Senior Research Associate 2, Analytical Development

Role: Senior Research Associate 2 in Analytical Development supporting biologics programs from early to late stages, including regulatory submission and commercialization. Responsibilities: lead hands-on bioassay and potency assay development, qualification, validation, transfer, troubleshooting, and lifecycle management; ensure analytical readiness for late-stage development and commercial launch; support reference standards and reagent qualification; maintain cGMP compliance, support regulatory submissions, and oversee laboratory operations; collaborate with Quality Control and Quality Assurance to ensure data integrity and inspection readiness. Requirements: Bachelor's degree with 8+ years or Master's with 4+ years in life sciences; expertise in bioassays such as ELISA, cell-based potency, flow cytometry; knowledge of assay validation, transfer, and relevant guidelines (ICH, FDA, USP); experience with reagent qualification and stability monitoring; strong analytical, scientific, communication, and technical writing skills; proficiency in Microsoft Office. HighValue: biologics, polyclonal antibodies (SAB-142), bioassays, potency assays, cGMP, regulatory submissions, late-stage development, reference standard qualification. WorkSetup: laboratory environment; travel not typical.