Turnaround Lead - API/Drug Substance Ops

Merck & Co.; Elkton (VA); On-site; USD 96,000 - 151,000; Full time

Job summary

Merck & Co. in Elkton, VA seeks a Turnaround Lead to plan, coordinate, and lead turnaround activities for API/Drug Substance operations, supporting a future Small Molecule facility. You will ensure safe, compliant, and efficient turnaround execution across campaigns.

Lead a cross-functional team, develop standard work, and drive continuous improvement using lean principles. Collaborate with Production, Quality, Engineering and Maintenance to enable reliable campaign transitions and long-term

Qualifications

• Bachelor's degree in Engineering, Operations, Manufacturing, Chemical Engineering, Pharmaceutical Engineering, or related technical discipline.
• Minimum 5 years in regulated GMP manufacturing environments.
• Experience leading turnaround, changeover, shutdown, campaign transition, or operational readiness activities.
• Strong lean principles and data-driven mindset.

Responsibilities

• Lead planning, coordination, and execution of turnaround activities for API/Drug Substance operations.
• Ensure turnarounds are safe, compliant, efficient, and minimally disruptive to operations.
• Develop and maintain a standardized turnaround model for consistent campaign transitions.
• Lead and develop a cross‑functional Turnaround team and operations personnel.
• Establish clear expectations, accountability, and growth for team members.
• Collaborate with Production Lead and stakeholders for readiness and effective execution.
• Define turnaround scope, sequencing, staffing, materials, and work plans in advance.
• Drive handoffs, coordination, and right-first-time performance across phases.
• Monitor performance and identify opportunities to improve schedule, quality, safety, and cycle time.
• Apply lean principles and visual management to strengthen turnaround execution.
• Track KPIs related to duration, rework, downtime, and execution quality.
• Foster ownership, teamwork, and continuous learning for operational excellence.
• Support day-to-day operations while maintaining turnaround readiness and improvement.
• Contribute to future Small Molecule operating model development in Elkton, VA.

Skills

Adaptability

Aseptic Manufacturing

Biopharmaceutical Industry

cGMP Compliance

Data Analysis

Employee Performance Standards

Interpersonal Relationships

Inventory Management

KPI

Lean Process Improvements

Manufacturing

Manufacturing Quality Control

Operational Efficiency

Operational Excellence

Operational Turnarounds

Organizational Turnarounds

Packaging Operations

People Leadership

Performance Improvements

Process Engineering

Process Improvements

Production Operations

Production Scheduling

Productivity Improvements

Education

Bachelor's degree

Job description

Merck & Co. in Elkton, VA seeks a Turnaround Lead to plan, coordinate, and lead turnaround activities for API/Drug Substance operations, supporting a future Small Molecule facility. You will ensure safe, compliant, and efficient turnaround execution across campaigns.

Lead a cross-functional team, develop standard work, and drive continuous improvement using lean principles. Collaborate with Production, Quality, Engineering and Maintenance to enable reliable campaign transitions and long-term