Gwynneth Borges

Scientist Iii @Thermo Fisher Scientific

South San Francisco, CA, US

Lead the tech transfer and implementation for a decentralized manufactured autologous CAR-T process to manufacture Phase I/II drug product and autologous Phase I cell therapy process to manufacture clinical drug product of gene modified CD34+ HSPCs • Generated New Product Introduction (NPI) documents for new programs assessing the material, equipment and documentation for GMP production suitability. Assisted with new business opportunities by developing production models for multiple new businesses• Assessed multiple processes through verification runs and generated a process risk assessment and FMEA to de-risk the process. Generated Bill of Materials (BoM), Bill of Equipment (BoE) and material specification documents for client processes.• Authored documentation packages such as Standard Operating Procedures (SOP), Tech Transfer Protocols and Master Batch Records (MBRs) and reviewed documentation for lot disposition. • Informed process development decisions with respect to facility fit and GMP suitability. Improved procedures to ensure operating methodologies in production processes were GMP compliant. Identified minor and major deviations and aided in investigations, root cause analyses, and product impact assessments• Collaborated with external customers to provide updates and engage in development discussions. Assisted with client trainings, Aseptic Operator Qualifications (AOQ) and Aseptic Process Simulations (APS) for manufacturing processes

University of Mumbai

Bachelor of Engineering, Chemical Engineering

Johns Hopkins Whiting School of Engineering

Master's degree, Chemical and Biomolecular Engineering