Associate Scientist, Potency Method Development

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.

Pay

For Location: Lexington, MA 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. U.S. based employees may be eligible for short-term and/or long-term incentives.

Benefits

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.