Scientist, Analytical Cell Line Engineering & Bioassay Development

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Job Description Join Takeda as a Scientist, Analytical Cell Line Engineering & Bioassay Development plays you will support the design, generation, characterization, and maintenance of analytical cell lines used as critical reagents for potency assay development, functional characterization, and analytical control strategies. Working at the interface of Discovery, Global Biologics, Analytical Development, Process Development, and Quality Control, you will design and execute experiments, analyze and interpret data, and develop cell-based bioassays and impurity testing methods, including ELISA and qPCR assays, to support biologics development.

Leveraging expertise in cell biology, molecular biology, and mammalian cell culture, you will collaborate closely with Scientists and cross-functional partners to solve technical challenges, advance analytical technologies, support technology transfers, author technical and regulatory documentation, and deliver high-quality analytical methods and critical reagents throughout the development lifecycle.

About the role:

You will report to the Associate Director, Analytical Cell Line Engineering and Bioassay Development within the Analytical Development and Quality Control (Biologics) team, you will support the design, generation, characterization, and maintenance of analytical cell lines used as critical reagents for potency assay development, functional characterization, and analytical control strategies. Scientist, Analytical Cell Line Engineering & Bioassay Development is responsible for managing and performing scientific research, development, and testing of new products, manufacturing processes, and raw materials.

This role contributes to Takeda's mission by developing and testing theories on the physical, chemical, and/or biological properties of materials and ingredients under various conditions. How you will contribute:

Develop, characterize, and maintain mammalian analytical cell lines for potency assays and functional characterization.

Perform transfection, transduction, stable pool generation, clone screening, clonal isolation, cell banking, and cell line maintenance activities.

Develop, optimize, qualify, and run cell-based potency assays and functional bioassays using molecular and cellular methods.

Develop, optimize, and execute impurity testing methods, including ELISA and qPCR assays.

Assess assay performance, analyze results, and resolve technical issues with project teams.

Prepare technical reports, protocols, assay development summaries, method documentation, characterization reports, and technology transfer documents.

Support method transfers to internal laboratories, external testing sites, vendors, and Quality Control groups.

Follow quality, documentation, and data integrity requirements while improving laboratory workflows.

Work with Discovery, Global Biologics, Process Development, Quality Control, Regulatory Affairs, and external partners to support project deliverables and timelines.

Stay current with advances in cell line engineering, bioassay development, molecular biology, automation, and emerging analytical technologies.

What you bring to Takeda:

Ph.D in Cell Biology, Molecular Biology, Bioengineering, Biochemistry, Immunology or a master's degree with 3 or more years of relevant industry experience; or a bachelor's degree with 5 or more years of relevant industry experience.

Hands-on…