Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Leslie Santuo

Brentwood,MD

Summary

Achieved compliance with cGMP regulations by executing thorough lab testing procedures. Facilitated successful FDA audits through proactive preparation and documentation. Optimized laboratory performance by effectively utilizing advanced pharmaceutical instrumentation in BSL-2 and BSL-3 environments.

Overview

7
7
years of professional experience

Work History

Senior Downstream Biomanufacturing Technician

Charles River Laboratories
06.2025 - Current
  • Apply, Modify and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements
  • Effectively execute a range of tasks, in line with SOPs, in one of the following areas:
  • Downstream Activities (e.g., cell lysis, chromatography purification, centrifugation, Tangential Flow Filtration (TFF), and final formulation steps).
  • Fill-Finish Activities (e.g., making buffers and solutions, and preparation of equipment and materials for final drug product).

Associate Scientist (Contract)

AstraZeneca
01.2023 - 07.2024
  • Complete and document quality control tests for products
  • Proficient Use in HPLC and analyzing data
  • Conduct tech transfer for lab test methods

Lab Tech - Immunology

NIH (NIAID)
01.2022 - 01.2023
  • Assisted in conducting experiments to better understand the immune response to Mycobacterium tuberculosis in the macaque animal model
  • Performed a wide variety of procedures and techniques including, but not limited to cell culture, clinical/diagnostic microbiology, DNA analysis, DNA isolation, DNA purification, DNA sequencing, flow cytometry, gene cloning, manipulation of radioactive isotopes, natural product isolation, organic synthesis, peptide synthesis, protein analysis, RNA isolation
  • Processed primate and murine tissue and samples for downstream applications
  • Performed flow cytometric cell sorting and/or analysis of research scientist-supplied sample
  • Published Author on nlm.nih.gov

BACH1 promotes tissue necrosis and Mycobacterium tuberculosis susceptibility

QC Analyst II

Emergent BioSolutions
09.2020 - 12.2021
  • Performed testing as required to support method verification/validation and material & supplier qualification
  • Inspected incoming raw materials and performed sampling for release testing
  • Coordinated testing and shipments of samples with contract testing laboratories
  • Performed identification, assay and limit testing of raw materials and packaging components to support manufacturing requirements

QC Data Reviewer

Catalent Gene Therapy
03.2021 - 10.2021
  • Performed detailed data review for test results on assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC, Capillary Electrophoresis, Bioburden, endotoxin, TOC, and membrane filtration testing, generated by QC Department for compliance with cGMP, internal SOPs, and Specifications, to support production, stability studies, and lab operation

Downstream Biomanufacturing Technician

Catalent Gene Therapy
11.2019 - 10.2021
  • Developed processes and techniques for protein isolation and purification under GMP compliance.
  • Proficient in Processes such as TFF1, Final TFF, AKTA Ready, AKTA Pilot, Viral Filtration

Education

B.S. - Chemistry, Minor Biology

Shenandoah University
01-2019

Skills

  • Liquid Chromatography Systems (AKTA Ready, AKTA 450 & AKTA Pilot)
  • FTIR Spectroscopy
  • High-Performance Liquid Chromatography (HPLC)
  • ELISA (Enzyme-Linked Immunosorbent Assay)
  • RNA Isolation (BLOOD, BAL, Bone Marrow)
  • Inductively Coupled Plasma (ICP)Analysis
  • TFF 1,2 & Final (Tangential Flow Filtration)
  • RNA isolation
  • Protein purification
  • Assay development
  • Gel electrophoresis
  • Immunohistochemistry

Accomplishments

BACH1 promotes tissue necrosis and Mycobacterium tuberculosis susceptibility

Timeline

Senior Downstream Biomanufacturing Technician

Charles River Laboratories
06.2025 - Current

Associate Scientist (Contract)

AstraZeneca
01.2023 - 07.2024

Lab Tech - Immunology

NIH (NIAID)
01.2022 - 01.2023

QC Data Reviewer

Catalent Gene Therapy
03.2021 - 10.2021

QC Analyst II

Emergent BioSolutions
09.2020 - 12.2021

Downstream Biomanufacturing Technician

Catalent Gene Therapy
11.2019 - 10.2021

B.S. - Chemistry, Minor Biology

Shenandoah University