The Senior Scientist, Bioanalysis will be responsible for methods and analytical assay development for novel small molecule drugs and potential drug metabolites. Assays must be suitable for quantifying analytes in biological fluids (plasma, blood, urine, tissues) utilizing HPLC-MS/MS (high performance liquid chromatography-mass spectrometry/mass spectrometry) equipment. This scientist must have strong knowledge of HPLC with ultraviolet and/or fluorescence detection, LC-MS/MS, metabolite identification, and good documentation practices.
Develop accurate and reliable methods for the detection of parent drug and metabolites in biologic samples with HPLC-MS/MS instrumentation to support pharmacology, pharmacokinetic and toxicology studies.
Conduct metabolic screening using in vitro assays (e.g., microsomes) and analysis.
Ability to troubleshoot instrument performance and maintain analytical equipment.
Adept at solid-phase extraction and liquid-liquid extraction techniques for isolation of parent compound or metabolite(s) from biomatrices (blood, plasma, urine and/or various tissues).
Skilled at troubleshooting, including measures to determine source of error in sample extraction techniques and follow-on experiments to address the findings.
Report results both written and verbally.
Perform other duties, as required, including maintaining supplies for the MS Laboratory, rough pump maintenance, sample cone/source cleaning and replacement.
Maintain inventory of bioanalytical samples.
Interaction with contract laboratories for assay transfer and report review.
Knowledge of Good Laboratory Practices.
Experience with regulatory submissions, a plus.
Demonstrate commitment and support for company goals, objectives and procedures.
Represent Reata by developing collaborative relationships with site personnel, colleagues and vendors.
Demonstrate professionalism and adherence to moral, ethical and quality principles
Participate in corporate and departmental meetings.
Comply with applicable regulations, guidances, corporate policies and procedures.
Masters or PhD in relevant scientific field.
Five to seven years of experience with the following instrumentation: LC-MS, GC-MS, LC-MS/MS and qToF-MS modes of analyte detection and software.
Work experience within a pharmaceutical company is preferred.
Knowledge of Waters HPLC instruments and Waters software (MassLynx and Empower) and Agilent HPLC-MS systems.
Individual must have a thorough understanding of mass spectrometer operation and the requirements for such operation e.g., API and collision gas flow rates and voltage settings for optimal compound ionization.
Individual must be proficient in cleaning internal mass spectrometer components and returning the mass spectrometer to the original performance status.
A working knowledge of drug metabolism and solvents/chemical characteristics.
Experience supporting pharmacology research including; pharmacokinetics, pharmacodynamics and drug metabolism in pharmaceutical development.
Demonstrated experience in vitro metabolism assays, i.e., microsomes, hepatocytes and S9 liver fractions.
The ability to troubleshoot drug isolation from biologic fluid, analytical and instrumentation problems and perform routine instrument maintenance.
Qualified candidates must be legally authorized to be employed in the United States
About Reata Pharmaceuticals
At Reata Pharmaceuticals, our mission is to develop innovative therapies that change patients’ lives for the better.We’re committed to positively impacting the lives of patients with life- threatening diseases. With rigorous science and research as our foundation, we are a team of problem solvers, trail blazers, and people who want to make a difference. Our ideal candidates are those who are excited by a challenge and driven to succeed.