Director, Manufacturing Operations

Director, Manufacturing Operations

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Manufacturing Operations based in the United States.

This role will lead manufacturing strategy and operational execution for commercial and late-stage clinical pharmaceutical assets. You will shape manufacturing plans that balance quality, supply continuity, cost efficiency, regulatory compliance, and commercial readiness. The position works across regional operations, supply chain, program leadership, and CMC teams to translate business priorities into executable manufacturing strategies. You will oversee critical activities spanning contract manufacturing, process development, technical transfers, validation, and production planning. A key focus will be strengthening the global CDMO network while identifying opportunities for cost savings, supply redundancy, and process improvement. You will also lead and develop manufacturing engineering talent while serving as a technical authority with external manufacturing partners. This is an influential opportunity for an experienced pharmaceutical manufacturing leader who thrives in a dynamic, international, and highly collaborative environment.

Accountabilities

• Partner with contract manufacturers to ensure product quality, delivery performance, and costs consistently meet or exceed expectations.
• Provide strategic oversight of manufacturing, quality, and development activities from mid-stage clinical development through commercial launch.
• Collaborate with CMC leadership to develop, sustain, monitor, and continuously improve internal and external contract development and manufacturing organization strategies.
• Identify and implement opportunities for cost savings, supply redundancy, manufacturing efficiency, and process improvement across the CDMO network.
• Work with Program Leadership, Supply Chain, and CMC teams to develop short- and long-term manufacturing and capacity strategies aligned with current and future commercial plans.
• Lead the resolution of complex technical manufacturing issues, ensuring effective and timely business outcomes.
• Support quality investigations and non-conformances by providing relevant product and manufacturing expertise.
• Lead, develop, and performance-manage a team of manufacturing engineers, strengthening capabilities and enabling the team to exceed organizational objectives.
• Serve as the technical lead for business reviews with suppliers and contract manufacturing organizations.
• Oversee technical transfers and process validation activities across internal and external manufacturing sites.
• Provide manufacturing and operational input to ensure processes support regulatory compliance, product quality, supply continuity, and commercial viability.

Requirements

• Bachelor's degree in Engineering, Biology, Chemistry, or another relevant scientific or technical discipline.
• 10+ years of combined experience in late-stage clinical through commercial cGMP manufacturing, engineering, contract manufacturing, quality, or related pharmaceutical operations.
• At least 3 years of previous people management experience, with a demonstrated ability to develop high-performing technical teams.
• Direct experience with sterile injectable filling and lyophilization of drug products or substances supporting both clinical and commercial programs.
• Experience working with international contract manufacturing organizations and managing complex external manufacturing relationships.
• Strong understanding of manufacturing operations, process development, technical transfers, validation, quality requirements, and supply planning within regulated pharmaceutical environments.
• Experience with secondary packaging of parenteral drugs is preferred.
• Experience with complex formulations of bulk drug substances and biologic drug substance manufacturing is preferred.
• Strong technical problem-solving skills, with the ability to assess complex issues and develop practical, business-focused solutions.
• Excellent communication and collaboration skills, with the ability to work effectively with technical teams, senior leaders, suppliers, and cross-functional stakeholders.
• Results-oriented mindset with strong organizational skills and the ability to adapt to changing priorities.
• Demonstrated integrity, resilience, accountability, and commitment to continuous learning and professional development.
• Inclusive and collaborative leadership style, with a commitment to creating an environment where diverse perspectives and expertise are valued.
• Willingness and ability to travel approximately 30% domestically and internationally.

Benefits

• Competitive base salary.
• Annual performance-based bonus opportunity.
• Equity-based incentive program.
• Generous paid vacation.
• Paid wellness days.
• Learning and professional development support.
• Remote work environment with flexibility across the United States.
• Opportunity to collaborate with an international, multidisciplinary team.
• High-impact role supporting the development and commercial delivery of precision medicine solutions for oncology and rare diseases.
• Supportive and engaged working environment focused on collaboration, innovation, excellence, and continuous improvement.