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About the Role
Regeneron is seeking a Supervisor of Quality Control (QC) Lab Operations to lead a team responsible for the technical and operational lifecycle of QC laboratories within a new, highly automated drug substance manufacturing facility. This role involves managing lab builds, technology implementation, and upgrades, ensuring alignment with QC and site objectives, and maintaining compliance with FDA cGMP and ALCOA+ standards.
Responsibilities
- Hire, onboard, and develop team members, defining individual development plans.
- Set goals, provide 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.
- Manage the integrated portfolio of lab builds, technology implementations, and upgrades, including scope, schedule, and resource loading.
- Review scoping and business cases, recommending prioritization and funding.
- Track achievements and report status, risks, and resource constraints.
- Coordinate implementation timing to protect testing capacity and release timelines.
- Review User Requirement Specifications, assay-to-space models, and material/sample flow designs.
- Set consistent standards for lab bus, LIMS, and CDS integration requirements.
- Serve as the technical escalation point for issues during installation, qualification, and post-handover support.
- Verify team deliverables meet cGMP, 21 CFR Part 11, EU Annex 11, and site data integrity requirements.
- Apply knowledge of equipment qualification, computerized system validation, and laboratory system integration.
- 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 and track remediation actions.
- Partner with lab leadership to evaluate emerging laboratory technologies.
Requirements
- 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.
Skills
- Equipment qualification (IQ/OQ/PQ)
- Computerized system validation (CSV)
- Laboratory system integration (CDS, LIMS, instrument interfacing, networked data acquisition)
- GMP document authorship
- FDA cGMP
- ALCOA+
Location
- Rensselaer, New York, United States
Work Type
- On-site
- Monday-Friday, 8am-4:30pm
Experience Level
- 5+ years of experience
Education Level
- BS/BA in Life Sciences, Chemistry, or Engineering discipline
Salary/Compensations
- $80,300.00 - $131,300.00
Benefits
- 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
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
- We believe we do our best work when we are together.
Equal Opportunity
- 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.