Ishwor Poudel Email & Phone Number

🚀 Pharmaceutical Scientist | 6+ years of experience across academic, industrial, and regulatory settingsAt the forefront of pharmaceutics research, my participation as an ORISE Fellow at the USFDA integrates rigorous dissolution testing with a commitment to advancing generic oral dosage form approvals. With a PhD from Auburn University, my focus on personalized drug delivery systems is underpinned by a strong foundation in formulations and drug product characterization, evidenced by the development and validation of HPLC methods and pioneering 3D printing & drug delivery techniques.🔬 Core Competencies:🧪 Preformulation and Formulation Development: Expertise in optimizing drug solubility, stability, and bioavailability for small molecules.Experienced in solid dispersions, lipid-based systems, and nanoparticle formulations.⚗️ Process Development and Scale-Up: Proven ability to translate lab-scale processes for scale-up, including optimization of unit operations, API compatibility, and stability testing. Hands-on with solid, semi-solid, parenteral, topical & implantable/LAI formulations.🟦 Additive Manufacturing: Advanced knowledge of pharmaceutical 3D printing, specializing in extrusion-based technologies (thermoplastic, pneumatic, syringe pump) and droplet-based printing to develop personalized dosage forms, drug-eluting implants, and biomedical scaffolds.🌡️ Nanocarrier Drug Delivery: Proficient in liposome-based formulations. Comprehensive understanding of nanoparticle characterization, in vitro release, and cell culture studies.💊 Solubility and Stability Enhancement: Expertise in using cyclodextrins to improve the solubility and stability of poorly soluble compounds, supported by advanced solid-state characterization techniques like XRD, FTIR, NMR, SEM & molecular modeling.❄️ Lyophilization: Hands-on experience with pilot-scale lyophilization using Lyostar 3, focusing on optimizing process parameters and enhancing the stability of freeze-dried products. Skilled in DSC and Freeze-Drying Microscopy (FDM).🧪 Analytical Method Development: HPLC/ UPLC/ UV-Vis spectroscopy for method development, validation, and assay of small molecule APIs, with contributions to regulatory submissions and collaborative projects.💧 In Vitro Dissolution Testing and Biopharmaceutics: Extensive experience with USP dissolution apparatus I-IV, biorelevant dissolution, and Physiologically Based Biopharmaceutics Modeling (PBBM) for predicting in vivo performance.Let’s connect to explore synergies in pharmaceutical research and innovation. 💡

Listed skills include Regulatory Affairs, Sop, Clinical Research, Gmp, and 31 others.