Analytical Laboratory Technologist with hands-on experience in Class 100 fill operations, potency assays, and cleanroom preparation. Skilled in sample processing and quality documentation in compliance with cGMP and FDA regulations. Known for precision, problem-solving, and supporting research and clinical teams to achieve reproducible and reliable results.
Overview
7
7
years of professional experience
Work History
Production Technologist/Team Leader
Charles River Laboratories
09.2021 - Current
Performed all PTS production operations with 100% adherence to cGMP and FDA regulations, contributing to the successful completion of over 500 sterile production batches annually.
Adhere to and help develop SOPs, batch records, and other protocols to ensure consistent and compliant production
Executed cleanroom preparation and sanitation of ISO Class 7 and 8 areas, ensuring environmental compliance with zero contamination events and maintaining audit-ready conditions.
Abide by and enforce Good Manufacturing Practices (cGMP) by performing laboratory procedures, including procedures requiring aseptic technique or special handling methods that decreased invalid rates by 50%
Conducted pre-fill potency tests and prepared reusable materials for autoclaving and depyrogenation, ensuring sterility and accuracy across 100+ process cycles per month.
Completed all batch documentation, logbooks, and deviation reports in compliance with FDA, ISO, and company documentation policies, ensuring full data traceability and accuracy.
Coordinated workflow among team members to optimize operational efficiency.
Trained and mentored new staff on equipment operation and safety protocols.
Collaborated with cross-functional teams to streamline production processes and enhance operational efficiency.
INBRE 2019 Spring Lab Research Program
South Carolina State University
01.2019 - 05.2019
Maintained and monitored 5+ arthropod colonies (including Aedes aegypti and Drosophila melanogaster) to support multiple efficacy and behavioral research studies.
Conducted daily care and environmental control for over 1,000 live specimens, ensuring >98% colony survival rate across the study period.
Researched and analyzed insect ecology and physiology, focusing on interspecies interactions, reproduction, and population dynamics using microscopy and behavioral observation techniques.
Collected and recorded quantitative data on insect life cycles and activity patterns, supporting two faculty-led research projects later presented at a university symposium.
Designed and initiated a breeding and rearing program for controlled populations, increasing available test subjects by 35% for subsequent efficacy trials.