AS FL 分析高级科学家

Work Scope Lead and mentor junior scientists to develop liquid chromatography and electrophoresis-based analytical methods for protein therapeutics across early and late development stages, including method development, assessment,

, troubleshooting, and continuous improvement of workflows, analytical technologies, and business capabilities. Serve as the analytical function lead to support CMC projects, including: Manage analytical timelines and deliverables Provide cross-functional support and technical feedback to facilitate project progress Prepare and review CMC analytical sections for regulatory submissions (e.g., IND and BLA filings) Qualifications Master’s degree or above in Analytical Chemistry, Biochemistry, Pharmacy, or a related discipline. Relevant experience requirements: Master’s degree: ≥5 years of relevant industry experience Proven expertise in analytical method development and demonstrated scientific achievements are required. Extensive hands-on experience with analytical technologies such as HPLC, CE, and MS. Industry experience in method development, qualification, and validation for CMC applications is preferred. Solid experience in biochemical and physicochemical characterization of protein therapeutics. Excellent communication and interpersonal skills, with strong verbal and written proficiency in both English and Chinese. Strong knowledge of CMC development and regulatory requirements is highly preferred. Experience in interacting with regulatory authorities (e.g., FDA, EMA, NMPA) is preferred.