- Production Lead (Upstream). - Production Lead (Downstream). - New product introduction Lead. - Stock control Champion. - Standardized work Champion - Training Champion - Method one & Green Belt Certified - QTS Investigations. - GMP documentation - Production area Audit prep. -Superuser in DeltaV/MES/MCS/PDOCS/SAP/PLS/QTS/LIMS - Equipment Validation. - 5S Methodology. - LEAN Production Methodology I've had a successful nine year carrier at Grange Castle Biopharmaceutical plant. Starting as a process technician in Buffer Formulation, I eventually became an SME of an Upstream production process. This job gave me an opportunity to engage in virtually every aspect of Etanercept® production. Over the last few years I was part of three biggest projects in Drug Substance building, High Capacity Etanercept production, 5S methodology implementation and transition from Paper Batch Records(PBRs) to Electronic Batch Records(EBRs). Within this job my main responsibilities were: • Leading manufacturing team to meet schedule and production demands. • Maintaining full control of the manufacturing area to avoid any downtime. • Engaging with Schedulers and QA on everyday basis to ensure continuous production. • Writing investigations and working with QA team to close them out. • Training new team members. • Facilitating weekly stock check meetings across the plant. • Providing validation support for new processes and equipment. • Working on CI projects .

I have worked in FAB-24 from the day it was opened and was part of implementation and validation of the production cycle. I enjoyed the challenges of a plant start-up and learned to work on my own initiative without any supervision. My main duties were : • Equipment validation and maintenance. • FOUP cycle within the plant. • Process modifications to improve production rate and reliability. • Writing and updating SOPs. • Training new staff. .