Pharma Turnaround Lead: Operations & Excellence

Biopharma Careers; Elkton (KY); On-site; USD 96,000 - 151,000; Full time

Job summary

Biopharma Careers in Elkton, VA seeks a Turnaround Lead to plan, coordinate, and direct API/Drug Substance turnaround activities. The role focuses on safe, compliant and efficient execution across campaigns and enabling a high-performing cross-disciplinary team.

The candidate will develop a standardized turnaround model, drive continuous improvement, and ensure readiness with stakeholders. Strong leadership, planning, and lean skills are essential for success.

Qualifications

• Bachelor’s degree in engineering, operations, manufacturing, chemical or pharmaceutical engineering, or related technical discipline.
• Minimum of 5 years in regulated GMP manufacturing environments.
• Experience leading turnaround, changeover, shutdown, campaign transitions, or operational readiness activities.
• Strong continuous improvement mindset and 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.

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.

Skills

Aseptic Manufacturing

Biopharmaceutical Industry

cGMP Compliance

Data Analysis

Lean Process Improvements

Operational Excellence

Process Engineering

Production Operations

Production Scheduling

Manufacturing Quality Control

Operational Turnarounds

Organizational Turnarounds

Packaging Operations

People Leadership

Performance Improvements

Process Improvements

Education

Bachelor’s degree in a technical discipline

Tools

Lean Manufacturing Tools

Job description

Biopharma Careers in Elkton, VA seeks a Turnaround Lead to plan, coordinate, and direct API/Drug Substance turnaround activities. The role focuses on safe, compliant and efficient execution across campaigns and enabling a high-performing cross-disciplinary team.

The candidate will develop a standardized turnaround model, drive continuous improvement, and ensure readiness with stakeholders. Strong leadership, planning, and lean skills are essential for success.