Scientist

1 week ago

Navi Mumbai, Maharashtra, India Bharat Serums and Vaccines Limited Full time
  • Thorough knowledge of HPLC based analysis of recombinant proteins. Viz. RP-HPLC, SE-HPLC, glycan analysis etc.
  • Independently design method development of proteins, qualification, transfer following ICH/USP/EP/IP guidelines, including the writing and review of protocols, transfer plans, and reports.
  • Carry out day-to-day analytical work and working in co- ordination with the Cell culture and downstream teams in Biotech R&D.
  • Set-up product related test/ release specifications and analytical protocols Biotech products.
  • Design inhouse /outsource methods for Physico-chemical characterization of biological products.
  • Co-ordination with QC for smooth implementation of new methods.
  • Maintenance of equipment logs and documentation in the lab.
  • Maintaining and monitoring stability of various products in Biotech.
  • Responsible for preparation of lab related documents, regulatory submission documents and QC supports (SOP, STP, COA, MOA, Specification).
  • Interpret data and write reports in support of regulatory submissions
  • Reviewing of analytical data for in-process & stability related activities.

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