Head of Process Analytics Development

Objectives and 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.

• 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.

• 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…