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TECHNOLOGY TRANSFER SPECIALIST

Descripción de la oferta de empleo

Key informationJob Title: Tech Transfer Specialist Contract length: 2 YearsLocation/onsite requirements: Barcelona/HybridTarget start date (Not ASAP): Jan 2025Technical Interface to external supplier:Support respective external suppliers with Science- and Risk-based approaches to ensure that product quality can be sustainably reproduced during the Transfer.Product/Technical Stewardship for defined key molecules: Act as SPOC to maintain the oversight and knowledge for entire manufacturing process throughout the entire transfer at given external suppliers. Ensure a proper understanding of manufacturing process and influencing factors (i.e. CQAs, CMAs and CPP) to ensure product quality and process robustness at the commercialization site. Analyse product-specific manufacturing data from APQRs and other relevant sources where needed and agree on state of controlAssess impact of technical changes, assess technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of proposed technical changes. Contribute to the registration strategy and ensure alignment of (regulatory) timelines for technical changes, transfers, launches and/or major deviations. Lead / support root cause investigation of product and process failures.Effectively liaise with external suppliers to initiate and lead/support product / process remediation/ improvement activities, involving cross-functional teams and with clear interfaces to Quality, Operations, Engineering and Technical Development.• Maintain Division and/or cross-division networks to share lessons learned and best practices related with
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Detalles de la oferta

Empresa
  • BioTalent
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 25/12/2024
Fecha de expiración
  • 25/03/2025
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