Senior Research Associate, Analytical Development - Separation Sciences
Takeda
August 29, 2026
On-site
Lexington, MA
$89,900 - $141,240 USD yearly
Clinical Research and Development
Senior Research Associate, Analytical Development – Separation Sciences
Responsibilities:
- Independently design, plan, execute, analyze, and document routine, moderately complex, and selected advanced separation sciences experiments.
- Perform chromatographic and electrophoretic analyses for biologics (e.g., monoclonal antibodies, bispecifics, therapeutic proteins) to assess purity/heterogeneity, charge/size variants, glycan profiles, degradation products, stability-indicating attributes, and related properties.
- Support method development, optimization, qualification, validation, transfer, troubleshooting, lifecycle management, and QC readiness.
- Prepare/review protocols, laboratory records, technical reports, data summaries, method documents, SOPs, and technology transfer documentation; collect and summarize data using electronic systems and scientific software.
- Identify and communicate technical issues (methods, samples, instruments, data analysis, documentation, software, vendors) and propose solutions with supervisor support.
- Contribute to CMC project activities (stability, comparability, process/formulation development, manufacturing support, regulatory submission support) and coordinate testing as assigned.
- Maintain laboratory safety, data integrity, good documentation practices, GMP awareness, and compliance.
Qualifications/Required Skills:
- Associate degree with 4+ years, bachelor’s with 2+ years, or master’s with 0+ years relevant industry experience in analytical chemistry/biochemistry/protein chemistry/biologics analytical development/quality control (or related).
- Required: hands-on laboratory experience.
- Experience with separation-based analytical methods for biologics/proteins/peptides/complex molecules.
- Practical knowledge of one or more: SEC-HPLC, IEX-HPLC, RP-HPLC, HIC-HPLC, UPLC, CE-SDS, icIEF, cIEF, glycan analysis (or related).
- Experience with analytical instrumentation and digital systems (chromatography data systems, ELNs, LIMS).
- Understanding of biologics quality attributes (purity, heterogeneity, variants, degradation, stability-indicating attributes).
- Ability to execute experiments, analyze data, interpret results, troubleshoot, document, and communicate conclusions.
Optional/Skills:
- Comfort using digital and AI-enabled tools.
Application instructions:
- By clicking the “Apply” button, you confirm understanding of the employment application process and attest information is true to the best of your knowledge.
Responsibilities:
- Independently design, plan, execute, analyze, and document routine, moderately complex, and selected advanced separation sciences experiments.
- Perform chromatographic and electrophoretic analyses for biologics (e.g., monoclonal antibodies, bispecifics, therapeutic proteins) to assess purity/heterogeneity, charge/size variants, glycan profiles, degradation products, stability-indicating attributes, and related properties.
- Support method development, optimization, qualification, validation, transfer, troubleshooting, lifecycle management, and QC readiness.
- Prepare/review protocols, laboratory records, technical reports, data summaries, method documents, SOPs, and technology transfer documentation; collect and summarize data using electronic systems and scientific software.
- Identify and communicate technical issues (methods, samples, instruments, data analysis, documentation, software, vendors) and propose solutions with supervisor support.
- Contribute to CMC project activities (stability, comparability, process/formulation development, manufacturing support, regulatory submission support) and coordinate testing as assigned.
- Maintain laboratory safety, data integrity, good documentation practices, GMP awareness, and compliance.
Qualifications/Required Skills:
- Associate degree with 4+ years, bachelor’s with 2+ years, or master’s with 0+ years relevant industry experience in analytical chemistry/biochemistry/protein chemistry/biologics analytical development/quality control (or related).
- Required: hands-on laboratory experience.
- Experience with separation-based analytical methods for biologics/proteins/peptides/complex molecules.
- Practical knowledge of one or more: SEC-HPLC, IEX-HPLC, RP-HPLC, HIC-HPLC, UPLC, CE-SDS, icIEF, cIEF, glycan analysis (or related).
- Experience with analytical instrumentation and digital systems (chromatography data systems, ELNs, LIMS).
- Understanding of biologics quality attributes (purity, heterogeneity, variants, degradation, stability-indicating attributes).
- Ability to execute experiments, analyze data, interpret results, troubleshoot, document, and communicate conclusions.
Optional/Skills:
- Comfort using digital and AI-enabled tools.
Application instructions:
- By clicking the “Apply” button, you confirm understanding of the employment application process and attest information is true to the best of your knowledge.