Process and analytical development scientist with expertise in donor-derived and iPSC derived allogeneic cell therapy platforms and leading technology transfer of manufacturing processes/QC methods into GMP for Phase I clinical trials.
Melissa’s career started in a T cell immunology research lab at Duke University Medical Center where she developed up to 18-color flow cytometry panels and Luminex assays to characterize several patient treatment populations and time course studies within the pulmonary, allergy, and critical care department. Additionally, she worked very closely with the Pratt School of Engineering to design and perform novel magnetic bead isolations for lab-on-chip applications.
After that, Melissa joined Precision BioSciences where she was responsible for leading a team of researchers within the Cell Therapy CMC Analytical group. In this capacity, she served as the technical subject matter expert in bioassay and flow cytometry method development for three allogeneic CAR-T cell therapies currently in human clinical trials. Melissa developed several highly novel deep characterization and QC-ready analytical methods in support of cell therapy product in-process control and release. Before assuming this role, Melissa was one of the original team members of the CAR-T process research and development team and played a significant part in the early development of the company’s allogeneic CAR-T platform.
From there, Melissa went to OrganaBio where she led Immunology Process and Product development. At OrganaBio, Melissa leveraged the company’s propriety supply chain of perinatal tissue to develop processes to isolate HSC, NK, and T cells from cord blood and placental tissue. Melissa also developed comprehensive flow cytometry panels to phenotype each cell type to market them to cell and gene therapy drug developers. In addition, Melissa served in an outward facing role to support generation of SOWs for process development work and response to RFPs for GMP work for its prospective customers.
Immediately prior to joining Dark Horse Consulting, Melissa was leading MS&T and Analytical Development at Cytovia Therapeutics. Melissa was one of the first members of the scientific team and worked closely with Cytovia’s collaborators on-site to document and internalize the iPSC-derived NK cell process and tech transferred the process into its new internal R&D site and subsequently transferred the improved process to its GMP manufacturing facility including batch record level protocols. Melissa simultaneously identified and led the development and pre-qualification of all the analytical methods needed for in-process controls and release including flow cytometry, qPCR, and bioassays.
Cytovia Therapeutics
Associate Director, MS&T and Analytical Development
Senior Manager, MS&T and Analytical Development
OrganaBio, LLC
Manager, Immunology Process and Product Development
Precision BioSciences, Inc.
Scientist I, Cell Therapy BioAnalytical Development
Associate Scientist, Cell Therapy BioAnalytical Development
Research Associate, Cell Therapy BioAnalytical Development
Research Assistant, Cell Therapy Process Development
Duke University Medical Center
Laboratory Research Analyst
Research Technician II
University of Florida
M.S. in Medical Microbiology and Biochemistry, Concentration in Cell Science
North Carolina State University
B.S. in Biological Sciences, Concentration in Human Biology, Minor in Business Administration
