Executive - Biotechnology (Urgent)

4 weeks ago

Vadodara Gujarat, India Sun Pharmaceutical Industries Full time

Job Objective Searching for highly motivated candidate having technical expertise in Biosimilar product analysis Key Responsibilities The candidate is expected to develop HPLC based methods for protein and peptide products The candidate is expected to design and implement integrated strategies linking appropriate analytical tools to perform a qualitative and quantitative assessment of product related variants and impurities Develop and apply novel sample preparation with emphasis on RP-HPLC SEC-HPLC CEX-HPLC etc Responsible for designing advance workflows to measure characterize process related impurities at different stages of product development such as Host cell protein HCPs Host Cell DNA HCD Leachable The candidate is expected to qualify the methods for intended purpose for all pipeline products Responsible for routine in process sample analysis Responsible for preparation and review of method development reports MDR and analytical test procedures ATP Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations Responsible for managing the regulatory queries The candidate is expected to draft the technical content for regulatory dossier Educational Qualification M SC in Biochemistry Life Sciences Biotechnology Technical functional Skills Sound knowledge of analytical method development qualification Experience in biosimilar development for regulated market is desirable Experience of analytical development for monoclonal antibodies and peptide is highly desirable

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