Overview
Work History
Education
Skills
Timeline
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Rebecca Naill

Morrisville,NC

Overview

4
4
years of professional experience

Work History

QA Auditor I

BioAgilytix
09.2024 - Current
  • Performs Quality Assurance audits, inspections, and monitors procedures against SOPs, methods, protocols/plans, guidance, and regulations
  • Issues QA statements for reports as needed
  • Reviews and assists in closing deviations, investigations, corrective actions, and preventive
    actions plans with management assistance
  • Assists in document management activities

Associate Scientist

BridgeBio Gene Therapy
04.2024 - 09.2024
  • Performed a variety of assays for recombinant AAV-based gene therapy candidates to support process and analytical development activities
  • Actively worked to minimize assay turnaround times while prioritizing work according to program needs to meet timelines
  • Contributed to the assay development of Lumit Capsid Quantification and AAV9 Ligand Leakage ELISA
  • Collaborated with cross-functional teams to design and execute studies

Research Associate II

KBI Biopharma Inc.
07.2022 - 04.2024
  • Executed expedited ELISA- and qPCR-focused client projects
  • Conducted pre-formulation projects using an array of characterization tests (UNcle, BIG TUNA, HPLC, RheoSense, A280)
  • Became a Qualified Trainer for the site and designed official training courses for the UNcle, BIG TUNA, and RheoSense
  • Performed Inter-Laboratory Method Validations for the FDA
  • Successfully executed an ELISA with zero observations by the EMA (European Medicines Agency) during a laboratory audit
  • Drafted and revised methods, data worksheets, protocols, data summaries and reports

Scientist I

Eurofins Scientific
05.2021 - 07.2022
  • Executed testing including N-Glycan Profiling, Size Exclusion Chromatography, Capillary Electrophoresis, Imaged Capillary Isoelectric Focusing, SoloVPE, and Compendial Testing (pH, Appearance, UV-VIS)
  • Experience working in a BSL2 Laboratory
  • Upheld good documentation practices utilizing Electronic Laboratory Notebooks (ELN) 
  • Promoted within 9 months from Associate Scientist to Scientist I

Education

Bachelors of Science - Biology

Union College
Schenectady, NY
03-2021

Skills

  • ELISA
  • qPCR / ddPCR
  • HPLC / UPLC
  • RheoSense
  • BIG TUNA
  • iCIEF
  • CE
  • HIAC
  • SoloVPE
  • Compendial Testing
  • UNcle
  • Experience with LIMS and ELN
  • Good Documentation Practices / Good Laboratory Practices
  • GxP Auditing Experience
  • Acute attention to detail

Timeline

QA Auditor I

BioAgilytix
09.2024 - Current

Associate Scientist

BridgeBio Gene Therapy
04.2024 - 09.2024

Research Associate II

KBI Biopharma Inc.
07.2022 - 04.2024

Scientist I

Eurofins Scientific
05.2021 - 07.2022

Bachelors of Science - Biology

Union College

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Rebecca Naill