Director of Bulking Operations

GForce Life Sciences; Windsor; On-site; CAD 140,000 - 210,000; Full time

Job summary

GForce Life Sciences is seeking an experienced manufacturing leader to oversee a complex bulking operation supporting aseptic and non-aseptic production. You will provide strategic and operational leadership across multiple product streams while ensuring GMP compliance, supply, and manufacturing readiness.

You will manage a 75–80 person team, drive continuous improvement, and partner with Quality, Engineering, MS&T, Facilities, and R&D to deliver robust processes and successful technology

Qualifications

• 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.
• Experience supporting FDA inspections, regulatory audits, and inspection readiness.
• Proven success stabilizing and improving complex manufacturing operations.

Responsibilities

• Lead bulking operations across Paloperidone, Syringe A/B, and polymer production in a 24/7 environment.
• Oversee a 75–80 person multi-shift bulking organization and develop managers and supervisors.
• Drive process improvement, equipment reliability, and automation initiatives across bulking operations.
• Partner with Quality, Engineering, MS&T, Facilities, and R&D to improve process performance.
• Support FDA inspections, mock audits, and overall regulatory readiness.

Skills

People leadership

GMP compliance

Aseptic processing

Process improvement

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Job 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 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