- Directly supporting product introduction (NPI) and technology transfer processes.- Authored GMP documentation: 26 Production Protocols across 5 projects/clients as per Technical Transfer Protocol. - GMP Quality Management System: led/authored change controls on a time-sensitive schedule and actioned items in a timely manner.- Batch preparation: solution, process step and consumable documentation, batch data tracker setup (PIMS), Batch readiness schedule setup.- Continuous Improvement: Update of the production protocols as per feedback, SOP update. - Batch close out: authored campaign summary reports.- Regular on-the-floor observation of USP production steps in operation.- Performed duties in cooperation with several departments: supply chain, QA, QC, Operations, and client, all involving continuous communication. - Cross department support to the Process Validation department: raised a change control, updated an extractable and leachable report, and was responsible for client communication.- Chemical Safety Officer responsible for chemical risk assessments across the entire site.

- Directly involved in the purification of clinical phase mAbs at large scale in cGMP cleanroom environment.- Trained on single-use large-scale DSP unit operations and equipment as well as automated process control softwares. - cGMP recording practices, close-out and reconciliation of batch records.- Supporting batch preparation: buffer list, sampling plan, timing of operations.- Initiator of changes to improve the systems in place, such as updating batch record template and SOPs; implementing CAPA. - Supporting the procurement of new consumables and equipment on site.- Leader in collaborative tasks involving communication with warehouse, QA departments as external supplier. - Crossfunctional communication: presentation of DSP operation to other departments followed by a tour of the production suites. - Crossfunctional support to USP department for Harvest, inoculation, daily monitoring process operations.- Chemical Safety Officer responsible for chemical risk assessments across the entire site.

Biomedical Engineering

Implementation of the wavebag antibody expression plateform. - Mammalian cell culture in shake flasks up to wavebags.- Stable CHO cell line generation for monoclonal antibody production.- Plasmid DNA preparation: culture of the bacteria and mega or giga preparations.- CHO cell transfection for transient monoclonal antibodies expression.- Organisation of the routine transient expressions: stocks of consumables, preparation of the cells and associated documentation.- Leading experiments to optimise the upstream process (e.g. choice of growth medium).

USP optimisation, scale up & scale down:Mammalian cell culture process & harvest development for Mab production.Mammalian cell culture (shake flasks, waves, 2-10L and 80L fed-batch process).- Performed 2 & 10L bioreactor experiments.- Organised, prepared and led 80L consolidation runs: bioreactor set-up, SIP, process monitoring, feeding control, CIP and associated documentation.- Trained staff members on the 80L automated bioreactors for cell culture process.- Actively taken part in team meetings and DoE discussions.- Designed & led harvest development experiments (centrifugation, depth & membrane filtration).- Completed small scale purification (ÄKTAEXpress), and titer analysis (Octet).- Analysed experiments data.

DSP Troubleshooting- Progress assessment for a cleaning process performance qualification on a chromatography system.- Specification - related issue addressed, in order to optimise and finalise the validation.- Writing of the Validation Report.

University-Hospital work placementResearch project: Interference due do the complement system in the clinical research & identification of anti-HLA antibodies.- Bibliographic research- Design of experiments- Luminex technology:Methods for research (Labsecreen® Mixed beads) and identification (Labscreen® Signle Antigen beads) of HLA antibodies. (Supplier: One Lambda)- Data compiling and analysisArticle published in Transplantation. 2014 Sep 27;98(6):625-31. (2nd author)

Production/ Engineering & QA