Assay Development Jobs in Boston, MA (NOW HIRING)

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 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 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) 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 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 development.This 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 data,identifytechnical 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 level,establishtechnical 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: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 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, 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,demonstratedability to influence technical strategy across multiple programs, define novel approaches,establishbest 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 product. In 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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