Scientist, Analytical Cell Line Engineering & Bioassay Development

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); On-site; USD 116,000 - 182,000; Full time

Job summary

Takeda in Lexington, MA is seeking a Scientist in Analytical Cell Line Engineering & Bioassay Development to design, generate, and maintain analytical cell lines used for potency assays and impurity testing. You will develop cell-based bioassays, perform ELISA and qPCR, and collaborate across Discovery, Global Biologics, Process Development, Quality Control, and Regulatory Affairs to deliver robust analytical methods.

Ph.D.

Qualifications

• Ph.D. in Cell Biology, Molecular Biology, Bioengineering, Biochemistry, Immunology or a Master’s with 3+ years of industry experience; or a Bachelor's with 5+ years of industry experience.
• Hands-on experience with mammalian cell culture and stable cell line engineering.
• Experience developing and executing cell-based potency assays and functional bioassays; ELISA and qPCR experience preferred.

Responsibilities

• Develop, characterize, and maintain mammalian analytical cell lines for potency assays and functional characterization.
• Perform transfection, transduction, clone screening, and cell line maintenance activities.
• Develop and run cell-based potency and functional bioassays using molecular and cellular methods.
• Develop and execute impurity testing methods including ELISA and qPCR.
• Prepare technical reports, protocols, and transfer documents; support method transfers and regulatory documentation.

Skills

Mammalian cell culture

Flow cytometry

Transfection

Transduction

Cell line screening

ELISA

qPCR

Bioassay development

Education

Ph.D in Cell Biology

Master's in related field

Bachelor's + 5+ years experience

Tools

Flow cytometer

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.

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 - $182,270.00 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 job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

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.

Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Company Information

Takeda is an industry‑leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.