At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
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, N-Glycan, 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), method qualification reports (MQR) 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
