• Performs basic Downstream purification and mRNA production activities, such as in-vitro transcription (IVT) reactions, chromatography, tangential flow filtration (TFF), viral filtration, bulk drug substance filling, and column packing/qualification.• Performs basic troubleshooting during chromatography, TFF, viral filtration, IVT reactions, and column packing/qualification.• Qualified Trainer

• Facilitate Rapid Response Team as deviations occur, documenting critical information to determine true root cause.• Participated in the creation and use of a logbook corrections excel tool to help facilitate and streamline the logbook correction process and ensure timely completion of corrections.• Lead cross-departmental project to revise and overhaul the bulk drug substance freeze down process SOPs to create a more robust procedure and prevent recurring deviations.• Lead Rust Remediation team responsible for remediating stainless steel equipment, tables, and fixtures in the manufacturing space, saving an estimated $250,000 in replacement costs.• Lead initiatives to improve process compliance culture, including on-going cGMP understanding and application, including self-audit and CAPA programs.• Participated in internal audits and closure of applicable findings. • Actively engaged in Inspection Readiness activities and teams. • Helped to identify and correct training issues, instruction problems, or new educational needs regarding specific employees or groups or equipment.• Assists in identifying improvements for safety and provides on the floor manufacturing support.• Helped to write deviations as needed to achieve site-wide goals for total number of open deviations.• Responsible for owning and completing CAPAs in TrackWise and Elevate.

● Designated reviewer and approver for column master batch records and technical transfer reports.● Subject matter expert and primary buffer/media master batch production record and technical transfer report reviewer and approver.● Deviation investigation and developing/implementing changes based on root cause analysis.● Facilitate client visits and in-process observation of various Downstream activities.● Involved in building and populating batch production records in Catalent’s CPV database tool “Madison PIMS”.● Collected and analyzed data from historical GMP Solution BPR’s to improve recipes and instructions.● Supported Catalent’s Baltimore site with deviation writing and buffer/media batch record review to maintain audit readiness.

● Designated Media Preparation, Training, and Event/Deviation writing Lead● Performed statistical analysis of previous failure rate by the solution preparation group to establish an internal Key Performance Indicator (KPI)● Utilized technical writing skills to author and revise standard operating procedures. ● Subject matter expert and primary buffer/media Master Batch Production Record reviewer● Rapid Response Team Member tasked with investigating quality events in manufacturing● Involved in data gathering and analysis to provide justification for quality event decisions● Certified cGMP Trainer, including a 3-month bubble shift to assist the Catalent Training department.● Completed a bubble shift assignment as shift lead to kickstart the Sun-Wed PM shift. Involved training 8 new associates in addition to ensuring daily tasks were completed.● Aptitude for managing and solving in-process delays caused by equipment and lack of document clarity.