QC Lab Operations Supervisor - Automation & Compliance Lead

Regeneron Pharmaceuticals; Rensselaer (IN); Presencial; USD 80.000 - 131.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Leadership experience

Lab operations

Educación

BS/BA in Life Sciences, Chemistry, or Engineering

Descripción del empleo

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.