Job Title: Research Scientist - ADL
Purpose of Job
To develop, qualify, and support analytical methods for biotherapeutic products by applying advanced chromatographic and electrophoretic techniques, ensuring accurate and timely analytical deliverables that support product development, process characterization, and regulatory compliance.
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/ MTech Biotechnology
Competencies
Biotech, Ahmedabad, GJ, IN, 382213