An exciting opportunity has arisen DSP MSAT Specialist to be responsible for the scale-up strategy prior to tech transfer of manufacturing processes to GMP manufacturing. You will introduce and qualify new processes, whilst managing risk associated with process transfer as well as leading process optimization and improvement activities. The company’s state of the art manufacturing facilities are located in Reykjavik, Iceland.
This company is well resourced and financed with significant growth plans. Be part of a company who has established itself as a fully integrated biopharmaceutical company, ranging from cell line development of biosimilars to manufacturing, clinical development and registrations. Their manufacturing process is based on 1,000L and 2,000L single use bioreactor fermentation design and has a total capacity of 16,000L and is run almost totally on renewable energy. Their assets include six biosimilar monoclonal antibodies (mAbs).
Suitable candidates will need to possess skills/experience in the following areas: -
- MSc degree in biological science or biochemical engineering or related field.
- Experience of cell culture principles, techniques, scale up, technology transfer and process validation activities.
- Be a recognized expert in field DSP drug substance operations from working in a cGMP environment.
- Several years technical transfer expertise gained from a drug substance manufacturing environment.
- A solid understanding of manufacturing process