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Director, Bioanalytical - Lexington, MA, US

Company: Translate Bio
Location: Lexington
Posted on: June 19, 2019

Job Description:

Job Summary

The Director, Bioanalytical reports to Executive Director, Translational Development and is an integral part of the Translational Development team. The BA Director is responsible for leading, building and expanding the bioanalytical team's expertise and capacity.

Job Responsibilities

  • Lead and grow a comprehensive bioanalytical function to support all stages of discovery and development for mRNA lipid nanoparticle therapeutics
  • Provide Scientific leadership and oversight of the Bioanalytical group, as well as providing expertise in Regulatory aspects of Bioanalytical to project teams
  • Manage bioanalytical assay method development, characterization, validation and method transfer (to external CRO's) of sophisticated bioanalytical methods
  • Manage CRO method transfer and sample analysis activities; review and approve Bioanalytical protocols, reports, associated summaries, regulatory sections and associated documentation
  • Support in-house early discovery projects related bioanalytical needs

    Required Skills & Qualifications

    • PhD in a pharmaceutical sciences related field
    • 10+ years of experience working in a Bioanalytical role within the pharmaceutical or biotechnology industry is required
    • Evidence of scientific/technical leadership in a range of BA methods to support small molecule, oligonucleotide, mRNA, proteomics, and immunogenicity assessments.
    • Extensive experience in the outsourcing and external oversight of regulated (GLP, GCP) Bioanalytical studies to support nonclinical and clinical activities.
    • Demonstrate knowledge of regulatory requirements and expectations for Bioanalytical packages to support regulatory filings and clinical studies including thorough knowledge of GLP, GCP, ICH and other applicable guidelines

Keywords: Translate Bio, Leominster , Director, Bioanalytical - Lexington, MA, US, Executive , Lexington, Massachusetts

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