Lead cross-functional teams for scale up and tech transfer process of drug substance mRNA vaccines, viral gene therapeutics and mammalian derived antibodies for successful release of Phase I and II drug substance in clinical facility.Executed building readiness assessments and operational capability to manufacture incoming projects.Conducted budget analysis and material forecasting for incoming projects.Created manufacturing batch records, DeltaV automation recipes, and LIMS sample builds.Implemented process changes to improve production efficiency, provided on-floor support during operations, presented campaign summaries, prepared technical report for Leadership Team, and transferred processes for commercial manufacturing.Authored the Control of Materials IND section and prepared Data Verified Memos for regulatory submission.Coordinated COVID Biologics License Application amendments and notified global Pfizer sites and industry partners.Authored investigations and lead cross-functional teams to implement CAPAs and Change Controls.Assisted with annual facility capital budget, assessed facility needs, and the procurement process.

Authored quality assurance investigations and CAPAs to prevent incident reoccurrence.Routinely engaged with multiple stakeholders to determine the impact of a deviation on material quality.Prioritized investigative efforts to meet clinical material release timelines particularly for COVID vaccine.

Facilitated undergraduate and graduate student comprehension of biomedical engineering concepts.

Learned concepts in intellectual property law, licensing negotiations, and material transfer agreementsDeveloped non-confidential summaries of Tufts owned intellectual properties.Researched and presented market access reports for potential market opportunities of Tufts intellectual properties.Identified potential industry partners to license Tufts owned intellectual property.

Developed, authored, and maintained protocols for process validation, product processing, analytical procedures, and quality systems. Researched, analyzed, and developed methods to calculate silk microparticle size and topographical structure using spectroscopy techniques. Authored and presented complete manufacturing Failure Modes and Effects Analysis (FMEA) and mitigation documents to lead quality engineers and chief science officer.Authored quality product analysis and statistical analysis submitted for 510(k) filing with the FDA.Trained new technicians in analytical techniques.

Recorded data for a clinical study investigating the efficacy of the HPV vaccine among high-risk adolescent girls, and correlated specific behaviors to HPV persistence.