Department: Analytical Method Development and Validation
Designation: Research Trainee
As a Research Trainee in the Analytical Method Development and Validation Department, my responsibilities entail conducting analytical method development and validation for drug substances and products using UV, HPLC, and UPLC techniques. Additionally, I am tasked with performing testing and preparing reports for developmental, stability, and exhibit batches of formulations, utilizing UV, HPLC, UPLC, DSC, and KF (moisture content) methods. Calibration of laboratory instruments, including weighing balances, Dissolution test apparatus, pH meters, KF instruments, UV Spectrophotometers, HPLCs, and UPLCs, is also within my purview. I meticulously maintain contemporaneous laboratory notebooks and ensure adherence to Good Laboratory Practices (GLPs) throughout all processes.
At Sun Pharmaceutical Industries Ltd in Gurugram (Ranbaxy R&D), as a Formulation Scientist in the Formulation Development (PDR) department, my role involves a comprehensive range of tasks to bring pharmaceutical formulations from conception to commercialization. This includes conducting thorough literature surveys to understand the formulation landscape, devising strategic plans in collaboration with group leaders and managers, and executing preformulation studies for solid oral, liquid oral, and topical formulations. Additionally, I develop one or more prototype solid oral formulations based on Quality Target Product Profile (QTPP) requirements, subjecting them to stability testing before preparing documents for product transfer to the plant.
Further, I execute batches for clinical trials, bioequivalence studies, and stability testing at the plant, ensuring seamless technology transfer to manufacturing locations. Throughout this process, I meticulously collate all necessary documentation for regulatory filings, adhering to stringent quality and compliance standards at every stage of formulation development and commercialization.
As a Teaching Assistant at IIT-BHU, I have been actively involved in instructing both B. Tech. (2nd year) and M. Tech. (1st year) students in various courses since January 2022. These courses include Nanotechnology Drug Delivery (PH-413), Nano-pharmaceutics (PH-514), Dosage Form Design (PH-412), and Physical Pharmaceutics (PH-211) for B. Tech. and M. Tech. programs.
In addition to classroom teaching, I have served as a Lab Teaching Assistant for the same classes during the period from January 2022 to April 2023. This role involved assisting B. Tech. (2nd year) and M. Tech. (1st year) students in laboratory sessions for Nano-pharmaceutics (PH-514) and Physical Pharmaceutics (PH-211) courses.
The In Vivo Live Imaging System (Optical Imaging) enables non-invasive visualization and tracking of drug delivery and targeting in real-time within living organisms. This advanced technology provides high-resolution images, allowing researchers to study the efficacy and biodistribution of therapeutic agents dynamically.
The In Vivo Ultrasound and Photoacoustic Imaging system allows for non-invasive visualization and tracking of biological processes in real-time within living organisms. This advanced technology combines high-resolution ultrasound with photoacoustic imaging, enabling researchers to study vascular dynamics, tissue oxygenation, and molecular targeting dynamically.
Nuclear Magnetic Resonance Spectroscopy (NMR) is essential in chemistry for elucidating molecular structures, determining the purity of samples, and studying molecular dynamics. In polymer synthesis, NMR is used to analyze polymer composition, chain configurations, and molecular weight distributions. Additionally, it plays a crucial role in identifying and characterizing complex organic compounds, aiding in the discovery and development of new materials.
Fourier-Transform Infrared Spectroscopy (FTIR) is widely used in chemistry for identifying functional groups and molecular structures by measuring the absorption of infrared light. In polymer synthesis, FTIR helps determine polymer composition, monitor reaction progress, and assess material properties. It is also essential for identifying and characterizing organic and inorganic compounds, ensuring quality control, and studying chemical interactions and transformations.
X-ray Photoelectron Spectroscopy (XPS) is a powerful tool for surface analysis in materials science, providing detailed information on the elemental composition, chemical states, and electronic states of materials. In polymer synthesis, XPS is used to analyze surface modifications, monitor polymer coatings, and investigate adhesion properties. It is also crucial for characterizing thin films, catalysts, and nanomaterials, aiding in the development and optimization of advanced materials and surface treatments.
X-ray Diffraction (XRD) is a critical technique in formulation development, providing insights into the physical state of drugs, such as their crystalline or amorphous forms. It helps determine polymorphic forms, which can significantly impact a drug's bioavailability and solubility. XRD is essential for optimizing drug formulations to enhance stability, dissolution rates, and therapeutic efficacy.
Atomic Force Microscopy is a vital tool for characterizing nanoparticles, offering high-resolution imaging of surface topography and morphology. It provides detailed information on particle size, shape, and surface roughness, essential for optimizing nanoparticle formulations and understanding their interactions. AFM also aids in assessing the mechanical properties and stability of nanoparticles, crucial for their application in drug delivery, diagnostics, and nanotechnology.
The X-RAD225 system is designed for small animal irradiation and targeted studies, offering the largest internal x-ray chamber available. It is ideal for large cell cultures and small animal applications. Key features include focal irradiation with automated or fixed collimators, full screen, real-time specimen viewing, and a motorized turntable with an adjustable programmable specimen shelf. The system also features integrated filter recognition, daily automated dose QA, and imaging capabilities with the OptiMAX imaging module, which allows for quick changes between imaging modalities and precise co-registration of images.
Semi-preparative High-Performance Liquid Chromatography (HPLC) with a Photodiode Array (PDA) detector is a powerful technique used for the purification and analysis of compounds in a mixture. This method combines the high-resolution separation capabilities of HPLC with the advanced detection capabilities of a PDA detector, which can simultaneously monitor multiple wavelengths. The semi-preparative scale allows for the collection of larger quantities of purified substances compared to analytical HPLC, making it ideal for applications in research and development, such as isolating bioactive compounds, synthesizing intermediates, or purifying pharmaceutical ingredients. The PDA detector enhances the method's efficiency by providing detailed spectral information, ensuring precise identification and quantification of the components in the sample.
I have extensive experience in in vitro cell culture and cancer biology, with a strong focus on mammalian cell culture using both 2D monolayers and 3D spheroid models for cancer research. My expertise includes performing assays to evaluate cell viability (MTT assay), studying cellular uptake, and analyzing mechanisms of cell death through apoptosis and cell cycle analysis. I am skilled in investigating oxidative stress through reactive species generation and mitochondrial membrane potential assays, assessing DNA damage using the comet assay, and examining cellular aging through senescence assays. Additionally, I have hands-on experience in protein analysis via western blotting, contributing to a comprehensive understanding of cancer cell behavior and therapeutic responses in preclinical studies.
In vivo animal handling encompasses ethical and meticulous care of laboratory animals during experiments, ensuring their welfare and reliable experimental outcomes.
With over 7 years of experience, I am proficient in handling various laboratory animals including rats, mice, hamsters, and guinea pigs. My expertise extends to administering doses via oral, intravenous, subcutaneous, intradermal, intraperitoneal, topical, rectal, and ocular routes. I am adept at withdrawing blood samples via retroorbital route and cardiac puncture, as well as isolating vital organs such as the brain, heart, lung, liver, kidney, and spleen. My extensive experience includes conducting preclinical research experiments in pharmacokinetics, toxicology studies, and animal models for cancer (breast, lung, and colon). Additionally, I have conducted in vivo imaging studies and histopathological investigations.
Maintaining rats and mice for inducing breast tumour by syngenic method and performing in vivo antitumor activity
Zebrafish (Danio rerio) has emerged as a powerful model for testing nanoparticles, drugs, and other experimental therapies due to their unique biological advantages. Their transparent embryos allow real-time observation of biological processes, and their genetic similarity to humans (approximately 70% of human genes are present in zebrafish) makes them an ideal organism for studying disease mechanisms and therapeutic responses. In the context of nanomedicine, zebrafish provide a cost-effective, ethically favorable, and efficient platform for assessing nanoparticle distribution, toxicity, and drug efficacy, accelerating preclinical testing and translational research.
I have experience with the Zebrafish model, breeding, embryo collection, compatibility, anti-inflammatory, cancer model, etc.