Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We’re hiring a Supervisor of Quality Control (QC) Lab Operations to support our new, highly automated drug substance manufacturing facility. The Supervisor leads a team that manages the technical and operational lifecycle of QC laboratories, including new builds, fit-outs, relocations, technology implementation, and ongoing capability upgrades. Maintaining a portfolio-level view of lab demand, capacity, equipment, data flow, and staffing, the Supervisor sets priorities that align with QC and site objectives. They are accountable for the quality, schedule, and compliance of team deliverables (qualification packages, CSV support, SOPs, and analyst readiness), partner with cross-functional teams, and apply FDA cGMP and ALCOA+ expertise to keep changes inspection-ready and represent the team in inspections and audits.
When & where:
Location: Rensselaer, New York, United States
Work model: Monday-Friday, 8am-4:30pm
Travel: 50% domestic, mostly capital region
Discover your role:
Hire, onboard, and develop team; define individual development plans tied to technical and leadership competencies
Set goals, provide ongoing coaching and feedback, and conduct performance reviews; address performance gaps through documented coaching and improvement plans
Maintain training compliance for direct reports and a team skills matrix covering equipment qualification, CSV, LIMS and CDS integration, and GMP document authorship
Maintain the integrated portfolio of lab builds, technology implementations, and upgrades scope, schedule, resource loading, and cross-project dependencies
Review scoping and business cases developed by the team; recommend prioritization and funding requests to QC management
Track achievements and first-test dates; report status, risks, and resource constraints to QC leadership and site partners
Coordinate implementation timing with lab leaders to protect testing capacity and release timelines during installation, qualification, and cutover
Review User Requirement Specifications, assay-to-space models, material and sample flow designs, and integration requirements for technical completeness and consistency across areas
Set a consistent standard for lab bus, LIMS, and CDS integration requirements across the portfolio so that data integrity controls are built into design rather than remediated after installation
Serve as the technical escalation point for issues during installation, FAT and SAT, qualification, and post-handover support
Verify team deliverables meet cGMP, 21 CFR Part 11, EU Annex 11, and site data integrity requirements before routing for QA review and approval
Apply knowledge of equipment qualification (IQ/OQ/PQ), computerized system validation, and laboratory system integration, including CDS, LIMS, instrument interfacing, and networked data acquisition
Responsible for change controls, deviations, and CAPAs initiated by or assigned to the team; monitor investigation quality and closure timeliness
Oversee data integrity risk and gap assessments across the portfolio and track remediation actions to closure
Partner with lab leadership to evaluate emerging laboratory technologies, including automation, sample management, and digital integration, against current and projected operational needs
This role requires:
BS/BA in Life Sciences, Chemistry, or Engineering discipline and 5+ years of experience; or an equivalent combination of education and experience
Previous experience with at least one laboratory build, relocation, major fit-out, or significant technology implementation from requirements through handover
Previous people leadership/ supervisory experience
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all…