Senior Research Associate, Potency Method Development

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Job Description

Join Takeda as a The 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.

·       Troubleshoot 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.
• 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: $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.

For information about our benefits, please click here .

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.