Director, Operations

Site Leadership & Strategic Partnership

• Serve as a key member of site leadership and trusted advisor to the VP, Site Lead on operational strategy, business planning, and organizational priorities.
• Provide leadership and direction across manufacturing operations to ensure alignment with company objectives, customer commitments, and growth initiatives.
• Act on behalf of the VP, Site Lead as needed in operational decision-making, issue escalation, and cross-functional leadership activities.
• Lead execution of site-wide strategic initiatives, operational readiness programs, and business transformation efforts.
• Drive organizational alignment across Operations, Engineering, Quality, Supply Chain, Maintenance, EHS, and supporting functions.
• Support long-range planning for manufacturing capacity, operational scalability, capital investments, and workforce growth.
• Establish operational governance, accountability systems, and performance management processes across the site.

Manufacturing & Operational Excellence

• Direct day-to-day manufacturing operations to ensure safe, compliant, reliable, and efficient production performance.
• Drive operational excellence across production, scheduling, staffing, throughput, quality, productivity, and cost performance metrics.
• Ensure manufacturing operations comply with all applicable FDA, cGMP, DEA, EPA, OSHA, and ICH Q7 regulatory requirements.
• Develop and implement strategies to improve operational efficiency, manufacturing reliability, capacity utilization, and schedule attainment.
• Lead Lean Manufacturing, Six Sigma, and continuous improvement initiatives across the organization.
• Partner with Engineering and Maintenance to improve equipment reliability, process robustness, and plant scalability.
• Support technology transfer, process scale-up, process optimization, and commercial manufacturing readiness initiatives.
• Champion operational discipline, visual management, tiered accountability, and data-driven decision making throughout the organization.

Quality, Compliance & Risk Management

• Foster a culture of quality, safety, compliance, accountability, and operational excellence across the site.
• Partner closely with Quality Assurance to ensure strong inspection readiness and sustainable compliance performance.
• Provide leadership support for deviations, investigations, CAPAs, change controls, and audit responses.
• Lead root cause analysis and corrective action efforts related to operational, quality, or safety events.
• Ensure operational risks are proactively identified, mitigated, and escalated appropriately.
• Support development and continuous improvement of site quality systems, operational procedures, and compliance programs.

Organizational Leadership & Talent Development

• Build, lead, and develop high-performing operational teams and leadership talent across the organization.
• Provide coaching and mentorship to managers and functional leaders to strengthen organizational capability and succession readiness.
• Create a culture centered on accountability, collaboration, engagement, continuous improvement, and execution excellence.
• Lead workforce planning, organizational scaling, succession planning, and talent development initiatives to support site growth.
• Establish strong communication rhythms through operational reviews, leadership meetings, KPI reporting, and tiered escalation processes.
• Drive employee engagement and leadership visibility throughout manufacturing operations.

Financial & Business Management

• Lead operational planning and execution to achieve site financial objectives and operational performance targets.
• Partner with Finance and Supply Chain on budgeting, forecasting, inventory strategy, standard costs, variance management, and capital planning.
• Support development of CAPEX strategies, manufacturing investments, and operational prioritization initiatives.
• Monitor and improve cost performance through operational efficiency, productivity improvements, and resource optimization.
• Prepare and present operational updates, strategic recommendations, business risks, and performance metrics to executive leadership.

Experience & Qualifications

• Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Sciences, or related technical discipline required; advanced degree preferred.
• 12+ years of progressive pharmaceutical manufacturing experience, including senior leadership responsibility within regulated operations.
• Strong preference for API manufacturing experience.
• Experience supporting both small kilo-scale and large-scale metric ton manufacturing operations.
• Experience with process scale-up and design for manufacturability.
• Batch processing experience and familiarity with flow chemistry operations.
• Understanding of potent compounds, containment strategies, and OEB/OEL requirements.
• Demonstrated success leading complex manufacturing organizations and cross-functional teams within cGMP environments.
• Deep understanding of FDA, cGMP, ICH Q7, environmental, health, and safety regulatory requirements.
• Experience supporting site expansion, operational scaling, capital projects, technology transfers, or major operational transformation initiatives.
• Proven ability to lead organizational change and drive operational excellence initiatives.
• Strong executive presence with the ability to influence across all levels of the organization.
• Demonstrated experience implementing Lean Manufacturing, Six Sigma, or operational excellence methodologies.
• Strong financial acumen, analytical capabilities, and strategic decision-making skills.
• Excellent communication, organizational, and leadership skills.

Key Attributes

• Exceptional oral and written communication skills, including regulatory technical writing skills.
• Ability to work in a cross-functional team environment with dynamic timelines and priorities.
• Exhibits the highest level of reasoned judgment, discretion, and integrity.
• Collaborates with others to achieve shared objectives.
• Ability to thrive in a fast-moving, continuous learning environment; iterating and learning as a team.
• Active listener with a curious and open mind.
• Steadfastly pursues excellence in execution.
• Servant leader.
• Self-starter.
• Ability to deal with ambiguity.

Physical Requirements

• Constantly required to see & utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
• Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
• Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
• This will be both a manufacturing and office role.
• Occasionally lift and/or move up to 10 pounds.