Scientist, Biologics Characterization

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); On-site; USD 116,000 - 182,000; Full time

Job summary

Takeda is seeking a Scientist, Biologics Characterization in Lexington, MA to independently plan, execute and report characterization experiments using MS, biophysical methods and HPLC/UPLC separations.

You will support product understanding, comparability, stability, manufacturing readiness, tech transfer and regulatory submissions while collaborating with cross-functional partners.

Qualifications

• Bachelor’s degree in analytical development, protein chemistry or related field required or equivalent experience.
• 8+ years (Bachelor) / 6+ years (Master) / 0 years (PhD) in relevant industry analytical development.
• Experience with biologics characterization, protein analytical methods and MS/biophysical methods.

Responsibilities

• Independently design, plan, execute, analyze, and report characterization experiments.
• Prepare technical reports, data summaries and transfer documents.
• Lead characterization studies to support regulatory submissions and technology transfer.
• Present technical results internally and contribute to publications or patents as appropriate.

Skills

LC-MS

Glycan analysis

UPLC/HPLC

AUC

CD

DSC

DLS

Biologics characterization

Analytical data interpretation

Troubleshooting

Education

Bachelor’s degree in analytical sciences/biochemistry/biophysics

Master’s degree in related field

PhD in relevant field

Tools

LC-MS

Peptide mapping

Intact mass analysis

Glycan analysis

SEC‑HPLC

RP‑HPLC

IEX‑HPLC

HIC‑HPLC

Job description

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 module3 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, visualisation, 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 elevate 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 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

• 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 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.

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.

Locations

Location: Lexington, MA

Base Salary Range

U.S. Base Salary Range: $116,000.00 - $182,270.00

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, or local laws, and any other characteristic protected by law.

Employment Details

Worker Type: Employee | Worker Sub‑Type: Regular | Time Type: Full time | Job Exempt: Yes