JOBS

Back

Process & Analytical Development Team Leader (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 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. To lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for a highly motivated Process & Analytical Development team leader.

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.
  • Follows 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 Catalent’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

People management

  • Leads a team of Experts and Specialists, reports to the Group Leader and Head of Department
  • Ensures individual development plan of his/her team member is in place and followed up
  • Is responsible of the generic training matrix of his/her team under his/her responsibility
  • Performs yearly evaluations for the team

Candidate profile

The Candidate

  • Experience in Cell & Gene Therapy, preferably > 5 years
  • Relevant degree in Life Sciences
  • 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.

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)
  • A permanent contract and related benefits
  • A company car with fuel card
  • The opportunity to take part in a growing CDMO
  • 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