Scientific Associate Director, Analytical Sciences and Technology, Cell Therapy

Role: Scientific Associate Director within Cell Therapy Analytical Sciences and Technology (ASAT), responsible for analytical method lifecycle management, including validation, transfer, investigations, and performance optimization. Responsibilities: lead complex analytical programs, provide scientific leadership, troubleshoot method issues, drive continuous improvement, and ensure regulatory compliance through authoring reports and representing the team in inspections. Collaborate with internal teams and external laboratories to support method transfer and validation; promote digital and automation initiatives, and mentor staff. Requirements: Bachelor's in a scientific discipline, 10+ years in biotech/pharma, with expertise in analytical validation, GMP, and regulatory standards (FDA, EMA, ICH). Preferred: advanced degree (MS or PhD), global program leadership experience, and familiarity with cell and gene therapy regulations. High-Value: focus on biologics, cell therapy, and gene therapy products; analytical lifecycle management; GMP-regulated environment; cross-functional collaboration; regulatory interactions. Work setup: not specified; based in Devens, MA, with potential for remote or hybrid options.