Product Lifecycle Scientist

☞ Thermo Fisher Scientific

Visualizza: 145

Giorno di aggiornamento: 16-11-2025

Località: Charleroi Hainaut

Categoria: Consiglio di amministrazione

Industria:

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Contenuto del lavoro

The Product Lifecycle Scientist is responsible for preparing, designing and implementing plans for the characterization, validation or lifecycle of commercial processes according to Regulatory Authorities guidances. He/She works closely with relevant R&D, QA, QC, GMP Manufacturing representative and reports to the Product Lifecycle Lead.

Roles and responsibilities:

  • By working closely with all relevant internal stakeholders (R&D, QA, QC, GMP Manufacturing) and customers:
    • Build strong product knowledge and associated process-related risk or gap assessments to prepare for characterization and validation activities.
    • Define activities and plans relevant to process characterization and validation
    • Define and evaluate parameters and outputs, with their ranges and classifications for a specific process
    • Design validation supportive studies such as hold times, stability, cleaning, bacterial challenge test, media fill test, container integrity test, mixing and homogeneity, extractible & leachable, viral clearance
    • Design the Continued Process Verification and identify appropriate solutions for process monitoring (trends, deviations, process outputs)
  • Provide well-written, accurate and timely protocols, reports relevant to these activities
  • Provide on-site support to the R&D and GMP units during the implementation and execution of characterization and validation campaign
  • Provide support during regulatory inspections, VMP or Annual Quality Reviews activities, acting as the process lifecycle representative

Required Qualifications

Master degree in a life sciences or Chemical Engineering discipline

Minimum of 3 years of relevant experience in Process characterization, validation and life cycle management for biologics, vaccines or cell/gene. Demonstrated knowledge in some of the following fields applied to viral vectors: upstream/downstream/drug product process, cell culture, chromatography, filtration, raw material management

Knowledge in biostatistics and analytical methods

Ability to work cross-boundaries

Excellent written and verbal communication skills

Language skills: French and English

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Scadenza: 31-12-2025

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