Julien BAZIN

MANUFACTURING TECHNOLOGY

Motivated and lead a team of 21 lab technicians, 2 assistant managers and 1 administrative assistant :
# Team management : objectives definition, skills follow-up, training plan development, individual interview …
# Assays and human resources forward planning, operational Assays follow-up
# Scientist, technological and methodological aids

In charge of fermentation and purification laboratories (pilot scale – level 3 protection) :
# Activity functioning (interface with 16 internal customers, quality system, HSE …)
# Facilities optimisation (maintenance, qualification and education)

INDUSTRIALIZATION OF BIOLOGICAL RAW MATERIALS

Implementation of recombinant protein manufacturing activity (fermentation and purification) :
# 350 000 € of investment, Conditions of the contract writing, Equipment delivery and installation
# IQ / OQ / PQ participation and metrology strategy implementation
# Collect of documentation, organisation and planning of the activity, Technicians education
# Technological development and issue resolution – Supplier contact

Conducted and managed transfer and industrialization process of R&D projects to Manufacturing :
# Managed and conducted 6 “raw material” transfer projects (from R&D to Manufacturing)
# Ability with Microsoft Project and Microsoft Office tools
# Project and process risk analysis, Process industrialization plans elaboration (scale-up)
# Strong interface with others departments : R&D, Manufacturing, Quality, Marketing, Affairs Regulatory …
# Represent biological raw materials in project team

DEVELOPMENT - BACTERIAL FERMENTATION

Clarification of vaccine process production by fermentation (pathogenic and recombinant bacteria):

# Work in GMP, BPF, ISO 9001 and ISO 14 001 conditions / Work in a level 3 protection laboratory
# Conduct of 1 to 1000 liters fermenter (batch or fed-batch culture)
# Harvest method : clarification, cell lysis, Cross flow filtration, continuous centrifugation
# Protein purification : precipitation and chromatography techniques
# Protein characterization : gel electrophoresis, western blot, enzymatic or spectroscopy analysis