Manufacturing Changeover Manager - Drug Substance

MSD•Elkton, VA

7d•$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 execution of turnarounds between manufacturing campaigns, meeting turnaround targets while minimizing disruption to manufacturing operations. The manager leads a cross-skilled turnaround team and operators supporting day-to-day facility operations, building a culture of accountability, collaboration, operational discipline, and continuous improvement. In partnership with the Production Lead and cross-functional stakeholders, the manager establishes a repeatable, standardized turnaround model that supports reliable campaign transitions, reduces downtime, and advances long-term operational excellence. The position contributes to the development of the future Small Molecule operating model at the Elkton site. The company describes the site as a purpose-built, agile small molecule manufacturing facility focused on quality, safety, environmental responsibility, compliance, and operational excellence.

Requirements

Bachelor’s degree required; an engineering degree is not required.
Minimum of 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

A degree in 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, 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.
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 and prepare turnaround scope, sequencing, staffing, materials, and work plans in advance.
Drive disciplined handoffs, 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 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.