Associate Scientist, Biologics Characterization

BioLife Plasma; Lexington, Northern (MA, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Takeda is seeking an Associate Scientist, Biologics Characterization to lead analytical work using mass spectrometry and biophysical methods. You will independently design, execute, and report characterization experiments to support CMC, process development, and regulatory submissions.

You will work with cross-functional partners to ensure data quality and drive product understanding, with opportunities to mentor colleagues and contribute to technological advancements.

Qualifications

• Hands-on experience in analytical development for biologics required.
• Proficiency with mass spectrometry and biophysical characterization.
• Strong ability to plan, execute, and interpret experiments and report results.

Responsibilities

• Design, plan, execute, and report biologics characterization experiments.
• Perform analytical and biophysical studies on structure, stability, and variants.
• Prepare protocols, reports, data summaries, and technology transfer documents.
• Communicate results to cross-functional teams and project leads.
• Troubleshoot instrument, method, or data issues and propose solutions.
• Coordinate characterization activities and contribute to regulatory submissions.

Skills

Mass spectrometry

Biologics characterization

HPLC/UPLC

LC-MS

Protein chemistry

Biophysics

Analytical chemistry

Data analysis

Education

Bachelor's degree in a related field

Master's degree in a related field

PhD in a related field

Associate degree with 8+ years experience

Tools

LC-MS

Glycan analysis

SEC-HPLC

RP-HPLC

IEX-HPLC

AUC

CD

DSC

DLS

Job description

**\\*Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info.**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 and. 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 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:**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 Takeda's mission to bring life-changing therapies to patients worldwide.# **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 8+ years, 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.* 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 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