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Associate Director, Digital Lab Orchestration

Regeneron · Troy, NY · Yesterday
On-siteInformation Technology$126k–$241k/yrFull-time

About the role

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.

Responsibilities

  • 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.
  • Affirm compliance with IT compliance guidelines including PIC/S, 21 CFR Part 11, Annex 11, and GAMP.
  • Affirm compliance 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.
  • Support the development and maintenance of internal documentation and training materials for lab integration processes.
  • Collaborate with cross-functional teams to identify and implement improvements to the lab orchestration ecosystem.

Requirements

  • BS/BA in Information Technology or a related field, or equivalent combination of education and experience.
  • Senior Manager: 8+ years of experience in Information Systems and Technology, including 6+ years managing employees and budgets, with 5+ years in a GMP biotech or pharma environment.
  • Associate Director: 10+ years of experience in Information Systems and Technology, including 8+ years managing employees and budgets, with 7+ years in a GMP biotech or pharma environment.
  • May consider equivalent combination of education and experience.
  • Level is determined based on qualifications relevant to the role.
  • Industry experience implementing lab orchestration solutions including platforms such as Scitara, Tetra Science, or other emerging tools preferred.
  • Knowledge of IT compliance guidelines including PIC/S, 21 CFR Part 11, Annex 11, and GAMP preferred.

Qualifications

  • BS/BA in Information Technology or a related field, or equivalent combination of education and experience.
  • Senior Manager: 8+ years of experience in Information Systems and Technology, including 6+ years managing employees and budgets, with 5+ years in a GMP biotech or pharma environment.
  • Associate Director: 10+ years of experience in Information Systems and Technology, including 8+ years managing employees and budgets, with 7+ years in a GMP biotech or pharma environment.
  • May consider equivalent combination of education and experience.
  • Level is determined based on qualifications relevant to the role.
  • Industry experience implementing lab orchestration solutions including platforms such as Scitara, Tetra Science, or other emerging tools preferred.
  • Knowledge of IT compliance guidelines including PIC/S, 21 CFR Part 11, Annex 11, and GAMP preferred.

Skills

  • Experience with IT compliance guidelines including PIC/S, 21 CFR Part 11, Annex 11, and GAMP.
  • Experience with lab automation and integration technologies such as Scitara, Tetra Science, or similar platforms.
  • Strong understanding of GxP, ALCOA+, 21 CFR Part 11, and Annex 11 requirements.
  • Experience with API design, event-driven architectures, message queues, and file-based approaches.
  • Experience with real-time and near-real-time data flow from lab instruments to enterprise systems.
  • Experience with incident resolution, root cause analysis, and continuous improvement across the lab orchestration ecosystem.
  • Experience with vendor platforms and integration tools for orchestration capabilities.
  • Experience with technical discussions with system integrators and software suppliers.
  • Experience with auditability, traceability, and controlled change management across all integrations.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

  • Annual bonuses or other incentive plans
  • Equity awards
  • Pension or retirement benefits
  • 401(k) company match
  • Health and wellness programs
  • Fitness centers
  • Insurance benefits (e.g. medical, dental, vision, life and disability)
  • Paid time off
  • Family support benefits

Pay

$126,300.00 - $241,200.00 annually

Schedule

Monday - Friday 8am - 4:30pm

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