Senior​/Principal Scientist Cell Potency Assay

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Join Takeda as a Senior/Principal Scientist, Cell Based-Potency Assay Development. As an expert professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues, requiring in-depth analysis and judgment. You also engage with key contacts outside your expertise area and contribute to the development of new concepts and standards. Operating with considerable autonomy, you serve as a consultant to management and an external spokesperson on major matters, often working independently and leading function teams or projects.

Additionally, you play a role in training and mentoring junior staff.

You will report to the Head of Cell-Based Potency Assay within Analytical Development, Biologics. You will provide technical leadership for cell-based potency assay development, qualification, validation, transfer, and lifecycle management across biologics programs. You will translate mechanism of action insights into phase‑appropriate analytical methods that support product characterization, process development, GMP release and stability testing, comparability, regulatory submissions, and analytical control strategy.

You will bring deep hands‑on expertise in mammalian cell culture, potency assay development, assay troubleshooting, statistical analysis, data interpretation, documentation, and cross‑functional technical leadership. This role requires expertise in statistical analysis for potency assays, including relative potency assessment, dose‑response modeling, curve fitting, parallelism or similarity assessment, reference standard comparison, assay acceptance criteria, assay variability, and lifecycle monitoring. The scope may include broader cross‑program or platform leadership depending on final level.

This role is lab‑based and does not include direct people management.

• Lead the design, execution, analysis, and reporting of complex potency assay development, characterization, optimization, qualification, validation, and lifecycle management studies.
• Develop, optimize, validate, and implement cell‑based potency assays and functional bioassays to support product characterization, GMP release and stability testing, comparability, and lifecycle management.
• Translate product mechanism of action understanding into biologically relevant assay formats, including assessment of assay performance, robustness, suitability for intended use, and linkage to analytical control strategy.
• Provide significant or sole technical leadership for assigned assay development work streams, programs, or functional initiatives.
• Serve as an Analytical Development representative on project teams, CMC sub‑teams, and cross‑functional technical discussions, communicating functional strategy, risks, recommendations, and resource needs.
• Develop project and scientific strategy within the potency assay area, including recommendations for assay design, method readiness, validation strategy, transfer approach, and lifecycle management.
• Lead statistical analysis of potency assays, including dose‑response modeling, relative potency estimation, curve fit assessment, parallelism or similarity evaluation, reference standard comparison, and establishment of scientifically justified assay acceptance criteria.
• Design and interpret statistical approaches for qualification, validation, transfer, and lifecycle monitoring, including assessment of accuracy, precision, specificity, linearity, range, robustness, system suitability, assay variability, trending, and method performance.
• Plan and coordinate work with departmental, cross‑functional, and external stakeholders, including Process Development, Quality Control, contract testing laboratories,…