Scientist, Biologics Characterization

Join Takeda as a Scientist, Biologics Characterization plays a key role and will contribute to biologics characterization activities using mass spectrometry, biophysical methods, and/or HPLC/UPLC-based separations. You will independently plan, execute, analyze, and report characterization experiments to support product understanding, process development, comparability, stability, manufacturing readiness, technology transfer, and regulatory submissions. You will work with departmental and cross-functional partners to generate high-quality data, troubleshoot technical issues, and communicate results that support decision‑making for biologics CMC.

You will bring hands‑on laboratory experience, technical curiosity, and the ability to develop expertise in one or more characterization platforms such as LC‑MS, peptide mapping, intact mass analysis, glycan analysis, UPLC/HPLC fractionation, AUC, CD, DSC, DLS, spectroscopy, or related protein characterization methods. This role does not include direct people management.

As a Scientist, you will report to the Associate Director, Characterization Biologics within Analytical Development, Biologics. You will contribute to biologics characterization activities using mass spectrometry, biophysical methods, and/or HPLC/UPLC-based separations. You will independently plan, execute, analyze, and report characterization experiments to support product understanding, process development, comparability, stability, manufacturing readiness, technology transfer, and regulatory submissions. You will develop project specific technical strategies to characterize biotherapeutics products supporting CMC aspects of clinical products.

You will work with departmental and cross‑functional partners to prepare, coordinate and/or execute characterization studies that support decision‑making for biologics CMC. You will bring hands‑on laboratory experience, technical curiosity, and the ability to develop expertise in one or more characterization platforms such as LC‑MS, peptide mapping, intact mass analysis, glycan analysis, UPLC/HPLC fractionation, AUC, CD, DSC, DLS, spectroscopy, or related protein characterization methods.

This role does not include direct people management.

• Independently design, plan, execute, analyze, and report basic and complex biologics characterization 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.
• Apply methods such as LC‑MS, peptide mapping, intact mass, glycan analysis, HPLC/UPLC, electrophoretic methods, spectroscopy, thermal analysis, and other characterization tools.
• Author documents of characterization studies supporting product and process understanding, comparability, stability, process or formulation development, technology transfer and regulatory submissions.

• Prepare experimental protocols, technical reports, data summaries, method documents, technology transfer documents, and internal presentations.

• Lead the characterization of biologics to support relevant module 3 regulatory sections.

• Develop/propose characterization strategies and communicate to relevant stakeholders such as but not limited to departmental colleagues, project teams, or cross‑functional partners.

• Serve as an Analytical Development characterization contact for assigned project activities and align with the supervisor or project lead before committing resources or timelines.

• Troubleshoot non‑routine method, sample, instrument, data analysis, software, documentation, or vendor‑related issues and propose solutions.

• Coordin…