Xiang-Yu W. Email & Phone Number

United States

Shanghai

Drug Product Lead:*Pioneered the product development of a groundbreaking dual-chamber device drug delivery system, achieving product feasibility and patent application within an impressive 18 months—marking the first of its kind in the greater China market.*Successfully managed three large molecule products, ensuring seamless oversight of IND & BLA dossier preparation, review, and update.*Orchestrated the development and execution of a comprehensive NIFDC testing sample plan.CMC Project Management:*Collaborated closely with a local Contract Development and Manufacturing Organization (CDMO) to facilitate efficient tech transfer and local manufacturing processes.*Spearheaded the process development of a novel drug product, notably introducing the first dual-chamber system to the greater China area.Global Collaboration:*Led the intricate technical transfer process from the licensor to local CDMO, showcasing effective leadership and cross-border collaboration.*Conducted a thorough registration gap analysis, implementing strategic mitigation plans to address identified gaps and ensure compliance with regulatory requirements.

Shanghai

CMC Project Management:*Successfully oversaw the technical transfer of a late-phase oncology project, specifically dealing with a monoclonal antibody.*Managed critical aspects of process performance qualification and facility fit, ensuring alignment with project goals and regulatory requirements.*Managed commissioning and qualification processes for essential process equipment.Biologic Product Development:*Led the technical transfer and PPQ of new products for large molecules.*Acted as the process lead for a significant vaccine project for certain virus, pre-F protein, leveraging expertise in biologic process development, including formulation development.Digital Ambassador Project:*Initiated and spearheaded the first digital project in China, focusing on the digitization of smart factory processes. Only 2 candidates from China, out of 30 globally.*Actively participated in the global collaboration committee for digital initiatives, contributing to the integration of digital technologies in global operations.Other Responsibilities:*Provided support for secondary packaging, clean utility functions, and automation teams, contributing to overall operational efficiency.*Engaged in the Phase III expansion project, demonstrating a commitment to the strategic growth and development of the organization.

Hangzhou

Project Manager:*Led the formulation system renovation project, demonstrating strong leadership and coordination skills among various stakeholders.*Acted as the SME of formulation process, as well as project manager, coordinating vendors and internal teams*Oversaw the project budget, maintaining financial forecasts to ensure fiscal responsibility.*Managed on-site construction Environmental Health and Safety (EHS) measures, prioritizing a safe working environment.Other Responsibilities:*Provided support for the office building renovation project, contributing to the enhancement of working spaces.*Coordinated various projects across Abbott Medical Optics, showcasing versatility in handling diverse responsibilities.Global Mentoring Project:*Contributed as a global committee member, playing a key role in facilitating the establishment of a global mentoring network.*Played a pivotal role in mentor-ship initiatives, contributing to the formation of mentor/mentee pairs for a substantial number of colleagues.

Suzhou, Jiangsu, China

Global Insulin Filling (DP) Project:*As the Drug Product (DP) process Subject Matter Expert (SME), played a pivotal role in the filling system's ownership.*Global collaboration involvement in facility Design Qualification (DQ), equipment DQ, Installation Qualification (IQ), and Operational Qualification (OQ) across international sites (US/Italy/France).*Orchestrated a successful Factory Acceptance Test (FAT) engineering shakedown in the Suzhou site.*Led the technology transfer of a commercial product to the local site, coordinating seamlessly with the global team.On-site Project Management:*Managed on-site operations encompassing move-in, temporary installation, relocation, permanent installation, room finish, and utility tie-in.*Headed the design, review, documentation, and approval of the aseptic filling line with oRABS.*Drafted, reviewed, and approved various technical documents, including User Requirements, Technical Specifications, System Overviews, Functional Specifications, and Commissioning and Qualification work plans and test cases.*Designed and executed the installation of two purified water skids for the temporary testing of filling equipment.*Spearheaded the design and manufacturing of a set of mockup equipment crucial for operator training purposes.

Lafayette, Indiana Area

*Experimental simulation to the 2010 DWH oil spill; *Theoretical analyse of the multi-phase properties of oil flow which paved way for future research

Master Of Science (Ms), Microfluidics, 3.8

Bachelor Of Science - Bs, Bioengineering, 3.7