職位描述
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.
