Director of Manufacturing

Job Description

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

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

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• Bachelor's degree in Engineering, Life Sciences, Manufacturing, or related technical discipline
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• 10+ years of pharmaceutical, medical device, or highly regulated manufacturing experience
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• Strong experience leading automated manufacturing, packaging, assembly, or related production operations
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• Experience leading managers, supervisors, and multi-shift manufacturing organizations
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• Strong technical background in automated equipment, process troubleshooting, and manufacturing systems
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• Experience managing investigations, deviations, CAPAs, root cause analysis, and GMP/compliance activities
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• Experience supporting FDA inspections, regulatory audits, and inspection readiness
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• Proven success improving equipment reliability, throughput, OEE, and manufacturing efficiency
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• Excellent people leadership, communication, and cross-functional collaboration skills
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• Ability to work fully on-site within a multi-shift 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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• Pharmaceutical packaging, sterile injectable packaging, combination product, syringe, or automated assembly experience
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• Engineering background with advanced equipment troubleshooting and automation expertise
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• High-mix, low-volume manufacturing experience
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• Lean Manufacturing, Six Sigma, SMED, Continuous Improvement, or Operational Excellence experience
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• Experience with OEE, downtime reduction, changeover optimization, and run-rate improvement
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• Manufacturing scale-up, technology transfer, and facility expansion experience
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• Experience developing automation business cases and managing CapEx/equipment implementation
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Term & Start

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