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.
- 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.
- Leadership qualities.
- Strong communication skills in English.
- Planning and organizing skills, coaching skills, flexibility, problem solving, result driven, accuracy, tidiness.