Development Associate Scientist
Boston, Massachusetts, Us
Served as Early Phase (I/II) project lead to develop, optimize, and validate robust, scalable protein purification processes for growth factors, monoclonal antibodies, Fc-fusion and immunocytokine proteins (mammalian and microbial). Activities include process intermediate stability, DOE, small-scale model, virus clearance validation studies, and product quality testing (SEC, rPA, ELISA, SDS-PAGE, and IEF). Transferred downstream processes to the pilot plant and provided support throughout ENG and GMP campaigns. Regulatory support provided for CMC sections of INDs/IMPDs. Authored virus clearance A2 section as well as providedsupport for downstream S.2.6 sections. Optimized and adapted various ELISAs (e.g. HCP, Protein A, Insulin, Pluronic, etc.) for new projects. Transferred assay