职责描述： • Working in immunoassay area to provide GLP-compliant service to world-class pharma and biopharma. • Serve as an internal expert to design, develop and validate assays to measure biological drugs, their targets, or anti-drug antibody (ADA), neutralizing antibody (Nab) in biological fluidic samples from pre-clinical and clinical studies • Develop and maintain high level of scientific achievements for the BA team. Be expected to be point of contact for technic supporting, and troubleshooting in assays, , including email and video/tele- conference with customers. • Effectively communicate and interface with business partners, internal Quality Assurance Unit and external regulatory authorities in order to fully comply with GLP and other pertinent regulations. • Conduct regulatory agency inspections, and serve as a technical liaison to engage and onboard domestic and international clients. • Prepare, review or approve assay validation and bioanalytical reports and present data to clients • Provide training and mentorship to internal staffs Method Development Leader- Small Molecule Key responsibilities: • Lead the method development with bioanalytical scientists in LCMS/MS small molecular team to provide GLP-compliant service to world-class pharma and biopharma; • Serve as an internal expert to design, develop and validate assays and utilize professional knowledge and experience to solve complex technical issues in small molecule clinical bioanalysis; • Develop and maintain high level of scientific achievements for the BA team. Be expected to be point of contact for technic supporting, and troubleshooting in assays, , including email and video/tele- conference with customers. • Team working with bioanalytical team including SD/PI, bioanalyst and other related scientific staff. Oversee multiple MD projects/studies conducted at the same time: Manage activities, aggressive timelines, priorities, resources, establish work schedules, and keep meticulous records to ensure on time deliverables. Serves as a center to connect between MD and the project teams; • Involve in process optimization to improve operation efficiency and quality to reduce the cost and improve customer’s satisfaction. • Be well versed with WuXi’s program management system in tracking the progress of projects with regard to meet timeline and finance milestones, follow-up actin items for resolutions. • Effectively communicate and interface with business partners, internal Quality Assurance Unit and external regulatory authorities in order to fully comply with GLP and other pertinent regulations. • Participate in regulatory audits of projects; Perform duties complied with the related SOPs and according to OECD, USFDA and NMPA (Previous CFDA), etc., GLP guidelines as well as other applicable regulations. • Provide training and mentorship to internal staffs 任职要求： Essential: • PhD degree in Biochemistry, Analytical Chemistry, Pharmacy, or a related field, or a Master’s degree in a related field with extensive clinical work experience (5 years’ work experience). • A minimum of 2/3 years of industrial experience in CROs and/or pharmaceutical companies • A minimum of 3/5 years direct experience in large molecules bioanalysis in support of preclinical and/or clinical PK/TK/PD, ADA, and vaccine studies • Strong understanding of large molecules bioanalysis technologies and GLP/GCP/GCLP • In-depth understanding of small molecule bioanalytical techniques, including but not limited to HPLC, LC-MS, GC-MS, and their applications in clinical trials. • Familiar with pharmaceutical R