Clinical Research Flow Cytometry

AKANKSHA SUKHTANKAR

********.**********@*********.*** · 443-***-****

http://www.linkedin.com/in/akanksha-sukhtankar-a09123270 PROFESSIONAL Graduate student SUMMARY equipped in pharmaceutical research and drug development. Adept at conducting in-depth data analyses and working as a team player. Strong record of contributing to research projects involving formulation, optimization, and development. Strong verbal and written communication skills. EDUCATION Master of Science, Pharmaceutical Sciences Expected Dec. 2024 University of Maryland, School of Pharmacy Baltimore, MD M. Pharm in Pharmacognosy Aug. 2022

Goa College of Pharmacy Panjim, Goa

B. Pharm, Pharmaceutical Sciences Aug. 2020

Goa College of Pharmacy Panjim, Goa

TECHNICAL SKILLS

UV-visible spectrophotometer, Sonicator, Column chromatography, TLC, Franz diffusion cell, Overhead stirrer, Centrifugation, differential scanning colorimetry, FTIR spectroscopy, Mass spectroscopy, Titrations, XRPD, Scanning Electron Microscopy, Confocal microscopy, Inverted microscope, Particle size analyzer, rheometer, osmometer, pH meter, mammalian cancer cell lines and CAR-T cell culturing, Laminar air flow, Mammalian cell culture, Aseptic technique, Immunology, Experimental design, cell counter-Countess, xCELLIgence-real-time cytotoxicity assay, flow cytometry, ELISA, proliferation assay.

Computer Skills: Gained Proficiency in Design Expert (v-13), MS Word, Excel, PowerPoint, GraphPad prism, REACT, RAVE. EXPERIENCE

Research Co-op, CART Cell Therapy, Oncology Department June 2024 – present AstraZeneca Gaithersburg, MD

• Acquired wet lab skills-cell culturing and counting of primary cancer cell lines using aseptic techniques and analyzing the impact of cytokines on the therapeutic efficacy and persistence of CAR-T cells via ELISA assay

(colorimetric) and flow cytometry (Capstone project/poster presentation).

• Enhanced data management accuracy by collaborating with the clinical research team on ADC drug lung cancer trials, analyzing CRFs, utilizing RECIST 1.1 guidelines, and employing software such as EDMS, REACT, and RAVE for comprehensive data cleaning and analysis.

• Participated in journal clubs and seminar sessions to review and present the latest developments in oncology treatment, contributing to a deeper understanding of current research trends. Research Intern, Dr. Stephen Hoag’s Lab Jan. 2024- May. 2024 University of Maryland School of Pharmacy Baltimore, MD Worked as a Research Intern at Dr Stephen Hoag’s lab, under the guidance of Dr Iram Maqsood on the project -

‘Development of polymeric hydrogels for post-endoscopic resection bleeding prevention and control’ that involved mathematical modelling of calcium alginate gel formation and diffusion of bioactive molecules from alginate-based gels, analyzing of thermodynamic properties of injectable and bio- adhesive gel followed by its characterization, as a collaboration with John Hopkin’s University.

Trainee, Clinical Research Department Sept. 2022- Mar. 2023 UNICHEM, R&D, Goa Pilerne, Goa, India

• Implemented and executed comprehensive data analysis strategies for BA/BE clinical trial documentation, leading to enhanced regulatory compliance and process optimization.

• Led the coordination and execution of clinical research studies, achieving an increase in participant recruitment, streamlining enrollment processes, and enhancing the follow-up protocol, which improved study retention rates.

• Worked collaboratively with principal investigators, study sponsors, and regulatory authorities, ensuring stringent adherence to study protocols, regulatory requirements, and ethical standards, which drove successful study outcomes and facilitated regulatory approval.

• Enhanced data integrity and study reliability by collecting and maintaining accurate and complete clinical trial data, meticulously documenting adverse events, protocol deviations, and study outcomes.

• Successfully streamlined the management of study-related documentation, including informed consent forms, case report forms, and regulatory submissions, significantly reducing submission errors and accelerating approval timelines.

• Consistently enhanced compliance and efficiency in clinical research processes by mastering SOPs and USFDA, EMA, ICH/GCP, and ANVISA guidelines, utilizing advanced software like Electronic Document Management System (EDMS) and REACT to streamline document storage and analysis.

• Successfully applied for Import Licenses in accordance with DCGI requirements and executed literature reviews, leading to a 30% reduction in regulatory approval time and a 25% increase in the accuracy of clinical documents such as CRFs, CSRs, ICFs, and study protocols.

• Analyzed and prepared presentations of reports of in-vivo and in-vitro pre-clinical studies on Protein Molecules for Psoriasis, accompanied by their market analysis.

• Successfully monitored on-site BA/BE dosing periods of small molecule generic drugs for ANDA approval, ensuring strict adherence to protocols, enhancing study accuracy, and driving successful regulatory submissions. Graduate Apprentice, Quality Assurance Department Jan. 2022- July 2022 Indipharma PVT LTD Bethora, Ponda-Goa, India

• Successfully completed comprehensive training in documentation practices within the Quality Assurance department, significantly enhancing compliance with cGMP and GLP guidelines and contributing to improved overall departmental operational efficiency.

• Implemented SOPs across departments and gained expertise in export documentation, dossiers, and QA reports, leading to streamlined processes and improved compliance. Intern, Production Department June 2018

CIPLA Industries Pvt Ltd Verna, Ponda-Goa, India

• Successfully completed comprehensive induction and training in SOPs for multiple departments, including Production, QA, QC, Packaging, and Stores, resulting in improved cross-departmental efficiency and a 20% reduction in procedural errors.

RESEARCH EXPERIENCE

• Conducted research for a thesis and delivered a poster presentation on "Porous Polymeric Vesicles of Vitis vinifera: Fabrication and Evaluation," focusing on their applications in novel drug delivery systems for anti- hyperpigmentation activity. This work was presented at the Goa College of Pharmacy in 2022.

• Presented poster - ‘Formulation of Rutin and Quercetin micro sponges and it’s characterization’ at the 6th Annual International Conference on IPR (Dec,2022) and the 20th International e-Symposium held by the CRS (Feb,2022).

• Presented a poster at the MS Departmental Seminar 2024 at the University of Maryland, Baltimore, on my research project- "Impact of CAR-T Cell-Derived IFN-gamma on Hematologic Malignancies", a collaboration with AstraZeneca, MD.

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