Director, Operations

About the Role

Director, Operations provides strategic and operational leadership by setting the manufacturing vision across departments and overseeing the development, implementation, and continuous improvement of pharmaceutical manufacturing processes. This role ensures efficient, compliant, and cost-effective operations while upholding the highest standards of quality, safety, and regulatory compliance.

Responsibilities

• Lead all site operations (manufacturing and maintenance), including compounding, equipment prep, filling, inspection, and packaging; optimize throughput, capacity, and labor utilization to meet demand.
• Ensure product quality, safety, and efficacy in full compliance with GMPs, regulatory requirements, SOPs, and product specifications.
• Build, develop, and sustain high-performing teams across manufacturing, maintenance, and operational excellence.
• Ensure effective Operations and Quality controls are in place to meet sterile manufacturing requirements.
• Deliver production targets, efficiency metrics, and on-time customer supply.
• Establish, monitor, and act on KPIs for productivity, quality, cost, and delivery.
• Drive process optimization, waste reduction, and continuous improvement initiatives (Lean, Six Sigma).
• Ensure execution of capital projects, operating budgets, and manufacturing schedules to meet performance targets.
• Support product launches, technology transfers, and scale-up activities.
• Ensure full compliance with environmental, health, and safety policies and procedures.
• Resolve complex operational issues using data-driven analysis and sound judgment.
• Collaborate cross-functionally and engage senior leadership to align operations with business objectives and foster a culture of teamwork.

Communications and Working Relationships

• Site reports, Commercial Leadership, R&D leadership
• FDA/Regulatory agencies, CMOs, Key Suppliers/vendors, Industry forums/consortiums

Requirements

• BS in Engineering, Life Sciences, or related field; MS or MBA preferred.
• Minimum 8-10 years of progressive manufacturing experience in FDA-regulated pharmaceutical operations; sterile injectable manufacturing experience preferred.
• Working knowledge of FDA regulations and cGMP requirements for sterile injectable products.
• Demonstrated experience hosting FDA inspections and managing audit remediation plans.
• Proficiency in aseptic process simulation/media fills, and sterility assurance principles.

Skills

• Demonstrates a strong leadership presence with the ability to influence cross-functional stakeholders and drive alignment at all organizational levels.
• Effectively directs multi-department operations through leadership teams, ensuring accountability for performance, cost, and workforce management.
• Interprets complex operational, financial, and statistical data to inform strategy and resolve business and technical challenges.
• Strong understanding of budgeting, cost control, capital planning, and financial performance management.
• Ability to interface with internal engineering teams and external partners to address technical issues and optimize manufacturing performance.
• Successfully manages multiple, competing priorities in a fast-paced manufacturing environment while ensuring execution of key objectives.
• Exceptional ability to communicate complex information clearly and effectively to diverse audiences, including executive leadership.
• Applies structured, critical thinking to identify root causes and implement sustainable solutions.