Scientist, Immunogenicity Bioanalytical
Core
Develop, validate, and implement bioanalytical methods for detection and characterization of anti-drug antibodies (ADA) and pre-existing antibodies in nonclinical and clinical studies to assess immunogenicity profiles of therapeutic molecules.
Role type
Senior IC bioanalytical scientist (immunogenicity)
Builds
Robust immunogenicity assays and data packages for regulatory submissions and drug development decisions
Domain
Biopharmaceuticals / Immunogenicity Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Bioanalytical method development and validation, GLP/GCP compliance, assay optimization, data interpretation and reporting, project management, scientific problem-solving, regulatory guidance knowledge
Preferred skills
Pharma/biotech experience, bioanalytical assay execution and transfer to CROs, immunology/antibody biology expertise, novel assay design for complex modalities
Technologies
Electrochemiluminescence (ECL), MSD platforms
Responsibilities
Develop and optimize sensitive, specific, and robust anti-drug antibody and pre-existing antibody assays; Design and execute validation of ADA methods in accordance with regulatory guidance; Conduct sample analysis in accordance with GLP and GCP guidelines; Author and review bioanalytical documents including validation reports; Develop mitigation strategies for challenging assay conditions; Provide scientific oversight of internal and external CRO bioanalytical work
Seniority
Senior, hands-on IC
