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: 

• 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.