Research Associate Process Development
CurrentResearch Associate in product development at Cello Therapeutics with experience gained from initial product development, through animal studies, and approved for Phase I.• Assisted in GMP production of batches used for IND submission, which was approved in 1 month• Completed two batches of drug product in a GMP facility through fill finish• Built and acted as the company’s QA department including inventory receipt and disposition, instrument IQ/OQ/PM, procedure qualifications, batch record keeping, incident reporting, and batch release• Contributed to report writing for IND submission• Conducted stability tracking of the two batches since production• Developed a novel membrane coated, mRNA loaded LNP production process• Performed extensive research and trials in LNP formulation• Used T-junction and herringbone pattern microfluidics• Developed an assay to determine mRNA loading efficiency• Conducted in-vitro transfection experiments to support my product• Began patent writing with my method and supporting data• Familiarity gained with methods such as dissolution, DLS/Zeta-potential measurements, microfluidization/high energy homogenization, and TEM• Maintained familiarity with HPLC