
Executive - Biotechnology
24 hours ago
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 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.
Educational Qualification
- M.SC. in Biochemistry / Life Sciences / Biotechnology.
Technical/functional Skills
- 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.
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