Senior Manager, GMP OT Applications & Automation

Regeneron Pharmaceuticals, Inc; New York (NY); Sur place; USD 121 000 - 231 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager to lead the IOPS Manufacturing Automation and Engineering team in Menands, NY. You will oversee automation projects, ensure regulatory compliance, and develop staff across manufacturing and laboratory operations.

The role requires strong SDLC and Quality Risk Management knowledge, plus several years of supervisory experience, and a deep understanding of cGMP biotech operations. On-site with a focus on safety and collaboration.

Qualifications

• BS/BA in Science, Engineering, or Software Programming.
• Manager: 7+ years of experience and 4+ years of supervisory experience.
• Senior Manager: 8+ years of experience and 5+ years of supervisory experience.
• Knowledge of cGMP biotech and pharma operations, regulatory and quality policies, procedures, and documentation methods.
• Strong knowledge of Software Design Lifecycle and Quality Risk Management; project management capabilities preferred.

Responsabilités

• Manage the Automation group through direct reports, ensuring training, development, and compliance of staff.
• Oversee configuration, installation, and support of biopharmaceutical process and QC lab equipment; coordinate workflows.
• Serve as SME during regulatory inspections and investigations; support compliance through audits and quality systems development.
• Lead automation projects related to process equipment and laboratory software; provide technical personnel for equipment configuration and qualification.
• Develop procedures for executing automation projects; ensure data integrity for manufacturing and testing data.
• Advise Manufacturing, QC, and Maintenance as a technical resource; enforce safety and regulatory requirements.
• Coach and develop personnel; present to senior management and regulatory agencies as needed.

Connaissances

Leadership

Project management

Regulatory compliance

Quality systems

Formation

Bachelor's degree in Science, Engineering, or Software Programming

Description du poste

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager to lead the IOPS Manufacturing Automation and Engineering team in Menands, NY. You will oversee automation projects, ensure regulatory compliance, and develop staff across manufacturing and laboratory operations.

The role requires strong SDLC and Quality Risk Management knowledge, plus several years of supervisory experience, and a deep understanding of cGMP biotech operations. On-site with a focus on safety and collaboration.