Senior GMP Manufacturing Operator

Evotec Modena Srl; Modena; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading company in cell and gene therapy manufacturing is seeking a Senior GMP Manufacturing Operator in Modena. This role is crucial for ensuring compliance with GMP standards and involves aseptic manufacturing processes. The ideal candidate will have a strong background in GMP guidelines, aseptic environments, and relevant educational qualifications. Join a dynamic team dedicated to innovative therapeutic solutions.

Competenze

• At least 1 year of aseptic manufacturing experience in Pharma/Biotech.
• Experience working in clean rooms.
• Mandatory previous experience in cell culture.

Mansioni

• Carries out ATMP manufacturing in compliance with GMP and SOPs.
• Executes manufacturing operations in a clean room.
• Prepares equipment and raw materials for manufacturing.

Conoscenze

Knowledge of GMP guidelines

Proficiency in writing SOPs

Strong risk analysis skills

Team-oriented

Problem-solving skills

Intermediate proficiency in scientific English

Formazione

MS Degree in Biomedical Laboratory Techniques

MS Degree in Biotechnology

MS Degree in Biology

Strumenti

Microsoft Office

Descrizione del lavoro

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Senior GMP Manufacturing Operator, Modena

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Client:

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Job Category:

Manufacturing

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EU work permit required:

Yes

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Job Reference:

2b9407c29f2c

Job Views:

2

Posted:

12.05.2025

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Job Description:

Evotec is a leader in the discovery and development of novel small molecule drugs with operational sites in Europe and the US. The Company has built substantial drug discovery and development expertise and an industrialized platform that can drive new innovative small molecule compounds into the clinic. In addition, Evotec is building an integrated platform to deliver iPSC-based therapeutics to patients and an innovative off-the-shelf cell therapy project portfolio. Leveraging these skills and expertise, the Company intends to develop best-in-class differentiated therapeutics and deliver superior science-driven discovery and development alliances with pharmaceutical and biotechnology companies.

For our cell therapy manufacturing site in Modena, we are looking for a highly motivated GMP Manufacturing Operator, expert in aseptic manufacturing. This position will play a key role in the Cell and Gene therapy Manufacturing team to ensure company and intercompany ATMP manufacturing activities.

Essential Functions

1. Carries out ATMP manufacturing in compliance with GMP and SOPs.
2. Executes manufacturing operations in a clean room, following cGMP requirements and sterile gowning procedures.
3. Prepares equipment and raw materials for manufacturing.
4. Performs aseptic process simulations (media fill).
5. Follows batch records precisely during manufacturing.
6. Reads and updates production batch records and equipment logbooks in real time.
7. Ensures cleaning and routine maintenance of manufacturing equipment.
8. Immediately reports deviations, errors, or relevant issues during manufacturing.
9. Works in accordance with safety policies.
10. Prepares for different types of production batches and identifies specific requirements.
11. Reports accidents, incidents, injuries, and hazards promptly.
12. Participates in training and continuous education.
13. Contributes to writing and revising SOPs and manufacturing documents.
14. Participates in quality investigations related to production.
15. Supports regulatory audits related to manufacturing.
16. Assists with periodic qualification of clean rooms with QA and engineering teams.
17. Engages in process-related meetings and collaborates with Process Development to ensure GMP compliance.

Required Skills & Abilities

• Knowledge of GMP guidelines, especially for ATMPs.
• Proficiency in writing SOPs and batch records.
• Strong risk analysis skills.
• Ability to gown successfully in aseptic environments.
• Team-oriented with problem-solving skills.
• Precise, organized, and able to meet deadlines.
• Intermediate proficiency in scientific English (spoken and written).
• Good command of Microsoft Office applications.

Education

• MS Degree in Biomedical Laboratory Techniques, Biotechnology, or Biology.

Experience

• At least 1 year of aseptic manufacturing experience in Pharma/Biotech.
• Experience working in clean rooms.
• Mandatory previous experience in cell culture.
• Experience with iPSC is an advantage.
• Experience in transferring processes from Development to GMP is a plus.

In line with our Diversity policy, Evotec encourages applications from all qualified candidates, including those with disabilities.