JOBS

Back

Microbiology QC supervisor (M/F)

January 11th 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

The microbiology QC supervisor main role is to supervise the activities linked to microbiology in the Quality Control department. These activities are divided in these different fields:

  • EM validation, cleaning validation.
  • Aseptic Process Validation, Gowning validation.
  • EM monitoring.
  • Sterility tests on final product.
  • Growth promotion tests.
  • EM Trends.
  • As microbiologist, he/she analyses the impact of the current species on deviations, trends analysis and propose actions to improve the EM/cleaning process.
  • In order to fulfill his/her role, the Microbiology QC Supervisor:
  • Supervises a team of different experts, and QC supports.
  • Takes part to internal and/or external audits, if necessary.
  • Follows regulatory updates.
  • Among the activities of the current clinical facility, the current challenges are:
  • Set-up of the EM validation, cleaning validation of the future commercial facility.
  • EM samples management: set up of a planning to anticipate workload.

In addition the QC supervisor will support the QC Manager/Director with the general improvement of the quality system linked to EM/cleaning/QC microbio as part of the commercial readiness program.

Candidate profile

The Candidate

  • At least Master level in bioengineering, biochemistry, biology, etc.; with a specialisation in microbiology.
  • At least 5 years experience in cGMP and QC or experience in a similar position.

​Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Delivers Results
  • Leads with Integrity and Respect
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

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.
  • A company car with fuel card

Contact Details

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