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Team Leader Cell Therapy Manufacturing - Netherlands  

Company managed [?] Still accepting applications

Posted on : 10 April 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.



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 clean room. 
  • 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:
  • 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.