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Title:  Manager-1

Date:  Apr 10, 2024
Location:  Tandalja - R&D
Company:  Sun Pharmaceutical Industries Ltd
  • The candidate will supervise the team of eight members and provide the guidance.

 

  • The candidate is expected to work with cross functions like Upstream, Downstream & clone development team.
  • 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 (MDRs) and analytical test procedures (ATPs).
  • 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.

 

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