Principal Scientist
Current• Lead and participate in drug product development and stability assessment activities that include candidate screening and selection for preclinical and Phase 1 clinical studies, and develop formulations for Phase 2/3 clinical studies and commercialization including assessment and selection of primary container closure system such as pre-filled syringes• Develop drug product formulation for a diverse set of modalities such as mAbs, mAb-like proteins, Bispecfic antibodies, and siRNA• Directly lead or indirectly guide Research Associates in conducting research and developmental work and investigate/solve developmental problems. Set goals, assign tasks, and provide performance management and development as needed• Independently design, write, execute and document stability studies and other experiments to support stability testing and understand quality attributes to support formulation and drug product development• Develop and use analytical methods to support formulation development and stability testing of mAbs, Bispecific, siRNA, and other modalities• Seek out, recognize and assess new technologies to improve formulation development and analytical characterization• Present work at group, department and inter-department meetings, serve as a team representative in drug development team meetings, and share knowledge and expertise of formulation development at cross-functional team meetings• Author and review formulation development sections of regulatory and technical documents, study reports and technology transfer documents• Collect, process and document data by following the organizational standard methodologies and policies• Utilize statistical knowledge and software packages (e.g. JMP) for study design and data analysis• Keep updated on the latest scientific findings by reading peer-reviewed science journals, and attending and presenting at relevant scientific conferences
