Koustav Maity, PhD

• Led process development, optimization, characterization and comparability studies of enzymes, Fabs, and full-length antibodies using 2-10L bioreactor scale-up, AKTA FPLC (UNICORN) purification systems, and TFF processes achieving 90-95% purity targets for GMP manufacturing readiness for rapid molecular diagnostics. • Collaborated with operations to define and implement production plans, scale up and transfer activities of high-density solutions at 90 liters. Defined analytical density specs, conducted risk assessments, and established QC release criteria for GMP compliance. • Served as the technical lead for the development, optimization, and validation of analytical methods for enzyme activity. Collaborated with CDMOs and QC to establish release criteria for product consistency. • Process improvement of membrane protein purification to improve diagnostic assay capability. • Established analytical methods for enzyme background activity, specific activity, and a reverse phase HPLC-based method for purity assessment. • Troubleshot product quality like protein precipitation, stability, and purity issues using HPLC and Fluorescence based thermal stability assay (Prometheus analyzer). • Demonstrated scientific accountability and proactive problem solving in managing ambiguous, fast-changing program priorities across multiple enzyme and antibody development programs. Managed multiple projects by using data-driven analysis to prioritize activities and maintain timelines, aligning with GMP manufacturing readiness milestones. • Maintained thorough and accurate documentation, including SOP draft and review, batch records, data packages, and technical presentations and reports in electronic laboratory notebooks to demonstrate accountability and integrity, while ensuring compliance and reproducibility.

• Demonstrated project leadership by driving workflows for recombinant protein production, including strain engineering, vector design, plasmid DNA purification and high-throughput screening to improve yield and quality. Established protocols for OSCA protein expression and purification (AKTA/FPLA), and reported the Cryo-EM structure and gating mechanism using biochemical, biophysical, and computational methods. • Applied directed evolution with bacterial display to identify and optimize high-affinity nanobodies against membrane transporters and ion channels, followed by expression, purification, and screening using BLI. • Published a first-author article in PNAS and a co-corresponding author paper on rational design of therapeutic antibodies through protein engineering to enhance binding and manufacturability. Also published two conference papers in the Biophysical Journal. • Successfully collaborated with multiple laboratories with complementary and interdisciplinary skills. • Trained, supervised, and managed daily schedules of 1 MS student, 3 lab technicians and 5 undergraduates. • Operated and maintained x-ray crystallography equipment and crystallization robot (Gryphon), providing technical direction to assist other scientists in performing their experiments. • Nominated F1000 Associate faculty member (2014-2017).

• Developed a protocol for expressing and purifying ionotropic glutamate receptors from mammalian cells for structure-function studies and established conditions for single-particle image analysis using EM imaging.

• Solved multiple enzyme–inhibitor complex structures (PfFabI, PfFabZ) to define structure–activity relationships and guide rational inhibitor optimization. Applied structure-based analysis to interpret ligand binding modes. • Published 5 first-author and 3 co-authored peer-reviewed structural biology studies. • Supervised junior researchers and trained students in crystallography and protein purification techniques. • Awarded Best Poster at the Indo-US Symposium on Modern Trends in Macromolecular Structures (2011).