My current role encompasses the technical and logistical support in the management/co-ordination of biological drug product development, primarily for activities around formulation design and in the transfer to GMP drug product manufacturing sites.• Technology transfer of manufacturing processes for early Phase biological drug products to GMP manufacturing sites• Development of processes at suitable scale for manufacturing stability and clinical batches for Phase 1 and 2• Performing risk assessments as required for drug product batch scale-up and process changes• Assist in additional product development activities required to support technology transfer (e.g. - fill volume assessments, shear studies)• Performing compatibility studies of drug product with the intended clinical administration ancillaries (e.g. - iv bags, syringes etc.)• Authorship and review of formulation documentation supporting CMC regulatory submissions and regulatory briefing documents using Mikado EDMS• Recording of deviations, change controls and CAPAs in TrackWise system• Managing of external CMOs, batch scheduling, raising purchase orders in SAP system, organising shipments of finished products, monitoring progress and chairing project meetings and visits as required• Ensuring products are manufactured in accordance with quality systems, GMP and latest regulatory requirements• Support to clinical group (e.g. - input and review of pharmacy manuals, attendance of clinical site initiation meetings to provide support/training on dilution procedures for the drug product)• Performing investigations as required for clinical complaints• Troubleshooting of drug product manufacturing issues at CMOs • Support to Quality Assurance for audit of drug product CMOs

My current role encompasses the technical and logistical support in the management/co-ordination of biological drug product development, primarily for activities around formulation design and in the transfer to GMP drug product manufacturing sites.• Technology transfer of manufacturing processes for early Phase biological drug products to GMP manufacturing sites• Development of processes at suitable scale for manufacturing stability and clinical batches for Phase 1 and 2• Performing risk assessments as required for drug product batch scale-up and process changes• Assist in additional product development activities required to support technology transfer (e.g. - fill volume assessments, shear studies)• Performing compatibility studies of drug product with the intended clinical administration ancillaries (e.g. - iv bags, syringes etc.)• Authorship and review of formulation documentation supporting CMC regulatory submissions and regulatory briefing documents using Mikado EDMS• Recording of deviations, change controls and CAPAs in TrackWise system• Managing of external CMOs, batch scheduling, raising purchase orders in SAP system, organising shipments of finished products, monitoring progress and chairing project meetings and visits as required• Ensuring products are manufactured in accordance with quality systems, GMP and latest regulatory requirements• Support to clinical group (e.g. - input and review of pharmacy manuals, attendance of clinical site initiation meetings to provide support/training on dilution procedures for the drug product)• Performing investigations as required for clinical complaints• Troubleshooting of drug product manufacturing issues at CMOs • Support to Quality Assurance for audit of drug product CMOs

Working on multiple projects at various stages of development, I had a specific responsibility for managing drug product manufacture at CMOs.• Project co-ordination of manufacturing activities for Phase 1, 2 and 3 development projects• Specific responsibility for managing drug product manufacturing at CMOs for biological products• Establishing and maintaining working relationships with external and internal contacts• Agreeing drug product manufacturing schedules at CMOs and prioritising to meet clinical supply demands and project timelines• Setting-up and chairing of project team and external CMO meetings, including preparation of agendas, writing minutes and follow-up of agreed actions• Developing and managing project plans• Supporting manufacturing managers in budget forecasting• Developing an expertise in drug product manufacturing and shipping of temperature sensitive products• Providing support to the regulatory group for regulatory submissions

DSP Team Leader, managing a team of 16 DSP operators.• Scheduling of activities in DSP facilities to meet production timelines• Improving production efficiency and troubleshooting problems arising in the manufacturing area• Ensuring GMP and safe working practices were followed• Approving of GMP documentation and authorising hand amendments during production runs• Act as deputy to the purification manager, including interviewing for new personnel and assisting with budgeting activities and continuous improvement programs• Staff development, through training, coaching, the setting of SMART objectives and the appraisal system

Seconded from DSP to work as a process technologist and DSP team leader in the Slough pilot plant for a customer specific project.• Process technologist from design to commissioning of the pilot plant including support in URS preparations for DSP, layout design, commissioning of new equipment (in particular cryo-granulator) and engineering runs for operational qualification• First-line troubleshooting of the DSP process in the pilot plant• Technology and operations transfer to GMP manufacturing facility in the USA• Managing small team of DSP operators for manufacture of pilot scale batches

Deputy Supervisor in DSP.• Large scale purification of monoclonal antibodies to GMP using a variety of purification techniques • Prioritise and plan the activities in the purification facility, ensuring the best use of staff and resources• Generate documents for new processes as required• Generate manufacturing directions (MD) from templates and revise existing SOPs (Standard Operating Procedure) in conjunction with QA documentation• Review completed process documents prior to batch release

After joining King’s College as a laboratory technician I gained several promotions to reach a senior level, where I managed a team of technicians responsible for the preparation of undergraduate practical classes in Biochemistry and Molecular Biology. For the last 18 months of my time at King’s I was seconded onto a Science & Engineering Support Council (SERC) funded grant and worked full time on several Metalloprotein research projects.• Operation and maintenance of 20L fermenter (bacterial), harvesting by centrifugation, mechanical breaking of cells using a French press, separation of cell debris by centrifugation• Small scale purification of proteins, preparation of samples for analysis by EPR (Electron Paramagnetic Resonance Spectrometry)• Support to Metalloproteins research laboratory, specifically maintenance and operation of EPR Spectrometer and an anaerobic glove box• Managing the technical team responsible for preparation of undergraduate practical classes in Biochemistry and Molecular Biology• Preparation and support for Biochemistry undergraduate and Molecular Biology MSC practical classes (specialist in isolation of mitochondria from rat liver and alcohol dehydrogenase from yeast suspensions)• Maintenance of teaching laboratories and associated equipment

• Preparation and support for practical classes in Chemistry, Biology, Physics and Environmental Sciences• Maintenance of laboratories and associated equipment

• Preparation and support for practical classes in Chemistry, Biology, Physics and General Sciences• Maintenance of laboratories and associated equipment