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Fill & Finish Expert (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 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

  • Expert’s responsibilities need to be adapted according to the development phase of the project from early process development, technical transfer, or GMP production. The manager or the supervisor could delegate activities to the Expert. The below list is not exhaustive.
  • Can be involved in all stages of production process maturity (from development or acquisition to continuous commercial GMP production) and follow up of closed projects.
  • Deals with technology, productions, and team management.
  • Generates and ensures finalization documentation (procedures/instructions/forms/protocols) to perform specific production or generic documentation which could be eventually approved by Supervisor and relevant stakeholder prior to production start.
  • Follow and compiles KPIs of his/her team and feed continuous improvement of the production team;
  • Generates and/or ensures finalization and/or approves of all GMP documentation related to performed production for final approval by hierarchy/certified reviewer.
  • Upon specific request will represent the project he/she manages to internal/external meetings.

Quality

  • For his/her direct responsibility ensures cGMP implementation through MTC’s quality system and feeds continuous quality improvement.
  • Ensures his/her team is adequately staffed, trained, equipped to execute required work.
  • Takes special care to continuously train colleagues working in an aseptic environment and manages all A/B/C/D area monitoring.
  • Support to change control preparation and derogation.
  • participate in investigations and CAPA for hierarchy approval.
  • Generate product investigations related to OOS opened by QC.
  • Involved in preparation and execution of any audits/inspection.

People management

  • Lead a team of maximum 6 operators
  • Ensure individual development plan of his/her team member is in place and followed.
  • Is responsible for the generic training matrix of his/her team under his/her responsibility.
  • Could delegate activities to operator/specialist.
  • Perform, with adequate functional Expert, newcomer/yearly evaluations.

Candidate profile

  • Work in commercial readiness.
  • Good knowledge of production in a GMP/commercial context with, if possible, a background in a development/industrialization context.
  • Very good writing skills in French
  • Knowledge in English is a must.
  • Ability to benchmark with people who have process knowledge

Catalent’s standard leadership competencies that are used to interview and for Performance & DevelopmentDelivers Results

  • Leads with Integrity and Respect
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Engages and Inspires
  • Coaches and Develops
  • Position Benefits

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