Job Summary
This role is responsible for overseeing and optimizing manufacturing processes related to the production of sterile biologic drug products including technology transfer (TT) of products to the site. Designing, implementing the TT manufacturing program and driving the trouble shooting and improvement of the regular manufacturing processes.
Main Responsibilities
- Optimize manufacturing processes to produce sterile biologic drug products.
- Design and implement process improvements to enhance product quality, yield, and efficiency.
- Perform process risk assessments.
- Collaborate with cross-functional teams, including manufacturing and quality assurance to support product commercial manufacturing activities.
- Coordinate and drive the technology transfer activities to ensure smooth transfer of processes from development to manufacturing.
- Develop process documentation such as standard operating procedures (SOPs), protocols and other similar GMP documents.
- Provide technical support, oversight, and training to manufacturing personnel to ensure proper execution of tech transfer batches (PPQs) and commercial manufacturing processes.
- Contribute to the design and qualification of manufacturing equipment and Single Use systems.
- Conduct studies and risk assessments to identify potential hazards and mitigation strategies.
- Support troubleshooting equipment and processes to ensure efficient operation and minimal downtime.
- Provides on-floor manufacturing support for equipment and processing issues.
- Product Life Cycle management - Analyze process data to identify trends, optimize performance, and drive continuous improvement initiatives.
- Technical expertise to ensure compliance with industry standards and regulatory requirements, such as FDA, ISO, and cGMP.
- Support client audits and regulatory inspections as required.
- Support Manufacturing in the investigation and resolution of production related deviations and compliance issues in a timely manner including identifying effective CAPAs.
- Participating in validation activities, including IQ/OQ/PQ protocols, to ensure the effectiveness and reliability of the processes.
- Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures.
- Makes decisions regarding technical risk assessments for new manufacturing equipment.
- Participate in identifying continuous improvement projects within unit operations, in partnership with Manufacturing when applicable.
Job Requirements
- B.Sc. degree in chemical engineering, Biotechnology, Biochemical Engineering, or a related field required.
- 2-3 years experience in process engineering within the pharmaceutical or biotechnology industry, with a focus on sterile biologics manufacturing preferred.
- Proficiency in written, read and spoken Arabic and English Languages.
Professional Knowledge
- International and EU Health Authority Regulations
- Good Manufacturing Practices (GMP), Good Documentation Practices (GDP)
- Ministry of Health Regulations
- General Safety Regulations
- Aseptic Processing
- Gowning Procedures
- Process Validation
- Equipment Qualification
- Single Use Technology
- Continuous Improvement
- Statistical Analysis
- MS Office Suite
