Cell Therapy Specialist
They are a biopharmaceutical company engaged in the development of innovative immune therapies for cancer.
You are responsible for cell processing and cell expansion in a cGMP manufacturing facility. In this role, you work with other Cell Therapy Specialists utilizing GMP and aseptic practices to manufacture and assemble blood derived components in a cleanroom environment. Due to the nature of the starting material (patient cells), this role requires high level of proficiency and ownership of the process, with the highest skill level of aseptic and sterile techniques.
- To perform all tasks associated with the manufacturing of clinical and commercial products in A and B grade area following batch records and standard operating procedures (SOPs);
- To work as part of a dedicated and committed team to execute GMP runs in close collaboration with Product Sciences, Material Management, and Quality Assurance & Quality Control;
- Draft new and revise existing manufacturing Batch records / SOP’s / WI’s to support process improvements and maintain GMP compliance;
- Assist in investigations required to manage deviations;
- Assist in managing change controls;
- To successfully troubleshoot processing and equipment issues;
- To strictly comply with SOPs and cGMP regulations; accurately complete documentation associated with clinical and commercial manufacturing;
- To ensure a consistent process execution to guarantee high quality output;
- To maintain cleanrooms in an optimal state;
- To continuously look for improvements to the processes to increase quality and efficiency.
- An MBO or BSc degree;
- Experience in a pharmaceutical / biotechnology manufacturing environment;
- A ‘hands-on, can-do’ mentality.
- You must also be comfortable with working in full gowning requirements in a completely aseptic environment.
- Be able to work in shifts and have the willingness to accommodate schedule adjustments.