04/02/2020

Analytical Development Research Scientist for in vitro, Cell Therapy (m/f/d)


  • Develop analytical methods to characterize our cell products with several analytical techniques for incoming component/raw material inspection/testing, in-process testing, product QC testing and product deep characterization to support releasing of cell therapy drug product to clinical trial.
  • Execute analytical method transfer to contract manufacturing organizations and/or contract testing laboratories on product QC testing and product deep characterization for the IMP manufactured at Takeda facility and/or contract manufacturing organization.
  • Execute and/or manage analytical method validation for the IMP release test at Takeda facility and/or contract testing laboratories.
  • Manage stability studies at contract manufacturing organizations and/or contract testing laboratories.
  • Actively participate in problem identification, problem solving, and change initiatives in cooperation with other teams and functions.
  • Supports local and global initiatives which may include leading initiatives or work streams.
  • Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary.
  • Strong analytical knowledge and techniques, and practical experience with analytical methods for cell therapy field (e.g. cell based-potency assay, flow cytometry, cell count, q-PCR, etc.) and advanced experience in at least one technique.
  • Able to work in a lab setting.
  • Bachelor's Degree in Cell Biology, Biology or another relevant field. Masters preferred.
  • CMC experience; More than three-year experience in analytical methods development, validation and transfer for biologics products and cell therapy products preferred.


» Job description


Employer:
Takeda
Location:
Fujisawa [J]