Job Title: Research Associate - ADL
Purpose of Job
Responsible for delivering timely analytical results for Biotherapeutic projects, primarily focusing on characterization activities to support clone development, evaluation, and cross-functional teams within R&D.
Skill Required
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Proficiency in chromatographic techniques (SEC, IEX, HIC, RP) and HPLC/UPLC operation.
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Experience with N-glycan analysis and higher-order structure analysis (preferred).
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Skilled in electrophoretic methods: cIEF, CE-SDS (reducing and non-reducing), CE-LIF.
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Strong background in method development, qualification, and validation for biologics.
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Proficient in MS Office and software relevant to analytical instrumentation.
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Experience in preparing regulatory and technical documentation.
Roles and Responsibilites
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Analytical Deliverables:
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Lead and execute analytical tasks for biotherapeutic projects, including QTPP assessments, process support, method development, qualification, and transfer activities.
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Experimental Work:
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Perform hands-on bench work using various analytical techniques:
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Chromatographic methods (SEC, IEX, HIC, RP via HPLC/UPLC)
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Electrophoresis techniques (cIEF, CE-SDS NR/R, CE-LIF)
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Colorimetric and spectrophotometric assays
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Data Interpretation & Documentation:
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Independently interpret experimental results and derive meaningful conclusions.
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Document work accurately, ensuring compliance with GLP and regulatory standards.
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Reporting & Communication:
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Prepare and review protocols, method development reports (MDRs), SOPs, and method of analysis (MOAs).
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Contribute to scientific presentations and project documentation.
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Lab Practices:
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Ensure laboratory practices are aligned with GLP and safety standards.
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Support overall lab organization and compliance.
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Qualification Required
MSc Biotechnology / MSc Biochemistry
Competencies
Relevant skills / Industry experience
1-3 Years of experience with biosimilars
Biotech, Ahmedabad, GJ, IN, 382213