Ravindra More

Background

About Ravindra More

26+ years’ in-depth and sound experience / expertise in bioprocess development / bioprocessing (from conception to commercialization) in R&D as well as Manufacturing (Drug Substance / API and Drug Product) of Biopharmaceutical / Biosimilar / Biological / Biotechnology Products like recombinant proteins, PEGylated proteins, fusion proteins, monoclonal antibodies, & plasma-derived proteins produced by Microbial Cells / Mammalian Cell Lines / Yeast Cells / Natural Sources. Core Competencies / Expertise: Leading organization comprising of all departments / functions as Plant Head. Biopharmaceuticals / Biosimilars Commercial / Clinical Manufacturing Operations (cGMP / Cleanroom environment) Bioprocess development (downstream, upstream, formulation, analytical, fill and finish, lyophilization, packaging. distribution etc.) Process and Technology transfer Bioprocess scale up / scale down Process characterization and Process improvement Process validation and Cleaning validation Protein / Peptide analysis by different analytical techniques Efficient use of available resources, improving manufacturing efficiency, & cost reduction without compromising Quality Quality Management System (QMS) Start-up plan and execution: Greenfield / Brownfield / Orangefield projects, designing and set up of GMP Facility, Warehouse, R&D, QC (designing / renovation / expansion / commissioning) for the biopharmaceutical manufacturing. Various audits like CDSCO, USFDA, EMA, Health Canada, Brazil ANVISA, Indonesia BPOM, South Korea MFDS, Australia TGA, Saudi FDA, HSA Singapore, Client / Customer Audits etc. handled. Sound knowledge of various functions like QA, QC, RA, Purchase, Stores, Warehouse, SCM, BD, Finance etc. Writing / Reviewing / Approving various documents like SOPs, Protocols, SOPs, MFRs, BPRs/BMRs, Concept notes, Reports / Summaries, Deviations, OOS, OOT, Change controls, CAPAs etc.