Associate Director - Process Analytics Lead (US)

Takeda•Lexington, MA

76d•$154,400 - $242,550•Onsite

About The Position

The Associate Director - Process Analytics Lead is responsible for leading process analytics method development and platform implementation across multiple programs and product types within Analytical Development. In this role, you will shape high-throughput, fit-for-purpose analytical methods, support automation and robotics, and help build standardized ways of working that improve productivity, data integrity, and execution consistency. You will partner with Process Development, Quality, Compliance, Digital, Information Technology, and external vendors to align priorities, support delivery, and build scalable capabilities.

Requirements

Typically 8 to 12 or more years of relevant industry or laboratory experience in analytical development or process analytics, with demonstrated delivery of high-throughput methods and or automation and process analytical technology implementations.
Degree in a relevant scientific or engineering field such as Chemistry, Biochemistry, Pharmaceutical Sciences, or Chemical Engineering; bachelor’s, master’s, or doctorate accepted, with level and scope calibrated to degree and experience.
Proven experience designing and scaling automation solutions across workflows, teams, and or sites, with measurable performance outcomes.
Demonstrated experience deploying robotics-enabled high-throughput analytical workflows, including method transfer and validation considerations, assay robustness, and operational use in a research and development laboratory environment.
Strong experience with analytical development strategy, standards, and governance, including analytical quality by design (AQbD) method frameworks and performance measures.
Demonstrated ability to bridge high-throughput methods to GMP release and stability methods in partnership with Quality and Process Development teams.
Demonstrated people and matrix leadership experience, including mentoring, coaching, prioritization across multiple programs, and influence with senior stakeholders; direct people management experience is preferred.
Strong ability to partner with and influence senior scientific stakeholders, translating scientific needs into scalable automation and operating model solutions.
Fluent in English; fluent in Japanese is a plus.
Experience operating in regulated environments with automation, process analytical technology, and inspection readiness expectations is desirable.
Familiarity with automation and artificial intelligence-assisted knowledge work within appropriate compliance constraints is desirable.

Nice To Haves

Fluent in Japanese is a plus.
Experience operating in regulated environments with automation, process analytical technology, and inspection readiness expectations is desirable.
Familiarity with automation and artificial intelligence-assisted knowledge work within appropriate compliance constraints is desirable.
Direct people management experience is preferred.

Responsibilities

Lead the development, optimization, and sustainment of high-throughput analytical methods for process and product development across small molecule and biologic programs, using phase-appropriate approaches and analytical quality by design principles.
Define standards, performance measures, and governance for method lifecycle management within your area of responsibility.
Ensure successful transfer, training, and implementation of developed methods into process development laboratories, including clear documentation, troubleshooting plans, and ongoing support for consistent non-good manufacturing practice platforms.
Work with the Process Analytical Development team to deliver the platform roadmap, including automated analytical methods and end-to-end workflows with robotics where appropriate.
Support vendor selection and vendor management for automation and analytical platforms, and help drive cross-site standardization.
Lead strategy and multi-year roadmaps for analytical development and automation within the function, aligning priorities across partners and managing risks, trade-offs, and value delivery.
Modernize laboratory operations, including sample and data management, instrument connectivity, workflow standardization, and data traceability.
Provide technical and people leadership to the Process Analytics Development capability area through planning, prioritization, coaching, and change adoption.
Lead cross-functional workstreams, resolve dependencies, and represent Analytical Development organization in governance and collaboration forums.