Senior Manager, Manufacturing Execution Systems (MES) and Automation Lead

About This Role

Lead the Manufacturing Execution Systems (MES) and automation team for the CAR-T facility, overseeing MES architecture, deployments, validation, and operations to support manufacturing workflows, product quality, and compliance.

Responsibilities

• Provide direct leadership to a team of systems engineers and technology professionals, fostering a positive work culture that empowers employees and cultivates high-performance teams, including establishing hiring priorities, training plans, and performance objectives.
• Lead MES and automation strategy for the CAR-T site, including roadmap, standards, architecture, and governance aligned to manufacturing and quality requirements.
• Own end-to-end delivery of MES projects: including requirements, design, integration, commissioning, CSV (IQ/OQ/PQ), and lifecycle support.
• Implement CAR-T process changes into MES functionality: patient lot tracking, chain of identity and chain of custody, electronic batch records (EBR/EBR templates), recipe management, deviations/CAPA integration, and audit trails.
• Implement industrial cybersecurity and OT controls consistent with regulatory and company policies, partnering with Corporate IT/cyber teams for secure OT/IT convergence.
• Deliver MES support for controlled materials handling: lot and reagent traceability, barcode/RFID systems, label generation, and controlled dispensing workflows.
• Partner closely with Quality, Manufacturing, and MSAT to define requirements, prioritize roadmap items, and ensure operational readiness.
• Lead change management, training, and go-live support to ensure user adoption and sustained operation of MES capabilities.
• Represent the MES function during regulatory inspections and audits.

Requirements

• 10+ years’ experience in manufacturing automation, MES, and OT/IT integration
• 5+ years in regulated pharma/biotech manufacturing
• Direct experience supporting cell therapy, ATMP, or biologics
• Proven track record of implementing and validating MES/EBR in GMP environments
• Strong knowledge of CSV (computer system validation) practices, validation deliverables, and experience authoring IQ/OQ/PQ protocols and trace matrices
• Demonstrated capability managing multi-disciplinary projects from concept through sustained operation, including vendor management and budget ownership
• Strong written and verbal communication skills for technical documentation, SOPs, validation documentation, and audit responses

Qualifications

• Bachelor’s degree in Science or Engineering (Master’s or higher preferred)
• 10+ years’ experience in manufacturing automation, MES, and OT/IT integration; minimum 5 years in regulated pharma/biotech manufacturing.

Nice to Have

• Manufacturing CAR-T experience
• Experience integrating MES with LIMS, ERP (e.g., SAP), WMS, and clinical systems
• Understanding of lab QC workflows and sample management
• Werum PAS-X experience

Skills

* Required skills

Benefits