Sr Scientist, Analytical Ops

Job Overview

We are seeking a highly motivated Senior Scientist to join the Method Development and Automation team within Analytical Development. This high-impact role will shape the next generation of automated analytical workflows that improve throughput, reproducibility, data integrity, operational efficiency, and readiness for deployment across Process Development, QC, and Manufacturing environments. The role applies method automation, analytical science, and digital integration to build scalable, data-rich automated workflows for cell therapy development and manufacturing readiness. The successful candidate will lead the design, implementation, and lifecycle management of automated analytical methods and integrated laboratory workflows that streamline operations and improve infrastructure efficiency. Working at the intersection of analytical science, automation engineering, and digital systems, this individual will enable robust, compliant, and scalable testing strategies that support product and process development, QC transfer, lifecycle management, and operational decision-making.

Why this role matters

This role offers the opportunity to build capabilities that directly influence how analytical methods are developed, automated, transferred, sustained, and scaled. The successful candidate will accelerate testing timelines, improve data quality, reduce manual variability, strengthen laboratory capacity, and establish durable automation solutions that support development and QC readiness.

Key Responsibilities

• Lead the development, optimization, automation, and lifecycle management of analytical workflows across plate-based, culture-based, molecular, impurity, and related assay formats.
• Translate manual and semi-manual methods into robust, reproducible automated workflows using liquid handlers, integrated workcells, analytical instruments, scheduling software, and digital tools.
• Design and execute studies supporting method development, robustness, comparability, verification, validation, QC transfer, and lifecycle management.
• Evaluate, implement, and sustain automation platforms, consumables, instrument integrations, and enabling technologies that improve throughput, reproducibility, capacity, and compliant execution.
• Develop automation strategies, user requirements, workflow maps, risk assessments, and acceptance criteria for new or expanded laboratory capabilities.
• Integrate automated workflows with LIMS, ELN, structured data systems, instrument connectivity, and electronic records to support data integrity and efficient review.
• Apply scripting, scheduling, and workflow-control tools to optimize instrument utilization, error handling, sample tracking, and unattended operation.
• Partner across Process Development, MSAT, QC, Manufacturing, Attribute Sciences, IT, engineering, and Analytical Lifecycle Management to align automation solutions with business needs, GMP readiness, and transfer expectations.
• Author, review, and present technical documentation, data packages, procedures, recommendations, and project updates supporting compliant execution, investigations, change controls, and technology transfer.
• Serve as a subject matter expert and mentor, building scalable laboratory automation capabilities and effective end-user practices across teams.

Basic Qualifications

• PhD with 2+ years of relevant experience in analytical development, method development, laboratory automation, bioassay development, or a related biopharmaceutical laboratory environment.
• OR MS with 6+ years of relevant experience in analytical development, method development, laboratory automation, bioassay development, or a related biopharmaceutical laboratory environment.
• OR BS with 8+ years of relevant experience in analytical development, method development, laboratory automation, bioassay development, or a related biopharmaceutical laboratory environment.
• Hands-on experience developing, optimizing, automating, or transferring analytical methods in a regulated or quality-focused biopharmaceutical, cell therapy, gene therapy, biologics, or complex therapeutic setting.
• Experience with liquid handling systems, integrated analytical instruments, automated workcells, assay workflow optimization, or comparable enabling technologies.
• Working knowledge of analytical method development, experimental design, data analysis, troubleshooting, technical documentation, GMP expectations, and data integrity principles.
• Ability to translate scientific workflows into clear automation requirements and collaborate effectively with scientists, engineers, vendors, IT partners, and end users.
• Strong communication, collaboration, prioritization, and problem-solving skills in cross-functional, fast-paced environments.

Career Growth Opportunities

• Build visible expertise at the intersection of analytical development, laboratory automation, digital integration, and operational excellence.
• Shape automation strategies that influence method development, QC transfer, manufacturing readiness, laboratory capacity, and lifecycle management.
• Partner with cross-functional leaders to drive high-impact technology evaluations, workflow standardization, capability building, and sustainable platform deployment.
• Grow as a technical subject matter expert, mentor, and strategic contributor within Analytical Development and broader CMC networks.

Preferred Qualifications

• The ideal candidate will bring strong scientific judgment, hands-on automation expertise, curiosity for emerging laboratory technologies, and the ability to influence in a fast-paced, matrixed environment.
• Experience developing, optimizing, automating, and deploying analytical methods in biopharma, cell therapy, gene therapy, biologics, or other complex therapeutic environments.
• Hands-on expertise with liquid handling and automation platforms such as Hamilton, Tecan, Beckman Coulter Biomek, Integra, or comparable systems.
• Experience with high-throughput assays and analytical method lifecycle activities, including robustness, comparability, verification, validation, QC transfer, and lifecycle management.
• Experience with integrated workcells, scheduling software, robotic devices, automated sample preparation, instrument connectivity, LIMS, ELN, or structured data systems.
• Experience with automation scripting, vendor-specific programming environments, workflow orchestration, data handling, or comparable tools.
• Demonstrated ability to troubleshoot complex automated workflows, perform root-cause analysis, and implement sustainable corrective and preventive improvements.
• Working knowledge of GMP, ALCOA+, 21 CFR Part 11 expectations, ICH guidance, regulated documentation, change control, deviation, investigation, and transfer practices.
• Demonstrated ability to lead cross-functional initiatives, influence technical direction, mentor scientists or end users, and build sustainable laboratory automation capabilities.