Eric Mathieu Email & Phone Number

EXPERIENCE:*cell&gene therapy: Prod, QA, QC, Supply, engineering & it direction/management (from 10 to 220 people in 7 years) including gmp and development activities for autologous and allogenic products*Plant Facility and Operations: from design to ready to operate phases; growth management in a multi-projects facility and in CDMO environment. *cGMP and R&D environment in big pharma and in start-up companies.*running FDA approved site, starting cGMP site including audits, revamping activities and their approval to operate by authorities. *Cell culture processes : process transfer, industrialization, intensification and manufacturing. Stem cells, suspension and adherent cell lines.*Disposable and Classical bioreactors : new devices development, urs and P&ID set-up, testing and commissioning, automated operations description (FDS), component approvals.*People management (>200 people) *Project management (multi projects)*Upstream Project engineer in a brand new building for industrilaization: user representativeGOALS: Bring my expertise in small/medium companies/entities by building teams and facility, by coaching employees and starting organization from scratch. PROFILE: Efficiency and Quality System oriented. Team spirit, communication and partnership. Reliable and focused on results, very pragmatic.Specialties: cGMP (FDA audits, AFMPS certification), building/ process/ equipment commissioning, QA and manufacturing coaching, people management (hiring, day to day, ...), building and facility management (from zero and from existing situation), Large Cell Culture processes (high cell densities, stem cells),

Listed skills include Gmp, Biopharmaceuticals, Cell Culture, R&D, and 16 others.

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  Gembloux Agro-Bio Tech - Université De Liège