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.
• Robust 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
📌 Executive (India)
🏢 Emcure Pharmaceuticals
📍 India
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