Hana Hamdan

• Helped develop a robust, end-to-end continuous flow chemistry API manufacturing process entailing 3 telescoped
reactions in continuous stirred reactors, flow reactors, and a liquid-liquid extraction cascade
• Developed analytical tools and calibration for concentration and yield as orthogonal profiling methods to analyze
the performance of the continuous manufacturing platform as well as enhance the remote process control platform
• Performed batch experiments in EasyMax to collect data on parameter optimization to mimic them on the scaled-up continuous platform
• Troubleshooted the manufacturing platform during several 10-hour continuous manufacturing runs with a focus on solving the formation of fouling, solid-buildup, and pump performance
• Worked with a team of MIT postdoctoral associates on a 48-hour experiment to demonstrate the competence of the continuous platform and performed off-line analysis using GC, NMR, HPLC, and titration
• Analyzed process data trends from all continuous experiments to understand new ways to obtain better system
performance

• Developed an Extractables and Leachables Automatic Risk Assessment tool for single-use polymeric components
used during drug substance and bulk drug product manufacturing and sterile fill-finish operations for the companys
manufacturing sites
• Performed a step-by-step E&L assessment for drug products buffer solutions and developed a leachability de-risk
plan based on the criteria scores to ensure product safety and quality are attained during development
• Worked closely with QA on design verification for specifications of a non-commercialized drug-device
combination product by monitoring internal control plan and user needs and verifying them against documents
provided by an external manufacturing supplier entity
• Validated packaging and labeling quality and procedures to meet GMP requirements included in Validation Master
Plans for finished goods and commercial drug products
• Executed comparison charts of Continuous Process Verification (CPV) during a manufacturing process for different drug products to understand future process development in terms of parameter monitoring throughout various unit operations
• Worked on validation database and metadate verification to certify all data comply with cGMP regulations which
aim to ensure data integrity