Dissolution Analytical Development Lead

GOALS:

• Leadrationaledissolutionmethoddevelopmentandplatformtechnologyestablishmentacrossmultipleprograms,enablingphaseappropriatemethoddevelopment,qualification, tech-transfer,biopharmaceuticsassessmentandrobustcomparability.

• Establishthedissolutionstrategies(bothinregulatoryand technicalaspects)asa center ofexcellenceto accelerateclinicaldevelopmentand mitigate theriskstogetherwithformulationteam.

• Partner with senior stakeholders (Formulationdevelopment,processdevelopment,R&Dqualityandregulatoryaffair) toalignthequalitycontrolandregulatorystrategythroughoutearlyto late stagedevelopment.

ACCOUNTABILITIES: 

• Analytical Development:Leaddissolution methoddevelopment,qualificationand tech-transfer across the programsto ensure thereliableproduct quality,stabilityandconsistentperformance 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 ofclinicaldevelopment.

• PlatformTechnologyDevelopment:Collaboratewithprocess analyticsand characterization teams,lead theimplementationofautomated dissolution systemand biorelevant dissolutionassessmenttoestablishgloballyharmonized approach.

• Roadmapsand Cross-functional Collaboration:Lead strategy and multi-year roadmaps for capability expansion in dissolution technologies andalign priorities across stakeholders; manage risks and value realization; and drive continuous improvement and innovation.

• Lead theDissolutionAnalytics Development team to deliverprecise,robustandreproducibledissolution methodsand meaningful specificationsettingacross the programs.

• Buildthe end-to-end control strategiesrelateddissolutionusingAQbDprinciples, ensuring scientific rigor and phase-appropriate bridging to GMP release and stability methods. 

• Establish theautomated dissolution system and data managementplatformto accelerate themethoddevelopment and oversight the dissolution data across the programs. 

• Understand thetrends in dissolution technology andrelevantregulations within the industry and work to ensure their adoption throughout the organization

• Ensure transfer and implementation of developed methods intoGMPtestingorganization

• Assistin the development of theDissolutionAnalytical Developmentstrategy and roadmaps across analytical development,biopharmaceutics, andformulation development, while driving cross-functional collaboration and stakeholder alignment. 

Technical/Functional (Line) Expertise

• Demonstratedexpertiseanalytical development strategy and standards, includingaQbD/QbD-based method frameworks, governance, and performance metrics fordissolution.
• Demonstratedexpertiseinautomated andhigh-throughput method development and lifecycle managementusing statistical assessment. 
• Proven experience using phase-appropriateapproaches to qualify methodsand specificationto illustrate that they arescientificsound. Experiencebridginghighly-discriminablemethodsto GMP release/stability methods, in close partnership with Quality&formulationdevelopment teams to enable their use forFormulation developmentor GMP use where appropriate. 
• Technicalexpertiseindissolution testing and biopharmaceutics, including defining vision, selecting enabling technologies, and architecting scalable platform workflows (instrument connectivity, integration patterns, vendor solutions).
• Strongexpertisein 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

• Providestechnical and people leadership for theDissolutionAnalytics Development capability area,deliveringresultsthrougheffectiveplanning,execution, andprioritizationacrossprograms.
• Leads cross-functionalworkstreams;alignsscope, timelines, andresourceswith stakeholders;mentorsanddevelopsstaffthroughcoaching and feedback.
• Establishesstandards and governance formethods/platformsand ways of workingacrossteams/sites,includingphase-appropriatebridgingto GMPwhereapplicable.
• Builds team capabilitythroughhiringinput, coaching,developmentplanning, andchangeadoption/training to shiftbehaviorstowardautomated,standardizedworkflows.

Decision-makingand Autonomy

• Operates with significantindependence 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 withPharmSciandprocessdevelopmentfunctionalleaders (e.g., DPDD, SMPD) toalignanalyticalstrategy,priorities, and deployment of high-throughputmethods.
• Leadscollaborationwith digital/automationleads,enterprisearchitecture/product/platformteams, and data governance stakeholders tomodernizeend-to-end laboperations(instrumentconnectivity, sample/data management, workflowstandardization).
• EngagesQuality/Compliance partners toensurephase-appropriatemethoddevelopmentandbridgingto GMPmethods;representsAnalyticalDevelopment inenterpriseautomationandanalyticalgovernance forums.
• Managesexternalvendor/solutionprovider partnerships foranalyticsplatforms;representsAnalyticalDevelopment inexternalindustryandregulatoryforumsasneeded.

Innovation

• Collaborates closely with thePharmSciInnovation 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:

• Typically8–12+ yearsrelevant industry/laboratory experience in analytical development and/orformulation development, withdemonstrateddelivery ofreliablemethods and/or biopharmaceutics assessment.

• Degree in a relevant scientific/engineering field (e.g.,AnalyticalChemistry,Formulation,PharmSci, Chemical Engineering, Automation/Robotics):BS/MS/PhDaccepted; level and scope will be calibrated to degree and experience.

• Demonstrated ability to partner with and influence senior scientific stakeholders, translating scientific needs intodissolution,biopharmaceuticsandoperating-model solutions.

• Demonstrated people and matrix leadership experience, including mentoring/coaching, prioritization across multiple programs, and influencing senior stakeholders; direct people management experience preferred.

• Proventrack recorddesigning 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:analyzescurrent and future scenarios, disrupts the status quo with innovation, whileremainingpragmatic and focused on priorities

• Fluent in English (Japanese is a plus).

• Experienceoperatingin regulated environments withinstrumental management,dataintegrityandinspection readiness expectations.

• Familiarity with automation and AI-assisted knowledge work withinappropriate complianceconstraints.