Dissolution Analytical Development Lead
Description
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Job Description
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.
GOALS
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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 .
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Establish the dissolution strategies ( both in regulatory and technical aspects ) as a center of excellence to accelerate clinical development and mitigate the risks together with formulation team .
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Partner with senior stakeholders (Fo rmulation development , process development , R&D quality and regulatory affair ) to align the quality control and regu l atory strategy throughout early to late stage development .
A CCOUNTABILITIES
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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.
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Dissolution Strategy Establishment : S trategically 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.
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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.
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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.
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Lead the Dissolution Analytics Development team to deliver precise, robust and reproducible dissolution methods and meaningful specification setting across the programs.
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Build the end-to-end control strategies related dissolution using A QbD principles, ensuring scientific rigor and phase-appropriate bridging to GMP release and stability methods.
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Establish the automat ed dissolution system and data management platform to accelerate the method development and oversight the dissolution data across the programs.
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Understand the trends in dissolution technology and relevant regulations within the industry and work to ensure their adoption throughout the organization
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Ensure transfer and implementation of developed methods into GMP testing organization
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Assist in 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.
Technical/Functional (Line) Expertise
- 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 at 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 o r 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, sample/data management, workflow standardization, and defining data product expectations to enable traceability and decision-making.
Leadership
- Provides technical and people leadership for the Dissolution Analytics Development capability area, delivering results through effective planning, execution , and prioritization across programs .
- Leads cross-functional workstreams ; aligns scope, timelines, and resources with stakeholders; mentors and develops staff through coaching and feedback.
- Establishes standards and governance for methods / platforms and ways of working across teams/ sites , including phase -appropriate bridging to GMP where applicable .
- Builds team capability through hiring input, coaching, development planning, and change adoption/training to shift behaviors toward automated , standardized workflows.
Decis ion-making and Autonomy
- Operates with significant independence day -to-day, within agreed governance/standards.
- Makes key technical and strategic decisions for the function, especially for automation-related direction and priorities.
- Escalates when needed, bringing clear options, trade-offs, and impact to speed decisions.
- Drives resolution of cross-functional conflicts and removes dependency bottlenecks to keep programs moving.
- Decisions influence platform choices, roadmaps, and execution consistency (productivity, throughput, data integrity), affecting multiple teams/sites
Interaction
- Partners with PharmSci and process development functional leaders (e.g., DPDD, SMPD) to align analytical strategy, priorities , and deployment of high-throughput methods .
- Leads collaboration with digital/ automation leads, enterprise architecture /product/ platform teams, and data governance stakeholders to modernize end-to-end lab operations ( instrument connectivity , sample/data management, workflow standardization ).
- Engages Quality/Compliance partners to ensure phase -appropriate method development and bridging to GMP methods ; represents Analytical Development in enterprise automation and analytical governance forums.
- Manages external vendor / solution provider partnerships for analytics platforms ; represents Analytical Development in external industry and regulatory forums as needed .
Innovation
- Collaborates closely with the PharmSci Innovation and Technology lead to ensure tight alignment and integration with the overall Innovation and Technology Strategy
- Enables repeatable innovation through productized w