▷ 3 Days Left: Manager

3 weeks ago


Vadodara India SUN PHARMA Full time

Job Description Key Responsibilities - The candidate is expected to develop LC-MS based methods for protein and peptide product characterization. - The candidate is expected to qualify the methods for intended purpose for all pipeline products. - The candidate is expected to design and implement integrated strategies, linking appropriate chromatography and mass spectrometry tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on LC-MS, CEX-MS, SEC-MS Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile. - Responsible for designing advance workflows such as multi-attribute methods for PTMs, sequence variants, qualitative and quantitative profiling of HCPs, Disulfide shuffling and bond analysis, cell culture metabolite analysis, glycan analysis etc. - 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. - The candidate is responsible for the operation and maintenance of the MS instruments - To manage chemicals,consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issues. - Responsible for managing the regulatory queries. - The candidate is expected to draft the technical content for regulatory dossier. Educational Qualification - M.SC./M.Tech in Biochemistry / Life Sciences / Biotechnology. Technical/functional Skills - Sound knowledge of analytical method development, qualification and structural and functional characterization of therapeutic proteins. - Experience of biosimilarity assessment of biologics for regulated market is desirable. - Experience of analytical development for monoclonal antibodies and fusion proteins and peptide is highly desirable.



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