Manufacturing Technology Lead
Thermo Fisher Scientific
Gosselies, Belgium
4 dagen geleden

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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