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

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