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Team Leader Cell Therapy Manufacturing (TL CTM) Maastricht Netherlands,  

PharmaCell (company)


Posted on : 21 October 2017

Project Description

The position:

The goal is to oversee and preform the manufacturing (cell- and tissue culturing) of cell therapy products in accordance with GMP regulations. You are the linking pin between the Production Team and other departments within the company. You will lead a team of 2 to 10 (Senior) Biotech Associates who work on flexible hours on execution of planned GMP activities.

Tasks and responsibilities:

  • GMP manufacturing activities: managing, performing and witnessing all cell- and tissue culture activities in compliance with cGMP regulations. Plan, organize and coordinate production/maintenance/cleaning activities in production areas.
  • Organize and coordinate logistic activities: Reception of materials, preparing and organizing shipping final product, if applicable.
  • Assisting QE qualification activities and managing materials for cleanroom.
  • To ensure generation, review and approval of manufacturing documents in coordination with other departments and in accordance with GMP regulations.
  • Initiation and timely follow up of deviations, CAPA s and Changes, in coordination with QA department.
  • Suggesting and implementing process, planning and training improvements.
  • Responsible for the qualification and development of the team.
  • Safeguarding quality and overall GMP compliance related to manufacturing activities.
  • Responsible for appropriate handover of information between teams
  • Notification of supervisor of all observed deviations in a timely manner.

Qualifications and skills:

  • BSc/MSc in biochemistry/biotechnology with focus on cell biology and/or human cell culturing techniques.
  • Three years tissue or cell culture experience in a laboratory/GMP environment.
  • Leadership qualities.
  • Strong communication skills in English.
  • Planning and organizing skills, coaching skills, flexibility, problem solving, result driven, accuracy, tidiness.

Locations

6229 EV Maastricht, Netherlands

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