JVT Advisors

Sr. Research Associate

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length: 6+ months

 

Job Summary: This individual will support early to late phase development, technical management of CRO/CMO, and conduct data review generated with analytical methods for all raw materials.

 

Responsibilities:

  • Contribute to strategy and document, create a RMQ testing panel and document
  • Undertake technical management for analytical testing at external CRO/CMO
  • Co-ordinate internally and externally to supply method documents and materials, obtain from Vendor or drive initiating test methods
  • Review test method documents and validation documents
  • Troubleshoot and support establishment of methods
  • Troubleshoot and support validation
  • Compile information and create RMQ reports
  • Compile Work orders and PO for budget updates and finance reporting

Requirements:

  • BS with 8-10 years or MS with 5-8 years of relevant industry experience in analytical chemistry.
  • BS/MS in Chemistry, Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field.
  • Knowledge of chromatographic separation, biophysical characterization, and spectrophotometric techniques, equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, ChemStation, Empower).
  • Knowledge and hands-on industry experience of raw materials, lipids, small molecules, nanoparticle drug products, liposomal products, nucleic acid chemistry and biology and standard methods of analysis of these molecules is a plus.
  • Experience is early to mid-phase development: Experience in late phase development is a plus
  • Knowledge of GMP and ICH guidance documents
  • Knowledge of late phase validation and/or early phase qualification of methods

Christian Griffith

Recruiter

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