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.