An exciting opportunity has arisen DSP Manufacturing Specialist to aseptically purify monoclonal antibodies (mAbs) and recombinant protein products using chromatography and filtration. You will also prepare buffers and write, review and approve SOPs, BMRs and other GMP documentation.
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: -
- Degree in a relevant discipline
- Knowledge/experience of protein purification for production of monoclonal antibodies and recombinant protein therapeutic products.
- Hands-on experience operating downstream processing equipment
- Experience of protein purification principles, techniques, scale-up, technology transfer and process validation activities.
- Knowledge of cGMP compliance and associated documentation.