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Process & Analytical Development 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 modelling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

Mission Description

  • 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 the Team Leader and relevant stakeholder prior to production start.
  • Follow and compiles KPIs of his/her team and feed continuous improvement of the P&AD team;
  • Generates and/or ensures finalization and/or approves of all documentation related to performed process and analytical development 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 a special care to continuously train colleagues working in GLP environment and manages all area monitoring.
  • Supports to change control preparation and derogation.
  • Generates product investigations related to OOS opened by QC.
  • Involved in preparation and execution of any audits/inspection.

People management

  • Leads a team of maximum 6 P&AD Specialists.
  • Ensures individual development plan of his/her team member is in place and followed.
  • Is responsible of the generic training matrix of his/her team under his/her responsibility.
  • Could delegate activities to Specialist.
  • Performs yearly evaluations.

Candidate profile

  • Works in commercial readiness environment
  • Good knowledge of production in a GMP/commercial context with, if possible, a background in a development/industrialization context. 
  • Very good communication skills in English.
  • Ability to benchmark with people who have analytical or process knowledge
  • Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

Offer

  • ·Full-time position (40h/week)
  • ·A permanent contract and related benefits
  • ·The opportunity to take part in a growing CDMO
  • ·A pleasant working environment with plenty of room for interaction

Contact Details

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