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Flow Cytometry QC Coordinator (H/F/X)

June 23rd 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 Role

The Flow Cytometry QC Coordinator main role is to support the Flow Cytometry QC Supervisor in his / her function to achieve goals of the platform and customers.

The Flow Cytometry QC Coordinator reports to the Flow Cytometry QC Supervisor.

Support the Flow Cytometry QC supervisor in the team management

perform 1 to 1 meeting to discuss issues and achievements with his/her N-1

Perform the annual performance review and set up annual  SMART objectives of his/her N-1

Support the Flow Cytometry QC supervisor by ensuring the requested delegated tasks:

Plan the QC tests related to the platform and organize the work with the team

Manage the action log related to the platform and respect the timelines

Organize/participate in weekly team meetings to assess the follow-up of all tasks

Ensure the role of backup of the Flow Cytometry QC supervisor during his / her absence

Maintain effective, constructive and positive communication with all QC team members and other departments

Attend internal and/or external meetings with PL / client to present and discuss QC topics, results or issues when required

Quality

Be a reference person for questions regarding methods performed / equipment used in the platform

Share his/her expertise in analytical methods with other members of the QC team; participate in troubleshooting of experiment and equipment issues

Interpret analytical results and warn immediately the QC PL / Supervisor / Manager in case of unusual event/result/OOS

Initiate or review deviations, OOS, CHC linked to the Flow cytometry platform and lead necessary investigation. Implement CAPA

Double check filled forms or data generated by QC Experts / Specialists / Technicians, for testing which he / she is trained

Fill certificates of analysis and ensure that a product will only be released if its specifications are met

Participate to the drafting / review of instructions and forms in collaboration with MSAT / P&AD department

Ensure that all documents (forms, etc) and files (DWH, etc) are filled / double checked and CoA are generated in a timely manner according to release planning

Warn the QC Supervisor or QC Manager in case of problem

Takes part to internal and/or external audits, if necessary

Candidate profile

The Candidate

Master degree or higher in biology, biomedical sciences, biochemistry, clinical chemistry or relevant experience in a similar position in the sector of biotechnology/pharma/cell therapy

Experience in people management is a must

Experience in Flow Cytometry is a strong asset

At least 2 years of experience in cGMP environment and/or quality control

Organization skills, multitasking, flexibility and autonomous

Efficient communication

Technical expertise in main analytical FCM methods used at Catalent Gosselies, teamwork and teaching skills

Skills in use of FACS Celesta – FACS Verse – FACS MACSQuant Flow Cytometers are a plus

Results oriented; problem solving

Quality minded, rigorous and pro-active and continuous improvement driven

Fluent in French and in English (at least B1 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:

Delivers Results

Leads with Integrity and Respect

Demonstrates Business Acumen

Fosters Collaboration and Teamwork

Champions Change

Engages and Inspires

Coaches and Develops

Offer

Position Benefits

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