(Senior) Manufacturing Process Specialist – Process Owner
They are a global biopharmaceutical company, that works hard to treat, cure, stop and prevent some of the most devastating and complex diseases of our time — from heart disease, diabetes, and psoriasis to Alzheimer’s, HIV, and cancer.
The Operations Bioprocessing department supports commercial products and projects that introduce new products into the main facility. The processes that they support are all direct manufacturing operations starting at Preculture and ending at the filling of API into their containers. They do this by ensuring that processes and the equipment used in processing are ready for use. As Process Owner you are responsible for the manufacturing process of a product (depending on the size and complexity of a product, this can also be part of a manufacturing process). Al work is done in compliance with cGMP and EHS&S guidelines.
This is a position for 6 months, with a limited chance of extension.
- Investigate problems and, once you have determined the root cause, identify and implement actions that help prevent such problems from happening again;
- Act as the expert for the manufacturing process of the product;
- Make sure that the process is running properly, i.e., delivering product of the right quality and quantity
- A completed BSc/MSc/PhD in a relevant life sciences field, e.g., biopharmaceutical sciences, biotechnology, biochemistry, or chemical engineering:
- BSc: 5 years experience minimum
- MSc+ level: 2 years experience minimum
- Knowledge of and experience with biotechnology and manufacturing processes (that can be in the fields of fermentation/cell culture and/or purification);
- Affinity with automation and data analytics is desirable;
- Is capable of leading teams;
- Strike a balance between theoretical/conceptual thinking and applying expertise in a practical and pragmatic way;
- Can work in a quality-oriented environment (CGMP).