Scientist, Immunogenicity Bioanalytical

Role: Immunogenicity Bioanalytical Scientist focused on developing and validating assays to detect and characterize anti-drug antibodies (ADA) in nonclinical and clinical studies, supporting immunogenicity risk assessment and regulatory submissions. Responsibilities: design and optimize sensitive, specific ADA and pre-existing antibody assays using platforms like MSD; validate methods per regulatory standards; analyze samples under GLP/GCP; author validation and study reports; develop strategies for complex assay challenges; oversee external CRO work; contribute to technological and methodological advancements. Requirements: PhD or equivalent with relevant immunogenicity bioanalytical experience; prior pharma/biotech background preferred; experience with GLP/GCP, regulated bioanalytical assays, and assay transfer; understanding of immunology and antibody biology. High-Value: focus on biologics, immunogenicity, regulated bioanalysis, early and late-stage clinical studies, multi-project environment. Collaboration involves internal teams and external labs; no specific location/travel details provided.