职位描述
Responsibilities/Duties
• Support DMPK in vitro and/or in vivo assays including assay design, biosample analysis, method development and validation and report for various compounds and components in compliance with appropriate SOPs and regulatory agency guidelines.
• Support in setting up, validating, and conducting DMPK in vitro assays from protocol design, experiment, and report.
• Support in conducting and coordinating DMPK in vivo projects from protocol design, experiment, and report.
• Set up and performs method development and validation of various analytes in a variety of matrices with supervision.
• Set up, maintain, operate and perform routine and non-routine maintenance on general equipment, including problem identification and resolution.
• Inform Study Director, Principal Investigator and/or management of any problems and/or deviations that may affect the integrity of the data and recommends corrective action.
• Suggest and perform modifications to test methods or procedures where precedence exists.
• Organize, conduct and evaluate analytical results and testing.
• Performs QC review of data.
• Maintain study documentation and laboratory records.
• Promote a cohesive team environment.
• Provide input and participate in project meetings, plans, monitors and guides project work.
• Maintain a clean and safe laboratory work environment.
• Train and assist less experienced staff.
• Participate in process improvement initiatives.
• Participate in client visits as needed, assist in communicating technical information.
• Effectively plan and utilize personnel and resources for timely completion of assigned projects.
• Assists in writing reports and protocols.
• Writes SOPs and methods.
• Assist in evaluation of data for incorporation into written reports.
• Perform other related duties as assigned.
Education/Qualifications
• BS/BA degree in science plus at least 3 years or above experience or MS degree with 1 years or above experience in analytical chemistry, pharmacokinetics, or metabolism.
Experience
• 1 years or above experience in analytical chemistry, pharmacokinetics, or metabolism
• Familiar with the use of standard laboratory equipment (e.g., balances, pipettes, centrifuges).
• Experience with use and trouble shooting of analytical equipment such as LC-MS/MS.
• Knowledgeable on a variety of study types, analysis procedures and methodologies.
