scientist

.

.

Leeza Shrestha

Scientist

Address Silver Spring, MD 20904

Phone +1-870-***-****

E-mail ad5dp0@r.postjobfree.com

U.S. Permanent Resident

• Accomplished and goal-oriented scientist with 8 years of research experience.

• Well-versed in vaccine research, immuno-toxicology, animal models, peptide chemistry, cancer biology, medicinal chemistry, drug design and characterization.

• Have excellent review and problem-solving skills, as well as effective communication talent.

• Highly collaborative as well as independent.

Education

Aug 2020 -

May 2021

Graduate Certification in Regulatory Sciences

University of Arkansas for Medical Sciences - AR

Jan 2016 -

Dec 2019

Ph.D.: Pharmaceutical Sciences

The University of Louisiana - Monroe

Advisor: Dr. Seetharama Jois

Sep 2009 -

Jan 2014

Bachelor of Pharmaceutical Sciences

Pokhara University - Nepal

Professional Experience

Jan 2023 –

Mar 2024

Scientist (Analytical Development)

Vaccine Research Centre, NIH, Gaithersburg, MD

• characterizing vaccine candidates like L9LS ab (Malaria), CAP256-VRC26.25 Ab (HIV), EVD68 VLP and H1ssF mRNA LNP (influenza) vaccines.

• Evaluated identity, potency, purity, and quality parameters using advanced analytical techniques.

• Developed cell-based potency assay for mRNA and mRNA LNP vaccines by transfection in mammalian cells and in vitro mRNA translation techniques.

• Designed assays, including ELISA, Western blot, and Peggy Sue, to quantify protein expression.

• Developed methods for residual testing using ELISA

• Developed method for detection of VP0, VP1 and VP3 using capillary electrophoresis

(Peggy sue).

• Conducted binding analysis and assessed antibody titers using OCTET BLI technology

.

.

• Qualified and validated assays for accuracy, precision, repeatability, and robustness.

• Authored and reviewed Standard Operating Procedures (SOPs) to ensure adherence to quality standards and compliance

• Facilitated technology transfer of the assays to vaccine clinical material program

(VCMP/NIH)

• Facilitated training sessions for Associate scientists, ensuring proficiency in relevant techniques and methodologies.

• Collaborated with divisions within VRC including the cell line development division, upstream, and downstream departments, and external entities like Duke University and Akagera Medicines to support sample acquisition and assay development initiatives.

Jan 2021 –

Jan 2023

Visiting Scientist

National Centre of Toxicological Research, FDA, Jefferson, AR

• Accomplished flow cytometric analysis of anti-SARS-CoV antibodies in human plasma

• Achieved protein linking to aldehyde/sulfate latex beads and conducted screening for the presence of anti-SARS-CoV-2 antibodies in plasma/serum samples from COVID-19 patients and healthy blood donors.

Jan 2020 –

Jan 2021

ORISE Postdoctoral Fellow

National Center For Toxicological Research, FDA, Jefferson, AR

• Designed and assessed the inflammatory activity of Polyethylene Glycol (PEG) and investigated the immunotoxicity induced by high molecular weight PEG

• Determined the impact of PEG on the release of cytokines including TNF-α, IL-1β, IL-12, IL-6, and INF-γ,by immune cells using ELISA, providing insights into the inflammatory response

• Utilized Caspase-Glo Inflammasome Assay to measure the activity of caspase 1 in PEG-treated cells, contributing to the understanding of inflammasome activation pathways

• Quantified nitrite concentration in the culture medium as an indicator of NO production using Griess reagent assay, facilitating the assessment of cellular signaling and inflammatory processes

• Detected reactive oxygen species through H2DCF-DA assay upon stimulation of cells with PEG, enabling the characterization of oxidative stress responses and cellular oxidative damage.

Jan 2016 -

Dec 2020

Graduate Teaching & Research Assistant

University of Louisiana, Monroe, Monroe, LA

• Thesis: Physicochemical characterization, Pharmacokinetic and Pharmacodynamics studies of a Her-2 targeted peptidomimetic

• Designed a peptidomimetic targeting Domain IV of the HER2 receptor and evaluated its anti-cancer activity through in vitro assays, including anti-proliferative assays and cell-based assays

• Confirmed its binding to HER2 through docking and Surface Plasmon Resonance

.

.

• Investigated the mechanism of action, including downstream cell signaling, utilizing techniques such as Western blot, Proximity Ligation assay, and Surface Plasmon Resonance

• Assessed in-vitro stability through Circular Dichroism, HPLC, etc

• Measured the anti-cancer activity in vivo using experimental metastasis mice model

• Proficiently executed tissue fixation, paraffin embedding, and Hematoxylin and Eosin

(H&E) staining to prepare tissue samples for histological analysis.

• Applied advanced immunohistochemistry techniques, including Proximity Ligation Assay (PLA), to investigate molecular interactions within lung tumor tissues. May 2019 -

Aug 2019

Intern/Vaccines Drug Product

GlaxoSmithKline, Rockville, MD

• Explored liquid formulations for a vaccine candidate, aiming to identify novel excipients that enhance antigen stability

• Gained expertise in high-throughput technologies, including the automated liquid handler Tecan, and employed methods to expedite the screening of excipients for improved protein stability in liquid formulations

• Successfully identified a stable formulation and conducted a thorough evaluation of the antigen's physicochemical properties using advanced techniques such as Surface Plasmon Resonance (Biacore T200), Prometheus NanoDSF, etc. Oct 2014 -

Dec 2015

Quality Assurance Officer

Yetichem Drug Distributors, Kathmandu, Nepal

• Monitored the entire process, from receiving goods to the release and storage of products for distribution in the market, ensuring the maintenance of high-quality standards at every stage

• Reviewed and evaluated services provided by outsourced vendors, identifying and addressing in-house training needs for relevant personnel as necessary

• Collaborated with engineers and QA officers from biotech companies, including Pfizer and Sanofi, to conduct audits of the drug storage warehouse and distribution chain as a QA Officer

• Addressed and corrected comments on SOPs, ensuring alignment with audit findings and maintaining compliance standard

• Developed Standard Operating Procedures (SOPs), conducted employee training sessions, and maintained documentation related to Quality Assurance. Oct 2014 –

Dec 2014

Intern

G.M.P. Pharma, Kathmandu, Nepal

• Acquired exposure to outpatient care, including drug dispensing

• Developed skills in patient record keeping and documentation.

• Demonstrated proficiency in Narcotic Drug Handling and meticulous record-keeping. A

May 2014 Intern

Simca Laboratories Pvt. Ltd., Kathmandu, Nepal

.

.

• Acquired knowledge of manufacturing techniques and analytical methods employed in the quality control department

• Demonstrated expertise in the documentation and handling of raw materials and packaging materials in the store.

Feb 2014 Intern

Birendra Military Hospital, Kathmandu, Nepal

• Gained exposure to hospital pharmacy setup, actively involved in counseling patients, dispensing medicines, and maintaining patient records

• Demonstrated proficiency in handling narcotics, ensuring adherence to protocols, and maintaining meticulous records

Skills

mRNA and mRNA LNP characterization; Residual testing; Cell Culture; Cellular Assay Development; Transfection; In Vitro Translation; Western blot; ELISA; Proximity Ligation Assay; Assay qualification OCTET BLI System; Surface Plasmon Resonance (Biacore); Nano Analyzer; Circular Dichroism; HPLC; NMR ; Infrared Spectroscopy; Nano DSF; Nanodrop; Flowcytometer; Automated Liquid Handling System; Tecan Freedom Evo; Animal Handling; Surgery; Intravenous and intraperitoneal dosing; Isolation of mice organs; Tissue processing

Intravital Imaging System (IVIS);

Fluorescent and Confocal microscopy

Immunocytochemistry; Immunohistochemistry;

Drug designing and Synthesis; Molecular Docking

Professional Involvements

• Member of Society of Toxicology

• Member of American Association of Pharmaceutical Scientists (AAPS)

• Registered Pharmacist at Nepal Pharmacy Council

• Member of Nepal Pharmaceutical Association (NPA)A Publications

• Shrestha L, Singh SS, Parajuli P, Dahal A, Mattheolabakis G, Meyer S, Bhattacharjee J, Jois SD. In vivo studies of a peptidomimetic that targets EGFR dimerization in NSCLC. Journal of Cancer. 2020 Jan 1;11(20):5982-99.

• Singh SS, Dahal A, Shrestha L, Jois SD. Genotype driven therapy for non-small cell lung cancer: Resistance, pan inhibitors and immunotherapy. 2020 Current Medicinal Chemistry 27 (32), 5274-5316

.

.

• Parajuli P, Sable R, Shrestha L, Dahal A, Gauthier T, Taneja V, Jois S. Modulation of costimulatory signal from CD2 CD58 proteins by a grafted peptide. 2021 Chemical Biology & Drug Design 97 (3), 607-627 7.

• H Naik, JJ Sonju, S Singh, I Chatzistamou, L Shrestha, T Gauthier, S Jois. Lipidated Peptidomimetic Ligand-Functionalized HER2 Targeted Liposome as Nano-Carrier Designed for Doxorubicin Delivery in Cancer Therapy.2021 Pharmaceuticals 14 (3), 221

• A Dahal, P Parajuli, S Singh, L Shrestha, J Sonju, P Shrestha, I Chatzistamou, Seetharama Jois Targeting Protein-Protein Interaction for Immunomodulation: A Sunflower Trypsin Inhibitor Analog Peptidomimetic Suppresses RA Progression in CIA model. 2022 Journal of Pharmacological Sciences, 143 (3), 124-138.

Contact this candidate