GMP Manufacturing Technician en REXGENERO BIOSCIENCES

GMP Manufacturing Technician
REXGENERO BIOSCIENCES
Sevilla, 7 Oct.
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Descripción
- Manufacture of cellular therapies using cell processing equipment according to GMP manufacturing guidelines.
- Coordination of activities related to the clean-room (cleaning, maintenance, other activities).
- Development of experimental procedures and methodologies including preparation of Standard Operating Procedures (SOPs).
- Maintenance of products in cell culture using aseptic technique to culture cells in vitro.
- Execution of analytical tests for processes and products development.
- Performance of immunoassays (e.g. ELISA).
- Performing validation procedures to establish, Maintenance of products in cell culture.
- Documentation of procedures and experimental results according to GLP and GMP standards.
- Support tech transfers, process validations, equipment validation and qualification, stability studies and materials management.
- Responsible for periodic checks, calibration and maintenance of equipment and GMP facilities.
- Assistance with analysis and preparation of materials documenting manufacturing, cell processing, cellular and functional characterisation to support EMA, FDA and other regulatory filings, including performing and documenting specific studies if required.
- Management of projects according to agreed timelines and budgets.

Numero de vacantes: 1
Tipo de contrato: Obra o servicio
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Requisitos
- BSc sciences in biological, biomedical sciences or similar
- Master´s degree in biological or biomedical sciences preferred
- Minimum two years of experience in ATMP manufacturing under GMP conditions under clinical trial (Phase III preferred) or commercial development.
- Deep knowledge and experience working on stem and progenitor cells, cell culture and cell processing techniques
- Good written and speaking proficiency in English
- Proficient using Microsoft Office applications
- Ability to work independently as well as team player
- Domiciled or willing to move in Seville

Estudios mínimos
Licenciado
Idiomas
Inglés nivel Alto.
Experiencia mínima
5 años
Disponibilidad para viajar
Ninguna



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