Manufacturing Changeover Manager - Drug Substance

Job Purpose

The Manufacturing Changeover Manager - Drug Substance is responsible for planning, coordinating, and leading highly effective turnaround activities for the Drug Substance/API operations supporting the future Small Molecule facility in Elkton, VA. This role will ensure safe, compliant, predictable, and highly efficient turnaround execution between manufacturing campaigns ensuring that turnaround targets are achieved. The incumbent will lead a cross skilled Turnaround team in addition to operators supporting day-to-day facility operations. A key expectation of the role is to build a high-performing team culture that drives accountability, collaboration, operational discipline, and continuous improvement. In close partnership with the Production Lead and cross-functional stakeholders, this role will establish a repeatable and standardized turnaround model that supports reliable campaign transitions, reduces downtime, and enables long-term operational excellence.

Primary Responsibilities

• Lead the planning, coordination, and execution of turnaround activities for API/Drug Substance operations.
• Ensure all turnarounds are executed safely, compliantly, efficiently, and with minimal disruption to manufacturing operations.
• Develop and maintain a standardized, repeatable turnaround model that supports consistent and predictable campaign transitions.
• Lead, coach, and develop a high-performing team of mechanical, electrical, and operations personnel, as well as operators supporting daily facility operations.
• Establish clear expectations, reinforce accountability, and support the growth and capability of team members.
• Partner with the Production Lead and cross-functional stakeholders to ensure readiness, alignment, and effective execution of turnaround activities.
• Ensure turnaround scope, sequencing, staffing, materials, and work plans are defined in advance and fully prepared for execution.
• Drive disciplined handoffs, strong coordination, and right-first-time performance across all phases of 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 the use of standard work, visual management, and performance metrics to strengthen turnaround execution.
• Track and report key performance indicators related to turnaround duration, rework, downtime, and execution quality.
• Foster a culture of ownership, teamwork, continuous learning, and operational excellence.
• Support day-to-day facility operations while maintaining focus on turnaround readiness and improvement.
• Contribute to the development of the future Small Molecule operating model in Elkton, VA.

Minimum Required Education, Experience

• Bachelor’s degree required. Engineering, Operations, Manufacturing, Chemical Engineering, Pharmaceutical Engineering, or a related technical discipline preferred. Engineering degree 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 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 with the ability to monitor performance and drive improvement.
• High attention to detail and commitment to operational discipline.