Lavori attuali relativi a Senior GMP Manufacturing Specialist - Modena, Emilia-Romagna - Evotec WD
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Senior GMP Manufacturing Specialist
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Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pienoJob Title: Senior GMP Manufacturing OperatorEvotec Modena Srl is seeking a highly skilled Senior GMP Manufacturing Operator to join our Cell and Gene Therapy Manufacturing team in Modena. 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...
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Senior GMP Manufacturing Specialist
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Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pienoJob Title: Senior GMP Manufacturing OperatorEvotec Modena Srl is seeking a highly skilled Senior GMP Manufacturing Operator to join our Cell and Gene Therapy Manufacturing team in Modena. 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...
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Senior GMP Manufacturing Specialist
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Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pienoEvotec Modena Srl is a leading company in the discovery and development of novel small molecule drugs. We are seeking a highly motivated GMP Manufacturing Specialist to join our team in Modena.This position will play a key role in our Cell and Gene Therapy Manufacturing team, ensuring the successful execution of ATMP manufacturing activities in compliance...
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GMP Manufacturing Specialist
2 settimane fa
Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pienoEvotec 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...
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GMP Manufacturing Specialist
2 settimane fa
Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pienoEvotec 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...
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GMP Manufacturing Specialist
4 settimane fa
Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pienoJob Title: GMP Manufacturing OperatorEvotec Modena Srl is seeking a highly motivated GMP Manufacturing Operator to join our Cell and Gene therapy Manufacturing team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our manufacturing processes.Key Responsibilities:Carry out ATMP manufacturing in compliance with...
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GMP Manufacturing Specialist
3 settimane fa
Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pienoJob Title: GMP Manufacturing OperatorEvotec Modena Srl is seeking a highly motivated GMP Manufacturing Operator to join our Cell and Gene therapy Manufacturing team in Modena. As a key member of our team, you will be responsible for ensuring the quality and compliance of our manufacturing processes.Key Responsibilities:Carry out ATMP manufacturing in...
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GMP Manufacturing Specialist
3 giorni fa
Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pienoJob SummaryEvotec Modena Srl is seeking a highly motivated GMP Manufacturing Operator to join our team in Modena. As a key member of our Cell and Gene therapy Manufacturing team, you will be responsible for ensuring the successful execution of ATMP manufacturing activities.Key ResponsibilitiesCarrying out ATMP manufacturing in compliance with Good...
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Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pieno**Job Summary**Evotec Modena Srl is seeking a highly motivated and experienced Senior Manufacturing Operator - ATMP to join our Cell and Gene therapy Manufacturing team in Modena. 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)...
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Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pieno**Job Summary**Evotec Modena Srl is seeking a highly motivated and experienced Senior Manufacturing Operator - ATMP to join our Cell and Gene therapy Manufacturing team in Modena. 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)...
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Senior GMP Manufacturing Specialist
2 mesi fa
Evotec WD is a leading biotechnology company that specializes in the discovery and development of novel small molecule drugs. We are seeking a highly motivated Senior GMP Manufacturing Specialist to join our team at our cell therapy manufacturing site in Modena.
Key Responsibilities
- Carry out ATMP manufacturing in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (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 the batch records
- Read and fulfill in real-time production batch records and equipment logbooks
- Assure the cleaning state and routine maintenance of the manufacturing equipment
- Report any deviations occurred during manufacturing execution or preparation, errors in the documentation, or any potential matter relevant for the correct completion of the manufacturing to the management
- Carry out work in compliance with company Safety Policies
- Prepare for production (engineering batch, full-scale batch, clinical batch) and identify batch-specific requirements
- Report any accidents, incidents, and injuries immediately and notify any hazards, unsafe procedures, or conditions in the workplace
- Participate in training courses and opportunities to stay up to date
- Participate in writing and revision of SOPs and Manufacturing documents
- Participate in quality investigation from the production side
- Participate in Regulatory Authorities audits for aspects pertaining to the role
- Support activities for periodic qualification of clean room interacting with QA and engineering
- Be involved in process-related meetings
- Collaborate with the Process Development team to bring the manufacturing process in GMP
Requirements
- Knowledge of current GMP guidelines, especially GMP for ATMPs
- Competence in writing SOPs, Manufacturing Batch records
- Expertise in Risk Analysis
- 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 them 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
- Experience in technology transfer of the process from Development to GMP is a plus
