Director of Manufacturing

Job Description

Director / Senior Director, Manufacturing Operations

Pharmaceutical Manufacturing | Aseptic Operations | Operational Excellence

Summary:

Our client is seeking an experienced manufacturing leader to oversee a complex pharmaceutical manufacturing operation supporting aseptic production, packaging, regulatory readiness, process improvement, and site scale-up activities. This individual will provide strategic and operational leadership across multiple manufacturing departments while ensuring product supply, GMP compliance, operational excellence, and team development.

Duties / Expectations of Role:

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• Lead manufacturing operations across multiple production areas within a 24/7 pharmaceutical environment
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• Directly oversee managers, supervisors, and large manufacturing teams
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• Support aseptic bulking, filling, packaging, and production operations
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• Drive operational excellence, OEE improvements, and continuous improvement initiatives
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• Lead complex investigations, deviation reduction efforts, and root cause analysis activities
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• Ensure FDA inspection readiness and support regulatory and customer audits
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• Partner with Quality, Supply Chain, Engineering, Maintenance, and Technical Operations
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• Improve equipment reliability, manufacturing efficiency, and schedule attainment
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• Support growth initiatives, manufacturing scale-up, and capacity expansion projects
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• Develop leadership capability within management teams through coaching and accountability
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• Balance immediate operational priorities with longer-term strategic planning
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• Maintain a strong culture of safety, quality, compliance, and employee engagement
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Mandatory Requirements:

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• Bachelor's degree in Engineering, Life Sciences, or related technical discipline
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• 10+ years of pharmaceutical manufacturing experience
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• Extensive GMP and aseptic manufacturing experience
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• Experience leading managers, supervisors, and large manufacturing organizations
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• Strong technical background in manufacturing equipment and complex production processes
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• Experience managing investigations, deviations, CAPAs, and compliance activities
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• Experience supporting FDA inspections and regulatory audits
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• Proven success in fast-paced manufacturing environments
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• Excellent leadership, communication, and cross-functional collaboration skills
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• Ability to work fully on-site within a 24/7 manufacturing operation
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Nice to Have:

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• Director or Senior Director-level Manufacturing leadership experience
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• Sterile injectable or aseptic filling experience
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• Engineering background with equipment troubleshooting expertise
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• Packaging operations leadership experience
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• Lean Manufacturing, Continuous Improvement, or Operational Excellence experience
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• Manufacturing scale-up and facility expansion experience
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• Experience in highly manual and technically complex manufacturing environments
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• Automation implementation experience
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Term & Start:

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• Immediate need- contract or contract to hire position.
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• On-site role, Fort Collins, CO area
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• Contract, contract-to-hire, or direct hire consideration
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• Potential long-term leadership opportunity based on organizational needs and candidate fit
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