临床LC-MS/MS平台负责人(J23738)

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

Education and Experience required

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 (10+years’ work experience).
• In-depth understanding of small molecule bioanalytical techniques, including but not limited to HPLC, LC-MS, GC-MS, and their applications in clinical trials.
• Solid laboratory skills and data analysis capabilities, capable of conducting high-precision experiments in a clinical environment.
• In-depth understanding of clinical trial processes and regulations, with experience in clinical trial design and execution.
• Strong teamwork and communication skills, able to work under pressure and meet project requirements.
• Proficient in English reading and writing, able to read and write scientific literature in English.”

Preferred

• Overseas education and working experience
• Marketing and Operation working experience

Key Attributes

• Fluent English speaking and writing skills
• Well organized, detail oriented, and adaptable to changes
• Well-developed management skills
• Effective oral and written communication skills and excellent interpersonal skills
• Ability to work under pressure of timeline and milestones
• Ability to effectively prioritize workload and manage changes in direction
• Ability to work in a team environment