JVT Advisors

Research Associate, Analytical Development

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length:  6+ months

 

Job Summary:  This individual will be generating and reviewing method performance data to support late phase test method robustness assessment and close gaps identified during method transfer.

 

Responsibilities:

  • Perform release and stability HPLC/UPLC test methods to support method robustness assessment for late phase programs.
  • Review analytical method performance data on non-GMP materials to close gaps identified during method transfer.
  • Draft tech memos and analytical reports to support regulatory filings and internal communications.
  • Review and compile non-GMP stability data for development batches.
  • Perform data analysis using biostatistical tools to support assay performance assessment, process development and specification setting.

Requirements:

  • BS with 1-3 years or MS with 0-2 years of relevant industry experience in analytical chemistry.
  • BS/MS in Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field.
  • Knowledge and hands-on experience in analytical techniques including spectroscopy (UV, Fluorescence) and separation techniques (UPLC, HPLC, CE).
  • Experience in early and late phase drug development.
  • Knowledge of the regulatory guidelines on analytical method development, method qualification and method validation.
  • Knowledge and extensive hands-on experience of equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, Empower and Openlab).
  • Familiarity with electronic notebooks, LES and LIMS.

Michael Liuzza

Senior Recruiter

As a Senior Recruiter, Michael Liuzza brings almost a decade of sourcing and hiring experience to the JVT team. In his current role, Michael is responsible for full lifecycle recruiting, partnering with JVT's Contract Recruiting Team to match superior available talent with career building opportunities.

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