Medical Manufacturing
Resume:
Clint Bender
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***********@****.***
Profile
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Professional biologist with proven performance in sample analysis, instrumentation, regulatory compliance, and reporting.
Career Related Skills
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Aseptic technique, cell culturing, gram staining, endotoxin (LAL) validation, soil/ water/ air sampling, weighing/ measuring, pipetting, SOP writing and revision, environmental monitoring, distillation, titration, electrophoresis
Career Summary
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Dendreon May 2011 to Nov 2011 Union City, GA
Cellular Manufacturing Associate- Transforming lives through the autologous treatment of prostate cancer.
• Aseptic separation and culturing of clinical and commercial human derived white blood cells in a clean-room environment for the treatment of prostate cancer.
• Adhere to strict time lines to maintain cell viability.
• Weigh, measure, and check raw materials to ensure batches manufactured contain proper ingredients and quantities.
• Maintain records and clean room environment to comply with regulatory requirements, cGMP, and aseptic processing of clinical and commercial products.
• Provide general upkeep of the clean-room and equipment in manufacturing areas to maintain necessary certifications.
• Review batch records to ensure proper regulatory compliance.
• Chosen to be a member of the influential clinical trial manufacturing team.
WuXi AppTec Oct 2007 to May 2011 Marietta, GA
Lab Technician II- Ensuring the sterility of biopharmaceuticals and medical devices.
• Sterility validation testing on medical devices, pharmaceuticals, combination products, and biological materials (blood, tissue, bone, stem cells) to assess the absence of viable microorganisms.
• Schedule testing for the lab to maximize daily output and adhere to strict turnaround time.
• Execute advanced aseptic testing to meet the need of individual clients.
• Adhere to all cGMP/cGLP, FDA, ISO, OSHA, USP, and AAMI guidelines and regulations to assure proper compliance.
• Critical contract review of all incoming tests for potential discrepancies.
• Write and revise current SOPs to streamline procedures and insure lab safety.
• Provide daily scheduling for media preparation department to meet the needs of the sterility department.
• Train new technicians on testing techniques and aseptic behavior.
• Restructured lab layout to maximize work flow.
• Reduced overhead through testing revisions resulting in less media consumption.
Computer Skills________________________________________
Microsoft Word, Excel, PowerPoint, Outlook, Internet Explorer, LIMS, Oracle
Education________________________________________Georgia College & State University, May 2006
Milledgeville, GA
Bachelor of Science
Major: Biology
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