Senior Scientist
Hercules, Ca, Us
Process Development, Transfers Optimization and Manufacturing support.Developed, transferred and optimized functional and/or analytical tools, experiments and assays to ensure continuous manufacturability of production processes (QC procedures, Continuous Improvement projects…) using statistical analysis approaches including, but not limited to, Specifications Analysis/Setting, Process Capability Indexes analysis (Graph Pad, JMP software).- Revised and/or developed several Quality Control assays (including, but not limited to, testing, validation and procedure revision and implementation):• Real-Time Nuclease contamination detection assay, reducing costs of the procedure by $80,000/year while improving the limit of detection by 3 fold. • Isothermal polymerase activity assay improvement, reducing cost of goods by 90%, hands-on time by 75%, experiment-to-experiment variation by 45% and increasing first pass rate to 99%. Trained and mentored Chemists on this project• Real-Time Isothermal Reverse-Transcriptase assay for activity quantification. This Real-Time dye-based assay increased unit definition accuracy by 60%, while reducing experiment-to experiment variation to 5%. Trained and mentored the whole QC group on this project.• Real-Time Isothermal DNA polymerase assay for activity quantification. Similar concept as for the Reverse-Transcriptase assay. Limited to troubleshooting assay for legal reasons.- Led troubleshooting studies of two customer complaint cases linked to potential quality issues. Provided clear Yes/No answer to upper management, ultimately saving respectively $850,000 and $600,000 worth of dispensed products. Developed procedures and new methods that were not available for future troubleshooting needs.