As a CAR-T production Supervisor, you are the lynchpin of our production. These are your responsibilities:
* Leadership and supervision: You will manage operational teams and supervise various operational units within the CAR-T production process.
* Quality and compliance: You manage all aspects of quality and ensure strict compliance with cGMP standards. As a domain expert for Quality and Operations, you play a central role in GMP inspections.
* Collaboration: You are the first point of contact for production problems and work closely with other departments to find solutions.
* Documentation management: You will manage and review critical documentation within the production areas, such as procedures, work instructions, logs and transfer forms.
* Batch record supervision: You oversee the release and review of batch records for quality control.
* Training: As a manager, you make sure that everyone on your team gets the training they need to perform at their best.
* Operational excellence: You initiate projects that increase efficiency, reduce costs and improve quality. You encourage and inspire your team to continuously improve.
Who Are We Looking For?
Education:
* You have a bachelor's or master's degree in science, bio-engineering, pharmacy or a related field of study or you are equivalent through experience.
Experience & Expertise:
* You have at least 3 years of experience in a GMP or ATMP environment, preferably in the biotech or pharmaceutical industry.
* You have a knowledge of cGMP regulations and clean room operations.
* You can work fluently with Microsoft Office tools such as Word, Excel, PowerPoint and Outlook.
* Experience with aseptic GMP production is a nice to have.
* You have a knowledge of cGMP regulations and clean room operations.
* You can work fluently with Microsoft Office tools such as Word, Excel, PowerPoint and Outlook.
* Familiarity with Manufacturing Execution Systems (MES) and Electronic Batch Record (EBR) systems is a plus.
Languages:
* You speak and write fluent English.
Strengths:
* You have excellent communication and organizational skills.
* You are an empathetic people manager with strong leadership skills.
* You have a positive attitude and adapt easily to rapidly changing circumstances. You inspire others to do the same.
* You are good at problem solving, prioritizing and multitasking.
* You have an eye for detail and procedures.
SPractical:
* Work is carried out in a 4/4 system of 10 hours per day in both early and late shifts.