The Pharmacoanalytical Shared Resource (PhASR) supports various clinical trials and drug development projects through the development and utilization of bioanalytical assays for ELISA and LC-MS/MS methodologies according to FDA guidance. This position is a term position with the potential to extend beyond the one year term. The Senior Researcher will be responsible for:
The application of in-depth knowledge of analytical chemistry and bioanalytical methodologies to drive efficient project design and implementation.
The development and validation of analytical assays using LC-MS/MS, ELISA, or other appropriate analytical platforms according to FDA guidelines.
Managing projects, supervising individual contributors in assay development and validation, and guiding/leading less experienced researchers.
Planning, development, and management of analytical methods to quantitatively characterize mechanisms of absorption, distribution, metabolism, and excretion of novel drugs or drug candidates.
Troubleshooting and maintenance of LC-MS/MS systems.
The preparation of biological specimens by protein precipitation, phospholipid removal, liquid-liquid and solid phase extraction for ELISA and LC-MS/MS analyses, and for analysis by other methods as appropriate.
Leading and training less experienced researchers on the preparation of biological tissues for experimental studies.
Leading and participating in the development of study-related goals.
Development and testing of experimental designs, sampling techniques and analytical methods to make recommendations for implementation.
Researching published studies and incorporating new knowledge and information into PhASR projects.
Maintaining accurate and detailed research records, including a laboratory notebook, method, and project related documentation.
Consulting and collaborating with principal investigators to guide bioanalytical and pharmacology aspects of their research.
Performing FDA Bioanalytical method validation on newly developed and existing methods.
Working with the technical director to ensure adherence to strict quality control standards by serving as a quality control reviewer.
Establishing quality control standards for developed analytical assays in adherence with the FDA guidance.
Developing of SOPs and maintaining laboratory equipment by performing routine maintenance and scheduling contracted maintenance services when necessary.
Generating invoices, tracking expenses, and producing quotes for analytical services.
Assisting with day-to-day operations including receipt of samples and packages while completing appropriate documentation.
Following established laboratory safety procedures to ensure compliance with OSHA regulations and local, state, and federal regulations.
Preparing method and project reports, research papers and manuscripts for publication and presentation at national conferences and workshops.
Serving as a resource for less experienced scientists.
Training and supervising other staff on developed protocols, equipment, and laboratory procedures.
Performing additional duties as assigned.
Ohio State University Wexner Medical Center
Feb 14, 2025