Job Summary
This is a leadership role focused on our Bio Site, overseeing Product/GMP operations across all production areas. The role involves ensuring proper staffing and training, supporting a dynamic and flexible production planning process to meet stakeholder and client needs. The manager will direct staff to meet production, quality, safety, and financial goals, manage all manufacturing activities, and monitor key performance metrics.
Main Responsibilities
- Lead all aspects of drug product manufacturing operations at the facility to produce commercial parenteral products according to approved procedures, regulations, and schedules.
- Guide and oversee validation and commissioning activities at the facility.
- Maintain site inspection readiness and represent the manufacturing facility during regulatory and client audits.
- Ensure Drug Product operations comply with SFDA, FDA, and EU requirements.
- Support and participate in cGMP audits and GEMBA walkthroughs of all production areas.
- Oversee and approve production schedules, plans, and material requirements.
- Ensure timely and compliant execution of production plans.
- Provide direction to Drug Production operations, including dispensing, formulation, filling, lyophilization, inspection, packaging, and area recovery.
- Collaborate with engineering, maintenance, quality, and warehouse departments to address technical and managerial challenges.
- Develop or revise procedures to improve compliance, safety, and efficiency in conjunction with relevant departments.
- Investigate non-conformities and deviations, implementing CAPAs to prevent recurrence.
- Manage manufacturing metrics, support program milestones, and drive continuous improvement.
- Communicate issues promptly to Senior Leadership and resolve manufacturing and facility issues to prevent supply disruptions.
- Optimize the use of materials, equipment, and personnel to produce quality products and meet profitability targets.
- Participate in setting strategies, budgets, goals, and departmental planning.
- Hire, train, develop, and evaluate staff; establish training and qualification programs.
- Ensure safety compliance with HS&E requirements.
- Manage production assets—machines and personnel—to achieve departmental and company objectives.
Requirements
- Master's degree or B.Sc. in Pharmacy, physical or biological sciences, or Chemical Engineering.
- At least 12 years of related experience, with a minimum of five years in a supervisory role.
- Proficiency in Arabic and English, both written and spoken.
Professional Knowledge
- International and EU Regulations.
- General Safety Regulations.
- GMP standards.
- Gowning procedures.
- Ministry of Health Regulations.
- Operation excellence methodologies and tracking.