Hyewon Song Email & Phone Number

South Korea

Daejeon, South Korea

1. Facilitated Collaborative Projects with Global CDMOsManaged and coordinated joint projects with Contract Development and Manufacturing Organizations (CDMOs), focusing on drug substance development. This role required extensive cross-functional collaboration to ensure alignment on project timelines, quality standards, regulatory compliance, and fluency in English to facilitate communication between both parties.2. Process Optimization and Technical Transfer ExpertiseLed a small-scale process optimization study aimed at higher efficiency and yield of siRNA. This involved hands-on experimentation, data analysis, and iterative process adjustments. The insights gained were meticulously documented in technical transfer reports facilitating the smooth scale-up and implementation of optimized processes at larger manufacturing scales.3. Laboratory Setup for Downstream ProcessingPlayed a key role in the establishment of a state-of-the-art downstream processing laboratory. This included the selection and installation of critical equipment, and designing workflows. The facility was optimized for the purification and formulation of siRNA, enabling high-throughput and high-purity production capabilities.4. Proficient in Oligonucleotide Manufacturing EquipmentDemonstrated versatility in operating and troubleshooting specialized oligonucleotide manufacturing equipment, including the OP100 for small to medium-scale synthesis, as well as downstream process equipment such as purification systems and tangential flow filtration (TFF) units. 5. Equipment QualificationsExecuted comprehensive equipment qualifications (IQ/OQ) for critical process equipment, ensuring they met all operational specifications and regulatory requirements. This included the review of qualification documents, execution of qualifications, and reporting of qualification results, thereby ensuring that all manufacturing processes were under validated conditions and met stringent quality standards.