Manufacturing Transfer & Integration in Biologics Clinical Manufacturing

Below were my main responsibilities in addition to day-to-day tasks at Downstream Biologics Clinical Manufacturing. ADC (Antibody Drug Conjugate) campaign SMEI lead ADC campaigns; I lead cycle counting materials, buffer planning, kitting, writing equipment methods, setup, process, and breakdown. I practiced vigilance, followed the science, and maintained active communication with necessary parties for successful completion of each lot. I lead both internal and cross-functional discussions with MTI and PPS-TT to improve current ADC campaign practices and eliminate weak points, streamline processes, improve safety, and achieve coherent and accurate MPRs and SOPs. As part of this endeavor, I lead NMIs to improve GMP compliance and efficiency. Purification processesI mainly lead and provided trainings for chromatography and TFF (Tangential Flow Filtration) setups and operations using GE Chromatography skids, AKTA skids, Pall DF skids and Pall Allegro SUTFF skids. I identified complex problems that arise during process and provided suitable solutions.TrainingI identified training and knowledge sharing needs and initiated presentations of technical information concerning specific campaigns, projects, or routine tasks. I dedicated myself to expanding the team knowledge base and heightening the team training level to build a team that can achieve consistent, lasting success. GMP documentsI reviewed GMP documents and edited or provided feedback for technical accuracy and quality assurance. I lead trainings for GMP document request flow.Sample and DLIMS SMEI was involved in regular cross-functional communications with QC and PPS-TT, provided DLIMS training and troubleshooting for the team, and lead cross-functional implementation new sample logging method for IDB.

My main responsibilities included managing and budgeting company finances and administering employee contracts and compensation. Additionally, I was involved in writing the employee handbook, constructing the business plan, managing sales, writing NDAs and grant applications, and aquaculture and hydroponics operations.

My first project as the scientist and lab manager was establishing a new R&D lab, which included equipment procurement, lab renovation and budgeting. My research projects include: screening products for high levels of mycotoxin using ELISA and developing methods to reduce mycotoxin to prevent recalls and suspension; and analyzing lipid accumulation inhibition capabilities of products, under the supervision of Professor Nam Keun Lee of Chung-Ang University. I presented research findings at 2017 International Conference on Food Chemistry and Technology in Baltimore, MD.

I identified the dominant bacterial species in gochujang using gel electrophoresis and PCR under the supervision of Professor Young Tae Ham at the Microbial Genetics and Engineering lab.