Join Takeda as a Senior Research Associate Analytical Development-Separation Sciences you work independently on assignments with definedobjectivesand 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 policiesidentifyand communicate technical issues and propose solutions with supervisor support. You build productive relationships within the department and acrossPharmScifunctions contribute to project execution and mayprovideinformal technical guidance to junior colleagues

About the role:

The Senior Research Associate is responsible for contributing to separation-based analytical activities supportingbiologicsdevelopment 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 antibodiesbispecific and other therapeutic 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-SDSicIEFcIEF glycan profiling or related analytical technologies. This role does not includepeopleleadership or people management responsibilities.

How you will contribute:

• Independently design plan execute analyze and document routine moderately complex and selected advanced separation sciences experiments under general 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 methods such as SEC-HPLC IEX-HPLC RP-HPLC HIC-HPLC UPLC CE-SDSicIEFcIEF 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 manage analyze interpret and summarize data using established procedures electronic systems and scientific software tools.

• Identifyand 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 morebiologicsprograms 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.

• Maintainhigh standardsfor 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.

What you bring to Takeda:

• Associate degree with 4 years bachelors degree with 2 years or masters degree with 0 years of relevant industry experience in analytical chemistry biochemistry protein chemistry biologics analytical development quality control or a related discipline.

• Previoushands-on experience working in a laboratory setting isrequired.

• 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-SDSicIEFcIEF glycan analysis or related techniques.

• Experience with analytical instrumentation chromatography data systems electronic laboratory notebooks LIMS or related digital laboratory systems.

• Working understanding ofbiologicsquality 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 ofgood 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 whilemaintainingattention 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 effectivelyina multidisciplinary team environment.

Important Considerations:

At Takeda our patients rely on us to deliver quality products. As a result we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the this role you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head face hands feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up jewelry contact lenses nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold wet environment.
• Work multiple shifts including weekends or be asked to work supplemental hours as necessary.
• Work around chemicals such as alcohol acids buffers and Celite that may require respiratory protection.

More about us:

At Takeda we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer Takeda offers stimulating careers encourages innovation and strives for excellence in everything we do. We foster an inclusive collaborative workplace in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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