Lavori attuali relativi a Senior Aseptic Manufacturing Specialist - Modena, Emilia-Romagna - Evotec Modena Srl
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Senior Aseptic Manufacturing Specialist
2 mesi fa
Evotec Modena Srl is at the forefront of the discovery and development of innovative small molecule therapies, with a strong presence in Europe and the United States. The organization possesses significant expertise in drug discovery and development, providing a robust platform to propel groundbreaking compounds into clinical trials. As part of its expansion, Evotec is committed to delivering advanced therapeutics to patients through iPSC-based treatments and off-the-shelf cell therapy initiatives. By harnessing these capabilities, Evotec aims to develop high-quality therapeutics and foster scientific partnerships with pharmaceutical and biotech firms.
We are currently looking for a GMP Manufacturing Operator who specializes in aseptic manufacturing for our cell therapy production facility.
Key Responsibilities
- Conducts Advanced Therapy Medicinal Product (ATMP) manufacturing in accordance with GMP and Standard Operating Procedures (SOPs).
- Performs manufacturing tasks within clean room environments, adhering to current Good Manufacturing Practices (cGMP).
- Prepares necessary equipment and raw materials for the manufacturing process.
- Executes aseptic process simulations to ensure compliance.
- Maintains accurate documentation and oversees equipment upkeep.
- Immediately reports any operational issues to management.
- Ensures adherence to safety regulations and policies.
- Participates in training sessions and contributes to the development of SOPs.
- Assists in quality investigations and supports clean room qualification activities.
- Collaborates effectively with the process development team.
Required Skills & Qualifications
- In-depth knowledge of GMP regulations.
- Proficient in drafting SOPs and batch records.
- Experience in Risk Analysis methodologies.
- Ability to work effectively in aseptic manufacturing settings.
- Strong collaborative skills and problem-solving capabilities.
- Excellent organizational and prioritization skills.
- Intermediate proficiency in scientific English.
- Competence in Microsoft Office applications.
Educational Background
- Master's Degree in Biomedical Laboratory Techniques, Biotechnology, or Biology.
Professional Experience
- A minimum of one year of experience as a Pharma/Biotech aseptic Manufacturing Operator.
- Experience working in clean room environments.
- Prior experience in cell culture is essential.
- Familiarity with iPSC technology is advantageous.
- Exposure to technology transfer from Development to GMP is beneficial.
FR: Evotec valorise la diversité en étudiant toutes les candidatures, notamment celles des personnes en situation de handicap.
ENG: Evotec promotes diversity by considering all applications equally, including those from people with disabilities.