Primary role is to support the technology-transfer of client and internal projects; developmental, clinical, commercial biopharm productsWork hands-on at the lab, pilot, and large scale to perform downstream purification of proteins from various biologic sources Experienced with set-up and operation of liquid bioprocessing techniques such as centrifugation, depth filtration, column chromatography, viral inactivation, tangential flow filtrationProvide support with validation/qualification of new equipment and processesDevelop and follow approved SOPs, work orders, batch production records used in commercial production. Act as trainer and process expertDeep understanding, experience with support systems used in biomanufacturing; CIP/SIP systems, solution/buffer formulation, filter integrity testing, aseptic filling, packagingAdhere to client specifications, cGMP principles and regulatory requirements, report deviations/OOS' promptly and objectivelyMaintain sanitation requirements in production clean-rooms JHSC Certified Management Rep

Worked with the analytical group preparing samples for analysis with Optical Emission Spectroscopy or Mass Spectrometry using chemical techniquesPerforming analysis using ICP-OES, often achieving accurate results for 200 samples daily.Daily maintenance, cleaning, and optimizations of the instrumentWorked with the operations group to conduct mini-plant campaigns. Involved with construction, modification, and maintenance of systems in preparation for campaignsOperating assigned equipment, filling batch documents, in-process sampling and logging using LIMSProcessing, neutralizing, and disposing of waste campaign products per environmental regulationWorked with the Occupational Health and Safety department to implement and carry out a safety assessment program for fume hoodsResearched other fume hood safety programs from industry and academia; provided advice on current practiceCarried out inspections, prepared report, documents, and revised floor plans using research material and compiled dataCarried out noise survey in two facilities