Associate Scientist, Potency Method Development

Takeda•Lexington, MA

4d•Onsite

About The Position

The Associate Scientist, Potency Method Development is 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.

Requirements

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.

Nice To Haves

Experience programming and operating automated liquid handling platforms such as the Hamilton Vantage preferred but not required.

Responsibilities

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.