Scientist, Analytical Cell Line Engineering & Bioassay Development

3316 Takeda Development Center Americas•Lexington, MA

6d•Onsite

About The Position

This role supports the design, generation, characterization, and maintenance of analytical cell lines used as critical reagents for potency assay development, functional characterization, and analytical control strategies. The position operates at the intersection of Discovery, Global Biologics, Analytical Development, Process Development, and Quality Control. Responsibilities include designing and executing experiments, analyzing and interpreting data, and developing cell-based bioassays and impurity testing methods (ELISA, qPCR) to support biologics development. The role requires leveraging expertise in cell biology, molecular biology, and mammalian cell culture to collaborate with scientists and cross-functional partners, 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. The Scientist reports to the Associate Director, Analytical Cell Line Engineering and Bioassay Development within the Analytical Development and Quality Control (Biologics) team. This role is responsible for managing and performing scientific research, development, and testing of new products, manufacturing processes, and raw materials, contributing to Takeda's mission by developing and testing theories on the physical, chemical, and/or biological properties of materials and ingredients under various conditions.

Requirements

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 experience with mammalian cell culture, stable cell line engineering, flow cytometry, and molecular undefined
Experience with transfection, transduction, clone screening, clonal isolation, cell banking, and cell line characterization.
Strong scientific writing, presentation, communication, and collaboration skills.
Ability to independently execute experiments, analyze multidimensional data, and communicate scientific conclusions.
Comfort with emerging digital tools and openness to artificial intelligence-enabled processes for data analysis and laboratory workflows.

Nice To Haves

Experience developing and executing cell-based potency assays and functional bioassays supporting biologics development is preferable.
Experience using ELISA and qPCR methods for analytical characterization and impurity testing is preferable.
Knowledge of receptor biology, cellular signaling pathways, and mechanism-of-action-based assay development.
Knowledge of good manufacturing practice and regulatory expectations related to bioassays, potency assays, analytical methods, and impurity testing is preferable.

Responsibilities

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.