Cork, County Cork, Ireland
▪ Manufacturing support by leading and supporting process related investigations through root cause analysis, 5-why, change controls and CAPAs and ownership of deviations within the sites quality system (Trackwise) ▪ Batch record updates and recipe batch record updates for commercial process and provide training on batch record updates to operational team members ▪ Assist with audit preparations ▪ Preparation of production annual product review (APR) ▪ Method 1/yellow belt investigations to determine root cause of manufacturing deviations and appropriate corrective and preventive actions ▪ Collation and analysis of process manufacturing performance data including yield performance, weekly batch throughput, molar yield ▪ Trending using Pi Vision and DeltaV ▪ Liase with supply chain colleagues for batch material staging ▪ Conduct process capability and molar yield data analysis using minitab ▪ Process safety support through closure of safety related actions and safety investigations and participation in process HAZOPs Courses Completed ▪ DeltaV ▪ Technical writing ▪ Yellow Belt Certified
▪New product introduction/tech transfer - supported the introduction and validation of two new products to site ▪Process validation procedures (protocols and reports) ▪Preparation of protocols/reports for intermediate hold studies and API stability studies ▪Development of cleaning evaluation reports, cleaning validation protocols and reports for product changeover cleandown ▪Calculation of cleandown test limits for product changeover ▪Use tests experiments for new supplier qualification ▪Range finding/hold point experiments for manufacturing batch records ▪Review/approval of manufacturing/ cleandown batch records ▪Designation of parameter criticality including the preparation of critical process parameter report ▪Creation of bill of materials/master recipes on SAP and master raw material lists for new process introductions/cleandowns ▪Initiation of change controls on Trackwise for SAP code creation ▪Validation and technical services impact assessments for change controls, including purchased material qualification activities Project lead for API reprocess campaign and associated equipment cleandown ▪Creation of project standard work plan and hosted weekly standard work plan meetings with cross functional team as well as Tier 1 updates for reprocess campaign ▪Communication of project plan, risk register, project timelines etc to project stakeholders and customer ▪Liaised with external third party for coordination of development of analytical cleandown test methods and analysis of rinse/swab samples ▪Presentation of project at change control committee meeting prior to implementation of major change Regulatory Filing Support ▪Supported the regulatory filing of one API including initiation of change control for collation of all documentation for regulatory filing ▪Preparation of Technical Services documentation i.e. process validation protocols and reports, API equivalency memos etc. for API regulatory filing
▪ Manufacturing and change control support – Process development/DOE optimization studies (yield, robustness and quality) for process change implementation. ▪ Execution of experimental studies for introduction of new raw material vendors. ▪ Process characterization and analysis of all analytical data. ▪ Provide technical reports to stakeholders detailing project updates and key project milestones. ▪ Generation of process recipes and support of laboratory process automation strategy.
▪ Optimization of chemical conjugation of small molecules to protein/peptides. ▪ Macromolecule purification (size exclusion chromatography, membrane filtration). ▪ Characterization (LC-MS) of conjugation products. ▪ Peptide synthesis
▪ Two month research contract under supervision of Dr. Eddie Myers. ▪Design and development of a small-molecule for selective photoinitiated transformation of cysteine into a potential reactive bioconjugation handle.
▪Crystal engineering research placement under the supervision of Professor Michael Zaworotko. ▪Crystallization (liquid-liquid diffusion) of a novel material for gas absorption. ▪One peer-reviewed publication.