Leading Analytical Development, Extractables and Leachables Groups.Providing End-to-end Analytical Support for Injectable Drug Products (Prefilled Syringes, Suspensions, Lyophilized Powders, and Ready to use Bags)

• Led Analytical Development Group to develop and validate assay and related substance methods for various drug dosage forms and APIs; to address scientific queries related to US/EU DMFs and ANDAs; and to guide API process development issues as well as drug product impurity identification and synthesis.• Developed assay and related substance methods for critical drug formulations, active pharmaceutical ingredients, and chiral drugs with multiple isomers.• Extracted drug product impurities present at 0.15% from the complex matrix of drug product, purifying and characterizing via 1D, 2D NMR, and LC-MS. Synthesized drug product impurities and characterized using HPLC, NMR, and mass spectrometry.• Supported formulation group from early stage development to ANDA filing. Provided analytical support to API manufacturing from raw materials to finished API.• Transferred validated analytical methods to contract manufacturing organizations (CMOs).• Wrote draft methods, method validation protocols, and validation reports. Prepared formal analytical reports for filing ANDAs and DMFs. Reviewed open part DMFs and requested missing data.• Completed multiple projects under tight deadlines without compromising quality of work.• Handled HPLC (uv, PDA, RI, PAD), GC-FID, HS-GC, LC-MS, ion chromatography, and dissolution instrumentation.

• Synthesized Oregon Green/BODIPY labeled paclitaxel and generated albumin-bound nanoparticles for tumor-specific uptake studies in vitro and in vivo. Prepared curcumin/doxorubicin-encapsulated albumin nanoparticles.• Developed liposomal vector for gene therapy applications and delivered microRNAs to mice bearing pancreatic tumors, cardiac disease, and cystic fibrosis.• Designed and synthesized bis-chalcones (proteasome inhibitors) and tested their efficacy in six different pancreatic cancer cell types. Synthesized mutant KRASG12D inhibitors for pancreatic cancer.

• Synthesized HDAC inhibitor MS-275, decitabine and its prodrugs, and small peptide-conjugated prodrug of cyclopamine.• Developed and investigated nanoparticle formulation bioavailability of potent hedgehog pathway inhibitor HPI-1 (NanoHHI) in combination with other drugs in subcutaneous, orthotopic pancreatic tumor, mouse medulloblastoma allograft, subcutaneous, orthotopic liver cancer, and transgenic mouse pancreatic tumor models. • Studied highly bioavailable, iv-injectable curcumin formulation in intracranial brain tumor, EAE mouse, myocarditis, and liver cancer models. Analyzed formulation of curcumin (NanoCurc) in combination with gemcitabine in subcutaneous and orthotopic mouse pancreatic xenograft models. • Tested a composite nanoparticle formulation of curcumin and doxorubicin in multidrug resistant tumor model.• Prepared several nanoparticle formulations of less bioavailable drugs like cyclopamaine, paclitaxel, doxorubicin, SANT-1, GANT-61, parthenolide, E3330, honokiol, and synthesized analogs of curcumin; tested these drugs in vitro and in vivo.• Developed polymeric nanoparticles either conjugated or encapsulated with curcumin, 5-fluorouracil, cis-platin, doxorubicin, gemcitabine, and paclitaxel. • Cultured multiple pancreatic cancer cell lines and performed in vitro cytotoxicity studies and Western blot analysis. Implanted subcutaneous tumors into mice and conducted in vivo treatment studies by intraperitoneal, intravenous, and oral gavage drug administrations.• Characterized nanoparticle formulations for their physicochemical properties, evaluated in vitro/in vivo pharmacokinetics, and tested for anti-cancer efficacy in various cancer mice models.• Handled wide range of instruments, such as Malvern Zetasizer, uv-vis spectrophotometer, Western blot analysis instrument, NanoDrop spectrophotometer, Ultracentrifuge, High-power Sonicator (probe and bath), Vacufuge, Microplate reader, Fluorescent microscope, and qRT-PCR.

• Synthesized modified peptide nucleic acids (PNAs) and analyzed the fields of antisense, antigene, cellular uptake, and biodistribution to treat cancer and genetic diseases.• Synthesized modified nucleobase G-Clamp (a cytosine analogue) and G-Clamp-modified oligonucleotides sequence specifically bound to the mixed-sequence B-DNA under physiological conditions.• Synthesized guanidine linker-modified γGPNA monomers and oligonucleotides, which entered preferentially into cancer cells.• Developed modified nucleobases, such as benzo-fused, sugars-attached, and PEG-modified nucleobases.• Purified and characterized PNAs using HPLC, NMR, ESI-MS, MALDI-Tof, and CD spectrometry. Performed DNA strand invasion and thermal denaturation experiments utilizing uv-vis spectrophotometer.• Trained graduate and undergraduate students in lab in addition to maintaining instruments (HPLC, UV), serving as chemical safety in-charge, and overseeing group purchases and hazardous waste management.