Scientist, Analytical Cell Line Engineering & Bioassay Development

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Join Takeda as a Scientist Analytical Cell Line Engineering & Bioassay Development plays you will support the design generation characterization and maintenance of analytical cell lines used as critical reagents for potency assay development functional characterization and analytical control strategies. Working at the interface of Discovery Global Biologics Analytical Development Process Development and Quality Control you will design and execute experiments analyze and interpret data and develop cell-based bioassays and impurity testing methods including ELISA and qPCR assays to support biologics development. Leveraging expertise in cell biology molecular biology and mammalian cell culture you will collaborate closely with Scientists and cross-functional partners to solve technical challenges advance analytical technologies support technology transfers author technical and regulatory documentation and deliver high-quality analytical methods and critical reagents throughout the development lifecycle.

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 support the design generation characterization and maintenance of analytical cell lines used as critical reagents for potency assay development functional characterization and analytical control strategies. Scientist Analytical Cell Line Engineering & Bioassay Development is responsible for 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 testing theories on the physical chemical and/or biological properties of materials and ingredients under various conditions.

• Develop characterize and maintain mammalian analytical cell lines for potency assays and functional characterization.
• Perform transfection transduction stable pool generation clone screening clonal isolation cell banking and cell line maintenance activities.
• Develop optimize qualify and run cell-based potency assays and functional bioassays using molecular and cellular methods.
• Develop optimize and execute impurity testing methods including ELISA and qPCR assays.
• Assess assay performance analyze results and resolve technical issues with project teams.
• Prepare technical reports protocols assay development summaries method documentation characterization reports and technology transfer documents.
• Support method transfers to internal laboratories external testing sites vendors and Quality Control groups.
• Follow quality documentation and data integrity requirements while improving laboratory workflows.
• Work with Discovery Global Biologics Process Development Quality Control Regulatory Affairs and external partners to support project deliverables and timelines.
• Stay current with advances in cell line engineering bioassay development molecular biology automation and emerging analytical technologies.

• Ph.D in Cell Biology Molecular Biology Bioengineering Biochemistry Immunology or a masters degree with 3 or more years of relevant industry experience; or a bachelors degree with 5 or more years of relevant industry experience.
• Hands-on experience with mammalian cell culture stable cell line engineering flow cytometry and molecular
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• Experience with transfection transduction clone screening clonal isolation cell banking and cell line characterization.
• Experience developing and executing cell-based potency assays and functional bioassays supporting biologics development is preferable.
• Experience using ELISA and qPCR methods for analytical characterization and impurity testing is preferable.
• Knowledge of receptor biology cellular signaling pathways and mechanism-of-action-based assay development.
• Knowledge of good manufacturing practice and regulatory expectations related to bioassays potency assays analytical methods and impurity testing is preferable.
• Strong scientific writing presentation communication and collaboration skills.
• Ability to independently execute experiments analyze multidimensional data and communicate scientific conclusions.
• Comfort with emerging digital tools and openness to artificial intelligence-enabled processes for data analysis and laboratory workflows.

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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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

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 actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race color religion sex sexual orientation gender identity gender expression parental status national origin age disability citizenship status genetic information or characteristics marital status status as a Vietnam era veteran special disabled veteran or other protected veteran in accordance with applicable federal state and local laws and any other characteristic protected by law.

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