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CMC Lead US - Payload Linker

WuXi XDC

WuXi XDC (stock code: 2268.HK), a leading Contract Research, Development and Manufacturing Organization (CRDMO) focused on the global antibody drug conjugates (ADCs) and broader bioconjugate market, is a pioneering CRDMO offering integrated, end-to-end services. Services are provided from proximately located, state-of-the-art laboratories and manufacturing facilities, allowing for a significant reduction in development timelines and costs. Headquarter in Shanghai, China, our over 1,000 skilled employees work across a global network to deliver expert-driven, high-quality and right-first-time project execution for our customers. By offering a single-source, open-access platform with the most comprehensive capabilities and technologies, WuXi XDC enables our biopharmaceutical partners to speed the development of innovative therapies for the benefit of patients worldwide. About the job Summary: The incumbent will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical teams and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting WuXi XDC’s services at conferences/trade shows. Responsibilities: Participate in CMC projects. Coordinate with sponsors and internal expertise to design appropriate studies to meet regulatory requirements and project’s needs. Closely monitor the project with continuous scientific and technical support. Proactively identify potential issue and provide constructive suggestions timely. Prepare the analytical sections of filing dossiers to support regulatory submission including INDs and BLAs. Directly communicate with domestic and international clients to report analytical progress and solve technical issue of projects. Assist with development and manufacturing alliance management, product development and manufacturing strategy. Coordinate efforts and facilitate communication to ensure alignment between WuXi XDC and clients. Work with a high-performance team to ensure best quality services. Enhance current service offering and develop new clients. Qualifications: PhD holders in organic chemistry, analytical chemistry, chemical engineering, and other related fields. Proficient in basic theories of organic chemistry, familiar with analytical spectrum analysis, post-treatment of organic synthesis reactions, purification and other professional skills. Good team player with excellent interpersonal, communication and presentation skills (both written and verbal). Independent researcher; strong problem solving and troubleshooting capabilities; proactive and self-motivated; good at multi-tasking. Working experience in ADC is preferred. Good English communication skills, including reading, listening, writing, and speaking. Personal Growth/Career Development Embrace a multi-level, diversified talent training and development system of WuXi XDC, comprehensively developing general skills, technical capabilities and leadership. Gain extensive technical experience for biopharmaceutical analysis through WuXi XDC’ global technology platform. Accumulate abundant CMC project experiences in a few years, not only in analysis, but also in process development, manufacturing and regulation submissions. Have chance to learn, work and grow with WuXi XDC in long-term development. #J-18808-Ljbffr WuXi XDC

Vacancy posted 2 days ago
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