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Staff Scientist, Drug Metabolism and Pharmacokinetics
* Assay development and quantitative analyses of drug and metabolites in various biological matrices.
* PK data analysis and interpretation for animal PK studies
* Develop methods and analyze biological samples from radiolabeled preclinical/clinical studies for mass balance, and metabolite ID.
* Organize experimental data, interpret and present study results to management and project teams in a timely fashion. Write study reports
* Assist department personnel on bioanalytical method development, PK, PK/PD and metabolism issues
* Serve on selected project teams and/or sub teams
* Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
* Ph.D. or equivalent in Bioanalytical sciences, Pharmacokinetics, Pharmaceutical Sciences, or related discipline 6-8 years or more of industry and/or related ADME/PK experience.
* Must have hands-on experience in bioanalytical sample analysis using HPLC, LC/MS/MS and metabolite isolation/identification
* Must have experience conducting in vitro and in vivo metabolism studies.
* Good knowledge of drug metabolism, pharmacokinetic and pharmacodynamic principles, PK analysis
* Must have working knowledge of WinNonLin and other PK modeling software
* Experience working with radiolabeled drugs preferred but not a requisite.
* Excellent written and oral communication skills.
* Strong commitment to business ethics
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