the resolution of non-conforming product
  • Maintain supply chain needs by regularly taking warehouse inventory and ordering materials, as needed
  • Receive materials and equipment for facilities and complete Raw Material Specifications
  • Implement IQ/OQ/PQ protocols to qualify small equipment
  • Conduct various Quality Control procedures, including Direct Transfer Sterility Testing , and oversaw environmental monitoring in cleanroom environments

MSAT Research Group Lead

Eurofins PSS Insourcing Solutions
10.2022 - 07.2023
  • Lead 4-person team through large-scale feeder cell production
  • Expansion up to (36) 10-layer cellSTACK factories; final product formulation, fill finish, and cryopreservation in cryovials or cryobags
  • Culture, harvest, expand, and cryopreserve 2D mammalian cell lines for R&D and manufacturing use
  • Perform routine monitoring of cell viability, preparation of cell media, preparation of cytokines/small molecules
  • Perform QC assays such as post thaw viability and IRV assay
  • Perform replication incompetence trials of irradiated OP9-DLL4 feeder cells; perform cell staining and flow cytometry assays for OP9-DLL4 feeder cells
  • Plan quarterly forecasting of reagent stocks, cytokines, small molecules, and mammalian cells
  • Schedule deliverables based upon forecast
  • Daily monitoring, operation, and maintenance of lab equipment
  • Good documentation of materials used, restock consumables in the lab when needed
  • Good documentation of experiments performed
  • Calculate, evaluate, review, and properly communicate data verbally and in written format
  • Develop and implement performance monitoring systems to track team progress

Global Regulatory Affairs Intern

IQVIA Biotech
02.2022 - 10.2022
  • Identified and interpreted regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
  • Reviewed protocols, consent forms, reports, scientific documents, publications, and related papers, as appropriate for various clinical research projects to ensure compliance with regulations
  • Served as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities
  • Recorded time allocated to projects and updated master tracking documents
  • Facilitated communication between internal and external project stakeholders to keep all parties well-informed
  • Provided assistance with preparation of project-related reports, manuscripts and presentations

Associate Research Technician

NYU Langone Health
10.2021 - 02.2022
  • Assisted with the ordering and tracking of laboratory supplies
  • Conducted centrifugation, flow cytometry and Western blot
  • Isolated, cultured, maintained, passaged, and preserved human and mice fallopian tube tissues to prepare for 3D organoid culture
  • Prepared R-spondin-1-conditioned medium and FT organoid culture medium
  • Performed routine technical tasks and assisted in the general maintenance of the lab, such as preparing stock reagents


Fermentation R&D Intern

Bosque Foods
New York, New York
09.2021 - 12.2021
  • Assisted the R&D team in planning, executing, and analyzing benchtop fermentation trials, including operations of fermentation reactors and downstream separation systems, to improve growth and other characteristics
  • Assisted in generating new scientific ideas to help shape Kinoko Labs’ (now known as Bosque Foods) overall direction as a company and support its evolving needs
  • Effectively present lab findings to Lead Scientist and wider team
  • Make up fermentation media and dosing chemicals, including bag sterilization
  • Performed medium and strain screening at lab scale.

Research Assistant

C-SPEC
07.2020 - 12.2021
  • Attended seminars and symposiums to improve overall knowledge and understanding of marine mammalian behavior
  • Conducted directional orientation analysis of over 4,300 archival photographs of pinnipeds in New York City
  • Collaborated with principal investigators to identify relevant questions and determine best methods of collection
  • Gathered, arranged and corrected research data to create representative graphs and charts highlighting results for presentations
  • Presented technical research results to diverse audiences through written, visual and oral media

Laboratory Technician Intern

Wnt Scientific
10.2020 - 04.2021
  • Analyzed and observed experimental procedures to validate adherence to standards and specifications
  • Conducted various techniques such as mammalian hemocyte cell culture, SDS-Page, and Western Blot
  • Investigated atypical results and discrepancies to determine causation
  • Maintained and conducted sterility of lab equipment using appropriate tools
  • Prepared chemical solutions, reagents and specimens for microscopic examination

Education

Master of Science - Biotechnology

Johns Hopkins University
Remote
09.2021 - Current

Associate of Science - Biology

LaGuardia Community College of The City University of New York
Long Island City, NY
09.2019 - 06.2021

Bachelor of Arts - Hospitality Management

New York City College of Technology of The City University of New York
Brooklyn, NY
09.2013 - 01.2018

General Skills and Qualifications

  • OP9-DLL4 and K562 feeder cell processing
  • 3D organoid culture (human and mice fallopian tube tissues)
  • Large-scale and small-scale aseptic cell culture (adherent cell lines)
  • Aseptic product formulation, fill-finish, and cryopreservation
  • Culture expansion using T-flasks and CellSTACK factories
  • Use of various cell counters: Cellometer K2, Vi-Cell XR, NucleoCounter NC200
  • Use of specialized equipment: LOVO Cell processing system, CliniMACS Prodigy, Rad-Source X-ray Blood Irradiator, Controlled Rate Freezer (CRF), Tuttnauer EZ10 Autoclave, TSCD II Sterile Tube Welder, Omni Sealer
  • Culture media and reagent formulation
  • Gowning qualified for Grade A, B, C & D cleanroom environments
  • In-process QC sample collection and submission
  • Deviation documentation and investigation
  • Materials inventory and purchasing
  • Strong understanding of GDP and cGMP
  • Aseptic technique in ISO5/Grade A qualified BSCs
  • Excellent oral and written communication skills
  • High collaborative
  • Acute attention to detail

Certification

CITI Program Responsible Conduct of Research

Affiliations

  • New York Academy of Science
  • New York Cares
  • American Association for the Advancement of Science

License

  • Life, Accident and Health Insurance Agent (NIPR Producer #: 19181621)

Presentations

  • Hofmann, Eric., (2020, November). ePortfolio Showcase. Digital portfolio presented at the ePortfolio Showcase, Long Island City, New York.
  • Xu, N., & Ye Y. (2020, November). Wnt Scientific Internship Experience. Powerpoint presented at the STEM Internship and Opportunities event, Long Island City, New York.
  • President's Society: Environment., (2021, January). The LaGuardia Community Greenway. Powerpoint presented to President Adams to request his support for the LaGuardia Community Greenway, Long Island City, New York.
  • SUNY Undergraduate Research Conference., (2021, April). The Directional Orientation of Harbor and Gray Seals at Swinburne Island in New York City, Long Island City, New York.
  • Conference on Climate Change Education (C4E)., (2021, April).Teaching Climate Change Using a Data-Driven Approach. Presentation presented to CUNY educators to discuss best educational practices to inform students and the public about climate change, Long Island City, New York.
  • CUNY LaGuardia Undergraduate Research Day., (2021, May).The Directional Orientation of Harbor and Gray Seals at Swinburne Island in New York City, Long Island City, New York.

Timeline

Biomanufacturing Associate II

Gallant Therapeutics
08.2023 - Current

MSAT Research Group Lead

Eurofins PSS Insourcing Solutions
10.2022 - 07.2023

CPR/AED/First Aid

09-2022

Global Regulatory Affairs Intern

IQVIA Biotech
02.2022 - 10.2022

Associate Research Technician

NYU Langone Health
10.2021 - 02.2022

COVID-19 Public Training

10-2021

Introduction to the Cytometry and Cell Sorting Laboratory (CCSL)

10-2021

Fermentation R&D Intern

Bosque Foods
09.2021 - 12.2021

Master of Science - Biotechnology

Johns Hopkins University
09.2021 - Current

Laboratory Technician Intern

Wnt Scientific
10.2020 - 04.2021

Research Assistant

C-SPEC
07.2020 - 12.2021

Associate of Science - Biology

LaGuardia Community College of The City University of New York
09.2019 - 06.2021

Bachelor of Arts - Hospitality Management

New York City College of Technology of The City University of New York
09.2013 - 01.2018

CITI Program Responsible Conduct of Research

2020-06

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Victoria LuongBiomanufacturing Associate II