Job Specifications
Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.
At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.
Position Summary
The Director of Manufacturing is responsible for leading the day-to-day execution of GMP manufacturing operations to ensure the safe, compliant, and timely delivery of client programs. This role provides strategic and operational leadership to the manufacturing organization, overseeing production activities, staffing, and operational readiness to support clinical and commercial manufacturing of cell and gene therapy products. The Director of Manufacturing drives operational excellence through a strong quality culture, data-driven decision making, and disciplined execution of manufacturing processes. The role partners closely with Quality, MSAT, Supply Chain, Engineering, Validation, and Program Management to ensure manufacturing activities are executed in compliance with current Good Manufacturing Practices (cGMP) and aligned with client expectations and regulatory requirements. This leader is responsible for building and developing high-performing teams while fostering a collaborative, accountable, and continuous improvement–focused culture. The Director plays a key role in ensuring operational performance across safety, quality, delivery, and cost while supporting successful tech transfers, process scale-up, and lifecycle management of manufacturing processes. The position also serves as a key interface with internal stakeholders and client teams, representing Manufacturing in cross-functional forums and contributing to strategic initiatives that enhance the site’s manufacturing capabilities and operational performance.
Essential Functions And Responsibilities
Operational Execution & Manufacturing Delivery:
Provide strategic and operational leadership for GMP manufacturing operations supporting pre-clinical, clinical, and commercial cell and gene therapy programs.
Ensure safe, compliant, and timely execution of manufacturing activities in accordance with cGMP regulations, internal quality systems, and client requirements.
Oversee production planning and scheduling to ensure efficient utilization of manufacturing capacity and adherence to customer timelines.
Lead successful execution of client manufacturing programs, including technology transfers, process scale-up, verification runs, and routine GMP manufacturing.
Collaborate closely with MSAT, Quality, Supply Chain, Facilities, Validation, and Program Management to ensure operational readiness and seamless execution of manufacturing programs.
Ensure operational processes, batch records, and manufacturing documentation are developed, maintained, and executed in compliance with regulatory requirements and internal procedures.
Drive continuous improvement initiatives to enhance manufacturing efficiency, reliability, and scalability of production operations.
Quality, Compliance & Inspection Readiness
Promote and sustain a strong culture of quality, compliance, and Right-First-Time execution across manufacturing operations.
Ensure all manufacturing activities comply with cGMP, regulatory requirements, and company quality systems.
Partner with Quality Assurance and Quality Control to ensure proper investigation, resolution, and prevention of deviations, CAPAs, and quality events.
Maintain a continuous state of inspection readiness within manufacturing operations.
Represent Manufacturing during client audits, regulatory inspections, and quality reviews.
Ensure manufacturing personnel are appropriately trained and qualified to perform their duties in accordance with regulatory requirements and company procedures.
Business & Client Partnership
Partner with Business Development, Program Management, and technical teams to support client proposals, manufacturing strategies, and operational planning for new and existing programs.
Contribute to the development of Manufacturing Service Agreements (MSAs), Scopes of Work (SOWs), and operational resource models to ensure successful program execution.
Act as a key operational interface with clients to support program planning, execution, and issue resolution.
Maintain high levels of client satisfaction through reliable execution, transparent com