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About the role
Description supplied by the original job listing.
Position: Sr. Research Fellow / Research Scientist (Executive / Asst. Manager)
Department: Biosimilar R&D (Analytical – Physicochemical parameters)
Location: Hinjewadi, Pune
Qualification: M.Sc. / M.Tech in Pharmaceutical Sciences, Biotechnology, or Biochemistry
Experience: 3 – 6 years of industrial experience in protein characterization and analytical methods
Key Responsibilities:
Hands-on experience with bio-analytical instruments (HPLC, gel-electrophoresis, spectrophotometer, gel documentation, bio-analytical assays).
Ensure strict GLP compliance in the bio-analytical lab.
Prepare Standard Test Procedures (STP), method development, qualification, and validation reports.
Handle CMC and RCGM dossier preparations.
Strong knowledge of ICH, WHO, FDA, and EMA guidelines.
Draft specifications for in-process, drug substance, and drug product along with CoAs, calibration records, and logbooks.
Added Advantage: Experience in structural studies and mass spectrometry analysis
Work arrangement
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