• Developed and validated robust release and stability characterization methods (e.g., CGE-R/NR, SEC, iCE) for biologics, including monoclonal antibodies and ADCs, ensuring compliance with cGMP and successful transfer to QC labs.• Acted as Subject Matter Expert for drug product and substance testing in biologics, employing technologies such as CE-SDS, iCIEF, HPLC, and UPLC to support clinical manufacturing and ICH guidelines.• Managed cross-functional projects as Single Point of Contact, coordinating characterization, bioassay, and QC testing efforts with CRO partners, while overseeing project timelines and adherence to CMC strategy.• Demonstrated hands-on experience with qPCR, Protein A ELISA , Tecan Liquid handler Automation technologies to support the project needs.• Authored technical documents and reports, supported training, developed data quality initiatives, and created interactive dashboards to enhance R&D project management and information excellence

● Work within a strong and collaborative team contributing to the preparation of metrics, dashboards, and tracking to facilitate the efficient execution of the Methods Trending and Monitoring department’s deliverables and to the creation and maintenance of necessary documentation including Standard Operating Procedures, Work Instructions, and Protocols.● Assuring the accuracy and completeness of all collected data from multiple sources for methods including SEC, CEX, iCE (iCEF), CGE, A280, potency, and impurities assays.● Execute weekly/monthly reporting packages using a variety of systems including Excel, databases, and visualization software (ex. Spotfire, Minitab) and perform as a cross-functional liaison between method development, GMP operations, Commercial operations, and our external outsourcing partners to communicate method performance and identify underperforming methods for redevelopment.

● Execute biologics separation assays in GMP/GLP environment on monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs) and fixed drug ratio combination (FDRC) products to support clinical development of therapies, particularly against immuno-oncology (IO) and oncology diseases following respective SOPs. ● Execute electrophoretic-based and chromatography-based testing of biologics, including but not limited to CE-SDS, iCIEF, SE-HPLC, SE-UPLC, CE-ID, BMT, RP-HPLC analyses as necessary, to support Research & Development (e.g. clinical release and stability, reference material qualification, and product development).● Demonstrate practical knowledge of analytical techniques to contribute to development of phase-appropriate validation, robust and reproducible analytical methods for use in the GMP clinical laboratory.

● Performed analytical analysis of Finished API’s, In-process, Intermediates, Stability samples testing by USP/NF methods and In-House methods following SOP, cGMP and FDA regulations.● Performed Assay, Related substance, Chromatographic purity studies using various instruments such as HPLC/UPLC (Empower 3), GC (Shimadzu), Density, Particle size, KF, UV/VIS of In-process, Intermediates, Finished API’s, Stability samples, Dissolution studies.● Performed method development and pre-validation, Gap, Cleaning validation of analytical methods under the guidance of analytical expert.