Head of Process Analytics Development
Takeda
Boston, Massachusetts
Full-Time
$177,000
RemoteDirector
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Objectives/Purpose:
The Head of Process Analytics Development will lead the Process Analytics Development team who are responsible for developing high throughput methods using traditional technologies, automation, PAT and robotics. The leader will oversee the method development of high throughput IPM methods using QbD principles and ensure scientific rigor and phase appropriate bridging to GMP release and stability methods. The Head of Process Analytics Development will identify and prioritize high-value opportunities, leading to the delivery of automated & PAT programs that increase productivity, throughput, data integrity, and consistency of laboratory execution. In this role, they will partner with scientific and functional leaders to modernize end-to-end lab operations (sample and data management, instrument connectivity, workflow standardization) and ensure scalable, compliant solutions. You will provide leadership across multiple site locations, establish governance and standards, oversee external vendor partnerships, and be accountable for program delivery, resourcing, and stakeholder alignment.
Accountabilities:
Analytical Development: Responsible for establishing high-throughput, non-GMP IPM methods to provide analytical support for DPDD, SMPD, and BPD teams. This includes designing, optimizing, and developing methods to ensure efficient and reliable analytical testing for research and development projects. Method development is executed using phase-appropriate approaches and Quality by Design (QbD) principles to ensure robust and fit-for-purpose analytical solutions. Oversee the design and adoption of non GMP platform methods for small and large molecules.
Method Transfer & Implementation: Responsible for the transfer and implementation of the methods developed to the process development groups. Ensures the non GMP platforms for small and large molecules and consistently established and maintained across cross functional teams.
Automation and Robotics: Develops automated analytical methods and end-to-end workflows, integrating robotics to streamline operations across all modalities for both GMP and non-GMP applications. Also responsible for strategy development and the generation of comprehensive roadmaps that guide the adoption and implementation of automation, ensuring processes adhere to regulatory standards and improve laboratory efficiency.
PAT Methods Development: Creates Process Analytical Technology (PAT) methods and models to support the analysis of small molecules and biologics for GMP and non-GMP purposes. Oversees the strategic direction and roadmap generation for advanced analytical techniques, implementing solutions to monitor and control manufacturing processes, thereby enhancing product quality and compliance.
Strategy, Roadmap Generation, and Cross Collaboration: Leads the development of strategies and comprehensive roadmaps across all aspects of analytical development, automation, and PAT methods. Actively fosters cross collaboration among teams and departments, aligning objectives with organizational goals to promote continuous improvement and innovation.
Core Elements Related to this Role:
Lead the Process Analytics Development team to deliver high-throughput analytical methods using traditional technologies plus automation, PAT, and robotics.
Build and govern high-throughput IPM method development using a QbD/QbD principles, ensuring scientific rigor and phase-appropriate bridging to GMP release and stability methods.
Identify and prioritize high-value opportunities and deliver automation/PAT programs that improve productivity, throughput, data integrity, and execution consistency.
Modernize end-to-end lab operations (sample & data management, instrument connectivity, workflow standardization) with scalable, compliant solutions.
Ensure transfer and implementation of developed methods into process development groups and establish/maintain consistent non-GMP platforms across teams.
Set strategy and roadmaps across analytical development, automation, and PAT, while driving cross-functional collaboration and stakeholder alignment.
Provide multi-site leadership, establish standards/governance, manage external vendor partnerships, and own program delivery and resourcing
Dimensions and Aspects:
Technical/Functional (Line) Expertise:
Demonstrated expertise analytical development strategy and standards, including aQbD/QbD-based method frameworks, governance, and performance metrics for high-throughput IPM.
Demonstrated expertise in high throughput method development and lifecycle management.
Proven experience using phase-appropriate approaches to qualify methods to illustrate that they are scientific sound. Experience bridging high throughput methods to GMP release/stability methods, in close partnership with Quality & process development teams to enable their use for Process Characterization or GMP use where appropriate.
Deep technical expertise in E2E automation and robotics, including defining technical vision, selecting enabling technologies, and architecting scalable platform workflows (instrument connectivity, integration patterns, vendor solutions).
Proven expertise in PAT strategy and deployment, including advanced analytics/modeling to enable in-process monitoring and control for small molecules and biologics in GMP and non-GMP contexts.
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:
Leads a team of 20 people, setting direction and prioritizing workload
Sets strategic direction, identifies high-value opportunities, builds multi-year roadmaps across analytical development, automation, and PAT by aligning with diverse stakeholders.
Governance & standards setting establish scalable standards and governance for methods, platforms, and ways of working across sites (including phase-appropriate GMP bridging).
People leadership & capability building: lead multi-site teams; develop talent, adoption programs, and training to shift behaviors toward automated, standardized workflows.
Decision-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, BPD) 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 automation and 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, PAT analytics, 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
Operates across small and large molecule assets
Balances speed and innovation with strong compliance and inspection readiness expectations
Qualifications:
Essential:
Hands-on familiarity with common automation platforms (e.g., Hamilton, Agilent, Tecan, Opentrons) and the ability to guide platform selection, standardization, and vendor engagement.
10-12 + years of experience in an industrial or laboratory setting with strong cross functional project management capabilities
Ph.D. in a relevant scientific field (either degree in Lifesciences with automation & PAT experience or degrees in Automation, Robotics, or Engineering Sciences, coupled with experience in analytical method development)
Demonstrated ability to partner with and influence senior scientific stakeholders, translating scientific needs into scalable automation, PAT and operating-model solutions.
Proven ability to manage a team of direct reports
Experience with PAT concepts and application (e.g., real-time/at-line/in-line measurements, multivariate data analysis, chemometrics, and control strategy enablement) and the ability to translate PAT opportunities into practical, compliant implementations.
Proven track record designing and scaling automation solutions (off-the-shelf and custom) across multiple workflows, teams, and/or sites with measurable performance outcomes.
Demonstrated experience deploying robotics-enabled, high-throughput analytical workflows, including method transfer/validation considerations, assay robustness, and operationalization in an R&D laboratory environment.
Hands-on familiarity with common automation platforms (e.g., Hamilton, Agilent, Tecan, Opentrons. HiRes) and the ability to guide platform selection, standardization, and vendor engagement
Excellent communication and interpersonal skills, stakeholder management skills
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
Preferred:
Experience operating in regulated environments with automation, PAT and inspection readiness expectations
Familiarity with automation and AI-assisted knowledge work within appropriate compliance constraints
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
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:
Boston, MAU.S. Base Salary Range:
$177,000.00 - $278,080.00
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.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
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Job Exempt
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