Director, Operations

DSJ Global; Washington (District of Columbia); On-site; USD 180,000 - 240,000; Full time

Job summary

DSJ Global seeks a Director of Operations to lead readiness for a major U.S. growth investment in small molecule manufacturing. You will guide design, commissioning, qualification, validation, start-up, and transition to routine production, partnering with executive leadership to establish the operating model.

You will build the organization, align with Engineering, Quality, and Project teams, and drive readiness programs across regulatory inspections and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline.
• 10+ years of leadership experience in pharmaceutical, API, chemical, or related manufacturing environments.
• Experience leading or supporting manufacturing operations for small molecule, API, chemical process, or regulated production environments.
• Experience supporting major capital projects, facility expansions, start-ups, greenfield, or brownfield manufacturing investments.
• Strong understanding of GMP manufacturing, process validation, commissioning, qualification, regulatory inspections, and operational excellence.
• Experience working in complex, containment-intensive manufacturing environments is preferred.
• Proven success leading cross-functional teams and influencing stakeholders across multiple functions.
• Track record of building organizations, developing talent, and implementing scalable operating models.

Responsibilities

• Lead operational readiness strategy and execution for a large-scale capital investment project.
• Develop the future manufacturing organization, including workforce planning, organizational structure, training strategy, and operating processes.
• Represent Operations throughout facility and process design to ensure manufacturing requirements are incorporated into project decisions.
• Partner closely with Engineering, Quality, Technical Operations, Automation, EHS, and Project Management teams.
• Drive manufacturing readiness through commissioning, qualification, validation, inspection preparation, and start-up activities.
• Support technology transfer, process implementation, and new product introductions.
• Identify and mitigate operational, technical, and project-related risks.
• Build and develop a high-performing operations team while providing strategic recommendations and readiness updates to senior leadership.

Skills

Leadership

Regulatory Compliance

GMP

Capital Projects

Cross-functional Leadership

Education

Bachelor's degree in Engineering, Chemistry, Life Sciences

Advanced degree preferred

Job description

A global CDMO is seeking a Director of Operations to lead operational readiness for a major U.S. growth investment focused on small molecule manufacturing. This individual will play a critical leadership role in bringing a new manufacturing operation online, ensuring readiness across facility design, commissioning, qualification, validation, start-up, and commercial operations.

This is a highly visible position that will partner with executive leadership and cross-functional teams to establish the operating model, build the organization, and ensure a successful transition into routine manufacturing operations.

Key Responsibilities

• Lead operational readiness strategy and execution for a large-scale capital investment project.
• Develop the future manufacturing organization, including workforce planning, organizational structure, training strategy, and operating processes.
• Represent Operations throughout facility and process design to ensure manufacturing requirements are incorporated into project decisions.
• Partner closely with Engineering, Quality, Technical Operations, Automation, EHS, and Project Management teams.
• Drive manufacturing readiness through commissioning, qualification, validation, inspection preparation, and start-up activities.
• Support technology transfer, process implementation, and new product introductions.
• Identify and mitigate operational, technical, and project-related risks.
• Build and develop a high-performing operations team while providing strategic recommendations and readiness updates to senior leadership.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related technical discipline. Advanced degree preferred.
• 10+ years of leadership experience within pharmaceutical, API, chemical, or related manufacturing environments.
• Demonstrated experience leading or supporting manufacturing operations for small molecule, API, chemical process, or highly regulated production environments.
• Experience supporting major capital projects, facility expansions, start-ups, greenfield, or brownfield manufacturing investments.
• Strong understanding of GMP manufacturing, process validation, commissioning, qualification, regulatory inspections, and operational excellence.
• Experience working in complex, containment-intensive manufacturing environments is preferred.
• Proven success leading cross-functional teams and influencing stakeholders across multiple functions.
• Track record of building organizations, developing talent, and implementing scalable operating models.
• Strong communication, strategic planning, and change management capabilities.

NOTE: This client is unable to sponsor or take over sponsorship of an employment visa at this time.