Senior Scientist (Immunoassay)
Core
Develop, optimize, qualify, validate, and troubleshoot complex bioanalytical assays (cell-based NAb and flow cytometry) supporting nonclinical and clinical drug development programs.
Role type
Senior Scientist (Immunochemistry / Bioanalytical Assay Development)
Builds
Bioanalytical methods and study data for drug development
Domain
Biopharmaceuticals / Clinical Research / Regulated Laboratory
Required skills
cell-based neutralizing antibody (NAb) assay development, flow cytometry assay design and data analysis, assay validation and qualification, GLP/GCP compliance, regulatory documentation, technical mentorship
Preferred skills
biologics/cell and gene therapies/vaccines experience, method transfer activities, advanced therapeutic modalities
Technologies
Flow cytometry platforms, data analysis software
Responsibilities
Lead design and validation of bioanalytical methods, oversee execution of regulated bioanalytical studies, review raw data and study results, provide technical mentorship to junior scientists, support regulatory submissions and audits
Seniority
Senior, hands-on IC with mentorship responsibilities