Senior GMP Manufacturing Operator

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 have a key role in Cell and Gene therapy Manufacturing team to guarantee company and intercompany ATMP manufacturing activities.

Essential Functions

1. Carries out the ATMP manufacturing in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs)
2. Executes manufacturing operations in clean room, following cGMP requirements and wearing sterile gowning
3. Prepares equipment and raw materials for manufacturing
4. Performs (preparation and execution) aseptic process simulation (media fill)
5. Executes all steps outlined in the batch records
6. Reads and fulfills in real time production batch records and equipment logbooks
7. Performs and assures the cleaning state and routine maintenance of the manufacturing equipment
8. Immediately reports 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
9. Carries out the work in compliance with company Safety Policies
10. Prepares for production (engineering batch, full scale batch, clinical batch) and identification of batch specific requirements
11. Reports any accidents, incidents and injuries immediately notifying any hazards, unsafe procedures, or conditions in the workplace
12. Keeps up to date by participating in training courses and opportunities
13. Participates in writing and revision of SOPs and Manufacturing documents
14. Participates in the quality investigation from production side
15. Participates in Regulatory Authorities audits for aspects pertaining to the role
16. Supports the activities for periodic qualification of clean room interacting with QA and engineering
17. Is involved in process-related meetings
18. Collaborates with Process Development team to bring manufacturing process in GMP

Required Skills & Abilities

1. Knowledge of current GMP guidelines, especially GMP for ATMPs
2. Competence in writing of SOPs, Manufacturing Batch record
3. Expertise in Risk Analysis
4. Demonstrated ability to successfully gown into aseptic manufacturing areas
5. Positive, team player and problem-solving attitude
6. Accurate, with excellent prioritization and organization skills
7. Commitment to the assigned deadlines and ability to deliver them tightly
8. Scientific English intermediate level is required (written and spoken)
9. Good knowledge of Microsoft Office applications

Education

1. MS Degree in Biomedical Laboratory Techniques/Biotechnology/Biology

Experience

1. Pharma/Biotech aseptic Manufacturing Operator (1+ years)
2. Experience in clean room environments
3. Previous experience in cell culture is mandatory
4. Previous experience with iPSC is a plus
5. Experience in technology transfer of process from Development to GMP is a plus

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.