Job Summary:
- Scientific and operational staff responsible for method development/validation projects and analysis of samples.
- 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.
- Responsibilities/Duties
- Study Execution
- Set up, validate, conduct and coordinate DMPK in vitro/in vivo assays from protocol design, experiment, and report.
- Expert in setting up and performs method development and validation of various analytes in a variety of matrices with minimum supervision.
- Expert in setting 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.
- Effectively plan and utilize personnel and resources for timely completion of assigned projects.
- Assist in evaluation of data for incorporation into written reports.
- Perform other related duties as assigned.
- Serve as lead DMPK scientist on projects, overseeing a small group of technical staff, with minimal supervision.
- Schedules staff and assigns resources.
- Develops appropriate training plans and ensure staff is trained.
- Assure staff compliance to SOPs and other regulatory agency guidelines.
- Participates in process improvement initiatives.
- Document work and maintain study documentation and laboratory records.
- Promotes a cohesive team environment.
- Writes, revises and reviews methods, SOPs and portions of reports and protocols.
- Provides input and participates in project meetings, plans, monitors and guides project work.
- Performs QC review of data.
- Science
- Demonstrates basic knowledge of relevant assays and developing knowledge in the drug development process. Developing understanding of current technical applications in field, and familiar with the use of standard laboratory equipment and analytical instrumentation.
- Demonstrates good level of scientific knowledge in chosen field. Shares scientific knowledge through internal meeting presentations.
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