Senior Research Associate, Analytical Development - Separation Sciences

Job Description

Join Takeda as a Senior Research Associate, Analytical Development – Separation Sciences. You work independently on assignments with defined objectives and general direction. You plan and execute most routine and moderately complex experiments, analyze and interpret data using established procedures, and contribute to technical documents and project deliverables. You apply judgment within defined procedures and policies, identify and communicate technical issues, and propose solutions with supervisor support.

You build productive relationships within the department and across Pharm Sci functions, contributing to project execution, and may provide informal technical guidance to junior colleagues.

The Senior Research Associate is responsible for contributing to separation‑based analytical activities supporting biologics development, quality control readiness, method transfer, process and product understanding, comparability, stability, and regulatory submissions. You will independently plan, execute, analyze, and document routine and moderately complex experiments using chromatographic and electrophoretic methods for biologics, including monoclonal antibodies, bispecific, and other therapeutic proteins. You will work with departmental and cross‑functional partners to generate high‑quality data, troubleshoot technical issues, and support analytical deliverables for CMC programs.

You will bring hands‑on laboratory experience, strong documentation practices, technical curiosity, and the ability to develop deeper expertise in separation sciences methods such as U/HPLC, SEC, IEX, RP, HIC, CE‑SDS, icIEF, cIEF, glycan profiling, or related analytical technologies. This role does not include people‑leadership or management responsibilities.

• Independently design, plan, execute, analyze, and document routine, moderately complex, and selected advanced separation sciences experiments under general direction. Perform analytical and biophysical studies to assess biologics structure, heterogeneity, purity, stability, degradation pathways, post‑translational modifications, higher‑order structure, and product‑related variants.
• Perform chromatographic and electrophoretic analyses to assess biologics purity, heterogeneity, charge variants, size variants, glycan profiles, product‑related variants, degradation products, and stability‑indicating attributes. Apply methods such as SEC‑HPLC, IEX‑HPLC, RP‑HPLC, HIC‑HPLC, UPLC, CE‑SDS, icIEF, cIEF, glycan analysis, and related separation‑based techniques.
• Support method development, method optimization, qualification, validation, transfer, troubleshooting, lifecycle management, and QC readiness activities.
• Prepare and review experimental protocols, laboratory records, technical reports, data summaries, method documents, SOPs, and technology transfer documentation. Collect, manage, analyze, interpret, and summarize data using established procedures, electronic systems, and scientific software tools.
• Identify and communicate technical issues related to methods, samples, instruments, data analysis, documentation, software, or vendors, and propose practical solutions with supervisor support.
• Contribute to project activities across one or more biologics programs, including stability, comparability, process development, formulation development, manufacturing support, and regulatory submission support.
• Work with departmental colleagues and cross‑functional partners, including Process Development, Quality, Regulatory, Manufacturing Sciences, QC, and external laboratories, to support project timelines and analytical deliverables.
• Coordinate defined internal or external testing activities, including sample coordination, data‑package review, and consolidation of results, as assigned.
• Communicate experimental results, technical observations, and risks clearly to supervisors, project leads, departmental colleagues, and cross‑functional partners.
• Maintain high standards for laboratory safety, data integrity, good documentation practices, GMP awareness, and compliance with applicable procedures.
• Support continuous improvement of laboratory…