Senior Scientist, Translational Science

Role: Senior Scientist, Translational Science responsible for supporting outsourced bioanalytical and biomarker activities in clinical programs. Main objectives include assay development, qualification, validation, sample analysis, data interpretation, and ensuring regulatory compliance. Responsibilities encompass managing CRO activities for PK, immunogenicity, and biomarker assays, reviewing technical documents, coordinating clinical sample analysis, and troubleshooting assay issues. Qualifications: PhD in biology, biochemistry, pharmacology, chemistry, or related field with 2+ years of industry experience or MS with 5+ years in regulated bioanalysis; expertise in large-molecule PK and immunogenicity assays, and proficiency with platforms like LC-MS/MS, ELISA, MSD, and multiplex assays. Preferred skills include CRO oversight, familiarity with GLP/GCLP standards, and experience contributing to regulatory submissions. High-value specifics: focus on biologics, immunology therapeutics targeting pathways such as IL-23, IL-17A/F, TL1A, and α4β7, supporting clinical-stage programs. The role involves collaboration with CROs and internal teams, with a remote work setup and no travel requirements specified.