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Scientist/Sr Scientist

Ion Idea

Scientist/Sr Scientist

San Diego, CA
Full Time
Paid
  • Responsibilities

    Job Description

    SCIENTIST/SR SCIENTIST - ANALYTICAL DEVELOPMENT

    LOCATION: SAN DIEGO, CA

    PAY RATE: $120-150K

    POSITION SUMMARY: 

    This position will be responsible for leading and executing the analytical development strategy for our preclinical and clinical scale candidates in development. The candidate will be expected to work in collaboration with our internal research group, process development group, as well as our external manufacturing and analytical development partners to identify, develop, and implement appropriate analytical methods to characterize AAV based gene therapy products across our pipeline. The successful candidate will be a subject matter expert in contemporary analytical methods used to support biological products and will be required to identify and mitigate quality risks to enable successful product development. The successful candidate will also contribute to the preparation of quality sections of INDs and other regulatory documents. As an early stage startup this position will require flexibility, creativity and a can-do attitude to enable efficient execution of company objectives.  The level of the position will be commensurate with experience.

    KEY RESPONSIBILITIES:

    • Contribute to the development and qualification of analytical methods for the release and characterization of AAV gene therapy products, in process controls, and starting materials in support of early phase clinical development
    • Optimize and execute test methods to support of AAV based process development activities (e.g. viral genome titer, capsid titer, cell-based potency, SDS-PAGE, residual impurity characterization)
    • Identify, evaluate, and implement novel analytical technologies for finished products, in process methods, and starting materials.
    • Participate in the writing/reviewing method qualification protocols to ensure compliance with regulatory guidance’s and S/he will be highly communicative and function at a high level in a matrixed management environment.

    KEY REQUIREMENTS

    ·         Degree in Biochemistry, Cell and Molecular Biology, Genetics or related discipline. Scientist level applicants should have a PhD in Biochemistry OR a Master’s degree with >5 years of relevant experience; Senior Scientist level applicants should have a PhD, a post-doc, and >2 years of relevant experience

    ·         Hands-on experience optimizing and executing AAV testing and characterization techniques such as: ddPCR, qPCR, SDS-PAGE, ELISA, Western blots, Capillary Electrophoresis, Analytical Ultracentrifugation, HPLC and cell- based potency and infectivity assays

    ·         Experience working with viral vectors for gene therapy and with contract research or manufacturing organizations is ideal