Johnson & Johnson Loopbaan
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Manufacturing Specialist (Upstream) cGMP
Requisition ID: 1700206128W
The department Drug Substance Operations (DSO) is an international team of about 35 people are working on manufacturing of clinical batches to support the development of new vaccines. Execution of the manufacturing process is done in close collaboration with the development department, as well as EVM, QCD, QA, warehouse, etc. Within DSO, we are looking for a cell culture expert.
As an Manufacturing Specialist / Sr. Operator, you will be responsible for:
- Taking part in / coordinating all activities related to the production of cGMP clinical batches of Biopharmaceuticals produced on mammalian cell lines. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.
- Working precisely and meticulously and to detect and communicate possible abnormalities.
- Accurately completion of documentation such as batch records, logbooks, etc.
- Coordinate setting up documentation to ensure successful production runs.
- Initiating and leading ideas for continuous improvement that progresses your work for quality, EHS and efficiency perspective. Implement by making use of cross functional teams.
- Process Excellence activities to continuously improve the work as well as personal skills.
- Leading in deviation investigation and follow up
- BSc (or equivalent) with 5+ years’ experience in a biotechnology or biopharmaceutical industry environment
- Experienced in cell culture, virus propagation
- Experienced in working with bioreactors
- Experience with cGMP environment is required
- Certified Lean Green Belt
- Precise and careful
- Organizing skills
- Team player
- “Can do” attitude
- Proven process excellence experience
- Good communication in English (and Dutch), written and spoken
Janssen Vaccines & Prevention BV (8852)