Mohamed BEN RAHOU

En résumé

Entreprises

• Novartis Biotechnology - Sr. Process Unit Coordinator and Scientific Expert

  2012 - maintenant  Ensure adequate allocation of human and technical resources to achieve objectives
   Coordinate, monitor, and improve production processes in conjunction with MT and other teams
   Execute the production strategy and ensure operation tactics are aligned with strategy
   Translating the long range production planning into actionable tasks and overseen the execution
   Responsible for the compliance and timely closure of quality related activities and events as well as monitoring the progress of all due activities (Trackwise)
   Provide process knowledge and support to the operations manager to increase through-put, yield and quality in a LEAN operational environment
   Provide support in the internal and/or external audits program
   Lead the Annual product review process for the process unit and ensure actions defined are implemented
   Ensure all actions defined in the Site Quality risk assessments and Site Quality plans are tracked and timely executed (actions related to own Process Unit)
   Write, review and/or approve the GMP procedures related to the department activities – ensuring robust processes through effective SOP’s (Esops)
   Support implement and maintain excellent documentation practices including cGMP change management
   Comply Environmental Protection and HSE as specified by Company Policy and relevant statutory provisions
  

• Crucell, Johnson & Johnson - Manager Process development/Pilot Plant

  2011 - 2012  Building-up, commissioning and validation of cGMP facility for the CTM production (phase I/II/III) of a viral vaccine (cell/virus culture processing, virus purification trains, media and buffer preparation)
   Line management of a high performing multinational group of 16 process engineers and technicians
   Tech-transfer & scale-up of process, optimization of processes, late stage process development
   Integration/implementation of Quality systems and EHS into the facility operations
   Management of GMP production of drug substance
   Implementation of disposable technologies into production processes
   Core team member for IND application process
   Project management, departmental and project budgeting, implementation of continuous improvement, cross departmental and cross site projects and collaborations
   Thorough knowledge of cGMP guidelines (FDA, ICH Q7,Q8,Q9, PIC/S)

• Crucell, Johnson & Johnson - DownStream Process Teamleader

  2009 - 2011  Building-up, commissioning and validation of cGMP facility for the CTM production (phase I/II/III) of a viral vaccine (cell/virus culture processing, virus purification trains, media and buffer preparation)
   Conception and qualification of equipments
   Aseptic purification process design using single-use technologies, in compliance with FDA guidelines
   Design and validation of the media/buffer production process (Single-use technology)
   Design, qualification and validation of cleaning, decontamination and sterilization equipments
   Definition of analytical tools and methodology used for process and product characterization.
   Supervision of the purification street set-up
   Supervision of the purification of feasibility batches, technical transfer batches, clinical material batches (phase I/II/III) and validation batches
   Production follow-up (ERP MOVEX and SAP implementation)
   Definition of the production, sampling and process characterization plans
   Responsible for the follow-up of IPC and release samples (LIMS)
   In charge of the production and management of media and buffer
   Responsible for the product and process quality follow-up (Trackwise)
   Preparation, implementation and review of procedures (SOP) needed for GMP compliance of the performed activities (eflow)
   Work under GMP conditions in conformity with existing procedures and Crucell’s quality standards
   Part of the process continuous improvement

• Merck-Serono - DSP SPecialist

  Lyon 2008 - 2009  HU-14.18-IL2 (immuno-cytokine) et Rebif (interferon β) scale-up and purification process implementation using single use technology
   Purification of feasibility and validation Batches of HU-14.18-IL2 and Rebif
   Production follow-up (ERP OPM)
   Responsible for the production and management of media and buffer
   Quality management (Trackwise)
   Equipments qualification (IQ, OQ, PQ)
   In charge of the cleaning process re-validation of the complete site (project Lean Six Sigma green belt)
   Preparation, implementation and review of procedures (SOP) needed for GMP compliance of the performed activities (GxP Docs)
   Work under GMP conditions in conformity with existing procedures and Merck-Serono’s quality standards
   Involvement in the process continuous improvement

• AFMB, UMR 6098, CNRS - Manager PCML (Plateforme de Criblage de Marseille Luminy)

  2006 - 2008  Set-up and optimization of the production and purification of the targeted viral proteins
   Design and optimization of automated radioactive/fluorescent screening tests for viral propagation inhibition on the different viral targets (Biomek 3000 and NX)
   Medium throughput screening of 23.000 compounds on the different viral targets, determination of "hits" compounds and follow-up of the synthesis of analogues for "hit to lead" tests
   Characterization of the interaction and affinity protein/inhibitor (Ki ; IC50 ; EC50)
   Inhibitors specificity tests set-up and follow-up
   Implementation of an ISO 9001 certification and acquisition of the label IBISA
   Management of a compound library of 50’000 compounds (20'000 from the national compounds library and 30’000 commercial compounds)

• AMGEN Inc. - Research Assistant

  2006 - 2006  Metabolic pathways analysis with measurements of the targeted kinase activity
   Screening of inhibitor compounds on the targeted kinase, pharmacokinetic and toxicology study of the selected compounds
   Inhibitors effect measurement on cells viability (21 cell lines tested)
   Quantitative analysis of the metabolites produced by the targeted kinase submitted to hypoxia/normoxia conditions
   Set-up and automatization of tests to assess the structure/activity correlation of the tested compounds

Formations

• Ecole Nationale Supérieure Ingénieurs Luminy

  Marseille 2004 - 2006 Biotech
  
  GBMA

• Universite Des Sciences Et Techniques Du Languedoc UM2

  Montpellier 2001 - 2004 Biologie moléculaire et cellulaire
  
  IUP Bioinductrie

Réseau

• Angélique LE

• Cedric ROGER

• Damien HIBLOT

• Eric DUFLOS

• Flora REY-GIRAUD

• Isabelle DESOIZE

• Nicolas MARCEAU

• Patrice MASCALCHI

• Sophie GRAVY

• Vincent ROY