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, NY03-2021
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