Supervisor Quality Control Lab Operations

Regeneron Pharmaceuticals • Rensselaer, IN

2d • $80,300 - $131,300 • Onsite

About The Position

Regeneron is hiring a Supervisor of Quality Control (QC) Lab Operations to support a new, highly automated drug substance manufacturing facility. The Supervisor leads a team responsible for the technical and operational lifecycle of QC laboratories, including new builds, fit-outs, relocations, technology implementation, and ongoing capability upgrades. The role maintains a portfolio-level view of laboratory demand, capacity, equipment, data flow, and staffing, and sets priorities aligned with QC and site objectives.

The Supervisor is accountable for the quality, schedule, and compliance of team deliverables, including qualification packages, computerized system validation (CSV) support, SOPs, and analyst readiness. The role partners with cross-functional teams and applies FDA cGMP and ALCOA+ expertise to ensure changes are inspection-ready, while representing the team in inspections and audits.

The position is located in Rensselaer, New York. The stated work schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m., with 50% domestic travel, mostly in the Capital Region.

Requirements

• Bachelor of Science or Bachelor of Arts in Life Sciences, Chemistry, or an Engineering discipline, plus at least 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 or supervisory experience.

Responsibilities

• Hire, onboard, and develop team members, and define individual development plans tied to technical and leadership competencies.
• Set goals, provide ongoing coaching and feedback, conduct performance reviews, and 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 laboratory builds, technology implementations, and upgrades, including scope, schedule, resource loading, and cross-project dependencies.
• Review team-developed scoping and business cases and recommend prioritization and funding requests to QC management.
• Track achievements and first-test dates, and report status, risks, and resource constraints to QC leadership and site partners.
• Coordinate implementation timing with laboratory 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 consistent laboratory bus, LIMS, and CDS integration requirements across the portfolio so data integrity controls are incorporated into designs.
• Serve as the technical escalation point for issues during installation, FAT and SAT, qualification, and post-handover support.
• Verify that team deliverables meet cGMP, 21 CFR Part 11, EU Annex 11, and site data integrity requirements before routing them 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.
• Manage 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 laboratory leadership to evaluate emerging laboratory technologies, including automation, sample management, and digital integration, against current and projected operational needs.
• Represent the team in inspections and audits and keep changes inspection-ready.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager