Dissolution Analytical Development Lead

Role: Lead Dissolution Analytical Development for biopharmaceutical programs at Takeda, focusing on establishing and advancing dissolution methods and platform technology to support formulation and clinical development. Responsibilities: develop, qualify, and transfer dissolution methods; create regulatory and technical dissolution strategies; lead automation and biorelevant assessment initiatives; build capability roadmaps; and ensure phase-appropriate bridging to GMP. Collaborate with formulation, process development, quality, regulatory, and digital teams to integrate dissolution strategies across development stages. Requirements: 8–12+ years in analytical or formulation development, expertise in dissolution testing, biopharmaceutics, automation, and data management; degree in Analytical Chemistry, PharmSci, Chemical Engineering, or related fields; proven leadership in cross-functional teams and vendor partnerships. Preferred: experience in regulated environments, automation, AI-enabled workflows, and global harmonization of dissolution approaches. High-Value: focus on synthetic molecules, with regulatory involvement and GMP bridging, in early to late-stage development; located in Cambridge, MA, with hybrid work; no travel specified.