Job Description

Catalent seeks a Manager for Manufacturing Technical Operations at its FDA-licensed gene therapy facility in Maryland. This role involves leading a technical operations team supporting CGMP manufacturing, overseeing investigations, continuous improvement, and operational excellence initiatives across advanced therapeutic production.

Responsibilities

• Build and manage Manufacturing Technical Operations team supporting ongoing and future manufacturing operations
• Oversee investigations, deviations, and corrective/preventive actions to ensure quality manufacturing results
• Lead continuous improvement initiatives and operational excellence projects aligned with site objectives
• Manage manufacturing documentation, bill of materials, data analytics, scheduling, and suite readiness
• Coordinate technology transfer support and maintain stakeholder communication and accountability

Requirements

• Master's degree in scientific, engineering, or biotech field with 6+ years CGMP production/quality experience; or Bachelor's with 8+ years
• Minimum 3 years progressive leadership experience including performance management and people development
• Strong knowledge of GMP, FDA regulations, and manufacturing documentation procedures
• Experience with quality systems, process deviation investigations, remediation, and technical document authoring
• Demonstrated ability to lead cross-functional teams and execute projects on time and budget
• Excellent technical writing and communication skills across diverse audiences

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