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Bioanalytical Project Manager

Company: Job Juncture
Location: Washington
Posted on: September 14, 2019

Job Description:

My client is expanding and looking to hire a Bioanalytical Manager to oversee internal testing and CRO relationships. The ideal candidate will take on the following tasks:

  • Serve as point of contact of CROs for Bioanalytical Sciences Team
  • Transfer and validate assays for external CROs and manage internal and external pre-clinical and clinical assays
  • Coordinate bioanalyses in support of preclinical and clinical studies.
  • Stay current with preclinical and clinical trial conduct including GLP, GCP, internal SOPs and regulatory
  • Periodically inspect and audit external CROs performing assays
  • Write and review protocols, reports, SOPs, and documents for regulatory submissions

    The ideal candidate will possess the following qualities:

    • BS/MS/PhD in biochemistry, molecular biology, etc. with 3-5+ years of industry experience
    • Working knowledge of bioanalytical techniques including Elisa, ECL, ELISPOT, cell-based, PCR
    • Demonstrated knowledge of regulatory agencies guidance documents and white papers
    • Prior experience working in regulated environment and knowledge of GLP and GCP as they apply to laboratory practices
    • Expertise with the following assays: PK, Cell-based, Immunogenicity, Biomarkers
    • Exceptional organizational and time management skills, coupled with excellent communication skills and attention to detail

Keywords: Job Juncture, Washington DC , Bioanalytical Project Manager, Executive , Washington, DC

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