Senior Manager, GMP Automation & Manufacturing Systems

Regeneron Pharmaceuticals; Town of Colonie (NY); On-site; USD 121,000 - 231,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Pension benefits

401(k) match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family benefits

Job summary

Regeneron Pharmaceuticals in Menands, NY is seeking a Senior Manager to lead the IOPS Manufacturing Automation and Engineering team, overseeing configuration, installation, and support of biopharmaceutical process and QC laboratory equipment.

You will drive automation projects, ensure regulatory compliance, mentor staff, and serve as SME during inspections. This on-site role offers a collaborative environment within a fast-growing science-driven organization committed to patients.

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.
• May consider equivalent combination of education and experience; level determined based on qualifications.
• Current 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; proven project management capabilities preferred.

Responsibilities

• Manage the Automation group through direct reports, ensuring training, development, and compliance of direct reports and subordinate staff across all automation functions
• Oversee configuration, installation, and ongoing support of biopharmaceutical process and QC laboratory equipment; coordinate workflow within automation support groups, setting priorities and vetting requests for automation services
• Serve as Subject Matter Expert during regulatory inspections and internal investigations; support regulatory compliance through audit participation and quality systems development
• Manage automation projects related to process equipment and laboratory software; support the Validation Department by providing technical personnel for equipment configuration and qualification
• Develop procedures and methods for executing automation projects and support activities; ensure data integrity is maintained for data generated during manufacturing and testing of drug product
• Support Manufacturing, QC, and Maintenance as a technical advisor; maintain a safe and compliant working environment by enforcing procedures, policies, and regulations
• Coach and develop personnel; influence cross-functional leaders on automation solutions and present to senior management and regulatory agencies as needed

Skills

Project management

Regulatory knowledge

Quality systems

SDLC

Risk management

Education

BS/BA in Science, Engineering, or Software Programming

Job description

Regeneron Pharmaceuticals in Menands, NY is seeking a Senior Manager to lead the IOPS Manufacturing Automation and Engineering team, overseeing configuration, installation, and support of biopharmaceutical process and QC laboratory equipment.

You will drive automation projects, ensure regulatory compliance, mentor staff, and serve as SME during inspections. This on-site role offers a collaborative environment within a fast-growing science-driven organization committed to patients.