Responsible for bioanalysis of drug development and clinical projects. The primary role of the Principal Researcher is to develop and validate LC-MS/MS methods, perform sample analysis, and data tabulation for pharmacokinetic (PK) and toxicokinetic (TK) studies. The duties also include preparation of method validation protocols and study reports, presentation of analytical and PK/TK results to project teams, and compiling analytical reports for regulatory submissions. The results generated may have direct or indirect impact on projects advancement/discontinuation.
Responsibilities include but are not limited to::
Operate LC-MS/MS instruments efficiently and conduct routine troubleshooting independently
Develop and validate LC-MS/MS and/or ELISA methods for new chemical and biological entities
Develop scientifically-sound assays independently, based on existing or literature procedures
Analyze samples for pharmacokinetics and toxicokinetics to support milestone achievement of projects at various stages of drug development
Maintain laboratory equipment, and train others in its use.
Communicate effectively with project teams to ensure reliable and efficient delivery of analytical and PK results. Participate in research group discussion and project meetings.
Communicate research results to supervisor in a timely manner
Utilize literature searches to solve specific research and assay development issues independently
B.S. (5-7 years experience) or M.S. (3-5 years experience) in Analytical Chemistry/Biology, Pharmaceutical Sciences.
Excellent analytical skills, specifically in LC-MS/MS and/or ELISA.
Familiar with regulatory requirement for method validation.
Good knowledge in pharmacokinetics concepts.
Experience in software for lab information management and pharmacokinetic analysis, such as Watson and WinNonlin.
Good time management skills and capable of independently design efficient and well-controlled experiments.
Good communication and presentation skills
Limited Travel: Less than 5% to attend meetings and conferences, etc