Deepa Dadlani Karnani Email & Phone Number

New Jersey, United States

Milan, It

• Revise product test methods using USP, ICH Q2(R2) and Q14 guidelines with QA/QC• Rubidium linearity testing for CapInTec using the Cardiogen elution test vial• Develop test methods, set specifications, for Stannous tin testing, Microscope mean and Subvisible HIAC 9703+ particle size distribution, Protein content• Collaborate with CDMO for technology transfer of process knowledge on a manufacturing production level, formulation fill and finish, lyophilization, stability, shelf-life, extractables / leachables testing• Perform in-lab production level process-development Design of Experiment studies for protein drug development of radiolabeled macroaggregates for best-case analysis of drug attributes in Minitab• Perform process continuous improvement to manufacturing methods through testing & development of filters, drug substance formulation analysis, evaluate source manufacturers of raw materials/ excipients• Review of RCP-TLC and RCP-HPLC release testing and stability data for API manufacturing performed at contract sites as part of Quality assurance and Compliance • Prepare Process Development Report and edits for external manufacturing and further licensing of Human Albumin Macroaggregates drug substance / product technologies

Thousand Oaks, Ca, Us

• Phase-appropriate analytical development document drafting in collaboration with other departments, e.g. Process Development, QA and QC, etc. to support analytical development validation and transfer of technology globally for study execution in PPQ/MA approvals• Prepare program documents (e.g., CMC analytical method validation, plan documents, transfer protocols for partial validation, etc.) on pipeline antibodies e.g. CEX, RP-UPLC, UHPLC and CE-SDS, etc.• Statistically evaluate equivalency studies using Datascience Workbench, bivariate analysis, REML, Linear regression analysis, in Jmp® for method transfer for variety of methods such as cIEF, Potency, Receptor-gene binding, peptite map, HILIC N-Glycan, titer, fixed and variable pathlength UV, Appearance, Color, Clarity, rCE/ nrCE, Mycoplasma, for both upstream/downstream drug substance and drug product technologies

Lawrence Township, Nj, Us

• Prepare technical reports/summaries (e.g., method validation protocols and reports, analytical methods, specifications, etc.).• Present analytical data and communicate issues/strategies related to research projects, N-Glycan mapping for mAbs/ bispecifics development• Work in collaboration with other departments, e.g. Process Development, QA and QC, etc. to support phase appropriate analytical development validation• Troubleshooting and improve existing analytical methods when necessary• Work in compliance with cGMP/cGLP regulations, ICH guidelines, OSHA and safety procedures

Indianapolis, Indiana, Us

• Instituted a faster run time for SEC by testing different columns and programmable automated test methods in Waters HPLC, Empower3® workstation to deliver results 1/3 speed and in real-time• Trained scientists, interns and internal personnel in impurity ELISA assays, HPLC , qPCR and purification for unit operations, filtration techniques, UF/DF and buffer exchange for bi-specific/ pipeline mAbs• Managed projects, results delivery and related queries from internal customers• Commissioned and Decommissioned Equipment and followed Change Management (QMS) procedures• Early phase studies on different resins, buffers to check peak column performance and yield for manufacturing facility-fit process parameters• IEX resin / molecule specific single vs multiple spiking studies using the Statease® DOE to measure maximum levels of DNA/HCP clearance to meet regulatory standards• Reviewed reports for small scale purification, virus clearance studies, resin aging and reuse studies for data integrity, accuracy prior to report generation and submission for BLA/IND applications• Analyzed dynamic binding capacities (DBCs) studies, robustness studies, impurity clearance studies• HPLC intra-assay variability and robustness studies to evaluate system performance for current mAbs

Us

• Led Low pH studies for cut-off pH for virus reduction• Executed media comparison studies to test clones selection for platform purification process • Led ProA / Low pH small scale purification studies to analyze unit operations• Led filtration studies with A1HC /B1HC depth filters, UF/DF small scale to mid-scale• Researched to identify new purification alternatives for CHO media in ion-exchange chromatography• Performed impurity spiking studies to test robustness of HCP/DNA/rPA levels in ion-exchange (IEX)

Certification, Data Science

Master Of Science, Biomedical Engineering

Bachelor Of Engineering, Biomedical Engineering