Senior/Principal Scientist Cell Based Potency Assay

Role: Senior/Principal Scientist in Cell-Based Potency Assay Development within Analytical Development, Biologics, focusing on biologics, vaccines, or cell/gene therapies. Objectives: lead technical development, qualification, validation, and lifecycle management of cell-based functional assays translating mechanism of action insights into phase-appropriate analytical methods. Responsibilities: design and execute complex assay studies, develop and validate assays supporting product characterization, GMP release, stability testing, and regulatory submissions; provide technical leadership and cross-functional collaboration; perform statistical analysis for assay qualification, validation, and lifecycle monitoring; troubleshoot assay issues; lead transfer activities; prepare technical documentation; and mentor junior staff. Qualifications: Ph.D. in relevant fields with 3+ years (Senior) or 7+ years (Principal); expertise in cell-based potency and functional bioassays, statistical analysis, mammalian cell culture, and assay qualification/validation; experience with platforms such as luminescence, fluorescence, ELISA, flow cytometry, and neutralization assays; strong knowledge of GxP, data integrity, and regulatory standards. High-Value: biologics, vaccines, cell/gene therapy, assay development, validation, lifecycle management, statistical modeling, GMP compliance, and cross-functional leadership. Location: Lexington, MA. Role operates independently with no direct reports, serving as a technical resource and mentor within a lab-based environment.