Director of Bulking Operations | Pharma Manufacturing

Tier4 Group; Windsor (CO); On-site; USD 160,000 - 230,000; Full time

Job summary

Tier4 Group seeks a Director of Manufacturing Operations (Bulking) to lead sterile and non-sterile bulking in a regulated pharma setting. You will drive safety, quality, and efficiency across multiple products, managing schedules, budgets, and cross-functional programs.

Champion Lean/Six Sigma and continuous improvement, develop leadership pipelines, and partner with Quality, Engineering, Maintenance, Validation, and Regulatory teams to meet customer commitments and regulatory standards.

Qualifications

• Bachelor's degree in Engineering, Biological Sciences, Chemistry, Pharmaceutical Sciences, or related STEM; advanced degree preferred.
• 10+ years progressive experience in regulated pharma/biotech/device environments with significant leadership in production.
• Significant experience in sterile or aseptic manufacturing operations; formulation, bulking, filling or related processing preferred.
• 5+ years of people leadership, including leadership of leaders and/or multi-shift manufacturing teams.
• Demonstrated success in improving operational performance in a regulated environment.

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.

Skills

Operations leadership

Pharma manufacturing

Lean Six Sigma

Regulatory compliance

Cross-functional leadership

Quality systems

Process improvement

Aseptic processing

Budget management

CAPA & deviation

Education

Bachelor’s degree in Engineering/Science

10+ years in regulated manufacturing with leadership

Job description

Tier4 Group seeks a Director of Manufacturing Operations (Bulking) to lead sterile and non-sterile bulking in a regulated pharma setting. You will drive safety, quality, and efficiency across multiple products, managing schedules, budgets, and cross-functional programs.

Champion Lean/Six Sigma and continuous improvement, develop leadership pipelines, and partner with Quality, Engineering, Maintenance, Validation, and Regulatory teams to meet customer commitments and regulatory standards.