Director of Manufacturing

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:

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

Mandatory Requirements:

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

Nice to Have:

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

Term & Start:

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