Exe

Job Objective

Searching for highly motivated candidate having technical expertise in Biosimilar product analysis.

Key Responsibilities

• 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 p reparation and review of method development reports (MDR) and analytical test procedures (ATP).
• 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.

Skills Required

Hplc, Method Development, sample preparation