Dissolution Analytical Development Lead

GOALS:

• Leadrationaledissolutionmethoddevelopmentandplatformtechnologyestablishmentacrossmultipleprogramsenablingphaseappropriatemethoddevelopmentqualification tech-transferbiopharmaceuticsassessmentandrobustcomparability.

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

• Partner with senior stakeholders (FormulationdevelopmentprocessdevelopmentR&Dqualityandregulatoryaffair) toalignthequalitycontrolandregulatorystrategythroughoutearlyto late stagedevelopment.

ACCOUNTABILITIES:

• Analytical Development:Leaddissolution methoddevelopmentqualificationand tech-transfer across the programsto ensure thereliableproduct qualitystabilityandconsistentperformance 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 teamslead 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 deliverpreciserobustandreproducibledissolution 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 developmentbiopharmaceutics 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 areadeliveringresultsthrougheffectiveplanningexecution andprioritizationacrossprograms.
• Leads cross-functionalworkstreams;alignsscope timelines andresourceswith stakeholders;mentorsanddevelopsstaffthroughcoaching and feedback.
• Establishesstandards and governance formethods/platformsand ways of workingacrossteams/sitesincludingphase-appropriatebridgingto GMPwhereapplicable.
• Builds team capabilitythroughhiringinput coachingdevelopmentplanning andchangeadoption/training to shiftbehaviorstowardautomatedstandardizedworkflows.

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) toalignanalyticalstrategypriorities and deployment of high-throughputmethods.
• Leadscollaborationwith digital/automationleadsenterprisearchitecture/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 automationdata 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:

• Typically812 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.AnalyticalChemistryFormulationPharmSci 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 intodissolutionbiopharmaceuticsandoperating-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 managementdataintegrityandinspection readiness expectations.

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