Process Expert Planning Biologics Drug Substance

Vor 6 Tagen

Pfaffenhofen an der Ilm, Deutschland Hobson Prior Vollzeit

Hobson Prior is looking for a Process Expert Planning Biologics Drug Substance to join a fantastic pharmaceutical corporation on a contract basis located in Germany. Our client is focused on expanding and enhancing the lives of many people through drug discovery and medicine.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- The headquarters has given the order to start planning for possible new biotechnology development and production building.
- The planning phase initially includes a feasibility study and then a concept design.
- A process expert with extensive biotechnological process experience in the production of monoclonal antibodies in the pharmaceutical environment is required, who is responsible for the process within the project for DSE.
- Technical management of the process team within the project.
- Coordination of the project communication and technical contact person for the process in the cooperation between the DSE team and the external planning company.
- Technical advice for the project leader and the project manager in the course of the project for the process area.
- Responsibility for the process within the scope of the project. In particular with regard to the manufacturing processes, their temporal and spatial sequences, the equipment, the premises, the in-process controls, the analytics, the personnel requirements and GMP-specific requirements.
- Planning of the processes to be integrated with the new building, the associated equipment and the specific requirements (e.g. BSL).

**Requirements**:

- Completed studies as a biotechnologist, or comparable, with a strong background in process technology; Promotion an advantage.
- Several years of project management experience in the field of biotechnological production ( mammalian cell culture, single-use bioreactors, perfusion technology, USP, DSP ) in the pharmaceutical environment.
- Sound GMP knowledge in the biotechnological production of active substances (mAB), especially monoclonal antibodies.
- Knowledge of the technical building requirements (HVAC, locks, buffer preparation, etc.) is desirable.
- Very good written and spoken German and English skills - if necessary only English skills.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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