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Director of Bulking Operations
Job Description & How to Apply Below
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 Cap Ex 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
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