Dissolution Analytical Development Lead

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

• Lead dissolution method development, qualification and tech-transfer across the programs to ensure the reliable product quality, stability and consistent performance in clinical development.
• 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.
• Collaborate with process analytics and characterization teams, lead the implementation of automated dissolution system and biorelevant dissolution assessment to establish globally harmonized approach.
• 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 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.
• Technical expertise in dissolution testing and biopharmaceutics, including defining vision, selecting enabling technologies, and architecting scalable platform workflows.
• Strong expertise in lab digitalization at scale, including data integrity principles, sample/data management, workflow standardization, and defining data product expectations.

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, affecting multiple teams/sites.

Interaction

• Partners with PharmSci and process development functional leaders 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.
• 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 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.