Digital Lab Orchestration Director

BioSpace; City of Troy (NY); Sur place; USD 126 000 - 241 000; Plein temps

Résumé du poste

Regeneron seeks an Associate Director of Digital Lab Orchestration to lead the QC Lab orchestration layer, coordinating across laboratory instruments and middleware with API, event-driven, and file-based approaches. You will translate QC processes into automated workflows for sample lifecycle, tests, results, and release.

The role focuses on scalable, resilient lab integrations, real-time data flow, and risk-based validation strategies (GxP, 21 CFR Part 11).

Qualifications

• ,

Responsabilités

• Lead the design and implementation of the QC Lab Orchestration Layer, enabling workflow coordination across laboratory instruments and middleware; define integration patterns including APIs, event-driven architectures, message queues, and file-based approaches
• Translate QC business processes into orchestrated digital workflows, enabling automated sample lifecycle management, test execution, result capture, review, and release
• Ensure scalability, resilience, and performance of lab integrations; incorporate resiliency into architecture as the organization moves toward a connected lab platform
• Support real-time and near-real-time data flow from lab instruments to enterprise systems; make decisions on integration patterns and drive connected lab progression
• Ensure all integrations comply with GxP, ALCOA+, 21 CFR Part 11, and Annex 11 requirements; partner with Quality and CSV teams to support risk-based validation strategies including CSA where applicable
• Act as the primary integration point between QC, IT, automation, and external vendors; evaluate vendor platforms and integration tools for orchestration capabilities and lead technical discussions with system integrators and software suppliers
• Support incident resolution, root cause analysis, and continuous improvement across the lab orchestration ecosystem
• Assist in annual IT budgeting, vendor negotiations, and resource allocation; ensure auditability, traceability, and controlled change management across all integrations

Connaissances

Leadership

Budget management

IT governance

Data governance

Cross-functional collaboration

Formation

BS/BA in Information Technology or related field

Equivalent combination of education and experience

Outils

Scitara

Tetra Science

Description du poste

Regeneron seeks an Associate Director of Digital Lab Orchestration to lead the QC Lab orchestration layer, coordinating across laboratory instruments and middleware with API, event-driven, and file-based approaches. You will translate QC processes into automated workflows for sample lifecycle, tests, results, and release.

The role focuses on scalable, resilient lab integrations, real-time data flow, and risk-based validation strategies (GxP, 21 CFR Part 11).