Bio

•Progressive industry experience in protein biochemistry and characterization of biologics •Broad working expertise in biochemical, biophysical and cellular assay development •Detailed understanding of the regulatory and industry guidelines in bioanalytical assay development •Strong scientific understanding of bioanalytical properties entailing drug substance, drug product and formulation development •Experienced in writing and reviewing technical documents and contributing to regulatory filings to FDA and EMA. •Extensive experience managing CRO relationships including setting up contracts and participating in quality audits as technical expert •Demonstrated leadership capabilities in developing a high performing team, driving change and influencing internal and external stakeholders •Strong interpersonal, communication and negotiation skills Specialties: Assay (Bioassay & Immunoassay) development (ELISA, receptor binding, kinetic-, cell-based assays) Protein Expression in various systems (E.coli, Yeast, baculovirus/insect cells, mammalian cells) Recombinant and native protein purificationStrong chromatographic separation background Kinetic and thermodynamic characterization of proteins Assay development, qualification and validation Monoclonal antibody generation and effector function assay development Process-specific host cell protein assay development Protein reagent development/modification Protein Engineering