Greater Cheshire West and Chester Area
15 years experience in downstream processing. During this time experience has been gained in all aspects of downstream processing, from clarificaiton through to drug substance formulation. Currently leading the robustness and tech transfer team, responsible for applying QBD to early stage projects prior to transfer of process. Also act as technical expert in support of GMP manufacture previously my role has been in process development and tech transfer. Have optimised platform processes as well as introdcuing new technologies to the DSP tool box such as membrane chromatography and various clarification technologies. Specialties: The use of Design of Experiments for process optimisation, identification of design space and application of QbD. Problem solving Intorducing new technologies to increase efficientcy and cost of goods
Responsible for all USP & DSP process development for Ipsen's biologics portfolio
Responsible for downstream process development and late stage process development strategy.
Group leader Process Development and Tech Transfer. Manage team responsible for downstream process development, robustness and transfer (mAbs, bispecifics, fusion proteins).
Lead a team responsible for process robustness and tech transfer. Perform robustness testing of all downstream unit operations, and assigning limits for all Critical Process Parameters (CPPs). Preparation of documentation required for tech transfer and regulatory filings. Support of GMP manufacturing and viral clearance studies.
The job is in the Downstream Process Development and Tech Transfer team. Design of experiments is used to optimise all downstream process operations including clarification, chromatography, virus filtration and TFF. Once design space is defined processes are transfered to manufacturing for clinical production.
Downstream process development and tech transfer. Optimisation of various processing steps including conjugation reactions.