Responsibility:
- Lead or design, conduct and report in vitro ADME studies (absorption, distribution, metabolism and excretion) including assay designs, LC-MS/MS based bioanalytical method development, sample generation and sample analysis, data analysis, interpretation and reporting.
- Develop new in vitro ADME assays as needed to address specific project or study issues, or new service capability.
- Serves as a DMPK representative on discovery and preclinical programs and initiatives; performing CYP450 and transporter mediated drug-drug interaction potential and in vitro - in vivo correlation analysis, ADME data interpretation and application.
- Manage and supervise an in vitro ADME group; and collaborate with various functional DMPK groups,
- Communicate effectively with clients for study update, project management and technical support.
- Keeps up to date with emerging new mass spectrometric technologies, ADME assays such as transporters and regulatory technical guidelines.
- Possess good interpersonal, oral and written communication skills.
Qualifications
- A M.S. or Ph.D. degree in drug metabolism, pharmaceutical science, organic chemistry, analytical chemistry, biochemistry, or related discipline with 5 - 10 years’ experience in pharmaceutical and biotechnological companies, or contract research organizations.
- Hands-on experience in designing, conducting, analyzing and reporting in vitro ADME studies, including study designs, bioanalytical method development, sample generation and analysis, data analysis and reporting to support drug discovery and preclinical projects.
- Working experience in quantitative LC-MS/MS method development and sample analysis with AB Sciex API LC-MS/MS and other vendors’ mass spectrometry systems; experience with high throughput autosamplers and programming automated liquid handlers.
- Familiar with IND-enabling in vitro ADME studies to support regulatory filing (China NMPA, US FDA, EMA).
- A thorough understanding of various small and large animal PK/TK studies are desirable.
- 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 in English and Chinese.
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