Director, Manufacturing Operations

Summary

The Director, Manufacturing Operations provides leadership, direction, and oversight for manufacturing operations at the Kansas City site. The role is accountable for the safe, compliant, efficient, and customer-focused execution of clinical and commercial manufacturing programs while meeting business objectives for employee engagement, quality, delivery, and cost.

As a member of the Site Leadership Team, the Director, Manufacturing Operations partners across functions to develop and execute site strategy, support business growth, and continuously improve operational performance. The Director establishes a culture of safety, quality, accountability, inclusion, continuous improvement, and employee development.

The Role

• Provide strategic leadership and oversight of manufacturing operations supporting both clinical and commercial programs.
• Ensure safe, compliant, efficient execution of manufacturing activities while meeting customer expectations.
• Lead capacity planning, resource allocation, project onboarding, and operational readiness to support current and future business demand.
• Drive operational performance by prioritizing resources and achieving targets for quality, delivery, productivity, cycle time, and cost.
• Champion a strong culture of safety, GMP compliance, and regulatory readiness across all manufacturing activities.
• Partner with Quality and cross-functional teams to address investigations, deviations, CAPAs, audits, inspections, and compliance matters.
• Own manufacturing metrics, forecasting, budgeting, and financial performance, including operating and capital expenditure planning.
• Identify, justify, and implement operational and capital improvement initiatives that enhance safety, quality, efficiency, capacity, and profitability.
• Foster a culture of Lean manufacturing, continuous improvement, data-driven decision making, and operational excellence.
• Build and develop a high-performing organization through talent acquisition, coaching, succession planning, employee engagement, and inclusive leadership while contributing to overall site strategy and stakeholder relationships.

The Candidate

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Business, or a related field required; advanced degree preferred.
• Minimum 12 years of experience in pharmaceutical, biotechnology, CDMO, or other highly regulated manufacturing environments.
• At least 7 years of manufacturing leadership experience, including leading managers and developing high-performing teams.
• Proven success supporting regulatory inspections, client audits, customer interactions, and pharmaceutical quality systems.
• Strong knowledge of GMP regulations, pharmaceutical manufacturing operations, and Quality-Operations partnerships; oral solid dosage experience preferred.
• Demonstrated business and financial acumen with the ability to balance quality, customer, operational, people, and financial priorities.
• Expertise in Lean manufacturing, operational excellence, continuous improvement, and data-driven problem solving.
• Excellent communication, presentation, client-service, and cross-functional collaboration skills.
• Strategic and change-oriented leader with the ability to translate business goals into operational priorities while driving organizational alignment and transformation.
• Strong talent development, decision-making, and leadership capabilities, with a track record of building succession pipelines, coaching leaders, influencing stakeholders, and representing the organization with employees, customers, regulators, and senior executives.