The Associate Director of Digital Lab Orchestration will lead the design, integration, and deployment of an orchestration layer that connects QC laboratory systems into a cohesive, compliant, and automated ecosystem. This role bridges QC operations, IT/OT, automation, and data governance to enable end‑to‑end digital QC workflows.
Typical Day Responsibilities
- Lead the design and implementation of the QC Lab Orchestration Layer, enabling workflow coordination across all laboratory instruments and middleware.
- Define integration patterns such as REST APIs, event‑driven architectures, message queues, and file‑based interfaces.
- Ensure scalability, resilience, and performance of lab integrations.
- Translate QC business processes into orchestrated digital workflows.
- Enable automated sample lifecycle management, test execution, result capture, review, and release.
- Support real‑time and near‑real‑time data flow from lab instruments to enterprise systems.
- Assist in annual IT budgeting, vendor negotiations, and resource allocation.
- Ensure integrations comply with GxP, ALCOA+, 21 CFR Part 11, Annex 11, and data integrity requirements.
- Partner with Quality and CSV teams to support validation strategies (risk‑based, CSA where applicable).
- Maintain auditability, traceability, and controlled change management.
- Act as the primary integration point between QC, IT, automation, and external vendors.
- Evaluate vendor platforms and integration tools for orchestration capabilities.
- Lead technical discussions with system integrators and software suppliers.
- Support incident resolution, root cause analysis, and continuous improvement.
- Make decisions on integration patterns and drive a connected lab progression in 2026 and beyond.
- Ensure resiliency is incorporated into the architecture as we move into a connected lab platform.
Desired Skills and Experience
- Knowledge of integration technologies: REST APIs, middleware/iPaaS, message brokers, ETL.
- Familiarity with orchestration/workflow engines.
- Understanding of lab instrument connectivity and data flows.
- Experience with cloud and/or hybrid architectures (AWS, Azure, or similar).
- Industry experience implementing lab orchestration including Scitara, Tetra Science, or other emerging tools.
- Experience with IT compliance guidelines including PICS, CFR21 Part 11, Annex 11, and GAMP preferred.
Requirements
In order to be considered for this position, you must hold a BS/BA in Information Technology or a related field.
- Senior Manager: 8+ years industry experience in Information Systems and Technology or equivalent. 6 years must involve managing employees and budgets, 5+ years in a GMP manufacturing environment, and experience in a biotech/pharma environment.
- Associate Director: 10+ years industry experience in Information Systems and Technology or equivalent. 8 years must involve managing employees and budgets, 7+ years in a GMP manufacturing environment, and experience in a biotech/pharma environment.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
Salary Range (annually) $126,300.00 - $241,200.00
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