Senior/Principal Scientist, Analytical Cell Line Engineering and Bioassay Development

About the role

Join Takeda as a The Senior/Principal Scientist, Analytical Cell Line Engineering and Bioassay Development plays a key role in managing and performing scientific research, development, and testing of new products, manufacturing processes, and raw materials. This role contributes to Takeda's mission by developing and implementing new products, processes, and standards that impact functional results.

Responsibilities

• Design, generate, characterize, and manage analytical cell lines that serve as critical reagents for potency assay development, functional characterization, and analytical control strategy.
• Translate product mechanism of action into cell line designs and cell-based assay concepts aligned with potency and analytical control strategy.
• Develop and support cell-based bioassays, including reporter gene assays, signaling pathway assays, proliferation or cytotoxicity assays, and other mechanism-based functional readouts.
• Evaluate assay and cell line performance attributes, including sensitivity, specificity, robustness, stability, reproducibility, and fitness for intended use.
• Independently design and execute complex experimental plans, interpret data, identify technical risks, and recommend scientifically justified solutions.
• Represent Analytical Development on cross-functional program teams and provide technical input on potency strategy, functional characterization, cell line suitability, and control strategy.
• Author and review technical reports, protocols, method documents, cell line characterization packages, technology transfer documents, and CMC source documentation supporting regulatory submissions.
• Ensure that analytical cell line generation, assay development, documentation, and data packages are aligned with applicable quality and compliance expectations, good documentation practices, and data integrity principles.
• Lead or contribute to technical transfers to internal laboratories, external partners, vendors, or quality control functions, providing the technical rationale and knowledge needed for transfer.
• Identify opportunities to improve workflows, increase assay robustness, reduce development timelines, and establish platform or semi-platform approaches where scientifically appropriate.
• Mentor junior scientists and associates through technical guidance, experimental design review, data interpretation, and development of scientific judgment.

Qualifications

• Ph.D. in Cell Biology, Molecular Biology, Bioengineering, Biochemistry, Immunology, or a related discipline with relevant industry experience in biologics analytical development, bioassay development, cell line engineering, or functional characterization.
• Senior Scientist level typically, a doctoral degree with 3+ years, a master’s degree with 9+ years, or a bachelor’s degree with 11+ years of relevant industry experience.
• Principal Scientist level typically, a doctoral degree with 7+ years, a master’s degree with 13+ years, or a bachelor’s degree with 15+ years of relevant industry experience.
• Deep technical expertise in stable mammalian cell line engineering, including vector design, transfection or transduction, clonal isolation, clone screening, genomic characterization, copy number analysis, flow cytometry, and expression stability assessment.
• Experience developing analytical cell lines and cell-based potency or functional assays to support biologics development.
• Strong understanding of receptor biology, cellular signaling, reporter systems, mechanism of action, and their application to potency assay design.
• Experience with technologies such as flow cytometry, qPCR, ddPCR, sequencing, cell imaging, luminescence or fluorescence-based detection, and high-throughput clone screening is preferred.
• Working knowledge of regulatory expectations for potency assays, analytical control strategies, cell-based methods, and lifecycle management of critical assay reagents.
• Experience authoring or reviewing technical reports, regulatory source documents, CMC sections, assay development reports, or cell line characterization packages.
• Demonstrated ability to independently solve complex technical problems, interpret multidimensional data, and communicate scientific conclusions clearly to project teams and functional leadership.
• Ability to work effectively in a matrixed, cross-functional environment across Analytical Development, Global Biologics, Process Development, Quality Control, Regulatory, and external partners.
• Strong scientific writing, presentation, collaboration, and technical mentoring skills.
• Openness to using digital, automation, and AI-enabled tools to improve data analysis, documentation, knowledge management, and scientific workflows.
• For Principal Scientist level, demonstrated ability to influence technical strategy across multiple programs, define novel approaches, establish best practices, and contribute to broader capability development within the function.

Pay

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in 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, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.