Associate Scientist, Potency Method Development

Takeda; Lexington (MA); On-site; USD 103,500 - 162,690; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Tuition reimbursement

Paid time off

Well-being benefits

Job summary

Takeda seeks an Associate Scientist, Potency Method Development to design, develop, and transfer cell-based and ligand-binding potency assays for biologics programs. You will execute phase-appropriate analytical methods supporting product characterization, process development, and regulatory submissions.

You'll work with mammalian cell culture, troubleshooting, data interpretation, and documentation, while engaging with multiple stakeholders.

Qualifications

• MS in Biology, Biochemistry or related discipline with 0–2 years of industry experience in product and process development.
• Experience with aseptic technique, tissue culture, multichannel pipetting, and reagent prep per procedures.
• Ability to plan, execute, interpret, and communicate complex experimental work across two or more projects with limited supervision.

Responsibilities

• Design, develop, optimize, and implement cell-based and ligand-binding potency assays for product characterization, release, stability, and lifecycle management.
• Assess assay performance and suitability for intended use through phase-appropriate method qualification.
• Coordinate work with cross-functional stakeholders including Process Development, Quality Control, QA, and other Analytical Development teams.
• Troubleshoot complex analytical methods and identify contributors to performance issues.
• Prepare and review technical docs: method development reports, transfer docs, SOPs, and validation/qualification reports.
• Present findings internally and externally through presentations, posters, publications, or invention disclosures.
• Complete required training and maintain safety, data integrity, and GxP awareness.

Skills

Cell culture

Assay development

Aseptic technique

Data interpretation

Documentation

Cross-functional collaboration

Experiment planning

Automated liquid handling

Education

Master's degree in Biology/Biochemistry

Bachelor's degree in Biology/Biochemistry

Tools

Hamilton Vantage

Job description

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Join Takeda as an Associate Scientist, 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, you will be responsible for designing, developing, qualifying, and transferring cell‑based and ligand binding potency assays and related methods for biologics programs. You will independently execute phase‑appropriate analytical methods that support product characterization, process development, regulatory submissions, and analytical control strategy. The successful team member will work effectively in a team environment on multiple projects of varying complexity requiring development of robust and reliable cell‑based and ligand binding analytical methods. You will bring hands‑on experience in mammalian cell culture, potency assay development, assay troubleshooting, data interpretation, and documentation. This role is lab‑based and does not include direct people management.

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.
• Assess assay performance, biological relevance, and suitability for intended use through phase‑appropriate method qualification design and execution.
• Plan and coordinate work with departmental, cross‑functional, and external stakeholders, including Process Development, Quality Control, CTOs, Analytical Sciences, Quality Assurance, and other Analytical Development teams.
• Troubleshoot complex analytical methods and identify contributors to method performance issues.
• Prepare and review technical documentation, including method development reports, technology transfer documents, standard operating procedures, and qualification or validation protocols and reports.
• Present findings internally and externally through presentations, posters, publications, invention disclosures, or patent‑related contributions.
• Complete all required training and maintain high standards for safety, data integrity, GxP awareness, and documentation quality.

What you bring to Takeda

• MS in Biology, Biochemistry or related discipline with a minimum of 0‑2 years relevant industry experience in product and process development.
• BS in Biology, Biochemistry or related discipline with a minimum of 1‑3 years relevant industry experience.
• Experience with aseptic technique, tissue culture, multichannel pipetting, reagent preparation based on established procedures, and general laboratory upkeep and equipment maintenance.
• Ability to plan, execute, interpret, and communicate complex experimental work across two or more projects or functional priorities with limited supervision.
• Demonstrated ability to work effectively in a collaborative team environment and communicate with cross‑functional partners.
• Ability and motivation to gain in‑depth understanding of new technologies, method platforms, and scientific concepts.
• Experience with a variety of assays, including cell‑based assays, ELISAs, flow cytometry, SPR, and/or other assays used to study function and assess potency of biologics.
• Demonstrated ability to perform routine calculations related to sample preparation and method execution.
• Experience programming and operating automated liquid handling platforms such as the Hamilton Vantage preferred but not required.

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.

U.S. Base Salary Range: $103,500.00 - $162,690.00

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.

U.S. based employees may be eligible for short‑term and/ or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

YesIt 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.