Characterization Scientist

The Characterization Scientist will contribute to the formulation and process development of biotherapeutic products. This laboratory-based role is responsible for performing analytical testing and comprehensive characterization of candidate molecules using a range of biophysical, biochemical, and particulate characterization techniques. The position also supports routine laboratory operations and maintenance.This role supports biotherapeutic products across the development lifecycle, from preclinical and Phase I clinical trials through late-stage development, license application, and commercialization. Additional responsibilities include data compilation, preparation of presentations and reports, and support of departmental documentation.ResponsibilitiesKey responsibilities include, but are not limited to:Support the development of parenteral formulations for a variety of biotherapeutic modalities, including monoclonal antibodies, antibody–drug conjugates, proteins, mRNA, and vaccines.Perform rapid and comprehensive characterization of candidate molecules to assess stability profiles using biophysical, biochemical, and particulate characterization techniques, including:HPLC methods (SE-HPLC, IEX, HIC, RP-HPLC)Capillary Gel Electrophoresis (CGE)Imaged Capillary Electrophoresis (iCE)Spectroscopic techniquesLight obscuration and microflow imagingAdditional analytical characterization methods as neededProvide general laboratory support, including reagent and consumable ordering, equipment maintenance, continuous improvement activities, and participation in periodic laboratory inspections.Collaborate effectively with a multidisciplinary team of scientists to support formulation optimization and overall candidate progression.Prepare data summary presentations, support data verification activities, compile and manage datasets, and utilize laboratory data systems such as Empower and electronic laboratory notebooks (ELNs).Communicate effectively with laboratory scientists, project managers, and cross-functional colleagues.