Manufacturing Changeover Manager - Drug Substance

Merck • Elkton, VA

10d • $96,200 - $151,400 • Onsite

About The Position

The Manufacturing Changeover Manager - Drug Substance is responsible for planning, coordinating, and leading turnaround activities for Drug Substance/API operations at the future Small Molecule facility in Elkton, Virginia. The role ensures safe, compliant, predictable, and efficient transitions between manufacturing campaigns while achieving turnaround targets and minimizing downtime.

The manager leads a cross-skilled turnaround team and operators supporting day-to-day facility operations. In partnership with the Production Lead and cross-functional stakeholders, the role establishes a repeatable, standardized turnaround model that supports reliable campaign transitions and long-term operational excellence. The manager also builds a high-performing team culture centered on accountability, collaboration, operational discipline, and continuous improvement.

The position supports the development of the future Small Molecule operating model at the Elkton site. The role is based at the manufacturing facility, with a first-shift schedule, 10% travel, and domestic relocation available. The posting lists a base salary range of $96,200 to $151,400 for the primary location, with eligibility for an annual bonus and long-term incentive if applicable.

Requirements

• Bachelor’s degree required; engineering is not required. Engineering, Operations, Manufacturing, Chemical Engineering, Pharmaceutical Engineering, or a related technical discipline is preferred.
• At least 5 years of experience in pharmaceutical, biotechnology, chemical, or other regulated GMP manufacturing environments.
• Experience leading turnaround, changeover, shutdown, campaign transition, or operational readiness activities.
• Strong continuous improvement mindset and practical understanding of lean principles.
• Experience leading teams and coordinating cross-functional stakeholders in a manufacturing environment.
• Demonstrated ability to develop standard work, operating systems, and performance metrics.
• Strong knowledge of safe and compliant execution in regulated operations.
• Proven leadership skills, including the ability to coach, develop, and motivate teams.
• Strong planning, prioritization, problem-solving, and decision-making skills.
• Excellent communication and influencing skills.
• Ability to work effectively across Operations, Engineering, Quality, Maintenance, Planning, and EHS.
• Data-driven mindset and ability to monitor performance and drive improvement.
• High attention to detail and commitment to operational discipline.

Nice To Haves

• Engineering, Operations, Manufacturing, Chemical Engineering, Pharmaceutical Engineering, or a related technical discipline.

Responsibilities

• Lead the planning, coordination, and execution of turnaround activities for API/Drug Substance operations.
• Ensure turnarounds are executed safely, compliantly, and efficiently, with minimal disruption to manufacturing operations.
• Develop and maintain a standardized, repeatable turnaround model for consistent and predictable campaign transitions.
• Lead, coach, and develop mechanical, electrical, and operations personnel, as well as operators supporting daily facility operations.
• Establish clear expectations, reinforce accountability, and support team members’ growth and capability.
• Partner with the Production Lead and cross-functional stakeholders to ensure readiness, alignment, and effective execution.
• Define turnaround scope, sequencing, staffing, materials, and work plans in advance and prepare them for execution.
• Drive disciplined handoffs, effective coordination, and right-first-time performance throughout turnaround execution.
• Monitor turnaround performance and identify opportunities to improve schedule adherence, quality, safety, and cycle time.
• Apply lean principles and continuous improvement tools to eliminate waste, reduce variability, and improve operational efficiency.
• Support standard work, visual management, and performance metrics to strengthen turnaround execution.
• Track and report key performance indicators for turnaround duration, rework, downtime, and execution quality.
• Foster ownership, teamwork, continuous learning, and operational excellence.
• Support day-to-day facility operations while maintaining focus on turnaround readiness and improvement.
• Contribute to development of the future Small Molecule operating model in Elkton, Virginia.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.
• Domestic relocation.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager