2023 Master's in Chemistry - Study Director, Medical Device Chemistry Lab
WuXi AppTec's Medical Device Testing business, has operating entities in both the United States and China. This division provides an integrated testing platform for medical devices which includes biocompatibility testing, chemical characterization, toxicological risk assessment, biological evaluation, large animal studies, microbiological testing, etc. The testing platform has established its China Medical Device Testing Center in Suzhou Wuzhong District with international FDA GLP, OECD GLP, CNAS, ISO13485, A2LA quality management standards and Chinese CMA and AAALAC operational standards, comprising of the outstanding International technical and management teams. At the same time, WuXi Clinical has ability to provide clinical studies and product registration services for medical devices from phrase I to IV. WuXi MedKey has rich experience in operating more than 200 medical device clinical trials and working closely with 1000 Chinese hospital clinical trial centers.
Job Location: Suzhou, China
- Assist or be responsible for the operation and management of chemical testing related experimental work. Responsible for study design, cost and TAT evaluation
- Assist or be responsible for analytical testing studies, generate study protocol, reports and their amendments (if needed); supervise the analytical works as described in the study protocol.
- Assist or be responsible for the review of analytical data and investigate abnormal and unforeseen events that could affect the accuracy of the analytical results. Assists or be responsible for the interpretation of reports and data generated by the department, and produce impact statements.
- Master degree in chemistry, pharmacy, materials science or related.
- Experience in chromatography, mass spectrometry operation, analytical method development and validation for organic compounds or elemental impurities is a plus.
- Strong learning activity and execution, good scientific research literacy and problem solving ability
- Good ability of communication, project management and time management; ability to work under pressure.
- Good English reading and writing skills, English expression and communication skills are preferred.