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R&D Downstream Process, Biosimilars Intas

6.0 - 11.0 years

0 - 0 Lacs

ahmedabad

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Job Summary Execute downstream process development for biosimilar projects, including chromatography, filtration, tech transfer, scale-up, and data documentation, ensuring compliance with quality and regulatory standards. Key Responsibilities Perform downstream processing using AKTA chromatography (SEC, IEX, HIC, RP), filtration (TFF), virus validation, and cleaning validation. Operate, troubleshoot, and optimize AKTA systems and downstream unit operations. Support tech transfer, process scale-up, and characterization using QbD principles. Prepare and review protocols, reports, and regulatory documents. Collaborate cross-functionally with UPD, ADL, DPD, QA, and manufacturing teams. Ensure ac...

Posted 1 month ago

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