Head of Research & Production en Michael Page

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Head of Research & Production
Michael Page | (15) ofertas activas
Sevilla, 24 Mar.
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Descripción

Medicine company looks for a Head of Research & Production based in Seville

Detalles del cliente

Medicine company

Descripción de la oferta


  • Operations management for manufacturing operations and line management responsibility for the managers of Rexgenero's Manufacturing and QC groups





  • Oversight of development, maintenance and regulatory compliance of Rexgenero's cell therapy GMP manufacturing facilities in Seville and manufacture of Rexgenero cell and gene therapies for clinical trials





  • Development of and execution of a strategy plan for CMC development and integration in integrated development plan





  • Design of manufacturing processes, QC assays and other product characterization methods





  • Project management of CMC process development for commercial manufacturing of REX-001 and other cell and gene therapies including process closure and integration of electronic quality management systems (eQMS) and process tracking systems





  • Development and integration of eQMS and administration systems for application in GMP manufacture





  • Characterization and of cell therapy attributes and process characteristics relevant to the biological activity and quality of cell and gene therapies





  • Management of technology transfer of REX-001 manufacturing to additional facilities in North America





  • Oversight of preparation of CMC sections for regulatory filings





  • Establishment and management of external relationships for project partnerships in cell and gene therapy CMC development and manufacture





  • Drafting, editing and updating of regulatory materials including IMPD, briefing packages etc.





  • Documentation of projects, processes, technical findings in internal documents and manuscripts for publication in scientific journals



Perfil del candidato


  • Degree in relevant cell biology, biochemistry, immunology, pharmacy, pharmaceutical development or related discipline




  • Minimum 10-year experience of pharmaceutical manufacture in a regulated GMP environment





  • Extensive experience with the GMP manufacture of cell and gene therapies





  • Experience of project management of CMC development preferably for cell and gene therapies





  • Extensive experience of documentation of technical findings





  • Experience in line management of laboratory and/or manufacturing personnel





  • Creative problem-solving abilities in CMC development




  • Experience of interaction with local and international pharmaceutical regulators (especially EMA and FDA)





  • Experience of managing technology transfer of complex pharmaceutical manufacturing processes





  • International experience outside of Spain (preferable)





  • Track record of publications in international scientific or technical journals and presenting at scientific conferences





  • PhD in relevant discipline





  • Fluency in written and spoken English, Spanish language to intermediate level or above



Oferta de empleo

Una buena oportunidad para tu desarrollo profesional.


Numero de vacantes: 1
Tipo de contrato: Full-Time
Remuneración anual: bonus
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Requisitos
Medicine company looks for a Head of Research & Production based in Seville

Degree in relevant cell biology, biochemistry, immunology, pharmacy, pharmaceutical development or related discipline





Estudios mínimos
Diplomado
Experiencia mínima
5 años
Disponibilidad para viajar
El 100% del tiempo laboral

Para inscribirte a esta oferta, tendrás que acceder a la web de la siguiente empresa y cumplimentar la plantilla del curriculum. Tus datos serán almacenados en la base de datos de dicha empresa, por lo que PMFarma no se responsabiliza del uso de los mismos.


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