Job Title: Associate Scientist - BDL
Purpose of Job
This role involves contributing scientifically to the development, qualification, and execution of cell-based assays, ELISA-based methods, and process-related impurity assays. The Junior Scientist will support method transfers and provide analytical support for the commercialization of biosimilar and small molecule products while ensuring compliance with regulatory guidelines
Skill Required
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Assay Development Expertise: Hands-on experience with cell-based assays, ELISA, SPR/BLI-based assays, and process-related impurity assays for biotherapeutic products.
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Method Development & Qualification: Solid understanding of method development, validation, and qualification processes as per regulatory guidelines.
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Data Review & Analysis: Ability to interpret and analyze data, perform trending analysis, and identify key insights.
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Good Documentation Practices (GDP): Experience in adhering to GDP and Data Integrity standards in GxP operations.
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Cross-Functional Collaboration: Strong communication skills to present data effectively in scientific discussions and project review meetings.
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Problem Solving: Ability to troubleshoot and resolve technical challenges in assay development and execution.
Roles and Responsibilites
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Develop and qualify cell-based assays, ELISA, and SPR/BLI-based assays for biotherapeutic products, ensuring regulatory compliance.
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Contribute to method development, execution, and validation as per project requirements.
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Conduct sample analysis for stability, analytical similarity, and forced degradation studies.
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Review, compile, and analyze assay data, providing insights to cross-functional teams.
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Ensure compliance with Good Documentation Practices (GDP) and Data Integrity requirements in all GxP operations.
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Review SOPs, protocols, raw data, and study reports to ensure scientific and regulatory accuracy.
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Communicate findings and data to cross-functional teams and participate in project review meetings.
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Respond to regulatory queries with scientifically sound, data-driven information.
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Troubleshoot and resolve technical challenges in assay development and execution.
Qualification Required
M.Sc. in Biotechnology, Biochemistry, or a related field
Competencies
Relevant professional / Educational background
3-5 years of relevant experience in assay development, characterization, and analytical support within the biotechnology or biopharmaceutical industry
Biotech, Ahmedabad, GJ, IN, 382213