Sudhir Alugupally

WORK HISTORY

EDUCATION

SKILLS

ABOUT SUDHIR ALUGUPALLY

Over 17 years of experience in IVD multiplex assay design and development, which includes BLAST search, multi target primer/probe design, sample prep with multiple clinical sample types, multiplex PCR, nested PCR and real time PCR optimization and integrating sample prep with Real Time PCR.• Over 12 years of experience in DNA amplification, detection and analysis using different PCR, qPCR, RT PCR and Digital PCR based assays.• Over 3 years of experience in technical operations supporting Manufacturing, Supply Chain and Quality teams on complex assay investigations, path-forward recommendations and providing input on procedural implementations. • Strong experience in Real Time PCR assays using TAQMAN, Scorpion and different fluorescent dye based Probes.• Worked on Design, Development, Product transfer and Validation of 3 US-IVD released products and 3 CE-IVD released products.• Comprehensive knowledge on design controls for US-IVD (510K) and CE-IVD submissions, which include performing various DIR studies, writing reports and analyzing clinical data. • Experience with JMP and Minitab statistical software for DOE setup, root-cause investigation, data analysis and setting Specifications for Manufacturing and QC.• Excellent documentation skills and experience in training Manufacturing and QC department for the product transfer following QSR guidelines and Agile doc control.• Extensive technical skills in Cloning, gene expression, 96 well protein purification, bacterial transformation, DNA gel Isolation, Primer Design etc in BSL 1/2 lab setting.• Worked with third party vendors (Zeptometrix, MMQCI) to develop control materials for Manufacturing and QC purpose. • Excellent demonstrational skills for problem-solving and data analysis.• Great leadership skills in guiding Research Associates and working along cross functional teams.