Giacomo Fernandez

Method Development and Validation

• Conducts comprehensive stability studies on biopharmaceutical products, ensuring compliance with regulatory guidelines and internal protocols.
• Plays pivotal role in method validation and development processes, focusing on robustness, accuracy, and precision of analytical methods.
• Collaborates closely with cross-functional teams to design and execute experiments, analyze data, and interpret results.
• Utilizes advanced analytical techniques, such as HPLC, iCIEF, Slope Spectroscopy UV/VIS to characterize product stability profiles and identify degradation pathways.
• Ensures that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and GLP regulations.

GMP Biomanufacturing Operator II - Jan 2023/Mar2024

• Subject matter expert on core downstream processes and equipment such as ATKA systems/ UNICORN software.
• Reviews and modifies SOPs and forms associated with those SOPs.
• Provide leadership support during troubleshooting of equipment, operation, and processes.
• Apply technical skills to help complete deviations, change controls, and form reviews.
• Complete quality control techniques such as spectrophotometry, gel electrophoresis, and osmolality to ensure product meets specifications.

GMP Biomanufacturing Operator I - Dec2023/Jan2023

• Executes bacterial resuspension, lysis, and neutralization, performs routine chromatography (2-step procedures) and final dissolution via serial diafiltration.
• Participates in support deviation initiation, investigations for closure.
• Assist production material flow by ordering and maintaining inventory through Microsoft Dynamics365