Keith O'Brien, B.Sc, Ph.D Email & Phone Number

Ireland

Ireland

New York, New York, Us

Cork, Ie

• Vaccine tech transfer and process validation • Author of Gap assessment, risk assessment, mitigation plan (GARAMP), engineering and PPQ protocols and reports, media validation strategies, initial process verification plan, additional sampling plan• Lead investigations to determine root causes, impact assessments, small scale study design and implementation of process and operational and process improvements• Presentation and representation of the manufacturing site at internal and global MSAT teams for data presentation and global investigations • Key achievements: improvement of media validation strategy, improvement of ViCELL operations, seed train operations and design, root cause determination and effective CAPA implementation

New York, New York, Us

• Transfer / scale up of up and downstream mammalian processes for clinical manufacturing in disposable and 12K facilities• Cross functional coordination and recommendations into facility fit, automation, equipment and process design for new production introduction • Process demo, process validation and regulatory filing• Gap assessment, risk assessment, SOP authoring, protocol generation, automation support, batch record authoring and review• Coordination of up and downstream BOMs for execution of process trials and manufacture• Generation of data packs and data verification memos post demo batches and during process validation for regulatory filing• Key skills/technical attributes:Delta V / MCS AMPS (electronic batch records)Visio GMPData analysis SAPLIMS Process troubleshooting

Dublin, Co Dublin, Ie

• Leading tech transfer, development, optimisation, characterisation, DoE and validation of a platform tangential flow filtration process for commercial manufacturing • Successfully lead tech transfer of developed up and downstream process to CMO• Development, optimisation and characterisation of mammalian and bacterial growth in shake flasks and WaveBag bioreactors (bench scale)• Evaluation of new technologies; development; optimisation and qualification of novel bioanalytical techniques• Data generation, analysis and presentation to clients and stakeholders• Authoring project reports and recommendations to clients and manufacturing sites • Authoring and issuing SOPs, batch records and risk assessments • Training new staff in bioprocessing and bioanalytical techniques• Key technical skills: Tangential flow filtration / UF/DF DoEFlow cytometryMammalian and bacterial cell culture SpectroscopyData analysis PCRProcess analytical technologyMicroscopyUnicorn Raman Spectroscopy

Dublin, Ie

My research investigated potential of extracellular vesicles (30-150nm membrane vesicles), derived from in vitro cancer models and breast cancer patients, to mediate the metastatic potential of breast cancer cells. To assess their relevance as blood based biomarkers, in vitro and patient derived extracellular vesicles were analysed for their sensitivity to detect disease presence. In addition, this work aimed to manipulate the molecular components of extracellular vesicles to deliver therapeutics to cancer cells.

Dublin, Ireland, Ie

Research was undertaken as part of my final year undergraduate project and thesis to investigate Epstein-Barr virus mediated resistance of B-cells to apoptotic stimuli. This project aimed to elucidate an association between pro-apoptotic protein levels and Epstein-Barr virus apoptotic resistance. This research also aimed to stably overexpress pro-apoptotic proteins, representing therapeutic intervention to potentially overcome apoptosis resistance of Epstein-Barr virus infected B-cells.

Lawrence Township, Nj, Us

During my placement in Bristol-Myers Squibb, I was responsible for validating vendors for the BMS-Swords site, by ensuring all current and historical QC data met BMS quality specifications. Subsequent Vendor Validation Reports were published on the BMS local documentation database, as per company SOPs. In collaboration with QA, QC and Material departments, I initiated a company-wide project to update and streamline all testing standards used in BMS QC departments, by reviewing protocols and raising change controls. As part of my QA-regulatory duties, I updated regulatory and batch restrictions to ensure that all active pharmaceutical ingredients produced by BMS-Swords were sold to approved markets only.

Doctor Of Philosophy (Ph.D.), Breast Cancer Derived Extracellular-Vesicles As Naturally-Occurring Biomarkers And Therapeutics

Bachelor Of Science (B.Sc.), Genetics And Cell Biology

Leaving Certificate