Associate Director, Analytical Quality by Design and Platform Analytical Method Lifecycle

Role: Associate Director of Analytical Quality by Design (AQbD) and Platform Analytical Method Lifecycle in biopharma, focusing on implementing AQbD principles across development to enhance method robustness, lifecycle management, and regulatory readiness. Responsibilities: lead the strategic deployment of analytical methods, standardize practices, oversee method development, validation, transfer, and lifecycle monitoring; collaborate with R&D, QC, QA, Regulatory CMC, MSAT, and external labs; support regulatory submissions and inspections; and promote continuous improvement. Requirements: BS in Analytical Chemistry, Pharmaceutical Sciences, or related field with 15+ years, MS with 13+ years, or PhD with 7+ years of industry experience; deep expertise in analytical development for small molecules, biologics, or modalities; strong knowledge of ICH Q14/Q2(R2), validation, and lifecycle management; proven track record in implementing AQbD workflows and cross-functional leadership. HighValue: biopharma, analytical development, AQbD, lifecycle management, validation, cross-program standardization, global matrix environment, regulatory compliance, expertise in small molecule or biologics modalities. WorkSetup: hybrid in Lexington, MA; fluent in English, Japanese an asset.