Head of Process Analytics Development
Listed on 2026-06-29
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Science
Biotech Research, Pharmaceutical Science/ Research
Job Description
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Objectives / PurposeThe Head of Process Analytics Development will lead the Process Analytics Development team 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 role 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.
The leader partners 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. The Head provides leadership across multiple site locations, establishes governance and standards, oversees external vendor partnerships, and is accountable for program delivery, resourcing, and stakeholder alignment.
- Analytical Development – establish high-throughput, non‑GMP IPM methods to support DPDD, SMPD, and BPD teams, including designing, optimizing, and developing methods to ensure efficient and reliable analytical testing for research and development projects using QbD principles.
- Method Transfer & Implementation – transfer and implement methods developed to the process development groups, ensuring consistent platform methods for small and large molecules across cross‑functional teams.
- Automation and Robotics – develop automated analytical methods and end‑to‑end workflows, integrating robotics to streamline operations across all modalities for both GMP and non‑GMP applications, and generate comprehensive roadmaps for adoption.
- PAT Methods Development – create Process Analytical Technology (PAT) methods and models for small molecules and biologics in GMP and non‑GMP settings, implementing solutions to monitor and control manufacturing processes to enhance product quality and compliance.
- Strategy, Roadmap Generation & Cross‑Collaboration – lead development of strategies and roadmaps across analytical development, automation, and PAT methods, fostering cross‑team collaboration to align objectives with organizational goals and promote continuous improvement.
- 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 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 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.
- Technical/Functional Expertise – demonstrated expertise in analytical development strategy, QbD-based method frameworks, governance, and performance metrics for high‑throughput IPM.
- High‑throughput method development and lifecycle management expertise.
- Proven ability to qualify methods with scientific soundness and…
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