Chao-Hsiang (Richard) Wu 吳朝翔 Email and Phone Number

Leadership and Strategy:● Lead a team of 10 staff members, focusing on maintaining and advancing the infrastructure that supports all analytical and operational activities within the AS organization.● Enhance AS's ability to deliver accurate, compliant, and timely analytical results, supporting the full product lifecycle from pre-Tox studies to post-commercial stages.Infrastructure and Compliance:● Optimize and standardize business processes, ensuring comprehensive compliance with industry and regulatory standards.● Manage the lifecycle of critical reagents and analytical equipment, ensuring they meet regulatory and developmental requirements.Sub-Groups Management:● Oversee the Systems (Compliance and Business Processes), Technical (Critical Reagents Management), and PM (Pre-commercial and Commercial) sub-groups.Data Integrity and Standardization:● Implement sustainable procedures to ensure data integrity and conduct thorough GMP assessments, supporting quality compliance throughout the product lifecycle.● Standardize all laboratory practices to enhance traceability and data integrity from initial research through post-commercialization.Stakeholder Collaboration:● Engage with key stakeholders and partners outside of Analytical Sciences, including regulatory agencies, suppliers, vendors, CROs/CMOs, and various internal departments (e.g., QA, QC, Finance, HR).Performance Metrics and Budgeting:● Develop and implement a comprehensive set of Key Performance Indicators (KPIs) and performance metrics that align with the objectives of the Group.● Integrate resource planning tools to streamline project and resource management, enhancing budget tracking and forecasting.Safety and Equipment Management:● Promote a safety culture and integrate safety practices by implementing 6S initiatives.● Ensure fit-for-function instrument qualification, maintenance, and audit-readiness, supporting regulatory compliance and operational readiness across all stages.

With a strong background in the biotechnology industry, I have successfully led high-performing teams to manage multi-modality First-in-Human (FIH) pipeline projects and navigated complex partnerships to advance innovative programs, while maintaining adherence to regulatory guidelines and delivering key clinical trial applications. My expertise spans across diverse projects, including Amgen-TeneoBio assets, novel bi-specific UniDab molecule, and CMC guidelines compliance.● Leading a high performing Pre-pivotal Attribute Sciences (PPAS) portfolio project team of six (6) Attribute Sciences Team Leads (ASTLs) to manage multi-modality First-in-Human (FIH) pipeline projects: AMG 235, AMG 256, AMG 424, AMG 442, AMG 513, AMG 562, AMG 592, AMG 624, AMG 643, AMG 659, AMG 691, AMG 728, and AMG 757.● Managing externalized Amgen-TeneoBio assets consists of TNB-409, TNB-625 and TNB-928 through Contract Development and Manufacturing Organization (CDMO) engagement for method development, qualification, transfer, and validation for product release and stability testing.● Being the specification Business Process Owner (BPO) for PPAS function to ensure Amgen CMC guideline adherence and alignment to cGMP and Regulatory Agency (RA) expectations.● Delivered Investigational New Drug (IND) Module 3 (M3) Quality Clinical Trial Applications (CTAs) for several programs.

I have been at the forefront of innovation in biomanufacturing, implementing transformational Process Analytical Technologies (PAT) and establishing In-Process Control (IPC) and Real-Time Release Testing (RTRT) strategies for continuous manufacturing processes. My scientific leadership roles have spanned across multiple projects, guiding teams to achieve groundbreaking results in biomanufacturing efficiency and quality control.● Introduced and implemented transformational and novel Process Analytical Technologies (PAT) to enable the realization of the Industry 4.0 aspirations to reduce costs, increase efficiency, and improve the overall competitiveness of biomanufacturing at Amgen.● Established & implemented the In-Process Control (IPC) & Real-Time Release Testing (RTRT) strategy for the industry-leading, highly integrated biological Drug Substance (DS) and Drug Product (DP) Continuous Manufacturing (CM) process at ATO B6 pilot facility.● Realized an industry-first close-loop PAC capability through novel PAT deployment and execution at ATO B6 pilot facility. This ensured product Critical Quality Attributes (CQAs) were compliant to the final Quality Target Product Profile (QTPP).● Scientific Leadership: - ATO B6 Integrated CM PAT and RTRT Implementation Project Lead - ATO Pilot Plant PAT and PAC Implementation Project Lead - ATO B18S Pre-pivotal PAT Analytics Implementation Lead - AS Biological and Synthetic PAT and PAC Cross-site Cross-functional Team Lead - PD/AS Scientific Advisory Committee (SAC) Member - Automation Technical Action Team (TAT) Team Member - IQ PAT for Biological CM Working Group

I demonstrated exceptional leadership and management skills by leading the cross-site Rapid Analytics group, overseeing multiple site-based line managers, and implementing phase-appropriate GMP and 6-Sigma DMAIC practices to ensure compliance and quality. My commitment to operational excellence and LEAN transformation has resulted in significant improvements in testing turnaround times and laboratory efficiency.● Led the cross-site Rapid Analytics (RA) group, and supervised multiple site-based line managers, to provide quality analytical support (HPLC, UPLC, RCE, NRCE, LC-MS, AAA, Tecan Atoll, LabChip, UV-Vis, HILIC-FL, LS, etc.) to pre-pivotal, pivotal, and commercial teams’ process development activities and regulatory filings.● Implemented Phase-Appropriate GMP and 6-Sigma DMAIC practices to meet organizational compliance and quality standards.● Executed Operational Excellence (OE) and LEAN transformation to optimize workflow and space usage resulted in 30% reduction in testing result turnaround time (TAT) and 35% reduction in laboratory footprint.● Scientific Leadership: - PD Innovation Summit committee - PD technology development advisory committee

● Managed a core, automation-centric, and high throughput-oriented analytical laboratory with highly skilled scientists to support pre-pivotal/pivotal projects, and technology development, method qualification and transfer to QC organization.● Pioneering in novel Process Analytical Technology (PAT) to achieve Product Attribute Control (PAC) technology imperative in the PD department. Managed a cross-functional analytical team to synergize effort to realize departmental technology imperatives.● The capability and the potential of both Tecan Atoll purification processes and µSI technology were recognized at Translational Sciences All Staff Meeting by Joe Miletich (Senior VP). The goal was to bring the µSI technology to manufacturing floor.● Transferred the uSI technology to AWA and AMA site implementation.● Contributed to scientific journal articles and complex technical documents as lead author.

● Expanded mass spec assay capability for water soluble vitamin assay using UPLC-TQD MS, monosaccharide assay by UPLC-TQD MS, and incorporated Waters QDa MS detector for higher throughput in the HILIC-Glycan and other small molecule assays (< 2150 Dalton mass).● Expended automation platform efficiency by implementing IMAC Tecan Atoll mini-prep purification process for BiTE molecules, doubling the Atoll RoboColumn on Tecan and Tecan-Rotanta platform process capacity, and implementing high-throughput small scale sample cleanup/purification process using PhyTips on Caliper Sciclone robotic platform.● Implemented High Throughput automation technology (implemented automatic HT ProA sample purification processes using to increase capacity and sample logistics within the group, implemented PhyTips HT ProA in a miniaturized format to allow PQA to be assessed for clone selection. This will allow better decision at the early stage of product development, and implemented Caliper GX to increase assay throughput and capacity. Also provided an opportunity for assay development for new modalities.● Subject matter expert in micro sequential injection (µSI) technology - a miniaturized wet chemistry assay platform - and has designed at-line, real-time bioreactor monitoring of glucose, mannose, product concentration (titer), amino acids, glycan map, and peptide map. Successfully interfaced multiple bioreactors to analytical instruments such as UPLC and MS for real-time monitoring of substrates and product attributes at Cell Sciences and Technology (CS&T) department. Incorporated µSI technology in MS-PAT and PAC Playbook as a future technology guidance in PD department.

● Discovered the root causes of the discoloration (yellowing) of certain monoclonal antibodies (mAbs) that have solvent-accessible Tryptophan (Trp) residues and lack of protective oxygen scavenger residues, such as Methionine (Met), in the central CDR3 domain after a prolonged duration of ambient light (containing UV rays) exposure. The discovery influenced the future roadmap of Amgen mAb products to strategically design and produce yellowing-resistance mAb products with the aims of better safety and patience experience. This has been a good example of "product-by-design" concept.● Characterization and identification of proteins and monoclonal antibodies primary structure, biomarker assays development, and exploration and evaluation of novel PAT methodologies for critical cell cultures attributes monitoring and automatic feedback mechanisms for bioreactors.