Experience

AMPHASTAR FRANCE PHARMACEUTICALS

• France
• Biotechnology Research
• 1 - 100 Employee

• Superviseur des procédés de fermentation

  • Aug 2016 - Present

  Startup of new production workshops using biotechnology (Production of inclusion bodies from fermentation of E.Coli bacteria). Participation of engineering studies (conference call between suppliers and US engineering department).Conduct of validation tests and improvement production tests.Hiring and training of the new operators in several workshops of this new facility.Creation and writing of new production documentations ( batch records, ...) and new operational and structural procedures.Assessment of batch records before Quality Assurance review.Coordination with supports departments (Technical department, Quality Assurance, HSE, Metrology, ... )I received process training in China during 2 weeks (at Amphastar Nanjing Pharmaceuticals) for this facility startup. Show less

• Responsable des opérations de production

  • Dec 2014 - Aug 2016

  Manager of production department ( approximately 40 employees including workshop head, workshop lead, and operators), and IPC laboratory technician.Coordination between several departments of plant to production management (Qualtity assurance, technical department, chemical and microbiological department...). Participation in customer audits and authorities inspections (FDA, ANSM, DREAL).Completion of internal audits and supplier audits (slaughterhouses).Completion of Quality documents (CCR, CAPA, APR, DO ...).Completion of Porduction Investigation if needed (NCR). Show less



AJINOMOTO EUROLYSINE S.A.S

• France
• Biotechnology Research
• 1 - 100 Employee

• Ingénieur R&D Extraction

  • Aug 2013 - Mar 2014

  Technical manager of chemical extraction laboratory, between R&D and production department. Management of 3 laboratory technicians. Laboratory studies to production capacity increase of amino acid (Tryptophan). Participation in R&D meeting with japanese R&D manager on site (presentation of laboratory tests). Technical manager of chemical extraction laboratory, between R&D and production department. Management of 3 laboratory technicians. Laboratory studies to production capacity increase of amino acid (Tryptophan). Participation in R&D meeting with japanese R&D manager on site (presentation of laboratory tests).