Scientist And Head Of Cro Operations
Current Heading industrial and academic projects in mammalian and stem cell culture e.g., In vitro cytotoxicity and DMPK studies, cell isolation and expansion, Caco-2 and Blood brain barrier models, skin irritation assay on 3D tissue models like SkinEthic RHE (Episkin) adhering to GLP, OECD and ISO 10993 guidelines. Purifiying antibodies and proteins like IgG, hyaluronic acid, albumin, asparaginase, and peptides (Jelleins). o Performing upstream processes such as mammalian cell and microbial fermentation for protein production at lab scale (5L to 50L), and carrying out transient and stable gene expression in CHO & HEK293 cell lines. o Downstream processes such as fractionation and purification of proteins by depth filtration, ultrafiltration, tangential flow filtration (Pellicon, Merck Millipore) and chromatography (Bio-Rad NGC systems). Flow cytometry assay and panel design, execution, and data analysis for research assays and clinical tests adhering to ICCS & CLSI guidelines. Gene expression analysis by RT-qPCR, protein analysis and detection by SDS-PAGE, western blotting, and protein quantification by ELISA, BCA, and Bradford method. Bioinformatics analysis in RStudio & Galaxy e.g., RNAseq data analysis (MultiQC, STAR, Salmon, DESeq2, GO, KEGG, data visualization), Microbiome R package & QIIME2 metagenomic analysis of microbiome. Analysis and interpretation of analytical data from GC/LC-MS, ICP-MS, and Spectrometry. Developed COVID-19 Viral Transport Medium (IVD). Headed the production & scale up during the COVID-19 pandemic. Ensuring sterility of clean rooms, equipment calibration, cGMP compliance, and QMS (ALCOA+, ISO 9001:2015 & ISO 13485:2016). Statistical data analysis using GraphPad prism, Minitab, and RStudio. Collaborating with research heads from various companies and institutions. Management responsibilities including work distribution, team monitoring, training, development and evaluation of employees.
