Alexandra González Burgos
New Port Richey,FL
Summary
Data-driven R&D Chemist with 10 years of experience in the pharmaceutical industry, specializing in process understanding, drug product stability analysis, and data-driven troubleshooting within GMP-regulated environments. Currently pursuing an MBA in Data Analytics to further strengthen advanced analytics and data-driven decision-making capabilities.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Product Development Research Chemist
Lonza
Tampa, Florida
09.2021 - Current
- Executed consistent data delivery through analysis using HPLC, UPLC, and coulometric titrator methodologies.
- Performed analysis across 15+ early and commercial phase projects with multiple DOE, informal stability studies (ISS) studies evaluating time/humidity effects on product stability and performance, including data trending and deviation detection
- Analyzed multivariate datasets (Assay/RS, Dissolution, KF) to identify key process drivers, interactions, and sources of variability
- Applied data analysis to support troubleshooting investigations and process optimization decisions
- Interpreted and reported analytical data to support development and validation activities
- Developed validation protocols, technical reports, and data summaries used for internal and client decision-making
- Collaborated cross-functionally with AMD, QC, PM, and clients to align data insights with project goals
- Achieved successful project progression by delivering impactful client presentations and actively participating in project calls.
- Conducted sample testing to validate informal stability during pre-formulation and method development phases.
AR&D Associate Scientist
Catalent Pharma Solutions
St. Petersburg, Florida
07.2020 - 09.2021
- Knowledge of HPLC, UPLC, KF, UV/VIS, Particle Size Determination, Dissolution (App1 & 2).
- Evaluation of data and testing of Finished Product samples for soft gel capsules.
- Assisted with creating protocols, data summary reports and method specific documents.
- Assisted/tested products for validations and method development samples.
- Knowledge in physical testing (hardness, burst, appearance, rupture, and disintegration).
- Ordering/maintaining inventory materials for specific project and as per customer requests.
Chemical Analyst
Merck-LPO
Las Piedras, Puerto Rico
09.2017 - 06.2020
- Executed HPLC analysis and troubleshooting using Agilent systems.
- Utilized Empower 3, GLIMS software for commercial sample trending and monitoring .
- Performed Finish Product testing (Assay, CU, Dissolution, Water Activity) and tabulation/interpretation of results.
- Preparation of test solutions/standards and disposal of Hazardous Waste.
- Raw Data, Solution and Laboratory notebook documentation and review in GMP environment.
- Authorized and escorted personnel into controlled drug substance areas.
Education
MBA - Data Analytics
Saint Leo University
Saint Leo, FL05-2026
Bachelor's degree - Chemistry
Universidad Ana G. Mendez-Recinto Gurabo
Gurabo, PR01-2015
Skills
- Analyzing data
- Cross-functional collaboration & client communication
- Technical writing & scientific reporting
- Formulation development
- Knowledge of computer skills (Microsoft Office 365 Apps)
- Achieve results using analytical, organizational and decision-making tools
- Knowledge of local and federal regulations pertaining to GMP, OSHA, EPA, DEA, EEO and FDA environment and any other regulatory agencies concerning our operations
Certification
Lonza Customer Interaction Training
LANGUAGES
Spanish and English
Timeline
Product Development Research Chemist
Lonza
09.2021 - Current
AR&D Associate Scientist
Catalent Pharma Solutions
07.2020 - 09.2021
Chemical Analyst
Merck-LPO
09.2017 - 06.2020
MBA - Data Analytics
Saint Leo University
Bachelor's degree - Chemistry
Universidad Ana G. Mendez-Recinto Gurabo