Dissolution Analytical Development Lead

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as the Dissolution Analytical Development Lead based in Cambridge, MA reporting to the Head, AD Synthetic Molecule.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

• Lead rationale dissolution method development and platform technology establishment across multiple programs, enabling phase appropriate method development, qualification, tech-tran s fer, biopharmaceutics assessment and robust comparability.
• Establishthedissolutionstrategies (both in regulatory and technical aspects) as a center of excellence to accelerate clinical development and mitigate the risks together with formulation team.
• Partner with senior stakeholders (Fo rmulation development, process development, R&D quality and regulatory affair) to align the quality control and regu latory strategy throughout early to late stage development.

• Analytical Development:
  Lead dissolution method development, qualification and tech-transfer across the programs to ensure the reliable product quality, stability and consistent performance in clinical development.
• Dissolution Strategy Establishment:
  Strategically develop and implement dissolution testing from both regulatory and technical perspectives to serve as a guide for formulation and clinical development, contributing to the acceleration of clinical development.
• Platform Technology Development:
  Collaborate with process analytics and characterization teams, lead the implementation of automated dissolution system and biorelevant dissolution assessment to establish globally harmonized approach.
• Roadmaps and
  
  Cross-functional Collaboration:
  
  Lead strategy and multi-year roadmaps fo r capability expansion in dissolution technologies and align priorities across stakeholders; manage risks and value realization; and drive continuous improvement and innovation.
• Lead the Dissolution Analytics Development team to deliver precise, robust and reproducible dissolution methods and meaningful specification setting across the programs.
• Build the end-to-end control strategies related dissolution using AQbD principles, ensuring scientific rigor and phase-appropriate bridging to GMP release and stability methods.
• Establish the automated dissolution system and data management platform to accelerate the method development and oversight the dissolution data across the programs.
• Understand the trends in dissolution technology and relevant regulations within the industry and work to ensure their adoption throughout the organization.
• Ensure transfer and implementation of developed methods into GMP testing organization.
• Assistin the development of the Dissolution Analytical Development strategy and roadmaps across analytical development, biopharmaceutics, and formulation development, while driving cross-functional collaboration and stakeholder alignment.

• Demonstrated expertise analytical development strategy and standards, including aQbD/QbD-based method frameworks, governance, and performance metrics for dissolution.
• Demonstrated expertise in automated and high-throughput method development and lifecycle management using statistical assessment.
• Proven experience using phase-appropriate approaches to qualify methods and specification to illustrate th that they are scientific sound. Experience bridging highly-discriminable methods to GMP release/stability methods, in close partnership with Quality & formulation development teams to enable their use for Formulation development or GMP use where appropriate.
• Technical expertise in dissolution testing and biopharmaceutics, including defining vision, selecting enabling technologies, and architecting scalable platform workflows (instrument connectivity, integration patterns, vendor solutions).
• Strong expertise in lab digitalization at scale, including data integrity principles,…