General Position Summary/Purpose:
Responsible for hands-on LC/MS/MS bioanalysis of preclinical and clinical samples for studies performed internally and at contract laboratories. Responsible for bioanalytical methods qualification.
Key Accountabilities/Core Job Responsibilities:
Conducts bioanalytical evaluations to determine concentration of parent molecules and metabolites in various biological matrices including plasma, urine, and bile to support preclinical and clinical studies.
Develops bioanalytical methods and performs method qualification.
Optimizes conditions for quantitation and chromatographic separation of analyte from other detectable components in biological samples.
Writes bioanalytical and pharmacokinetic reports to support pharmacokinetic analyses for in-house studies.
Provides technical review of study reports that contain bioanalytical data.
Writes, reviews, and revises departmental SOPs.
Maintains laboratory inventory, manages instrumentation and schedules maintenance.
Education, Qualifications, and Experience Requirements (degree, certifications, etc.):
PhD degree/equivalent with at least 1-3 years (or MS degree with at least 5-7 years) of experience in bioanalysis or related area within the pharmaceutical industry.
Knowledgeable in best practices of bioanalytical assessments. Ability to troubleshoot instruments and methods.
Ability to optimize conditions for quantitation and chromatographic separation of analyte from other detectable components in biological samples.
Proficient in sample preparation and precise and accurate laboratory techniques.
Proficient with data capture, quantitation, and analysis software.
Understanding of the physical principles involved in performing measurements (e.g., HPLC, LC-MS, SDS-PAGE,) and to apply these to assay design.
Proficient in HPLC-UV and LC-MS/MS instrumentation and supporting software.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled