Cell Therapy Professional, Hoofddorp, Noord-Holland

The company
This client is a trailblazer in immunotherapy and engineered T cell therapy, revolutionizing cancer treatment with personalized solutions. Their dynamic and constantly evolving environment fosters daily breakthroughs, showcasing collective and individual capabilities. This company is seeking highly motivated individuals to join in developing innovative cancer immunotherapies and delivering these treatments to patients in need.     

Role description
Production Support Team - 

• Handling apheresis accession and transfer to manufacturing areas.
• Preparing growth media in C Grade cleanroom environments.
• Reviewing batch documentation to ensure timely product release.
• Decontaminating materials before delivering them to manufacturing suites.
• Supplying manufacturing suites with necessary materials and components.
• Transferring batch documentation to cleanroom areas.
• Conducting visual inspections of the final product.
• Cryopreserving excess cells and final products.
• Submitting samples to Quality Control sample management. 

Production Team - 

• Performing all tasks related to the manufacturing of clinical and commercial products in A and B grade areas, following batch records and SOPs.
• Collaborating with Production Support Teams, Product Sciences, Material Management, and Quality Assurance & Quality Control to execute GMP runs.
• Drafting and revise manufacturing batch records, SOPs, and work instructions to support process improvements and maintain GMP compliance.
• Assisting investigations related to deviations.
• Contributing to successful change management implementation.
• Troubleshooting processing and equipment issues.
• Strictly complying with SOPs and cGMP regulations, and accurately complete documentation.
• Ensuring consistent process execution to guarantee high-quality output.
• Maintaining the cleanroom in optimal condition.
• Continuously seeking process improvements to enhance quality and efficiency. 

Responsibilities 

This role requires working in shifts (morning and evening shifts, including weekends). As you will work with blood products, the client strongly recommends hepatitis B vaccination. You should already be vaccinated or willing to get vaccinated. The first month of this job includes intensive training after which you’ll be assigned to one of the above teams. 

Requirements

• MLO/MBO/HBO (MBO Level +) with a background in Life Sciences.
• Vapro A and B, or LITOP A and B are a plus.
• Experience with cGMP in a pharmaceutical, biotechnology, or similar manufacturing environment.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products.
• Proficiency in Microsoft Word, Excel, and data analysis.
• Awareness of and adherence to SOPs, with a curiosity and interest in learning and growth.
• Comfort in a fast-paced, growing company environment with minimal direction and the ability to adjust workload based on changing priorities.
• Self-motivation and a willingness to take on temporary responsibilities outside of the initial job description.
• Excellent interpersonal, verbal, and written English communication skills (Dutch is not required).
• An open mindset and the ability to adapt to Kite's cultural and core values in your daily work. 

Other information 
Apply to our vacancy for more information. Looking forward to getting in touch!

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