Exe
SUN PHARMA
Date: 3 weeks ago
City: Vadodara, Gujarat
Contract type: Full time
Job Objective
Searching for highly motivated candidate having technical expertise in Biosimilar product analysis.
Key Responsibilities
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.
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