Job Title: Research Associate - BDL
Purpose of Job
This role requires both scientific proficiency and troubleshooting abilities. The Junior Scientist will contribute to the development, qualification, and implementation of cell-based assays, ELISA-based methods, process-related impurity assays, and method transfer. The role also involves supporting the commercialization of biosimilar/small molecule products while ensuring compliance with regulatory guidelines.
Skill Required
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Scientific Proficiency: Hands-on experience in developing and qualifying cell-based assays, ELISA, SPR/BLI-based assays, and process-related impurity assays for biotherapeutic products.
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Method Development & Qualification: Strong understanding of the process of method development, validation, and qualification per regulatory guidelines.
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Data Review & Analysis: Ability to analyze and interpret assay data, generate meaningful insights, and identify trends.
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Cross-Functional Collaboration: Strong communication and presentation skills to effectively communicate data to cross-functional stakeholders.
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Good Documentation Practices (GDP): Experience with documentation practices ensuring compliance with GxP and Data Integrity standards.
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Problem Solving & Troubleshooting: Ability to troubleshoot and resolve technical issues during 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
MSc Biotechnology
Competencies
Relevant skills / Industry experience
1-3 Years of experience with biosimilars
Biotech, Ahmedabad, GJ, IN, 382213