• Collaborated with cross-functional teams on the tech transfer of the clinical processes to a modern commercial facility, creating meticulous documentation, evaluating procedures, and ensuring the compatibility of new equipment with established high-quality standards.• Developed robust User Requirement Specifications (URS), Installation, Operational Qualification (IOQ) protocols, and Standard Operating Procedures (SOP) to ensure the thorough validation of new equipment for the state-of-the-art commercial facility, emphasizing a commitment to quality standards.• Offered meticulous oversight for the execution of Factory Acceptance Testing (FAT), Cycle Development, and Site Acceptance Testing (SAT) for the VHP system.• Collaborated with cross-functional teams to conceptualize and implement an asset management system aligning with CFR 21 Part 11/Annex 11 standards. Key contributions include:o Providing constructive feedback on system design to enhance functionality.o Developing and revising 15 Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure compliance and efficiency.o Designing and executing User Acceptance Testing (UAT) protocol to validate system performance.o Spearheading a Change Control initiative to enhance the work request system and maintain regulatory alignment.

• Contributed to the development of a first-generation high-speed cell sorter byo Spearheading the creation of comprehensive test protocols.o Executed meticulous testing procedures with acute attention to detail, ensuring the accurate evaluation of system performance. o Proactively identified quality gaps and areas for improvement through systematic analysis, providing valuable feedback to the development team. o Played a pivotal role in refining the sorter's functionalities to meet and exceed stringent quality standards.

• Perform production and filling of manufactured formulation• Perform clean room sanitization• Mange inventory by performing weekly and monthly cycle counts• Manage prevent maintenance program for all manufacturing equipment

• Support installation qualification/operational qualification/performance qualification of CIP Skids, Large scale centrifuge, and Bioreactors • Created and revised standard operating procedures, batch records and User Requirement Specification documents

• Performed and monitored production processes for phase 2 clinical cGMP manufacturing operations per standard operating procedures and batch records• Created, reviewed, and revised SOPs and batch records• Participated in validation/qualification activities• Prepared and presented data associated with manufacturing processes to internal departments• Actively recognized and corrected errors in process operations prior to failure• Recommended changes to process operations to reduce risk, increase efficiency and increase proficiencies of compliance requirements and departmental policies • Participated in Process development/Manufacturing process transfer activities• Assisted in GMP facility care and maintenance-inventory management, environmental monitoring

• 10 yrs. performed large and small-scale media preparation, buffers and reagents preparation, sampling, cell counts, sterilization, bioreactor inoculation, harvesting use large scale centrifuge, and weighing raw material • 5 years performed large-scale protein chromatography and tangential flow filtration• Promoted to lead technician in both Purification and Cell Culture departments and performed the following duties: o Prioritized operations and realign resources during the shift to meet production requirementso Led troubleshooting for equipment and process failures using analytical problem solving and engineer documents• Executed Discrepancy Management System (DMS) activities which include: o Assisting with the initiating of DMS records for process anomalies. o Providing Additional Actions and Evaluations for process anomalies o Assisting with the closing of Incidents o Training other technicians on DMS o Serving as the shift SME for CAPAs and Investigations, as applicable • Contributed to the success of a new plant start-up, focusing on error-proofing, validating automated recipes and equipment, and ensuring FDA compliance.

Created and delivered trainings using PowerPoint presentation to leadership staff and union workers.Ensured company training records were inspection-ready for regulatory agencies.