Senior Research Associate, Analytical Development - Separation Sciences

Takeda•Lexington, MA

6d•Onsite

About The Position

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 PharmSci functions, contribute 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 people management responsibilities.

Requirements

Associate degree with 4+ years, bachelor’s degree with 2+ years, or master’s degree with 0+ years of relevant industry experience in analytical chemistry, biochemistry, protein chemistry, biologics analytical development, quality control, or a related discipline.
Previous hands-on experience working in a laboratory setting is required.
Experience with separation-based analytical methods for biologics, proteins, peptides, or related complex molecules.
Practical knowledge of one or more relevant methods such as SEC-HPLC, IEX-HPLC, RP-HPLC, HIC-HPLC, UPLC, CE-SDS, icIEF, cIEF, glycan analysis, or related techniques.
Experience with analytical instrumentation, chromatography data systems, electronic laboratory notebooks, LIMS, or related digital laboratory systems.
Working understanding of biologics quality attributes, including purity, heterogeneity, charge variants, size variants, product-related variants, degradation products, and stability-indicating attributes.
Ability to independently execute experiments, analyze data, interpret results, and communicate conclusions within established procedures and project expectations.
Ability to prepare and review technical documentation, including protocols, reports, data summaries, method documents, SOPs, and transfer materials.
Understanding of good documentation practices, data integrity principles, laboratory safety, and basic GMP expectations.
Ability to troubleshoot technical issues, propose practical solutions, and escalate risks appropriately.
Ability to work across departmental and cross-functional teams with an understanding of project timelines, deliverables, and data quality expectations.
Ability to manage multiple assignments with general direction while maintaining attention to scientific quality, timelines, and documentation standards.
Ability to communicate technical information clearly in writing, in meetings, and in scientific discussions.
Comfort using digital and AI-enabled tools to support data analysis, workflow improvements, documentation, and scientific decision-making.
Ability to work independently while contributing effectively in a multidisciplinary team environment.

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 workflows, data review practices, method execution, documentation, and analytical processes.
Serve as a technical resource for selected instruments, methods, or laboratory workflows, and may train or mentor colleagues, interns, or co-ops.
Stay current with relevant separation sciences technologies, biologics analytical methods, digital tools, and regulatory expectations.