Vinayak is an expert business and science manager with core competence in Quality and analytical science. He has independently established regulated laboratories from design to production both in GLP and GMP environment. His expertise spans across fields in pharmaceuticals, clinical diagnostics and drug discovery, food, nutraceuticals,biologics as well as API manufacturing. Excellent knowledge of regulatory guidelines like FDA, ICH, CLIA , GxP, ISO15189, ISO17025, ISO13485, ISO22000 , ISO9001 and process efficincy tools like QbD ,5S and Six Sigma. Expertise in Singapore MOH, HSA guidelines for testing laboratories and other Singapore laboratory licencing requirement. Capable of managing laboratory accredited under SPRING Singapore as well as other international agencies. Excellent communication , presentation skills. Knowledge of project management and Grant Writing. Highly instrument savvy person with expert troubleshooting skills and maintenance of sophisticated instrumentation.Specialties: Domain knowledge: Drug discovery, biotransformation, clinical testing, CMC, Bioanalysis,pharma ,food and nutraceutical analysis,Proteomics, BiomarkerInstrumentation: LCMS, HPLC, NMR etcManagement and QA: GMP, GLP , Safety, Project and Laboratory managementSoftware: Statistical analysis tools (SPSS,Minitab, prism,Matlab) , pagination and creativity tools (photoshop,corel draw, pagemaker) , Chemo informatics tools (chemoffice,chemdraw,spotfire,scifinder) office tools