
Detail-oriented Manufacturing Associate with expertise in cGMP documentation and risk analysis. Proven ability to execute critical upstream cell culture processes, ensuring compliance and operational efficiency.
Completed minor internal manufacturing investigations to support Compliance team and senior investigators with major investigations.
Drafted Gemba, Pre-Approval, and Summary reports for major investigations while utilizing systematic causal analysis methods.
Executed all critical stages of cGMP Upstream Cell Culture Manufacturing (vial thaw through small-scale bioreactors) for both CHO and SF-21 cell lines.
Managed and ensured the compliant execution of all upstream unit operations, specializing in Single Use Technology (SUT).
Performed complex aseptic sampling protocols (shake flask, wavebag, and bioreactor) while maintaining strict adherence to cGMP Standard Operating Procedures (SOPs).
Finalized and closed out batch records, including generating required process trend reports and reconciling all unused materials.
Led Tier 1 changeover meetings, ensuring effective and clear communication of critical process status, deviations, and operational needs to the incoming Cell Culture team.
Operated complex development-scale equipment, including bioreactors, filter trains, Tangential Flow Filtration (TFF), and chromatography systems.
Performed culturing and characterization of both aerobic and obligate anaerobic organisms to produce and analyze phage activity across diverse bacterial strains.
Developed and optimized protocols for CRISPR-based solutions in microbial systems.
Conducted laboratory experiments following established protocols to ensure compliance with safety regulations.
Operated and maintained laboratory equipment to support accurate data collection and analysis.
Served as the Primary Liaison between the Manufacturing Science and Technology (MS&T) Department and the offsite cGMP storage location, ensuring seamless supply chain and material readiness.
Attention to Detail
cGMP Documentation
Continuous Improvement
Risk Analysis
Lean Six Sigma Yellow Belt
Solomon EOS, LLC