Director of Bulking Operations

Summary
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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 RoleLead bulking operations across Paloperidone, Syringe B, Syringe A, and the in-house polymer operation within a 24/7 pharmaceutical environmentDirectly oversee managers, supervisors, and an approximately 75–80 person multi-shift bulking organizationConsolidate currently siloed bulking teams, establish cross-training, and improve organizational flexibility and coverageLead highly complex aseptic and non-aseptic processes, including Paloperidone, Syringe B, Syringe A, and polymer manufacturingDrive process improvement, operational excellence, equipment reliability, and automation initiatives across bulking operationsLead complex investigations, deviation reduction, root cause analysis, CAPAs, and GMP compliance activitiesPartner closely with Quality, Engineering, MS&T, Facilities, and R&D to improve process performance and manufacturing readinessImprove manufacturing efficiency, schedule attainment, process robustness, and operator success within highly manual and technically complex operationsSupport new product introduction, technology transfer, manufacturing scale-up, and upcoming CapEx initiativesDevelop managers, supervisors, and operators through coaching, accountability, cross-training, and consistent leadership practicesSupport FDA inspection readiness and address findings from mock audits and ongoing compliance activitiesBalance immediate operational stabilization with longer-term process, people, automation, and capacity improvementsMandatory RequirementsBachelor's degree in Engineering, Life Sciences, or related technical discipline10+ years of pharmaceutical, biopharmaceutical, or highly regulated manufacturing experienceExtensive GMP and aseptic manufacturing experience, including complex sterile processesExperience leading managers, supervisors, and large multi-shift manufacturing organizationsStrong technical background in aseptic processing, complex production processes, and manufacturing equipmentExperience managing investigations, deviations, CAPAs, root cause analysis, and compliance activitiesExperience supporting FDA inspections, regulatory audits, and inspection readinessProven success stabilizing and improving complex manufacturing operationsExcellent people leadership, communication, and cross-functional collaboration skillsAbility to work fully on-site xzbcwsv within a 24/7 manufacturing operationNice to HaveDirector or Senior Director-level manufacturing leadership experienceSterile injectable, aseptic filling, or complex suspension manufacturing experienceEngineering, MS&T, or technical operations background with equipment troubleshooting expertiseExperience consolidating siloed teams and building cross-training/accountability culturesLean Manufacturing, Six Sigma, Continuous Improvement, or Operational Excellence experienceManufacturing scale-up, technology transfer, and facility expansion experienceExperience in highly manual, technically complex, and regulated manufacturing environmentsAutomation implementation or process automation experienceTerm & StartImmediate needOn-site role in Windsor, ColoradoPermanent, Full-time position$200-$250k base salaryBenefits included