Associate Scientist, Biologics Characterization

Takeda; Lexington (MA); On-site; USD 104,000 - 163,000; Full time

Job summary

Takeda in Lexington, MA seeks an Associate Scientist, Biologics Characterization to perform mass spectrometry, biophysical methods, and HPLC/UPLC separations, planning, executing, analyzing and reporting experiments supporting CMC, 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

Qualifications

• Hands-on laboratory experience in analytical development.
• Experience with mass spectrometry and biophysical characterization.
• Knowledge of protein analytical methods and chromatography.
• Ability to communicate results to technical and cross-functional stakeholders.

Responsibilities

• Design, plan, execute, analyze, and report biologics characterization experiments under general direction.
• Perform analytical/biophysical studies for structure, heterogeneity, purity, stability, and product variants.
• Apply LC-MS, mapping, intact mass, glycan analysis, HPLC/UPLC and spectroscopy.
• Prepare protocols, reports, and tech transfer documents.
• Communicate results to teams and align with project leads.

Skills

Analytical development

Biologics characterization

Mass spectrometry

HPLC/UPLC

Data interpretation

Documentation

Cross-functional collaboration

Education

Bachelor's degree in analytical chemistry

Master's degree in biochemistry

Tools

LC-MS

Peptide mapping

Glycan analysis

SEC-HPLC

RP-HPLC

IEX-HPLC

DLS

Job description

Job Description

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.

About the role:

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 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.

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.
• 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.

What you bring to Takeda:

• Associate degree with 7+ years, bachelor's degree with 5+ years, or master's 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, SPR, 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 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 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 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.

#GMSGQ #ZR1 #LI-MA1

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:

Lexington, MA

U.S. Base Salary Range:

$103,500.00 - $162,690.00

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 job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.