Production Operations Lead — GMP & Multi-Shift

Merck & Co.; Elmora (NJ); On-site; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement plan

Paid holidays and leave

Job summary

Merck & Co. is seeking an Associate Director, Production Operations to lead FLEx Non‑Sterile manufacturing across shifts, ensuring readiness, scheduling, and execution.

This role partners with Tech Ops, Process Engineering, Quality, Supply Chain, and Maintenance to deliver on-time campaigns with safe, compliant operations. The position emphasizes daily manufacturing execution, staffing, and performance metrics, with a focus on continuous improvement, lean practices, and strong leadership of

Qualifications

• Bachelor's degree in Engineering, Science, Operations Management, or related discipline or more than 15 years experience in pharmaceutical manufacturing or similar industry.
• Minimum 8 years of pharmaceutical, biotechnology, or manufacturing operations experience.
• Minimum 5 years of people leadership experience.
• Demonstrated experience leading GMP manufacturing operations.
• Strong understanding of production planning, scheduling, and manufacturing execution.
• Proven track record of leading cross‑functional teams and driving operational performance.

Responsibilities

• Lead manufacturing operations across all shift production teams.
• Provide direction and oversight to Production Supervisors and production technicians.
• Ensure safe, compliant, and efficient execution of all clinical manufacturing campaigns.
• Own daily production performance, schedule attainment, and operational execution metrics.
• Establish clear production priorities and ensure alignment across shifts.
• Drive operational accountability through tiered meetings, production reviews, and performance management processes.
• Serve as escalation point for manufacturing execution challenges and operational risks.
• Own production readiness processes to ensure successful campaign startup and execution.
• Coordinate staffing, training, equipment availability, materials, and operational support requirements.
• Lead readiness reviews with cross‑functional stakeholders prior to campaign initiation.
• Identify and proactively mitigate schedule or execution risks.
• Ensure robust turnover and communication processes between shifts.
• Partner with Tech Ops and Process Engineering to ensure technical readiness for new products and processes.
• Own the granular production schedule for FLEx Non‑Sterile operations.
• Translate forecasted manufacturing demand into executable production plans.
• Balance customer priorities, manufacturing capacity, staffing availability, and equipment utilization.
• Chair scheduling meetings and align stakeholders on production priorities.
• Monitor schedule adherence and implement recovery plans when disruptions occur.
• Drive optimization of campaign sequencing, changeovers, and resource utilization.
• Lead and develop a high‑performing production organization.
• Provide coaching, performance management, and talent development for supervisors and direct reports.
• Build succession plans and organizational capabilities to support future growth.
• Drive employee engagement and foster a culture of accountability, teamwork, and continuous improvement.
• Model leadership behaviors aligned with company values and leadership expectations.
• Drive improvements in safety, quality, delivery, productivity, and cost performance.
• Utilize Lean Manufacturing, MPS, and problem‑solving methodologies to eliminate waste and improve operational reliability.
• Lead initiatives that improve throughput, cycle times, schedule attainment, and labor productivity.
• Establish operational performance dashboards and metrics.
• Drive continuous improvement efforts focused on production execution.
• Partner closely with Tech Ops Engineering Lead for technical support and continuous improvement initiatives.
• Process Engineering for campaign execution support and process optimization.
• Supply Chain and Scheduling teams for production planning and prioritization.
• Quality and Compliance teams to maintain inspection readiness and GMP compliance.
• Facilities and Maintenance teams to ensure operational asset readiness.
• Ensure manufacturing operations comply with GMP, safety, environmental, and company requirements.
• Maintain inspection‑ready operations.
• Support deviation investigations, CAPAs, change controls, and risk assessments.
• Drive quality culture and right‑first‑time execution.
• Ensure production personnel maintain required training and qualification status.

Skills

Change Management

Decision Making

GMP

Lean Six Sigma

Manufacturing

Operations Management

People Leadership

Process Improvements

Strategic Alliances

Strategic Thinking

Education

Bachelor's degree in Engineering, Science, Operations Management, or related discipline

Tools

SAP

Manufacturing analytics

Digital manufacturing

Job description

Merck & Co. is seeking an Associate Director, Production Operations to lead FLEx Non‑Sterile manufacturing across shifts, ensuring readiness, scheduling, and execution.

This role partners with Tech Ops, Process Engineering, Quality, Supply Chain, and Maintenance to deliver on-time campaigns with safe, compliant operations. The position emphasizes daily manufacturing execution, staffing, and performance metrics, with a focus on continuous improvement, lean practices, and strong leadership of