Dissolution Analytical Development Lead

Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as the Dissolution Analytical Development Lead based in Cambridge, MA reporting to the Head, AD Synthetic Molecule.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. 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.

• Leadrationaldissolutionmethoddevelopmentandplatformtechnologyestablishmentacrossmultipleprograms,enablingphaseappropriatemethoddevelopment,qualification,tech-transfer,biopharmaceuticsassessmentandrobustcomparability.
• Establishthedissolutionstrategies(bothinregulatoryandtechnicalaspects) ascenterofexcellence toaccelerateclinicaldevelopmentandmitigaterisksourwithformulationteam.
• Partnerwithseniorstakeholders(Formulation development,process development,R&Dqualityandregulatoryaffair) toalignthequalitycontrolandregulatorystrategythroughoutearlytolatestagepdeveloper.

• Analytical Development:Leaddissolutionmethoddevelopment,qualificationandtech-transferacrosstheprogramstoensurethereliableproductquality,stabilityandconsistentperformanceinclinicaldevelopment.
• Dissolution Strategy Establishment:Strategicallydevelopandinstrumentandtestingsystemstoprovideguidanceforthesystematicdevelopment,pathwayforimplementationandopportunitiesforclinicallyrelevantdata.
• Platform Technology Development:Collaboratewithprocessanalyticsandcharacterizationteams,leadtheimplementationofautomateddissolutionsystemandbiorelevantdissolutionassessment,toestablishgloballyharmonizedapproach.
• Roadmapsand
  
  Cross-functional Collaboration:
  
  Lead strategyandmultiyearroadmapsforcapabilityexpansionindissolutiontechnologiesandalignprioritiesacrossstakeholders;managerrisksandvaluerealization;anddrivecontinuousimprovementandinnovation.
• Lead the Dissolution
  
  Analytics Development team to deliver precise,robustandreproducible dissolutionmethodsandmeaningfulspecificationsettingacrosstheprograms.
• Build the end-to-endcontrolstrategies relatedto dissolution using AQbD principles,ensuringscientificrigorandphase-appropriatebridgingtogMPreleaseandstabilitymethods.
• 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.

• Demonstratedexpertiseanalyticaldevelopmentstrategyandstandards,includinga
  
  QbD/QbD-basedmethodframeworks,governance,andperformancemetricfordissolution.
• Demonstratedexpertiseinautomatedandhigh-throughputmethoddevelopmentandlifecyclemanagementusingstatisticalassessment.
• Provenexperienceusingphase-appropriateapproachesqualifymethodandspecificationtoillustratethattheyariscientificsound. Experiencebridginghighly-discriminablemethods 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.
• Technicalexpertisein dissolution 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.

• Provides technical and people leadership for the Dissolution Analytics Development capability area, delivering results through effective planning, execution, and…