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 in office 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

📌 Director of Bulking Operations (Windsor)
🏢 GForce Life Sciences
📍 Windsor