Description
Professional Summary I have over ten years of experience in the Biotech industry in both Research and Development and Quality Control). Accomplishments/Skills Technical experiences skills including: * Protein purification using anion exchange, affinity, HIC and SEC as well as HPLC. * Operation of an Agilent and Water's HPLC * Operation of the GE AKTA and Bio-Rad NGC FPLC systems * Cloning and expressing proteins in E. coli. * Optimizing the growth conditions, temperature and media/supplements, for optimal protein expression. * Operate 200L New Brunswick fermenter. * Experience growing mesophilic and thermophilic Bacteria as well as yeast. * Ten years of mammalian tissue culture experience. * Experience with generating and purifying polyclonal and monoclonal antibodies * Experience in both end point, qPCR and multiplex PCR * Experience performing ELISA assays * Experienced in enzyme assays using by radioisotope and fluorescent assays. Operations skills include: * Experience with both internal and external customers to customize product and provide a customized formulations. * Experience with 4th Shift and JD Edward MRP systems. * Writing SOPs, Batch Records and validation protocols. * Experience performing both product, process and equipment validations * Working understanding of ISO 13485 and FDA * Experience in Product development and Process Development. * Trained and experienced with reviewing and implementing product and process Change Control per the corporate quality procedure. * Implemented Lean and 5S manufacturing. * Experience with process improvement and scale up. * Microsoft Office Suite, Outlook, Word, Excel Access PowerPoint and MS Project.
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