Director, Operations

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

Job summary

DSJ Global is seeking a Director of Operations to lead readiness for a major U.S. growth investment focused on small molecule manufacturing.

The role will partner with executive leadership to establish the operating model, build the organization, and transition into routine manufacturing operations. The position requires deep GMP/regulated environment expertise, capital project experience, and a track record of shaping scalable operating models and high-performing teams across design,

Qualifications

• 10+ years of leadership experience in API manufacturing or highly regulated production environments.
• Experience leading operations for small molecule/API manufacturing.
• Experience with major capital projects, facility expansions, start-ups, greenfield/brownfield investments.
• Strong GMP, process validation, commissioning, qualification, regulatory inspections knowledge.
• Experience working in complex containment environments and building 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 and operating processes.
• Represent Operations in facility and process design to ensure manufacturing requirements are included.
• Partner with Engineering, Quality, Technical Operations, Automation, EHS, and Project Management teams.
• Drive manufacturing readiness through commissioning, qualification, validation, inspection prep, and start-up activities.
• Support technology transfer, process implementation, and new product introductions.
• Identify and mitigate operational, technical, and project risks.
• Build and develop a high-performing operations team with updates to senior leadership.

Skills

Leadership experience

Cross-functional collaboration

Strategic planning

Change management

Communication

Education

Bachelor's degree in Engineering or related field

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 API 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.