Director of Manufacturing

Summary

Our client is seeking an experienced manufacturing leader to oversee a complex pharmaceutical packaging operation supporting highly automated syringe assembly, labeling, visual inspection, packaging, equipment reliability, regulatory readiness, and process improvement. This individual will provide strategic and operational leadership across a multi-shift packaging organization while improving equipment performance, throughput, changeovers, and team capability.

Duties / Expectations of Role

• Lead packaging, visual inspection, labeling, and related operations across a multi-shift pharmaceutical manufacturing environment
• Directly oversee managers, supervisors, and an approximately 40–50 person packaging organization across three shifts
• Improve performance of highly automated packaging assets, including customized syringe-connecting robotics, the Syringe Assembly Machine (SAM), labeling equipment, and the carton case packer/palletizer (CCP)
• Drive OEE, run-rate, downtime, changeover, scrap, and schedule-attainment improvements across packaging operations
• Partner closely with Engineering to diagnose technical gaps, resolve recurring equipment failures, and restore equipment to expected performance
• Lead complex investigations, deviation reduction, root cause analysis, CAPAs, and GMP compliance activities related to packaging and equipment performance
• Optimize packaging operations for high-mix, low-volume production, including frequent changeovers and equipment ramp-up constraints
• Evaluate and develop business cases for automation, including automated visual inspection and additional future CapEx
• Improve manual visual inspection processes for Paloperidone and support automation opportunities while maintaining product quality and compliance
• Partner with Quality, MS&T, Manufacturing, Engineering, and other functions to ensure new equipment is fit-for-purpose and user-friendly
• Support FDA inspection readiness, mock-audit remediation, and ongoing regulatory compliance
• Develop managers and supervisors through coaching, accountability, performance management, and floor-level engagement

Mandatory Requirements

• Bachelor's degree in Engineering, Life Sciences, Manufacturing, or related technical discipline
• 10+ years of pharmaceutical, medical device, or highly regulated manufacturing experience
• Strong experience leading automated manufacturing, packaging, assembly, or related production operations
• Experience leading managers, supervisors, and multi-shift manufacturing organizations
• Strong technical background in automated equipment, process troubleshooting, and manufacturing systems
• Experience managing investigations, deviations, CAPAs, root cause analysis, and GMP/compliance activities
• Experience supporting FDA inspections, regulatory audits, and inspection readiness
• Proven success improving equipment reliability, throughput, OEE, and manufacturing efficiency
• Excellent people leadership, communication, and cross-functional collaboration skills
• Ability to work fully on-site within a multi-shift manufacturing operation

Nice to Have

• Director or Senior Director-level manufacturing leadership experience
• Pharmaceutical packaging, sterile injectable packaging, combination product, syringe, or automated assembly experience
• Engineering background with advanced equipment troubleshooting and automation expertise
• High-mix, low-volume manufacturing experience
• Lean Manufacturing, Six Sigma, SMED, Continuous Improvement, or Operational Excellence experience
• Experience with OEE, downtime reduction, changeover optimization, and run-rate improvement
• Manufacturing scale-up, technology transfer, and facility expansion experience
• Experience developing automation business cases and managing CapEx/equipment implementation

Term & Start

• Immediate need
• On-site role in Windsor, Colorado
• Contract-to-hire or direct hire opportunity
• Benefits included