Manufacturing Changeover Manager - Drug Substance

Merck•Elkton, VA

13d•$96,200 - $151,400•Onsite

About The Position

The Manufacturing Changeover Manager - Drug Substance plans, coordinates, and leads turnaround activities for Drug Substance/API operations at the future Small Molecule facility in Elkton, Virginia. The role is responsible for safe, compliant, predictable, and efficient transitions between manufacturing campaigns, achieving turnaround targets while minimizing downtime and disruption to manufacturing. 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 standardized, repeatable turnaround model that supports reliable campaign transitions and long-term operational excellence. The manager also builds a high-performing team culture focused on accountability, collaboration, operational discipline, and continuous improvement, and contributes to developing the site's future operating model.

Requirements

Bachelor’s degree required; an engineering degree is not required.
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.
Leadership skills with 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

A degree in Engineering, Operations, Manufacturing, Chemical Engineering, Pharmaceutical Engineering, or a related technical discipline is preferred.

Responsibilities

Lead planning, coordination, and execution of turnaround activities for API/Drug Substance operations.
Ensure turnarounds are executed safely, compliantly, efficiently, and 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.
Set clear expectations, reinforce accountability, and support team members' growth and capability.
Partner with the Production Lead and cross-functional stakeholders on turnaround readiness, alignment, and execution.
Define turnaround scope, sequencing, staffing, materials, and work plans in advance and ensure they are prepared for execution.
Drive disciplined handoffs, coordination, and right-first-time performance throughout turnaround execution.
Monitor turnaround performance and identify improvements in schedule adherence, quality, safety, and cycle time.
Apply lean principles and continuous improvement tools to eliminate waste, reduce variability, and improve efficiency.
Support standard work, visual management, and performance metrics for turnaround execution.
Track and report KPIs related to 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.