Principal Scientist, Immunogenicity and Ligand Binding Assays
Core
Lead scientific strategy and hands-on oversight of immunogenicity and ligand binding assays (LBA) for mRNA-LNP therapeutic development.
Role type
Principal Scientist, Clinical Bioanalysis
Builds
Regulated bioanalytical assays and data supporting clinical development decisions
Domain
Biopharmaceuticals / mRNA therapeutics / Clinical Bioanalysis
Required skills
Immunogenicity assay development, Ligand binding assay (LBA) validation, Anti-drug antibody (ADA) testing, Neutralizing antibody testing, GcLP/GLP/GCP compliance, Data interpretation, Regulatory submission support, Risk-based decision making
Preferred skills
RNA/biologics/cell therapy experience, ECL/Gyrolabs/reporter gene/DelPhia platforms, Watson LIMS, LabVantage eLBN
Technologies
ECL, Gyrolabs, Reporter gene assays, DelPhia assays, Watson LIMS, LabVantage eLBN
Responsibilities
Lead and facilitate regulated method development and validation for ADA and neutralizing antibody assays; Design and execute phase-appropriate clinical analytical strategies; Review raw analytical data and study reports to ensure scientific integrity; Collaborate with cross-functional teams on bioanalytical activities; Contribute to regulatory submissions and authority responses; Maintain knowledge of emerging scientific literature and regulatory guidance.
Seniority
Principal, hands-on IC with strategy leadership
