Responsibilities

? Lead to design, conduct and report in vitro ADME studies including LC-MS/MS based bioanalytical method development, sample generation and sample analysis, data analysis, interpretation and reporting.

? Lead the bioanalytical method development and non-GLP validation of LC/MS/MS methods, sample analysis, data analysis and PK modeling for small and large animal PK/TK studies.

? Direct IND-enabling ADME/PK/TK studies including study protocol and report writing according to regulatory technical guidelines (US FDA, China FDA, EMA) under a GLP-like setting.

? Develop new in vitro ADME and PK assays as needed to address specific project or study issues, or new service capability.

? Keeps up to date with emerging new technologies and assays in ADME/PK area and regulatory technical guidelines.

? Communicate effectively with clients for study update, project management and technical support.

? Communicate effectively with functional groups or departments. Set priority for the lab and allocate appropriate human resources/work schedule to ensure timely report delivery.

Requirements

? A M.S., or Ph.D. degree in drug metabolism, pharmaceutical science, organic chemistry, analytical chemistry, biochemistry, or related discipline with 5 - 15 years’ experience in pharmaceutical and biotechnological companies, or contract research organizations.

? Hands-on experience in designing, conducting, analyzing and reporting ADME/PK studies to support drug discovery and preclinical projects in discovery and GLP-like settings.

? Working experience in designing and conducting IND-enabling ADME/PK studies to support China and US FDA regulatory filing in a GLP-like setting.

? A thorough understanding and experimental skills of various ADME assays such as metabolic stability, CYP450 mediated drug-drug inhibition and induction, metabolic reaction phenotyping, permeability, Pgp and other efflux and uptake transporters, plasma or tissue protein binding, and bioanalytical data troubleshooting are desirable.

? Expertise in LC-MS/MS quantitation techniques including knowledge of various MS/MS and LC platforms especially AB Sciex MS/MS, Shimazu and Waters HPLC/UPLC.

? Experience in leading and supervising a group of lab scientists.

? Excellent oral and written communication, interpersonal, and organizational skills is required, along with demonstrated ability to interface effectively with clients and project team members.

上班地址：上海市外高桥富特北路233号