Senior/Principal Scientist Cell Based Potency Assay

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .  I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description 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.  About the ro le:     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.   T his 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.   T his role is lab-based and does not include direct people management.   How you will contribute:   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   workstreams, 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, Analytical Sciences, Quality Assurance, Regulatory, and other Analytical Development teams.   Evaluate the impact of assay-related decisions across CMC functions, including implications for method readiness, QC implementation, investigations, regulatory submissions, comparability, manufacturing changes, and lifecycle management.   Independently troubleshoot complex assay, cell culture, reagent, instrumentation, data analysis, software, transfer, or performance issues and coordinate cross-functional resolution plans.   Lead internal and external assay transfer activities, including preparation of transfer documentation, review of data packages, vendor or CRO technical interactions, and resolution of transfer-related issues.   Prepare, coordinate, and review technical documentation, including experimental reports, technology transfer documents, SOPs, qualification or validation protocols and reports, CMC sections of regulatory documents, and internal reports suitable for publication.   Identify   and implement improved approaches for data collection, analysis, visualization, interpretation, automation, and reporting to support robust and efficient decision-making.   Track relevant bioassay, statistical analysis, analytical technology, automation, data science, and regulatory developments, and propose improvements or functional initiatives within the department.   Serve as a technical resource across multiple laboratory technologies, providing guidance, training, and mentoring to scientists, interns, co-ops, and project contributors as   appropriate .   Present technical results internally and, when   appropriate , externally through posters, presentations, publications, inventio