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 is a senior manufacturing leadership opportunity supporting the development and commercialization of innovative products in precision medicine. The role will shape manufacturing and operational strategies across late-stage clinical development and commercial programs. You will work closely with Regional Operations, Supply Chain, Program leadership, CMC teams, and external manufacturing partners to ensure reliable global supply. The position combines strategic planning with hands-on technical leadership across sterile manufacturing, packaging, process development, and validation. You will oversee critical contract manufacturing relationships while driving quality, cost efficiency, capacity, supply resilience, and continuous improvement. As a people leader, you will develop manufacturing engineering capabilities and create a high-performing, collaborative team environment. This role offers the opportunity to influence global manufacturing strategy while contributing to therapies designed to improve outcomes for people living with cancer and rare diseases.

Accountabilities:: Develop and execute manufacturing and operational plans for commercial and late-stage clinical assets in partnership with Regional Operations, Supply Chain, Program leadership, and CMC teams.

Partner with contract manufacturers to ensure manufacturing quality, delivery performance, cost objectives, and regulatory expectations are consistently achieved.

Provide technical and operational oversight of products from mid-stage clinical development through commercial launch, ensuring manufacturing strategies evolve appropriately with product maturity.

Develop, sustain, monitor, and continuously improve internal and external contract development and manufacturing organization strategies.

Identify opportunities to strengthen the manufacturing network through cost savings, supply redundancy, capacity planning, process improvements, and long-term operational resilience.

Collaborate with Program leadership, Supply Chain, and CMC stakeholders to establish short- and long-term manufacturing and capacity strategies aligned with commercial and development plans.

Lead the resolution of complex technical and manufacturing issues, ensuring timely, effective, and commercially sound outcomes.

Support quality investigations, non-conformances, and other manufacturing-related quality activities by providing appropriate technical and product expertise.

Oversee technical transfers and process validation activities across internal and external contract manufacturing organizations.

Serve as the technical lead for business reviews with suppliers and contract manufacturing partners, ensuring performance, risks, priorities, and improvement opportunities are clearly addressed.

Lead, develop, and performance-manage a team of manufacturing engineers, building technical capabilities and coaching team members to maximize their contribution and performance.

Drive continuous improvement across manufacturing processes, operational planning, and external manufacturing relationships while maintaining the quality standards required for each stage of development and commercialization.

Requirements:

Bachelor’s degree in Engineering, Biology, Chemistry, or another relevant scientific or technical discipline, or equivalent experience.

10+ years of combined experience across late-stage clinical through commercial cGMP manufacturing, engineering, contract manufacturing, and/or quality functions.

At least 3 years of people management experience, with demonstrated ability to lead, develop, coach, and motivate technical teams.

Direct experience with sterile injectable filling and lyophilization of drug products or substances supporting both clinical and commercial programs.

Strong understanding of manufacturing operations, process development, technical transfer, process validation, quality requirements, and contract manufacturing environments.

Experience working directly with international Contract Manufacturing Organizations and managing complex external manufacturing relationships.

Experience with secondary packaging of parenteral drugs is strongly preferred.

Experience with complex formulations of bulk drug substances and biologic drug substance manufacturing is advantageous.

Strong ability to develop manufacturing strategies that balance quality, supply continuity, capacity, cost, regulatory compliance, and commercial requirements.

Excellent problem-solving and analytical skills, with the ability to navigate complex technical issues and drive effective business resolutions.

Strong communication and stakeholder-management skills, with the ability to work effectively across technical, operational, commercial, and executive teams.

Results-oriented mindset with a strong commitment to quality, accountability, operational excellence, and measurable outcomes.

Demonstrated adaptability, resilience, creativity, and willingness to operate effectively in a dynamic and rapidly evolving environment.

Collaborative and inclusive leadership style, with a commitment to knowledge sharing, continuous learning, ethical conduct, and professional development.

Ability and willingness to travel approximately 30% domestically and internationally.

Benefits:

Competitive salary aligned with experience, qualifications, and location.

Annual performance-based bonus opportunity.

Equity-based incentive program.

Generous vacation allowance.

Paid wellness days.

Learning and professional development support.

Flexible working arrangements within a global environment, including remote and hybrid opportunities.

Opportunity to work alongside an international, interdisciplinary team focused on advancing precision medicine.

Collaborative and supportive workplace culture centered on excellence, integrity, determination, and shared purpose.

Equal opportunity employment environment committed to diversity, inclusion, and respect.

Opportunity to contribute to the manufacturing strategy and global delivery of innovative therapies addressing significant needs in oncology and rare diseases.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1