Supported CCS' mission in partnering with CGT & Regenerative Medicine developers focused on addressing unmet need by improving the clinical outcome of patients with novel therapeutic approaches.

Developed the Genomic Medicine Clinical Partnership program, defining its mission, scope and associated procedures to realize ELT management's vision. Identified and strategically assessed collaboration opportunities within the USCAN territory and led the cross-functional team effort to negotiate / execute partnerships and their ongoing management once established.

Supported the Cell & Gene Therapy industry within the Mid-Atlantic territory as a Subject-Matter Expert/Technical Consultant offering clinical manufacturing & custom automation solutions.

Experienced Cell and Gene Therapy / Regenerative Medicine scientist / Subject Matter Expert (SME) focused on assessing cell and biologic based therapeutic treatments, the optimization of their manufacturing process and upscale potential for clinical and commercial success.My involvement in multiple client and internal programs at PCT designing protocols and performing extensive hands-on experiments with many different cell types intended for both patient specific and “off the shelf” allogeneic cellular treatments led towards better characterized, more robust products and automated, cost effective and cGMP compliant manufacturing procedures. - Managed various aspects of technology transfers such as generation of cGMP SOPs & batch records and oversee the execution of process / assay validations.- Led process development programs consisting of protocol generation, experiment execution & data analysis / reporting for cell & gene therapy products consisting of either Mo-DCs, APCs, MSCs, HSPCs, TReg cells, NK cells, NK-T cells, other stem cells (UCB / iPSCs), engineered CAR-T or TCR cells.- Supervised and train the staff (Lab Ops, QC & QA) on developed procedures for all phases of clinical implementation.- Performed detailed resource (manufacturing models), cost of goods (COGS) analyses and create program timelines as management and proposal aids.- Developed efficient, scalable, and functionally closed manufacturing methods as GMP compliant Cell Therapy production unit operations leveraging single use disposable system technologies. - Improved in-process quality control and functionality assays through R&D experimentation.- Compiled data and presented experiment results to clients providing insightful solutions to process limitations and inefficiencies (optimization via value stream mapping).- Generated CMC data and drafted CMC sections for IND submissions to Regulatory Agencies and troubleshooted manufacturing issues as an SME.

Responsible for manufacturing multiple GTP & cGMP cellular therapy products concurrently for clinical research within ISO 8, 7 & 5 cleanroom environments.Cultured, enriched, expanded, differentiated & analyzed different tissue / cell types such as Mo-DCs, APCs, MSCs, HSPCs, UCB stem cells, TReg cells, NK cells, NK-T cells, engineered CAR-T cells or TCR cells.Performed various QC assays on clinical / research samples such as kinetic chromogenic LAL endotoxin, RT-qPCR, flow cytometry immunophenotyping, cell viability, etc.Maintained cryogenic cellular product inventories as well as managed the logistics of clinical product shipments.Maintained the integrity of the cleanroom, laboratory equipment, patient medical files / databases & billing information.

Conducted various chemistry based stability experiments & prepared samples for Client presentation.