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Research Associate II - Sr. Research Associate I, DMPK

Position Summary:

We are currently seeking a Research Associate, Bioanalytical, who will be primarily responsible for executing qualitative and quantitative PK/ADME bioanalytical and analytical assays, including extracting biological matrices, running and maintaining HPLC and LC/MS/MS instrumentation, and dose solution analysis and stability. The level will be commensurate with the candidate’s training and experience. In addition, the candidate will manage databases, quality review data, and manage outsourcing of PK/ADME assays.

 

Primary Functions:

  • Develop HPLC and LC/MS/MS (Sciex) bioanalytical and analytical methods for quantitative bioanalysis of plasma and other biological matrices and execute analyses to support pharmacokinetic and in vitro ADME studies of novel small and large molecule therapeutics.
  • Perform protein binding analyses and in vitro stability assays.
  • Document, organize, and maintain research data and ensure proper archival.
  • Conduct detailed and thorough review of data to ensure data quality based on study design, quality control results, and trends.
  • Manage outsourcing of PK/ADME assays.
  • Ensure that high quality research reports and presentations are completed in a timely manner.

 

Preferred Experience:

  • 3-5 years of work experience in LC/MS/MS bioanalytical laboratory in pharmaceutical R&D.
  • Must have solid knowledge and demonstrated hands-on experience in qualitative and quantitative bioanalysis.
  • Should be familiar with ABI Analyst, Excel, and Prism in order to review and consolidate quantitative data for the team.
  • Laboratory instrument operation, maintenance, and troubleshooting.
  • Modeling of PK data using non-compartmental analyses.
  •  

Preferred Education:

  • BS/BA, MS/MA, or training in a scientific discipline and appropriate work experience.

Additional Skills:

  • Prefer familiarity with WinNonlin Phoenix and basic principles of in vivo pharmacokinetics.
  • Knowledge of FDA bioanalytical and PK-ADME guidances would be helpful.
  • Be able to work independently and in a team environment and adapt to rapidly changing priorities.
  • Desire to gain expertise in new fields, learn new skills, and establish assays in laboratory.
  • Other required skills include: biological sample preparation; data handling; and laboratory maintenance, organization, and automation. The candidate must demonstrate excellent organizational, record keeping, written and verbal communication, and interpersonal skills.  Problem solving and multitasking are required.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
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