Director of Bulking Operations

Summary

Our client is seeking an experienced manufacturing leader to oversee a complex pharmaceutical bulking operation supporting aseptic and non-aseptic production, process improvement, regulatory readiness, manufacturing scale-up, and team development. This individual will provide strategic and operational leadership across Paloperidone, Syringe A, Syringe B, and in-house polymer operations while ensuring product supply, GMP compliance, operational excellence, and strong people leadership.

Duties / Expectations of Role

• Lead bulking operations across Paloperidone, Syringe B, Syringe A, and the in-house polymer operation within a 24/7 pharmaceutical environment
• Directly oversee managers, supervisors, and an approximately 75–80 person multi-shift bulking organization
• Consolidate currently siloed bulking teams, establish cross-training, and improve organizational flexibility and coverage
• Lead highly complex aseptic and non-aseptic processes, including Paloperidone, Syringe B, Syringe A, and polymer manufacturing
• Drive process improvement, operational excellence, equipment reliability, and automation initiatives across bulking operations
• Lead complex investigations, deviation reduction, root cause analysis, CAPAs, and GMP compliance activities
• Partner closely with Quality, Engineering, MS&T, Facilities, and R&D to improve process performance and manufacturing readiness
• Improve manufacturing efficiency, schedule attainment, process robustness, and operator success within highly manual and technically complex operations
• Support new product introduction, technology transfer, manufacturing scale-up, and upcoming CapEx initiatives
• Develop managers, supervisors, and operators through coaching, accountability, cross-training, and consistent leadership practices
• Support FDA inspection readiness and address findings from mock audits and ongoing compliance activities
• Balance immediate operational stabilization with longer-term process, people, automation, and capacity improvements

Mandatory Requirements

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline
• 10+ years of pharmaceutical, biopharmaceutical, or highly regulated manufacturing experience
• Extensive GMP and aseptic manufacturing experience, including complex sterile processes
• Experience leading managers, supervisors, and large multi-shift manufacturing organizations
• Strong technical background in aseptic processing, complex production processes, and manufacturing equipment
• Experience managing investigations, deviations, CAPAs, root cause analysis, and compliance activities
• Experience supporting FDA inspections, regulatory audits, and inspection readiness
• Proven success stabilizing and improving complex manufacturing operations
• Excellent people 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, aseptic filling, or complex suspension manufacturing experience
• Engineering, MS&T, or technical operations background with equipment troubleshooting expertise
• Experience consolidating siloed teams and building cross-training/accountability cultures
• Lean Manufacturing, Six Sigma, Continuous Improvement, or Operational Excellence experience
• Manufacturing scale-up, technology transfer, and facility expansion experience
• Experience in highly manual, technically complex, and regulated manufacturing environments
• Automation implementation or process automation experience

Term & Start

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