Large Molecule Technical Operations

Operations SME for development of Electronic Batch Records. Delta V integration with MES - Operations oversight for Automation documentation.Development of Signature Rationale to ensure compliance and efficient transfer of Paper Batch Records to MES. Format Design of EBRs to ensure efficient transfer. Oversight and review of EBR design to ensure integrity of manufacturing process. Operations oversight of introduction of AgileDoc software for electronic review of Delta V reports. Development of True Copy Certification process.

Deviation and Investigation management. CAPA management. Single Use Design for start up. Process improvements. Start up activities - equipment walk down, commissioning documentation review, development of procedures. Troubleshooting of process issues on shift - UF/DF, Filtrations, Reactions Steps, Final Filtration and Fill, Buffer. Development of Delta V alarm management procedure and escalation process. Training of Operators on shift. Management of process to adhere to schedule. Area representative for safety change procedure. Completed Masters thesis on use of alternative pre-sanitised UF membrane system

Large scale chromatography. UF/DF, Final Filtration and Final Fill. Viral Inactivation. Viral Filtration. Deviation and CAPA Management. Continuous Process Improvement. SOP/Batch Record Updates. FMEA. Development of Product Changeover GMP Certification process.

At Mylan, I worked within the Technology Transfer and Process Development Team in Mylan, Dublin. My main focus was the transfer of manufacturing processes of an inhalation drug from pilot plant scale to a new commercial manufacturing facility. Regular activities to support the transfer include, writing of technical protocols, overseeing execution of said trials, analysis of analytical data and compilation of reports post execution. In addition to this, I lead a subgroup encompassing members of both facilities and chair weekly meetings with a focus on training, preparatory work for trials, risk assessments and troubleshooting. Other general activities include: Authoring and updating of BMR' s SOP's and memos. Preparation of batch documentation and review post batch execution. Use of Documentum and Trackwise software. Participation in FAT and SAT activities as part of cross functional team. Use of Lean Six Sigma tools/DMAIC principle and Root Cause Analysis. Procurement of API/Excipients for use in Development Trials.

I worked at Pfizer, Grange Castle for my college work placement. My main role was to assist the document controller in supplying relevant documentation to production, including Batch Records, SOP's and Logbooks. This role required a high level of organisation in order to ensure down-time was not incurred as a result of documentation not being to hand. Communication between departments was a crucial element in ensuring this. For this role I received training in SAP and Pdocs, Pfizers documentation software.