理化分析与项目分析管理高级研究员

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   Lead Analytical Activities in CMC Projects(1)Serve as the function leader or sponsor in Analytical Sciences, leadinganalytical efforts in CMC projects.(2)Collaborate with internal experts and cross-functional CMC teams to design andexecute tailored analytical studies that comply with regulatory standards andmeet project objectives.(3)Provide continuous scientific and technical support for project monitoring,proactively identify potential issues, and offer timely, constructivesolutions.(4)Prepare and review analytical sections for regulatory submission dossiers,including INDs and BLAs.2.Analytical Method Development(1)Develop and optimize physicochemical methods for critical quality attributessuch as purity, impurities, and drug-to-antibody ratio (DAR).(2)Demonstrate competency in troubleshooting, optimizing, and implementingchallenging and innovative assays, and participate in daily instrumentoperation, maintenance, and troubleshooting.3.Client Engagement and Technical Support(1)Communicate analytical progress directly with domestic and internationalclients, resolve technical challenges encountered during projects, and ensurealignment with client expectations.(2)Provide scientific guidance and technical support to process development teams(conjugation, purification, formulation) through in-process testing and datainterpretation.4.Talent Development and Continuous Improvement(1)Foster talent development within the team by sharing expertise and bestpractices in analytical techniques and project management.(2)Drive continuous improvement initiatives to enhance analytical efficiency, dataquality, and cost-effectiveness.5.Documentation and Regulatory Compliance(1)Author and review technical documents including but not limited to methoddevelopment reports, method

protocols and reports, standardoperating procedures (SOPs), comparability study protocols and reports, andregulatory filing dossiers, ensuring strict compliance with regulatoryrequirements.(2)Maintain high standards of data integrity and documentation practices.6.Instrumentation and Laboratory Management(1)Oversee operation, calibration, maintenance, and troubleshooting of liquidchromatographs and other advanced analytical instruments.(2)Ensure laboratory compliance with EHS, 5S, and quality management systems.(3)Participate in laboratory public affairs and training activities.Qualifications:

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   Ph.D. in analytical chemistry, biochemistry, protein science, or relateddisciplines, with specialized training in HPLC/UPLC, CE/iCIEF, or MStechniques.2.Proficient understanding of HPLC/CE/MS principles and technologies, withhands-on experience in operation, maintenance, and troubleshooting ofHPLC/CE/MS instruments.3.Demonstrated expertise in physicochemical analysis of proteins andbioconjugates is highly preferred.4.Strong team player with exceptional interpersonal, communication, andpresentation skills (both written and verbal).5.Proven track record as a proactive, independent researcher with advancedproblem-solving skills and multitasking abilities.6.Proficient in English communication, including reading, listening, writing, andspeaking.Career Development:

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   Embrace a multi-level, diversified talent training and development system atWuXi XDC, comprehensively developing general skills, technical capabilities,and leadership.2.Gain extensive technical experience for biopharmaceutical analysis through WuXiXDC’s global technology platform.3.Accumulate abundant CMC project experience over a few years, not only inbioconjugate analysis but also in process development, manufacturing, andregulatory submissions.4.Have the opportunity to learn, work, and grow with WuXi XDC for long-termcareer development.