Manufacturing Technology Lead

☞ Thermo Fisher Scientific

Ver: 120

Dia de atualização: 16-11-2025

Localização: Charleroi Hainaut

Categoria: Gestão executiva Produção / Operação

Indústria:

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Conteúdo do emprego

The Manufacturing Technology Lead acts as a transversal subject matter expert in either USP, DSP or DP processes for viral vectors to enable robust manufacturing capabilities from R&D to GMP. He/She works in close collaboration with (Senior) scientist in R&D and GMP representatives. This role will be part of the R&D leadership team.

Roles and responsibilities:

  • Enable the design and implementation of robust and scalable manufacturing process from development to commercialization
  • Ensure adequacy of process design with GMP requirements & facilities by working closely with all relevant internal stakeholders
  • Review Process Flow, Footprint, Batch records, Facility Fit, Bill Of Materials, Equipment,…
  • Support process transfer and validation activities in GMP facilities
  • Provide support to transversal studies such as cleanings, mixings, raw materials stability, extractible & leachable or risk assessment (FMEA)
  • Support process troubleshooting and resolve complex problems
  • Recommend process improvements, ensure harmonization of manufacturing solutions (incl. assemblies, buffers) and implementation of best practices from R&D to GMP
  • Support deviation investigations, identify relevant Corrective Action Prevention Plans (CAPAs), and Change Controls
  • Identify new manufacturing solutions encompassing technologies, data management, equipment and raw materials

Required Qualifications

Master degree in a life sciences or Chemical Engineering discipline and a minimum of 5 years of relevant experience in biologics, vaccines or cell/gene therapy development, MSAT, GMP operations or CMC life cycle management.

Min 3 years of experience in one of the following field: cell culture in adherence and suspension, downstream purification, chromatography, viral vector production, formulation, Drug Product technologies

Knowledge in raw material qualification and supply chain

Strong analytical, problem-solving, and critical thinking skills

Excellent written and verbal communication skills at all levels in the organization

Language skills: French and English

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Data limite: 31-12-2025

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