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MSAT Engineer (H/F/X)

June 9th 2021

Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

To lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for a highly motivated MSAT Engineer.

The Role

  • Ensure effectiveness of interface activity with QC, Mftg and P&AD
  • Ensures GMP compliance and implementation of CTLT’s QMS, product quality and team driven by patient safety
  • Define end deploy a strategy to deliver a Process History File able to capitalize on the process & analytical knowledge acquired along project
  • Establish and deliver comprehensive scientific and technical training package for other department like manufacturing or QC, Active contributor to C&GT academy on site, first intend
  • Scientific lead on Analytical Methods AND Process Transfer/Validation (A&PMT/A&PMV)
  • Review PMT/PMV and AMT/AMV protocols & reports
  • Approve the strategy and verify that it is is translated into validation protocol and experimental plan appropriately
  • Work closely with P&AD during the diagnostic phase through the detailed gap analysis in order to assess the potential of a new process or method to be validated under cGMP requirement as appropriate
  • Coordinate and promote continuous improvement activities associated to MSAT, as for broader company analytical and process projects

Candidate profile

  • 5 years of experience in a cGMP biopharmaceutical environment.
  • Or Proven experience in Process and analytical methods validation and statistics, tech transfer
  • Experience in cell therapy or quality control of cells from human tissue origin is a plus.
  • Experience in biopharma environment and Inspection readiness at the highest level ( FDA or equivalent) is a must.
  • Fluency in French and Excellent written and spoken English (At least level B2 required).

Offer

  • Full-time position (40h/week).
  • An indeterminate contract.
  • The opportunity to take part in a growing dynamic biotech company.
  • A human-sized working environment with a convivial atmosphere.
  • Attractive salary packing including additional benefits.

Contact Details

To apply for this job, please send your application on the following link : Catalent