Job Description

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 preparation 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.

• M.SC. in Biochemistry / Life Sciences / Biotechnology.

• Sound knowledge of analytical method development, qualification.
• Experience in biosimilar development for regulated market is desirable.
• Experience of analytical development for monoclonal antibodies and peptide is highly desirable.