Yue Huang

The objective of my project: Responsibilities: Collaborated with biopharmaceutical vendor to design the equipment through technological innovation; Organized a cross-functional team to plan and conduct scientific studies to achieve a practical technology transfer for the DS Formulation and Fill & Finish manufacturing line. Achievement: Reduced the equipment buying cost by 90% (from 1.5 million USD to 1 million RMB) through an innovative equipment design. Delivery the final process package without any delay on a tight schedule. My duties & responsibilities (included but not limited to): 1. Plan and conduct experiments on formulation screening for Mab drugs through DOE and single factor studies to support IND application. 2. Build up a freeze-thaw and lyophilization platform to conduct feasibility studies and development studies for multiple Mab drugs and scale up. 3. Work on process characterization studies (drug substance freeze-thaw, compounding, sterile filtration, lyophilization, E&L study on single-use systems and compatibility stuides) and utilize risk assessment through 3 biosimilar drugs development for NDA application. 4. Draft and review technical protocols, technology transfer report and memo to support BLA and NDA application. 5. Familiar with document retrieval sites and strong learning ability.

My duties & responsibilities (included but not limited to): 1. Work within a process development team in R&D department, specializing in assay formulation development and molecular reagent lyophilization cycle development. 2. Support team leader to design a snap-freezing module for Mab products as a CRO company and transfer it to a pilot manufacturing site with a contract over 2 million USD/year. 3. Independently design and execute analytical studies, make reports and troubleshoot for DSC, FDM and Karl Fischer titration, create method validation, method verification and SOPs for those analytical methods. 4. Cooperate with multiple assay formulation teams to plan the assay formulation development studies and create test method, which mainly focus on HIV, HBV, HCV primer and probe design with oligo optimization to reach RT PCR validity criteria. 5. Work with operation team to construct a pilot facility and qualify filling station, Lyophilizer, and packaging line to run the V&V lots. Monitor and cooperate with manufacturing site workers to conduct process characterization studies and pioneer runs to deliver the final manufacturing process package under pressure.

1)Acquire hands-on experience in the laboratory and in-depth understanding in sterile and anti-body products 2)Arrange management and product development meetings and compile experiment data and results 3)Collaborate with senior engineer to conduct the research and product development: lyophilization, Quality by Design (QbD), Design of Experiments (DOE) 4)Familiar with sterile product processing equipment and manufacturing facilities

1)Conduct ingredient and material analysis, water analysis, sanitation activities to assure the quality of assigned product 2)Participate in manufacturing projects relating to quality assurance and manufacturing 3)Collaborate with suppliers, customers and engineers to implement product introduction, design changes and improvement 4)Manage SOP process documents for Coca-Cola manufacturing