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

Takeda•Lexington, MA

1d•$154,400 - $242,550•Onsite

About The Position

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. As a senior technical expert within the function, you will apply deep scientific expertise in analytical cell line engineering and bioassay development to anticipate technical challenges, recommend improvements, and provide consultative guidance across programs. You will operate independently, lead complex technical workstreams, mentor colleagues, and contribute to technical standards, regulatory-ready documentation, and capability development within Analytical Development and Quality Control Biologics. You will report to the Associate Director, Analytical Cell Line Engineering and Bioassay Development, within the Analytical Development and Quality Control (Biologics) team. You will design, generate, characterize, and manage analytical cell lines that serve as critical reagents for potency assay development, functional characterization, and analytical control strategy. Operating at the interface between Discovery, Global Biologics, Analytical Development, and late-stage potency teams, this role translates product mechanism of action into scientifically sound, phase-appropriate cell line and assay strategies. You will lead complex technical workstreams, solve scientific problems, contribute to regulatory documentation, and help establish scalable approaches for analytical cell line engineering and bioassay development. At the Principal Scientist level, you will serve as a subject matter expert, influence cross-program strategy, and contribute to technical standards and capability development. This is an individual contributor technical leadership role with responsibility for mentoring junior scientists and leading technical work across programs.

Requirements

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.
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.

Nice To Haves

Experience with technologies such as flow cytometry, qPCR, ddPCR, sequencing, cell imaging, luminescence or fluorescence-based detection, and high-throughput clone screening is preferred.

Responsibilities

Lead the design, generation, characterization, and lifecycle management of stable mammalian analytical cell lines expressing targets of interest, receptor systems, or reporter constructs to support potency and functional bioassays.
Develop and implement technical approaches for plasmid and vector design, transfection or transduction, stable integration, clone screening, clonal isolation, genomic and copy number characterization, expression stability, and analytical cell banking.
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.
Contribute to early-stage potency assay development and ensure effective technical continuity with late-stage potency, validation, transfer, and QC implementation strategies.
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.
For Principal Scientist level, establish technical standards, influence cross-program strategy, lead complex scientific initiatives, and serve as a recognized subject matter expert in analytical cell line engineering and bioassay development.