Supervisor Quality Control Lab Operations

Regeneron Pharmaceuticals; Rensselaer (IN); On-site; USD 80,000 - 131,000; Full time

Job summary

Regeneron Pharmaceuticals in Rensselaer, NY is seeking a Supervisor of QC Lab Operations to lead a highly automated drug substance QC lab. You will guide a team through qualification, CSV support, SOPs and analyst readiness, ensuring FDA cGMP and data integrity across a busy portfolio.

This on-site role involves coordinating lab builds, implementation of new technologies, and ensuring inspection readiness while partnering with cross-functional teams and QC leadership.

Qualifications

• BS/BA in Life Sciences, Chemistry, or Engineering and 5+ years of experience.
• Experience leading a lab team and managing QC lab operations.
• Experience with qualification packages, CSV support, SOPs, and analyst readiness.

Responsibilities

• Hire, onboard, and develop the QC team with development plans.
• Set goals, coach, and conduct performance reviews; address gaps with coaching plans.
• Maintain training compliance for direct reports and a skills matrix (IQ/OQ/PQ, CSV, LIMS, CDS).
• Oversee lab builds, technology implementations, and project dependencies across portfolios.
• Review scoping and business cases; prioritize and funding requests to QC management.
• Track milestones and report status, risks, and resource constraints to QC leadership.

Skills

Leadership experience

Lab operations

Education

BS/BA in Life Sciences, Chemistry, or Engineering

Job description

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

We are committed to building a workplace with an inclusive culture. 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$80,300.00 - $131,300.00