GMP Operator / Technician - Multinational Company
The CompanyThis company, located in the Amsterdam, is leading in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. In this position you will be joining a newly formed team in which people of all backgrounds and experiences are respected. While working together with a focus on saving lives by finding a cure for cancer.
Role DescriptionYou will ensure that all components are adequately supplied and kitted to follow the production schedule along with the formulation and verification of all media lots. Due of the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process and media formulation. Together with the highest skill level of aseptic and sterile techniques.
- Performing all tasks associated with the manufacturing of clinical and commercial products following batch records and SOPs (Standard Operating Procedures)
- Working as a part of a dedicated and committed team to execute GMP runs in close collaboration with the different departments
- Assisting in the development and optimization of SOPs and Batch records
- Assisting investigations required to manage deviations
- Assisting in managing change controls
- Successfully troubleshoot processing and equipment issues
- Strictly complying with SOPs and cGMP regulations, accurately complete documentation associated with clinical and commercial manufacturing
- MBO/Bachelor's degree
- Preferably two years' of experience working in a GMP environment or other regulated environment (!)
- Preferably knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and cell culture products in combination with cell culture equipment experience
- Positive and can-do mentality
Are you interested or do you want more information? Do not hesitate to contact me by replying to this vacancy!