SeniorPrincipal Scientist Cell Based Potency Assay

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 organizationalobjectives. Your work involves addressing intricate issues requiring in-depth analysis and judgment. You also engage with key contacts outside yourexpertisearea 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-onexpertisein mammalian cell culture potency assay development assay troubleshooting statistical analysis data interpretation documentation and cross-functional technical leadership.This role requiresexpertisein 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-programor platform leadership depending onfinallevel.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.

• Developoptimizevalidate 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 ofaction understandinginto 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 assaydevelopmentworkstreams programs or functional initiatives.

• Serve as an Analytical Development representative on project teams CMC sub-teams and cross-functional technical discussions communicating functionalstrategy 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.

• Identifyand 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 asappropriate.

• Present technical results internally and whenappropriate externally through posters presentations publications invention disclosures or patent-related contributions.

• Complete all required training andmaintainhigh standardsfor safety data integrityGxPawareness and documentation quality.

• Ph.D. in cell biology molecular biology immunology biochemistry bioengineering pharmaceutical sciences statistics biostatistics or a related discipline with 3 years of relevant experience for Senior Scientist or 7 years for Principal Scientist; MS with 9 years for Senior Scientist or 13 years for Principal Scientist; or BS with 11 years for Senior Scientist or 15 years for Principal Scientist.

• Advancedexpertisein cell-based potency assay development functional bioassays or mechanism-of-action-driven analytical methods for biologics vaccines cell therapy gene therapy or related modalities.

• Advancedexpertisein statistical analysis of bioassays including relative potency 4-parameter logistic or nonlinear dose-response modeling parallelism or similarity assessment reference standard comparison system suitability assay variability and scientifically justified acceptance criteria.

• Strong mammalian cell cultureexpertise including cell bankthaw expansion maintenance assay-ready cell preparation and troubleshooting of assay variability.

• Proficiencywith relevant assay platforms and readouts such as luminescence fluorescence absorbance ELISA MSD flow cytometry reporter assays neutralization assays or other cell-based functional readouts.

• Strong working knowledge of assay qualification and validation principles including accuracy precision specificity linearity range robustness system suitability transferability and phase-appropriate method readiness.

• Sound knowledge of current Good Manufacturing Practices data integrity principles ELN/LIMS documentation SOPs technical reports CMC documentation and regulatory expectations for potency assays.

• Demonstrated ability to lead complex technical workstreams across multiple programs or functional priorities with minimal supervision.

• Experience preparing or contributing to regulatory filings validation documentation technology transfer documentation or responses to technical questions from internal or external stakeholders.

• Experience working with CROs contract testing laboratories vendors or external partners to support method development transfer validation troubleshooting or lifecycle management.

• Strong problem-solving written communication and presentation skills with ability to communicate complex technical and statistical information to functional teams project teams CMC stakeholders and broader scientific audiences.

• Demonstrated ability to mentor or train colleagues across relevant laboratory technologies assay development principles statistical analysis and documentation practices.

• Ability to work independently under general direction while contributing effectivelyina multidisciplinary team environment with comfort using emerging digital tools and openness to AI-enabled processes that support analysis documentation and decision-making.

As an expert professional within the organization you develop innovative solutions to complex problems aligned with organizationalobjectives. Your work involves addressing intricate issues requiring in-depth analysis and judgment. You also engage with key contacts outside yourexpertisearea 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.