Associate Scientist, Biologics Characterization

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Join Takeda as a The Associate 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.

Associate Scientist Biologics Characterization is responsible for managing and performing scientific research development and testing of new products manufacturing processes and raw materials. This role contributes to the development of innovative therapies by ensuring the quality and efficiency of manufacturing processes supporting Takedas mission to bring life-changing therapies to patients worldwide.

• 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.
• Contribute to characterization studies and source documentation 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.
• Interpret and communicate results to departmental colleagues project teams or cross-functional partners with supervisor or project lead alignment.
• 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.
• Stay current with relevant 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.
• Complete required training and maintain high standards for safety data integrity documentation quality and laboratory compliance.

• Associate degree with 7 years bachelors degree with 5 years or masters degree with 3 years 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.
• 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.

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.

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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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race color religion sex sexual orientation gender identity gender expression parental status national origin age disability citizenship status genetic information or characteristics marital status status as a Vietnam era veteran special disabled veteran or other protected veteran in accordance with applicable federal state and local laws and any other characteristic protected by law.

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