Job Description
Job Description
Relevant biosimilar experience from reputed biosimilar companies with Experience of development of cell-based assays, ELISA and Experience working on flow cytometry-based assays (preferable). Capable of designing experiment with minimal supervision and having experience with development of functional bioassays to evaluate different mechanism of action.
Experience of analyzing data using different software’s like PLA (equivalence testing), GraphPad Prism, Minitab etc. Development of ELISAs and other characterization bioassays for biosimilars with application of novel technical concepts.
Good understanding of assay kinetics and mode of action of receptor biology and Mabs Bioassay Method qualification/validation and transfer to Quality Control with good troubleshooting and documentation skills.
Writing protocols and reports, participation in scientific discussions, ability to work in a team. Knowledge of ICH and other regulatory guidelines is preferred.