Senior Research Associate, Potency Method Development

Takeda Pharmaceutical Co.; Lexington (MA); On-site; USD 90,000 - 141,000; Full time

Job summary

Takeda in Lexington, MA seeks a Senior Research Associate for Potency Method Development. You will design and transfer cell-based and ligand-binding potency assays, ensuring robust methods for biologics programs.

This hands-on role involves collaboration with Process Development, QC/QA, and external partners to drive product characterization and regulatory readiness. You will work under the Head of Cell-Based Potency Assay Development, contributing to method qualification studies and technology

Qualifications

• MS in Biology, Biochemistry, or related field with 0–2 years of industry experience; or BS with 1–3 years of experience.
• Experience with aseptic techniques and mammalian cell culture.
• Ability to plan, execute, analyze, and communicate complex studies with limited supervision.
• Strong collaboration and communication across cross-functional teams.
• Hands-on experience with potency/functional assays (cell-based, ELISA, flow cytometry, SPR).
• Experience with laboratory calculations and instrument operation.

Responsibilities

• Design, develop, qualify, and transfer cell-based and ligand-binding potency assays.
• Evaluate assay performance and fitness for purpose through qualification studies.
• Collaborate with Process Development, QC, QA, Analytical Sciences, CTOs, and partners to advance goals.
• Troubleshoot complex analytical methods to improve reliability and reproducibility.
• Author and review development reports, transfer packages, SOPs, and validation/qualification docs.
• Communicate findings via presentations, publications, posters, and patent-related contributions.
• Maintain compliance with quality standards, safety, data integrity, and documentation practices.

Skills

Aseptic techniques

Mammalian cell culture

Lab operations

Independent planning

Cross-functional collaboration

Education

MS in Biology/Biochemistry or related field

BS in Biology/Biochemistry or related field

Tools

Hamilton Vantage

Job description

Job Description

Join Takeda as a Senior Research Associate, Potency Method Development responsible for managing and performing scientific research, development, and testing of new products, manufacturing processes, and raw materials. This role contributes to the development of innovative therapies by ensuring the quality and efficiency of manufacturing processes, supporting Takeda's mission to bring life‑changing therapies to patients worldwide. As a senior professional, you're adept at solving a range of moderate scope and complexity problems, occasionally referring to policies and practices for guidance. Your work involves analyzing situations and data, exercising judgment within established procedures, and fostering productive relationships internally and externally. You possess solid knowledge of industry practices and contribute to departmental projects and goals, often engaging in frequent internal and external interactions. You may occasionally lead small project teams and provide informal guidance to junior staff, all while working with minimal guidance yourself.

About the role: Reporting to the Head of the Cell-Based Potency Assay Development team within Analytical Development, Biologics, the Senior Research Associate, Potency Method Development will be responsible for designing, developing, qualifying, and transferring cell‑based and ligand binding potency assays and related analytical methods for biologics programs. In this role, you will execute phase‑appropriate analytical methods that support product characterization, process development, regulatory submissions, and analytical control strategies. You will contribute to the advancement of innovative therapies by developing robust, reliable assays and partnering across functions to ensure high‑quality scientific outcomes. This is a hands‑on, laboratory‑based position with no direct people management responsibilities.

How you will contribute

• Design, develop, optimize, and implement cell‑based and ligand binding potency assays to support product characterization, release, stability, comparability, and lifecycle management.
• Evaluate assay performance, biological relevance, and fitness for purpose through the design and execution of phase‑appropriate method qualification studies.
• Collaborate with cross‑functional teams including Process Development, Quality Control, Quality Assurance, Analytical Sciences, Contract Testing Organizations (CTOs), and other Analytical Development partners to advance project goals.
• Trouble‑shoot complex analytical methods and identify factors affecting assay performance, reliability, and reproducibility.
• Author and review technical documentation including development reports, technology transfer packages, standard operating procedures (SOPs), and qualification or validation protocols and reports.
• Communicate scientific findings through presentations, publications, posters, invention disclosures, and patent‑related contributions as appropriate.
• Maintain compliance with applicable quality standards, safety requirements, data integrity expectations, and documentation practices.

What you bring to Takeda

• MS in Biology, Biochemistry, or a related scientific discipline with 0-2 years of relevant industry experience in product or process development; or BS in Biology, Biochemistry, or a related scientific discipline with 1-3 years of relevant industry experience.
• Experience with aseptic techniques, mammalian cell culture, multichannel pipetting, reagent preparation, and general laboratory operations and equipment maintenance.
• Ability to independently plan, execute, analyze, and communicate complex experimental studies across multiple projects with limited supervision.
• Strong collaboration and communication skills with the ability to work effectively across cross‑functional teams.
• Demonstrated scientific curiosity and the ability to quickly learn new technologies, analytical platforms, and scientific concepts.
• Hands‑on experience with potency and functional assays, including cell‑based assays, ELISA, flow cytometry, SPR, and related analytical techniques used to assess biologic products.
• Ability to perform routine laboratory calculations associated with sample preparation and method execution.
• Experience programming and operating automated liquid handling systems such as the Hamilton Vantage.

Compensation and Benefits Summary

For Location: Lexington, MA U.S. Base Salary Range: $89,900.00 - $141,240.00 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.

Location and Employment Type

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 Culture

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.