• Responsible for providing direct support and overall leadership to the manufacturing of Cell Therapy products, Master and Working Cell Banks, Gene Therapy products, Final Product fills according to cGMPs• Leads a technical and scientific team focused on supporting and improving operation performance in aspects of process and human performance• Develops and maintains systems and metrics to coordinate and communicate production expectations and preparation to present during regulatory inspections and audits. • Provide technical support with routine manufacturing, aid in troubleshooting through process monitoring, trending and risk identification• Provide process improvements to achieve safe, compliant and cost effective production • Provides leadership to a team that leads complex technical investigations, CAPA/action plans and change controls• Provides support during late stage programs in support of commercialization efforts• Supports commercial programs through the performance of process monitoring, trending, comparability and controls• Provides issue resolution, improvement programs, optimization and life cycle management

Vaccine Manufacturing Manager - Manage the cGMP production of HER-2/neu pulsed dendritic cell vaccines for patients with breast cancer- Train and guide junior staff on the manufacturing of a mammalian cell culture immunotherapy production operation - Advanced the manufacturing process towards a direct infusible cryopreserving solution for the application of phase III multiple center- Quality control monitoring under FDA, IRB and cGMP guidelines- Implementing new protocols for immune monitoring for more consistent, cost efficient and reliable results- Formulating manufacturing techniques to employ a less time intensive production and ultimately result in the ability for multiple center applicationsResearch Project Management - Managing regulatory the requirements and submissions- Screen, coordinate and monitor of subjects- Collaborate with numerous departments to orchestrate a cohesive treatment plan- Produce research documents including consent forms, HIPAA authorization forms, and protocol summaries in accordance to the sponsor or institutional requirements. - Generate multiple submission types (new protocols, deviations, amendments, modifications and continuing reviews) for IRB, FDA, and Abramson Cancer Center- Prepared and submitted IND reports- Deviations, modification, adverse event and amendment reporting- Collaborated with PI on the creation of new protocols and grant submissions

- Collaborated with the safety assessment and bioinformatics groups to establish a protocol for a meta analysis comparing the similarities or differences of outcomes in preclinical and clinical data- Multiple compounds genomic profiling on renal toxicities affects

- Performed siRNA knockdown and viral vector transfections