Senior/Principal Scientist Cell Based Potency Assay

Takeda • Lexington, MA

4d • Onsite

About The Position

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 role: 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.

Requirements

• 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.
• Advanced expertise in cell-based potency assay development, functional bioassays, or mechanism-of-action-driven analytical methods for biologics, vaccines, cell therapy, gene therapy, or related modalities.
• Advanced expertise in 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 culture expertise, including cell bank thaw, expansion, maintenance, assay-ready cell preparation, and troubleshooting of assay variability.
• Proficiency with 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 effectively in a multidisciplinary team environment, with comfort using emerging digital tools and openness to AI-enabled processes that support analysis, documentation, and decision-making.

Responsibilities

• 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, invention disclosures, or patent-related contributions.
• Complete all required training and maintain high standards for safety, data integrity, GxP awareness, and documentation quality.

Benefits

• medical, dental, vision insurance
• a 401(k) plan and company match
• short-term and long-term disability coverage
• basic life insurance
• a tuition reimbursement program
• paid volunteer time off
• company holidays
• well-being benefits
• up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree