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Scientific Leadership - Gene Therapy Analytical Development

Company: Job Juncture
Location: New Brunswick
Posted on: September 22, 2019

Job Description:

My client is expanding and looking to hire a Scientist for Gene Therapy Analytical Development.
The ideal candidate will take on the following tasks:


  • Provide subject matter expertise and leadership in developing analytical methods for AAV product release testing and product characterization
  • Oversee CROs and CMOs for developing, qualifying, and validating analytical assays for AAV products
  • Act as a CMC lead in analytical development team, lead the design and execution of comparability and stability studies for multiple programs
  • Oversee development, validation and execution of methods that are suitable for the release and stability of AAV based gene therapy products
  • Technical lead for GMP method development, validation, method transfer, data analysis and reporting -- ensure compliance with GCP, GLP and cGMP
  • Author and review assay development and validation reports, relevant sections of documents pertaining to AAV analytical methods development and documentation for submission to regulatory agencies.

    The ideal candidate will possess the following qualities:

    • Experience with viral vectors is required
    • Previous management of CROs and CMOs is preferred
    • Experience setting specifications based upon statistical analysis
    • Thorough knowledge of GMPs, ICH, USP, EP
    • Review of deviations, OOS, OOT, and change controls
    • Experience authoring CMC regulatory filings including IND, CTD and IMPD
    • In-practice knowledge of the ICH for assay qualification and validation
    • Strong, demonstrated ability to thrive in a fast-paced biopharmaceutical environment
    • Prior experience in developing and validating methods in a GMP/GLP environment
    • Experience with writing validation protocols, validation reports, relevant sections of regulatory documents, IND, IMPD and BLA
    • Experience in directing the development and validation of molecular biology test methods not limited to PCR (qPCR, ddPCR), Viral Infectivity, ELISA, SDS Page, Capillary Electrophoresis, AUC, and cell based potency assays at external sites
    • Excellent technical writing and communication skills

      This is a field based role (work from home) and the ideal candidate is based on the East Coast -- Boston, New York, Philadelphia, Baltimore, Washington DC, etc.
      --
      The title is commensurate with experience -- up to Director.

Keywords: Job Juncture, Jersey City , Scientific Leadership - Gene Therapy Analytical Development, Healthcare , New Brunswick, New Jersey

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