Biotechnology Process Expert
Since February 2015
Apply KPIs, Six Sigma principles and data mining tools in the context of process optimization initiatives. Facilitate continuous improvement projects on biotechnology process . Bring biotechnology and process expertise as Subject Matter Expert: Change Control, risk analysis, deviation, CAPA. Guarantor of the process and Project Leader. Scientific monitoring and technology surveillance.
Biotechnology & Operational Excellence Consultant
November 2013 --- December 2014
Analyse, design, development and implementation of operational processes. Identify and develop most effective methods of increasing productivity through methods of business organization and technology. Optimize processes to enhance quality, decrease waste and rework, reduce bottlenecks, improve process timing, increase output, ensure workplace safety, and reduce expenses Responsible for project management including work plan development, Gantt chart creation, critical path determination, and issue identification and resolution. Application of engineering techniques including flowcharting, simulation, statistical process control, operations research, benchmarking, time study, regression analysis, as well as Six Sigma and Lean methods. Provide on-going operational, engineering and management support and expertise. Facilitation of teams, data analysis communication and presentation, project status, recommendations, and results.
Manufacturing Area Manager
April 2013 --- October 2013
Lead a team of 50people and organize a workshop to achieve pharmaceutical production programs within the defined schedule, taking into account the priorities and technical issues that may arise Documentation Management and monitoring. Ensure the implementation of assigned activities Coordinate and plan the use of technical and human resources Maintain a high level of productivity to produce products that meet the criteria of quality and cost Communication and coordination with customer services or suppliers. Analyse and solve problems. Implement actions in compliance with HSE and GMP Continuous improvement through projects, working groups ensuring the follow-up of implemented actions.
Operations Support - Black Belt -
February 2012 --- July 2012
Six Sigma Black Belt specialized on DMAIC approach. Coach an international and multidisciplinary team through objectives, data culture and Six Sigma project management. Apply mathematical tools to determine manufacturing performance. Evaluate and report results to management. Improvement of innovative industrial biotechnology process. Solve production problems, minimize cost, maximize gains and process reliability. Introduce Data culture and Lean philosophy.
Bioprocess Engineer - Cell banking
October 2010 --- March 2011
Implement cell bank for preclinical batch production. Knowledge of cGMP practices, regulatory, Project management. Validate, optimize and develop process on mammalian cells. USP, DSP
February 2010 --- October 2010
Implement the IPC from the injectable plant. Analytical research. Microbiological Control of pharmaceuticals and hospital preparations.
September 2009 --- February 2010
Publication and organization of the conference: «Promises and abuses of genetic tests» («Promesses et dérives des tests génétiques»)
Scolarité in from Liceo Franco Mexicano in 2003
Expert en ingénierie des biotechnologies in Bioprocédés from Sup'Biotech in 0
Expert en Ingénierie des Biotechnologies in Production et Santé from Sup'Biotech in 0