Dissolution Analytical Development Lead

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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.

GOALS

• Lead   rationale   dissolution   method   development   and   platform   technology   establishment   across   multiple   programs ,   enabling   phase   appropriate   method   development ,   qualification , tech-tran s fer,   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 (Fo rmulation   development ,   process   development ,   R&D   quality   and   regulatory   affair ) to   align   the   quality   control   and   regu l atory   strategy   throughout   early   to late stage   development .

A CCOUNTABILITIES

• 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 :   S trategically 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 fo r 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   A QbD   principles, ensuring scientific rigor and phase-appropriate bridging to GMP release and stability methods.

• Establish the   automat ed 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 th at 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   o r 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.

Decis ion-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/o r 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.

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, MA

U.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, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It 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.