Gabi Villalon
Raleigh,NC
Summary
Results-driven chemist with 7 years of experience in a GMP laboratory environment. Expertise in the precise execution and documentation of various analytical techniques for release and stability testing of drug substances, drug products, and raw materials using multi-compendial, client-supplied, and in-house methodologies.
Overview
8
8
years of professional experience
Work History
Senior Associate Scientist
Catalent Pharma Solutions
Morrisville, NC
07.2022 - Current
- Perform analytical testing on APIs, drug products, and raw materials for in-process and release testing using various methodologies such as compendial (USP, EP, and JP), client-supplied, and in-house methodologies.
- Conduct development, transfer, validation of analytical test methods for HPLC analysis, HIAC particle counting, KF/cKF moisture content determination, osmolality evaluation, pH measurement, and assessment of physical appearance.
- Review laboratory notebooks and logbooks to ensure compliance with industry GMP guidelines.
- Serve as lead laboratory-based metrology contact for coordinating and overseeing instrument calibration, maintenance, and retirement.
- Provide guidance and training to new scientists on laboratory safety procedures and best practices.
- Utilize TrackWise software to document follow-up records, laboratory investigations, deviations, and change controls.
HPLC Chemist
Quality Chemical Laboratories
Wilmington, NC
03.2021 - 06.2022
- Performed analytical testing on finished drug products to support stability programs.
- Performed annual requalification testing on reference standard material using HPLC analyses, such as assay, identification, impurities and related substances.
- Prepared test protocols and client reports documenting experimental results and conclusions for review by senior scientists or management personnel.
- Conducted thorough review of laboratory notebooks, logbooks, and various other GMP documents.
R&D Associate Scientist II
Alcami
Wilmington, NC
03.2020 - 12.2020
- Assisted in the development of new analytical methods for HPLC analyses.
- Performed HPLC troubleshooting activities when unexpected results were obtained during experiments.
- Authored technical reports documenting test results and conclusions.
Research Associate (Formulations)
SePRO Corporation
Whitakers, NC
06.2017 - 03.2019
- Conducted performance testing on novel algaecides and aquatic herbicides to support product formulation.
- Performed genetic analysis on field samples to identify product susceptibility, resistance, and intolerance in aquatic plant species prior to field applications.
- Developed test methods for ICP-OES analysis to individually quantify internal and external copper concentrations in various algal species.
- Managed and oversaw daily laboratory and greenhouse operations.
Laboratory Analyst
Pfizer
Rocky Mount, NC
05.2016 - 06.2017
- Executed environmental monitoring of aseptic rooms, isolators, compressed air and water systems, and personnel in compliance with GMP standards.
- Processed in-process, finished, and stability products and raw materials using a range of wet chemistry techniques.
- Operated laboratory equipment such as centrifuges, autoclaves, incubators and pH meters in accordance with safety guidelines.
- Performed data entry into the LIMS database as well as analyzed and interpreted results from laboratory tests.
Education
Bachelor of Science - Cell And Molecular Biology
East Carolina University
Greenville, NC05-2016
Skills
- Good Manufacturing Practices
- Use of Agilent HPLC systems with VWD, PAD, ELSD, and RI detections
- Formal education in advanced processing techniques in Waters Empower 3 data acquisition software
- Expertise in analytical techniques such as HIAC, auto-titration, KF, cKF, Osmolality, pH, and gravimetric analyses
- Execution of method development, transfer, and validation protocols and completion of associated formal reports
- Proficient with GMP review of laboratory data
Timeline
Senior Associate Scientist
Catalent Pharma Solutions
07.2022 - Current
HPLC Chemist
Quality Chemical Laboratories
03.2021 - 06.2022
R&D Associate Scientist II
Alcami
03.2020 - 12.2020
Research Associate (Formulations)
SePRO Corporation
06.2017 - 03.2019
Laboratory Analyst
Pfizer
05.2016 - 06.2017
Bachelor of Science - Cell And Molecular Biology
East Carolina University
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