Production Lead – FLEx Non-Sterile Operations (Onsite)

About this role

Job Description

Position Summary   The Associate Director, Production Operations serves as the Production Lead for FLEx Non-Sterile operations and is accountable for end-to-end manufacturing readiness, production scheduling, and execution across both first and second shift operations.  

This role provides direct leadership for production teams and is responsible for ensuring safe, compliant, and reliable execution of manufacturing campaigns while balancing customer demand, resource utilization, and operational efficiency. The Production Lead partners closely with Tech Ops Engineering, Process Engineering, Quality, Supply Chain, Maintenance, and Program teams to ensure that manufacturing plans are executable and that production commitments are delivered on time.   This role owns daily manufacturing execution, resource readiness, shift integration, production scheduling, and operational performance.     Primary Responsibilities  

Production Leadership & Manufacturing Execution  

• 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.  

Manufacturing Readiness  

• 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.  

Production Scheduling & Planning  

• 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.  

People Leadership  

• 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.  

Operational Excellence  

• 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.  

Cross-Functional Partnership  

• 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.  

  Compliance & Quality Responsibilities   • 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.  

  Required 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.  

  Preferred Qualifications   • Advanced degree in Engineering, Operations, or related field.  

• Experience supporting clinical supply manufacturing operations.  

• Lean Six Sigma certification or equivalent operational excellence experience.  

• Experience managing multi-shift operations.  

• Knowledge of scheduling systems, SAP, digital manufacturing, and manufacturing analytics.  

  Leadership Competencies (M2)   • Leads through others and develops organizational capability.  

• Creates alignment across multiple functions and priorities.  

• Balances strategic thinking with operational execution.  

• Makes informed, data-driven decisions under uncertainty.  

• Builds strong partnerships and fosters a culture of accountability.  

• Champions

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