Kin-Chun Cheung

Manager C&Q CAR-T EMEA

Ghent, Flemish Region, Belgium

About

Life science professional (manager process & team) in engineering & qualification with international experience and an analytical and process oriented mind. Working experience in: - Pharmaceutical technical area (clean utilities) - Aseptic manufacturing - Pharmaceutical and aseptic formulation - Medical device - API manufacturing - Filling and packaging - Plant construction - Cleanroom construction At: - Janssen Pharmaceutica fill finish - Janssen Pharmaceutica API - J&J innovative medicine - GSK Bio (Waver) - Innogenetics - Pfizer (Puurs) - MSD - NVI - Sterigenics (Petit-Rechain) - Laboratoria Smeets - Pannoc - Heel Belgium - Blispac

Experience

  • Manager Commissioning & Qualification Car-T EMEA (advanced therapies) at Johnson & Johnson
    Jun 2023 - Present · 3 yrs 1 mo

    - Manager C&Q team - Owner C&Q processes (commissioning & qualification, equipment life cycle, VMP, periodic review...) - Spokesperson regulatory audits - Built C&Q team (internal & external) - C&Q resource allocation - Handover (receiving end) - Coach team members - Define C&Q strategy - Implement new processes - Budgetting

  • Manager Commissioning & Qualification (diagnostics) at Biocartis
    Jun 2020 - Jun 2023 · 3 yrs 1 mo

    - Manager C&Q team - Owner C&Q processes - Built C&Q team (hire team members internal & external) - Develop C&Q processes - Manage resource allocation - Define improvements and implement - Externalization of specific C&Q processes (phased) - Coach team members - Define budgets

  • The Janssen Pharmaceutical Companies of Johnson & Johnson (6 yrs 1 mo)
    • Commissioning & Qualification Process Lead (API manufacturing)
      Nov 2016 - Jun 2020 · 3 yrs 8 mos

      - Proces owner C&Q - Spokesperson regulatory audits - Member J&J global community of practice - Responsible contractors compliance work (+/-12) - Responsible contractors process improvements (+/-2)

    • Global LT Decission Support Lead DSL (API manufacturing)
      Mar 2017 - Nov 2018 · 1 yr 9 mos

      Support global leadership in decissionmaking, vision and defining actions

    • Project Engineer fill/ finish equipment (GTO Packaging COE by QBD)
      Mar 2016 - Nov 2016 · 9 mos

      Project management packaging equipment - Define - Design - URS - Construction - FAT - Installation - Support C&Q - Handover to end user Equipment standardization New technology & innovation - Feasibility study technology and implementation - Cross site/ industry benchmarks Packaging COE support to Xi'an Janssen site - T&T implementation (technology & process flow) - On site modifications - Packaging process validation

  • Project Manager Pharmaceutical Engineering | Engineering lead at QbD
    Jun 2013 - Nov 2016 · 3 yrs 6 mos

    Projects: - PFIZER - STERIGENICS - PANNOC - HEEL Belgium - LABO SMEETS - JANSSEN PHARMACEUTICA General role - Engineering lead - Qualification & validation lead - Project management * Resource management * Scheduling * Implementation & execution * Contract & scope - Project strategy * Design approach * Implement strategy/approach * Consultancy - Qualification & validation * Implementation of C&Q approach (small manufacturers) * Strategy/ approach * Training

  • Vlaamse Ingenieurskamer vzw (East-Flanders)
    • Board Member
      Apr 2010 - Feb 2016 · 5 yrs 11 mos

    • Chairman young engineers VIK East-Flanders
      Aug 2011 - May 2014 · 2 yrs 10 mos

      Tasks: - Strategy - Coordination - Restructuring, regrouping & reorganizing - Communication - Reposition of the organisation between the members and the corporate partners - Improve cooperation and ties to the engineering schools and university