Manufacturing Operations Director
3 days ago
About the Position:
We are seeking an experienced Manufacturing Operations Director to lead our biotech manufacturing team in Texas. This is a unique opportunity to join a pioneering joint venture between National Resilience and MD Anderson Cancer Center, accelerating cell therapies from bench to bedside.
Job Description:- Lead Manufacturing Team: Supervise a team of 20+ manufacturing managers and associates, driving high performance, employee engagement, and overall job satisfaction.
- Capacity Utilization: Manage GMP suite, equipment, and personnel optimization to ensure maximum efficiency and meet production goals.
- Technical Transfers: Coordinate with Process Development, Quality Control, Quality Assurance, and Project Leadership for timely completion of all Technical Transfers.
- Continuous Improvement: Drive enhancements in quality and safety standards through ongoing process improvements.
- Audit and Compliance: Serve as Manufacturing Lead for audits, inspections, submissions, and regulatory requests.
- Deviations and CAPAs: Ensure timely close out of all deviations, CAPAs, and change controls related to Manufacturing Processes.
Requirements:
- Bachelor's Degree: In a scientific field or equivalent education and experience.
- Manufacturing Experience: 12+ years in a related environment (cell therapy or biotech).
- Management Experience: 6+ years in a management or supervisory role.
- Certifications and Skills: Strong knowledge of GMP Practices, FDA requirements, ERP systems, and technical authoring skills.
Working Conditions:
This position works in an office and clean room environment, requiring frequent standing, walking, sitting, and reaching, occasional lifting up to 50 lbs, and frequent use of a computer/keyboard.
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