SUN PHARMA
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Job Location: Baroda
Department:
R&D Biotechnology-Protein Characterization, R&D Biotechnology – Analytical Development (In Process)
Grade:
Executive/Sr. Executive
Experience: 2-9 years
Qualification:
M.SC./M.Tech- Biotechnology or Biochemistry
Brief Job Description:
1) To develop LC-MS based methods for protein and peptide product characterization
2) To design and implement integrated strategies, linking appropriate chromatography and mass spectrometry tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on LC-MS, CEX-MS, SEC-MS Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile
3) Responsible for designing advance workflows such as multi-attribute methods for PTMs, sequence variants, qualitative and quantitative profiling of HCPs, Disulfide shuffling and bond analysis, cell culture metabolite analysis, glycan analysis etc
4) Preparation and review of method development reports (MDR) and analytical test procedures (ATP)
Technical/functional Skills:
•Sound knowledge of analytical method development, qualification and structural and functional characterization of therapeutic proteins.
•Experience of bio-similarity assessment of biologics for regulated market is desirable.
•Experience of analytical development for monoclonal antibodies and fusion proteins and peptide is highly desirable
1) To develop HPLC based methods for protein and peptide products.
(2) 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
3) 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
4) Responsible for preparation and review of method development reports (MDR) and analytical test procedures (ATP).
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.
Please send your resume to: [email protected]