Development Scientist III, Analytical Development and Clinical Quality Control

Introduction to role:

The Development Scientist III position is a technical position responsible for development, qualification, and optimization of bioassay (biological activity/potency assay of drug candidates) and process-derived impurity methods (HCP, residual Protein A, residual DNA), in order to support release and stability testing of biotherapeutic products, and also formulation and process development. This position also supports regulatory filing (IND and BLA) and responses to Health Authorities’ queries. Participation in methods transfer, validation, troubleshooting and investigations of bioassay and impurity methods to internal and external laboratories may be required. In addition, this position is expected to interact regularly with other functional areas, such as Research, Biologic Drug Substance Development, and Injectable Drug Product Development groups as well as Manufacturing, Quality Assurance and Quality Control groups. 

Accountabilities: