Director, Manufacturing Operations (Bulking)

Director, Manufacturing Operations (Bulking)

Direct Hire

Onsite - Windsor, CO

Position Summary

The Director, Manufacturing Operations (Bulking) provides leadership and accountability for sterile and non-sterile bulking operations within a regulated pharmaceutical manufacturing environment. This role is responsible for safe, compliant, reliable, and efficient execution of manufacturing activities, including production performance, product quality, process reliability, workforce capability, operational excellence, and continuous improvement.

Key Responsibilities

• Lead day-to-day bulking operations across multiple products, processes, and shifts.
• Ensure production schedules are executed safely, compliantly, and efficiently while meeting business and customer commitments.
• Drive performance across safety, quality, delivery, cost, capacity, yield, cycle time, right-first-time, and equipment reliability metrics.
• Establish operating standards, performance management routines, and accountability systems across the organization.
• Partner with Quality, Engineering, Maintenance, MS&T, Validation, Supply Chain, and Regulatory teams to improve process performance, resolve operational challenges, and support strategic objectives.
• Provide leadership for deviations, investigations, CAPAs, change controls, audits, inspections, and regulatory compliance activities.
• Support technology transfers, process scale-up, validation, equipment qualification, automation initiatives, and implementation of new manufacturing technologies.
• Develop managers, supervisors, technical specialists, and manufacturing teams while building organizational capability and succession pipelines.
• Lead Lean, Six Sigma, standard work, and continuous improvement initiatives to improve reliability, reduce variability, and increase operational efficiency.
• Manage operating budgets, capital investments, staffing plans, and resource allocation while supporting future growth and capacity requirements.

Knowledge, Skills & Abilities

• Strong knowledge of pharmaceutical manufacturing operations, including aseptic processing, contamination control, and cGMP requirements.
• Ability to lead a diverse portfolio of complex manufacturing processes while establishing consistent standards across products, teams, and shifts.
• Demonstrated success leading and developing managers and frontline teams in a regulated manufacturing environment.
• Strong understanding of process control, equipment reliability, validation, technology transfer, and manufacturing scale-up.
• Ability to interpret production, quality, capacity, and financial data and translate it into clear priorities and executable plans.
• Proficiency in risk assessment, root cause analysis, deviation investigation, CAPA, and change management.
• Track record of improving safety, quality, delivery, cost, workforce capability, and operational performance through disciplined execution.
• Strong judgment and decision-making skills, including the ability to balance patient safety, compliance, supply, and business needs.
• Effective communicator with the ability to influence senior leaders, technical partners, and frontline teams and represent Manufacturing during audits and inspections.
• Proven ability to lead cross-functional work with Quality, Engineering, Maintenance, MS&T, Validation, Supply Chain, and Regulatory partners.
• Working knowledge of Lean, Six Sigma, tiered management, standard work, or comparable continuous improvement systems.
• Strategic, hands-on, and adaptable leadership style suited to a fast-paced environment with changing priorities.

Education & Experience

• Bachelor's degree in Engineering, Biological Sciences, Chemistry, Pharmaceutical Sciences, or another STEM discipline required; advanced degree preferred.
• 10+ years of progressive experience in pharmaceutical, biotechnology, medical device, or similarly regulated manufacturing environments, including significant production operations leadership experience.
• Significant experience in sterile or aseptic manufacturing operations required; experience with formulation, compounding, bulking, filling, or related processing strongly preferred.
• 5+ years of people leadership experience, including leadership of leaders and/or multi-shift manufacturing teams.
• Demonstrated success improving operational performance, building workforce capability, and leading cross-functional change in a regulated environment.