Dissolution Analytical Development Lead

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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: Lead rationale dissolution method development and platform technology establishment across multiple programs, enabling phase appropriate method development, qualification, tech-transfer, biopharmaceutics assessment and robust comparability.   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.   Partner with senior stakeholders (Formulation development, process development, R&D quality and regulatory affair) to align the quality control and regulatory strategy throughout early to late stage development.  ACCOUNTABILITIES:  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 for 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  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 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, 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.    Decision-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 workflow automation, data analysis, and governed AI-assisted ways of working  Promotes reuse of knowledge and data products across programs and sites    Complexity  Operates across multiple technical domains, geographies, and governance layers with competing priorities  Balances speed and innovation with strong compliance and inspection readiness expectations  EDUCATION AND EXPERIENCE: Typically 8–12+ years relevant industry/laboratory experience in analytical development and/or formulation development, with demonstrated delivery of reliable methods and/or biopharmaceutics assessment.  Degree in a relevant scientific/engineering field (e.g., Analytical Chemistry, Formulation, PharmSci, Chemical Engineering, Automation/Robotics): BS/MS/PhD accepted; level and scope will be calibrated to degree and experience.  Demonstrated ability to partner with and influence senior scientific stakeholders, translating scientific needs into dissolution, biopharmaceutics and operating-model solutions.  Demonstrated people and matrix leadership experience, including mentoring/coaching, prioritization across multiple programs, and influencing senior stakeholders; direct people management experience preferred.  Proven track record designing and scaling automation solutions (off-the-shelf and custom) across multiple workflows, teams, and/or sites with measurable performance outcomes.  Excellent communication and interpersonal skills, stakeholder management skill. Strategic thinking: analyzes current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focused on priorities  Fluent in English (Japanese is a plus). Experience operating in regulated environments with instrumental management, data integrity and inspection readiness expectations. Familiarity with automation and AI-assisted knowledge work within appropriate compliance constraints.   Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.  For Location: Cambridge, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.  For information about our benefits, please click here. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.