Associate Director, Digital Lab Orchestration

BioSpace

City of Troy (NY)

Vor Ort

USD 126.000 - 241.000

Vollzeit

Vor 8 Tagen

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Zusammenfassung

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).

Qualifikationen

  • ,

Aufgaben

  • 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

Kenntnisse

Leadership
Budget management
IT governance
Data governance
Cross-functional collaboration

Ausbildung

BS/BA in Information Technology or related field
Equivalent combination of education and experience

Tools

Scitara
Tetra Science

Jobbeschreibung

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director of Digital Lab Orchestration to join our IOPS IT team, leading the design, integration, and deployment of the orchestration layer that connects QC laboratory systems into a cohesive, compliant, and automated ecosystem. In this role, you will bridge QC operations, IT/OT, automation, and data governance to enable end-to-end digital QC workflows while partnering with Quality, CSV teams, system integrators, and external vendors. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & Where

Location: Troy, New York, United States

Work model: Monday - Friday 8am - 4:30pm

Discover Your 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
This Role Requires
  • 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

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Please be advised that at Regeneron, we believe we do our best work when we are together.

Salary Range (annually)

$126,300.00 - $241,200.00

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