Director of Bulking Operations
$200k - $250kGForce Life Sciences
Summary
Check all associated application documentation thoroughly before clicking on the apply button at the bottom of this description.
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 xhyhwjd 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
- Permanent, Full-time position
- $200-$250k base salary
- Benefits included
Vacancy posted 9 hours ago
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