Deborah Mcelhone Email & Phone Number

Glasgow, Gb

Bearsden, Gb

Glasgow, Scotland, United Kingdom

Bringing complex consortia together across the Pharmaceutical industry and leading disruptive technology with the ultimate aim to ensure the success of new scientific innovation.

Glasgow, United Kingdom

Working in a high throughput Biosafety testing facility, I managed a highly proficient team of Program Managers within the UK facility. My team were accountable for managing high profile clients within our strategic portfolio, ensuring we built long term partnerships for the future. I pride myself on driving forward innovative client management and focusing on client centricity with both internal and external stakeholders. I aim to ensure our clients value our business as a partnership with collaboration at the centre. Key skills: People management (including Objective setting that suits business needs; Performance tracking; Capacity planning; Growing my staff to ensure continued development; Motivation and Empowerment) ; Client Management and Strategic partnership; Risk Mitigation; Key decision maker; Critical thinking ; overall Leadership

Grangemouth, Falkirk, United Kingdom

Main Technical responsibilities: 1. Accountable for successful technology transfer, process development, scale up of processes from POC projects through to Toxicology and then GMP manufacture2. Process characterisation to support successful BLA filing. Activities include defining QTPP , CQA determination, QbD / DOE experimentation, Control strategy design, support PPQ activities3. GMP support for the introduction of Phase I, II and III processes into the manufacture facility 4. Review of all GMP documentation for process introduction 5. Technical review of reports for client submission6. PIP / tech support to clients for first GMP manufactures 7. CAPA / Deviation support for technical issues Main Management Responsibility1. Direct management of 15 staff including appraisals, training, conflict management 2. Budget holder for both lab and clients3. Corporate reporting of milestone deliverables and financials 4. Implementation of system improvements ie quality procedures, equipment maintenance programs, introduction of KPIs, 5S and Kaizen, work schedules, resource planners, OTIF, improvements / efficiencies to paperwork output 5. FTE allocation for proposals 6. Client enquiries and face to face visits7. Close liaison with Business Development to promote “front of end” business

Grangemouth Scotland

ADC development, optimisation and production

Stirling

Technical and Personal Skills:1. Successful transfer of Process Description into the Laboratory, Sourcing all necessary equipment and planning daily process activities2. Direct Liaise with client throughout the lifespan of the project to ensure successful tech transfer 3. Safe and efficient working environment when dealing with virus and cell lines, including Category 3 viruses4. Main Scientist for the performance of client processes which include various techniques and skills: a. Chromatography on AKTA systems using a wide variety of chromatography resin i.e. Anion exchange, Cation Exchange, Protein A, HIC (experience using UPC-10s, Explorers, Unicorn software version 5 as well as the latest AKTA Pure, Unicorn software version 6.0) b. Constant Pressure Viral Clearance Filtrations i.e. Planova, DV-20/50, Viresolvec. Buffer preparation and manipulationd. Sample titrations on appropriate cell line for determination of viral log clearancee. Aseptic techniquef. Responsible for maintenance and installation of AKTA systems ensuring good traceable working order as required by GLPOffice based duties:1. Compiling GLP workbooks specific to the client process2. Data analysis 3. Liaise with project management to provide technical support4. Ensure relevant SOPs are in place and update any documentation

Grangemouth

Technical Skills:1. Process and Analytical Development of client API 2. HPLC, HPAEC, SEC, HIC, RF-HPLC, AKTA, Drug Assays, Aggregation studies, Electrophoresis, Spectrophotometry, Protein Purification, TFF, UF/DF3. Ensuring successful Technology Transfer between client and R&D laboratories both with Bioconjugation and Process validation4. Producing and formulating API material for the client5. Mentorship to lab staff, being readily available and accessible to resolve any issues6. Organising and planning the production of Tox phase material within the R&D labs and shipment of material to the client7. Organising and planning the production of GMP phase material within the GMP facility. For both Tox and GMP phase material this included the ordering of all materials and equipment; PI writing from initial stage through to QA approval; Deadline implementation of all stages; Main daily client liaise with weekly telecon updates; Data reporting; Leading the team to ensure correct lab set up and to ensure all strict guidelines were adhered to; Being part of the production team.Office based duties:1. To research and manage new campaigns 2. To actively investigate optimisation of the client process in terms of product quality, efficiency and productivity3. Direct liaise between customer and company including chairing international teleconferences with a weekly power point presentation4. To manage a team of scientists, actively training new staff members 5. Analysing raw data and transferring the data into final reports 6. Document preparation i.e. batch records, final and interim reports, SOP, protocols7. Working closely with QA to ensure Batch Records meet GMP standards by ensuring all deviations are addressed and closed out8. Responsible for the standard and implementation of the quality systems within the laboratory9. Elected member of the employee forum, a dedicated board responsible for addressing and resolving any employee issues and concerns

West Of Scotland Science Park, Glasgow

My role within this expanding international biopharmaceutical company was as a Quality Assurance Assistant within the Process Validation Department. Key responsibilities included:1. To assess and monitor compliance to Good Laboratory Practice (GLP) within the testing facility, as determined by the MCA2. Assessing compliance involved responsibilities, which included carrying out inspections of the various test facilities as well as Audits of ongoing protocols 3. Auditing of final reports and reporting any deficiencies with raw data to management4. Maintaining records, updating necessary documentation 5. Ensuring that the raw data was accurately and fully reflectedAlthough I worked with various departments within the facility, I was mainly involved with the Process Validation department, responsible for testing blood products, monoclonal antibodies, TSE agents and transgenic proteins, to name a few, and also responsible for performing virus validation on client manufacturing processes. For viral studies, this is determined through various filtration processes and chromatography techniques and for TSE studies, through the use of Western Blot assays. This department was involved primarily with phase 1 and phase 2 clinical trials and occasionally with phase 3 trials within the GMP facility.

Doctor Of Philosophy (Phd), Glycobioogy

Title: "Binding to alpha-1-acid glycoprotein (AGP) may affect the efficacy of anti-tuberculosis (TB) drugs."

Bsc (Hons), Biochemistry And Molecular Biology