GMP Manufacturing Specialist
4 settimane fa
Evotec Modena Srl is seeking a highly skilled GMP Manufacturing Specialist to join our Cell and Gene Therapy Manufacturing team. As a key member of our team, you will be responsible for ensuring the successful execution of ATMP manufacturing activities in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
Key Responsibilities:
- Carry out ATMP manufacturing in compliance with GMP and SOPs
- Execute manufacturing operations in clean room environments, following cGMP requirements and wearing sterile gowning
- Prepare equipment and raw materials for manufacturing
- Perform aseptic process simulation (media fill) and execute all steps outlined in batch records
- Read and fulfill production batch records and equipment logbooks in real-time
- Assure the cleaning state and routine maintenance of manufacturing equipment
- Report any deviations, errors, or potential matters relevant to manufacturing to management
- Carry out work in compliance with company Safety Policies
- Prepare for production and identify batch-specific requirements
- Report accidents, incidents, and injuries, and notify hazards, unsafe procedures, or conditions in the workplace
- Participate in training courses and opportunities to stay up-to-date
- Contribute to the writing and revision of SOPs and manufacturing documents
- Participate in quality investigations from a production perspective
- Participate in Regulatory Authorities audits for aspects related to the role
- Support periodic qualification of clean rooms, interacting with QA and engineering
- Be involved in process-related meetings
- Collaborate with the Process Development team to bring manufacturing processes into GMP
Requirements:
- Knowledge of current GMP guidelines, especially GMP for ATMPs
- Demonstrated ability to successfully gown into aseptic manufacturing areas
- Positive, team player, and problem-solving attitude
- Accurate, with excellent prioritization and organization skills
- Commitment to assigned deadlines and ability to deliver tightly
- Scientific English intermediate level (written and spoken)
- Good knowledge of Microsoft Office applications
- MS Degree in Biomedical Laboratory Techniques/Biotechnology/Biology
- Pharma/Biotech aseptic Manufacturing Operator experience (1+ years)
- Experience in clean room environments
- Previous experience in cell culture is mandatory
- Previous experience with iPSC is a plus
Evotec Modena Srl is an equal opportunities employer and welcomes applications from all qualified candidates, including those with disabilities.
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