CAR-T Operations Technical Lead Clean room

Would you like to participate in personalized cell therapy that is unique and progressive? If so, we would love to help you. We are proud to partner with our client who is committed to innovations in cell therapy, oncology and immune cell biology and engineering.

• Coordinate, manage and control all quality aspects related to specific production activities and production of batches in specific cGMP areas
• Control in a timely manner production-related QMS documentation (in line with cGMP) in collaboration with MS&T and Quality
• Deviations/events, and CAPA
• Support communication concerning KPI’s related to quality aspects in Production
• Production SME for internal audits and external audits in collaboration with QA (back-up of Operations Supervisor):
• Responsible to escalate production-related matters to Operations Supervisor out of their empowerment zone to ensure timely decision and follow-up

• Degree in Science, Bio-Engineering, Pharmacy or related field or equivalent experience required.
• Knowledge of cGMP regulations and EMEA guidance related to manufacturing of cell-based products, and cleanroom behaviors.
• Must exhibit Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Manager and Supervisors.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously.
• Strong developed organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
• Analytical, problem solving, pragmatic and positive critical thinking skills and the ability to act as a change agent to promote flexibility, creativity, and accountability.
• Can do attitude, Right first time and Hands-on approach
• Tenacity to drive issues until resolved and deliver results
• Self-motivated, enthusiastic personality, team player
• Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes
• Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• A working leader who can participate in production runs
• Strong communication and organizational behaviors skills are required.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
• Proficiency with MES/EBR is a nice to have
• Ability to accommodate shift work including evenings and weekends as required by the process.
• Ability to accommodate unplanned overtime on little to no prior notice

A contract for an indefinite duration.

A gross salary (based on level and relevant expercience).

Meal vouchers • Group Insurance

Hospitalisation Insurance • Supscription for your smartphone up to maximum 20 euros per month