Sr. Process Development Associate
9605 Medical Center Dr #200, Rockville, Md 20850
Worked on build out of new lab space when company moved from 9605 Medical Center Drive to 9713 Keywest Ave location. Was responsible for cleaning up the lab, packing equipment from 9605 medical center dr and decommissioning the radiological lab. Collaborated with vendors from VWR and ThermoFisher on purchasing BSCs, incubators, disposables and flooring at the Keywest Ave Site.Performed Process Characterization post FDA Hold in 2017 to get invossa off FDA hold and into the clinic by working with Dr. Kwangwook Ahn and consultants to retrofit its old process into a QbD Process and demonstrate the updated process was in control at the current CMO Vs not being in control at another CMO. Departed shortly before dosing began at US sites to gain more practice specifically in QbD and Process Characterization. Assist in scale-up of Invossa with CROs for Phase III Clinical trial and GMP manufacturing for potential market launch. Review CRO Data with PI.Assist in QbD process characterization including establishing design space through DOE, where experimental data will be used in multivariate regression analysis Participate in meetings between CROs, handle samples and shipping between TissueGene and CRO/CMO.Participate in QC tests for Invossa: qPCR, ELISA and Colorimetric AssaysParticipate in surface marker characterization of in house cell lines. Perform raw materials and reagent inventory for TissueGene experiments.Conduct ordering raw materials and reagents for scale up experiments with CROs.Maintain correspondence with contacts at CROs and materials vendors. Check out the company's paper!http://www.oarsijournal.com/article/S1063-4584(15)01057-2/abstract