Plant Startup Experience:Debug of recipe automation and equipment function with Process EngineeringDevelopment, Engineering, and Qualification Runs; First FDA Inspection and LicensureUtilize design documents, trending software, and batch records to find and drive solutionsValidation of all processes and equipmentQuality Inspection and GMP Release of facilities Discrepancy Management and Batch Record Review rollout Bio Process Job Duties:Use automated recipes, liquid handling systems, buffer preparation, chromatography purification, and diaflitration to produce therapeutic proteins for anti-cancer treatmentBiozone 3.1 Cleanroom EnvironmentFrontline for Engineering and Quality Management in GMP facilityRoot Cause Analysis - White Belt Six Sigma CertifiedEquipment Owner: support validation, maintenance, and calibration activitiesInventory Management (SAP) Sample Management (LIMS)Technical Writing: revise SOPs, training guides, and technical documentsCertified GMP Trainer Quality Management (TrackWise)GMP Batch Record ReviewInterviewer for contract employeesCross trained in Cell Culture ManufacturingFacility Inspection Readiness Team Lead (April, 2015 - Present):Audit facilities for Quality Compliance and Regulatory Inspection readiness Department Representative for Quality Compliance leadership level meetingsDevelop charter, recruit team members, schedule team meetingsDevelop Quality Culture and best practices through communications and trainingsKanban Program Manager: manage critical parts and supplies; implement Lean, Just-In-TimeManage department radio communication programWORKSHOP: participated in Site program overhaul with Quality and Six Sigma groups

Production of micro-arrays for genetic testing using automation and robotic instrumentation Production Scheduling: balance yields, prioritization, and QC turnaround timeInventory Management: SAP cycle counts, wasting, production managementTroubleshoot equipment; work with vendor techniciansTrainer for process, equipment, and production standardsBatch Record ReviewInstruments: Beckman-Coulter NX/FX; Automated Tooling System; Eppendorf Centrifuge

Chemical analysis of in-process, final container, and stability samples of biological medicinesGood Manufacturing Practices, Good Laboratory PracticesLab Management: materials, chemicals, equipment, 5SSample Management: documentation, audits, storage Safety and Compliance Auditor for chemical, biological, and clean-room labsLab Investigation: wrote, performed, and concluded a GMP Investigation to determine the root cause of a control failure. Worked directly with upper management in QC and QA.Kaizen culture: constant improvement of science and business practicesGMP TrainerPresentation of lab performance metrics to managementTechnical Writing: SOP revisions, InvestigationCross trained in HPLC and EmpowerInstruments:- 2-25μm particle analysis - HIAC/Royco - pH monitoring – Mettler Toledo- Moisture content – CKF Karl Fisher - SDS titration analysis – Orion - UV-vis Spectrophotometry protein analysis – ChemStation