SeniorPrincipal Scientist, Analytical Cell Line Engineering and Bioassay Development

Join Takeda as a The Senior/Principal Scientist Analytical Cell Line Engineering and Bioessay 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 Takedas 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 scientificexpertisein analytical cell line engineering and bioassay development toanticipatetechnical challenges recommend improvements andprovideconsultative guidance across programs. You willoperateindependently 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) 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 will lead complex technical workstreams solve scientific problems contribute to regulatory documentation and helpestablishscalable 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 is an individualcontributortechnical leadership role with responsibility for mentoring junior scientists and leading technical work across programs.

• 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 dataidentifytechnical 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.

• Identifyopportunities to improve workflows increase assay robustness reduce development timelines andestablishplatform or semi-platform approaches where scientificallyappropriate.

• Mentor junior scientists and associates through technical guidance experimental design review data interpretation and development of scientific judgment.

• For Principal Scientist levelestablishtechnical 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.

• 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:typicallya doctoral degree with 3 years a masters degree with 9 years or a bachelors degree with 11 years of relevant industry experience.

• Principal Scientist level:typicallya doctoral degree with 7 years a masters degree with 13 years or a bachelors degree with 15 years of relevant industry experience.

• Deep technicalexpertisein 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 supportbiologicsdevelopment.

• 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 qPCRddPCR 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 leveldemonstratedability to influence technical strategy across multiple programs define novel approachesestablishbest practices and contribute to broader capability development within the function.

At Takeda our patients rely on us to deliver quality products. As a result we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the this role you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head face hands feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up jewelry contact lenses nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold wet environment.
• Work multiple shifts including weekends or be asked to work supplemental hours as necessary.
• Work around chemicals such as alcohol acids buffers and Celite that may require respiratory protection.

At Takeda we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer Takeda offers stimulating careers encourages innovation and strives for excellence in everything we do. We foster an inclusive collaborative workplace in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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