● Orchestrated and led cross-functional clinical programs to achieve project goals and technology transfer to EU via 9 change controls containing 250+ change actions, leading to 2 CTA approvals, 1 IND approval, and 1 MHRA approval. ● Spearheaded over 50 triages for manufacturing process and documentation deviations on Sepax C Pro, Rotea, and CliniMACS Plus, ensuring a 93% manufacturing unit operation success rate through a systemic problem solving approach. ● Drove the implementation of a Clinical Visual Inspection program, with consideration of US, EU, and APAC regulatory bodies to create a process map, Gantt Chart, RACI, 2 SOPs, and operator training to execute the program. ● Developed and delivered a compressed 2 month timeline for a 5 month process to support a critical manufacturing change, ensuring continuous drug product production; utilizing key skills such as cross-functional collaboration, project management, department-wide presentations, and manufacturing hypercare with gained technical knowledge. ● Authored 2 clinical readiness and 2 stability protocols and trained 8 to 9 teams on executing the documents to confirm manufacturing readiness, adherence to regulatory standards, CMC expectations, and de-risking critical path activities. ● Accomplished a Lean Six Sigma Yellow Belt Project centered on an Electronic Batch Record gap assessment utilizing yellow belt tools such as SIPOC Diagrams to identify 18 gaps and initial actions providing $100,000 in yearly savings.

● Led the Titer and Amino Acid workflow within the analytics group under Preclinical Manufacturing and Process Development, analyzing over 3000 amino acid and 1000 protein samples using HPLCs. ● Performed cross functionally with the purification group to deliver titer data on harvest days by ensuring a 10-minute turnaround time from receiving the sample to relaying the data, speeding up the harvest by 14%.