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Cell Culture & Biochemistry QC Technician (H/F/X)

April 13th 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 modelling, 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 Cell Culture & Biochemistry QC Technician main role is to perform all administrative and laboratory activities inside the Cell Culture & Biochemistry platform in order to evaluate the quality of the cell therapy products with a GMP quality grade and in an efficient way.

The Cell Culture & Biochemistry QC Technician reports to the Cell Culture & Biochemistry QC Supervisor.

In order to fulfill his / her role, he / she:

  • Performs QC tests in due time according to the team planning, and in compliance with effective instructions /procedures and all laboratory/safety procedures
  • Ensures the availability of reagents, consumables in due time and assists the QC support in the management of QC Reagents stock level
  • Performs his/her duties and document his/her work according to Catalent’s current procedures and GMP rules
  • Interprets analytical results and warns immediately the QC PL / Supervisor / Manager in case of unusual event/result/OOS
  • Participates in troubleshooting of experiment and equipment issues
  • Initiates or reviews deviations, OOS, CHC linked to the cell culture & biochemistry platform and leads necessary investigation. Implement CAPA
  • Double checks filled forms or data generated by QC Experts / Specialists / Technicians, for testing which he / she is trained
  • Fills certificates of analysis and ensures that a product will only be released if its specifications are met
  • Fills datawarehouses; control charts and all other needed follow-up files
  • Participates to the drafting / review of instructions and forms in collaboration with MSAT / P&AD departments
  • Assists the QC support in daily maintenance of the laboratory (bench and floor cleaning, waste evacuation, general aspect, etc)
  • Warns immediately the QC Supervisor/ Manager in case of problem or failure or security issue
  • Participates actively to the weekly QC team meeting
  • Maintains effective, constructive and positive communication with all QC team members and other departments
  • Takes part to audits when necessary

Candidate profile

  • Bachelor degree or higher in biology, biomedical sciences, biochemistry, clincal chemistry
  • Experience in cellular and molecular biology methods such as cell cultures (WCB/MCB), cell-based assays, ELISA, PCR…. is a must
  • Experience in cGMP environment and/or quality control is a must
  • Organization skills, multitasking, flexibility and autonomous
  • Teamwork
  • Results oriented; problem solving
  • Quality minded, rigorous and pro-active
  • Fluent in French and in English (at least A2 level)
  • Computer skills:  Microsoft office, Compliance Wire, Ms Teams, TrackWise are a plus
  • Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

 

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

Contact Details

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