Scientist, Analytical Cell Line Engineering & Bioassay Development

BioLife Plasma; Lexington (MA); On-site; USD 116,000 - 182,000; Full time

Job summary

Takeda seeks a Scientist in Analytical Cell Line Engineering & Bioassay Development to design, generate, and maintain analytical cell lines for potency assays and impurity testing. You will work across Discovery, Global Biologics, and QA groups to deliver robust analytical methods and reagents.

The role involves transfection, cell banking, assay development, data interpretation, and regulatory documentation, with opportunities to influence technology transfers and process improvements.

Qualifications

• PhD in Cell Biology, Molecular Biology, Bioengineering, Biochemistry, Immunology or equivalent; or BA/BS with years of relevant experience.
• Hands-on mammalian cell culture, stable cell line engineering, flow cytometry, and molecular biology.
• 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; ELISA and qPCR methods for analytical characterization and impurity testing.

Responsibilities

• Develop, characterize, and maintain mammalian analytical cell lines for potency assays and functional characterization.
• Perform transfection, transduction, stable pool generation, clone screening, clonal isolation, and cell banking.
• Develop and run cell-based potency assays and functional bioassays; assess assay performance and resolve issues.
• Prepare technical reports, protocols, and transfer documents; support method transfers across labs and vendors.

Skills

Mammalian cell culture

Flow cytometry

Transfection

Transduction

Clonal screening

Cell banking

ELISA

qPCR

Molecular biology

Analytical development

Education

PhD in Cell Biology / Molecular Biology / Bioengineering / Biochemistry / Immunology

Master's with 3+ years industry experience

Bachelor's with 5+ years industry experience

Tools

ELISA

qPCR

Flow cytometry

Job description

## **Job Description**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. # **About the role:**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 Takeda's mission by developing and testing theories on the physical, chemical, and/or biological properties of materials and ingredients under various conditions. # **How you will contribute:*** 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. # **What you bring to Takeda:*** Ph.D in Cell Biology, Molecular Biology, Bioengineering, Biochemistry, Immunology or a master's degree with 3 or more years of relevant industry experience; or a bachelor's 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* undefined* 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. # Important Considerations: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. # More about us: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.#GMSGQ #ZR1 #LI-MA1 **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:**Lexington, MA**U.S. Base Salary Range:**$116,000.00 - $182,270.00The 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.