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Scientist/Sr. Scientist, Bioassay

  • Location: South San Francisco
  • £ Salary: 12-15% Bonus, RSUs per year
  • Job Type:Permanent

Posted over 1 year ago

  • Sector: Life Sciences
  • Contact: Shannon Griffin
  • Expiry Date: 23 October 2022
  • Job Ref: JN -092022-474087

Summary

The Scientist/Sr. Scientist will design, develop and qualify analytical methods for biopotency and viral vector characterization for development and manufacture of recombinant Ad5 vectors used for oral vaccines. Experience with cell-based assays such as infectivity, transgene expression and potency determination is strongly preferred. Support existing methods and development of new methods appropriate for product and process characterization, release testing, and for in-process testing of product and intermediates.




Responsibilities

  • Independently designs, develops and optimizes cell-based assays such as infectivity, transgene expression, and biopotency assays to support product development and characterization
  • Performs DOE studies to establish assay acceptance criteria to support method validation and product specifications applying appropriate statistical tools to comply with regulatory guidelines
  • Evaluates new assay technologies and innovates novel assay methodologies
  • Authors and review protocols, development reports, standard operating procedures, and other technical reports
  • Responsible for understanding and applying data generated from experiments and literature to support process development activities
  • Supports and trains staff as appropriate in laboratory activities; assures that training and compliance records for themselves are up to date and appropriate
  • Proactively communicates with internal and external stakeholders and supervisor, as well as peers

Qualifications

  • PhD degree in Cell Biology, Biochemistry, or related disciplines with 8+ years of experience, preferably in the biotech and pharma industry, with primary focus on biologics
  • Knowledge of FDA, cGMP, and ICH regulatory requirements in the context of bioassay/potency assay development and qualification is desired
  • Experience with method validation and transfer to in-house QC is required
  • Good understanding of statistical methods/tools for data analysis is required
  • Experience with Mammalian cell culture and production of viral vectors is a strong plus
  • Excellent written and oral communication skills are required



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