Description
Further duties will include:
- Carry out the manufacturing activities involved in Upstream (Fermentation) and/or Downstream (Purification) manufacture of the BAS product, safely, compliantly and efficiently.
- Optimisation of downstream processes e.g. Tangential flow filtration process development.
- Identify and utilise fit-for-purpose robust technologies.
- Work in compliance with HSE, cGMP regulations and Ipsen QA Systems at all times.
- Incorporate science-based approaches to product-process understanding.
- Interrogate the Facilities Management System (FMS) on a regular basis to ensure the continued compliant operation of the facility.
- Participate in process monitoring and continuous improvement projects.
- To assist in the development, transfer and validation support associated with new and existing products.
- Perform problem solving investigations and updates to key documents using work packages e.g. Trackwise and Veeva.
- Champion lean manufacturing philosophies and techniques to seek continuous improvement.
Skills, Experience & Education
Ideal: 3 years minimum exposure to handling of highly active substances in biological or fine chemical industry.
Minimum: 1-2 years exposure to handling of highly active substances in biological or fine chemical industry.