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Job description:
Summary:
In this role, the personnel will be independent contributor. The candidate will be involved in execution for development, qualification of cell based assays, Ligand binding assays (ELISA), process related Impurities (HCP and HCD quantitation) and commercialization of biosimilar products.
Roles & Responsibilities:
Method development, qualification, transfer (as applicable) of cell based assays, process specific impurities (estimation of HCP, HCD and LPA) for biosimilars.
Experience in estimation of relative potency for biosimilar molecules.
Data compilation of sample analysis, method development and qualification experiments.
Preparation of reports for method development and qualification.
Preparation of SOP’s.
Writing LNBs, compiling raw data diligently.
Calibration of the equipment as per the schedules.
Required Skills:
Hands on experience in Cell culture techniques, ELISA, SDS-PAGE, Immunoblotting
Understanding of the data analysis software like SoftmaxPro®, PLA®
Efficient writing and verbal communication skills
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