Pratyusha Peri

Background

About Pratyusha Peri

Having inter disciplinary knowledge of biopharmaceutical Quality Assurance, cell culture,fermentation,IBs, biotechnology and various instruments.Passionate to solve complex problems in biological process development by understanding process conditions and protein engineering techniques which will lead in developing novel cancer drugs in biopharma, pharmaceutical industry and seeking a challenging position that would give research, practical experience and would contribute to the growth of the organization, carve a niche in my career. Biosimilars production(small molecules/ MAb’s) and technology transfer Worked for execution of Commercial, Engineering, R&D, Toxicology, Clinical, Process validation, Cleaning validation and IND campaigns of different commercial and new products and also for review and approval of different documents.Working for Quality Assurance Document review,deviation,CAPA,Master Formulation record,Batch procession record, Protocols, Reports,SOP,Change Control,Deviations,investigation,LMS,SAP release and approval,root cause analysis,operations management. Knowledge of softwares like, SAP, JMP, Simplify (process-pad) for process data analysis.Specialities:Document review, preparation,SOP, Change Controle,CAPA,Deviation management,MFR,BPR,BOM, development documents,DFM,DFQ, protocols,report writing,deviation.• Operation of 5L,50L and 200L Bioreactor (Sartorius, Bioengineering).• Working with media preparation, buffer preparation vessel and CIP skid, DHS, Autoclave.• Mammalian cell culture, cell separation, Harvest.• Bacterial fermentation.• Clean rooms and C-GMP, Regulatory aspects, documentation.• Bioprocess engineering and validation.Instruments: Bio-safety cabinet, laminar air flow unit,pH meter, conductivity meter, turbidity meter, osmo meter, NOVA Bio-profile, Blood Gas analyzer. Micro & ultra centrifuge, batch centrifuge, Homogenizer, Rota vapor, T-can, Spectrophotometer, Nano-Spectrophotometer.