理化分析高级研究员

• Lead the design, execution, and interpretation of analytical studies using HPLC (SEC, RP, IEX, etc.) and CE (CE-SDS, icIEF, etc.) to characterize and assess the quality of biotherapeutics. • Develop, optimize, and qualify/validate analytics for product characterization, release, and stability testing, consistent with applicable regulatory expectations. • Lead implementation, lifecycle management, and continuous improvement of platform analytical methods across the organization. • Investigate and resolve complex analytical issues, applying sound scientific and statistical principles to identify root causes and effective solutions. • Analyze, interpret, and document analytical data with a strong focus on data integrity, scientific rigor, and compliance with applicable quality standards. • Author technical reports, analytical protocols,

/validation documents, and regulatory submission content; communicate results effectively to cross-functional teams and clients. • Provide technical mentorship, training, and scientific guidance to junior scientists. • Support lab operations, including instrument qualification and maintenance, analytical resource planning, and adherence to GMP/GLP, safety, and quality requirements. • Collaborate closely with CMC, Process Development, Project Management, Regulatory Affairs, and other cross-functional teams to advance projects and meet milestones. Qualifications: • Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline with 2+ years of relevant industry experience; M.S. with 6+ years; or B.S. with 8+ years of relevant experience. • Strong hands-on expertise in HPLC and capillary electrophoresis, including techniques such as SEC, RP, IEX, CE-SDS, and icIEF. • Strong track record in analytical procedure development, optimization, qualification, and validation for biopharmaceutical products. • Proficiency with Empower or equivalent chromatography data systems for data acquisition, processing, and analysis. • Strong understanding of physicochemical characterization of biotherapeutics and vaccines, including structural attributes, purity, heterogeneity, aggregation, charge variants, and molecular integrity. • Broad knowledge of analytical characterization techniques and their application to critical quality attributes (CQAs) of biotherapeutics. • Working knowledge of ICH, FDA, and EMA regulatory expectations and GMP/GLP laboratory practices. • Experience with analytical procedure lifecycle management, platform methods, and laboratory/instrument management is preferred. • Prior experience supporting or authoring regulatory submissions (e.g., IND, BLA) is highly desirable. • Excellent scientific judgment, problem-solving, organizational, and communication skills. • Demonstrated ability to independently manage multiple projects, prioritize competing activities, and deliver high-quality results in a fast-paced environment. • Strong interpersonal and collaboration skills, with the ability to work effectively in a team-oriented, cross-functional environment.