GLP Bioanalysis

Major Responsibilities：

• Collaborate with line management in setting the outsourcing strategy and provide timeline coordination for clinical and preclinical studies;
• Provide technical support and monitoring to GLP bioanalysis studies in Asia Pacific;
• Provide bioanalytical support to in house PK/PD experiments;
• Explore new technology and approaches to improve bioanalytical data quality and throughput;
• Provide necessary training to fellow scientists on analytical instrumentation and biological sample preparation
• May provide scientific input and represent DMPK in program/project teams, including timely written and oral communication of program related issues to multidisciplinary teams and line management;
• Contribute to a positive work environment that fosters teamwork, innovation and professional development

Requirement：

• Ph.D. or equivalent in Analytical Chemistry, Biochemistry or Pharmaceutical Science with at least 2 years hands-on industry experience in GLP bioanalysis including responsibilities as study director and principal investigator
• Familiar with FDA, EMA, SFDA regulatory requirements
• Demonstrated strong knowledge and background in LC/MS instrumentation, separation science and sample preparation techniques.
• Basic understanding of different aspects of in vitro/in vivo DMPK in drug discovery and development;
• Knowledge and experience in biomolecule immunoassay are desirable;
• Strong English/Chinese communication and interpersonal skills.