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職責(zé)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 任職要求： 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