Mark Cullen Email & Phone Number

Vancouver, British Columbia, Canada

Quality Lifecycle Management

Vancouver, British Columbia, Canada

QA for plasmid DNA production for CAR-T Cell therapy. QA for mycoplasma detection assays in cell cultures.IS027001 information security management systems for supplier evaluation and access control.CAPA program coordinator.

Grangecastle, Dublin

Led process investigations, Root Cause Analysis using DMAIC methodology and implementation of CAPAsWrite product/process impact and technical assessments in support of investigation closureAssist in raising and execution of change controlsSupport Compliance Inspections from Regulatory AgenciesProvide process expertise for trouble-shootingReview documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation plans, annual revalidation plans, risk assessments, Provide technical and compliance review of testing protocols, reports and applicable manufacturing SOPsImplement continuous improvement projects

Grangecastle, Dublin

Provided technical support and troubleshooting to support manufacture of 13 drug substance vaccine conjugatesLed major process investigations, including generation of product impact and technical assessments, root cause analysis using Lean Six Sigma tools (DMAIC methodology) and implementation of CAPAs, across multiple departments and other Pfizer sites when necessary• Supported Manufacturing Sciences and Technology (MSAT) pilot plant and Tech Services by authoring and executing protocols in manufacturing suitesRaised and executed change controls for process improvementsSupported Boards of Health Inspections, e.g. EMA, FDA, CFDA, Health Canada and ANVISAReviewed GMP validation documentation, e.g. requalification/periodic review of equipmentPerformed revalidation of equipment, including autoclaves, lyophilizers and controlled temperature unitsInvestigated process outliers as part of Continuous Process Monitoring program

Grange Castle, Dublin

Assisted in maintaining a GMP environment and troubleshooting during start-up, validation, and GMP production on a second filling and inspection line in parenteral suiteOperation of EISAI inspection machine of filled syringes Provided input on equipment installation, operation and troubleshootingAssisted in training of personnel in procedures and equipment operationPerformed media fills and visual inspections of syringes for validation of the filling process

Microbiological support to the pilot plantRegular water sampling and testing including bioburden, TOC, endotoxin and conductivityCarrying out ELISA’s, SDS-PAGE and western blots on batch samplesUpdated microbiological database and producing the annual water report

Master Of Science (Msc), Biotechnology, Masters

Activities and Societies: Biological Research Society - DCU Assessment of pharmaceutical residues in industrial wastewater. Techniques.

Bachelor Of Science (Bsc), Biotechnology, 2.1 (2Nd Class Honours)

Activities and Societies: Biological Research Society Fluid Flow & Thermodynamics Tank geometry and design Bioprocessing Microbiology.