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Head of Process Analytics Development

Takeda Pharmaceuticals International GmbH

Overview The Head of Process Analytics Development will lead a team focused on developing high‑throughput methods using automation, PAT, and robotics. The role drives method development, strategy, and cross‑functional collaboration to modernize laboratory operations and deliver scalable, compliant solutions. Responsibilities Lead the Process Analytics Development team across multiple site locations, setting direction, priorities, and roadmaps. Establish high‑throughput, non‑GMP IPM methods using QbD principles and bridge to GMP release and stability methods. Oversee method development, transfer, and implementation for both small‑molecule and large‑molecule platforms. Develop automated analytical workflows and robotics integration to improve productivity, data integrity, and consistency. Create PAT methods and models for small‑molecule and biologic applications, supporting in‑process monitoring. Define and maintain governance, standards, and scalable platform workflows across sites. Manage external vendor partnerships and ensure regulatory compliance. Collaborate with scientific leaders, digital and automation teams, quality and compliance partners, and stakeholders to align analytical strategy. Drive cross‑functional collaboration, innovation, and continuous improvement initiatives. Qualifications 10–12+ years of industrial or laboratory experience in analytical development, automation, or automation‑PAT. Ph.D. in life sciences, automation, robotics, or engineering sciences with relevant experience in analytical method development. Hands‑on familiarity with automation platforms (Hamilton, Agilent, Tecan, Opentrons, etc.) and ability to guide platform selection. Experience with PAT concepts, real‑time and at‑line measurements, chemometrics, and control strategy enablement. Proven track record designing and scaling automation solutions across workflows, teams, or sites with measurable outcomes. Ability to manage and develop a direct‑report team of approximately 20 people. Strong stakeholder‑management, communication, and strategic‑thinking skills. Fluent in English; knowledge of Japanese is a plus. Experience operating in regulated environments with automation, PAT, and inspection readiness expectations. Location & Notes Boston, MA, U.S. The role is classified as hybrid in accordance with Takeda’s Hybrid and Remote Work policy. 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. #J-18808-Ljbffr Takeda Pharmaceuticals International GmbH

Vacancy posted 2 days ago
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