Scientist, Biologics Characterization Lexington, MA Category: Pharmaceutical Sciences

Job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description 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. About the role: 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. How you will contribute: 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. Coordinate defined internal or external characterization activities, including review and consolidation of vendor data packages, as assigned. Propose and implement improved approaches for data collection, analysis, interpretation, visualization, and reporting within assigned scope. Build technical capabilities for the department with up-to-date analytical technologies, biologics characterization methods, data analysis approaches, and regulatory expectations. Serve as a technical resource for selected laboratory technologies and may train or mentor colleagues, interns, and co-ops. Present technical results internally and may contribute to posters, internal reports, external presentations, publications, invention disclosures, or patent-related activities, as appropriate. What you bring to Takeda: Bachelor’s degree with 8+ years, or master’s degree with 6+ years, or Ph.D. with 0 yr relevant experience of relevant industry experience in analytical development, biologics characterization, protein chemistry, biochemistry, biophysics, analytical chemistry, or a related discipline. Previous hands-on experience working in a laboratory setting is required. Experience with biologics characterization, protein analytical methods, mass spectrometry, biophysical characterization, chromatography, electrophoresis, or related analytical technologies. Practical knowledge of one or more relevant methods such as LC-MS, peptide mapping, intact mass, glycan analysis, SEC-HPLC, RP-HPLC, IEX-HPLC, HIC-HPLC, icIEF, CE-SDS, AUC, CD, DSC, DLS, fluorescence spectroscopy, or related techniques. Strong understanding of proteon structure/function associations. Ability to independently plan and execute experiments, analyze data, interpret results, and communicate conclusions to technical and cross-functional stakeholders. Working understanding of biologics structure, product heterogeneity, stability, degradation pathways, product-related variants, and critical quality attributes. Ability to prepare and review technical documentation, including protocols, reports, data summaries, method documents, SOPs, and technology transfer materials. Demonstrated problem-solving skills, including the 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. Understanding of data integrity principles, ELN/LIMS documentation, laboratory safety, and good documentation practices. Ability to manage multiple priorities with general direction while maintaining attention to scientific quality, timelines, and documentation standards. Ability to communicate technical information clearly in writing and in conversation, and to present technical information clearly to scientific and project stakeholders. Comfort using emerging digital and AI-enabled tools to support data analysis, workflow improvements, and scientific decision-making. Ability to work independently while contributing effectively in a 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 product. In 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 C