临床小分子生物分析主任

The WuXi AppTec bioanalysis business for small and large molecules have been well established for many years – they are the preferred partner for many businesses in China. In 2014 WuXi AppTec acquired XenoBiotic Laboratories* in the US making their capabilities global and thus fulfilling part of an ongoing key strategic objective of WuXi AppTec Senior Leadership to enhance the company image globally. GLP bioanalytical laboratory operations comprise c.600 staff based in China (Shanghai and Suzhou) and the US (New Jersey). In line with current industry trends WuXi AppTec Bioanalytical Services (BAS) are experiencing exponential growth in demand for Large Molecule Bioanalytical Services (BAS) both in China and the US. It is a head of small molecular science position with responsibility for providing both high level local and global client engagement and, trouble-shooting, supporting of external markets promotion, development and maintenance of overseas clients, and high level leadership on small molecular technic team. The senior status of the position recognizes both the scientific focus of the position and the responsibility of interacting with the QA team, not only on the study conduct, quality, but also group operation. JOB DESCRIPTION Key responsibilities: • Lead a team of bioanalytical scientists in LCMS/MS small molecular area to provide GLP-compliant service to world-class pharma and biopharma; • Act as the small molecular technical lead for market promotion; • Establish and maintain business relationship with worldwide companies. Develop and maintain high level of scientific achievements for the company. Be expected to be point of contact for project coordination, including email and video/tele- conference with customers. • 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; • Project management of a bioanalytical team including SD/PI, bioanalyst and other related scientific staff. Oversee multiple 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 customers 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; • Provide training and mentorship to internal staffs