Manager, Process Operations

Merck seeks a Manager of Process Operations to lead upstream and downstream production teams at a new state-of-the-art biologics manufacturing facility in Rahway, NJ. The role involves directing daily GMP operations, ensuring regulatory compliance, managing team development, and supporting facility launch and operational readiness initiatives.

Responsibilities

• Lead and direct upstream and downstream production operations teams with daily work assignment and execution oversight
• Drive cGMP and EHS compliance, maintain strong safety culture, and ensure floor presence during GMP operations
• Ensure team qualification, training completion, and support facility launch and operational readiness activities
• Troubleshoot technical and process issues, initiate deviations, perform impact assessments, and author/approve SOPs and batch records
• Manage production planning, oversee equipment qualification, support technology transfer programs, and provide on-call support as needed

Requirements

• Bachelor's degree in chemical/biochemical engineering, pharmaceutical sciences, or related field with minimum 5 years GMP biologics manufacturing experience
• Master's degree with minimum 3 years relevant experience in regulated drug substance manufacturing
• Prior experience leading operations teams with demonstrated performance monitoring capabilities
• Strong understanding of upstream and downstream processing in GMP environments with cGMP and EHS knowledge
• Proficiency writing SOPs and technical documents with working knowledge of DeltaV, MES, and SAP systems
• Ability to train employees in technical, compliance, safety, and environmental procedures; strong troubleshooting skills
• Experience with single-use systems, facility assessments, process transfer, and clinical manufacturing preferred