Senior Scientist - Immunoassay
Core
Lead the development, optimization, qualification, validation, and troubleshooting of complex bioanalytical assays, specifically cell-based neutralizing antibody (NAb) assays and multicolor flow cytometry, to support nonclinical and clinical drug development programs.
Role type
Senior Scientist (Immunochemistry/Bioanalytical Assay Development)
Builds
Regulated bioanalytical studies and data packages for drug development
Domain
Biopharmaceuticals / Clinical Research / Bioanalytical Sciences
Required skills
Cell-based neutralizing antibody (NAb) assay design and execution, Multicolor flow cytometry assay development and data analysis, Bioanalytical method validation and qualification, Regulatory compliance (GLP/GCP), Technical mentorship, Cross-functional collaboration
Preferred skills
Experience with biologics, cell and gene therapies, or vaccines, Assay transfer activities, Technology evaluation for new methodologies
Technologies
Flow cytometry software platforms, Bioanalytical data analysis tools
Responsibilities
Design and validate bioanalytical methods, Oversee execution of regulated bioanalytical studies, Provide technical guidance to junior scientists, Ensure compliance with GLP/GCP and quality systems, Collaborate with cross-functional stakeholders for regulatory submissions
Seniority
Senior, hands-on IC with mentorship responsibilities
