Director of Manufacturing

GForce Life Sciences; Loveland (CO); Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

GForce Life Sciences in Fort Collins, CO is seeking a Director/Senior Director of Manufacturing Operations to lead a 24/7 pharmaceutical manufacturing operation, including aseptic production, packaging, and regulatory readiness.

You will direct managers, supervisors, and large manufacturing teams, driving operational excellence, OEE improvements, and continuous improvement initiatives while ensuring GMP compliance.

Qualifikationen

• Bachelor's degree in Engineering, Life Sciences, or related discipline.
• 10+ years of pharmaceutical manufacturing experience.
• Extensive GMP and aseptic manufacturing experience.
• Experience leading managers, supervisors, and large teams.
• Strong technical background in manufacturing equipment and processes.
• Experience managing investigations, deviations, CAPAs, and compliance activities.
• Experience supporting FDA inspections and regulatory audits.
• Proven ability to lead in fast-paced manufacturing environments.
• Excellent leadership, communication, and cross-functional collaboration.

Aufgaben

• Lead operations across multiple production areas in a 24/7 pharmaceutical environment.
• Direct managers, supervisors, and large manufacturing teams.
• Support aseptic bulking, filling, packaging, and production operations.
• Drive operational excellence, OEE improvements, and CI initiatives.
• Lead investigations, deviation reduction, and root cause analysis.
• Ensure FDA inspection readiness and support regulatory audits.
• Partner with Quality, Supply Chain, Engineering, Maintenance, and Technical Ops.
• Improve equipment reliability and manufacturing efficiency.
• Support growth, scale-up, and capacity expansion projects.
• Develop leadership within management teams through coaching.
• Balance immediate priorities with long-term strategy.
• Maintain safety, quality, compliance, and employee engagement.

Kenntnisse

Leadership

Cross-functional collaboration

GMP knowledge

Aseptic manufacturing

Operational leadership

Process improvement

Root cause analysis

FDA inspections readiness

Team development

Ausbildung

Bachelor's degree in Engineering or Life Sciences

Jobbeschreibung

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
• Lean Manufacturing, Continuous Improvement, or Operational Excellence experience
• Manufacturing scale-up and facility expansion experience
• Experience in highly manual and technically complex manufacturing environments

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