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 LCMSMS.
Knowledgeable on a variety of study types, analysis procedures and methodologies.
