- Company Name
- Minaris Advanced Therapies
- Job Title
- Director, Manufacturing Operations
- Job Description
-
**Job Title:** Director, Manufacturing Operations
**Role Summary:** Lead GMP manufacturing operations for cell and gene therapy products, ensuring compliance, efficiency, and alignment with client and regulatory requirements. Drive operational excellence and high-performance teams.
**Expectations:** Strategic leadership in manufacturing execution, compliance adherence, and cross-functional collaboration to deliver safe, timely, and scalable production of clinical and commercial programs.
**Key Responsibilities:**
- Provide strategic and operational leadership for GMP manufacturing of cell and gene therapy programs across pre-clinical, clinical, and commercial phases.
- Oversee production planning, scheduling, and execution to meet client timelines and capacity goals.
- Ensure compliance with cGMP, regulatory standards, and internal quality systems through documentation, audit readiness, and risk mitigation.
- Lead technology transfers, process scale-up, verification runs, and lifecycle management of manufacturing processes.
- Foster a culture of continuous improvement in efficiency, reliability, and safety.
- Partner with Quality, Supply Chain, Validation, and Program Management to align operations with product needs.
- Represent Manufacturing in audits, inspections, and cross-functional initiatives to enhance capabilities and performance.
- Collaborate on client proposals, service agreements, and operational strategies with Business Development and technical teams.
- Ensure personnel training and qualification to meet regulatory and procedural standards.
**Required Skills:**
- Advanced organizational leadership and team development experience.
- In-depth knowledge of GMP/cGMP, compliance, and quality systems for biopharma manufacturing.
- Data-driven decision-making and problem-solving capabilities.
- Strong cross-functional collaboration and stakeholder management skills.
- Expertise in manufacturing processes for cell and gene therapies.
- Project management proficiency (e.g., tech transfers, scale-up).
**Required Education & Certifications:**
- Bachelor’s degree in engineering, life sciences, or related field; advanced degree preferred.
- Minimum 10+ years of manufacturing leadership experience in biopharma, preferably in cell and gene therapy.
- Relevant certifications (e.g., PMI-PBA, PMP, Six Sigma) or equivalent project management qualifications.