Dissolution Analytical Development Lead
Cambridge, Massachusetts Job ID R0184037 Category Pharmaceutical Sciences Subcategory Research & Development Business Unit Research & Development Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
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.
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.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Cambridge, MAU.S. Base Salary Range:
$154,400.00 - $242,550.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Cambridge, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
