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GMP Manufacturing Specialist
1 mese fa
Evotec Modena Srl is seeking a highly skilled GMP Manufacturing Specialist to join our Cell and Gene Therapy Manufacturing team. The successful candidate will be responsible for ensuring the compliance of our manufacturing processes 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 for manufacturing completion 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 activities for 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 compliance
Required Skills & Abilities:
- 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 is required (written and spoken)
- Good knowledge of Microsoft Office applications
Education:
- MS Degree in Biomedical Laboratory Techniques/Biotechnology/Biology
Experience:
- Pharma/Biotech aseptic Manufacturing Operator (1+ years)
- Experience in clean room environments
- Previous experience in cell culture is mandatory
- Previous experience with iPSC is a plus
