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 on execution of planned GMP activities.
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.
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.
Strong communication skills in English.
Planning and organizing skills, coaching skills, flexibility, problem solving, result driven, accuracy, tidiness.