Ideate, develop and launch various digital clinical solutions to enhance site and clinical team experience using Design Thinking.- Empathize with users by conducting design thinking sessions- Ideate product prototype using tools like Figma- Conduct user testing, gather feedback, and iterate on product features and functionality - Collaborate with business and development teams to ensure successful product development and launch- Develop and maintain strong relationship with key stakeholders, including customers, partners, and internal teams

Serve as a SME of the Reference Drug product Procurement Management projectLead Bioassay Project Management by creating Project Plans using Microsoft Project, prepare Gantt chart, WBS, assign resources and manage project due dates. Write risk assessments, and change control plan if necessaryRepresent Analytical Department in Biosimilar Development Team (BDT), convey important updates from analytical department to the BDT meetings and vice versa, coordinate meetings with Analytical department heads to effectively communicate information and updatesCommunicate with various suppliers worldwide, generate RFP, and purchase reference drugs at competitive price for analytical sciences and clinical trialsParticipate in safety, compliance and regulatory inspections

Develop immunoassays and bioassays (ELISA, Proliferation, Cytotoxic, In-Cell ELISA, and Effector function assay) to evaluate bioactivity of monoclonal antibody therapeutics -VEGF Anti-proliferation assay using HUVEC cells to evaluate ability of anti-VEGF drug to bind and block VEGF from binding to its receptor on cells-Evaluation of Apoptotic mechanism of Anti-TNF antibody on THP-1 cells. Expression of transmembrane TNF on THP-1 cells by stimulation with PMA, LPS and inhibition of TNF cleavage using GM inhibitor. -Cells based ELISA to measure binding of anti-TNF therapeutic drugs to Transmembrane TNF on TmTNF transfected CHO-M cell-Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Complement-Dependent Cytotoxicity (CDC) assays -Maintenance various types of cell lines for different assays (L929, THP-1, HUVEC, SKOV-3, CHO) -Utilized SoftMax Pro 5 and GraphPad Prism software for analysis of dataDevelop analytical kinetics/affinity methods using Surface Plasmon Resonance on Biacore T200 for various types of monoclonal antibody to measure binding kinetics of proteins -Receptor ligand kinetics methods for 3 blockbuster biosimilar drugs -Antibody half-life screening by FcRn binding characteristics -Fc Receptor binding evaluation for various monoclonal antibody drugs Set up Quality Control (QC) division within BioAssay development department. Responsible for routine equipment calibration/maintenance, reviewing results and lab notebooks. Write Standard Operating Procedures (SOPs), method summary reports and preparing method development presentations. Solid understanding of method qualificationAssist in IND filling by contributing in briefing book preparation

Basic Principle: The basic principle of gene therapy is to introduce, delete or repair a faulty gene in the patient's body. This can be accomplished by delivering the desired gene into the patient's cells using a vector (usually a virus or plasmid).Gene delivery vectors: Commonly used gene delivery vectors include viral vectors (e.g., adenovirus, adeno-associated virus) and plasmids. They are designed to efficiently deliver genes into the patient's cells.Gene Repair and Replacement: One goal of gene therapy is to repair or replace faulty genes in the patient's body. This may include repairing a mutation, replacing a missing gene, or providing a copy of a missing gene.Gene suppression: Sometimes the goal of gene therapy is to treat a disease by suppressing the expression of specific genes. This can be accomplished through RNA interference or other techniques.Cancer treatment: Gene therapy has applications in cancer treatment. For example, by altering the genes of cancer cells to induce their death, or by enhancing the immune system's attack on cancer cells.Hereditary Disease Treatment: Gene therapy can be used to treat a number of hereditary diseases, such as cystic fibrosis and hereditary blindness.Immunotherapy: Some gene therapies are used to enhance the activity of the immune system, for example, by genetically altering T-cells so that they are better able to attack tumor cells.Clinical research and treatment: Gene therapy is still under active research and development, and some gene therapies have entered clinical trials and are being used for treatment in some specific cases.

-DNA Collection: Collection of a DNA sample from an individual, which can be done through saliva, blood, buccal swabs, or other sample sources.-DNA Extraction: The extraction of DNA from a collected sample.This usually involves a series of biochemical steps to isolate and purify the DNA.-Genotyping: Analyzing an individual's genotype, i.e., the specific type of variation (e.g., mutation, polymorphism, etc.) in a gene, for a known gene.-Genetic Variation Analysis: Identify and analyze genetic variation in the genome, including single nucleotide polymorphisms (SNPs), insertions/deletions, and gene rearrangements.-Association Analysis: Explore the relationship between genotype and specific phenotypes (e.g., risk of disease onset, physiological traits, etc.) and perform association analysis to understand the impact of genes on in-Functional annotation: Functional annotation of identified genetic variants, i.e., understanding how these variants may affect gene function and expression.-Disease Risk Assessment: An assessment of an individual's disease risk based on the results of genetic analysis. This may include assessment of genetic risk for certain diseases, drug response, etc

-Single Base Editing: Single base editing techniques allow the alteration of a single base directly in the genome without affecting other parts. This includes techniques such as gene base editing (Base Editing) and modification (Prime Editing).-Gene Repair: Defects in target genes can be repaired by insertion of exogenous DNA fragments. This can be accomplished with the gene editing tools mentioned above.-ZFNs (Zinc Finger Nucleases): Zinc Finger Nucleases are DNA-binding proteins that can be engineered to recognize and bind to specific DNA sequences, and then cleave the target genes by a nuclease.ZFNs were an early gene editing tool, and are now being superseded in some areas by CRISPR-Cas9.-TALENs (Transcription Activation-like Nucleases): TALENs were developed from proteins found in a plant pathogen and can cleave target genes by designing specific DNA recognition sequences.TALENs are similar to CRISPR-Cas9, but are slightly more complex to design and synthesize.-CRISPR-Cas9 System: This is one of the most commonly used gene editing tools. the CRISPR-Cas9 system directs the Cas9 protein to precisely cut specific DNA sequences by means of a guide RNA (sgRNA). This process can lead to DNA repair, resulting in the introduction or deletion of the target gene.