An exciting opportunity has arisen USP MSAT Specialist with strong experience of cell culture, scale up, technology transfer and process validation for an organization who develop and manufacture high quality biosimilar products. Their assets include six biosimilar monoclonal antibodies (mAbs) which are manufactured at their state of the art facilities 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.
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 recognised expert in field USP 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.